Archive for the ‘Hormone Physician’ Category

Mikel Kelly: There's a lot going on in the world, but at the end of the day, nothing means 'as much as my own health'

On Monday, June 15, I celebrated the 20th anniversary of the day I was told by a physician's assistant at Kaiser Permanente, following a biopsy conducted by that very same man (at Mother Joseph Plaza annex, next door to St. Vincent Hospital), that I had tested positive in five out of six samples taken for prostate cancer.

It was June 15, 2000, and even though it seemed like every other famous man over 50 was announcing to the world that they had this same brand of cancer, it completely floored me. I was 52 and otherwise very healthy.

It was almost embarrassing how little I knew about this disease, but because I had to sort through the various "treatments" (which included, oddly enough, doing nothing) I quickly learned a whole lot about it.

First of all, I discovered I was lucky. Of all the kinds of cancer out there, prostate cancer is one of the most common but even more important, one of the slowest moving. People who contracted breast cancer, pancreatic cancer, esophageal cancer and others soon learned that time is of the essence, and in most cases, the earlier discovered the better.

My most immediate challenge was to learn as much about the disease as possible and then choose the kind of attack I was going to employ.

My cousin Dennis, in Seattle, was a few months ahead of me in his own fight with the disease, and he quickly rounded up a huge bundle of magazine articles, medical reports and journals on the subject and sent them to me. He had chosen the therapy in which they plant a number of radioactive seeds in the walnut-size organ.

There was also a lot of support for the "normal" radiation treatment, where they blast you down there in the groinal region with the invisible rays 35 times every week day for seven weeks (more about this approach later).

The do-nothing option was never appealing to me. Maybe if I was 75 or 80 at the time, I'd consider it because they say it's such a slow-growing cancer it's not that hard to outlive it. Usually, the medical folks tell you, you'll die of something else entirely.

No, I selected what they called "the gold standard" the surgery where they cut a hole in you (eerily similar to the slice one makes when cleaning a trout) and remove the whole enchilada. My own surgery was of the "nerve sparing" variety, meaning the doctor I settled on, Chris Mershon, would as delicately as possible try to extract the prostate from the web of nerves surrounding it which, in turn might allow me to retain sexual function, no small item to a 52-year-old fellow. It was a success, I was told, and I was further advised that I came through it with good margins.

But (you knew there would be a "but" didn't you?), almost exactly five years later, my PSA (the prostate specific antigen, the number all prostate cancer sufferers live and die by) began to rise again.

Unfortunately, at exactly that moment in time, the company I worked for announced that it would no longer include Kaiser Permanente in the insurance choices we were offered -- so, with the help of my doctor, I picked a new physician to handle my care, a Legacy urologist, Dr. Bruce Lowe, and together we sorted out the options and settled on radiation therapy as my next adventure.

Unlike the prostatectomy I underwent back in 2000, the radiation is the treatment that really kicked my butt. Though the actual treatment, in the opening weeks of 2006, went smoothly enough, the after-effects in subsequent years were significant. As time went by, I lost all sexual function, and have had a continual battle with urinary incontinence. Then, this February I was subjected to an even more serious indignity that no one had ever mentioned up to then: blood clots in the bladder that had me climbing the walls of the Good Samaritan ER until they finally poked a drain in me to take the pressure off. Apparently, this blood clotting thing is not uncommon in cases where radiation has been used.

So, while everybody else was staying home and staying safe, I was making numerous and repeated visits to see health professionals, my urologist in Portland, the surgeon in Seattle who installed an artificial sphincter in me two years ago to control my peeing (which was damaged during my ER adventure and no longer was working) AND my brand new medical oncologist (Dr. Julie Graff and her team) at the OHSU Knight Cancer Center, where I began a new round of treatment because my PSA had decided to swing back up again.

This latest attack on my cancer is a ferocious brand of hormone treatment, called androgen deprivation therapy in which I get a shot in the belly fat every three months, along with a fairly aggressive "oral chemo" that involves me taking a couple of horse pills every day exactly two hours after breakfast and at least an hour before lunch. The side effects of this round of treatment is significant, though not yet intolerable. They mostly consist of fierce hot flashes about every hour, along with a tendency to poop out quickly during uphill walks.

So, this is why I'm kind of losing touch with all that's going on out there in the real world the COVID-19 pandemic, the Black Lives Matter protests going on in pretty much every community of any size, the financial tailspin that everybody but the very wealthiest in our nation is in and the utter lack of leadership from the White House.

All of those things worry me a lot. Not as much as my own health, maybe, but still a lot.

Stay safe out there. And if you're a guy and there's any history of prostate cancer in your family, get it checked. If you do, you might be lucky enough to hang around a few more years, like me.

Mikel Kelly, a former editor with Pamplin Media Group, retired from Community Newspapers a little over four years ago. He no longer chases fire trucks and police sirens, but he does have a tendency to send in these "observations" to us.

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Opinion: This month my cancer turned 20, but I am still standing - Pamplin Media Group

You open your microwave and discover a cup of coffee you reheatedyesterday. Names escape you. And wherefor the 1,000th timedid you leave those dang AirPods? It's normal to be forgetful every once in a while, but if you find yourself battling multiple brain farts daily, it may be time to dig deeper to uncover the cause. Don't panic: Chronic forgetfulness doesn't always mean Alzheimer's disease. In fact, there are a whole host of reasons your memory might be stalling. Find out if one of these could be causing your brain drain.

1You're taking a medication that has memory side effects.

"If you're concerned with your memory, one of the first things to do is to review your medication list with your physician," says Lauren Drag, Ph.D., a neuropsychologist at Stanford Health Care. Several prescription and OTC drugs can mess with your memory, she notes. Topping that list are anticholinergics, which are drugs that interfere with a neurotransmitter in your brain called acetylcholine. Antihistamines like Benadryl, reflux drugs like Zantac, muscle spasms treatments like Flexiril, and depression drugs like Paxil and Elavil are all considered anticholinergics. Other medications to watch for include certain blood pressure drugs, sedatives like Valium, and some pain medications. If you suspect your treatment is to blame for your memory blips, ask your doctor if there's an alternative worth considering.

2You're struggling with depression.

When you're in a mental funk, it's hard to focus on what's in front of youwhich makes recalling it later virtually impossible. Depression may actually reshape certain parts of your brain, says Drag. "Research suggests that it can be associated with changes in the size and functioning of brain regions that are important to skills such as memory, the speed at which we think, attention, and problem-solving ability."

3You're drinking too much.

You know booze muddles your mind while you're drinking, but it can also make heavy drinkers forgetful after they've dried out. "Interestingly, research has shown that sobriety can lead to a temporary worsening in memory and thinking, as you go through a detox period," says Drag. Some peoplemainly life-long alcohol abusersmight never get their sharpness back. But most people can expect the fog of forgetfulness to eventually lift, says Drag, though it can take anywhere from weeks to months.

RELATED: Are you drinking too much in quarantine?

4Your tension level is through the roof.

Stress distracts your brain when it should be memorizing information. That's why a phone number you've just been told can escape you before you even have time to pull the phone out of your pocket and dial.In the short-term, "someone who is feeling anxious can have difficulty following a conversation because he or she is ruminating over a worrisome topic," says Drag. And chronic, severe stress is even worse. "It can have a significant impact on the brain, presumably through long-term exposure to hormones that are released during periods of stress," she explains. Even the everyday hassle of managing household bills and busy schedules can chip away at your memory skills. "Juggling multiple tasks at once, staying up late to finish tasks, not exercising and not eating wellall of these factors can increase forgetfulness," says Drag.

5You have a chronic or undiagnosed health issue.

Any ailment that affects your brain's blood supplylike diabetes, high blood pressure, or high cholesterolcan cause mental blocks. "A variety of health conditions, such as hypothyroidism, vitamin deficiencies, and hormone imbalances can also cause memory problems," says Drag. "In older adults in particular, urinary tract infections can cause sudden and temporary confusion." She recommends checking with your primary care physician for a physical to rule out these common causes and ensure there's nothing to worry about. In some cases, a simple vitamin supplement will help restore your brainpower.

6You're just plain exhausted.

Just because you're logging 8 (or more) hours under the covers doesn't mean you're getting good quality rest. Research has shown that people who spend less time in deep sleep have more trouble with memory. The good news? Sometimes all it takes is a quick power napeven if you snooze for as little as 6 minutesto give your brain a boost. If you're feeling abnormally tired despite your siestas, get a thorough checkup. "Sleep apnea, for example, can deprive the brain of oxygen and lead to changes in the blood supply to the brain which over time can negatively impact memory and thinking abilities," says Drag.

RELATED: 11 Best Multivitamins for Women in 2020

7You're just getting older.

As you age, your brain might show signs of wear and tearjust as your skin gets more wrinkled and your joints become creakier. Alzheimer's becomes much more likely after 65, but mild forgetfulness is even more common. So don't instantly freak out if you find yourself struggling to learn new skills, or to think of the word you want to use in a sentence. "The most common complaints I see from older adults are that they have difficulty coming up with words and walk into a room and forget why they are there," says Drag. "These lapses can certainly be normal."

How do you know if your forgetfulness has moved past what's normal? If your memory lapses start impacting your daily life, it's worth getting checked out. "An isolated incident of missing an exit or turning the wrong way when driving a new route isn't unusual," says Drag, "But if you're frequently getting lost while driving, particularly in familiar locations, talk with your doctor." In the meantime, exercising, making smart food choices, and surrounding yourself with a strong support network may help you stay sharper longer.

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7 Commons Reasons for Forgetfulness That Have Nothing to Do With Alzheimer's - Prevention.com

If you're looking for a more consistent sleep aid that helps you fall asleep and stay asleep, family medicine physician Robert Rountree, M.D., says magnesium is the way to go: "Melatonin does one thing very well, which is to provide a specific signal to the brain that it is time to initiate the sleep process. It isn't so great for maintaining sleep," he tells mbg.*"Magnesium helps to calm down the central nervous system, which helps to prepare the brain to turn off and also to keep it functioning at a calmer level throughout the night.*" Since magnesium is a mineral and not a hormone, there's less concern over taking it every day, though you should always talk to your doctor before introducing a new supplement into your routine.

This ability to promote a longer-lasting state of relaxation is why mindbodygreen chose magnesium as the workhorse of our new sleep supplement, magnesium+. We worked with Rountree on the formulation, which includes 120 mg of magnesium glycinate as well as other sleep promoters like jujube and pharmaGABA, to help you fall asleep faster, stay asleep longer, and wake up feeling refreshed.*

See the article here:
Melatonin vs. Magnesium: The Difference Between The Sleep Aids, Explained - mindbodygreen.com

The novel coronavirus has added a lot of terms to our collective vocabulary. The latest is antigens, and though these proteins may sound similar to antibodies and both will be key to test as doctors learn more about COVID-19 they actually play very different roles in the body and the course of the disease. POPSUGAR asked experts for a quick breakdown of these two terms and what they mean for the strategy moving forward.

Contrary to what it might sound like, antibodies actually protect your body! Your immune system produces these little Y-shaped proteins to defend you against invader cells (pathogens). "An antibody is the immunoglobulin (protein) produced by the immune system," Habib Sadeghi, DO, a physician and integrative medicine specialist in Los Angeles, told POPSUGAR.

Fun fact: antibodies are produced by certain lymphocytes. A doctor can check your antibody levels in your blood. For COVID-19, "doctors look for two kinds of antibodies to SARS CoV-2 to determine exposure: IgM antibodies that develop early in an infection and IgG antibodies that appear after levels start to drop about four weeks in," said Dr. Sadeghi. The latter would in theory allow you to develop some level of long-term immunity, but experts still aren't sure if that's the case.

Antigens are not produced by the body. "An antigen is any substance that induces a response from the immune system," Dr. Sadeghi explained. This can range from a toxin to simply a foreign substance. Remember the pathogens we just mentioned? Those invader cells? Antigens are part of pathogens the part that triggers the antibodies to spring into action.

From there, "an antibody is capable of binding with the antigen and neutralizing it," Dr. Sadeghi said. This is typically how your body fights off an infection.

Antigen tests are the latest offering in the fight against COVID-19, designed to help manage the large number of tests needed to detect active cases. Antigen testing is cheaper than nasal swab testing, and blood results come back faster.

"The antigen test looks for actual pieces of protein of the virus itself, where the antibody test looks for evidence of a person's immune system response to being infected," William Kimbrough, MD, of One Medical, told POPSUGAR. "This means that the antigen test is identifying people with active infections (similar to what the more broadly available PCR swabs do), where the antibody tests look for people who have been previously infected."

Your doctor can help you determine which test is right for you. Just remember: a positive result on the antibody test does not necessarily mean you have immunity, so please, keep social distancing and following CDC guidelines until there's a safe and effective vaccine.

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Confused About Antigen Testing For COVID-19? Here's How It Differs From Antibody Testing - POPSUGAR

A five-bedroom, two-bathroom house in Queensland,

Australia, is currently on the market for just under

$600,000, but theres a reason why its so cheap.

According to the real estate listing

posted by PRD Real Estate, the house

which is just a few minutes from the

beach is experiencing subsidence.

Translation? Its sinking.

In an interviewwith realestate.com.au,

marketing agent Danny ODonnell said that he

was surprised by how many people were interested

in the beach house despite the subsidence.

I spent four days straight answering calls. Each

time I hung up, I had seven new voice messages.

By Saturday morning Id had over 100 text messages

and phone calls and 58 emails. It was crazy.

When ODonnell hosted an open house

for the literal sinking ship, he was

shocked to find more than 200 people

lined up to tour the property.

Within days, PRD Real Estate had

offers that ranged from $550,000 to

$675,000, well above the asking price.

The owners of the house ended up accepting

a cash offer from a local buyer for $647,000

More here:
This 5-bedroom house is deeply discounted but there's a catch - Yahoo Lifestyle

The killing of George Floyd, a Black man who died as a Minneapolis police officer knelt on his neck, has triggered a global conversation about racism, anti-racism, racial bias, police brutality, how non-Black people understand their privilege, and how to be an effective and genuine ally.

But for many interracial couples, conversations about race and privilege have always been part of their lives.

Insider spoke to two couples in interracial relationships on how they met, fell in love, and how race has influenced the way they navigate the world together.

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Chelsie, 30, and Bedford, 35, told Insider they didn't think much about race when they first started dating. While Bedford is Black and of Haitian descent and Chelsie is white, they both grew up in Utah which is 90.7% white, and both come from a Christian background. Bedford said that might have influenced their conversation on race as a couple. The only big question on Chelsie's mind when they first met was how Bedford would react to her having a son, which had been a dealbreaker with other dates.

"A little after we had started dating that someone had made a comment to me a little along the lines of 'Well, your kids will never look like you,'" Chelsie told Insider.

"I was like 'Isn't that crazy?' and he was like 'That's actually not crazy. I've had quite a few people break up with me for that reason. Just because their kids will never have blonde hair and blue eyes, their genetics don't necessarily shine through in that way.'"

Since getting married in 2014, they've had three more kids, and now work together as content creators.

We were all meeting at a restaurant and I got pulled over about a block from the restaurant, my family's there, her family's there, we were all together for a birthday.

Because I know that, more often than not, police officers are scared when they pull people over, and some of them are scared of me. So coming in and my wife wanting to fight, scream, yell, be emotional, I'm like "No, this is going to be a whole lot worse if we don't keep our heads."

Bedford: The riots are happening, and we're aware of it. It's disappointing that the riots are happening, but only because riots occur only when people aren't being heard. I understand people are frustrated with things being broken, but at the end of the day, it's been hundreds of years of a demographic, of a group of people who have not been heard.

We had a conversation and she said "Are you scared?" and I'm not anymore scared than I've ever been and I think that was kinda a turning point for her when she realized "this is the unsettledness that you feel all the time, this is how you feel."

Chelsie: I told Bedford, "My fear with the riots is it just makes the police more afraid of you." Because we were talking one time and Bedford said, "You know, it's hard as a police officer in this situation if someone's walking towards you, how much time do you give them to find out what their intentions are?" And that's what's scary for me because I was like, "Well, you have good intentions."

Bree Koegel, 31, met CJ, 35, her now-husband and soon-to-be father of their first child, through their work as fitness models for Wilhelmina.

"This isn't the first interracial relationship I've been, and Bree had known that," CJ said. "I think between her and I, there was this lack of us going into some of those deep conversations because I think we both automatically felt we stood on the same principles."

I look at it from my perspective and said, "Well, if I have things I need to unlearn, better believe the people above me in my family have things that they need to unwind too because they've gone through a lot of stuff in this world too."

I've watched after my conversations and how I saw certain things being handled. It's simple things that I saw like getting into my dad's car on the way to the store and when he turns the car on, it was on a station of a history channel based off of learning about the inequalities of the Black community.

It's difficult to look at your family and see things that you know need to be changed. There's some people in my family who didn't go to my sister's wedding based off of the fact that they didn't want her to marry a Black guy.

Bree: He was like, "I don't know why this is just hitting me different. I know that this happens, and I know that we've seen injustice caught on film before, but this feels different."

Then to see George Floyd days later, and the whole world's reaction, all of a sudden it didn't feel taboo or aggressive to post about it. It was like, "Oh no, you know what? This isn't just a problem inside our relationship to address, this is a problem the world needs to address. If we can expose our conversation to the world, and help them move this along, then by all means with these, our platform to do so."

I think these conversations with me now being empowered and me now, not really giving a cr-p about offending somebody, it's going to change the way that we engage in this world, for the better. And it's going change the way we engage as parents for the better. As scary as everything has been, I'm excited for the revolution, because of what it means for our child.

Some public health experts support protests in spite of the coronavirus risks: 'White supremacy is a lethal public health issue'

A mother and daughter who just graduated from the same medical school are starting their careers as doctors at the same institution

Continued here:
Interracial couples on how they're talking about race, love, and Black Lives Matter: 'The conversation took a - Business Insider India

Logo of World Anti-Doping Agency. (Photo Credit: Getty Images)

The battle against the coronavirus pandemic has been a long drawn out one, with the end not really in sight. However, there was positive news in the fight when new data from the UK-led clinical trial known as RECOVERY showed that giving low doses of the generic steroid drug dexamethasone to patients reduced death rates by around a third among those with the most severe cases of infection.

The results, which are being described as a major breakthrough, has caused study authors to suggest that the drug should immediately become the standard medicine being prescribed for patients who are being treated in hospitals for the pandemic.

However, the steroid Dexamethasone is banned by the World Anti-doping Agency, a ruling which earlier in the year caused serious headaches to India's javelin thrower Davinder Singh Kang who failed a dope test for the said steroid.

According to the WADA rules on their website, "All glucocorticoids are prohibited when administered by oral, intravenous, intramuscular or rectal routes."

The list of the banned glucocorticoids includes:

Betamethasone

Budesonide

Cortisone

Deflazacort

Dexamethasone

Fluticasone

Hydrocortisone

Methylprednisolone

Prednisolone

Prednisone

Triamcinolone

The Asian Games bronze medal-winning javelin thrower Davinder Singh Kang had claimed that the root cause was a sore throat and is confident of being cleared in the disciplinary hearing.

I had severe sore throat and before Indian GP 5 last year, I consulted a private physician in Patiala after taking permission from team management. The doctor gave me two medicines Moxitas 500 and beta dexamethasone. The dope test result is because of this medicine, Kang was quoted as saying by PTI.

I also declared these two medicines in the dope sample collection form when people from Nada took the samples. I have not gained any advantage in my performance from these medicines. So, there is no fault on my part. I will explain this to the Nada and I hope I should be cleared of this doping charge, the 31-year-old had said.

Dexamethasone is a low-cost steroid and is available widely, including in India. It is known to be used to treat inflammations and conditions such as arthritis, blood disorders, lupus, allergic reactions and skin conditions. India has not officially recommended its use so far.

Also Read: Another Delay for Olympics Should be Considered, Says Tokyo 2020 Board Member

Dexamethasone, which has been used since the early 1960s to treat a wide range of conditions such as rheumatoid arthritis and asthma, is a prescription medication that is available as an oral tablet, oral solution, eye drops, and eardrops.

The oral tablet is used to treat conditions that cause inflammation, conditions related to immune system activity and hormone deficiency. It belongs to a class of drugs called steroids.

It is a low-cost steroid and is available widely, including in India. It is known to be used to treat inflammations and conditions such as arthritis, blood disorders, lupus, allergic reactions and skin conditions. India has not officially recommended its use so far.

https://pubstack.nw18.com/pubsync/fallback/api/videos/recommended?source=n18english&channels=5d95e6c378c2f2492e2148a2&categories=5d95e6d7340a9e4981b2e102&query=anti+doping+laws%2Ccoronavirus%2Ccoronavirus+medicine%2Ccoronavirus+pandemic%2CDavinder+Singh+Kang&publish_min=2020-06-13T21:45:00.000Z&publish_max=2020-06-16T21:45:00.000Z&sort_by=date-relevance&order_by=0&limit=2

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Steroid Dexamethasone That Could be a Life-saver Against Covid-19 is Prohibited by WADA - News18

Abemaciclib (Verzenio) in combination with fulvestrant and trastuzumab (Herceptin) demonstrated significant improvement in progression-free survival (PFS) and tolerable safety compared with standard of care chemotherapy combined with trastuzumab in patients with hormone receptor (HR)-positive, HER2-positive advanced breast cancer, according to published results from the monarcHER trial (NCT02675231).

Patients in the study were randomized 1:1:1 depending on the number of prior systemic regimens and their disease status. Patients in group A received abemaciclib, trastuzumab, and fulvestrant. In group B, patients received abemaciclib plus trastuzumab. In group C, patients received chemotherapy of the physicians choice plus trastuzumab.

Baseline screening showed that the median age for groups A, B, and C was 55 years (range 47-61 years, 54 years (range, 47-62 years), and 57 (range, 47-62 years), respectively. The majority of patients across the treatment arms were European (n = 111), but there were also 38 patients from Asia, 61 from North America, and 27 from South America.

Disease characteristics were sorted by metastatic site and measurable disease status. The most common site of metastasis in the study was visceral, which was the case for 73% of group A, 71% of group B, and 61% of group C. Respectively, 89%, 86%, and 87% of these patients had measurable disease.

In terms of prior systemic therapy, most patients had 3 or more. Overall, 80% of group A, 76% of group B, and 76% of group C had prior endocrine therapy. In addition, 97% of patients in group A, 96% in group B, and 100% in group C received prior trastuzumab.

In total, 78 from group A, 77 from group B, and 72 from group C received at least 1 dose of treatment during the study. However, at data cutoff, only 20% of the patients in group A remained on the study (n = 16), 11% in group B (n = 9), and 15% in group C (n = 10). Most patients discontinued treatment due to progressive disease, including 51 patients in group A, 58 in group B, and 62 in group C. Additionally, there were 11 deaths across the 3 study arms, and 4 treatment withdrawals based on physicians decision.

In the intention-to-treat population, there were 169 PFS events at the time of data cutoff. Of the PFS events, 56 (33%) occurred in group A, 61 (36%) in group B, and 52 (31%) in group C. At a median follow-up of 19.0 months (interquartile range [IQR], 14.7-25.1 months), the median PFS was 8.3 months (95% CI, 5.9-12.6) in group A compared with 5.7 months (range, 5.4-7.0 months) in group C (HR 0.67; 95% CI, 0.45-1.00;P=.051). PFS in the subgroup analysis of prior systemic treatment was consistent with the overall analysis.

Overall survival data have not yet matured in this study and will be reported at a later date.

In terms of response, group A was superior to group C in the overall analysis and the post-hoc analysis, which evaluated response based on disease status.

To our knowledge, this trial is the first randomized study to report positive results for a CDK4 and CDK6 inhibitor in combination with fulvestrant and trastuzumab versus standard-of-care chemotherapy and trastuzumab. The endocrine combination of abemaciclib plus fulvestrant and trastuzumab showed significant improvements in both progression-free survival and overall response compared with chemotherapy plus trastuzumab and was generally well-tolerated, wrote Sarah M. Tolaney et al. The current study is noteworthy as it directly compared an

the endocrine-based regimen with standard-of-care chemotherapy in combination with trastuzumab, potentially offering a chemotherapy sparing treatment option.

There were multiple post-hoc analyses in monarcHER. First, the patients were assessed according to Blinded Independent Central Review in a post-hoc exploratory analysis. The assessment showed no significant difference in PFS between group A, which had a median PFS of 7.1 months versus group C, which had a PFS of 6.9 months (HR, 0.883; 95% CI, 0.565-1.380; two-sidedP=.56 stratified). The median PFS for groups B versus C were 7.9 months versus 6.9 months (HR, 0.876; 95% CI; 0.5601.368; two-sidedP=.56 stratified), which also showed no significant difference, respectively.

Among patients with brain metastases, another post-hoc analysis was inconclusive based on the fact that 11% of the patient population had progressive disease.

In terms of safety, at least 1 grade 1 to 4 treatment-emergent adverse event (TEAE) was observed in 94% of patients in group A (n = 73), 97% in group B (n = 72), and 93% in group C (n = 72). Grade 3/4 TEAEs were seen in all groups, with a higher percentage observed in group A (68%). The most frequent TEAE in patients was grade 3/4 neutropenia, which occurred in 27% of patients in group A, 22% in group B, and 26% in group C.

In higher than 1% of the safety population of monarcHER, the most common serious AEs in group A were pyrexia (4%), diarrhea (3%), urinary tract infection (3%), and acute kidney injury (3%). In group B, the most common serious AEs were diarrhea (3%), and pneumonitis (3%). Finally, in group C, the most common serious AEs were neutropenia (6%) and pleural effusion (3%).

A total of 6 patients from group A, 11 from group B, and 6 from group C discontinued treatment due to AEs. Across the 3 treatment arms, dose reductions were required for 50% of group A, 42% of group B, and 28% of group C. Mostly, diarrhea was the AE that led to treatment discontinuation.

MonarchHER is an ongoing phase 2, randomized, multicenter, open-label study. Participants of monarchHER received 150 mg of abemaciclib every 12 hours on a 21-day cycle, along with 8 mg/kg of intravenous trastuzumab, and 500 mg of intramuscular fulvestrant. Trastuzumab is administered for 90 minutes on day 1 of cycle 1 and then at 6 mg /kg on day 1 of all subsequent cycles. Fulvestrant is administered on days 1 and 12 of cycle 1 and on day 8 of cycle 2, followed by once every 4 weeks. All study treatments were continued until disease progression as per RECIST v 1.1. criteria or unacceptable toxicity.

MonarchHER was conducted based on prior research from the MONARCH-1 (NCT02102490), MONARCH-2 (NCT02107703), and MONARCH-3 (NCT02246621) clinical trials, which provided evidence of activity with CDK4/CDK6 inhibition in combination with endocrine therapy and chemotherapy.

This study provides clinical validation of the preclinical hypothesis suggesting that treatment with a CDK4 and CDK6 inhibitor might overcome acquired resistance to trastuzumab. Furthermore, together with previously published data, abemaciclib has now shown activity in both HR-positive, HER2-negative and hormone receptor-positive, HER2-positive advanced breast cancer, Tolaney et al concluded in the published report.

Reference:

Tolaney SM, Wardley AW, Zambelli S, et al. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial. Lancet Oncol. 2020. Published Online April 27, 2020. doi: 10.1016/S1470-2045(20)30112-1

More:
Abemaciclib Triplet Improve PFS in HR+, HER+ Advanced Breast Cancer - Targeted Oncology

SMITHSONIANMAG.COM | June 10, 2020, 10:56 a.m.

More patients than ventilators. Understaffed hospitals. A snowballing pandemic. Seven decades before COVID-19, a similar crisis strained the city of Copenhagen. In August 1952, the Blegdam Hospital was unprepared and overwhelmed. A 12-year-old victim, Vivi Ebert, lay paralyzed before anesthesiologist Bjrn Ibsen, gasping for air and drowning in her own secretions. Seven years after liberation from Nazi occupation, a new shadow darkened the streets: the poliovirus. With his hands, a rubber bag, and a curved metal tube, Ibsen reset the boundary between life and death and taught the world how to breathe.

We were very afraid, remembers Ibsens daughter Birgitte Willumsen of the 1952 outbreak, everyone actually knew somebody affected by polio. Waves of young people with fever, headache, upset stomach and stiff neck heralded the arrival of the summer plague in cities throughout the United States and Europe. Masquerading as a common stomach virus, the infection established itself in the gut before spreading to the brain and spinal cord. The clinical picture ranged from a self-limited stomach bug to paralysis, shock and asphyxia. Some recovered, but lasting disability, or death, was typical. At the time, the best way to treat respiratory complications of polio was with the "iron lung," a tank that encased polio victims but allowed them to breathe with the help of a vacuum pump. Researchers understood that the virus was contagious, but they could not yet agree on its manner of spreading. Recalls Willumsen, We really learned to wash our hands. Nonetheless, the modern sanitation, water supply, housing and medical infrastructure of Western cities offered little protection. A vaccine was not yet available.

Blegdamshospitalet was the designated fever hospital for treating infectious diseases among the 1.2 million citizens of Copenhagen. During the summer of 1952, the staff treated more children with severe polio than they had in the previous decade. At the peak of the epidemic, up to 50 new patients limped, wheeled and wheezed onto the wards each day. With higher attack rates than preceding outbreaks in the U.S. and Sweden, the Copenhagen epidemic was the worst polio crisis that Europeand perhaps the worldhad ever seen. During these months we have in fact been in a state of war, wrote Henry Cai Alexander Lassen, Blegdams chief physician. We were not nearly adequately equipped to meet an emergency of such vast proportions. Hundreds of patients with bulbar polio. One state-of-the-art iron lung ventilator, and a few older, mostly impotent, devices. Concluded Lassen: Thus the prognosis of poliomyelitis with respiratory insufficiency was rather gloomy at the outbreak of the present epidemic in Copenhagen.

The prognosis was especially gloomy for young Vivi Ebert, who was dying in front of Ibsen and his colleagues on August 27, 1952, at the height of the epidemic. Vivi suffered from the bulbar variant of polio infection; in addition to causing paralysis, the virus disrupted brainstem control centers for swallowing, breathing, heart rate and blood pressure. At the time, about 80 percent of bulbar polio patients died comatose in the iron lung.

Physicians had long implicated overwhelming brain damage as the cause of bulbar polio deaths. A methodical problem-solver who logged even his music consumption (on November 24, 1997, for example, he listened to Arthur Rubensteins rendition of Fantaisie in F Minor by Chopin), Ibsen doubted the prevailing theory; he suspected that paralyzed chest muscles compromised respiration. The lungs themselves could sustain life if stronger mechanical muscles could be found. A world war and a chance encounter would lead him to the solutionand to an ethical dilemma that spurred accusations of murder.

Ibsen had been thinking about breathing for years. After completing medical school in 1940, he trained in Denmark's remote northern peninsula, where, according to his son Thomas, the healthcare system consisted of three persons: the doctor, the pharmacist and the priest. Ibsen delivered babies, assisted with surgery, spent long hours with the sick and raised his young children. Isolated by geography and Nazi occupation, opportunities for advanced medical training remained scant, even after the wars end. Ibsen and his peers looked abroad to the United States and United Kingdom.

In February 1949, Ibsen relocated his growing family to Boston so he could train in anesthesiology at the Massachusetts General Hospital, the institution credited with the first surgical administration of ether. In Boston, Ibsen fused ruffle-shirted Harvard medicine with Danish pragmatism. Accustomed to the privations of postwar Europe, the young Danes earned a reputation for medical creativity. This spirit would leave a lasting mark on medicine, as young Danes like Ibsen followed other pioneers to the United States and Great Britain to study.

In Boston, Ibsen learned the art of baggingthe use of a hand-squeezed rubber bag to breathe for anesthetized patients during surgery; the practice was foreign to Danish physicians at the time. He also learned to bag ventilate patients with tracheostomy tubesbreathing conduits placed in the windpipe through an incision in the neck. Although seemingly rudimentary, this technique became a crucial element of Ibsens answer to the bulbar polio crisis of 1952.

Ibsens bagging, known as positive pressure ventilation, was not widely used at the time, as it contradicted human physiology. Normally, air is instead drawn into the lungs by negative pressurethe vacuum created by diaphragm and chest muscle contraction. Outside of the operating room, negative pressure ventilators, such as Blegdams iron lung, were the sole means of artificial respiration.

Originally intended to treat victims of industrial accidents, the modern iron lung was developed at Harvard in 1928 by Philip Drinker and Louis Agassiz Shaw. Its nickname derived from the airtight cylindrical tank that enclosed the patients body. The head and neck protruded through a snug rubber collar. Electric pumps cycled air in and out of the tank to mimic normal breathing. John Emersonhigh school dropout, self-taught inventor and distant relative of Ralph Waldofashioned a rival model in 1931 that was cheaper, quieter and more adaptable. However, even Emerson tank ventilators remained prohibitively expensive for most hospitals and served as little more than a costly and claustrophobic deathbed for eight out of ten patients with bulbar polio. A better treatment was needed.

The breakthrough came in 1949 at the Los Angeles County Hospital, but few realized it at the time. For centuries, healers attempted positive pressure ventilation, using mouth-to-mouth resuscitation or even a fireplace bellows to treat victims of drowning, opioid overdose and other misfortunes. Physician Albert Bower and engineer Vivian Ray Bennett, supplemented the Emerson-style tank ventilator with an invention that simultaneously inflated the lungs through a tracheostomy. Their new positive pressure ventilator, modeled on an oxygen-supply system for World War II pilots, increased airflow to the lungs. The device decreased the mortality of severe polio from 79 to 17 percent. In 1950, the Bower-Bennett team published their results in an obscure medical journal. The article passed unnoticed by many, but Ibsen, who had returned to Denmark in February 1950 after completing his one-year fellowship in Boston, read it and immediately understood its significance. A reprint of Bower and Bennetts report in hand, Ibsen met with Lassen, Mogens Bjrneboe (a physician who worked with Lassen at Copenhagens fever hospital) and other senior physicians on August 25, 1952, as the bodies of Denmarks children were stacking high at Blegdam. Positive pressure ventilation, Ibsen argued, was the key to Bower and Bennetts success, and spare parts from the operating room could deliver Blegdam from catastrophe.

The following day, young Vivi Ebert arrived at Blegdam Hospital with headache, fever and a stiff neck. By morning, bulbar polio was manifest and death inevitable. Lassen agreed to let Ibsen proceed. At 11:15 a.m., at Ibsens direction, a surgeon placed a tracheostomy tube in her windpipe, but she deteriorated further. Oxygen levels fell.

Ibsen attached, to Vivis tracheostomy tube, a rubber bag filled with an oxygen supply. Air filled her lungs with each squeeze of the bag, but, agitated and drowning in mucus, she bucked and fought the breaths of the junior anesthesiologist. In desperation, to settle her, he administered a large dose of sodium thiopental. The assembled onlookers lost interest and left the room, figuring that the demonstration was culminating in a semi-intentional and lethal barbiturate overdose. However, as the sedative took hold, Vivis gasping ceased. Her struggling muscles relaxed, allowing Ibsen to breathe on her behalf. Her lungs cleared, and her condition stabilized. When the thiopental wore off, the team stopped bagging, but she again gasped and floundered. Primitive sensors, repurposed from U.S. Army Air Force and anesthesia applications, signaled falling blood oxygen and rising carbon dioxide. Ibsen and colleagues re-administered the sedative and resumed bag-ventilation, and, as before, she improved.

Vivi would live if they could keep squeezing the bag.

Standing on the shoulders of Bower, Bennett and unsung fireplace bellows-squeezers, Ibsen improvised the first practical treatment for bulbar polio. His breakthrough shepherded Vivi Ebert and the city of Copenhagen through the grimmest days of the outbreak, and cemented his reputation as a founding father of intensive care medicine. But later that afternoon, Ibsen and Lassen needed to find extra hands.

***

Over the next eight days, the leadership of Blegdam Hospital organized bag ventilation for every patient with respiratory failure. The effort consumed 250 ten-liter breathing gas cylinders each day. It was an unprecedented logistical challenge; up to 70 patients required simultaneous, around-the-clock ventilation at the height of the epidemic. In this manner we avoided being placed in the dreadful situation of having to choose, wrote Lassen. They recruited approximately 1,500 medical and dental students to assist. It was simply necessary and there were not enough physicians with these skills, remembered Ibsen. As young as 18 years old, the volunteers were but able-bodied reflections of the peers they were ventilating. Perhaps nothing but chance separated patient from practitioner. Amazingly, not a single bag-squeezer would catch polio while on duty at Blegdam.

The students assignment began with a few hours of instruction, and they were soon sent to the wards. They bagged in shifts, pausing for meals and cigarettes. The young students read to their patients and played games. They learned to read their lips. And they were heartbroken when their patients died. Uffe Kirk was 25 years old when he helped to organize the medical student response in 1952. In a letter to a colleague, he recalled: At worst, the patients died during the night. The light in the wards was dimmed in order not to disturb the patients in their sleep. But the faint light and the fact that the students were not able to tell anything from the ventilation made it impossible for the students to know that their patient had died. It was therefore a shock for the student when morning came and he/she realized that the patient had been dead for a while.

Few medical innovations would be so immediate and definitive. In one week, the mortality of bulbar polio fell from 87 to barely 50 percent. By November, the death rate dropped again to 36 percent. As the embers of the Copenhagen outbreak cooled in March 1953, only 11 percent of patients who developed bulbar polio died.

Healers from different specialties buttressed the mission of bag ventilation. The polio wards swarmed with internists, anesthesiologists, head and neck surgeons, physical therapists, experts in laboratory medicine and nurses. The team addressed nutrition and bedsore prevention. A comprehensive triage system facilitated recognition of impending respiratory failure. Ibsen and colleagues even ventured to outlying communities to collect stricken patients and ventilate them en route to Copenhagen. The Bledgam team cared for the mind as they cared for the body: The polio wards featured teachers, books and music.

The coordinated response was prescient. Decades before cross-functionality became a management buzzword, the leaders of the respective medical specialties gathered regularly at the Ibsen home for dinner and discussion. Detailed records on every polio admission to Bledgdam Hospital, compiled at Ibsens suggestion, facilitated clinical research. Even in 1952, the junior anesthesiologist sought answers in big data.

One-by-one, despite blood clots, pneumonias, bladder infections and other inevitable consequences of prolonged illness, victims weaned from ventilation as their muscle strength improved. There remained, however, a group of patients who were still unable to breathe on their own. In October 1953, well past the one-year anniversary of Vivi Eberts rescue, 20 of the original 318 patients treated by Ibsens method still required around-the-clock ventilation at Blegdam Hospital. By 1956, 13 patients remained dependent. As the first clinicians to practice modern intensive care medicine, Ibsen, Lassen, Bjrneboe and colleagues encountered the chronic respirator patient, an individual that medicine still struggles to serve nearly 70 years later.

at the beginning of intensive therapy it was a problem to keep the patient alivetoday it has become a problem to let him die.

-Bjrn Ibsen, 1975

Although the fundamentals had been practiced for centuries, the new discipline of critical care medicine blossomed in the wake of the 1952 Copenhagen polio outbreak. Lessons from Copenhagen bore fruit in Stockholm one year later during the next European polio epidemic. Engineers and physicians scrambled to build the first generation of positive pressure ventilators, applying declassified wartime insight on lung physiology and oxygen systems for pilots and sailors. Machines replaced bag-squeezing students.

Modern intensive care units or shock wards emerged in Copenhagen at the Kommunehospitalet, at the Los Angeles County General Hospital and at the Baltimore City Hospital. Mechanical ventilators, operating by positive pressure, improved survival for once-hopeless conditions such as shock, drug overdose and cardiac arrest. Temporary breathing tubes placed through the mouth soon obviated surgical tracheostomy. This technique of intubation made intensive care more accessible.

Of those patients ventilated in early I.C.U.s, many recovered, some died and others walked a path in between. Ibsens persistence in the summer of 1952 gave Vivi Ebert another chance at life. But the incomplete resurrection of many of the eras intensive care patients sparked new questions. What happens if the patient cannot be weaned from the ventilator? What happens when the body recovers and the mind does not? Does life support benefit all patients? Should intensive care be offered to everyone? The ethical and social weight of these concerns saddled Ibsen with somewhat conflicting roles as proud father and emerging conscience of this new brand of medicine.

In August 1974, he met with Christian Stentoft, a Danish radio journalist, and was presented with the question, Who helps when a human being is going to pass away? As related by Preben Berthelsena Danish anesthesiologist, intensive care physician and Ibsen scholarthe interview included this exchange:

Stenthoft: Do we prolong the death process?

Ibsen: Yes and often times it would be much more humane to give morphine, peace and comfort to patients with no hope of surviving.

Stentoft: Have you done that?

Ibsen: Yes I have.

Effectively, Ibsen confessed to removing patients from the ventilator when their illness was, in his opinion, insurmountable. He did not consult the next of kin. It serves no purpose that no one can die without having spent at least three months hooked up to a respirator. A risky admission, even for a national hero.

Newsmen pounced. Published excerpts of the interview, as Berthelsen explains, implied that Ibsen sought to euthanize the hopelessly ill. Patients beyond reach are helped to die! announced Danish headlines. Ibsen was suspended from hospital duties. Tabloids proclaimed him the first physician who openly supports and participates in active euthanasia. Jens Mller, the leader of the conservative Christian Peoples Party, cried murder. Others echoed his call for criminal charges.

Copenhagens chief medical officer, Hans Erik Knipschildt, summoned Ibsen to dissect fact from rumor. The anesthesiologist confirmed that he had removed dying patients from the ventilator and treated them with morphine. But the main aim, says Berthelsen, was to alleviate pain and secure comfort even if it hastened the demise of the patient. Knipschildt concluded that Ibsen acted reasonably and that his remarks had been interpreted out of context. Its of my understanding that if this conversation was provided in its original form, the whole havoc about Bjrn Ibsens business could have been avoided, Knipschildt told the media. Prosecutors declined to press charges. Though stoked by sensationalist journalism, the controversy surrounding the 1974 Ibsen-Stenthoft interview joined a growing international dialogue, including an address from the Pope on life support ethics, scientific acceptance of brain death, and landmark legal decisions that collectively recast traditional constructs of life and death in the age of the ventilator.

George Anesi, an intensivist and expert in intensive care utilization at the University of Pennsylvania, emphasizes: It took us a while to come to the conclusion that active withdrawal and passive declination, in the face of futility, are ethically equivalent events. This was a turning point that allowed for a more normalization of the idea of withdrawing support. If someone was sick enough that you would not put them on a ventilator if they were not on one, they were sick enough to justifiably remove a ventilator.

In his later years, Ibsen told his children, I am not afraid of dying, I am only afraid of how.

***

According to her medical chart, Vivi Ebert required continuous mechanical ventilation until January 1953. Quadriplegic, but alive, she left Blegdam in 1959 after a seven-year convalescence. After discharge, she moved with her mother, Karen, and a devoted rough collie named Bobby to an apartment complex for polio survivors. She relied on Karen for most daily needs like eating and toileting. Every evening, Vivi was wheeled to a penthouse unit where she slept on a ventilator under medical supervision.

Despite her condition she was a very positive person, says distant cousin Nana Bokelund Kroon Andersen. Optimistic and known for her smile, Vivi eventually completed her education from a wheelchair. Andersens mother, Sussi Bokelund Hansen, recalls that Vivi could turn pages in a book, type on a typewriter and paint with a long stick held in her mouth. She married her driver. She was beloved by generations of relatives.

Spirit alone could not shield Vivi from the complications of polio and critical illness. Like most survivors, her life was pockmarked by setbacks. Vivi and her husband eventually separated; not long thereafter, in 1971, she was readmitted to the fever hospital. Pneumonia and sepsis, determined the doctors, though her mother suspected a broken heart. She died a few days later at the age of 31. It is not clear whether Ibsen maintained contact with his most famous patient; he never spoke to his family about Vivi after their initial encounter in 1952.

In hindsight, Vivi Eberts journey after polio was as noteworthy as her August resurrection. Having endured the infection, she lived her remaining days dependent on people and machines to sustain her: too sick to survive on her own, but too well to surrender hope. Before intensive care, this manmade purgatory did not exist. Now termed chronic critical illness, this syndrome arises when recovery from catastrophe stops short. Patients with chronic critical illness often develop muscle wasting and weakness, fluid retention, neurologic dysfunction, anxiety, depression, post-traumatic stress disorder, hormone imbalances and increased susceptibility to infection. Its shadow may be life-long and, in retrospect, was visible in polio survivors like Vivithe worlds first graduates of intensive care.

Today, five to ten percent of all respiratory failure patients, about 100,000 Americans annually, share a similar fate. Of those discharged from the I.C.U. to specialized long-term ventilator rehabilitation facilities, about at least half will die within the year, and fewer than one in ten will ever return home able to walk, eat or dress independently. Older patients or those with a greater number of medical problems may face even tougher odds. Sadly, these statistics have not improved over the last 20 years, though not for lack of trying.

Faced with this understanding, modern critical care physicians must balance hope with reality when counseling the sick. An overly actuarial discussion of I.C.U. outcomes may alienate the patient and engender suspicion that the doctor is prematurely giving up. Conversely, skirting altogether the issue of prognosis risks more catheters, more needles and more setbacks, for little prospect of a life independent of machines and hospital walls. And even when physicians do begin these conversationstime pressure, prognostic uncertainty and fear of undermining patient trust are common barriersnot everyone is ready to listen.

Seven decades of scientific and historical examination defused the mystery of the poliovirus. As Ibsen and colleagues learned to bag ventilate, laboratory researchers unraveled the biology of viral growth and transmission. Arrival of the Salk vaccine in 1955 and the Sabin oral vaccine in 1961 halted epidemic polio in the West and laid the foundation for global eradication efforts.

By their disturbing and upsetting effects, writes the medical historian G.L. Wackers, epidemics, like wars, force the display of strengths and weaknesses in the political order of the infested societies. The events of August 27, 1952, bore the thumbprint of war, urbanization and centuries of biomedical innovation. Out of plague and disastermore patients than ventilatorsemerged a new lifesaving tactic, predicated on applied science and engineering, practiced in real time. The active approach and the fighting spirit in medicine are wonderful, Ibsen would remark in the 1970s. But Copenhagen also emphasizes how advances in medicine often trade one problem in the present for another in the future. Even prior to COVID-19, the healthcare system strained under the ethical and financial burdens of this active approach.

Over Ibsens career, intensive care became a victim of its own success. Bioethical reforms of the latter 20th century, justified and overdue, replaced the physician as arbiter of the ventilator switch with an unflinching commitment to patient autonomy. On the whole, medicine is more humane for it. But with its buffet of tubes and machines, sampled with insufficient consideration of risks versus benefits, intensive care lays bare one disquieting legacy of this transition. The nuance and complexity of this science, vastly evolved since 1952, challenge the expectation that laypersons can make dispassionate, informed decisionsand weigh the implications of incomplete recoveryamid gasping, weakening pulse and the need for immediate action. Bjrn Ibsen recognized this before most.

Many will benefit from intensive care medicine, but its ongoing availability in times of personal or global crisis hinges on careful identification of those who have the most to gain, and the least to lose, from this approach. Improved education and counseling could empower our sickest patients, or their surrogates, to weigh more fully the benefits and risks of medicines most heroic therapies. Increased patient and surrogate autonomy was an appropriate response to paternalistic medical abuses in the 20th century, Anesi explains, but true autonomy requires both the freedom to make ones own decision and the tools to make it an informed decision. Weve done better with the freedom part than the tools partmost notably, weve been short on education to put options in context and limiting options to those that may truly provide benefit and that align with the patients values.

To this end, an effective response to COVID-19and the inevitable next pandemicdemands grassroots conversations about the realities of life support and the journey after. Nations must also rebuild critical supply chains for ventilators, drugs, protective equipment and healthcare workers, which were undermined by years of myopic cost-cutting and lean management practices often by those who will themselves never be asked to face a contagious patient without an N95 mask or to improvise to save a human life. Just-in-time allocation of men and material is never more than one misfortune away from shortages and patient harm. Only those nave to history can expect otherwise.

In this origin story of the modern ventilator, the duality of intensive care medicine comes through: Its defining strength is also its weakness. Through Bjrn Ibsen and the breath-givers who preceded him, pandemic polio taught the first lesson: Actually, it does not matter what is the source of the patients gasping. You simply have to bring his breathing back in order.

Bradley M. Wertheim is a pulmonary and critical care physician and scientist at Brigham and Women's Hospital and Harvard Medical School. He has written for The Atlantic, the Los Angeles Times and peer-reviewed medical journals.

Read more:
The History of the Ventilator | Innovation - Smithsonian.com

Before you rush to the store or add the supplementsto your online checkout cart to combat COVID-19, it's important to know if you are vitamin D deficient.

Although vitamin D is called a vitamin, it's actually more of ahormone. When ultraviolet rays from sunlight strike your skin, the rays trigger vitamin D synthesis. You canbuild up your vitamin D levels through certain foods and supplements.

Genetics and age can play a big role in how muchvitamin D you have:

If you are worried that you are at risk of vitamin D deficiency, ask your physician to check your blood work.

It'sbeen known for years that vitaminD is essential formaintaining healthy bones and teeth. Without it, bones can become thin, brittleor misshapen.

Vitamin D also plays an important role in helping immune systems function. Low levels can lead to autoimmunity when the immune system attackshealthy cells and increase the chance of infection.

The immune system is like an army that prevents invaders, such as viruses and bacteria, from taking over the homeland your body.It is composed of the innate and adaptive immune systems.

Let's say a virus is present in a patient's lungs, specifically in the air sacs (alveoli), which can lead toacute respiratory distress syndrome (ARDS).

The first line ofdefenseis the innate immune system:Itcomes into play immediately or within hours of antigen detection.Antigens areproteins on the surfaces ofbacteria, fungi and viruses that the body doesnt recognize as its own.

Natural killer cells and macrophages, along with other immune cells, recognize, engulf and destroy pathogens.The main purpose of these cells is to prevent the spread and movement of harmful substancesthroughout the body. They are akin to soldiers shooting indiscriminately all over the enemy's camp.

Although the exact role of vitamin D in the immune system is not fully understood, studies have shown it may influence both innate and adaptive immune systems.

When the innate immune system is activated, its cells turn certain genes on to become more efficient at killing pathogens. Vitamin D binds to these cells and enhances this transformation, helping the innate immune system kill viruses.

If the pathogen manages to dodge the innate immune system, adaptiveimmunity kicks in.

The second line of defense is the adaptive immune system: Itrelies on B cellsandT cellsto carry out its tasks. These cells produce billions of antibodies.Antibodiesrecognize antigens and bind to them. They are like high-ranking officers thatconduct specific missions targeting only certain enemies. Antibodies makefuture responses against a specific antigen more efficient.

The problem with infections such as COVID-19, is that most of us are believed to be naive to the infection. So we don't have memory B cells ready, which means that adaptive immunity, even though it might be super powerful, can't recognize the pathogen, says Vadim Backman, professor of biomedical engineering at Northwestern University.

Cells of the adaptive immune system produce cytokines. These small proteins attract more immune cells and trigger inflammation. Sometimes, cytokines become too abundant and create a cytokine storm when immune cells spread beyond infected body parts and attack healthy tissue.

The way our immune system responds to the virusmay be a big part of this puzzle, Backman says. What does seem to be critical is acute respiratory distress syndrome. ARDS is caused by an overreaction of the immune system called a cytokine storm, which seems to be induced by the adaptive immune system, Backman says.

Backman saysVitamin D binds to the cells of the adaptive immune system and turnssome genes on while switching others off. This causes cells to produce fewercytokines, reducing inflammation and the possibility of cytokine storm.

When activated immune cells surge into the lungs as a result of a cytokine storm, the lungs can become inflamed. Fluid from the smallest blood vessels leaks into the tiny air sacs, resulting in acute respiratory distress syndrome (ARDS). The fluid prevents the lungs from filling with enough oxygen, so less reaches the bloodstream, causing organs to fail.

Many COVID-19-infected patients develop ARDS. Researchers in China examined risk factors for 191 coronavirus patients who died while being treated in two hospitals in Wuhan. The study showed50 of the 54 patients who died had developed ARDS; only nine of the 137 survivors developed ARDS.

A study in 2015showed that patients with ARDS and those at risk of developing it had vitamin D deficiency. Researchers demonstrated that vitamin D canreduce damage to capillaries that connect the alveoli to larger blood vessels that may prevent ARDS. In another study, Vitamin D was shown to have a protective effect on the lungs.

Another mystery of COVID-19 is why fewer children are seriously affected.

"Mortality and complications keep going up and up and up as age increases,"Backman says. Young children don't have mature adaptive immunity. They primarily rely on the antibodies that they have from their mother.

"There are always exceptions, but most children don't tend to overactivate their adaptive immune system. They don't develop cytokine storms because they just don't have the mechanisms, Backman says.

The research is in the early stages. According to a preprint studyBackman co-wrote, countries with low average vitamin D blood levels in the population had higher numbers of COVID-19 cases and deaths. A study from the U.K. looked at the nearly 450 patients diagnosed with COVID-19 and did not finda link between vitamin D concentrations and risk of COVID-19 infection.

In apaperpublished in theBritish Medical Journal,21 experts from the U.K., Ireland and the USA concludes that although vitamin D is essential for good health and may bolster the immune system, itcanbe dangerous in high doses.

Worldwide, about 1 billion people have inadequate levels of vitamin D in their blood, andinsufficiency affectsalmost 50% of the population. Most commonly, low levels of vitamin D are caused by insufficient exposure to sunlight.

In Louisiana, African Americans account for more than 50% of COVID-19 deaths despite representing only 32% of the population.

African Americans are at greater risk for vitamin D deficiency because they havehigher presence of melanin.Melanin reduces the bodys ability to produce vitamin D.PeoplefromSouth Asian backgroundsalso may not get enough vitamin D from sunlight in the summer.

Studies also have shown that African American adults have higher rates of hypertension, which isassociated with more severe cases of COVID-19.

"Vitamin D may simply correlate with some factor x, which for all we know has not been identified yet," Backman says."And that's factor x which causes or prevents complications."

Vitamin D deficiency can be caused by obesity.A body mass index greater than 30 is associated with lower vitamin D levels.The skin's ability to make vitamin D decreaseswith age.People who are homebound or rarely outside may have low levels of vitamin D as a result ofnot being able to getsun exposure.

If your levels are within normal ranges,here are some foods that will help with maintaining daily recommended value.

How much vitamin D you need depends on many factors, including age, race, latitude, season, sun exposure, clothing and more. The U.K.'s National Health Service recommends consuming 400 international units (10 micrograms) of vitamin D daily for adults.

"Let's say I knew that I'm vitamin D deficient," Backman says."It's something that is important for health. There are no benefits of vitamin D deficiency.So it's really guilt-free, risk-free to expose yourself to the sun for 20 minutes, get supplementation, get your levels within the normal level."

According to the NHS, people shouldn't take more than 4000 IUs (100 mcg)of vitamin Da day as it could be harmful.Children under 10 shouldn't have more than 2000 IUs(50 mcg) a day.

Taking too many vitamin D supplements over a long period of time can causetoo much calcium to build up in the body potentially weakening bones and damaging kidneys and heart.

Nutritionists say sticking to a healthy diet that includes a variety of nutrient-rich foods can boost the immune system.

"Ahealthy diet means eating food that is as close to its natural form is possible," says TamaraWard,a specialist in oncology nutrition at the University of Cincinnati Cancer Center."I don't say just eat real food. Because to a lot of folks, a box of Kraft macaroni and cheese is real because you can touch it, but it is highly processed. That little packet of flavoring isn't real food."

Other nutrients along with vitamin D aidtheimmune system. Consuming foods high in vitamin C, such as grapefruits and oranges, may increase white blood cell productionkey to fighting infection.

Adding carrots, spinach or kale to yourdiet mightbe a good idea. They containbeta-carotene that converts into vitamin A an anti-inflammation vitamin that enhances immune function.

Vitamin B-6 is essential in the formation of healthy red blood cells and is present in chicken, turkey and bananas. Garlic contains compounds that stimulatecertain immune cellsand helpregulate the immune system. Vitamin E and zinc are beneficial for fighting off diseases.

Ward recommends foods containing probiotics, such as yogurt:

"Once your gut is functioning really well, then that helps your gut to absorb all of the other nutrients that are in these foods, like zinc, vitamin B-6, vitamin D, the beta carotene," she says.

Go here to read the rest:
Can vitamin D help with symptoms of COVID-19? Possibly, it's key to helping your immune system function - USA TODAY

But if youre experiencing sudden weight gain that just doesnt seem to make sense to you (and it doesn't seem to have to do with normal life changes), then it may be a sign that something odd is going on with your bod. Think: out of whack hormones or other sneaky health conditions that are causing your metabolism to misfire.

Ultimately, you'll need to work with your doc to get a clear explanation for your unexplained weight gain. Before visiting the doc, keep a log of everything you eat as well as your exercise habits (including activity outside of your workouts) for at least a few days if not a week or two, says Melina Jampolis, MD, an internist and physician nutrition specialist. Maybe youre eating more calories now, or youve spent weeks sitting down more than usual thanks to a heavier workload.

Your doc can help you get to the bottom of whether any lingering health issues might be causing the weight gain. And there are tons of reasons for unexplained weight gain that have nothing to do with eating more and moving less.

Ahead, a list of conditions that could be causing your sudden weight gain, and how to tell if its time to see a doctor.

When a young woman walks into a docs office with unexplained weight gain, the thyroid is the first place most physicians will investigate, says Dr. Jampolis. And for good reason: A whopping one in eight women will develop athyroiddisorder in her life, according to theAmerican Thyroid Association.

That butterfly-shaped gland in the neck is responsible for secreting a hormone that regulates the metabolism, and if youve got an under-active thyroid (called hypothyroidism) the metabolism may slow down, triggering weight gain.

Women with hypothyroidism may also suffer from low energy levels or fatigue, dry skin, hair loss, hoarseness, or constipation, says Dr. Jampolis. Notice any of them and you should book a chat with your doc who can check on your thyroid with a simpleblood testif necessary.

Researchshows that as many as one in five women havepolycystic ovary syndrome(PCOS)an endocrine disorder that throws off the balance of reproductive hormones estrogen and testosterone, and can trigger a number of unpleasant symptoms like wacky periods, facial hair growth, and migraines.

PCOS can also muck up the way your body uses insulin (the hormone that helps turn sugars and starches into energy), which means (womp, womp) unexplained weight gain around the mid-section is common, says Dr. Jampolis.

If your menstrual cycles are off, a gyno will likely take a peek at your hormones to diagnose this one.

When you'restressed, you're thrown into fight-or-flight mode and get a surge of adrenaline, along with a heavy dose of the hormone cortisol, which is supposed to help you restore energy reserves and store fat. Because, hello, you just sprinted three miles from a tiger (okay, dramatic example)you're starving.

The problem? Lots of us getchronicallystressed sitting at our desk all day or just living a crazed life, says Dr. Jampolis. When your cortisol levels stay elevated for a prolonged period, then your body continues storing fat, which can lead to weight gain.

If youve persistently felt down in the dumps or anxious, have trouble sleeping, feel fatigued, or youve lost interest in the stuff that used to make you tick, talk with an MD or mental-health pro who can make suggestions for getting back on track if stress seems to be the culprit behind your sudden weight gain.

Theres nothing like a busted night ofsleepto make a girl crave sugar and fat (anything to survive at work the next day, right?). That's because missed shuteye does a number on your hunger hormones and metabolism: Sleeping too little raises ghrelin, the hormone that signals its time to eat, while lowering your levels of leptin, the hormone that conveys the Im full feeling, says Dr. Jampolis. The result: a totally unsatisfying chow-fest the next day.

Putting off sleep to watch just one more episode? That hour could be contributing to sudden weight gain. A2018 study in the journalSleepfound that people who slept just one hour more per week lost more fat than those who slept an hour less. The people who slept less lost lesseven though everyone in the study ate the same number of calories, proportionate to their weight at the start of the study.

The gut relies on good bacteria to function well (probiotics, anyone?), but theres also bad bacteria chilling in your digestive tract. When that balance of good to bad gets thrown off, small intestinal bacterial overgrowth (SIBO, for short) can take place, triggering extra gas in your GI tract along withbloating, abdominal pain, diarrhea, andyou guessed itsudden weight gain.

Docs arent entirely sure how SIBO may trigger those extra pounds, says Dr. Jampolis, but treatment for SIBO typically includes antibiotics to treat the bacterial overgrowth, according to theU.S. National Library of Medicine.

The transition period to menopause (a.k.a. perimenopause, which can start in women as early as their mid-30s, but usually starts in your 40s) triggers hormones like estrogen to rise and fall unevenly, which can cue weight gain in some women, says Dr. Jampolis. (Othersigns of perimenopauseinclude irregular periods, hot flashes, mood swings, and a change in your libidosymptoms your doc can usually suss out with her eyes closed.)

Compound perimenopause with the other inevitable body changes that happen with age (like a loss of muscle mass and increase in body fat), and it may feel like the scales tipping fast. Talk to your doctor to manage "the change" in stride.

There's a laundry list of both prescription and over-the-counter meds that can trigger sudden weight gain or water retention that shows up on the scale as extra poundage. Antidepressantsmost commonly the selective-serotonin reuptake inhibitors (SSRIs) such as Paxil, Lexapro and Prozacmay affect the appetite centre in the brain, says Roco Salas-Whalen, MD, an endocrinologist at theMedical Offices of Manhattan.

Meanwhile, beta-blockers (meds that reduce blood pressure) can slow your metabolism, and certain steroids (like prednisonean anti-inflammatory that causes water retention and an increase appetite) can add on pounds. Even OTC antihistamines like Benadryl, which can disrupt an enzyme in the brain that helps regulate food consumption, can trigger noticeable weight gain, says Dr. Salas-Whalen.

A word to the wise: Dont stop taking any pills cold-turkeychat with your doctor, who may be able to find a more waist-friendly substitute.

RELATED:8 Times Your Weight Gain Is A Sign Of A Bigger Health Problem

A super-rare condition called Cushings disease (only 10 to 15 people per million are affected, but 70 percent of those diagnosed are women) causes excess cortisol production and can trigger excessive weight gain just around the abdominal area (the legs and arms usually stay lean) and the back of the neck, says Reshmi Srinath, MD, assistant professor of diabetes, endocrinology, and bone disease at the Icahn School of Medicine at Mount Sinai.

Cushings typically presents with significantly low energy and complications like diabetes, high blood pressure, and high cholesterol. But the telltale sign is very large, red stretch marks on their belly, she says. If this sounds eerily familiar, talk to your doctor asap.

Theres a reason behind the bloat, and it may have just as much to do with the water you forgot to drink as the food that you ate.

Kristen Neilan, RD, a dietitian at University of Florida Health, says most of us arent drinking nearly enough water. Thats because many of us mistake the feeling of thirst for the feeling of hunger. Confusion, tiredness, and lightheadedness are all signs of even mild dehydration, she says. Sounds a lot like how we feel when were hankering for a snack.

Mixed signals arent the only possible culprits behind your unexplained weight gain. Adequate hydration increases mitochondrial functionwhat that basically means is that it increases your metabolism, says Neilan. Without enough water, your cells cant do their thing (namely, convert your food into energy) quickly and efficiently.

In rare cases, an expanding belly is the result of an ovarian tumour and fluid buildup associated with it, saysSanaz Memarzadeh, MD, PhD, a gynecologic cancer surgeon at UCLA Health. Patients come in with abdominal bloating, and their usual pants are not fitting, she says. Sometimes the tumour is so large it can cause distention of the abdomen, says Dr. Memarzadeh.

Women are more likely to be diagnosed with ovarian cancer after menopause. But its important for women at every age to look out for this symptom, as well as feeling full too quickly, pain in the lower stomach area, and extra pressure on the bladder. See your doc if the bloating persists, especially if your family has a history of ovarian cancer.

Smoking can often act as an appetite suppressant, so when you quit, the cravings can hit strong.Pouya Shafipour,MD, a weight-loss specialist atPaloma Health, explains that smoking can lead to a rise in dopamine, the neurotransmitter responsible for instant pleasure. It's the same kind of pleasure you get when you eat a sweet snack, like ice cream.

Quitting smoking causes that dopamine level drop, but your cravings for it still remain, and this craving for a dopamine hit can sometimes lead to eating something satisfying, and more than usual. "When one quits smoking, the body still has cravings for dopamine and often people get this craving from excess intake of refined sugar and starch (i.e., candy and other starchy snacks) and gain weight," says Dr. Shafipour.

To counteract the lower levels of dopamine once you quit smoking, it's important to engage in other behaviours, like exercise or meditation, that help release feel-good endorphins and also provide a nice distraction and healthy new habit.

Type 1 and type 2 diabetes both require insulin management in order to keep blood sugar levels regulated. In people with type 1, the pancreas essentially isn't producing enough insulin, so those that have it need to regularly insert themselves with the hormone. Insulin allows the body to absorb glucose (or sugar) and use it for energy.

Type 2 diabetes is associated with insulin resistance from a poor diet, a sedentary lifestyle, and unhealthy eating behaviours. That can usually contribute to weight gain in itself, explains Dr. Shafipour. Type 2 diabetics have a higher baseline insulin level which by itself causes more weight gain, typically around the belly," says Dr. Shafipour.

But an increase in insulin from external hormone treatments can also lead to weight gain. Insulin lets glucose into your blood cells so that it can be stored for energy, but if you're eating more calories than your body needs, your cells will take what they need leaving the remaining glucose to be stored as fat.

To counteract weight gain, it's important to closely monitor your diet and avoid eating too much fast food or foods high in refined sugar, Dr. Shafipour says.

Most cancers in their early stages will result in weight loss, instead of weight gain, unless it's a cancer that causes the release of cortisol, like a tumour in the adrenal gland.

However, as cancer progresses it can cause weight gain. "This weight gain can be due growth of the size of the tumor itself or [if it spreads] to other organs like the liver, which can cause fluid build-up in the stomach or the stomach cavity," says Dr. Shafipour.

But don't be too alarmed, as this is usually a worst-case scenario. Most cancers will cause other symptoms that may cause you to see a doctor while it's still in an early stage.

First, you should take a look at what your lifestyle's like. If your diet is poor, it's normal to gain between 1/4kg to 1/2 a kg a week. Your menstrual cycle can also caught your weight to fluctuate between 2-2.5kg depending on what stage of your cycle you are.

But when is weight gain a cause for concern? If you're gaining one to two pounds or more a week, and you don't see the numbers going down, then it might be time to see a doctor. "If one notices that they're gaining weight rapidly, more than 1kg a week, and it's not related to your menstrual cycle, poor sleep, anxiety or depression, or snacking or overeating, then they should probably see their primary care physician, who will do a thorough history and physical as well as some appropriate laboratory work-up to find the causes of weight gain," says Dr. Shafipour.

A doctor can work with you to determine whether an underlying condition is determining your weight gain, and find appropriate remedies to help you maintain a weight that makes you feel good.

This article originally appeared on Women's Health US.

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13 Common Causes Of Sudden, Unexplained Weight Gain - Women's Health

Heather Lanier, a registered nurse from San Jose, California, received a diagnosis of triple-negative breast cancer just weeks before the COVID-19 pandemic began in the United States.

Despite the rapid spread of the new coronavirus nationwide, Lanier never once considered stopping or delaying her chemotherapy.

I just wanted to get through it and get on with my life, Lanier, 49, told Healthline.

Lanier has continued to work during her treatment and has one final chemotherapy infusion left. Shell have surgery next month to remove one of her breasts.

Lanier knew there were risks involved in continuing treatment during the pandemic.

But she insists theyve been risks worth taking.

COVID-19 is scary because I am immunocompromised. I know I have to be careful. But I was more scared in the beginning than I am now, said Lanier, who strictly follows physical distancing guidelines.

I wear my mask religiously and I wash my hands a lot. I feel pretty safe. Its just my personality. I do not want to live in a bubble. I want to live my life, she said.

People being treated for cancer face a difficult dilemma when deciding when, where, and how to treat their disease in the age of COVID-19.

New studies announced last week at the annual American Society of Clinical Oncologists (ASCO) ASCO20 Virtual Scientific Program include new information about the high-risk relationship between COVID-19 and cancer.

The COVID-19 and Cancer Consortium (CCC19) registry presented at ASCO and published in The Lancet show that people with progressive cancer were five times more likely to die within 30 days of a COVID-19 diagnosis compared to people in remission or people with no evidence of disease.

The risk for death was 1.79 times greater for those with stable cancer compared to people who had no evidence of disease.

Dr. Jeremy L. Warner, MS, a lead author of the study and an associate professor of medicine and biomedical informatics at Vanderbilt University in Tennessee, and his colleagues assessed data on 928 patients for 30-day all-cause mortality.

In a press statement, Warner said his team is working to identify the factors that affect disease severity and death.

Warner says hes also interested in the effects of specific cancer treatments that are being used to treat people with cancer who have COVID-19.

The researchers say theres more to learn about the relationship between cancer and COVID-19.

How we improve the care we provide these patients and reduce the number of deaths and severe consequences associated with this disease are among the top questions, Dr. Howard A. Burris III, FACP, FASCO, the president of ASCO, said in a press statement.

Another study announced at the ASCO conference showed that people with lung and other thoracic cancers who were treated with chemotherapy within 3 months of their COVID-19 diagnosis had an increased risk for death compared to other treatment methods.

In an analysis of data on 400 cancer patients, researchers concluded that only the patients treated with chemotherapy, either alone or in combination with other therapies, had a significantly increased risk (64 percent) of dying from the virus compared to people who didnt receive chemo.

In a presscast, the registrys lead author, Dr. Leora Horn, a cancer researcher and director of the thoracic oncology program at Vanderbilt University Medical Center, said that research on COVID-19 and cancer death continues to evolve.

In a press release, Burris added that there are still more questions than answers, but that these findings give us some insights into outcomes for patients with cancer who develop COVID-19.

Dr. Matthew Cook, the founder of BioReset Medical, an integrative clinic that specializes in regenerative and functional medicine, says the interplay between COVID-19 and cancer inevitably involves the bodys immune system.

Chemotherapy, radiation, immunotherapy, and the cancer itself can all have a suppressing effect on the immune system, said Cook, whose medical approach is to use the most noninvasive, natural, and integrative ways possible to achieve optimal health.

Cook told Healthline that he works in cooperation with oncology to get best results for his cancer patients.

We take a fairly traditional approach. We are looking at all the bodys systems to see if there are problems that we can optimize, he said.

For example, he notes that the gastrointestinal system and the immune system are intimately connected, and that the traditional medical world is beginning to embrace this concept.

I think the oncology community is evolving into accepting some modalities that are integrative. Our goal is to try to take all that into consideration and then develop a treatment plan that supports their immune systems, Cook said.

While people with cancer are between a rock and a hard place when it comes making decisions about treatment, Cook says, the relative risk of a cancer patient getting an infection with the new coronavirus remains low.

Patients with these conditions just need to have a very careful approach and limit their exposure and risk of infection, he said.

In broad terms, I would say that people are generally well served by following their physicians guidance and, in most cases, moving forward with their cancer therapy, depending on their circumstances in life, Cook said.

Cancer patients and physicians have actually known about these risks for a long time. Patients with cancer who are on chemotherapy are already immunocompromised. We already know how to give them the best ways of protecting themselves, he added.

Binzee Gonzalvo, 47, a university lecturer in Tokyo, Japan, whos currently receiving treatment for marginal zone lymphoma, is being careful and using common sense.

Hes read the new statistics on cancer death and COVID-19. And while it does give him pause, hes decided to move forward with his treatment.

Its not the best timing to have a cancer diagnosis or relapse. Im just dealing with it the best way forward given the circumstances, Gonzalvo told Healthline. I had to be proactive and consider that in my decision making process. I have stayed indoors at home the whole time, with the exception of treatment days.

He adds that he wears a mask thats used for medical staff, and he purchased protective glasses to wear when using public transportation to his cancer center.

So far, so good and on schedule regarding treatment, Gonzalvo said.

He notes that COVID-19 has affected communication with his hematologist.

He was assigned to a COVID-19 task force, and so for my appointments in May for my second treatment, I had to talk with another hematologist who covered for him, Gonzalvo said.

However, he added on a positive note, Im staying strong with hope.

People with cancer and survivors of the disease are also finding it increasingly difficult to get necessary healthcare as the COVID-19 pandemic persists.

Many are experiencing financial stress and mental health issues as they try to navigate the difficult health and economic environment.

A survey by the American Cancer Society Cancer Action Network (ACS CAN) of cancer patients and survivors found that 87 percent of respondents have had their healthcare affected by the COVID-19 pandemic in some manner. That was up from 51 percent in an April survey.

Of those in active treatment, 79 percent reported delays to their healthcare, including 17 percent of patients who reported delays to cancer therapies such as chemotherapy, radiation, or hormone therapy.

The most commonly reported effects for those in active treatment were for changes to in-person cancer provider appointments (57 percent) as well as delays in access to imaging services (25 percent) and surgical procedures (15 percent).

About 20 percent reported delayed access to supportive services, including physical therapy or mental healthcare.

Nearly 1 in 4 patients surveyed say the pandemic has made it more difficult to contact their providers with questions about their healthcare needs.

And 1 in 5 say theyre worried their cancer could be growing or returning due to delays and interruptions caused by the COVID-19 outbreak.

The situation is getting worse, not better for cancer patients during this pandemic, Lisa Lacasse, president of the ACS CAN, said in a statement.

Health practitioners continue to work to balance safety for an immunocompromised population at increased risk for contracting COVID with timely treatment to prevent the spread of cancer. Unfortunately, this results in delays in treatment for many cancer patients, she said.

Amid the fear and anxiety caused by COVID-19, theres also good news for people receiving cancer treatment.

At the annual ASCO conference, a variety of new data on treatments for numerous types of cancer showed promise in clinical trials.

For example, the Food and Drug Administration has given the fast track designation to ME-401, an oral treatment from MEI Pharma for people with relapsed or refractory follicular non-Hodgkins lymphoma (NHL).

Follicular NHL is the most common subtype of low-grade (indolent) lymphoma, making up as much as 30 percent of all non-Hodgkins lymphomas.

Follicular lymphoma is treatable but doesnt have a current cure. For cases that dont respond to two prior treatments, next steps can be difficult to decide. There are few viable options.

MEI Pharma is conducting an ongoing phase II clinical trial called TIDAL thats evaluating ME-401 for cases of follicular lymphoma that havent responded to at least two prior systemic therapies, including chemo and an anti-CD20 antibody.

Daniel Gold, PhD, president and CEO of MEI Pharma, said in a press statement hes excited to continue expanding the opportunity that ME-401 represents for cancer patients.

We are particularly encouraged that the follicular lymphoma patients in the Phase 1b study the focus of our ongoing Phase 2 TIDAL study now have a median time on therapy in excess of 1 year with responses that are durable to date while remaining generally well-tolerated, he said.

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People with Cancer Have to Choose Between Treatment and COVID-19 Risks - Healthline

Save your business while saving lives, reads the website of Because Health, a Seattle tech startup selling two types of tests to employers willing to pay $350 a pop to learn whether their workers have been infected with COVID-19.

The Workplace Health plan includes not only nasal swab tests to detect infection, but also blood tests aimed at indicating whether workers have developed antibodies to the virus and, possibly, future protection.

Theres a tremendous consumer demand, said Dr. Lars Boman, the Boston-based medical director for the firm. Can they return to work? Can they return to life?

What the website does not make clear, however, is that public health officials have explicitly warned that antibody tests should not be used to make decisions about workplace staffing.

This is a personal choice of the business, of the consumer, Boman said.

Across America, untold numbers of employers, employees and ordinary citizens are turning to a slew of sometimes pricey new COVID-19 blood tests. Knowing whos already been infected could have important implications for understanding the spread of the disease, scientists say. But serious questions about the accuracy of some of the serology tests and the usefulness of the results they provide have prompted the federal Food and Drug Administration to try to rein in what several infectious disease experts described as the wild, wild West of antibody testing.

It does look as if companies sprang up overnight both importing these tests and distributing them, said Dr. Michael Busch, director of the nonprofit Vitalant Research Institute in San Francisco. Its outrageous that people were trying to make money off of this fear.

More than 200 tests have flooded the market in a matter of weeks, promising to detect antibodies, which are proteins that develop in the blood as part of the bodys immune response to an invading virus. These are different from the molecular tests, typically done with nasal swabs, used to diagnose infection.

As of June 1, only 15 antibody tests had received FDA emergency-use authorizations, which allow tests that havent been fully vetted to be used in a crisis. Even that standard has become a selling point for some large companies, such as LabCorp and Quest Diagnostics, which emphasize that they rely on tests that have received the FDA nod.

In late May, the FDA removed more than 30 serology tests from a list of commercially available kits, saying they should not be distributed for sale. Removal could result from a manufacturer not submitting an emergency-use authorization request within a reasonable period of time, or if the test shows significant problems that cannot be or have not been addressed in a timely manner, the agency said. The manner of enforcement remains unclear.

Last month, the CDC issued new guidelines warning that, given the low prevalence of the virus in the general population, even the most accurate tests could be wrong half of the time.

Serologic test results should not be used to make decisions about grouping persons residing in or being admitted to congregate settings, such as schools, dormitories, or correctional facilities, the guidelines state. Serologic test results should not be used to make decisions about returning persons to the workplace.

Such tests are most useful for understanding the epidemiology of the virus, not for making individual decisions, said Dr. Mary Hayden, director of the division of clinical microbiology at Rush Medical Laboratories in Chicago. Even the best tests cant yet answer the crucial question about whether antibodies confer immunity from future COVID infections, Hayden said.

The best possible scenario is that people get infected and they have protective immunity for a long time, she said. That would be awesome. But we just dont have that right now.

But a plethora of tests being pitched to consumers explicitly promise results aimed at allowing a return to work, school and other social arenas.

The tests offered by Because Health are among hundreds churned out since March, ranging from those offered by commercial labs and academic research centers to small developers seeking a toehold in the lucrative market spurred by a global pandemic. Because Health is using two antibody tests in tandem, one of which received emergency-use authorization on May 29; the other is still pending.

Anders Boman, the son of the medical director and co-founder of Because Health, said that until the COVID crisis occurred, the company, which launched in Seattle last year, was focused on a niche of integrative care and sexual health, including hormone treatments for men and women.

Consumers are not concerned about sexual health right now, Boman said, explaining the change in focus. Theyre concerned about how to get back to work, how to return to normal and are they safe?

The FDA normally follows a stringent approval process for tests to detect diseases, often a costly effort that can take months or years. That typically requires independent validation of the accuracy of the tests. But after being criticized for the fumbled rollout of diagnostic tests during the start of a global pandemic, the FDA swung hard in the other direction, waiving its usual requirements and letting firms rush self-validated tests into the market.

They sort of relaxed all regulatory oversight, Hayden said.

Several experts interviewed by Kaiser Health News said the FDA faced tremendous political pressure to make antibody tests available.

It was really a single pressure and that was the fact that the original inability to get a [diagnostic] test on the market in the U.S. as the outbreak escalated means they were trying to do basically everything they could to get these out, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

The relaxed rules drew concern from Congress, where a subcommittee of the Committee on Oversight and Reform detailed the FDAs failure to police the test market. Groups such as the Association of Public Health Laboratories also raised questions. Scott Becker, the APHLs chief executive, said he spoke to top officials at the U.S. Department of Health and Human Services in early April.

We just let loose and we said, This is a really bad policy, Becker said. Were going to get flooded and were going to lose control of quality. Were not going to know what to do with the results.

Thats exactly what has happened, said Osterholm. The FDA needs to bring much more discipline to this area and they need to articulate it clearly, he said.

A key issue is the accuracy of the tests, which rely on measures known as sensitivity and specificity. A highly sensitive test will capture all true positive results. A highly specific test would identify all true negative results.

In April, researchers at the University of California-San Francisco, led by immunologist Dr. Alexander Marson, analyzed 14 COVID-19 serology tests on the market and found that all but one turned up false-positive results, indicating that someone had antibodies to the coronavirus when they actually did not. False-positive rates reached as high as 16% in the study, which has not yet been peer-reviewed.

Unreliable results worry Dr. Jeff Duchin, the public health officer for Seattle and King County, Washington, where the first surge of COVID cases emerged in the U.S. A person who tests positive for antibodies that dont exist may mistakenly believe he or she is free to ignore guidance about preventing infection, potentially spreading the disease. Regardless of whether you test positive or negative, the workplace still needs to take steps, he said. They shouldnt think a testing program in any way relieves them of that responsibility.

FDA officials said theyre working now with the National Cancer Institute to independently validate serology tests on the market. Until that list is public, users must rely on the relatively few that have received the emergency-use authorizations to date. More than 190 others have asked for that authorization, pending FDA review.

But consumers may have little control, because they are most likely getting tests from their employers or doctors, with little understanding of why those products were chosen.

There isnt a national standard, there isnt a one-stop shop or a Consumer Reports for antibody tests, Becker said. I dont expect a member of the public is going to be able to figure this out.

Even savvy physicians can have trouble. US Acute Care Solutions, a physician-owned medical services group, was trying out a Chinese-made test supplied by Minneapolis-based Premier Biotech, with plans to test its staff of more than 3,500 doctors and employees, said the groups chief medical officer, Dr. Amer Aldeen. That test has been widely used, including in recent controversial serology surveys conducted by Stanford University and the University of Southern California.

When USACS used it, the Premier test failed to detect antibodies in several employees who had been ill and tested positive for the coronavirus on diagnostic tests, Aldeen said. The results could have been caused by faulty instructions rather than flaws in the test itself, he said. Still, the Premier test has not received FDA authorization and the results gave him pause.

It does no good to select a test that isnt FDA-approved, he said.

In a statement, Premier Biotech officials said they anticipate exceeding FDA standards, which call for tests that are at least 90% accurate in identifying positive antibodies in a sample and 95% accurate in identifying samples that contain no antibody.

Some might ask why the FDA didnt just identify several reliable antibody tests and require their use to avoid the chaos. An FDA official said making that type of choice would be outside the scope of the agencys responsibilities.

FDAs lane is to review these tests and make sure that they are safe and accurate for the American people, said spokesperson Emma Spaulding. It wouldnt be within our lane to say which test must be used.

Although health officials understand the desire for a test that could provide comfort amid the uncertainty of COVID-19, Duchin advised employers and consumers to wait a little longer.

There are costs to testing with unvalidated tests that might outweigh the benefits of satisfying your curiosity, he said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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JoNel Aleccia, Kaiser Health News and Anna Maria Barry-Jester

Kaiser Health News

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

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Hype Collides With Science As FDA Tries To Rein In Wild West of COVID Blood Tests - Physician's Weekly

Medication abortion, also known as medical abortion or abortion with pills, is a pregnancy termination protocol that involves taking two different drugs, Mifepristone and Misoprostol, that can be safely used up to the first 70 days (10 weeks) of pregnancy. Since the U.S. Food and Drug Administration (FDA) first approved the drug in 2000, its use in the United States has quickly grown, with over a third of abortions at 8 weeks gestation or less being medication abortions. While this protocol involves taking two medications, and does not involve a medical procedure, it is subject to many of the same abortion specific provider restrictions as other abortion methods, at both the state and federal levels. This factsheet provides an overview of medication abortion, with a focus on federal and state regulations pertaining to its provision and coverage, and the role of the drug in self-managed abortions.

The most common medication abortion regimen in the United States involves the use of two different medications: mifepristone and misoprostol. Mifepristone, sold under the brand name Mifeprex and also known as the abortion pill, RU-486, blocks progesterone, a hormone essential to the development of a pregnancy, and thereby prevents an existing pregnancy from progressing. Misoprostol, taken 24-48 hours after mifepristone, works to empty the uterus by causing cramping and bleeding, similar to an early miscarriage. A follow-up visit is typically scheduled a week or two later, to confirm that the pregnancy was terminated via ultrasound or blood test. Medication abortion is a safe and highly effective method of pregnancy termination if the pills are administered at 9 weeks gestation or less, the pregnancy is terminated successfully 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%).

Until 2019, mifepristone was only sold under the brand name Mifeprex, manufactured by Danco Laboratories. The FDA first approved Mifeprex in 2000, and in 2016, the FDA approved a new evidence-based regimen and drug label, which guides current clinical practice. This regimen approves use of medical abortions for up to 70 days (10 weeks) of pregnancy (Table 1).

Mifepristone cannot be dispensed by retail pharmacies like most other medications; rather pregnant patients can only obtain the drug directly from a certified medical provider who has filled out a prescriber agreement form from the manufacturer about the proper use of the drug. This is because the FDA has applied a Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex since 2011 (See Box 1).

If the FDA decides these measures are not sufficient to safely allow the drug on the market, the agency may require a more stringent version of REMS, including one or more Element to Assure Safe Use (ETASU). More than half of the currently approved REMS programs have one or more ETASU. FDA guidelines stipulate that an ETASU must be commensurate with the specific serious risk listed in the drugs labeling, and must not be unduly burdensome on access to the drug, especially for patients with serious or life-threatening diseases and who have difficulty accessing healthcare.

A variety of organizations, such as the American College of Obstetricians and Gynecologists (ACOG), support the elimination of REMS regulations for mifepristone, which they maintain are medically unnecessary and impede access to medical abortion. The former FDA commissioner, Jane Henney, and physician Helene D Gayle published a perspective arguing that the FDA should reevaluate the REMS regulations, in light of studies that show mifepristone as safe and effective. Some advocates suggest that the REMS process limits the pool of providers and consequently delay care for pregnancy patients, as they must search for certified providers. Finally, some providers are challenging the REMS designation for mifepristone in court.

The FDA guidelines and label for Mifeprex apply equally to the approved generic. The FDA-approved REMS program for Mifeprex, and now, the generic mifepristone, also includes Element to Assure Safe Use (ETASU), a stronger version of REMS, and contains three provisions:

On October 3, 2017, the American Civil Liberties Union (ACLU) filed a lawsuit, on behalf of a group of providers, against the FDA challenging the REMS requirements for mifepristone. These plaintiffs cite the low rate of complications associated with medical abortions and assert that other drugs with similar or more serious risks do not have REMS restrictions, and are unduly burdensome on patients trying to access the drug, particularly patients in rural or medically underserves areas. The District Court of Hawaii is waiting to take action on this case until the Supreme Court issues a decision in June Medical Services LLC v. Russo which involves both the third-party standing of providers to bring legal challenges on behalf of their patients, and the assessment of undue burden in abortion cases. In May 2020, the ACLU filed another lawsuit challenging the REMS requirement that mifepristone be dispensed in-person; this wasfiled on behalf of the American College of Obstetricians and Gynecologists (ACOG), in addition toother organizations.

Federal and state-level regulations have effectively limited the use of mifepristone, particularly in underserved areas without a nearby clinic. Studies show providers of medication abortion are mostly concentrated where surgical abortion is already available. Many state laws regulating abortion providers apply to all types of abortion procedures. For example, 17 states require the clinic to meet structural standards comparable to ambulatory surgical centers, such as maintaining standard operating rooms, surgical examination tables, and more. Seven states require that abortion providers have hospital admitting privileges or an alternative arrangement in place. Many states have also passed laws specifically pertaining to medication abortion, such as specific counseling and provider requirements. Currently, the 33 states permit only licensed physicians to dispense mifepristone pills (Figure 1). Research demonstrates that advanced practice clinicians (APCs), such as nurse practitioners, physician assistants, or nurse-midwives, can dispense provide abortion pills as safely as physicians can, but they are only permitted do to so in 17 states and DC.

Arkansas, Idaho, Kentucky, Nebraska, Oklahoma, South Dakota, and Utah have enacted laws that require providers to counsel patients that medication abortion may be reversed if given a high dose of progesterone after taking mifepristone despite a lack of scientific evidence to support this claim. Similar laws were passed in Arizona, North Dakota, and Kansas, with courts blocking the laws in Arizona and North Dakota, and the Governor vetoing the bill in Kansas.

Insurance coverage for abortion is heavily regulated at both the federal and state level. Since 1977, the federal Hyde Amendment has banned the use of any federal funds for abortion, unless the pregnancy is a result of rape, incest, or if it is determined to endanger the womans life. After the FDA approved Mifeprex in 2000, this law also applied to medication abortions. However, a 2019 study from the U.S. Government Accountability Office (GAO) found that 14 state Medicaid programs do not cover mifepristone even in the cases of rape, incest, and life endangerment as is required by the Hyde amendment.

States also regulate fully insured private insurance, including plans on the Affordable Care Act (ACA) Marketplaces. 11 states limit abortion coverage in private insurance plans some of these states follow the Hyde exceptions, while others are more restrictive. In 2020, 33 states had no ACA Marketplace plans that offered abortion coverage, with 26 states categorically banning it. Several plans that offered coverage for abortion procedures did not cover medication abortion, and some plans that did offer abortion coverage had differences in gestational limits, annual/lifetime caps on claims, and coverage of mifepristone. Conversely, six states (California, Illinois, Maine, New York, Oregon, and Washington) require all state-regulated private health plans (including Marketplace plans) to include abortion coverage. Self-insured plans are not regulated by state insurance law, and federal law does ban or require abortion coverage in self-insured plans. Although there has been no recent research on abortion coverage offered by fully insured plans in the remaining 33 states and the District of Columbia, Danco Laboratories offers a collection of state payer policies and how they relate to Mifeprex.

In 2014, the average amount paid for a medication abortion up to 10 weeks was $535, while the average amount paid for an abortion in a clinic and local anesthetic was $508. Although Danco Laboratories does not make the cost of Mifeprex public, providers report that Mifeprex costs them around $90 a pill. GenBioPro, the manufacturer of the generic mifepristone drug also does not report the cost of their pill, but has stated that they want to drive down costs for those who choose medication abortion.

For those who do not have abortion coverage, there are other a limited means of financial support, promoted on both Danco and GenBioPros website. The National Abortion Federation, as well as local abortion funds are sometimes able to cover some of the cost of an abortion (including travel) for a pregnant person. Outside of these funding sources or a sliding fee scale clinic, there are few options to help with abortion costs.

Although the overall rate of abortion has continued to decline, the use of medication abortion has greatly increased over the years, and now makes up roughly 41% of all abortions at 8 weeks gestation or less (Figure 2).

According to Danco Laboratories, by 2016, over 2.75 million women in the United States have used Mifeprex since its FDA approval in 2000. Data from the Centers for Disease Control and Prevention (CDC) shows that from 2007 to 2016, reported abortions at 8 weeks gestation or less increased by 2.5%, while reported abortions between 9-13 weeks decreased by 7.9%. A 2017 Guttmacher Institute Report found that medication abortion performed up to 9 weeks gestation accounted for 39% of all nonhospital abortions.

Telemedicine, or telehealth, can be used to expand access to health services in areas where the number of providers is limited. Many women, particularly those who live in rural communities, have to travel long distances to obtain abortion services, which has raised interest in the potential of telemedicine to expand access medication abortion. Because the newest FDA label allows women to take the pills after leaving the clinic, telemedicine has emerged as a viable option to expand the availability of abortion to women who are either unable to travel to clinic or for other reasons wish to have an abortion in the privacy of their own home.

As part of efforts to limit abortion access, many states have taken action to block the use of telemedicine for abortion. Six states, Arizona, Arkansas, Idaho, Missouri, Louisiana, and West Virginia, have passed laws specifically banning telemedicine for abortion provision. In addition, 15 other states have enacted laws that require the clinician providing a medication abortion to be physically present during the procedure, effectively prohibiting the use of telemedicine to dispense medication for abortion remotely (Figure 3).

Self-managed abortion, sometimes referenced as self-induced or at-home abortion, is when a person ends a pregnancy outside the medical care setting, typically by ordering abortion pills online. This practice is legal in the U.S., but is permitted in some other countries. Women may w may seek to manage their own abortion for many reasons, including clinic access barriers, cost, transportation, and privacy. The median cost of mifepristone-misoprostol products ordered online is approximately $205, about half of the average charge for a clinic abortion. Legal barriers, such as the threat of criminal charges, to self-managed abortion affect pregnant people as well as those who help them in ending their pregnancy.

Women Help Women, which already operates to provide pills to women in other countries, recently launched Self-managed Abortion; Safe and Supported (SASS), to provide information about self-managed medication abortion to women in the United States. However, due to legal barriers, they do not ship pills to women in the United States. A few projects, such as the Plan C Campaign, are now working to inform women in the US about self-managed abortions, including how to appropriately take the drugs, how they might access funds to pay for them, and a list of online retailers with reviews on price, ship time, product quality, and physician oversight. The FDA has issued warning letters to some of these organizations, including Aidaccess.org and RAblon, asking them to immediately cease the introduction of abortion medications into the U.S., as mifepristone may only be legally dispensed using the REMS protocol.

Even as overall rates of abortion decline, the use of medication abortion has grown significantly since its approval by the FDA in 2000. The drugs availability may have shifted the average time abortions occur to earlier in pregnancy. Its uptake, however, has been limited by federal and state regulations. Including the FDA REMS requirement, bans on telemedicine and requirements for in person dispensation of mifepristone, and requirements for in person counseling visits and other tests that are not medically recommended for safety. While some states continue to impose regulations that restrict access, others are exploring ways of increasing access by allowing non-physician clinical providers to prescribe mifepristone and testing the effectiveness of telemedicine to expand access to abortion services for those who seek them.

Read the original here:
The Availability and Use of Medication Abortion - Kaiser Family Foundation

Most American women use some type of contraception in their lifetimes, according to the Centers for Disease Control and Prevention. Nearly 13% of women aged 15 to 49 are currently on the pill, while about 10% use an intrauterine device or contraceptive implant.

Those birth control options are often touted as safe and effective methods for preventing pregnancy or addressing hormonal imbalances.

But Dr. Jolene Brighten suggests that isnt the whole story. Dr. Brighten, a naturopathic physician and womens health specialist by training, explores the effects hormones can have on womens health.

Dr. Jolene Brighten teaches women about the effects of birth control.

Thats why she wrote the book Beyond the Pill: A 30-Day Program to Balance Your Hormones, Reclaim Your Body, and Reverse the Dangerous Side Effects of the Birth Control Pill, to delve deep into the issues that can arise with the use of the pill.

I wanted to provide women with a users manual for their bodies and give them the information I wish Id been given early in life, Dr. Brighten said.

If women are diagnosed with a hormonal issue, theyre often offered the pill as the first or sometimes only solution. But Dr. Brighten seeks to educate women about the effects hormone imbalances can have on their well-being. The book also offers advice to remedy these imbalances through lifestyle changes, supplements, and nutritional modifications.

Some women experience side effects when they start birth control, including hair loss, lagging libido, extreme fatigue, and chronic infection. And those issues arent always taken seriously by their doctors. But women may not realize that they dont have to live with those problems. Dr. Brighten discusses in her book how to locate the root cause of hormonal issues, attain a pain-free, manageable period free of cramps, acne, stress or PMS, and how to support liver detox, among other helpful topics.

The book also provides them with tools to have a more productive conversation with their doctors and monitor and support their health if they do choose hormonal birth control, Dr. Brighten said.

In addition to books, her website, http://www.drbrighten.com, has articles and resources to help women identify their symptoms and have more informed interactions with their doctors.

Dr. Brighten said she doesnt think women always have the right tools to understand their own bodies. Instead, she believes that women are often recommended birth control without clearly understanding its risks.

Birth control can lead to a variety of issues in women, including thyroid dysfunction, adrenal problems, loss of libido, menstrual irregularities, PMS, and anxiety.

Women dont always link these problems to birth control or hormones, however. Until they read Dr. Brightens writings or consult with her, many believe they have to live with these symptoms.

We serve women all over the world who are struggling and feeling dismissed by doctors about their concerns, Dr. Brighten said.

But Dr. Brighten said she doesnt think that birth control is inherently bad. Instead, she said she believes that women should have all the information about it when making choices about what to put in their bodies.

I advocate for informed consent and want to support women in making the best decisions for themselves and staying healthy regardless of what decision that is, Dr. Brighten said.

In addition to her two books, Dr. Brighten and her team are always adding new content to her website and social media channels. The information comes from a variety of people with different backgrounds, as several members of the team have masters or doctoral degrees in public health or nutrition science. Others have personally struggled with their hormones or have seen their loved ones face issues.

Our teams mission is to help women take back their health by putting the foundational medicine in their hands, helping them understand their bodies, and advocate for better care from their providers, Dr. Brighten said.

In addition to reaching a global audience with her writing, Dr. Brighten is also a clinician who works with clients.

In her clinical practice, she focuses on teaching women to make better choices that support their wellness. Often, that focus turns to diet and supplement changes to promote hormonal balance.

Dr. Brightens expertise on the connection between womens hormones and nutrition informs those recommendations. She also shares that nutritional healing advice on her website.

As both my family and myself leverage supplements, I wanted to have a line of the highest quality products I could trust to give to my family and take myself. One of our core values is to think about our customers like our family, Dr. Brighten said.

Dr. Brighten offers a line of nutritional and herbal supplements that promote hormone health.

With that goal in mind, Dr. Brighten and her team created a line of nutritional and herbal supplements designed to support hormonal health. She began creating a supplement line when pursuing her degree in nutrition. During her research, she discovered that supplement quality varied considerably from product to product. So she decided to develop a standard, wholesome line of supplements to boost womens health.

Women struggling with digestive problems can benefit from Dr. Brightens Gut Rebuild supplements. If they feel like Omega-3, vitamin B, or magnesium are lacking in their diet, they could take a supplement or two every day to boost their health. Dr. Brighten also offers products that support balance, the adrenal glands, and prenatal health.

Women can either take supplements for a limited time or subscribe to have them delivered to their home once a month.

We aim to provide exceptional products that help women take back their hormones and their health, Dr. Brighten said.

Dr. Brighten has helped many women understand their bodies over the years. And plenty of them have spoken about the impact her work has had on their lives.

One client said, If it wasnt for Dr. Brightens work I wouldnt have my son. After all doctors gave up on me, I made an appointment to see her for one last chance at getting pregnant. She is warm, funny, and incredibly knowledgeable.

Even with all of the praise, Dr. Brighten is not resting on her laurels. Shes working on her next book, based on the feedback shes received from the community about the support women need.

Furthermore, Dr. Brighten said she aims to expand her website to become even more of a go-to resource for womens health. As the so-called Google of Womens Health, the site offers a wealth of advice relevant to improving womens lives.

She also said she plans to continue her research on post-birth control syndrome (PBCS), a collection of symptoms that occur after women discontinue birth control. Her recent book was the first to include a conversation on the topic.

We provide medically accurate information regarding womens bodies, health, and options. My primary aim is to give women information, so they know what steps to take to reduce their risk of side effects and when they need to advocate for themselves with a doctor, Dr. Brighten said.

Read the original post:
Dr. Jolene Brighten Helps Women Understand the Effects of Birth Control on Their Bodies and Hormones - DatingNews

COVID-19 emerged just over six months ago and in this short span of time, researchers have found a lot about the disease. So far, it is known that men, the elderly and those with co-morbidities are at a higher risk of severe COVID-19.

Now, a group of researchers suggest that men with male pattern baldness (or androgenic alopecia) are more likely to develop severe COVID-19. The link has been proposed on the basis of two different studies on patients in Spain.

The researchers are calling this risk factor the Gabrins sign after Dr Frank Gabrin, the first US physician to die of COVID-19. Dr Gabrin had androgenic alopecia and he was also fighting bilateral testicular cancer.

The studies

For the first study, 41 COVID-19 patients with bilateral pneumonia were analysed. They were all Caucasian men. Out of them, 71 percent had clinically significant androgenic alopecia (AA) while the rest 29% had some signs of the AA. A total of 39% had severe AA.

For the second study, the researchers studied 175 COVID-19 patients. The male to female ratio was 2.3:1. Out of the group, about 79% of the men and 42% of the women had androgenic alopecia. However, most women were in the older age group as compared to men.

Representational image. Image by Ira Lee Nesbitt from Pixabay

Androgenic alopecia, androgens and SARS-CoV-2

Androgenic alopecia is the most common cause of hair loss in men. Though it also occurs in women, the pattern of hair loss differs in both genders. As per the US National Library of Medicine, in men, hair loss occurs at the temples and crown and leads to a receding hairline whereas in women, this hair loss is from all over the head and there is no receding of the hairline. Also, the condition may lead to complete baldness in men but not in women.

Though the exact cause of the condition is unknown, experts suggest that it occurs due to variations in the androgen receptor gene located on the X chromosome. Androgens are male hormones such as testosterone and dihydrotestosterone. These variations increase the activity of androgen receptors. It has been previously shown that an increase in the expression of the androgen receptor gene leads to higher activity of a protein that activates the spike protein of SARS-CoV-2 virus, which, in turn, helps it bind to the ACE-2 receptors.

More things to consider

In the first study, the authors mentioned that it was only based on visual diagnosis and no information was available on whether any of the people in the study already had got anti-androgen treatment as it would then change the finding of the study.

Regardless, it was suggested that that given the association, anti-androgen therapy may be beneficial for COVID-19 patients.

The study also pointed out that hydroxychloroquine (HCQ), the most debated drug for COVID-19, has shown some androgen (specifically, testosterone) reducing action in mice and a combination of HCQ and itraconazole is currently being studied for prostate cancer treatment. Androgens promote the growth of prostate cancer so those with the disease are given hormone therapy to reduce the production or use of androgens in the body.

For more information, read our article on Baldness.

Health articles in Firstpost are written by myUpchar.com, Indias first and biggest resource for verified medical information. At myUpchar, researchers and journalists work with doctors to bring you information on all things health.

See the original post:
People with male pattern baldness may be more susceptible to severe COVID-19, says study by Spanish... - Firstpost

PHILADELPHIA The pandemic is helping U.S. abortion-rights advocates achieve a long-standing goal: Make it easier for women to use pills to end pregnancies up to 10 weeks.

Federal and state regulations have restricted access to medication abortion ever since the Food and Drug Administration approved it two decades ago. Nonetheless, use of the two-drug regimen has grown steadily, accounting for at least 40% of all abortions, even as the national abortion rate has fallen to historic lows, data show.

Before the coronavirus made seeking medical care in person risky for both patients and providers, efforts were well underway to expand access to abortion pills through telemedicine and mail-order pharmacies. Now, those efforts are accelerating and multiplying because suddenly a divisive political issue is also a matter of public health.

For patients seeking abortion, urgent modifications of current protocols are needed to ensure that patients can continue to obtain this time-sensitive treatment while limiting transmission of infection, 11 prominent reproductive health experts wrote last month in the journal Contraception.

The group, led by obstetrician-gynecologist Elizabeth Raymond, proposed reducing in-person clinic visits by eliminating ultrasounds and other tests that research shows are unnecessary for a safe, effective pill-induced abortion.

Planned Parenthood Southeastern Pennsylvania, which adopted the test-less approach in mid-March, quickly saw a shift. Although the total number of medication and surgical abortions remained about 800 a month, the proportion that used pills increased from 55% before the pandemic to 65% now.

We wouldnt be offering it if it werent safe, said Dayle Steinberg, president and CEO of the Southeastern Pennsylvania affiliate. The pandemic is showing us that we have to be nimble and adapt.

WHEN PRECAUTIONS BECOME DANGERS

Some background: Medication abortion starts with a pill called mifepristone, which blocks a hormone vital to pregnancy. That is followed 24 to 48 hours later by at least two misoprostol pills, which induce contractions. (Misoprostol is also used to treat stomach ulcers.)

In 2000, when the FDA made the controversial decision to approve mifepristone, it imposed stringent safety requirements. The drug can be dispensed only by specially certified health-care providers and only in clinics, hospitals, and medical offices not pharmacies like most prescription drugs.

Medical societies and public health experts have called on the FDA to remove the restrictions. Physician Jane E. Henney, FDA commissioner when mifepristone was approved, added her voice last year. Last month, so did Democratic Sens. Elizabeth Warren and Patty Murray, urging a reevaluation in light of the growing coronavirus disease pandemic.

The FDA has not budged, even though its own review says medication abortion has been increasingly used as its efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare.

Advocates have not been deterred by the FDAs inflexibility.

Over the last year, Gynuity Health Projects a New York City-based nonprofit that Raymond joined in 2010 has expanded its FDA-approved study of medication abortion via telemedicine from five states to 13. It enables women to have video conferences with certified doctors, then get the pills mailed to them to take at home.

Still, Gynuitys TelAbortion has served fewer than 1,000 women over more than three years. Partly, thats because the FDA requires all study participants to have an initial in-person visit and an ultrasound to make sure they are no more than 10 weeks pregnant.

BENDING THE RULES

Studies have shown an ultrasound is unnecessary; only 1% of women do not accurately recall the date of their last menstrual period, and medication abortion still works for the vast majority of them. Other parts of the typical medication abortion protocol a pelvic exam, blood tests, and a return visit to confirm the termination are also unneeded, research shows.

Thats why Raymond and her 10 colleagues wrote the Contraception article, which laid out a protocol for evaluating, treating, and following up with patients in a way that would bend but not break the FDA rules.

Although FDA-imposed restrictions on mifepristone may require patients to present to the abortion facility to obtain the drug, this protocol would enable every other part of the medication abortion process to be implemented without any in-person encounter, they wrote.

Nothing like an epidemic to accelerate innovations, Raymond said in an interview.

Abortion foes denounce such innovations as endangering womens health. So far, 18 states have enacted various laws designed to ban the use of telemedicine in medication abortion. More recently, several states have tried to ban all abortions under pandemic emergency orders restricting elective medical procedures.

While the political divide is wider than ever, even abortion-rights activists dont agree on how much medical support women seeking medication abortion need or how best to provide it.

Numerous international websites ship abortion pills without prescription or any medical oversight to women who self-manage the termination in secret. Recognizing that the internet makes such uncounted abortions virtually unstoppable, public health researcher Elisa Wells cofounded Plan C, a website with a report card that rates such websites on product quality, price, and shipping time.

In early March, as the pandemic deepened, Plan C took another step toward helping women self-manage: It asked doctors across the country to register with one of the two FDA-approved manufacturers of mifepristone so they can obtain pills to mail to women in their homes.

FDA regulations say mifepristone must be dispensed in a facility, but Plan C maintains that dispensing is different than delivering.

Most doctors read the (FDA regulations) to say the pills cant be mailed, Wells said, adding that a handful of doctors have joined the new initiative. We disagree.

Aid Access, a mail-order abortion-pill service overseen by Dutch physician Rebecca Gomperts, has already been ordered to cease and desist by the FDA.

Gomperts set up Aid Access last year using the model of her first abortion-pill service, Women on Web, which serves women in countries were abortion is illegal. Basically, the pregnant woman consults online with the prescribing doctor, then gets a script to email to an Indian company that ships the pills. Instructions explain how to use the drugs, what to expect, and when to see a doctor if problems occur.

Although Gomperts didnt respond to a request for comment, she was recently quoted in the New York Times saying that the pandemic has fueled demand, with about 3,000 women requesting help from Aid Access since late March.

As for the FDA, Gomperts has a complaint against the agency pending in federal court. The FDA, she maintains, is trying to deny the constitutional right to abortion.

Dr. Gomperts has standing to assert the constitutional rights of her patients seeking medical abortions in the U.S., her legal brief says.

More here:
Coronavirus pandemic is fueling efforts to increase access to abortion pills - Greater Milwaukee Today

The world was gaslit by misreporting about George Floyds initial autopsy report. As concerned physicians, we write to deconstruct the misinformation and condemn the ways this weaponization of medical language reinforced white supremacy at the torment of Black Americans.

Gaslighting is a method of psychological manipulation employed to make a victim question their own sanity, particularly in scenarios where they are mistreated. The term comes from a 1938 play and, later, a popular film, wherein a predatory husband abuses his wife in a plot to have her committed to a mental institution. He dims the gas lights in their home; then, when she comments on the darkness, knowingly rejects her observation and uses it as evidence that shes gone insane. Its a torturous tactic employed to destroy a persons trust in their own perception of reality. Its a devastating distraction from oppression. Its insidious. And it happened recently when millions of people who had seen nine agonizing minutes of murder were told by an autopsy report that they hadnt.

In America, widespread anti-Black violence is often paired with structural gaslighting. Racism, after all, thrives when blame for its outcomes are misattributed. When Black families are refused loans in criminally discriminatory housing schemes, their credit is blamed. When youth of color are disproportionately stopped and frisked, they are told the process is random, and for their safety.

And when Black people are killed by police, their character and even their anatomy is turned into justification for their killers exoneration. Its a well-honed tactic. One analysis of the national database of state-level death certificate data found that fewer than half of law enforcementrelated deaths were reported. In addition to this undercounting, police actions were further minimized by the use of diagnostic codes that incorrectly labeled the cause of death as accidental or undetermined rather than police-related. For centuries, our systems have relied on this psychological torturea host of mental gymnasticsto deny the truth of what Black people have always known. The cause of death is racism.

On May 29, the country was told that the autopsy of George Floyd revealed no physical findings that support a diagnosis of traumatic asphyxiation, and that potential intoxicants and preexisting cardiovascular disease likely contributed to his death. This requires clarification. Importantly, these commonly quoted phrases did not come from a physician, but were taken from a charging document that utilized politicized interpretations of medical information. As doctors, we wish to highlight for the public that this framing of the circumstances surrounding Floyds death was at best, a misinterpretation, and at worst, a deliberate obfuscation.

A timeline of events illustrates how a series of omissions and commissions regarding Mr. Floyds initial autopsy results deceptively fractured the truth. On May 28, a statement released by the Hennepin County Medical Examiners office reported ongoing investigations and acknowledgement from the forensic pathologist that an autopsy must be interpreted in the context of the pertinent investigative information. As per standardized medical examination, Floyds underlying health conditions and toxicology screen were documented. These are ordinary findings that do not suggest causation of death, yet headlines and the May 29 charging document falsely overstated the role of Floyds coronary artery disease and hypertension, which increase the risk of stroke and heart attack over years, not minutes. Asphyxiasuffocationdoes not always demonstrate physical signs, as other physician groups have noted.

Without this important medical context, however, the public was left to reconcile manipulated medical language with the evidence they had personally witnessed. Ultimately,the initial report overstated and misrepresented the role of chronic medical conditions, inappropriately alluded to intoxicants, and failed to acknowledge the stark reality that but for the defendants knee on George Floyds neck, he would not be dead today.

By Monday, June 1, in the context of widespread political pressure,the public received two reports: the preliminary autopsy report commissioned by Floyds family by private doctors, andshortly thereaftera summary of the preliminary autopsy from the Hennepin County Medical Examiners Office. Both reports stated that the cause of Floyds death was homicide: death at the hands of another.

By inaccurately portraying the medical findings from the autopsy of George Floyd, the legal system and media emboldened white supremacy, all under the cloak of authoritative scientific rhetoric. They took standard components of a preliminary autopsy report to cast doubt, to sow uncertainty; to gaslight America into thinking we didnt see what we know we saw. In doing so, they perpetuated stereotypes about disease, risky behavior and intoxication in Black bodies to discredit a victim of murder. This state of affairs is not an outlierit is part of a patterned and tactical distortion of facts wherein autopsy reports are manipulated to bury police violence and uphold white supremacy. As Ida B. Wells said, Those who commit the murders write the reports. A similar conflict of interest between police departments and medical examiners offices continues today.

As physicians, we will not be complicit in the ongoing manipulation of medical expertise to erase government-sanctioned violence. Though we are relieved that two independent examinations invalidated the preliminary findings in the charging document and the headlines that deceitfully undermined Chauvins culpability in Floyds murder, our initial incense is not replaced by celebration.

For three days, Black Americans satand still sitwith the all-too-familiar pangs of being told that the truth is not true. Of fearing that the law would believe a physicians report over the reality they saw with their own eyes, and have lived with their own lives. It's a miscarriage of justice that deepens the cut; not only can Black people be killed with impunity; a physicians autopsy report can be twisted to replace the truth.

Medical science has long been used for the consolidation of power rather than for solidarity with the oppressed. We see how Black mothers are blamed for their own mortality in childbirth and how starkly high rates of COVID death in Black communities are preposterously misattributed to differences in hormone receptors or clotting factors; all the while letting racism off the hook.

We wish to remind fellow physicians that medical science has never been objective. It has never existed in a vacuum; there have and will always be social, political and legal ramifications of our work. Our assessments may be employed in criminal justice cases; our toxicology screens may have profound effects on the livelihood of patients; our diagnoses may perpetuate sexist and racist stereotypes. Our lack of ill intent cannot be our alibiwe must be accountable for not just our work but also how it is used, lest our medicine becomes the very weapon that harms. Medicine requires inclusion of the social context of disease in order to uphold its sacred oath of doing no harm. If we focus only on molecular pathways and neglect to articulate the role of structural inequitiesof racismin our country, our reports on the causes of death and injury in our patients will erase the roles of their oppressors.

We also write to remind our physician colleagues that the medical field is a place ripe for gaslighting. Bolstered by the perceived strength and legitimacy of a white coat and a stethoscope, our diagnoses and conclusionsabout physical or psychological abnormalities, about causes of illness and deathhave the power to eclipse reality, as weve seen in the case of George Floyd. Often, we stand by while other agents co-opt our frameworks, obscure our research and weaponize our language in the service of oppression.

The declarations, the truths, the realities of Black people in America are too often disregarded. Across the nation, Black people are suffocating under the weight of anti-Black hatred. They cannot breathe. And even as they gasp for air, structural gaslighting operates to deny the truths of the causes of their suffocation.

We write as physicians to denounce this psychological manipulation. We write to apologize for the discrimination our patients of color have received in the hospital under our watch, we write in gratitude for the tireless labor of Black activists, and we write to condemn how medicine has been weaponized in the service of white supremacy. We write to validate what Black people already knowhave always knownthat racism is a most pressing public health crisis. We pledge to fight this crisis as if our own breath depended on it.

Read this article:
George Floyd's Autopsy and the Structural Gaslighting of America - Scientific American

Save your business while saving lives, reads the website of Because Health, a Seattle tech startup selling two types of tests to employers willing to pay $350 a pop to learn whether their workers have been infected with COVID-19.

The Workplace Health plan includes not only nasal swab tests to detect infection, but also blood tests aimed at indicating whether workers have developed antibodies to the virus and, possibly, future protection.

Theres a tremendous consumer demand, said Dr. Lars Boman, the Boston-based medical director for the firm. Can they return to work? Can they return to life?

What the website does not make clear, however, is that public health officials have explicitly warned that antibody tests should not be used to make decisions about workplace staffing.

This is a personal choice of the business, of the consumer, Boman said.

Across America, untold numbers of employers, employees and ordinary citizens are turning to a slew of sometimes pricey new COVID-19 blood tests. Knowing whos already been infected could have important implications for understanding the spread of the disease, scientists say. But serious questions about the accuracy of some of the serology tests and the usefulness of the results they provide have prompted the federal Food and Drug Administration to try to rein in what several infectious disease experts described as the wild, wild West of antibody testing.

It does look as if companies sprang up overnight both importing these tests and distributing them, said Dr. Michael Busch, director of the nonprofit Vitalant Research Institute in San Francisco. Its outrageous that people were trying to make money off of this fear.

More than 200 tests have flooded the market in a matter of weeks, promising to detect antibodies, which are proteins that develop in the blood as part of the bodys immune response to an invading virus. These are different from the molecular tests, typically done with nasal swabs, used to diagnose infection.

As of June 1, only 15 antibody tests had received FDA emergency-use authorizations, which allow tests that havent been fully vetted to be used in a crisis. Even that standard has become a selling point for some large companies, such as LabCorp and Quest Diagnostics, which emphasize that they rely on tests that have received the FDA nod.

In late May, the FDA removed more than 30 serology tests from a list of commercially available kits, saying they should not be distributed for sale. Removal could result from a manufacturer not submitting an emergency-use authorization request within a reasonable period of time, or if the test shows significant problems that cannot be or have not been addressed in a timely manner, the agency said. The manner of enforcement remains unclear.

Last month, the CDC issued new guidelines warning that, given the low prevalence of the virus in the general population, even the most accurate tests could be wrong half of the time.

Serologic test results should not be used to make decisions about grouping persons residing in or being admitted to congregate settings, such as schools, dormitories, or correctional facilities, the guidelines state. Serologic test results should not be used to make decisions about returning persons to the workplace.

Such tests are most useful for understanding the epidemiology of the virus, not for making individual decisions, said Dr. Mary Hayden, director of the division of clinical microbiology at Rush Medical Laboratories in Chicago. Even the best tests cant yet answer the crucial question about whether antibodies confer immunity from future COVID-19 infections, Hayden said.

The best possible scenario is that people get infected and they have protective immunity for a long time, she said. That would be awesome. But we just dont have that right now.

But a plethora of tests being pitched to consumers explicitly promise results aimed at allowing a return to work, school and other social arenas.

The tests offered by Because Health are among hundreds churned out since March, ranging from those offered by commercial labs and academic research centers to small developers seeking a toehold in the lucrative market spurred by a global pandemic. Because Health is using two antibody tests in tandem, one of which received emergency-use authorization on May 29; the other is still pending.

Anders Boman, the son of the medical director and co-founder of Because Health, said that until the COVID-19 crisis occurred, the company, which launched in Seattle last year, was focused on a niche of integrative care and sexual health, including hormone treatments for men and women.

Consumers are not concerned about sexual health right now, Boman said, explaining the change in focus. Theyre concerned about how to get back to work, how to return to normal and are they safe?

The FDA normally follows a stringent approval process for tests to detect diseases, often a costly effort that can take months or years. That typically requires independent validation of the accuracy of the tests. But after being criticized for the fumbled rollout of diagnostic tests during the start of a global pandemic, the FDA swung hard in the other direction, waiving its usual requirements and letting firms rush self-validated tests into the market.

They sort of relaxed all regulatory oversight, Hayden said.

Several experts interviewed by Kaiser Health News said the FDA faced tremendous political pressure to make antibody tests available.

It was really a single pressure and that was the fact that the original inability to get a (diagnostic) test on the market in the U.S. as the outbreak escalated means they were trying to do basically everything they could to get these out, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

The relaxed rules drew concern from Congress, where a subcommittee of the Committee on Oversight and Reform detailed the FDAs failure to police the test market. Groups such as the Association of Public Health Laboratories also raised questions. Scott Becker, the APHLs chief executive, said he spoke to top officials at the U.S. Department of Health and Human Services in early April.

We just let loose and we said, This is a really bad policy, Becker said. Were going to get flooded and were going to lose control of quality. Were not going to know what to do with the results.

Thats exactly what has happened, said Osterholm. The FDA needs to bring much more discipline to this area and they need to articulate it clearly, he said.

A key issue is the accuracy of the tests, which rely on measures known as sensitivity and specificity. A highly sensitive test will capture all true positive results. A highly specific test would identify all true negative results.

In April, researchers at the University of California-San Francisco, led by immunologist Dr. Alexander Marson, analyzed 14 COVID-19 serology tests on the market and found that all but one turned up false-positive results, indicating that someone had antibodies to the coronavirus when they actually did not. False-positive rates reached as high as 16% in the study, which has not yet been peer-reviewed.

Unreliable results worry Dr. Jeff Duchin, the public health officer for Seattle and King County, Washington, where the first surge of COVID-19 cases emerged in the U.S. A person who tests positive for antibodies that dont exist may mistakenly believe he or she is free to ignore guidance about preventing infection, potentially spreading the disease. Regardless of whether you test positive or negative, the workplace still needs to take steps, he said. They shouldnt think a testing program in any way relieves them of that responsibility.

FDA officials said theyre working now with the National Cancer Institute to independently validate serology tests on the market. Until that list is public, users must rely on the relatively few that have received the emergency-use authorizations to date. More than 190 others have asked for that authorization, pending FDA review.

But consumers may have little control, because they are most likely getting tests from their employers or doctors, with little understanding of why those products were chosen.

There isnt a national standard, there isnt a one-stop shop or a Consumer Reports for antibody tests, Becker said. I dont expect a member of the public is going to be able to figure this out.

Even savvy physicians can have trouble. US Acute Care Solutions, a physician-owned medical services group, was trying out a Chinese-made test supplied by Minneapolis-based Premier Biotech, with plans to test its staff of more than 3,500 doctors and employees, said the groups chief medical officer, Dr. Amer Aldeen. That test has been widely used, including in recent controversial serology surveys conducted by Stanford University and the University of Southern California.

When USACS used it, the Premier test failed to detect antibodies in several employees who had been ill and tested positive for the coronavirus on diagnostic tests, Aldeen said. The results could have been caused by faulty instructions rather than flaws in the test itself, he said. Still, the Premier test has not received FDA authorization and the results gave him pause.

It does no good to select a test that isnt FDA-approved, he said.

In a statement, Premier Biotech officials said they anticipate exceeding FDA standards, which call for tests that are at least 90% accurate in identifying positive antibodies in a sample and 95% accurate in identifying samples that contain no antibody.

Some might ask why the FDA didnt just identify several reliable antibody tests and require their use to avoid the chaos. An FDA official said making that type of choice would be outside the scope of the agencys responsibilities.

FDAs lane is to review these tests and make sure that they are safe and accurate for the American people, said spokesperson Emma Spaulding. It wouldnt be within our lane to say which test must be used.

Although health officials understand the desire for a test that could provide comfort amid the uncertainty of COVID-19, Duchin advised employers and consumers to wait a little longer.

There are costs to testing with unvalidated tests that might outweigh the benefits of satisfying your curiosity, he said.

Read the original:
Hype collides with science as FDA tries to rein in 'wild west' of COVID-19 blood tests - Lebanon Democrat

JoNel Aleccia, Kaiser Health News and Anna Maria Barry-Jester

Save your business while saving lives, reads the website of Because Health, a Seattle tech startup selling two types of tests to employers willing to pay $350 a pop to learn whether their workers have been infected with COVID-19.

The Workplace Health plan includes not only nasal swab tests to detect infection, but also blood tests aimed at indicating whether workers have developed antibodies to the virus and, possibly, future protection.

Theres a tremendous consumer demand, said Dr. Lars Boman, the Boston-based medical director for the firm. Can they return to work? Can they return to life?

What the website does not make clear, however, is that public health officials have explicitly warned that antibody tests should not be used to make decisions about workplace staffing.

This is a personal choice of the business, of the consumer, Boman said.

Across America, untold numbers of employers, employees and ordinary citizens are turning to a slew of sometimes pricey new COVID-19 blood tests. Knowing whos already been infected could have important implications for understanding the spread of the disease, scientists say. But serious questions about the accuracy of some of the serology tests and the usefulness of the results they provide have prompted the federal Food and Drug Administration to try to rein in what several infectious disease experts described as the wild, wild West of antibody testing.

It does look as if companies sprang up overnight both importing these tests and distributing them, said Dr. Michael Busch, director of the nonprofit Vitalant Research Institute in San Francisco. Its outrageous that people were trying to make money off of this fear.

More than 200 tests have flooded the market in a matter of weeks, promising to detect antibodies, which are proteins that develop in the blood as part of the bodys immune response to an invading virus. These are different from the molecular tests, typically done with nasal swabs, used to diagnose infection.

As of June 1, only 15 antibody tests had received FDA emergency-use authorizations, which allow tests that havent been fully vetted to be used in a crisis. Even that standard has become a selling point for some large companies, such as LabCorp and Quest Diagnostics, which emphasize that they rely on tests that have received the FDA nod.

In late May, the FDA removed more than 30 serology tests from a list of commercially available kits, saying they should not be distributed for sale. Removal could result from a manufacturer not submitting an emergency-use authorization request within a reasonable period of time, or if the test shows significant problems that cannot be or have not been addressed in a timely manner, the agency said. The manner of enforcement remains unclear.

Last month, the CDC issued new guidelines warning that, given the low prevalence of the virus in the general population, even the most accurate tests could be wrong half of the time.

Serologic test results should not be used to make decisions about grouping persons residing in or being admitted to congregate settings, such as schools, dormitories, or correctional facilities, the guidelines state. Serologic test results should not be used to make decisions about returning persons to the workplace.

Such tests are most useful for understanding the epidemiology of the virus, not for making individual decisions, said Dr. Mary Hayden, director of the division of clinical microbiology at Rush Medical Laboratories in Chicago. Even the best tests cant yet answer the crucial question about whether antibodies confer immunity from future COVID infections, Hayden said.

The best possible scenario is that people get infected and they have protective immunity for a long time, she said. That would be awesome. But we just dont have that right now.

But a plethora of tests being pitched to consumers explicitly promise results aimed at allowing a return to work, school and other social arenas.

The tests offered by Because Health are among hundreds churned out since March, ranging from those offered by commercial labs and academic research centers to small developers seeking a toehold in the lucrative market spurred by a global pandemic. Because Health is using two antibody tests in tandem, one of which received emergency-use authorization on May 29; the other is still pending.

Anders Boman, the son of the medical director and co-founder of Because Health, said that until the COVID crisis occurred, the company, which launched in Seattle last year, was focused on a niche of integrative care and sexual health, including hormone treatments for men and women.

Consumers are not concerned about sexual health right now, Boman said, explaining the change in focus. Theyre concerned about how to get back to work, how to return to normal and are they safe?

The FDA normally follows a stringent approval process for tests to detect diseases, often a costly effort that can take months or years. That typically requires independent validation of the accuracy of the tests. But after being criticized for the fumbled rollout of diagnostic tests during the start of a global pandemic, the FDA swung hard in the other direction, waiving its usual requirements and letting firms rush self-validated tests into the market.

They sort of relaxed all regulatory oversight, Hayden said.

Several experts interviewed by Kaiser Health News said the FDA faced tremendous political pressure to make antibody tests available.

It was really a single pressure and that was the fact that the original inability to get a [diagnostic] test on the market in the U.S. as the outbreak escalated means they were trying to do basically everything they could to get these out, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

The relaxed rules drew concern from Congress, where a subcommittee of the Committee on Oversight and Reform detailed the FDAs failure to police the test market. Groups such as the Association of Public Health Laboratories also raised questions. Scott Becker, the APHLs chief executive, said he spoke to top officials at the U.S. Department of Health and Human Services in early April.

We just let loose and we said, This is a really bad policy, Becker said. Were going to get flooded and were going to lose control of quality. Were not going to know what to do with the results.

Thats exactly what has happened, said Osterholm. The FDA needs to bring much more discipline to this area and they need to articulate it clearly, he said.

A key issue is the accuracy of the tests, which rely on measures known as sensitivity and specificity. A highly sensitive test will capture all true positive results. A highly specific test would identify all true negative results.

In April, researchers at the University of California-San Francisco, led by immunologist Dr. Alexander Marson, analyzed 14 COVID-19 serology tests on the market and found that all but one turned up false-positive results, indicating that someone had antibodies to the coronavirus when they actually did not. False-positive rates reached as high as 16% in the study, which has not yet been peer-reviewed.

Unreliable results worry Dr. Jeff Duchin, the public health officer for Seattle and King County, Washington, where the first surge of COVID cases emerged in the U.S. A person who tests positive for antibodies that dont exist may mistakenly believe he or she is free to ignore guidance about preventing infection, potentially spreading the disease. Regardless of whether you test positive or negative, the workplace still needs to take steps, he said. They shouldnt think a testing program in any way relieves them of that responsibility.

FDA officials said theyre working now with the National Cancer Institute to independently validate serology tests on the market. Until that list is public, users must rely on the relatively few that have received the emergency-use authorizations to date. More than 190 others have asked for that authorization, pending FDA review.

But consumers may have little control, because they are most likely getting tests from their employers or doctors, with little understanding of why those products were chosen.

There isnt a national standard, there isnt a one-stop shop or a Consumer Reports for antibody tests, Becker said. I dont expect a member of the public is going to be able to figure this out.

Even savvy physicians can have trouble. US Acute Care Solutions, a physician-owned medical services group, was trying out a Chinese-made test supplied by Minneapolis-based Premier Biotech, with plans to test its staff of more than 3,500 doctors and employees, said the groups chief medical officer, Dr. Amer Aldeen. That test has been widely used, including in recent controversial serology surveys conducted by Stanford University and the University of Southern California.

When USACS used it, the Premier test failed to detect antibodies in several employees who had been ill and tested positive for the coronavirus on diagnostic tests, Aldeen said. The results could have been caused by faulty instructions rather than flaws in the test itself, he said. Still, the Premier test has not received FDA authorization and the results gave him pause.

It does no good to select a test that isnt FDA-approved, he said.

In a statement, Premier Biotech officials said they anticipate exceeding FDA standards, which call for tests that are at least 90% accurate in identifying positive antibodies in a sample and 95% accurate in identifying samples that contain no antibody.

Some might ask why the FDA didnt just identify several reliable antibody tests and require their use to avoid the chaos. An FDA official said making that type of choice would be outside the scope of the agencys responsibilities.

FDAs lane is to review these tests and make sure that they are safe and accurate for the American people, said spokesperson Emma Spaulding. It wouldnt be within our lane to say which test must be used.

Although health officials understand the desire for a test that could provide comfort amid the uncertainty of COVID-19, Duchin advised employers and consumers to wait a little longer.

There are costs to testing with unvalidated tests that might outweigh the benefits of satisfying your curiosity, he said.

View original post here:
Hype collides with science as FDA tries to rein in "Wild West" of COVID blood tests - wausaupilotandreview.com

At some point in their lives most men will struggle with penile health issues, when it comes to this these issues involve more than erections, ejaculations, and reproduction as poor penile health can be a sign of an underlying health condition.

Additionally issues that affect the penis can also impact other areas of your life including emotionally and socially. Bottom line is that routine maintenance in this area can also help to ensure optimum performance which includes managing stress, getting enough sleep, being physically active, and following a healthy well balanced diet.According to research from Harvard University men should masturbate(routine maintenance) 21 times a month to reduce the odds of prostate cancer by 33%.

Simply masturbating 21+ times a month is not enough to guarantee to avoid prostate cancer, but added to a healthy diet full of organic produce, getting enough sleep, managing stress, being active and exercising, this will go a long way. Ian Kerner, PhD, recommends a plant based diet and incorporating plenty of fish rich in Omega-3 fatty acids, as well as consuming red foods such as tomatoes that are rich in lycopene, as well as soy products that contain isoflavones, along with getting regular physicals that include a prostate exam, and plenty of exercise.

Diet and nutrition play a bigger part in health than most people understand, and this includes penile health. Certain types of food have been shown to affect penis health, for example studies have shown that diets rich in flavonoids, which occur naturally in fruits, vegetables and whole grains, are associated with a reduced risk of erectile dysfunction in men under the age of 70.

There are many things that can affect an erection like poor health, smoking, and certain medications. Following a sub par diet, how much you eat, and how often you eat can affect your mood, energy levels, blood flow, and hormones which are all very important to your sex life.

It stands to reason that if certain foods can boost your erection, keep sperm healthy, and boost testosterone levels then eating habits exist that can also kill your libido. Unhealthy fats and added sugars can exacerbate erectile issues, and lower testosterone levels. Alcohol is a depressant which can numb the feeling of sexual stimulation, alter the blood flow in/out of the penis, and decrease testosterone levels sapping libido, energy, and moods.

Achieving and maintaining an erection requires good blood flow and plenty of nitric oxide. Flavonoids have been shown to improve cardiovascular health by helping to increase blood flow and the concentration of nitric oxide in the blood. Dark chocolate is rich in flavonoids, other choices include tea, citrus fruits, berries, apples, legumes, onions, tomatoes, broccoli, tea, grapes, celery, red peppers, ginger, red cabbage, asparagus, and leafy greens.

Pistachios are good for more than a snack, a study published in the International Journal of Impotence Research suggests that consuming these nuts for several weeks improved several parameters of ED including improved International Index of Erectile function scores, improved cholesterol levels and improved blood pressure with no notable side effects being observed.

Watermelon may help to improve sexual function as a study from Texas A&M University found connections between ED and watermelon, suggesting that citrulline found in watermelon helped to relax blood vessels and improved blood flow in a similar manner as to medications for ED.

Bananas are a great source of potassium which is great for keeping the heart and circulation strong. Potassium also keeps blood pressure in check by stabilizing sodium levels. Bananas are also a rich source of vitamin B which helps to increase energy levels, and combat stress that can lead to erectile dysfunction.

Salmon is a great source of omega-3 fatty acids which can help to enhance blood flow and enhance erectile function by helping to relax your arteries easing the way for blood to flow to the entire body without exception, including your penis. Salmon also contains vitamin D, selenium and magnesium which are all required to support testosterone levels and healthy sperm.

Anthocyanins are great for cardiovascular health, cherries are loaded with anthocyanins, which are flavonoids, that help to protect your artery walls and help prevent fatty plaques from forming in the arteries ensuring good blood flow and circulation.

Soluble fiber such as that in oatmeal has been shown to be great for satiety, fighting inflammation, to lower cholesterol levels and helps to keep your blood vessels smooth, healthy and stretchy, which also can apply to penis health.

Cruciferous vegetables such as broccoli can help to combat cancer, and the high vitamin C content helps to boost blood circulation and it has been linked to an improved libido. Cruciferous veggies such as bok choy, cabbage, and Brussels sprouts also contain glucobrassicins which help to clear the body of excess oestrogen which may help to boost your sex drive.

The antioxidant phytochemical resveratrol helps to open arteries by enhancing the production of nitric oxide, production of nitric oxide allows blood vessels to expand, and increases blood flow. Resveratrol works by expanding the tiny and main arteries in the penis much like medications for ED. It also helps to block enzymes that trigger the body to push away testosterone, which will help maintain high levels of the hormone and strong erections that should last well beyond foreplay.

After reaching the age of 30 testosterone levels begin to decrease, fortunately there are simple diet fixes that may help you, and because your brain, heart and penis are all intimately connected this is also good for your overall health and well being. Aging also affects your penis, as a result many men experience erectile difficulties, if you are one of them please consult with your physician as it can be an indication of an underlying condition that shouldnt be ignored. Your physician can work with you to help determine the cause and work towards a solution, often lifestyle changes can help.

Read the original post:
Reducing The Risk Of Erectile Dysfunction With Nutrition - Anti Aging News

We caught up with Ann L. Steiner, MD, clinical professor of obstetrics and gynecology, who specializes in caring for menopausal women and practices at Penn Health for Women Radnor.

Penn Medicine for Women: When should you have your hormones checked?

Dr. Steiner: First of all, we don't routinely check hormone levels in women. Some women think that because they might be going into menopause, they need to have their hormones checked. Its not appropriate to do this, because we don't treat hormone levels.

The emphasis here is that in menopause, we treat symptoms. And therefore, there's no reason to check sex hormone levels routinely for women who are in the menopause.

Taking a history and hearing someone's story, especially if they have issues related to menopause, is much more important in guiding management than hormone level results. Really, it's the story and history that gives us guidance in joint decision making of care.

For instance, during menopause, a womens estrogen level is dropping and other hormones go up in response. We know what's going on. We treat her symptoms.

You might have one woman who's going into menopause, and she has absolutely no symptoms, she has no hot flashes, she feels great. And if we were to check her hormones, they would be reflective of menopause. We might have another woman who's the exact same age who is not sleeping well, and has terrible hot flashes, and her mood's off, and we check her hormones, and they're exactly the same as the woman who has no symptoms.

PM: Are there other times in a womans life when it would be appropriate to check hormone levels?

Dr. Steiner: Yes. There are other times when we need to check hormone levels.

For instance, if a woman stops getting her period prior to menopause, or has menstrual irregularity, we would check hormone levels to diagnose what is causing the problem, then treat her.

We commonly check thyroid stimulating hormone (TSH), a hormone that regulates metabolism, for women who are having hot flashes, symptoms of having too much thyroid, or not enough thyroid, fatigue, sleep issues or unexplained weight change. Abnormal thyroid levels can be associated with these symptoms, as well as abnormal menstrual changes.

PM: Are women who have reached perimenopause or menopause generally more concerned with hormone levels than those of reproductive age, or does it run the gamut?

Dr. Steiner: That's a tough question, because it's pretty subjective. My practice involves mostly women who are around the age of menopause, but I would just say over the years looking back, I've had women of all ages ask to have their hormones checked when they feel that something is not right or that there are changes.

For instance, if they experience mood changes, weight change, or fatigue, they often will ask to have their hormone levels checked, whether it's an appropriate thing to do or not.

View post:
Ask a Doctor: When Should I Have My Hormones Checked ...

Prostate cancer specialists are familiar with the role androgens can play in disease because in the prostate, the hormones stimulate an enzyme that boosts cancerous growth. In April, researchers published a paper in the journalCellwhich showed that the enzymeTMPRSS2is also involved in coronavirus infections.

To infect a cell, coronaviruses - including the novel SARS-CoV-2, which causes Covid-19 - use what is called a 'spike' protein that binds to the cell's membrane,a process that is activated by an enzyme. In this case, it appears that TMPRSS2 may be that enzyme.

Scientists do not yet know if the enzyme responds in the same way to androgens in the lungs as it does in the prostate, but other evidence appears to support the potential link.

A study from Veneto, Italy, of 9,280 patients found that men with prostate cancer who were on androgen-deprivation therapy - drugs that cut testosterone levels - were only a quarter as likely to contract Covid-19 as men with the disease who were on other treatments.

Karen Stalbow, Head of Policy at Prostate Cancer UK, said: There have been several recent pieces of research which indicate there may be a link between male hormones and increased risk of Covid-19. This has led some researchers to investigate whether hormone therapies commonly used to treat prostate cancer, such as enzalutamide, could reduce this risk.

However, most of the research so far has been in the lab, and there is conflicting evidence over whether the hormone therapies have the same impact in the lungs as they would in prostate cells. There are now several clinical studies starting which hope to address these issues, but much more evidence is needed before we can know whether these hormone therapies would be an effective treatment for Covid-19.

Read the rest here:
Bald men at higher risk of severe case of Covid-19, research finds - Telegraph.co.uk

Some argue that partnering with Dignity restrict care to LGBTQ+ people, women, others argue more are harmed by not partnering

Unable to agree on a single set of recommendations, a UC task force presented two options on how best to affiliate with health care systems outside of the system to UC President Janet Napolitano in the Working Group on Comprehensive Access (WGCA) Chairs Report of Findings and Recommendations.

The WGCA was formed in August of 2019 after public outcry in the spring when UCSF was revealed to be expanding affiliations with faith-based hospital system Dignity Health. The WGCA was composed of 15 UC officials: a regent, chancellors, deans, faculty, Academic Senate representatives and UC health leadership.

Ten of the 15 WGCA members had already expressed support for the UCSF and Dignity Health partnership before the formation of the WGCA. All three Academic Senate Representatives in the WGCA, as well as UC San Diego Professor Gabriel Haddad, were explicitly not in favor of a UCSF and Dignity Health partnership before the formation of the WGCA.

The group was tasked with creating a list of policy recommendations to ensure the values of the UC are upheld in all affiliations with other health care systems and that UC personnel would be unrestricted in providing medical care.

Unable to agree to one set of recommendations, the WGCA created two options which could be adopted individually or in combination with one another, according to UC Irvine Chancellor and Chair of the WGCA Howard Gillman.

Option 1, supported primarily by UC Health officials allow affiliations with organizations that have non-evidence-based policy restrictions on care if governed by appropriate policies and guidelines, Gillman said in the report. Option 2, supported by those who could not endorse the report was designed to impose a prohibition on such affiliations.

In short, Option 1 encouraged continued affiliation with health care systems that may restrict health care based on religious doctrine if clear guidelines are created to protect UC personnel. Option 2 discouraged continued affiliation with health care systems that have restrictions based on religion.

The two groups formed because the WGCA could not unite in answering two fundamental questions: Whether UC should affiliate at all with organizations whose institutional policies (a) prohibit the use of contraception, abortion, assisted reproductive technology, gender-affirming care for transgender people, and the full range of end-of-life options and (b) permit non-clinicians to make clinical decisions affecting the health and safety of individual patients irrespective of the professional judgment of health care providers and/or the informed decisions of patients.

Though the WGCA was tasked with making policy recommendations that protect the freedoms of UC personnel, enable the appropriate care of patients regardless of which facility they are first examined and encompass respect for a diversity of opinions, the issue comes down to the fact that some Catholic Church-sponsored hospitals restrict care based on religious convictions. These convictions, called Ethical and Religious Directives (ERDs), are determined by the U.S. Conference of Catholic Bishops (USCCB), not doctors.

The ERDs do not allow the prescription of any FDA-approved methods for preventing pregnancy including sterilization, elective abortion; assistive reproductive technology such as in-vetro fertalization (IVF) or the use of a surrogate for pregnancy; gender affirming care such as hormone replacement therapy or surgery or physician-assisted aid in dying.

Women and transgender individuals are those most affected by these policies, and gay couples who need IVF or a surrogate for biological pregnancy are also highly impacted.

Dignity Health, which has agreements with five of six UC medical centers, operates under the ERDs at 17 out of 31 California hospitals. At the other 14, they operate under the Statement of Common Values where they do not perform elective abortions, IVF or physician-assisted death.

Its pretty clear why [these policies are] discriminatory against transgender people, said WGCA member and UCSF Ob/Gyn Vanessa Jacoby. The discrimination against women is trickier to pick out, though, Jacoby argued.

Policies that prohibit women from getting standard of care services are discriminatory against women because the vast majority of our contraception is for women, Jacoby said. Women who are prohibited from getting contraception are the ones that bear the consequences of undesired pregnancy.

Because Jacoby views these policies as so discriminatory towards women and members of LGBTQ community, Jacoby is fundamentally against these partnerships as they conflict with the values of UC.

When Im considering a healthcare decision, if one of the harms is discrimination against any group, but in this case discrimination against women and against LGBT people and against transgender patients [] that, to me, overwhelms any potential benefit, Jacoby said. I dont believe UC should violate our anti-discrimination policies, no matter what the potential benefits are.

UC Davis ASUCD shares this belief and unanimously passed Senate Resolution #18 which calls for the UC to end all plans to expand affiliations with Dignity Health.

Others such as David Lubarsky, vice chancellor of Human Health Sciences and CEO for UC Davis Health, follows a different line of reasoning. Since many of Dignitys facilities are in rural areas, the only healthcare facilities for miles, UC would not have access to these patients if not for partnerships with Dignity Health. Lubarsky said he believes that more harm would be done to these rural communities by not partnering with systems like Dignity Health than could potentially be done by partnering with them.

We agree 100% that we have to do everything we can promote for Reproductive Rights and full access to health care for the LGBTQ community in every way, Lubarsky said in an interview earlier this year with The California Aggies Editorial Board. But that principle cannot trump the real harm that would be done to a large population of individuals who [would no longer be able to] get advanced care at a UC hospital.

Lubarsky put bluntly what a complete disengagement with Dignity Health would do: It prevents the poor people [which] Dignity primarily serves from having access to any UC hospital.

Lubarsky said he believes the WGCA did not get to the root of the problem: How can we balance the need of the underserved communities that need access to UC doctors through Dignity with our own values surrounding womens reproductive health care and LGBTQ+ healthcare?

It became an argument over a single issue, which was actually a mistake, Lubarsky said, saying he believes a broader discussion about How do we best serve the human beings were responsible for? would have been more productive.

Dan Loeterman, the director of External Communications for Dignity Health, said he agrees.

Its very clear to us that tens of thousands of Californians depend on [UC and Dignity] programs for their health each year, Loeterman said. We believe that theres a lot more where [UC and Dignity] agree than where we disagree.

Everyone does seem to agree on the fact that the partnership between UC and Dignity Health is highly political, especially because each is a powerhouse of medical care, since half of California doctors are trained at UC, and Dignity Health is the largest hospital chain in California.

UC Health will try to say this isnt about politics this is about one of the most important issues facing this country, said UC Davis Professor and Member of the WGCA Robert May. If Roe v. Wade is overturned, and theres a very good likelihood that that will happen, that will engender a major health crisis in this country. Our getting involved with this is just aiding that.

Lubarsky said he thinks otherwise. By participating in these affiliations, the UC is able to at least have some sway in the conversation regarding the treatment of patients at hospitals that operate under the ERDs.

By disengagement, we lose our voice in that argument, Lubarsky said. We think principled engagement plus support of organizations like Planned Parenthood will be a better tactic than disengagement.

Jacoby, however, did not adhere to this idea.

I really believe that the University of California can find solutions to address our clinical needs, our research needs, our educational needs, that do not compromise our core values and our anti-discrimination policies, Jacoby said. I would love [for leadership in the UC] to propose solutions that dont have this controversy around it and dont discriminate against women or LGBT people.

Written by: Jessica Baggott campus@theaggie.org

More:
UC task force unable to reach agreement on how to move forward with Dignity Health partnerships, gives two recommendations - The Aggie

Save your business while saving lives, reads the website of Because Health, a Seattle tech startup selling two types of tests to employers willing to pay $350 a pop to learn whether their workers have been infected with COVID-19.

The Workplace Health plan includes not only nasal swab tests to detect infection, but also blood tests aimed at indicating whether workers have developed antibodies to the virus and, possibly, future protection.

Theres a tremendous consumer demand, said Dr. Lars Boman, the Boston-based medical director for the firm. Can they return to work? Can they return to life?

What the website does not make clear, however, is that public health officials have explicitly warned that antibody tests should not be used to make decisions about workplace staffing.

This is a personal choice of the business, of the consumer, Boman said.

Across America, untold numbers of employers, employees and ordinary citizens are turning to a slew of sometimes pricey new COVID-19 blood tests. Knowing whos already been infected could have important implications for understanding the spread of the disease, scientists say. But serious questions about the accuracy of some of the serology tests and the usefulness of the results they provide have prompted the federal Food and Drug Administration to try to rein in what several infectious disease experts described as the wild, wild West of antibody testing.

It does look as if companies sprang up overnight both importing these tests and distributing them, said Dr. Michael Busch, director of the nonprofit Vitalant Research Institute in San Francisco. Its outrageous that people were trying to make money off of this fear.

More than 200 tests have flooded the market in a matter of weeks, promising to detect antibodies, which are proteins that develop in the blood as part of the bodys immune response to an invading virus. These are different from the molecular tests, typically done with nasal swabs, used to diagnose infection.

As of June 1, only 15 antibody tests had received FDA emergency-use authorizations, which allow tests that havent been fully vetted to be used in a crisis. Even that standard has become a selling point for some large companies, such as LabCorp and Quest Diagnostics, which emphasize that they rely on tests that have received the FDA nod.

In late May, the FDA removed more than 30 serology tests from a list of commercially available kits, saying they should not be distributed for sale. Removal could result from a manufacturer not submitting an emergency-use authorization request within a reasonable period of time, or if the test shows significant problems that cannot be or have not been addressed in a timely manner, the agency said. The manner of enforcement remains unclear.

Last month, the CDC issued new guidelines warning that, given the low prevalence of the virus in the general population, even the most accurate tests could be wrong half of the time.

Serologic test results should not be used to make decisions about grouping persons residing in or being admitted to congregate settings, such as schools, dormitories, or correctional facilities, the guidelines state. Serologic test results should not be used to make decisions about returning persons to the workplace.

Such tests are most useful for understanding the epidemiology of the virus, not for making individual decisions, said Dr. Mary Hayden, director of the division of clinical microbiology at Rush Medical Laboratories in Chicago. Even the best tests cant yet answer the crucial question about whether antibodies confer immunity from future COVID-19 infections, Hayden said.

The best possible scenario is that people get infected and they have protective immunity for a long time, she said. That would be awesome. But we just dont have that right now.

But a plethora of tests being pitched to consumers explicitly promise results aimed at allowing a return to work, school and other social arenas.

The tests offered by Because Health are among hundreds churned out since March, ranging from those offered by commercial labs and academic research centers to small developers seeking a toehold in the lucrative market spurred by a global pandemic. Because Health is using two antibody tests in tandem, one of which received emergency-use authorization on May 29; the other is still pending.

Anders Boman, the son of the medical director and co-founder of Because Health, said that until the COVID-19 crisis occurred, the company, which launched in Seattle last year, was focused on a niche of integrative care and sexual health, including hormone treatments for men and women.

Consumers are not concerned about sexual health right now, Boman said, explaining the change in focus. Theyre concerned about how to get back to work, how to return to normal and are they safe?

The FDA normally follows a stringent approval process for tests to detect diseases, often a costly effort that can take months or years. That typically requires independent validation of the accuracy of the tests. But after being criticized for the fumbled rollout of diagnostic tests during the start of a global pandemic, the FDA swung hard in the other direction, waiving its usual requirements and letting firms rush self-validated tests into the market.

They sort of relaxed all regulatory oversight, Hayden said.

Several experts interviewed by Kaiser Health News said the FDA faced tremendous political pressure to make antibody tests available.

It was really a single pressure and that was the fact that the original inability to get a (diagnostic) test on the market in the U.S. as the outbreak escalated means they were trying to do basically everything they could to get these out, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

The relaxed rules drew concern from Congress, where a subcommittee of the Committee on Oversight and Reform detailed the FDAs failure to police the test market. Groups such as the Association of Public Health Laboratories also raised questions. Scott Becker, the APHLs chief executive, said he spoke to top officials at the U.S. Department of Health and Human Services in early April.

We just let loose and we said, This is a really bad policy, Becker said. Were going to get flooded and were going to lose control of quality. Were not going to know what to do with the results.

Thats exactly what has happened, said Osterholm. The FDA needs to bring much more discipline to this area and they need to articulate it clearly, he said.

A key issue is the accuracy of the tests, which rely on measures known as sensitivity and specificity. A highly sensitive test will capture all true positive results. A highly specific test would identify all true negative results.

In April, researchers at the University of California-San Francisco, led by immunologist Dr. Alexander Marson, analyzed 14 COVID-19 serology tests on the market and found that all but one turned up false-positive results, indicating that someone had antibodies to the coronavirus when they actually did not. False-positive rates reached as high as 16% in the study, which has not yet been peer-reviewed.

Unreliable results worry Dr. Jeff Duchin, the public health officer for Seattle and King County, Washington, where the first surge of COVID-19 cases emerged in the U.S. A person who tests positive for antibodies that dont exist may mistakenly believe he or she is free to ignore guidance about preventing infection, potentially spreading the disease. Regardless of whether you test positive or negative, the workplace still needs to take steps, he said. They shouldnt think a testing program in any way relieves them of that responsibility.

FDA officials said theyre working now with the National Cancer Institute to independently validate serology tests on the market. Until that list is public, users must rely on the relatively few that have received the emergency-use authorizations to date. More than 190 others have asked for that authorization, pending FDA review.

But consumers may have little control, because they are most likely getting tests from their employers or doctors, with little understanding of why those products were chosen.

There isnt a national standard, there isnt a one-stop shop or a Consumer Reports for antibody tests, Becker said. I dont expect a member of the public is going to be able to figure this out.

Even savvy physicians can have trouble. US Acute Care Solutions, a physician-owned medical services group, was trying out a Chinese-made test supplied by Minneapolis-based Premier Biotech, with plans to test its staff of more than 3,500 doctors and employees, said the groups chief medical officer, Dr. Amer Aldeen. That test has been widely used, including in recent controversial serology surveys conducted by Stanford University and the University of Southern California.

When USACS used it, the Premier test failed to detect antibodies in several employees who had been ill and tested positive for the coronavirus on diagnostic tests, Aldeen said. The results could have been caused by faulty instructions rather than flaws in the test itself, he said. Still, the Premier test has not received FDA authorization and the results gave him pause.

It does no good to select a test that isnt FDA-approved, he said.

In a statement, Premier Biotech officials said they anticipate exceeding FDA standards, which call for tests that are at least 90% accurate in identifying positive antibodies in a sample and 95% accurate in identifying samples that contain no antibody.

(EDITORS: STORY CAN END HERE)

Some might ask why the FDA didnt just identify several reliable antibody tests and require their use to avoid the chaos. An FDA official said making that type of choice would be outside the scope of the agencys responsibilities.

FDAs lane is to review these tests and make sure that they are safe and accurate for the American people, said spokesperson Emma Spaulding. It wouldnt be within our lane to say which test must be used.

Although health officials understand the desire for a test that could provide comfort amid the uncertainty of COVID-19, Duchin advised employers and consumers to wait a little longer.

There are costs to testing with unvalidated tests that might outweigh the benefits of satisfying your curiosity, he said.

(Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.)

2020 Kaiser Health News

Visit Kaiser Health News at http://www.khn.org

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