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Archive for December, 2019

Study targets subretinal option for AMD treatment – Ophthalmology Times

Abstract / Synopsis:

RGX-314 gene therapy, a treatment for wet age-related macular degeneration delivered subretinally, showed dose-dependent sustained/improved vision and a good safety profile.

This article was reviewed by Jeffrey S. Heier, MD

RGX-314 (REGENXBIO) gene therapy, delivered subretinally to patients with neovascular age-related macular degeneration (AMD), who required a large number of prior injections of anti-vascular endothelial growth factor (VEGF) annually, provided a marked decrease in the number of injections needed and retained or improved the vision and anatomy in this challenging patient population.

RGX-314 uses a proprietary gene delivery platform that is hypothesized to deliver longer and higher protein expression with a lower immune response that earlier generation adeno associated viruses (AAVs) used for gene therapy.

The AAV8 vector is encoded to deliver a gene that leads to anti-VEGF antibody fragment protein production within the retina, said Jeffrey S. Heier, MD, co-president and director of Retinal Research, Ophthalmic Consultants of Boston.

Related: Anti-VEGF targeted as potential nAMD treatment

All 42 patients included in this study had undergone previous treatment for neovascular AMD and had a high need for anti-VEGF therapy, i.e., patients received more than 30 injections on average prior to coming in and an average of 9.6 annualized injections in the year prior to RGX-314.

In addition, the included patients had to have shown an anatomic response to anti-VEGF therapy during screening. After RGX-314 was delivered to the subretinal space, the patients were evaluated monthly to assess safety and the need for additional anti-VEGF therapy, Dr. Heier noted.

Re-treatment with an anti-VEGF drug could be provided beginning at four weeks after RGX-314 was delivered and then as needed every four weeks thereafter based on physician discretion, Dr. Heier explained. The criteria for retreatment was per investigator discretion which included choroidal neovascularization-related increased, new, or persistent fluid; vision loss of five or more letters as a result of fluid, or a new ocular hemorrhage.

Related: The ABCs of VEGF treatment for diabetic macular edema

The resultsFollowing delivery of RGX-314, Dr. Heier reported that the drug was well tolerated. No serious adverse events were reported; most adverse events were classified as mild, i.e., grade 1 in 79% of cases. In addition, no clinically determined immune responses occurred.

Two deaths that occurred were not related to RGX-314. Two serious adverse effects that were related to the delivery procedure were reported, specifically, a peripheral retinal detachment that was repaired successfully and a case of endophthalmitis that occurred after collection of an aqueous sample.

We observed a dose-dependent increase in RGX-314 protein across the five dose cohorts, he reported. The protein levels were measured in aqueous samples collected one month after delivery of RGX-314.

Cohort 3, which included six eyes treated with a dose of 6 x 1010 genome copies (GC)/eye, did well.

Cohort 3 had a gain in vision of +9 letters and stable anatomy of -40 m over 18 months despite relatively few injections, Dr. Heier reported.

Three of the six patients in this cohort were injection-free at 18 months. They had a mean increase of +11 letters of vision at 18 months and a concomitant mean decrease in the central retinal thickness of -21 m. The RGX-314 protein levels were sustained over one year.

Related: Decreasing burden of nAMD therapy

Originally posted here:
Study targets subretinal option for AMD treatment - Ophthalmology Times

The 2020s: The decade of psychedelic breakthroughs? – Big Think

Beyond the bright colors and hallucinogenic imagery of psychedelic artthe visuals of Ram Dass's 1971 book Be Here Now has never left public consciousness there has long been a crusade to clinically research substances such as LSD, psilocybin, MDMA, DMT, and ibogaine. We've been informed, again and again and again, about the various ways that current pharmaceutical treatments in our for-profit mental health system is not only not working, but doing more damage than healing. Discussion over health care inevitably defaults to mechanisms for paying for a broken model, rarely touching upon the root causes of why so many people are depressed, sick, anxious, and suicidal in the first place.

We. Need. Better. Solutions.

In regard to psychedelics, an entire herd of elephants remain locked in a room. Thanks to the questionable (and admittedly racist) wars launched by the Nixon and Reagan administrations (first dreamed up during the Anslinger crusades), we've been denied access to these potentially therapeutic substances. Fortunately, a renaissance is occurring in psychedelics research, with ketamine being the first to be legally prescribed psychedelic for treatment-resistant depression and both psilocybin and MDMA being fast-tracked by the FDA after being labelled breakthrough therapies.

One challenge psychedelics advocates will have to face is how these drugs are treated moving through the current medical model. Regardless of personal feelings on the subject, these substances have to contend with a system that requires expensive clinical trials and will be sold in a capitalist marketplace. There will inevitably be patent issues and territorial fights. Unlike cannabis, which is a relatively mild substance with few documented consequences, psychedelics need to be rigorously evaluated and tested. While some label everyone working in medicine as minions of Big Pharma, we need to separate researchers and scientists from the shady dealings of shareholders and profiteers.

Michael Ehlers is an industry figure that has long taken an interest in psychedelics, predominantly from an outsider perspective. Now the former executive vice president for research and development at Biogen is accepting an advisory role with Field Trip Health, the psychedelics-focused organization that recently opened the world's first psilocybin research center. (You can listen to my talk with Field Trip co-founder, Ronan Levy, here.)

I chatted with Ehlers, he is also the former chief scientific officer for neuroscience at Pfizer, about his interest in psychedelics, their potential efficacy, their historical usage in ritual, and how the current model will deal with their vetting and potential applications. With every question, he was informed and honest, offering what he knows and being truthful about what he does not. There is a lot of work ahead in pharmaceuticals, yet it is undeniable the mental health industry needs a reboot, in the same way psychedelics are said to reboot the neural circuitry of the brain, making this class of substances an ideal medicine for study.

Part of my conversation with Ehlers is below; you can read the full transcript here.

Photo courtesy of Michael Ehlers

Derek: You have an accomplished career in the pharmaceutical industry. Now you've taken on an advisory role with a company specializing in psychedelics. I would love to know when you first became interested in psychedelics as a potential therapeutic tool.

Michael: I've followed this area for quite some time. I've been intensely involved in different aspects of drug discovery and development, particularly, although not exclusively, within CNS or neuroscience drug discovery, including neuropsychiatric disease. I've followed more peripherally some of the efforts both in standard pharmacology and then some of the emerging work, whether it was more acute, high-dose psychedelics or microdosing psychedelics in neuropsychiatric disease.

At the same time, I was following a lot of the work on some of the core receptor biology and neurobiology, which was really advancing in systems neuroscience. Following this field and some of the early indications of potential clinical efficacy were some of the things that really got me quite excited. I was particularly close with aspects of what's been done over the past 10 years with ketamine, which is a very different agent but also in the class, initially leading from small trials on ketamine for acute, anti-depressive actions, now to Janssen and J&J using a variation of this, esketamine, to get full-on FDA approval for the first new mechanism in depression in 20 years. The combination of these things indicated to me that there could be a new paradigm change or highly-active psychopharmacology to potentially treat some of these otherwise fairly intractable types of neuropsychiatric disorders.

There are some other things that were also on the horizon. The history of CNS drug development, particularly in neuropsychiatric disease, has been one where the empirical observations in human patients have really guided efficacious therapeutics by and large. Even though I know we like to talk a lot about rational drug discovery and development, at least in the field of neuropsychiatry, because there's still so much that is not known that we've had to rely a lot more on empirical observations in humans.

There's probably no more profound CNS pharmacology out there than that with psychedelics like psilocybin or LSD or ketamine. I've actually long thought it was just a matter of figuring out what a treatment paradigm could look likehow maybe when you dose it could you alter aspects of its dose exposure and distribution and then in what exact disease or syndrome.

Derek: You have a history of working with rare diseases. Field Trip is going to tackle a wide range of studies, but the ones that are really on everyone's mind (in terms of what psychedelics could potentially help) ranges from PTSD to treatment-resistant depression and anxiety. These are much more common diseases. Do you have any background in those diseases and, in the advisory role, what will you be doing for them?

Michael: I've got a lot of background in that. I worked for nine years in large biopharma, six years at Pfizer. I started in neuroscience and pain, but ultimately ran several divisions of Pfizer R & D, that did include rare disease, but included a bunch of other things. Then I ran R & D advising for three-and-a-half years. I've done clinical trials in depression, schizophrenia, PTSD, generalized anxiety disorder, Alzheimer's disease, and Parkinson's disease. I've done both rare diseases and a lot of common disorders: hemophilia, genetic disease, and some of the rare diseases as well. I've done stroke trials. I've had experience across a range.

One thing I like is about what Field Trip is doing and the prospect of these diseases is that they're incredibly common. Roughly 25 percent of people will have some experience with major depression in their lives. One percent of the world has schizophrenia. These are serious and significant disorders. I really love the fact that this fieldand Field Trip is really part of that in a leadership roleis looking to take some of these on.

Although the lore has been that there hasn't been that much innovation, I actually think that's not true. I think we're just at the beginning of a whole new era of advances in neuropsychiatric disease. I can point to several things that indicate that. I have a feeling that if we really understand that the best way to dose and conduct trials with psychedelics like psilocybin and be able to segment patients who are the most likely to benefit, this can become quite important.

Derek: You mentioned that pharma companies stepping away from neuropsychiatric disease. There is obviously a problem with SSRIs over the long-term. Efficacy rates tend to be high in the short-term, but over the long-term prove problematic. When you're stepping into substances that potentially could help treatment-resistant mental health diseases in one dose (or just a couple of doses), how do you think that companies are going to be able to monetize this, especially given the incredible amounts of money that have to go into R & D and clinical trials?

Michael: It's a very good question. I think we haven't solved that problem yet. There are a lot of open questions. Will some of these therapies really be single dose or short regiments and you're done? Will it have to be that there's some degree of maintenance where there's some regularity in the need for therapy? Will it really be like antibiotics or gene therapy? We don't know.

A lot of these neuropsychiatric diseases, although they're complex, have genetic features that are polygenetic but they're related. Whether you're talking about, schizophrenia, autism, bipolar disorder, ADHD, there's a complex genetic architecture that has shared features across all of those. The risk of relapse and occurrences will be there in a given population. I tend to think the likelihood of things like ketamine or psychedelic treatments for depression will be one of periodic needs.

The question you raised is an excellent one, which is what ultimately is the commercial model for that? Certainly, the hope is that it doesn't go down the road of antibiotics for which the commercial incentivization for real R & D and drug development has been catastrophic. I don't see that in this space. I just don't think it's going to be quite as simple as "one and done." The prevalence alone will be a strong incentive for investment when there's real efficacy potential.

Derek: Please correct me if I'm wrong; I'm fascinated by neuroscience, but not having an academic background my knowledge is limited. That's why I love talking to people about this. From my understanding, SSRIs work in a much different manner in terms of the serotonin release then psychedelics. Do you see any potential benefits or dangers in the ways that psychedelics deal with the serotonergic system?

Michael: It is quite different. From a simple pharmacology point of view, SSRIs are, as their name indicates, selective serotonin reuptake inhibitors: they block serotonin transporters that would normally release serotonin back up into nerve cells so that it increases serotonergic tone. Once released, it stays released in the extracellular space for longer, acting on all the different receptors in the places that it does.

The psychedelics typically act directly on serotonin receptors within serotonin transporters, but their action at different receptors has different potency. It's not a clean pharmacology. People will talk about 5-HT-2A receptors and they're clearly important, and there's been a lot of study on that, but we also know that if you just give a pure 5-HT-2A receptor an agonist you do not reproduce the effects of psilocybin or LSD.

The pharmacology is complex; it's clearly different than SSRIs. Obviously, the behavioral and therapeutic groups are very different. It just highlights that we really need to understand it better. It's going to reveal I think very important things about psychiatric disease and fundamental neuroscience.

A shaman gathers the raw materials to make ayahuasca in the jungle outside of Iquitos.

Photo by Andrew Lichtenstein/Corbis via Getty Images

Derek: One of the criticisms of the way that the industry is right now is that, why would a doctor spend an hour talking to a patient when you can see six patients in an hour and write a script? Efficacy rates are different for different people, dealing with the microbiome, for example, and the way that their gut processes drugs. It's a very complex issue. One thing I believe is going to be important is that psychotherapy is going to be tethered with psychedelics, especially if people have never done them before. Will that coupling provide a sustainable model?

Michael: Here's an aspect of what's important to understand: the field has understandably taken a cautious approach, which I think is warranted in this whole guided therapy concept and that will probably be required for certain dosing regimens. I would personally like to see this converted into what is a very standard thing in a lot of drug administration in practice or trials, which is more about medical monitoring. Change it from the notion of it's guided therapy to monitoring like you would for a lot of things. People go to IV infusion centers to get their IV drug. It's different, but there's nothing that unusual about the notion of having a monitored pharmaceutical or pharmacological drug intervention even in standard practice. This will likely be part of that.

If you're a neurologist treating MS and you've got MS patients on Alemtuzumab or Natalizumab as your IV drugs. They come in, you've got your IV clinic. They come in regularly, every month or every quarter depending on the drug, and they get their IV infusion. They get monitored while it happens because they can have an immune response. I see a future for some of these psychoactive therapeutics where you have something similar.

Now the question will be to what extent does the guided as opposed to monitoring aspect of that influence the degree of efficacy? That's something which really would need to be studied. To the extent it really requires some special type of guided activity that will be a little bit more of a limitation. To the extent that it can be ultimately the design in a more monitoring approach with education, the more widespread this can become.

Does that analogy make sense to you? There's a lot of precedence for this in other areas. The way this has gotten utilized now is still a remnant of causing people to have profound hallucinations and behavioral stuff and paranoia. Some people get afraid of that, so we need to have some monitoring.

We need to understand doses. We need to know the extent to which those experiences are part and parcel to a therapeutic response or not associated with a therapeutic response.

Derek: How much do you think anecdote is going to matter? One main issue I have with the whole cannabis legalization process is the extraction of CBD being sold for every possible ailment out there when the actual evidence is almost nothing at this point, besides epilepsy. At the same time, dealing with mental health disorders, how much are we going to rely on anecdote? If people think they're getting better, there's placebo, and it actually helps them get better.

Michael: I hope we moved beyond anecdotes, and I think that you're right about CBD, but it's interesting the way you put that because of the fact that rigorous trials have been done in rare epilepsies, like Dravet and Lennox-Gastaut syndrome, nobody disputes that. Patients in need can get insurance companies or health systems in other countries to reimburse for that. That's what I mean by saying real location impact is going to require that component of it too. You'd like to be able to generate the evidence because nothing comes without safety concerns. The nice thing about putting this all through the lens of drug discovery and development is that it allows the communityand here I mean the medical community, policymakers, others to have a much clearer view of the benefit-risk, and where the benefit-risk is positive, in which case that's usually a required element for real access for patients.

Of course, you could argue and say, "well, if it's just out there, people can try it, we'll see and that's fine," but this doesn't allow us from a clinical scientific vantage point to really know when and where we are going to provide benefits. That's what we really need to work toward. There's enough anecdotal evidence out there to justify rigorous evaluation.

--

Stay in touch with Derek on Twitter and Facebook. His next book is Hero's Dose: The Case For Psychedelics in Ritual and Therapy.

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The 2020s: The decade of psychedelic breakthroughs? - Big Think

Cell and Gene Therapy Market Size Will Escalate Rapidly in the Near Future – Market Research Sheets

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Personalized Gene Therapy Treatment Market to Exhibit Impressive Growth by 2030 Bulletin Line – Bulletin Line

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Personalized Gene Therapy Treatment Market to Exhibit Impressive Growth by 2030 Bulletin Line - Bulletin Line

Gene Therapy Market gaining traction due to new market developments, says Polaris Analysts – News Cast Report

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Sickle cell patient is pain free after geneediting trial altered her DNA – The Times

Sickle cell disease is a genetic condition in which red blood cells, which should be circular, adopt a crescent shape and are sticky and rigidALAMY

The first patients to receive gene-editing treatments for inherited blood diseases will enter the new year free of agonising symptoms.

The experiments suggest that altering DNA could treat sickle cell disease (SCD) and beta thalassemia, conditions both caused by faulty genes that hamper the bloods ability to carry oxygen.

The companies behind the trials said that a patient in the US with SCD had been well since July. A thalassemia patient in Germany had been free of symptoms for nine months. Previously she had 16 blood transfusions a year.

British patients could be offered similar experimental therapies next year. The treatment for both conditions involved a high-precision gene-editing tool called Crispr-Cas9. It was used to alter the DNA of some of the cells of Victoria

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Sickle cell patient is pain free after geneediting trial altered her DNA - The Times

Leukaemia and lymphoma have a good survival rate – The Star Online

Of all blood cancers, leukaemia and lymphoma are among the most curable.

However, many people, including doctors, still believe the disease leads to immediate death.

This is no longer true today as they are not fatal.

With optimal treatment, the majority of patients go into remission and are considered cured.

These two cancers have been more extensively studied than other forms of cancer, due to the ease in obtaining samples from blood, bone marrow or lymph nodes, spurring the advent of novel targeted therapies for a cure, says consultant haematologist Dr Ng Soo Chin.

Most blood cancers start in the bone marrow, where blood is produced.

Bone marrow contains stem cells, which mature and develop into red blood cells, white blood cells or platelets.

In most blood cancers, normal cell development is interrupted by the uncontrolled growth of an abnormal type of a particular blood cell.

These abnormal blood cells, which are cancerous, prevent your blood from performing many of its functions, like fighting off infections or preventing serious bleeding.

Leukaemia or white blood is classified into acute and chronic disease, which is then divided further into subtypes: acute lymphocytic leukaemia, acute myeloid leukaemia, chronic lymphocytic leukaemia (CLL) and chronic myeloid leukaemia (CML).

The presentation between acute and chronic leukaemia differs.

The acute person will tell you he was well a week ago and is now down with symptoms such as lethargy, anaemia and recurrent infection.

Suddenly, he may look pale, so we check his blood count for any abnormalities. A bone marrow exam will further confirm whether it is acute.

With chronic leukaemia, the patient can be unwell for a couple of months.

We are increasingly picking up cases early because of blood test availability.

The survival rate has improved tremendously for acute leukaemia, with more than 50% fully cured because bone marrow transplants are easily available in the country.

For CLL and CML, 95% of patients are alive at the 10-year mark, says Dr Ng.

Generally, chronic leukaemia patients belong to the older age group (50 years and above), but acute leukaemia can occur in all ages.

Leukaemia symptoms are often vague and not specific, so its easy to overlook them as they may resemble symptoms of the flu and other common illnesses.

In fact, chronic leukaemia may initially produce no symptoms and can go unnoticed or undiagnosed for years.

Lymphomas, a type of blood cancer that begins in a subset of white blood cells called lymphocytes, can be classified into Hodgkins and non-Hodgkins.

The main difference between Hodgkins and non-Hodgkins lymphoma is the specific lymphocyte each involves.

Lymphocytes are an integral part of your immune system, which protects you from germs.

Five-year survival rates are high with Hodgkins lymphoma at 86% and non-Hodgkins lymphoma at 70%.

You can beat the disease even if it is detected at a late stage.

Multiple myeloma, which is the third kind of blood cancer, forms in a type of white blood cell called a plasma cell.

Patients often complain of bone pain, and unfortunately, this type of cancer has no cure.

Blood cancers typically involve abnormal white blood cells and can affect paople of all ages, depending on the type of cancer. 123rf.com

Fear of treatment

Chemotherapy is a much dreaded word among cancer patients.

But with advances in medicine, newer chemotherapy-free treatments are now available.

Dr Ng says, Traditionally, cancer is treated via surgery or radiation the layman says we fry and poison them, which is not far from the truth!

Radiation means burning the cancerous area, but a lot of times, the cancer can also be present elsewhere, so there is limitation to this treatment.

With chemotherapy, we use cytotoxic (cell-killing) drugs they go in and knock off both cancer and normal cells.

The short-term effects include vomiting, hair loss, appetite loss and weight loss.

But as doctors, we are looking at a different perspective. We are more worried about white cells dropping (neutropenia) because the patient can pick up an infection that can potentially kill him.

Neutropenia is a condition that results when the body does not have enough neutrophils, a type of white blood cell that is an essential first line of defence against infections.

Thats one risk of chemotherapy, although we can now improve neutropenia by giving a growth factor injection.

But for certain cancers, we need to step up the drugs.

He adds: We are scared of neutropenia, but patients are more concerned about bodily changes.

The older ones get upset over losing hair because they cannot take it when others ask them what has happened to their hair.

Young people are not as concerned with hair loss because it can be trendy.

We understand that chemotherapy is less than pleasant and strong doses can impair fertility in young patients, especially women.

Despite current technology, only one-third of patients are successful in freezing their eggs.

What he is concerned about is that chemotherapy can actually increase the patients risk of getting another cancer, especially blood cancer.

It can happen the day after! says Dr Ng.

Most experts believe chemotherapy damages stem cells, so if youre unlucky, you might get acute myeloid leukaemia after undergoing chemotherapy for breast cancer.

Its just like crossing the road there is always a risk of being knocked down.

All our cells have a biological clock and there is an orderly exchange of old and new cells.

But with blood cancers such as leukaemia, there is a clone of abnormal cells.

Cancer cells have an advantage over normal cells because they can survive longer.

Chemotherapy is still needed to treat most acute blood cancers, although if the mutation is known, targeted therapies can be applied.

For chronic blood cancers, there is no need for chemotherapy. Oral drugs are enough to combat the disease.

Eventually, many patients are able to wean off the drugs.

As we may be aware, immunotherapy is the buzzword in cancer treatment today.

Also called biologic therapy, it is a type of cancer treatment that boosts the bodys natural defences to fight cancer.

It uses substances made by the body or in a laboratory to improve or restore immune system function.

One of the latest treatment modalities is the CAR T-cell therapy, a form of immunotherapy that uses specially altered T cells a part of the immune system to fight cancer.

A sample of a patients T cells are collected from the blood, then modified to produce special structures called chimeric antigen receptors (CARs) on their surface.

When these CAR T-cells are reinfused into the patient, the new receptors enable them to latch onto a specific antigen on the patients tumour cells and kill the cells.

At the moment, this intravenous therapy is available in the United States and hasnt reached our shores yet. It has to be properly regulated first, says Dr Ng.

A volunteer is having his head shaved to donate hair to make wigs for cancer patients in this filepic. Hair loss is one of the side effects of chemotherapy that affect patients the most.

Following natural remedies

The consultant haematologist errs on the side of caution when patients ask about natural cancer remedies, or the dos and donts during treatment.

We always believe there should be a scientific approach to the problem.

If patients are doing okay while undergoing treatment and there is no weight loss, I tell them to go ahead and do what they always do.

However, just be particular about food hygiene, as there is a chance you may get food poisoning.

If youre undergoing chemotherapy, then youll land yourself in hospital, and if your luck is bad, you may even land up in the ICU (intensive care unit).

So make sure the food is cooked and not left overnight to reduce your chances of infection.

Eat a balanced diet, he advises.

When it comes to exercise, he says to work out within your limit.

Instead of pushing the body and running marathons or climbing mountains, go for walks.

Dr Ng says, Life should go on, but be sensible.

Dont go to crowded places because you may pick up an infection, but dont be withdrawn either. All humans need social interaction.

With the billion-dollar dietary supplements industry, companies are constantly trying to lure customers into buying their products.

A lot of supplements are just glorified vitamins in different packaging.

The more expensive they are, the more people will buy them, thinking they are good.

There are people with good intentions, but unfortunately, there are also a lot of scammers out there that is life.

For the amount you spend on supplements, why not keep the money aside and go for a trip once your treatment is over? he suggests.

Often, the late diagnosis is due to preference for alternative treatment.

These alternative treatments are like fashion shows, after some time, they go out of trend.

For me, youre wasting valuable time because cancer is not your friend.

Yes, chemotherapy is tough, but with the latest chemo-free regimen, patients are more willing to come forward.

The earlier it is treated, the higher your chances of recovering, he says.

To share his 30-odd years of knowledge and experience in the field, Dr Ng has written his third book titled Understanding Blood Disorders.

Intended for patients, caregivers and healthcare professionals, proceeds from the sales of the 270-page book will go to the newly set-up Faith Hope Love Hospice Care Malaysia in Petaling Jaya, Selangor.

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Leukaemia and lymphoma have a good survival rate - The Star Online

A blood cancer diagnosis helped me find true happiness – The Guardian

December 2017, and the Christmas party season is in full flow. Everywhere I look are scenes from some hilariously awful Dickens pastiche: revellers squeezed into warm pubs; joyful chatter spilling out on to the street; the sound of carols and the scent of mulled wine in the air. Its as if I am peering in at it all through frosted glass, wishing my own Christmas could be as carefree.

Instead, I have spent a morning turned on my side on a hospital bed while a nervous-looking young doctor works up a sweat attempting to force a long needle into my hipbone. He needs it to go deep enough that he can suck out some of the marrow inside, but my tough bones are making life difficult for him.

I dont feel so tough. My wife and I spend the next fortnight anxiously waiting for the results. Results that should confirm why my body is behaving in unexpected ways: the unusual infections; the crushing fatigue; the old jeans that suddenly slip off my waist.

Christmas is never a nice time to feel alone. Yet, despite the fact I am surrounded by loved ones, that is how I feel: terrifyingly alone. The emotions of the season get warped and amplified. I attempt to go to one party, see a friend who is going through her own hellish time, and we both sob on each others shoulders for five minutes straight. Everything feels raw and heavy. My little girl is not even 18 months old, and I love her more than anything but I find it hard to even be in the same room as her. Its all too much.

If Christmas has lost its religious meaning, then it hasnt for me. I try praying for the first time in about three decades: Er, yes, it has been a while sorry about that but could you just help me out with this one thing? I promise God and Santa Ill be all sorts of good if things turn out OK.

***

My results arrive on 22 December. There is a wait in a hospital corridor that is still too triggering to think about properly. And then a doctor calls me in, sits me down and tells me that I have a rare blood cancer called essential thrombocythemia, which sounds like some cult artist signed to Warp Records in the 90s (the doctor doesnt say that bit). There is no known cure. But dont worry, he says, its manageable. I just need to take some aspirin and keep an eye on it. You will lead a normal life, he says. My wife tells me my face instantly changed colour, the pallid grey lifting for the first time in weeks.

My little girl throws up all over the seat when we pull out of the drive, and it doesnt even feel slightly annoying

Its a strange gift, receiving blood cancer for Christmas. In some ways I preferred the Mr Frosty slushy-making kit I got when I was eight, and maybe even the Scalextric that never quite played out the way you hoped it would from the adverts. And yet what the doctor is telling me you will lead a normal life feels like the biggest and best present I have ever received. Queueing up to be discharged, I let wave after wave of euphoria run through me and think to myself: This has to be the weirdest cancer diagnosis ever.

A day later, we pack up the car and head off to my parents. My little girl throws up all over the back seat as soon as we pull out of the drive, and it doesnt even feel slightly annoying. We laugh. Life is good. That Christmas, for the first time since I can remember, I am truly happy; just living in the moment. The light seems brighter and more beautiful. I notice dew drops on plants and the smell of fresh air. I hug my wife and daughter even more tightly than usual.

***

All this relief is not to last long. In the first week of 2018, I attend a follow-up appointment and am told that, sorry, they hadnt seen all of the bone marrow samples before. My condition is, in fact, developing into a much more serious disease called myelofibrosis, which needs treatment.

A week on from that, I turn up at the hospital, steeled to start chemotherapy. But there is worse news: a team of specialists have discussed my case and they believe I am at high risk of developing acute myeloid leukaemia, a swift and deadly cancer. They recommend you have a stem cell transplant, says the doctor. I ask when. As soon as possible. If I can find a match on the stem cell donor register, then I will be dosed up with drugs so intense that my entire immune system will be wiped out; then a strangers cells will be fed into me and we will all cross our fingers and hope that my body doesnt reject them. The chance of survival and the disease not returning does not seem to me to be all that much better than 50/50. Even if it all succeeds, the recovery process will be long and gruelling.

I spend the next few weeks in a state of catatonic depression. Or do I? Because I am somehow getting things done: I organise a will, I arrange a sperm bank visit (the transplant, even if successful, will leave me infertile), I cry myself senseless writing a letter to my daughter in case the worst should happen. I also drink all the good bottles of wine I had been saving for special occasions. A bottle of Domaine Dujac Morey Saint-Denis 2012 on a Tuesday night with defrosted Quorn chilli not the pairing Id had in mind, but saving it for the future seems silly.

Through all the gloom I see something with startling clarity. I realise that what Im mourning is not so much my old life before all this started a life of pointless anxieties, petty rivalries and overthinking but rather the carefree, optimistic version of life I had briefly glimpsed over Christmas. And yet no sooner have I understood all this than the chance to enact it has been snatched away. I feel like an old professor who has finally unravelled the mysteries of the universe with his dying breath.

***

Over the next few months, something happens that I still find hard to believe. I am transferred to a new hospital with a more specialist team on the case. There are more blood tests and scans, and another long needle is forced into my hip. And then I get another gift, this one in time for Christmas 2018: my condition is not so serious as I was led to believe. It appears to be a peculiar version of a peculiar cancer caught somewhere between the relatively benign essential thrombocythemia and the more concerning myelofibrosis. But it is stable, at least for now, with no signs to suggest it will progress any time soon.

***

I like to think that this year I have made good on my promise to live like I did during the Christmas of 2017. My outlook has certainly changed. When people ask how, I always say the same thing: that its great to get older. The idea of panicking about a milestone such as my imminent 40th seems so ridiculous now. Instead, just think what a privilege it is to be able to get there.

I am more present for my family these days, and less consumed with things I cant control. I have returned to the volunteering role I thought I didnt have time for; I have got fit; I dont let work define my happiness; I am kinder to myself. I have bought lots more nice wine to replace the nice wine I drank with defrosted Quorn chilli.

Do I still get annoyed by delayed trains, lost keys or the fact my daughter is taking half an hour to put on a pink tutu, the only item of clothing in the house that shell wear? It would be a lie to say no. But the second I think: But youre not quite likely to die any more, the problem disappears. I am, undeniably, a happier person.

I still have a malfunction inside me and I still have to think about it every day. Its hard not to my spleen, inflated with excess blood cells, gently nudges against my ribs like an annoying acquaintance who would hate me to forget that all is not quite right. At some point in the future and not even the best doctors can predict exactly when the disease might whirr into life and start scarring my bone marrow, turning it into a barren wasteland that can no longer produce enough blood to keep me alive. Im hopeful that science will find a fix before that time comes. There are encouraging signs on the horizon. And if not? Well, these days I try not to dwell on the future. I am here, instead, for the present. I am alive. I am alive with the spirit of Christmas.

MPN Voice provides information and emotional support to people diagnosed with a myeloproliferative neoplasm

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A blood cancer diagnosis helped me find true happiness - The Guardian

Stem cells effective against rare bone disorder in trial with mice – Breitbart

Dec. 24 (UPI) Those with weak and brittle bones caused by a rare genetic disorder have reason for new hope with the discovery of a cell transplant treatment that may finally resolve the underlying cause of their disease.

In an article published Tuesday in the journal STEM CELLS, researchers show how they transplanted healthy donor bone marrow cells directly into the femur of mice with osteogensis imperfecta, or OI, a rare disease that affects bone strength.

One month following transplantation, the researchers found 18 percent of the surface that was injected with the donor cells expressed osteoblasts cells that help form new bone tissue an indication of engraftment, or growth.

In addition, long-term engraftment was then observed at three and six months post-transplantation.

This is a basic research study with potential for future translation into practice, study co-author Ivo Kalajzic, a researcher at the Center for Regenerative Medicine and Skeletal Development at the University of Connecticut, said in a statement.

Kalajzic and his colleagues also found that healthy donor cells replacing mutant collagen have the ability to improve bone strength and structure in transplant recipients.

OI are genetic disorders that mainly affect the bone. Patients with OI have bones that break easily, sometimes with no obvious cause.

In recent years, research has shown that the disorders are caused by genetic mutations associated with type 1 collagen molecules. These molecules help the body process collagen, and damage to them results in defective bone structure.

Currently, treatments for OI attempt to correct the defective bone structure, but dont focus on the underlying collagen defect.

The new findings demonstrate, however, that healthy donor stem cells that produce normal collagen in OI patients have the potential to increase bone mass and correct the collagen defect causing the condition.

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Stem cells effective against rare bone disorder in trial with mice - Breitbart

Abington working toward big win – Sports – The Intelligencer

The Galloping Ghosts are looking beyond the scoreboard to help classmate Juwan Adams battle pediatric cancer.

Khalis Whiting and her Abington girls basketball teammates have a different perspective this holiday season. A perspective that changed when through Kisses for Kyle they were put in touch with two area families who have a child battling pediatric cancer.

One George Hamlin is a student in Upper Dublin High School. The other, Juwan Adams, is a senior at Abington. Both families were on the receiving end of gifts and gift cards at the Abington-Upper Moreland game last week. It is the 10th annual giving back game since coach Dan Marsh initiated the project.

It was an amazing experience, said Whiting, the Ghosts sophomore point guard. I was not familiar with the families, but I have seen (Adams) a few times in school, but I never really knew the story until this came up and I researched him.

He has a powerful story, and hes such a strong young man to be going through this. Every time I see him in the hallways, hes always smiling and so positive. So you know give it to his family.

Adams, who has been battling Hodgkins Lymphoma since April of 2016, is in need of a match for an allogeneic stem cell transplant.

Right now, he is out of options, his mother, Andrea Adams, said. We know for sure that an allo stem cell transplant will cure him, but unfortunately, in order to do that, we need a donor.

We have tested everyone in our family, and no one is a full match, so were relying on the Be the Match registry to locate a donor. Sadly, for minorities theres a very slim chance to actually find a full 10-out-of-10 match because we dont have enough minorities on the registry.

Hes had almost every treatment available for Hodgkins, including an auto stem cell transplant, which is where he gave himself his own cells in February of 2017. He was in remission for about a year, and unfortunately, in May of this year, we found out the cancer is back, and its been spreading consistently since May.

Despite missing more than half of the last three-and-a-half years of school, Juwan maintains a 4.25 GPA and is a member of the National Honor Society.

Abington School District has been really great with accommodating him, giving him tutors, and whenever hes an in-patient, he does hospital school, Andrea said.

Juwan is the drum captain and lieutenant of Abingtons marching band, and since September is Pediatric Cancer Awareness month, for the past four years, the marching band has worn gold ribbons on their uniforms.

Since his diagnosis in eighth grade, Juwan has been active in pediatric cancer awareness events, and for the past four years, he has held toy and book drives that he presents to the children at CHOP on his birthday in July.

Last week, Juwan and his family were on the receiving end.

It was great because Juwan never wants gifts, Andrea said. Having a child with cancer, financially its tough, especially now that we have only have one person working fulltime, and that lifted a tremendous burden, and it was so unexpected.

To have him honored by his school and his peers, he was super excited about it, and he really appreciated it because a lot of kids (battling cancer) have to give up school, or their friends tend to abandon them.

I want to thank the team and the Abington students because it is very easy to turn your back on kids that are going through these things. These kids have really rallied around him. This is one of the reasons he fights so hard to be in school. He sometimes sneaks to school because he feels the love from his school and his peers. That was one thing he definitely wanted to do to finish his senior year with his class. They have really rallied around him, and this kind of thing gives him the extra push he needs to keep fighting.

Statistics say Juwan has a 23 percent chance of finding a perfect match, but the Abington senior has been proactive.

When they told him the odds of finding his match, he said he had to do something about it, Andrea said. He set a goal to register a thousand people on the national registry, half of those being minorities.

We have gone around holding bone marrow drives. Hes now an ambassador for Be the Match, and hes been an ambassador for CHOP for about two years.

Juwan is inviting everyone to join his fight.

"People are starting to wake up and realize kids with cancer more and more are dying each day, and if they have a chance to do something, they should take every step they can," Juwan said earlier this fall. It's been hard sometimes, but I have my friends and family to support me.

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Abington working toward big win - Sports - The Intelligencer

Blueberry Extract Market Analysis Of Growth, Trends Progress And Challenges Till Upcoming Year 2017 2025 – Market Reports Observer

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Blueberry Extract Market Analysis Of Growth, Trends Progress And Challenges Till Upcoming Year 2017 2025 - Market Reports Observer

We wish we’d written that: STAT staffers share their favorite stories of 2019 – STAT

As we look back on 2019, we at STAT find ourselves a little jealous.

There has been a lot of stellar health and science journalism this year, and below is a roundup of the stories we wish we had written.

And wed be remiss if we didnt admit the origins of this annual tradition Bloomberg Businessweek did it first, and head over there for more great reads.

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Story by Blake Ellis and Melanie Hicken, CNN InvestigatesPhotographs by Melissa Lyttle for CNN

Teaira Shorters appendix ruptured while she was in jail, serving time for minor offenses such as not wearing a seatbelt. She began to experience symptoms while in custody but her pleas for medical help were ignored for days which ultimately resulted in a life-threatening infection.

This investigation of an individual case sheds light on institutional problems in our foster care and prison system that put vulnerable populations at terrible risk. Melissa Lyttles photographs bring us directly into the life of this young woman trying to move forward. Contributed by Alissa Ambrose

By Ryan Cross, Chemical & Engineering News

When a young man in Wilsons clinical trial of a gene therapy died, in 1999, it basically shut down the field for a decade and made Wilson a pariah. C&ENs profile shows us not only how the tragedy made Wilson reassess his approach to science but also how it turned him into one of gene therapys most outspoken critics: Although he believes deeply that repairing genes can cure some of our most devastating diseases, Wilson is also outspoken about the risky approaches that some gene therapy studies are taking today. Contributed by Sharon Begley

By Ava Kofman, ProPublica

To read this piece is to see todays equivalent of a Dickensian debtors prison. Ava Kofman lays out, detail by infuriating detail, how digital technologies touted as progress are used to criminalize poverty. Supposedly, installing ankle monitors is a way to get people out of jail. But because companies charge the wearers daily fees they often cant keep up with and because their devices make it especially hard to land or hold down a job the practice ends up sweeping more people behind bars. Kofman masterfully weaves a tale of bodies controlled by private firms, of lives upended by machines that were supposed to set them free. As one young man puts it, I get in trouble for living. For being me. Contributed by Eric Boodman

By Martin Enserink, SciencePhotography by Tom Bouyer, Expedition 5300

Journalist Martin Enserink journeyed high into the Andes to write about research into the effects of chronic mountain sickness traveling, effectively, into thin air. He and photographer Tom Bouyer, whose striking photographs make this a visually arresting piece, traveled to La Rinconada, Peru, the worlds highest settlement and a gold mining town. If that activity draws to mind the wild, wild west, hang on to that thought. Enserink described La Riconada, which is north of Lake Titicaca, as Madmaxian, observing that the researchers typically retreat to their hotel rooms by 8 p.m. for safetys sake.

This forgotten part of the world is perilous for other reasons. People living in an environment with half the oxygen available to lungs at sea level can experience a host of physical ailments. These researchers would like to pave the way to therapies for chronic mountain sickness, but first need to better define what living and working at this altitude does to human bodies. Its a fascinating read. Contributed by Helen Branswell

By Ben Elgin, Bloomberg

At first, the foreboding ads flooding D.C.-area television sets didnt make much sense: Why would an advocacy group representing Americas sheriffs care whether states can import prescription drugs from Canada? Bloomberg investigated and found an answer: The pharmaceutical industry was funding the ads through an intermediary group, the Partnership for Safe Medicines. In a year already dominated by heavy-handed lobbying and advocacy surrounding prescription drug pricing, Bloomberg spotlighted one of the most brazen examples of indirect ad campaigns meant to gin up antagonism toward attempts at lowering drug prices. Contributed by Lev Facher

By Caroline Chen, ProPublica

Chens exhaustive investigation of the unregulated $2 billion stem cell industry showed how questionable marketing practices and misleading scientific claims are duping patients into paying thousands of dollars for injections of amniotic stem cells that dont work. Chens work prompted the Food and Drug Administration to ramp up its enforcement efforts. Contributed by Adam Feuerstein

By Rob Copeland and Bradley Hope, Wall Street Journal

This is the story of how Martin Shkreli, the cartoonishly disgraced biotech entrepreneur, continued to run his synonymous-with-greed drug company from federal prison. There are memorable cameos from inmates called Krispy and D-Block, fascinating details about a corporate power struggle, and an Austrian interior designer who made a regrettable investment. But the star of course is Shkreli, whose jailhouse persona lands somewhere between Jordan Belfort and Pepe the Frog. Despite lots of seemingly reasonable advice to just give it a rest, he remains convinced of his own gift for drug development and incapable of ever, for any reason, logging off. Contributed by Damian Garde

By Betsy McKay, Wall Street Journal

Our job as journalists is to notice the obvious, and this story does that brilliantly. For years, cardiovascular disease has been in decline, and it was expected to fall below cancer as the leading cause of death. In the words of Robert Anderson, chief of the CDCs mortality statistics branch, Its highly unlikely given the current trend that there will be a crossover anytime soon. In fact, the rates of heart attack and stroke mortality among people in their 40s and 50s are increasing. The story even takes a paragraph to embrace a celebrity angle, noting the deaths due to stroke of 90s icons John Singleton, who directed Boyz N the Hood and Luke Perry, who played bad boy Dylan McKay on Beverly Hills, 90210. But the story does more, explaining how heart disease patients have changed over 20 years. Once, they were men who smoked and had sky-high LDL levels. Now they are younger, more obese, and more likely to be women. The big question left behind is what society can do to put cardiovascular disease back in decline. Contributed by Matthew Herper

By Mike Hixenbaugh and Keri Blakinger, NBC News and the Houston Chronicle

In this series, reporters from NBC News and the Houston Chronicle reveal how incorrect determinations of various forms of child abuse have imprisoned relatives or separated them from children. These are incredibly complicated stories involving vulnerable children, and they show how difficult it can be to distinguish between accident and abuse. But the series reveals the ties among childrens hospitals and child welfare and law enforcement agencies and the authority conceded to doctors by the legal system. What comes across is how parents worries about a sick or injured child might just be the start of their nightmare. Contributed by Andrew Joseph

By Nellie Bowles, New York Times

Weve all heard the stories of the Silicon Valley pioneers who, after having gotten us all hopelessly addicted to our phones, now carefully limit their own childrens screen time. In this smart and provocative news analysis, reporter Nellie Bowles examines that phenomenon as well as its flip side. She tells the story of a health-tech startup called Care.Coach that employs workers in the Philippines and Latin America to operate digital avatars that live within tables and are being tested as companions for low-income seniors in the U.S. Its a telling example, she writes, of a growing class divide in how care, education, and all those services and interactions that make up our lives get delivered. As more screens appear in the lives of the poor, screens are disappearing from the lives of the rich, Bowles writes. Its an observation thats lingered with me and shaped how I, as a health-tech reporter, think about covering the growing number of health-care inventions that get delivered through screens. Contributed by Rebecca Robbins

By Anna Edney, Susan Berfield, and Evelyn Yu, Bloomberg Businessweek

Bloombergs Anna Edney has owned the generic drugs might kill you beat literally all year long, from three features over three days in January to a cover story in September to right up to the week she started her maternity leave. (Congratulations, Anna!) Pharmaceutical manufacturing and quality control is rarely the flashiest or the easiest thing to write about. But she and her colleagues showed real problems in the oversight of generic drug factories in the U.S. and overseas and illustrated the consequences lackluster oversight can have for real people. My hat is also tipped to Justin Metz, who did the simple and perfect cover photo illustration for one of Edneys stories in the Sept. 16 edition of Businessweek. Contributed by Kate Sheridan

By Sarah Zhang, The Atlantic

The Atlantics Sarah Zhang has done fantastic reporting this year on the cultural ramifications of consumer DNA testing, including this story about an Indiana fertility doctor named Donald Cline. Decades ago, Cline allegedly used his own sperm to impregnate his patients without telling them. DNA tests from 23andMe and Ancestry.com have turned up at least 50 children Cline fathered with his patients. This story told with sensitivity and gripping detail examines how those children found each other and how Clines actions have impacted their lives. Contributed by Megan Thielking

Excerpt from:
We wish we'd written that: STAT staffers share their favorite stories of 2019 - STAT

The First Cell: Dr. Azra Raza on Why the Slash-Poison-Burn Approach to Cancer Has Failed – Democracy Now!

This is a rush transcript. Copy may not be in its final form.

NERMEEN SHAIKH: Why has there been so little progress in the war on cancer? According to the director of the National Institutes of Health, Dr. Francis Collins, quote, Americans are living longer, healthier lives. Life expectancy for a baby born in the U.S. has risen from 47 years in 1900 to more than 78 years today. Among the advances that have helped to make this possible are a 70% decline in the U.S. death rate from cardiovascular disease over the past 50 years, and a drop of more than 1% annually in the cancer death rate over the past couple of decades. A drop of just over 1%? For the trillions of dollars that have been poured into cancer research, just over 1%? Today, we spend the hour with a renowned oncologist who says we should be treating the disease differently.

AMY GOODMAN: In her new book, The First Cell: And the Human Costs of Pursuing Cancer to the Last, our guest for the hour, Dr. Azra Raza, notes we spend $150 billion each year treating cancer, yet a patient with cancer is as likely to die of it today with a few exceptions as one was 50 years ago. She argues experiments and the funding for eradicating cancer look at the disease when its in its later stages, when the cancer has grown and spread. Instead, she says, the focus should be on the very first stages, the first cell, as her book is titled. She says this type of treatment would be more effective, cheaper and less toxic.

NERMEEN SHAIKH: Dr. Raza criticizes what she calls the, quote, protocol of surgery, chemotherapy and radiation the slash-poison-burn approach to treating cancer, which she says has remained largely unchanged for decades. She calls for a transformation in the orientation of cancer research, writing, quote, Little has happened in the past fifty years, and little will happen in another fifty if we insist on the same old, same old.The only way to deal with the cancer problem is to shift our focus away from exclusively developing treatments for end-stage disease and concentrate on diagnosing cancer at its inception and developing the science to prevent its further expansion. From chasing after the last cell to identifying the footprints of the first, Dr. Raza writes.

AMY GOODMAN: Well, for more, Dr. Azra Raza joins us to speak in her own words. Oncologist and professor of medicine at Columbia University, shes also the director of the MDS Center. MDS is myelodysplastic syndromes, a form of bone marrow cancer. In her book, she notes, again, that we spend $150 billion each year treating cancer, yet a patient with cancer is as likely to die of it today than one 50 years ago it is an astounding fact with a few exceptions.

Dr. Azra Raza, welcome back to Democracy Now! Its great to have you with us. How can this be? How can it be, the lack of progress that has been made in this last half-century?

DR. AZRA RAZA: Thank you for having me again, Amy. Im delighted to be here.

Since 1903, it has been well appreciated, actually, that its not cancer that kills; its the delay in treatment that kills. So, forever we have been making attempts to try and diagnose this disease early. In the last three decades, we have seen a 26% decline in cancer mortality, which is about 1% a year, as you pointed out. But thats not happened because we have developed some grand, new treatment strategy. It has happened because of two main things. One is the anti-smoking campaign, so the incidence started going down. And second is because we started using screening measures to diagnose cancers earlier and earlier.

This approach of preventive medicine, where you catch the disease early and intercept early, is what caused the drop in cardiovascular disease by 70%, because, there, the cardiologists were smarter than oncologists. They realized that if they allow a myocardial infarction, or a heart attack, to damage the heart muscle, then the only treatment would be a heart transplant, which is so draconian and so terrible. They started to diagnose not only earlier and earlier, but try and prevent the appearance by using anti-cholesterol drugs, for example. Thats a very clear case of early detection, but then even prevention of the disease. And 70% decline in mortality. Why arent we doing the same in cancer?

NERMEEN SHAIKH: So what is the answer to that?

DR. AZRA RAZA: Well, the answer is that we have been trying to do it. And the screening measures that were put in place, like mammography, colonoscopy, PSA testing, Pap smears, theyre the ones that caused the decline by 26% mainly, in addition to anti-smoking campaigns. But those measures were put in 50 years ago. Imagine, in this day and age of technology, we are still putting a tube into someones gut and looking to find cancer. That is primitive. Thats paleolithic for today.

AMY GOODMAN: And the alternative is?

DR. AZRA RAZA: The alternative is that we have milked these technologies as much as we could . They have yielded the 26% decline in mortality. Theyre not going anywhere else. We need to invest in developing technology based on current imaging, scanning devices, detection of biomarkers, for example, from blood, sweat, tears, saliva, urine, stool samples, and find the earliest footprint of cancer and see how we can intervene. And this is a strategy that is not limited to just cancer, Amy. This is a strategy that is going to apply to every single chronic disease in the coming years.

AMY GOODMAN: So, what has prevented that from happening?

DR. AZRA RAZA: I wish there was a very neat kind of answer about this, but its something like this. You take a frog and put it in cold water and start heating it slowly; nothing is going to happen. On the other hand, you throw a frog into boiling water, it will jump out. But if you heat it slowly, the frog dies without jumping out, because it slowly gets used to it. This is an apocryphal story, by the way; scientifically, its incorrect. Just a warning. As a purist, I have to add that. But the analogy is true, that things have happened so slowly that we keep getting desensitized to the next step. One thing is that there is so much hyperbole around cancer treatment. If a few months of survival are added by a drug, it is welcomed as a game changer. Let me

AMY GOODMAN: At the end of life.

DR. AZRA RAZA: Yes, exactly. Let me give you just a few statistics. I want to be very clear that using the slash-poison-burn approach, we are curing 68% of cancers that are diagnosed today. We are curing them. Thirty-two percent that present with advanced disease, their outcome is the same exact outcome that it was 50 years ago. The 68% we are curing, why are we still using these Stone Age treatments? You know how terrible it is to get chemotherapy and radiation therapy.

AMY GOODMAN: Explain how it works.

NERMEEN SHAIKH: Explain what yeah, yeah. What happens?

DR. AZRA RAZA: The first rule of medicine is first, do no harm. In fact, when a patient is diagnosed with cancer, its a silent killer. Thats the problem. It can reach stage IV disease without producing symptoms. So, somebody comes to us I recently saw a 42-year-old young man who has just finished a game of tennis and come to see me, and suddenly, because he was exhausted and feeling so tired, and now I diagnosing him acute myeloid leukemia. I look at this toned and tanned young man, and the first thought that comes to me is about what we are going to do to him with the chemotherapy we are going to give him.

It is unconscionable that in 2019 I am still going to give this young man the same combination of two drugs that we popularly known as 7+3, that I was giving in 1977, when I arrived in this country. I feel ashamed of myself, having to repeat the same side effects, that you are going to lose all your hair, throw your guts out, and your counts are going to tank. Your blood counts will go down to essentially zero for weeks on end, where you are going to be susceptible to all kinds of terrible infections. You will be in the hospital suffering with shivering night sweats and fevers and all kinds of aches and pains and constitutional symptoms. And then there is a chance that a percentage of those patients will improve. So, this is what we do with just chemotherapy alone.

AMY GOODMAN: Were going to break and then come back to this discussion and also hear about your personal story with your own husband, also a renowned cancer doctor, who died of the very disease that he was studying, and hear the stories of your patients. Were talking to the renowned cancer doctor, the oncologist, the professor of medicine at Columbia University, Dr. Azra Raza. She has a new book. It is called The First Cell: And the Human Costs of Pursuing Cancer to the Last. Stay with us.

[break]

AMY GOODMAN: Nocturnes, Op. 27, No. 2, in D-flat major, _lento sostenuto _, performed by Abbey Simon. Abbey Simon passed away December 18th at the age of 99. This is Democracy Now!, democracynow.org, The War and Peace Report. Im Amy Goodman, with Nermeen Shaikh, as we spend the hour with Dr. Azra Raza, a renowned oncologist, professor of medicine at Columbia University, where shes also the director of the MDS Center a form of bone marrow cancer her new book, just out, titled The First Cell: And the Human Costs of Pursuing Cancer to the Last.

NERMEEN SHAIKH: So, Azra Apa, Dr. Raza, we were talking earlier, in the first part of the program, about the slash-poison-burn approach to treating cancer, which youve been very critical of, which involves surgery, chemotherapy and radiation. You say that this has been responsible for curing 68% of cancers. So a couple of questions: Would it have been possible, even though this is counterfactual, to cure such a high number of cancers using alternative methods? And, two, what kinds of advances have been made in how chemotherapy is administered and how the effects of that, of changes in the way that its administered, have had on patients?

DR. AZRA RAZA: Both very good questions. So, the first question you asked is what could have been really done. And what have we been aiming at doing? So, sure, we started by using these blunt approaches. Its literally like taking a baseball bat to hit a dog to get rid of its fleas. Thats how bad this kind of treatment is. But we had to do it because we had no alternatives. In the meantime, we invested billions of dollars in trying to study the biology of cancer, hoping that we will identify some intricate signaling pathway, some genetic defect, that is going to allow us to target it specifically. And this did happen in two diseases. In chronic myeloid leukemia, we developed a targeted therapy, because theres one gene had gone wrong, and one magic bullet could target it and cure the disease. Now we

AMY GOODMAN: And again, just to note, youre one of the worlds leading authorities on AML, this kind of cancer.

DR. AZRA RAZA: On this, Im talking about chronic myeloid leukemia. But yes, youre absolutely right: I am an expert in myeloid diseases. And CML, chronic myeloid leukemia, is something Ive treated for decades.

Now, this was a huge advancement that happened in the early 2000s, that we could now use a targeted therapy which is not chemotherapy, which only goes and attacks the abnormal cell which is expressing this protein. While it helped patients, its also put the field behind by 20, 30 years. Why? Because we felt that this now establishes a paradigm. Every cancer will be caused by one genetic defect, for which we just have to develop one drug. So, one gene, one targeted therapy. Everybody and their grandmother has been trying to find the one gene for pancreatic cancer, the one gene for acute myeloid leukemia. It turns out that, unfortunately, for all other cancers, most of them, really, there are too many genes that are mutated simultaneously. And so the targeted therapies weve developed, even for those multiple proteins or one protein that is dominant, it turns out it works for a little bit.

So, let me give you some statistics again. Ninety-five percent 95% of the new drugs that we are bringing, the experimental drugs we bring to the bedside, 95% of them fail. And to bring one of those drugs to the bedside is a billion dollars almost. So imagine how much we are losing. Five percent that succeed should have failed, in my opinion. Why? Because theyre only prolonging survival by a few months. So, for example, theres a drug that extends the life of a pancreatic cancer patient by 12 days, at the cost of $26,000 a year and not every pancreatic cancer patient, just a fraction. So think of the financial toxicity we are causing to these patients now. For very little prolongation and survival, we are financially ruining 42% of cancer patients diagnosed, newly diagnosed with cancer today, by year two. They lose every penny of their life savings.

AMY GOODMAN: Speaking of which, before we go on to the incredible stories you describe in The First Cell, your thoughts on Medicare for All? I have spent a lot of time accompanying family and friends, for example, at Sloan Kettering, who are dealing with cancer. The astounding devastation of peoples, aside from lives, financial destruction. Medicare for All, what would that mean for cancer patients?

DR. AZRA RAZA: Amy, while Im not an expert on these issues, I have common sense. And one thing I can say is that the current situation is completely untenable. We are on the verge of a collapse with the healthcare system. We cant continue it the way it is going. And, to me, the only solution seems to be but again, its not speaking as an expert is to have Medicare available for everybody. I think thats the only compassionate and humane solution.

NERMEEN SHAIKH: Well, Azra Apa, I want to ask you about another incident that you mention in the book, before going on to the longer case histories of patients in their own words as well as in the words of their family members. I mean, the cost of cancer treatment, as you say, in the U.S. is exorbitant, and many families have been driven to financial ruin. But what about in places where cancer treatment is so prohibitive that it entirely deprives patients of access? You talk about arriving in Karachi and meeting in Karachi, Pakistan, which is where youre from and talking to Zaineb, a cancer patient about whom you write, quote, How does one go in and talk to a thirty-five-year-old woman for whom dying from leukemia is only her second-biggest problem? Could you talk about that, access to cancer treatment and who the people are who are entirely deprived of any treatment at all?

DR. AZRA RAZA: This is a subject which is very close to my heart, Nermeen, because, obviously, I am from that part of the world. The entire world looks to America for leadership. What kind of leadership are we providing? A leadership where we are developing drugs or cellular therapies now that will cost over a million dollars per patient, for helping very few patients. These are rarified cases for whom this kind of treatment will work. As you said, what about the 20 million new cancer patients being diagnosed universally all around the world? We just dont have a compassionate solution for them. Why arent we thinking not just of those even in America, in the remote areas and many, many places where healthcare is becoming harder and harder to access just because hospitals are closing down from financial ruin themselves? Why arent we thinking of them? Why arent we thinking beyond American borders, for humanity as a whole?

And when you think about that solution, I mean, you dont have to be a genius. No, no, look, the only thing that works in cancer if you have someone who gets diagnosed with cancer, the first thing youll say is, Was it advanced, or was it caught early? No, early, so theres hope. We know that early detection helps, right? Why are we investing money in chasing down the last cell, in which with drugs which have a 95% failure rate today? Because the pre-clinical testing platforms we are using are so artificial, and thats why we are bringing up drugs that are not going to be successful.

Instead of doing that, why arent we simply improving on the techniques we know work? What worked? Early detection. How do you do early detection? Well, mammography, colonoscopy, Pap smear, etc., has been reached to their maximal limits. Lets develop the new technology so that from one drop of blood, you can put it on a little chip, which can be read by a cellphone, which costs $180 for 12 cancers to be diagnosed early. This is something that was just announced by a Japanese company. So these are things not that are a pie in the sky. These are things that are happening now. Except how fast will it happen to reach the rest of the world? It depends on the amount of resources we invest.

AMY GOODMAN: Were talking to Dr. Azra Raza. Her book is called The First Cell. She is a leading oncologist in the world. She is a Pakistani American, a Muslim, a woman. You talk about your own story in the book, the story of your husband, also a leading oncologist. Dr. Harvey Preisler died of lymphoma in 2002. You write, Cancer is what I had been treating for two decades, yet until I shared a bed with a cancer patient, I had no idea how unbearably painful a disease could be. Lets first turn to your daughter, to Sheherzad Raza Preisler, speaking at the memorial service for her father, your husband, about his cancer diagnosis and the effect his condition had on the family. The 15th Harvey Preisler Memorial Symposium was held in New York in 2017.

SHEHERZAD RAZA PREISLER: What a cruel twist of irony it was that as he was directing the Rush University Cancer Center in Chicago, he was cut down in the prime of his life by the very disease he had dedicated his life to cure. I was only 3 when he was diagnosed and 8 when he died. My parents took great pains to never mention the C-word in my earshot, and yet most of my memories of Dad are related, at least in part, to the presence of this nameless other in our lives. And even though I was too young to know what was going on at any tangible level, I had some sort of instinctual knowledge that something was terribly wrong. I could sense my mother struggle as she was navigating through stages of optimism, pain, dread, despondency and, eventually, hopelessness, as my dad underwent a seemingly endless stream of experimental treatments. These stages are what most cancer patients and their caregivers and families experience.

AMY GOODMAN: That was Sheherzad Raza Preisler, the daughter of our guest today, Dr. Azra Raza, oncologist, professor of medicine at Columbia University, talking about her dad, who died of one of the cancers that he specialized in. He was head, Dr. Harvey Preisler, of the Rush Cancer Institute in Chicago. Tell us, as you begin your book, what happened to your husband, what happened to Harvey.

DR. AZRA RAZA: First of all, Amy, when I started writing this book, I had no intention of putting Harvey into the book. I was writing about my other patients. But when I wrote about them in such detail and with such painful granularity, I felt it would be dishonest if I held back my own story. And so, at that point, I decided to add. And once I decided that, this story became like a red line running throughout the whole book, because then I couldnt escape, at every level, where Harvey came in.

Ill give you just one example. I mean, he was the head of the cancer center. He gets the very disease hes trying to cure. And now he dies, after a very, very exceedingly painful almost five-years battle. Sheherzad was 8 years old when he died. And a couple of weeks after he died, she developed a terrible cold and flu and was pretty sick for a few days and then started getting better. And one morning I was sitting in the living room reading, and she suddenly comes out crying inconsolably. I was sure that shes had a relapse and is much worse. But when I was able to calm her down, this is what she said, Amy. She said, Actually, I feel perfectly fine now. But I know what it feels like to be so sick and how good it is to get better. And my dad never got better. Which brought on a second fit of crying. So, an 8-year-old, at a visceral level, is able to experience the kind of anguish that cancer patients suffer.

Being a cancer widow, did it make me into a different kind of doctor? No. But my perceptions changed entirely. You know, Marcel Proust has said that real voyage does not lie in finding new landscapes, but in having new eyes. And so it became a voyage of discovery for me, in having new eyes.

AMY GOODMAN: And that issue of prevention, of catching early, what happened in your husbands case? Who I mean, he was head of a major cancer institute.

DR. AZRA RAZA: The same thing that happens to all other cancer patients: He was diagnosed way too late. And actually, the lymphoma didnt kill him. The treatment we gave killed him. The chemotherapy we gave destroyed his immune system, so that he died eventually of sepsis. He didnt die of the lymphoma.

Theres a family friend of ours who once told my younger brother he said, Abbas, if the sun rose suddenly from the west one day, the entire world will stop and stare at it. But there are some people who watch the sun rise from the east every day, and they wonder why. And he said, Those are the only kinds of people who can make a difference in the world.

And thats the kind of person Harvey was. He was an extremely thoughtful person with a great curiosity about life in general, but specifically scientific issues. Yet what I learned from taking care of him and sharing a bed with him as a cancer patient was a deeply humbling acceptance of his condition. Basically, his attitude was I am a man, and a man is responsible for himself, even though I know that this is not going anywhere.

AMY GOODMAN: You write at the beginning of your book, in your introduction, From Last to First, talking about that idea of the first cell, I have learned new things about what I thought I already knew: like the difference between illness and disease; between what it means to cure and to heal; between what it means to feel no pain and to feel well. Can you elaborate on this?

DR. AZRA RAZA: I mean, really, the whole concept of this is can be expressed better in poetry. So, if you dont mind, I will recite a short piece by Emily Dickinson:

I measure every Grief I meetWith analytic eyes I wonder if It feels like Mine Or has an Different size.

I wonder if They bore it long Or did it just begin I cannot find the Date of Mine Its been so long a pain

I wonder if it hurts to live And if They have to try And whether could They choose between They would not rather die.

NERMEEN SHAIKH: Well, I want to ask about another patient who you profile in the book, who is in fact subjected to a particularly brutal form of this slash, burn and poison. And thats Andrew Slootsky, who died in 2017 at the age of only 23. The book includes a testimonial from his mother, Alena, who criticizes the attitude of the oncologists who treated him, but says she would have wanted Andrew to undergo any treatment that might have extended his life. So, could you talk about Andrew was also one of the best friends of your daughter, Sheher. Could you talk about the treatment that he was subjected to? What happened? And also your decision one of the most remarkable things about this book is not just, of course, your expertise in cancer and cancer treatment, but also these stories that you weave into the narrative, of patients youve treated, of patients families who have witnessed their family members being treated in this way and ultimately dying. And this is Alena, Andrews mother, saying that she would have Andrew go through all of this treatment, even if it meant the slightest possibility of extending his life.

DR. AZRA RAZA: Yes. Nermeen, actually, Andrew is the impetus for me to write this book. In 2016, when he gets diagnosed with cancer, he has weakness in his arm. He goes to the emergency room. They do an MRI. They find an inoperable brain tumor, nine centimeters long. They couldnt remove it. From the day one, every oncologist that treated Andrew knew that his chance of survival is 0.00, beyond what is to be expected. No matter what we give him, he was going to die. We all knew it.

This boy, when he opened his eyes, coming out of anesthesia, he turned to his mother, and he said, Mom, dont worry. Just call Azra. Shes on the cutting edge. She will find the best treatment and cure for me. And Alena called me. This young man, whos been in and out of my house since hes 15 years old, because hes best friends with my daughter. I felt so ashamed of myself that there is nothing I can offer this poor boy, and the fact that we are failing the Andrews and the Zainebs and the Harveys and the Omars of this world so spectacularly, and instead of feeling embarrassed, we go around pumping our chest, claiming that we are curing 68% patients. Sixty-eight percent of what? again and again I ask.

And what we do to Andrew in the next 16 months, even though we knew his chance of survival is zero, is we give him chemotherapy, radiation therapy, surgery after surgery, more chemo, more radiation, more immune therapy. And he suffered the side effects of every one of them, without benefiting from anything.

But then, the converse is also a problem. Lets say we didnt treat him and let the brain tumor take over. That death from advanced cancer is just horrendous. So, basically, the treatment, what are the choices we offered Andrew at this point? Either you die of your cancer or die of the treatment, but you are going to die. And the question I ask myself is Why? Why was Andrew diagnosed when his cancer was nine centimeters long? We know that cancer is a silent killer. We know no age is immune to getting cancer. At 22, this boy got cancer.

AMY GOODMAN: And specifically in his case, how could it have been detected earlier? Talk about the tests that you think need to be developed, and are actually already there but somehow missed him?

DR. AZRA RAZA: So, Amy, I am calling for a complete paradigm shift. What Im saying is that even the screening measures that we are using annually, for example, doing a mammogram is too late for some people. What we need to do is consider the human body as a machine and continuously learn to monitor it for the detection of diseases, whether its Alzheimers or cancer or diabetes. We need to catch all of these diseases early and try to nip them in the bud. This is what Im asking for. So, what has to be done for that? Children get cancer. Not that many, but certainly they do. And again, we treat them with these draconian measures, and they end up with developmental issues, fertility issues, all kinds of problems. So, what Im asking for is we need to develop those markers that can identify cancer at its inception. It is doable. It is possible.

A lot of research is going on, in this country and elsewhere also, to find footprints of cancer, for example Ill give you a couple of examples. When cancer starts, it divides fast its cells divide faster than normal cells, which means it needs more nutrition, so it starts making new blood vessels. As soon as that happens, the area becomes hot because of new blood going into that one area. This hot area can be detected. People are developing bed sheets and mattresses where you can go to sleep and you are overnight youre being scanned for hot areas. Lets say a hot area is detected in my pancreas one day. It doesnt mean the next morning I should have an open abdominal surgery and eviscerated and removal of all my no, it means that now theres something abnormal which needs to be monitored. I am now considered someone at high risk, so I should be monitored for other biomarkers. These cells which are developing in my pancreas will be shedding their proteins into the bloodstream. If theyre not shedding, you know one thing we can do? We can yell at them. How do you yell at them? You use sound waves, literally, ultrasound, to hit them. And they start shivering, and they start shedding their proteins into the blood. And we get the blood and detect the biomarker.

AMY GOODMAN: Is there a cancer-industrial complex thats preventing this kind of research and development of the preventive and the early-detection approaches to cancer?

DR. AZRA RAZA: Absolutely not, Amy. In fact, my contention and my conceit is that if heres an industry that is investing in an enterprise that has a 95% chance of failure, but they keep investing billions of dollars, because if one of their drugs makes it, if it improves survival by 10 seconds more than two months

AMY GOODMAN: So youre saying there is a cancer-industrial complex that is

DR. AZRA RAZA: But theyre not preventing it.

AMY GOODMAN: Right.

DR. AZRA RAZA: They just dont know whats a better thing to do. So, what Im saying is, we just set a new goal, and we financially incentivize the goal, then all these people will turn around and come to the first cell instead of going after the last cell.

AMY GOODMAN: What about Vice President Bidens moonshot challenge around curing cancer?

DR. AZRA RAZA: I was one of the fortunate people to meet Vice President Biden in his across his dining room table for the cancer moonshot and had a very wonderful discussion with Vice President Biden. His heart is in the right place. And there is a certain fraction of that billion dollars, the money that he has allocated for cancer research, is definitely towards prevention and early detection of cancer. But its not enough. That kind of vision is what we really need. But we need Im not saying all current research should stop. Nobody should misquote or mishear me. I am saying we have correct patients. Of course we have to worry about them, and we have to keep developing better treatments and better understanding of biology. But I think at least half of the resources, and all the resources going into these failing clinical trials, these billions and billions of dollars, can be redirected for future patients to try and detect the disease early a solution which will be applicable universally.

AMY GOODMAN: We have to break. Then were coming back to our guest, Dr. Azra Raza, oncologist, professor of medicine at Columbia University, where she directs the MDS Center, a form of bone marrow cancer. Her new book is out. Its called The First Cell: And the Human Costs of Pursuing Cancer to the Last. Stay with us.

[break]

AMY GOODMAN: New York by St. Vincent. The photos in the video were compiled by Kat Slootsky for her brother Andrew, one of the patients profiled in Dr. Azra Razas book, The First Cell: And the Human Costs of Pursuing Cancer to the Last. He died when he was 23 years old, of a particularly aggressive form of brain cancer. Im Amy Goodman, with Nermeen Shaikh. Were spending the hour with Dr. Azra Raza, the renowned oncologist, professor of medicine at Columbia University. Nermeen?

NERMEEN SHAIKH: So, Azra Apa, I want to ask you about one of the criticisms that your book has come under. In The New York Times, Dr. Henry Marsh praises the book but says youre too optimistic about the solutions you propose. Marsh writes, quote, Her diagnosis of the ills from which cancer treatment suffers strikes me as accurate, but her solutions seem infused with the same unrealistic optimism she identifies as the cause of so much suffering. This is Dr. Henry Marsh writing in The New York Times. Are you guilty of too much optimism?

DR. AZRA RAZA: No. Thats the short answer. But, Nermeen, you know, I started my career in oncology basically in 1977. I was 24 years old, fresh out of med school. I had come here. I started working at Roswell Park Cancer Institute, because I was going to cure cancer very quickly, I thought. And within seven, eight years, it was very clear to me, the disease that I had invested all my energies in, acute myeloid leukemia, that in my lifetime this disease will not be cured. It is so complicated.

So, at that point, I turned my attention toward studying an earlier form of the disease, because many of my patients who came with acute leukemia gave a history of having had some low blood counts and being anemic for a few months before it developed to leukemia. So I said to myself, Why not catch this disease earlier, the pre-leukemia phase, and intercept then and not let it become this end-stage monstrosity?

So I started collecting this is where being an immigrant helped me, Amy, because had I gone to school in this country, if I had started to study acute leukemia, my next step would have been to make a mouse model of this disease, which are very artificial and which just for drug development, at least. Theyre very good models for studying biology, but not for drug development. But because I was an immigrant, I simply started saying, Oh, I have to study cancer, so let me save these cells. And I started banking cells on my patients. Today I have a tissue repository which has 60,000 samples from thousands of cancer patients, followed longitudinally, well annotated, with all their clinical and pathologic data in the computerized forms. And this is a very precious resource, one of a kind. Not one single cell comes from another physician. I still do the bone marrows with my own hands, which Im going to do in the next hour, when I get to my clinic.

But the idea I had was that earlier detection will help. That was many years ago. Wheres my solution? So, the question you ask me and the criticism that Dr. Marsh is giving can be applied to me, yes, that 35 years ago I felt that detecting the disease early, pre-leukemia, would help me. It hasnt helped me, because pre-leukemia itself is a very malignant disease and can kill.

So then I realized that by using these samples of acute leukemia, working my way back to pre-leukemia, I can then ask the question: Why did some people get pre-leukemia, to begin with? Why did they get MDS? And once we can discover that, by using these tissue samples and the latest technology of proteomics, genomics, transcriptomics, metabolomics, panomics, we will find the same kind of thing you have, say, for breast cancer, the BRCA gene. Can we find something thats making people susceptible because of their inherited DNA?

AMY GOODMAN: What about targeted immunotherapy? People think that it has gone so far to help cancer patients. What is it? And what do you see are the prospects for it?

DR. AZRA RAZA: The answer to that is, first, you have to understand what is the cell therapy. So, there are many, many different forms of immune therapies, fourteen, fifteen different kinds. But the ones that are receiving all the attention are basically two types. Checkpoint inhibitors are drugs which cancer cells so, every cell expresses proteins that either say, Eat me, or Dont eat me. Cancer cells learn to express only proteins that say, Dont eat me. Dont eat me. Dont. So, this is how they deflect the immune system.

AMY GOODMAN: We have less than a minute.

DR. AZRA RAZA: And so, we tried drugs to do that. We succeeded. The response doesnt last. The other form of therapy is cell therapies that we use. Immune therapy using cells T cells, for example cannot distinguish between a normal cell and a cancer cell in the organ. All we can do is we can activate these T cells and say, Go kill the whole organ, and cancer will die with it. So the only cells we have succeeded in killing, or the only organ we have succeeded in killing, so far, is B cells, which are a kind of lymphoid cells in the body.

AMY GOODMAN: Ten seconds.

DR. AZRA RAZA: We kill them, and then we replace B cell function by giving immunoglobulins for the rest of their time. We cant do that for the liver. We cant kill the liver and expect to replace it. Thats why immune therapy using cells is not going to work.

AMY GOODMAN: Well, were going to have to leave it there, but people can pick up the book and take it from there. Dr. Azra Raza, oncologist, professor of medicine at Columbia University, heads up the MDS Center, a form of bone marrow cancer. Her new book, The First Cell: And the Human Costs of Pursuing Cancer to the Last. Im Amy Goodman, with Nermeen Shaikh.

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The First Cell: Dr. Azra Raza on Why the Slash-Poison-Burn Approach to Cancer Has Failed - Democracy Now!

Christmas In The City Thrives As Founder Battles ALS – WBUR

It's a Here & Now tradition that began in 2015 when the show first aired a holiday story about Boston's Christmas in the City, the world's biggest party for homeless children.

Since then, we've been sharing those kids' joy with our listeners, just as Christmas in the City has continued throwing its massive holiday party.

The event, founded as a 100% volunteer nonprofit by Jake Kennedy and his wife Sparky Kennedy, kicked off in 1989.

As Jake Kennedy explains, it started when their daughter was 2 years old.

"She got too many presents so she had no idea what Christmas meant and you know, we wanted to show her the other side of life, he says.

The first time they held Christmas in the City, the event was small, with only a few hundred kids at their family business, Kennedy Brothers Physical Therapy. Over time, the event took off.

By 2015, the number was around 4,000 people, and this year, about 6,000 kids were in attendance. The event is packed with presents, food, carnival rides, face painting, and of course, a visit from Santa Claus.

Jake told us in 2015 the event made him emotional.

"You don't understand people who have to wait in line, that no promises are kept, they don't know what school they're going to, they don't know where they're going to live, they don't know where the next meal is coming from, he says. What it means to be treated like princes and princesses."

"I wouldn't miss it," he continued. "I wouldn't miss it."

Speaking to him last week, the enthusiasm and the spirit are the same though his voice is lower, his speech slightly slurred. Because the man who's dedicated his life to fighting others' battles is now fighting his own.

He's been diagnosed with ALS also known as Lou Gehrig's disease an insidious disease that leaves the mind intact but ravages the body. Jake's father died of ALS, as did Jake's younger brother he called Squirrel. Another brother, Ratt, also has the disease.

Sparky says the diagnosis didn't come as a surprise. In fact, when the first symptoms appeared, she said she knew immediately.

"Jake was tested for the gene about five years ago. October 11 was when it was confirmed it was the ALS, she says. I noticed the symptom of stuttering speech the very last week in August, actually."

Jake and Sparky said they had a brief reprieve when Jake tested positive for Lyme disease, which could have produced that symptom. But in the end, it turned out that they were facing ALS.

Despite the diagnosis and the family history, Jake is anything but defeated. "I'm very optimistic about a cure," he says.

This is a time like no other time in research. And Dr. Brown, Zack, they are so optimistic, he adds.

Hes referring to his son Zack, a post-doctoral researcher at UMass Medical School in Worcester, Massachusetts, and Dr. Robert Brown, director of Neurotherapeutics at the University of Massachusetts.

The two are working together on ALS research.

"Approaches now for treating familial disease are very powerful in terms of inactivating the genes that cause this to run in families," Brown says. "So there's more hope for familial ALS then there's ever been."

Brown says it's also exciting that the lessons from the genetic forms of ALS also apply to the other 90% which are not familial. Zack adds that there are clinical trials that may benefit his father.

For Zack, family history was among the factors that drew him into ALS research.

"It's very motivating to know that your work will go into helping your family for sure," he says, growing emotional. "There are ups and downs, it gets heavy, but nothing good comes easy."

Zack says he's impressed with how his family, particularly his mother, are handling the new reality scheduling doctor's appointments, dealing with insurance and remaining positive.

Sparky says she's just taking it one step at a time. "Putting one front in front of the other is how I'm doing it right now, she says.

In some ways, Jake says Christmas in the City has given him the perspective he needs to deal with battling ALS.

"Because of the Christmas in the City, I feel how unjust society is, he says, so I think other people are far worse off than I am, right?"

"We talked about this before you were diagnosed. If I died tomorrow, I would have had the most blessed life ever, Zack says. And life's not fair."

"And so you just have to count your blessings and take it day by day, Zack continues, his voice trembling. And I think you'd agree that we've had such a blessed life. And it's very easy to forget that and it's easy to get angry.

Yet Jake calls his 65 years on the Earth a total blessing. He mentions his four children and their spouses, who have brought so much into his and Sparky's lives.

Jakes wish moving forward is for people to reach out and change society forever. So many families are socially and economically disparaged and I want that to end."

"We want research money and we want to find a cure, Sparky adds, and we're going to remain hopeful."

When the topic of testing is raised, Zack again is emotional. He says he was tested and is negative meaning he does not carry the ALS gene. The couple has a new baby.

"It's the most wonderful blessing," he says in a whisper. "But it's hard thinking about your siblings."

Click here for the Jake Kennedy ALS Fund.

See the article here:
Christmas In The City Thrives As Founder Battles ALS - WBUR

Once winded walking up stairs, Omaha man is back in gym thanks to new cystic fibrosis therapy – Omaha World-Herald

Nicholas Bell arrived at the gym on a sunny December afternoon, climbed aboard a treadmill and jogged, occasionally slowing for a breather.

His run done, he headed for the weights. Its a routine hes been trying to fit in three or four days a week.

But until a few months ago, Bell, 36, had largely stopped working out. Just walking up the stairs of his Benson-area home left him winded.

Then in late September, he started a new therapy for cystic fibrosis, the rare, progressive disease he was diagnosed with at 6 months old.

The treatment, a three-drug combo called Trikafta, has been hailed as the first to show dramatic improvement in lung function in most people with the disease. While not a cure, its expected to benefit 90% of patients, including those who have the most common mutation in the cystic fibrosis gene, called CFTR, which was discovered 30 years ago. The Food and Drug Administration approved the therapy in late October for patients 12 and older.

Now that hes back to working out, Bell realized it wasnt motivation he lacked, but the ability to do the work.

Its exciting I can work out and still have energy to walk the dog and go be with my friends, he said of his recent turnaround.

Until a few months ago, Nicholas Bell, 36, had largely stopped working out. Just walking up the stairs of his Benson-area home left him winded. Then in late September, he started a new therapy for cystic fibrosis.

Cystic fibrosis affects an estimated 30,000 people in the United States and 70,000 worldwide. It causes thick mucus to build up in organs, damaging patients lungs and digestive systems.

In clinical trials, the drug boosted lung capacity an average of 14%, said Dr. Peter J. Jim Murphy, program director of the Adult Cystic Fibrosis Program at the University of Nebraska Medical Center/Nebraska Medicine. That program and the Pediatric Cystic Fibrosis Center at Childrens Hospital & Medical Center form the Nebraska Regional Cystic Fibrosis Center, which treats more than 300 patients. One Childrens patient participated in clinical trials of the drug.

We face, every day, steady decline in lung function in virtually all of our patients, he said. In one fell swoop, youve turned that around. Its whoops and hollers for the cystic fibrosis team, and has driven quite a few patients to tears of joy.

And while most attention has focused on the initial boost the drug provides in lung function, Murphy said, doctors also are hoping it will decrease the rate of decline in that function by as much or more as earlier drugs. Long-term results, of course, are not yet in.

All adults face a decrease in function after age 30, he said, but its typically not enough to cause problems. Cystic fibrosis patients, however, lose lung function about four times faster on average than the typical person.

They very quickly cut into the lung function they need to live their daily lives, not just to run marathons, he said.

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Bell has had his own ups and downs with the disease, including a near-death episode in 2016 that prompted his doctor to suggest it was time to consider a lung transplant. He avoided that by focusing on his health, and saw some significant improvements. But he became really ill in mid-2018 after catching a bug.

He got Trikafta a bit before the FDA approved it through a program that offered the therapy to people like himself who at the time had low lung function.

By the two-month mark, his lung function had increased by 19%, the biggest gain hes ever seen. Hes been using that improvement as a springboard to bolster his physical fitness. Hes been working to push his mile time below 10 minutes, and he plans to train for a cystic fibrosis extreme hike in Colorado next fall. He hasnt experienced any notable side effects, although hes seen posts in online groups from some who have.

With his improved energy level, hes also back to doing more writing. A teaching artist with the Nebraska Writers Collective, he coordinates a program that sends instructors into prisons to teach creative writing and also helps teach a slam poetry class at Omahas Central High School. He and his wife, Kristin, celebrated their third anniversary earlier this month.

Im happy to be where Im at now, he said.

Hes also keeping on top of his cystic fibrosis treatment routine. That includes donning a percussion vest that breaks up mucus in his lungs three times a day for between 30 and 45 minutes. He also uses a nebulizer, a device that turns liquid medications into a mist he inhales.

He encourages other people with cystic fibrosis to do the same. A clinical trial is being launched to determine whether patients can pare back their regimens, but those results arent in. He said his fear is that younger patients will decide the disease is cured and drop their treatments.

I think its important for us right now to just stick to our regimen, he said.

Nicholas Bell said his fear is that younger patients will decide that with the new therapy, cystic fibrosis is cured and drop their treatments. I think its important for us right now to just stick to our regimen, he said.

Dr. Heather Thomas, director of Childrens cystic fibrosis center, is eager for results of other studies, those testing the drug in children ages 6 to 11.

Kids stand to benefit even more than adults if the therapy can slow the diseases progression.

The earlier we can get kids on, the better, she said. So far, theres no indication the therapy wont work in younger children.

Older pediatric patients who got the drug also experienced fewer pulmonary exacerbations, meaning they didnt get sick as often. That would be a huge win for families, Thomas said.

Research also is needed to help the 10% of patients whose disease is caused by different mutations. The Cystic Fibrosis Foundation launched a $500 million campaign in late October intended to accelerate efforts to cure the disease.

Another concern raised after the drugs approval was whether patients would have access to it, given its price tag of $311,000 a year.

But Murphy said patients have been able to get the drug through insurance and patient assistance programs, typically with a relatively small co-pay. A small minority have been denied, but those denials have been reversed on appeal.

Its dramatic, life-changing and, we believe, life-prolonging, he said. Its important to know that its not a cure, and that our job as cystic fibrosis providers is still going to be here. But its going to be different.

Bell, the poet, has his own word for it.

Its freeing, he said. It definitely has been very freeing.

This report includes material from the Washington Post.

Matthew Eledge and husband Elliot Doughertyplan to explain her out-of-the-ordinary birth to their daughter in terms she can understand: that her grandmother furnished the garden where she grew, and that her aunt, Lea Yribe, generously supplied the seeds.

One pothole did a passenger a favor when the ambulance he was in struck it, according to first responders. Gretna firefighters were taking a man suffering chest pain and a high heart rate to the hospital. While en route to Lakeside Hospital, the ambulance hit a pothole. The jolt returned the patients heart rate to normal.

Thought to be brain dead, doctors took former Creighton Bluejays play-by-play announcer T. Scott Marr off life support. Before his family settled on a funeral home, they decided to see their dad one more time. When they got there, he was awake and speaking.

Karla Perez was 22 weeks pregnant when she suffered a catastrophic brain bleed and was declared brain dead. Her unborn child was alive, but wouldn't survive delivery. So family and doctors kept her on life support.Angel was born eight weeks later.

Darnisha Ladd never imagined Snapchat would help save her life after she suffered a stroke. But needing a precise timeline of events, doctors and family relied on a post on the phone app and were able to give her a needed medication in time.

Lindsey and Derek Teten's triplets are one in a million. Literally. The Nebraska City couple's three daughters, born in late June 2017, are identical and were conceived without fertility treatments. The girls were the second set of spontaneous triplets born at Methodist Women's Hospital. The first set, also girls, was born in 2015.

Doctors diagnosed the paralysis that was creeping up Justin Chenier's legs as Guillain-Barre syndrome. It would become so serious that the Omaha man would nearly lose consciousness while screaming because of the pain. The syndrome was triggered by West Nile virus.

Kenze Messman's been diagnosed with several chronic illnesses. Sometimes her heart rate climbs, seizures send her to the floor and migraines leave her in the dark. And one of the ailments causes the 17-year-old to have allergic reactions to almost everything.

The skin on Sharan Bryson's leg was black from lack of circulation. She felt nothing but a sharp, stabbing pain. The leg was dead, and her best option was amputation. Bryson bounced back and put her hard work to the test by running a 5K.

Chase Tiemann has had numerous surgeries in his young life, including the amputation of his left arm. The Omaha boy has a condition that causes tumors sometimes benign, sometimes cancerous to form on his body. To boost his spirits after amputation, the Papillion Fire Department named Chase an honorary firefighter.

Wesley Woods battled heart disease for 20 years. He'd racked up nine heart attacks, multiple surgeries and one heart transplant. He was tired of hospitals. Tired of chest pain. Tired of feeling tired. Woods was lucky he received a second transplant.

Amber Kudrna wasn't sure she'd be able to have a child of her own. After two kidney transplants, doctors gave the Omaha woman a laundry list of potential pregnancy complications. Kudrna and husband Adam weighed their options and, in September 2018, welcomed a baby boy.

Joe Nolan couldn't take his son James' pain away. But he could find a way to share it. Nolan got a tattoo that arched across his head, just like his son's scar. James was born with a handful of ailments, including one that regularly requires his skull to be reshaped.

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Once winded walking up stairs, Omaha man is back in gym thanks to new cystic fibrosis therapy - Omaha World-Herald

The Art of Origami is Now A Key Tool That Helps Doctors Save Lives – Nature World News

Dec 23, 2019 05:03 AM EST

Origami's new role in the field of science and technology has definitely taken a turn for the better in the recent decade. Better known as origami engineering, the practice is used to reduce structures or maximize space and function.

Origami engineering has made great strides in the medical field in particular. The same principles used in origami, when applied to medical devices, allows implants to be folded to minuscule sizes and then unfolded to its actual size. The reverse is also applicable, where like toothpaste tubes, can be fully de-compressed.

Folding techniques could transform flat objects with wrinkles to increase resilience, shock-absorbance, strength, or rigidity. Origami provides a unique insight into how single pieces could sustainably be packaged without cutting, welding, or riveting, allowing for cheaper manufacturing costs and easier assembly.

The utility of origami engineering has captured the attention of people such as Rebecca Taylor, assistant professor at Carnegie Mellon University's Department of Mechanical Engineering. Taylor specializes in microfabrication and biomechanics, a study that has helped her fabricate microscale sensors to reliably assess cardiomyocytes derived from stem cells. A natural inclination to similar practice, Dr. Taylor has developed an origami-based DNA synthetic cardiac contractile protein, which allowed her to observe merging mechanics in multiprotein, acto-myosinc contractile systems.

As a professor, Taylor expands on the utilization of DNA origami in medicine. This technique (also referred to by Dr. Taylor as "bottom-up manufacturing"), allows improvement in nanomanufacturing and nanomechanics of multiprotein systems, paving the way for heart stents that could unfold in a very precise location.

The problem, however, is on how to deploy these structures in a 100% fault-free way. To illustrate this, a common problem that impedes the creation of pop-up tents that could self-assemble at the press of the button is when the folds of the tent get stuck during the folding process on occasion.

Understandably, this raises some concern among those who are keen to use self-folding nanomachines in medicine.

So this is where origami comes in.

According to University of Chicago scientists, the limits of self-folding structures could be intrinsic in that so-called "sticking points" seem to be unavoidable.

Previously thought possible to engineer around, the researchers observed the capacity of foldable structures by creating mathematical models. During the experiment, the team had designed structures capable of self-folding, such as paper origami and nanobots, and creating creases in them beforehand. The result was that when more pre-creases were added to the folds, the more branches in the next folding process could form and the more likely the self-folding mechanism is to get stuck.

Origami engineering is a relatively new innovation. Its application is vast and can be of use to not only technology but to medicine as well. The development of the field itself, then, needs to pick up at a faster pace in order to cater to the intelligent design of foldable structures and materials. But while there are creases in the field that needs to be smoothed out, the greater promise of origami engineering has brought about several research papers in its wake.

RELATED ARTICLE: Swallowed a Battery? Ingestible Origami Robot Made from Pig Gut Can Remove It,Stop Stomach Bleeding

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The Art of Origami is Now A Key Tool That Helps Doctors Save Lives - Nature World News

CRISPR: Are we the Masters of our Own Genomes? – The Times of Israel

CRISPR, kick-starting the revolution in drug discovery or A year after the first CRISPR babies, stricter regulations are now in place. read some of the recent headlines. CRISPR, a new gene editing technology, is making waves around the world and Israel is no exception. The Israeli startup eggXTt is preparing to use CRISPR-tech to mark chicken eggs by gender in an effort to reduce waste in the poultry industry, and research labs at institutes around the country regularly make use of CRISPR-tech to make groundbreaking discoveries in the biological sciences.

But how does CRISPR actually work, and what are the limitations of this new technology? CRISPR is often touted by scientists and science journalists as a pair of molecular scissors allowing us to edit our genomes at will in a point-and-click fashion. Although it is tempting to believe these buzzwords, they are not particularly accurate, and can be misleading for the public and policymakers considering the potential impacts of this new technology. After all, our DNA is not a tiny Microsoft Word document that can be altered however we see fit. In this article we will dive into exactly what CRISPR is, what it can and cannot do, and why we might not be seeing designer CRISPR babies for a few more decades (or centuries).

First of all, CRISPR is not a pair of molecular scissors. It is a system of proteins that evolved in bacteria to protect them against viruses. Proteins can take all shapes and sizes, and CRISPR proteins look something like the wire cleaning scrubbers you can find in many kitchens. The oft-mentioned analogy that CRISPR are molecular scissors is doubly misleading, because scissors imply that someone (ie: scientists) are somehow wielding them in a precise manner to cut and paste DNA as they please. This gives the false impression that scientists are the sole possessors of CRISPR knowledge, bestowing upon them the power to alter our genomes at will.

In reality, CRISPR proteins slide along DNA strands, recognizing specific areas by their unique feel. More specifically, the proteins move along the DNA until they find a spot on the DNA that matches perfectly with their recognition site, and then they squeeze down and cause the DNA to break at that point. This is similar to how your handprint fits well into its imprint in the sand. When you think about the wide variety of proteins in the human body (over 100,000) it makes sense that few other proteins would make the same match (a rubber duck or iron nail would not fit well into your handprint either). When the CRISPR proteins move along the DNA, they are only able to make the DNA break at these specific points. Scientists are able to take advantage of this tendency of CRISPR proteins, and can manipulate them to make breaks in DNA at the area they want removed or altered in their experiments. The CRISPR system also consists of a few other components, including a set of guide RNAs that help the CRISPR proteins match up with the DNA of their choice.

Unfortunately, CRISPR proteins are not perfect, and DNA is a very long and repetitive molecule, so it is possible for mistakes to occur. Other areas of DNA may look the same to the CRISPR proteins due to similar or identical sequences, causing the CRISPR proteins to break the DNA at undesired places. Recent research has noted that CRISPR can have a high frequency of off-target DNA breaks, up to 50% in many model systems. These issues mean that once CRISPR is released into a living organism it is sometimes hard to predict where these off target effects will occur. The challenge of off-target effects is one of the reasons CRISPR babies are likely a long way off. As a result a number of institutions and many scientists, including the World Health Organization, have called for a comprehensive ban on genetic modifications to reproductive or germline tissues. Despite this, a team of researchers in China recently managed to create a set of genetically altered twins, resulting in significant controversy. The ethical questions surrounding CRISPR in humans are another compelling reason to wait, particularly because edits of germline tissues like eggs and sperm could result in permanent changes to the human genome.

Another issue with the CRISPR system is that it needs to be inserted into living cells using a viral vector. This means the CRISPR system has to be translated into DNA, coded into a type of non-deadly virus, and injected into cells, which then produce the CRISPR proteins themselves. These viral systems are never 100% successful, and sometimes only enter 15-20% of all cells, which is not ideal for medical-grade treatments.

Despite these barriers there are several medical treatments in development using CRISPR-tech to address difficult-to-treat diseases. One of the most advanced is a CRISPR-based treatment for Duchenne Muscular Dystrophy (DMD), a rare and incurable muscle degenerative disease predominantly affecting children. DMD is caused by mutations in the dystrophin gene and is always fatal with an average patient lifespan of 26 years. Recent studies in mouse models and human heart cells in petri dishes have shown that CRISPR can cause reduction in muscular degeneration symptoms, which are the hallmark of this disease. Because DMD is caused by mutations in one specific region in the genome, scientists and clinicians can take advantage of CRISPRs targeted DNA-breakage effects to chop the affected section out of the genome by targeting two RNA guide probes, one to each side of the mutant piece of DNA. In most cases simply excising the mutant piece of DNA is not sufficient to remove symptoms of a disease. However, in this rare case removing the mutant DNA section allows for a partial improvement in some muscle cells, which is why this treatment has shown promise for clinical applications.

Many of the future CRISPR-based treatments will need to insert a new, healthy piece of DNA in addition to removing the mutant DNA. This is obviously many times more difficult as in addition to mitigating risk from off-target CRISPR effects, it will also be necessary to reduce the risk of the new piece of DNA inserting into the wrong portion of the genome and causing undesirable effects. Nevertheless, trials are now underway to translate this treatment method to the clinic in studies investigating the use of CRISPR for Sickle-Cell Anemia, Cystic Fibrosis and non-Hodgkins Lymphoma.

Although the major benefits of CRISPR-tech are likely decades away, CRISPR is already having significant impacts in the scientific, medical and biotech spheres. As long as this technology is used responsibly, we have much to gain from a world where we could one day become the masters of our own genomes.

This is an article in the series Science & Technology in the Holy Land, a regular column on innovations in science, tech, start-ups and futurism by Jamie Magrill, an MSc, Biomedical Sciences Candidate at the Hebrew University of Jerusalem.

Jamie Magrill is a scientist-scholar and world-traveler with an interest in entrepreneurship and startups, particularly in the biomedical and philanthropic fields, an MSc in Biomedical Sciences Candidate at the Hebrew University of Jerusalem, and a Masa Israel Journey alum.

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CRISPR: Are we the Masters of our Own Genomes? - The Times of Israel

Viewpoint: There’s a repeatability problem with CRISPR experiments. Only ‘self-governance’ can fix it – Genetic Literacy Project

Many scientists assume that if a chunk of a gene is missing then the protein that it encodes will not function, or even be produced.

Researchers at the European Molecular Biology Laboratory in Heidelberg, Germany used CRISPR to make cuts in 136 different genes. In about a third of cases, proteins were still produced from these damaged genes and, furthermore, many of the proteins remained partially functional. This strange phenomenon, of damaged DNA producing functional protein, does more than punctuate lifes remarkable adaptability and resilience.

It means that dozens, or hundreds, of studies that used CRISPR/Cas9 to knock out genes, but failed to validate that the encoded protein was fully removed, could be incorrect or misleading.

The problem with major scientific developments, especially CRISPR/Cas9, is that experimental tools often explode in popularity before scientists and editors can implement standard procedures.

Unfortunately, academic institutions and scientific publishers are hulking bureaucracies with slow-moving policy changes. Ensuring that CRISPR/Cas9 produces repeatable experiments rather than blemishes on the scientific record will require the collective action of scientists. It will demand self-governance.

Read full, original post: Heres why many CRISPR/Cas9 experiments could be wrong and how to fixthem

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Viewpoint: There's a repeatability problem with CRISPR experiments. Only 'self-governance' can fix it - Genetic Literacy Project

This Start-up Might Be the Next Gene Editing IPO – The Motley Fool

As the old saying goes, strike when the iron is hot. That's what a new gene editing start-up named Beam Therapeutics hopes to do by conducting an initial public offering (IPO) less than two years after forming and more than a year before it asks regulators for permission to begin clinical trials. Given the excitement over genetic medicines, it might be wise to take advantage of the open window now.

Assuming the IPO proceeds as planned, Beam Therapeutics will offer investors a second chance to own a next-generation gene editing technology platform and the first next-generation CRISPR tool. Here's why investors might want to keep the business on their radar.

Image source: Getty Images.

Beam Therapeutics bears some similarities to Editas Medicine (NASDAQ:EDIT). Both trace their origins back to the Broad Institute in Boston. They share a trio of all-star scientific founders: Dr. Feng Zhang, Dr. David Liu, and Dr. Keith Joung. Each company's technology platform is built on CRISPR-based tools.

But the differences are more important for investors. Editas Medicine is developing gene editing tools that require Cas enzymes to cut both strands of DNA. While that theoretically provides the ability to delete or insert genetic sequences to treat diseases, the approach relies on innate DNA repair mechanisms. When the built-in safeguards on those mechanisms break down, cells can turn cancerous. CRISPR-CasX tools can also create unintended genetic edits, and have a relatively low efficiency.

Beam Therapeutics is developing gene editing tools based on a new technique called base editing. The enzymatic approach doesn't make double-stranded breaks in DNA. Instead, it induces chemical reactions to change the sequence of the genetic alphabet -- A (adenine), T (thymine), C (cytosine), and G (guanine) -- one letter at a time. Base editing can make A-to-G edits, C-to-T edits, G-to-A edits, and T-to-C edits.

The next-generation approach decouples CRISPR gene editing tools and the need to make double-stranded breaks in DNA, which is the most pressing concern facing Editas Medicine, CRISPR Therapeutics (NASDAQ:CRSP), and Intellia Therapeutics (NASDAQ:NTLA).

Clinical Consideration

CRISPR-CasX Gene Editing

CRISPR Base Editing

Does it cut DNA?

Yes, enzymatically cuts both strands of DNA

No

Can be used to insert new genetic material into a sequence?

Yes

No, but it can enzymatically change an existing DNA sequence

Does it trigger DNA repair mechanisms?

Yes

No

Source: Beam Therapeutics, author.

While base editing can't make every possible edit (example: A-to-T edits), it can target a number of disease-driving genetic errors. And Beam Therapeutics has inked important collaboration deals to augment the capabilities of its technology platform:

After reviewing the details, investors see that there's a tangled web of related transactions that all flow back to the Broad Institute, which is going to great lengths to extract every ounce of value from its scientific discoveries. Similar actions have caused a stir in the scientific community in recent years. If the profit-seeking terms of the non-profit research institution's agreements are too strict, then it may pose a risk to Beam Therapeutics at the expense of investors.

Image source: Getty Images.

Investors familiar with gene editing stocks will immediately recognize the programs included in the pipeline of the base editing pioneer. The lead assets take aim at blood disorders, and are part of a push to engineer better immunotherapies to treat cancer.

In beta thalassemia and sickle cell disease, Beam Therapeutics is first attempting to increase the production of fetal hemoglobin, which confers natural immunity to both conditions. That's similar to the lead drug candidate of CRISPR Therapeutics, which recently demonstrated promising results from the first two patients in a phase 1 clinical trial.

A second program in sickle cell disease aims to directly correct the genetic mutation responsible for the blood disorder. It involves changing a single base -- perfectly suited for base editing.

In immunotherapy, Beam Therapeutics is working to engineer better chimeric antigen receptor T (CAR-T) cells that can be used as cellular medicines to treat various types of cancers. CRISPR Therapeutics, Editas Medicine, and Intellia Therapeutics are deploying CRISPR gene editing in the same applications, while Precision BioSciences (NASDAQ:DTIL) is leaning on ARCUS gene editing to do the same. The latter's lead drug candidates are in immunotherapy, a unique distinction among gene editing stocks.

Beam Therapeutics' pipeline also includes a range of potential assets aimed at gene correction, gene silencing, and more complex editing, but none have entered clinical trials. The company doesn't expect to file investigational new drug (IND) applications -- required for regulators to sign off on the start of clinical trials -- until 2021. But since the window for an IPO might be slammed shut by then, the business is exploring a market debut now.

There aren't many details in the company's S1 filing concerning a potential date for a market debut or how much money the company is aiming to raise. The filing says $100 million, but that's just a placeholder for the initial submission. The actual amount will be determined once Wall Street gets an idea of the level of interest in an IPO, which will determine the number of shares to offer and the price.

Assuming the IPO takes place, Beam Therapeutics and base editing offer investors a technological upgrade over the first-generation gene editing platforms leaning on CRISPR-CasX tools. The next-generation tools aren't perfect, and there are risks related to the agreements with the Broad Institute and sister start-ups, but this is certainly a gene editing stock worth watching.

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This Start-up Might Be the Next Gene Editing IPO - The Motley Fool

If You Had Bought CRISPR Therapeutics (NASDAQ:CRSP) Stock Three Years Ago, You Could Pocket A 212% Gain Today – Yahoo Finance

The most you can lose on any stock (assuming you don't use leverage) is 100% of your money. But when you pick a company that is really flourishing, you can make more than 100%. For instance the CRISPR Therapeutics AG (NASDAQ:CRSP) share price is 212% higher than it was three years ago. Most would be happy with that. On top of that, the share price is up 35% in about a quarter.

View our latest analysis for CRISPR Therapeutics

Because CRISPR Therapeutics made a loss in the last twelve months, we think the market is probably more focussed on revenue and revenue growth, at least for now. When a company doesn't make profits, we'd generally expect to see good revenue growth. Some companies are willing to postpone profitability to grow revenue faster, but in that case one does expect good top-line growth.

CRISPR Therapeutics's revenue trended up 87% each year over three years. That's much better than most loss-making companies. Along the way, the share price gained 46% per year, a solid pop by our standards. This suggests the market has recognized the progress the business has made, at least to a significant degree. Nonetheless, we'd say CRISPR Therapeutics is still worth investigating - successful businesses can often keep growing for long periods.

You can see below how earnings and revenue have changed over time (discover the exact values by clicking on the image).

NasdaqGM:CRSP Income Statement, December 20th 2019

CRISPR Therapeutics is a well known stock, with plenty of analyst coverage, suggesting some visibility into future growth. So we recommend checking out this free report showing consensus forecasts

We're pleased to report that CRISPR Therapeutics rewarded shareholders with a total shareholder return of 187% over the last year. That's better than the annualized TSR of 46% over the last three years. The improving returns to shareholders suggests the stock is becoming more popular with time. You could get a better understanding of CRISPR Therapeutics's growth by checking out this more detailed historical graph of earnings, revenue and cash flow.

If you are like me, then you will not want to miss this free list of growing companies that insiders are buying.

Please note, the market returns quoted in this article reflect the market weighted average returns of stocks that currently trade on US exchanges.

If you spot an error that warrants correction, please contact the editor at editorial-team@simplywallst.com. This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. Simply Wall St has no position in the stocks mentioned.

We aim to bring you long-term focused research analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Thank you for reading.

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If You Had Bought CRISPR Therapeutics (NASDAQ:CRSP) Stock Three Years Ago, You Could Pocket A 212% Gain Today - Yahoo Finance

Heres Why Many CRISPR/Cas9 Experiments Could Be Wrong and How to Fix Them – The Wire

Every living cell on Earth has proteins. Typically thousands of them, that serve as molecular machines to digest food, sense the environment, or anything else a cell must do. However, many genes, and the proteins they code for, have unknown functions. In humans, the function of about 1 out of 5 of genes is unknown. To explore these dark corners of the genome, scientists can break up DNA to disable a gene, making their encoded proteins nonfunctional, and watch what happens to cells as a result, inferring the lost function from what goes wrong.

When CRISPR/Cas9 came online in 2012, it offered scientists a tool to do exactly this cut genes. The Cas9 enzyme searches through DNA, using a guide RNA to look for a specific sequence, and makes a cut when it finds a match. The gene, split in two, is repaired by the cell, but often with a large chunk missing. Many scientists assume that if a chunk of a gene is missing then the protein that it encodes will not function, or even be produced.

In many cases, they would be terriblywrong.

Researchers at the European Molecular Biology Laboratory in Heidelberg, Germany used CRISPR to make cuts in 136 different genes. In about a third of cases, proteins were still produced from these damaged genes and, furthermore, many of the proteins remained partially functional. This strange phenomenon, of damaged DNA producing functional protein, does more than punctuate lifes remarkable adaptability and resilience.

It means that dozens, or hundreds, of studies that used CRISPR/Cas9 to knock out genes, but failed to validate that the encoded protein was fully removed, could be incorrect or misleading.

Also read: How Gene Editing Is Changing the World

While many labs that use CRISPR to knock out genes dovalidate that the encoded protein is no longer produced, other labs fail to check. Searching for one protein in a cell is time-consuming and technically challenging; testing for protein function takes even longer. There are some methodsavailableto look for specific proteins, but many CRISPR/Cas9 studies fail to run these experiments or scientific journals dont ask for the data.

Nature Methods, the same journal that published the paper from the Heidelberg laboratory, recognised shortcomings in CRISPR validation early on. In 2017, they highlighted a genome-editing consortium, in collaboration with theUS National Institute of Standards and Technology, that aims to develop standardized procedures for CRISPR research, including publishing guidelines that include which guide RNAs were tested, how they were designed, and which controls were used in experiments.

The problem with major scientific developments, especially CRISPR/Cas9, is that experimental tools often explode in popularity before scientists and editors can implement standard procedures. When DNA sequencing was developed in the 1970s, for instance, there was little need for standards because it was so challenging to decipher the sequence of even a short piece of DNA. A decade later, however, GenBank, a DNA sequence repository, came online and journals began to mandate that researchers deposit their sequences. This requirement, together with reporting standards issued by journals likeNature, have ensured that a rapidly growing collection of DNA sequences can be vetted and independently analysed by the scientific community. The same is true for methods like x-ray crystallography, with journals requiring that protein structures be independently validated and uploaded to publicly-accessible databases.

Today, every laboratory uses CRISPR/Cas9 in a different way, reports their findings in a different journal, and checks their results with a different technique. There is often little uniformity, and that needs tochange.

But while some scientists were shocked by the new study, others took a laissez-faire approach to the findings. On Twitter, many vented their rage at what they felt was a lack of careful controls by the scientific community. Raphael Ferreira, a postdoctoral fellow at Harvard Medical School, was inspired, perceiving this study as a game changer for the CRISPR community.

I was as surprised by the results in a really positive way, as this paper rings the wake-up call for every scientist using CRISPR/Cas9, Ferreira said.

Despite the enthusiasm, however, Ferreira will not change how he performs his own experiments. The few times I have [used CRISPR/Cas9] in mammalian cells, I have always confirmed them with a Western blot, referring to an experimental method to detect specific proteins.

Victor de Lorenzo, a research professor at the National Center for Biotechnology in Madrid, agreed, claiming that, the only way to ensure that a protein is altogether removed is by making a Western blot.

Down the hall or across the street from my office, dozens of scientists use CRISPR/Cas9 to uncover protein functions. One of these researchers is Shashank Gandhi, a PhD student at the California Institute of Technology (CalTech) that has published CRISPR/Cas9 methods to delete genes in chicken embryos. Though he agrees with Ferreira and de Lorenzo, Gandhi asserts that validations could be taken a step further, and believes that journal editors should take action.

Also read: Is There More to Gene Editing Than Creating Designer Humans?

I think that journal editors should encourage authors to present supplemental data on how the knockouts were validated, insists Gandhi. I know that Nature requires that information as part of a research summary document that is submitted to the journal with each paper submission.

If Nature, which is widely considered the premier academic research journal, takes action to ensure that CRISPR knockouts are validated, then perhaps other publishers will take notice. In the meantime, Gandhi and others are not taking any chances.

I use several approaches to validate my CRISPR knockouts. For starters, I design and test multiple [guide RNAs] targeting the same gene for all my knockout experiments. Secondly, wherever applicable, I try to perform rescue experiments to establish loss of function phenotypes, says Gandhi, referring to an experiment in which a deleted gene is restored to test whether that proteins phenotype returns, confirming a link between a gene and the function that was lost when the gene was broken.

While all of the scientists that I spoke with agreed that researchers could do more to double check their experiments, it is unclear what actionable steps could be taken. Perhaps a combination of scientific, academic, and institutional changes could alleviate the potential for misleading studies. Faster experimental methods to detect proteins, standardised publishing procedures, and an academic database that describes which guide RNAs have been tested in each organism, would all serve to enhance the rigour of current studies.

Unfortunately, academic institutions and scientific publishers are hulking bureaucracies with slow-moving policy changes. Ensuring that CRISPR/Cas9 produces repeatable experiments rather than blemishes on the scientific record will require the collective action of scientists. It will demand self-governance.

Nicholas McCarty, Bioengineering, California Institute of Technology

This article was published in MassiveScience. Read the original here.

More:
Heres Why Many CRISPR/Cas9 Experiments Could Be Wrong and How to Fix Them - The Wire

CRISPR And CRISPR-Associated (Cas) Genes Market Growth Analysis By Manufacturers, Regions, Type And Application, Forecast (2019-2026) – Market…

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The top 10 science stories of 2019 | NOVA – NOVA Next

1. New Horizons nails the most distant flyby in history

Just 33 minutes after ringing in the New Year, scientists at the Johns Hopkins University Applied Physics Laboratory cheered and threw confetti a second time. The New Horizons spacecraft had just conducted a flyby of a Kuiper Belt object 4 billion miles from Earth. And as the sun rose on January 1, New Horizons beamed back its first close-up images of the 19-mile-long peanut-shaped space rock, officially named 2014 MU69.

Images eventually revealed 2014 MU69 (initially nicknamed Ultima Thule), to be a surprisingly flat contact binary, a body composed of two once-separated rocks that slowly gravitated toward each other until they lightly touched and fused. Scientists believe the flyby data could offer insight into how planets formed in our solar system billions of years ago.

In November, NASA changed the rocks nickname from Ultima Thule, a term with links to the Nazi party, to Arrokoth, which means sky in the Powhatan/Algonquian language.

2014 MU69 is revealed to be a two-tiered snowman. According to the New Horizons team, this image supports the idea that planets in our system formed as bits of raw planetary matter coalesced over time. Image Credit: NASA/Johns Hopkins University Applied Physics Laboratory/Southwest Research Institute

Twelve years after a first patient was declared to be rid of HIV, another person achieved a similar milestone this year. In March, with the help of a stem cell transplant from a virus-resistant donor, the anonymous individual entered long-term remission from HIV.

In both cases, remission followed a transplant of bone marrow from a person with a mutation in the gene that encodes the protein CCR5, which many HIV strains use to infiltrate cells. Neither treatment was originally intended to eliminate the infection itself, but to treat blood cancers that had spread in both individuals.

While the intervention is likely to be effective in only a small fraction of HIV-positive individuals, the 2019 case shows that its efficacy was more than a one-time event.

In April, we were able to feast our eyes on the first-ever image of a black hole. The black hole, whose image was generated from data captured by a network of eight radio observatories that make up the Event Horizon Telescope, dwells in the center of a galaxy some 55 million light-years away from Earth.

As popular as the black hole image was, another aspect of the story that quickly unfolded online: the contribution of 29-year-old MIT scientist Katie Bouman, who crafted an algorithm to help translate the telescope data into the black hole image. Bouman, captured in a photo with a laptop, beaming behind her folded hands, quickly became a symbol for womens accomplishment in astronomy and computer science. But, Marina Koren writes for The Atlantic, This one image tapped into a multitude of questions about the role of women in science, the myth of the lone genius, and the pressure scientists have to promote themselves and their work on social media.

No one algorithm or person made this image, Bouman later wrote, referring to the black hole picture, in a Facebook post. It required the amazing talent of a team of scientists from around the globe and years of hard work to develop the instrument, data processing, imaging methods, and analysis techniques that were necessary to pull off this seemingly impossible feat.

CRISPR-Cas9 is a tool that lets scientists cut and insert small pieces of DNA at precise areas along a DNA strand. | Photo credit: Public Domain

In April, researchers began the first CRISPR-Cas9 gene-editing clinical trials in people in the United States. In the trials, scientists used CRISPR, a powerful gene-editing technique derived from an ancient bacterial immune system, to combat cancer and blood disorders. That month, two cancer patientsone with myeloma and one with sarcomawere treated using CRISPR.

In the cancer and blood disorder trials, researchers remove some cells from a patients body, edit the cells DNA using CRISPR, and inject the cells back in, now hopefully armed to fight disease, Tina Hesman Saey writes for Science News. But in another trial, conducted by Editas Medicine in Cambridge, Mass., researchers are using CRISPR to edit DNA directly in the human body by snipping a small piece of DNA out of cells in the eyes of people with an inherited form of blindness, Saey writes.

The trials come on the heels of Chinese scientist He Jiankuis gene-editing on twin girls born in November 2018, which was widely criticized as premature and highly unethical. .

Mammal fossils like this one, discovered by a team of paleontologists and paleobotanists led by Tyler Lyson in Corral Bluffs, Colorado, fill in a missing piece of the timeline of life. Image Credit: HHMI Tangled Bank Studios

This year, scientists gleaned new insight into the day the dinosaur-killing asteroid crashed into Earth 66 million years ago, and the first million years after the impact.

In April, paleontologist and graduate student Robert DePalma claimed to unveil an unprecedented time capsule of the asteroid-induced catastrophe. He reported finding scorched tree trunks and hundreds of well-preserved fossil fish beneath sediment at a site in North Dakota, forming a snapshot of the first minutes and hours after impact. (Some experts remain cautious about the finding, due in part to the fact that DePalmas discovery was first announced in a New Yorker article before publication of the peer-reviewed paper.)

Then, in October, new fossils that capture the million-year timeline of life after the dinosaurs died were revealed. Discovered in Colorados Corral Bluffs by paleontologist Tyler Lyson and his team, the fossils showcase the extraordinary resilience of life in the wake of disaster and help reveal the evolutionary journey of the mammals that survived the asteroid.

With the use of artificial intelligence on the rise, one serious flaw continued to make headlines in 2019: racial bias. In October, researchers announced that a particular algorithm, which predicts who might benefit from follow-up care and affects 100 million Americans, underestimates black patients need for additional treatment. The algorithm underestimates the health needs of black patients even when theyre sicker than their white counterparts.

Additionally, the U.S. remains one of the most dangerous developed nations in which to be pregnant and give birth, particularly for minorities. Pregnancy-related deaths are rising in the United States and the main risk factor is being black, Mike Stobbe and Marilynn Marchione write for AP News. A CDC report concludes black women, along with Native Americans and Alaska natives, are three times more likely to die before, during or after having a baby, and more than half of these deaths are preventable, Stobbe and Marchione write.

Also this year, researchers further investigated why black scientists are less likely to receive funding from the National Institutes of Health (NIH) than their white counterparts. A study published in October illustrated that topic choice contributes to the lower rates of NIH awards going to black scientists. Specifically, Jeffrey Mervis writes for Science Magazine, black applicants are more likely to propose approaches, such as community interventions, and topics, such as health disparities, adolescent health, and fertility, that receive less competitive scores from reviewers.

A replica of a fragment of a Denisovan finger found in Denisova Cave, Siberia, in 2008. Image Credit: Thilo Parg, Wikimedia Commons

New findings in 2019 added to anthropologists understanding of Denisovans, a species of early human that likely shared the planet with Homo sapiens as recently as 50,000 years ago.

This fall, scientists learned that although Denisovans DNA ties them more closely to Neanderthals, their fingers may have looked more like ours, suggesting Neanderthals broader digits evolved after their lineage split off from the Denisovans around 410,000 years ago. A few more fossils, Bruce Bower writes for Science News, plus genetic analyses indicated Denisovans were close relatives and occasional mating partners of Neanderthals and Homo sapiens tens of thousands of years ago. But there was too little evidence to say what Denisovans looked like or how they behaved.

Physicists reached a milestone in quantum computing this year, a method of computing that uses quantum physics to solve complex problems quickly.

In October, Google said it had achieved quantum supremacy. Its AI Quantum Team presented evidence that it had built a quantum computer that needs only 200 seconds to solve a problem that would have taken IBMs Summit, the worlds most powerful supercomputer, 10,000 years to crack. Though IBM disputed the claim, others in the computing community are tentatively optimistic about the breakthroughs promise. If validated, it may bring us closer to a future of ultra-efficient computing.

Just when you thought Saturn couldnt get any more awesome, it secured yet another claim to fame: the most known moons of any planet in our solar system (sorry, Jupiter).

On October 7, the International Astronomical Unions Minor Planet Center announced that researchers discovered an additional 20 moons orbiting Saturn, bringing its grand total to a whopping 82. Jupiter, the largest and oldest planet in our solar system, has 79.

The latest discoveries were made possible by Hawaiis Subaru telescope. A team led by Carnegie Sciences Scott S. Sheppard first eyed them in the spring of 2017, but because faraway moons are dim and tough to spot, researchers used Subaru to scan the skies periodically throughout the following years to confirm their finding. Then, they used a computer algorithm to link the data through time and confirm that the moons were indeed reliably orbiting Saturn.

Less than a week after the U.N. climate talks came to a close in Madrid this month, Australia recorded its hottest day ever, one day after its previous record. Just a few months ago, wildfires raged across not only the American West and Australian Outback but also Europe and the Amazon, an occurrence that many climatologists believe may have been exacerbated by climate change-induced drought and high temperatures. And in May, a United Nations report claimed that one million plant and animal species are on the verge of extinctionmore than in any other period in human historywith alarming implications for human survival. The warming climate, which heightens the effects of overfishing, pesticide use, pollution, and urban expansion is a major driver, the report concludes.

Three weeks ago, a bleak climate report, also from the U.N., predicted that global carbon emissions will climb despite promises from almost 200 nations to address climate change, propelling temperatures upward and threatening to shatter the threshold of 2C that scientists say would invite dramatic changes to ecology and the economy, Nathaniel Gronewald writes for Science Magazine. And many declared this months COP25 climate talks to be a massive failure.

But climate activists, particularly teens, have seized the spotlight this year. Greta Thunberg, a 16-year-old Swedish climate activist, was just named TIMEs Person of the Year. And at COP25, official youth constituency representatives expressed their disappointment to leaders and officials, Kartik Chandramouli writes for Mongabay. Do you want to be remembered as the ones who had the chance to act but decided not to as betrayers of our generation, of indigenous people and communities desperately fighting on the ground? Youth representatives said. We are rising, we are fighting and we will win.

Read the rest here:
The top 10 science stories of 2019 | NOVA - NOVA Next

7 Ethically Controversial Research Areas in Science and Technology – Interesting Engineering

Science and technology are the great drivers of innovation in the worldaround us.Technological and scientific breakthroughs help people every day, bringing drinking water to the needy, access to information through the internet to remote villages, cures for obscure diseases.

Many aspects of scientific discovery are under no ethical questions. But there are alsoa number of scientific endeavors that push the ethical lines of what science should revolve around. While all the areas of controversy we'll look into have great benefits, they also come with a lot of ethical burdens, like harm to animals, people, or the environment.

It all should make us stop and think, at what point do the negatives of innovation overshadow the good that it brings. And is there ever an innovation so beneficial to the world and mankind that it would be worth ethical tragedy on the road to scientific and technological progress? Ponder these questions as we look into 7 ethically controversial areas of science and technology...

Artificial intelligence is at the forefront of techno-jargon these days. Every company that has anything to do with technology is using it as a buzzword to sell their product. "New dog collar with built-in AI to detect when your dog is in distress! Install our simple computer plug-in and we'll optimize your workday."

AI certainlyhas its applications and benefits, but there are areas where it has some extensive drawbacks. Take two key AI technologies that have questionable benefits, or rather extensive drawbacks: deep fakes and Neuralink.

You've probably heard of deep fakes, the face-swapping technology that is used to make world leaders say things they never didor for less family-friendly things.

You might not know about Neuralink though. It's one of Elon Musk's technological endeavors that aims to improve brain-machine interfaces, record memories, and other technological advancements with the brain.

Focusing in on Neuralink first, questions surround the ethics of connecting human brains to machines and utilizing AI to make human brains function better. Ethical questions primarily focus on the development of said technology and potential side-effects. The company's goal is to optimize human brain function, but the testing that will be needed to get there will be extensive. This means human testing, on human brains, with unknown consequences. At what point is the potential promise of drastic technological advancement not worth the potential human loss in the development of the technology?

RELATED: AI CONTINUES TO ACT IN UNPREDICTABLE WAYSSHOULD WE BE CONCERNED?

Moving from Neuralink, we're met with technology, deep fakes, that pose less benefit to humanity. There's arguably little reason that anyone needs to replace someone's face with another's in a videoat least, little reason that isn't nefarious.

Yet, technology exists thanks to artificial intelligence and machine learning. It continues to be researched under the guise of benefits through improved video editing technology, but at the end of the day,there's no way to keep it from being used for negative purposes.

At the end of the day, artificial intelligence has the potential to completely change how we interact with the worldbut are there too many negatives? Time will tell...

Through CRISPR, scientists are able to edit human genomes. That means researchers can alter DNA sequences and alter how our genes function. That means the potential to correct genetic defects, preventing the spread of diseaseorrr for making designer babies.

CRISPR is short for CRISPR-Cas9, a gene-editing tool that utilizes the Cas9 enzyme to cut strands of DNA. It's basicallylike molecular scrapbooking.

The idea and implementation of CRISPR came from how bacteria defend themselves, by chopping up and destroying the DNA of foreign invaders before they are able to take hold of the organism.

CRISPR was just a theory until in 2017, a paper was published demonstrating just how CRISPR worked.

Chinese scientists have started using CRISPR to engineer designer babies or create human babies withedited genes, primarily lacking any tendency towards genetic defects. All of this seems noble and can potentiallyimprove humanity's quality of life, but at what cost? We largely don't know any potential side-effects and if there are any, we're talking about human life.

Designing humans also brings into question what exactly a human is. Are we naturally occurring beings, or does being a human just mean thinking like we do and form or process doesn't matter?

Moving on from human gene editing in CRISPR, we can examine the ethical issues with gene editing on other beings, like plants. Gene editing encompasses anytime a scientist intervenes in an organism's genetics.

This intervention creates GMOs or genetically modified organisms. This results in stronger, more drought-resistant crops. Or crops that have higher yields per acre, among a bounty of other things.

Today, gene editing happens across the world and it is done on both plants and animals, mostly in the pursuit of better food production. Looking into the animal realm,gene editing has been usedto create pigs that aren't susceptible to Porcine Reproductive and Respiratory Syndrom, or PRRS. Gene editing has been used to create pigs that are naturally very resistant to the disease, improving animal welfare.

The gene-editing process for all organisms is overseen by various federal agencies, obviously depending upon the country you're practicing this science in. It raises many ethical concerns, primarily along with the side-effects that might be caused by it, and it is still a much-debated topic by ethicists.

Animal testing is likely the most controversial area of scientific research on this list. Many people couldn't care less while others vehemently oppose it. For years, animal testing has been used to create newer and better pharmaceuticals, better makeup, better shampoos, etc.

The keyword here is "better" as it means better for humans. At the end of the day, animal testing places the prevention of human suffering over the importance of the prevention of animal suffering. In certain cases, the ethical argument for animal testing is easier, i.e. cancer research, or other pursuits that would prevent human death. In other cases, the argument is harder, as the development of a better lipstick.

The ethical debate around animal testing is essentially a real-life trolley problem. On one hand, you have human suffering and on the other, you have animal suffering. And we seem to have no problem with animal suffering as long as it is for a greater cause.

In introducing the subject, we've made it seem fairly cut and dry, but as science goes, it rarely ever is. An increasing number of scientists are starting to question the relevance of continued animal testing at a time where AI and other tech is starting to be able to accurately model and predict biological interfaces. A great deal of animals are harmed in the creation of many of the chemicals, and we musk as ourselves, is it worth it?

The natural progression from animal testing is human testing or trials of medication on human test subjects. Human subject research is often necessary to get drugs to the final phase of regulatory approval. It serves as the final check of how a givenmedicine or chemical will interact with the human system. Yet, time and time again it has hurt, maimed, or killed individuals. And we have to ask ourselves again, at what point does it become not worth it?

History hasn't been kind to the reputation of human trials, though scientists are making aconstant effort to create safety standardsin the process.

In 1947, it was discovered that two German physicians conducted deadly experiments on concentration camp prisoners during WWII. They were prosecuted as war criminals in the Nuremberg Trials. The Allies then established the Nuremberg Code, being the first international document for voluntary human consent for research.

With human testing today, the testing proceeds onlyif the patient consents to the study. Though this often leads to people with lesser fortune signing up for human trials to earn some extra cash. The ethics of the entire research situation can still be hotly debated.

Military weapon development is another major crossroad of science and ethics. Take, for example, the development of the atomic bombs during the Manhattan Project during WWII. In many ways, the research conducted during these experiments furthered humanity's understanding of atoms, molecules, and quantum. In other ways, this research killed tens of thousands of people.

Military power and weapon technology pose an ethical dilemma largelydue to the nature ofhumankind. If a givencountry doesn't invest resources into developing the best weapons technology, then another more powerful country will simplyswoop in and overpower them. That's the way it works nowadays. It's the unfortunate truth of the interaction of global superpowers. And once again, we're met with a real-life trolley problem.

Do we invest scientific resources into developing better weapons to protect ourselves and thus kill others, or do we let ourselves be killed and "protect" others? We would certainlynot opt for the latter, would we?

Since it seems like the earth has seen better days, maybe it's time to just abandon our planet and move to a new clean slate, like Mars. We know that there is flowing liquid water on Mars somewhere, and we know there are also other resources to help us survive.

So, why not just up and move humanity there?

The biggest ethical questions around Mars colonization are presented when you consider the potential of life on Mars or the potential of future life on Mars. We can't state with absolute certainty that there is life on the planet. Moving humanity there could harm it. We also don't definitively know that life won't occur on the planet through natural means. If humanity moving there interrupts the natural progression of Mars life, isn't that an ethical issue?

RELATED: SPACEX IS PREPARING A MISSION TO COLONIZE MARS BY 2026

The answers to those suppositions largely have to do with how humanity in total should approach its ethical responsibility. If you believe humanity's only ethical responsibility is to themselves, then it's likely not an issue. If you believe that we're responsible for all lesser life forms, then you'll run into countless ethical dilemmasin the process.

Closing out this discussion of ethical dilemmas in science and technology we're left again wonderingwhat are innovation and the betterment of humanity worth? The answer to that question will vary depending upon who you ask... but ask yourself, what is innovation worth?

Originally posted here:
7 Ethically Controversial Research Areas in Science and Technology - Interesting Engineering

Aytu BioScience and Innovus Pharmaceuticals Announce Filing of Form S-4 Registration Statement Related to Proposed Acquisition of Innovus by Aytu…

ENGLEWOOD, CO and SAN DIEGO, CA / ACCESSWIRE / December 24, 2019 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs and Innovus Pharmaceuticals, Inc. (OTCQB:INNV), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer health products, today announced that the companies have filed with the U.S. Securities and Exchange Commission a registration statement on Form S-4 containing a joint preliminary proxy statement/prospectus in connection with Aytu BioScience's proposed acquisition of Innovus Pharmaceuticals on December 23, 2019 after markets closed.

The registration statement containing the joint preliminary proxy statement/prospectus is available through the SEC's website at http://www.sec.gov and on each company's website on the respective company's Investor section.

As previously announced the companies signed a definitive merger agreement whereby Aytu will retire all outstanding common stock of Innovus for an aggregate of up to $8 million in shares of Aytu common stock, less certain deductions, at the time of closing, including amounts owed from Innovus to Aytu under a promissory note (currently $1.35 million principal amount), payments to be made to warrant holders, changes in Innovus liabilities and working capital, and other adjustments. This initial consideration to Innovus common shareholders is currently estimated to consist of approximately 3.9 million shares of Aytu stock. Each Innovus common shareholder will also receive contingent value rights ("CVRs"), representing the right to receive additional consideration of up to an aggregate of $16 million, paid for in cash or stock at Aytu's option, over the next five years if certain revenue and profitability milestones are achieved.

Innovus generated nearly $23 million in revenue during the twelve-month period ended September 30, 2019.

Through this combined entity, Aytu will expand into the $40 billion consumer healthcare market with a portfolio of over thirty-five consumer products competing in large therapeutic categories including diabetes, men's health, sexual wellness and respiratory health. This expanded product line broadens Aytu's portfolio beyond prescription therapeutics to enable wider revenue distribution, reduced seasonality associated with Aytu's seasonal antitussive product line, and higher revenue from an expanded base of proprietary products.

Combined, Aytu and Innovus generated approximately $43 million in revenue over the twelve-month period ended September 30, 2019. The companies believe this business combination will provide increased revenue scale and enable operational synergies that can be leveraged to accelerate the combined company's growth and path to profitability. Aytu will also take over the outstanding notes payable of Innovus which, at the time of signing, was approximately $2.8 million.

Upon closing, Aytu expects to operate the commercial aspects of the Innovus consumer business separately from Aytu's prescription business, while rationalizing general and administrative expenses through the removal of Innovus' public company costs and redundant administrative and operational processes, along with the reduction in overhead, administrative and facilities costs.

Aytu's prescription product portfolio will continue to be primarily commercialized through the existing Aytu sales force, while the consumer health products will continue to be primarily commercialized via Innovus' proprietary Beyond Human marketing platform. However, both lines of business are expected to benefit from opportunistic cross-selling such that some consumer products may be marketed in the physician office setting by Aytu's sales force, while the marketing of the prescription products may be bolstered through various online and direct-to-consumer marketing initiatives.

The boards of directors of both companies have approved the terms of the merger transaction, which is subject to the approval of both companies' shareholders. At the time of signing the definitive agreement, Aytu had collected voting agreements supporting the merger transaction that represent approximately 35% of current shares outstanding. Innovus has thus far collected voting agreements supporting the transaction that represent approximately 24% of shares outstanding.

Story continues

The transaction, which is expected to close on or around March 31, 2020, pending timing of review by the Securities and Exchange Commission and a shareholder vote, which would follow the effectiveness of the S-4/proxy statement. The merger is subject to customary closing conditions and regulatory approvals.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com.

About Innovus Pharmaceuticals, Inc.

Headquartered in San Diego, Innovus Pharmaceuticals is an emerging over the counter ("OTC") consumer goods and specialty pharmaceutical company commercializing, licensing and developing safe and effective non-prescription medicine and consumer care products to improve men's and women's health and vitality. The Company is dedicated to being a leader in developing and marketing new OTC medicines and branded Abbreviated New Drug Application ("ANDA") products. The Company is actively pursuing opportunities where existing prescription drugs have recently, or are expected to, change from prescription to OTC.

No Offer or Solicitation

Communications in this news release do not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval with respect to the proposed transaction or otherwise, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Communications in this news release do not constitute a notice of redemption with respect to or an offer to purchase or sell (or the solicitation of an offer to purchase or sell) any security of Innovus.

Additional Information and Where to Find It

In connection with the proposed transaction between Aytu and Innovus, Aytu and Innovus will file relevant materials with the Securities and Exchange Commission (the "SEC"), including an Aytu registration statement on Form S-4 that will include a joint proxy statement of Aytu and Innovus that also constitutes a prospectus of Aytu, and a definitive joint proxy statement/prospectus will be mailed to shareholders of Aytu and Innovus. INVESTORS AND SECURITY HOLDERS OF AYTU AND INNOVUS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the registration statement and the joint proxy statement/prospectus (when available) and other documents filed with the SEC by Aytu or Innovus through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Aytu will be available free of charge on Aytu's internet website at https://irdirect.net/AYTU under the heading "SEC Filings" or by contacting Aytu's investor relations contacts at (646) 755-7412 or james@haydenir.com. Copies of the documents filed with the SEC by Innovus will be available free of charge on Innovus' internet website at https://innovuspharma.com/Investors/ under the heading "SEC Filings" or by contacting Innovus' investor relations at ir@innovuspharma.com.

Certain Information Regarding Participants

Aytu, Innovus, and their respective directors and executive officers may be considered participants in the solicitation of proxies in connection with the proposed transaction. Information about the directors and executive officers of Aytu is set forth in its Annual Report on Form 10-K for the year ended June 30, 2019, which was filed with the SEC on September 26, 2019. Information about the directors and executive officers of Innovus is set forth in its Annual Report on Form 10-K for the year ended December 31, 2018, which was filed with the SEC on April 1, 2019 and its proxy statement for its 2019 annual meeting of shareholders, which was filed with the SEC on April 30, 2019. Other information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the joint proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed transaction when they become available. You may obtain these documents (when they become available) free of charge through the website maintained by the SEC at http://www.sec.gov and from Investor Relations at Aytu or Innovus as described below.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements, including but not limited to any statements regarding the expected timetable for completing the proposed transaction, the results, effects, benefits and synergies of the proposed transaction, future opportunities for the combined company, future financial performance and condition, guidance and any other statements regarding Aytu's or Innovus' future expectations, beliefs, plans, objectives, financial conditions, assumptions or future events or performance. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: failure to obtain the required votes of Innovus' shareholders or Aytu's shareholders to approve the transaction and related matters, the risk that a condition to closing of the proposed transaction may not be satisfied, that either party may terminate the merger agreement or that the closing of the proposed transaction might be delayed or not occur at all, the price per share utilized in the formula for the initial $8 million merger consideration may not be reflective of the current market price of Aytu's common stock on the closing date, the failure to meet the revenue and profitability milestones that trigger the CVRs such that Innovus shareholders never realize value from the CVRs, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the transaction, the diversion of management time on transaction-related issues, the ultimate timing, outcome and results of integrating the operations of Aytu and Innovus, the effects of the business combination of Aytu and Innovus, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, regulatory approval of the transaction, risks relating to gaining market acceptance of our products, obtaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for AYTU Investors:

James CarbonaraHayden IR(646)-755-7412james@haydenir.com

Contact for INNV Investors:

Randy BerholtzInnovus Investor Relations(858) 249-7865ir@innovuspharma.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/571135/Aytu-BioScience-and-Innovus-Pharmaceuticals-Announce-Filing-of-Form-S-4-Registration-Statement-Related-to-Proposed-Acquisition-of-Innovus-by-Aytu-BioScience

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Aytu BioScience and Innovus Pharmaceuticals Announce Filing of Form S-4 Registration Statement Related to Proposed Acquisition of Innovus by Aytu...

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