Then there are intralipids, an emulsion of soybean oil, egg phospholipids and glycerin administered intravenously and described as a way to decrease natural killer cell activation in the immune system and ostensibly aid in embryo implantation. This emulsion is priced around $400 per infusion; typically several are recommended. Side effects include headache, dizziness, flushing, nausea and the possibility of clotting or infection. A meta-analysis last year found that intralipids and other forms of immunotherapy should not be used in routine clinical practice.

Such procedures are often presented to patients in the form of a stack of papers, written in legalese or medical jargon. Resourceful patients might take to the internet to learn more, where searches might deliver densely written scientific articles, and ads might direct them to companies or clinics eager to promote their own brands of add-ons.

Why is all this happening? Its because IVF remains an under-regulated arena, and entrepreneurial doctors and pharmaceutical and life science companies are eager to find new ways to cash in on a growing global market that is projected to be as large as $40 billion by 2024.

It has been 41 years since the first successful birth through IVF, and for the past three decades or so, the multistage IVF procedure and core drug protocols have remained fundamentally unchanged (though, to be sure, the laboratory equipment involved has become more sophisticated).

But clinics know competition for patients is fierce. Before they found add-ons as a way to differentiate themselves, clinics frequently marketed themselves by emphasizing their superior performance (not always with veracity) and by offering to make peoples dreams come true, as we wrote in our paper. Now they boast expanded menus advanced treatments, cutting-edge labs, custom service packages and special financing options.

Under-regulation of IVF dates to before the procedure first became commercially available. Since the Roe v. Wade decision in 1973, the government has done its best to avoid funding anything associated with embryo research, including IVF. As a result, its a field that since its earliest days was shaped by commercial considerations, with early practitioners lobbying for self-policing. The Food and Drug Administration requires a rigorous assessment of safety and efficacy of procedures that manipulate human cells more than minimally, yet no fertility procedure has been deemed to do so.

We are not alone here in the United States. In 2016, the BBC looked at common add-on procedures sold in Britain and uncovered many unsubstantiated claims. Australian media have done similar reporting. Only one Australian state, Victoria, requires IVF clinics to provide their patients with the evidence, or lack of it, behind add-on treatments.

Read the original here:
The Big IVF Add-On Racket - The New York Times

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