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Women's health group launches campaign on risks of drug used in egg retrieval

Posted by Marcy Darnovsky on December 8th, 2008

An article in the December newsletter of the National Women's Health Network sounds an alarm about significant problems caused by the drug Lupron. Despite thousands of reports to the FDA of serious adverse reactions, Lupron is still being prescribed both for FDA-approved uses - prostate cancer in men and endometriosis and fibroids in women - and for "off-label" uses - shutting down the ovaries of women whose eggs are being retrieved either for their own or someone else's fertility treatment.

The article by Susan K. Flinn includes the stories of women who have contacted NWHN asking it to investigate the drug. Their stories are similar, Flinn reports: These women were healthy before using Lupron, but after using it they had serious symptoms that persisted for months or years. And despite thousands of adverse reactions reported to the FDA, neither the agency nor Lupron's manufacturer have indicated any interest in investigating the drug.

The NWHN is calling for

a concerted effort of women, physicians, health officials, researchers and media. The people who are considering taking Lupron are the ones who have the right to know that they are risking a lifetime of symptoms that may cost them their jobs, spouses, savings and quality of life.
Toward those ends, NWHN is initiating an educational and policy campaign "to get the word out about the misuse and dangers of Lupron® and other drugs," and together with Our Bodies Ourselves, the Center for Medical Consumers, and the Endometriosis Association, is about to launch The Informed Rx Decision-Making Consortium.

CIRM won't give up on eggs for cloning-based work

Posted by Jesse Reynolds on December 3rd, 2008

In the first draft of its revised strategic plan [PDF], the California stem cell research agency indicates that it will continue its recent push for women's eggs for cloning-based stem cell research, perhaps paying if necessary:

The second level of activity [concerning materials procurement policies of the California Institute for Regenerative Medicine (CIRM)] involves re-evaluation of existing policy regarding the procurement of oocytes for research. Some observers have suggested that Medical and Ethical Standards regulations have constrained efforts to develop stem cell lines through somatic cell nuclear transfer (SCNT). To discuss this important issue further, CIRM will convene a meeting with a range of participants, including those directly affected by oocyte donation and those with special interests in this process.

President Alan Trounson and board chair Robert Klein have led the charge, going public with their efforts at a meeting of the research standards advisory group in February and one of the full board in June. There, they proposed work-arounds of the prohibition on paying for eggs, one of the few ethical standards explicit in Proposition 71, which was authored by Klein to create the CIRM.

The work of Hwang Woo-Suk, however scandalous it was, did indicate that the supply of eggs may not be the problem. He burned through over 2200 eggs, some of them acquired in illegal and coercive ways. Yet Hwang, a skilled yet ethically-challenged researcher, was not able to produce clonal embryos, much less stem cell lines. And even if eggs were the limiting factor, do we wish to lower our agreed-upon ethical standards any time they impede research?

In any case, cloning-based stem cell research is a very speculative, largely unsuccessful path, and one whose goals are rapidly being achieved by an alternative method, cellular reprogramming, or iPS.

Known Unknowns

Posted by Pete Shanks on December 2nd, 2008


Denise Caruso recently made the interesting point that "in many respects scientists know less today about these mechanisms [that govern living organisms] than they did even just five years ago." That may seem counterintuitive, given the undeniable advances in genomic sequencing technology, but in a vaguely Socratic sense, this can be counted as a useful development: At least we are beginning to understand how little we understand.

Several recent reports, from different areas, underscore this:

All this may seem like bad news for those whose approach to research is driven by the impulse to market products immediately. It's not necessarily: As Prof. Michael Chapman points out, "if your only way forward is IVF, then an increase in risk from one in 100 to two in 100 for most people is an acceptable risk." It's worth remembering also that bone-marrow transplants, for example, became treatments before the mechanism behind the therapy was understood at all.

But anomalies are good news for science: more problems to solve! And basic science -- whose funding need not and should not be dependent on specific applications -- is what is needed to produce real cures in the long run.

Picking the Best Baby

Posted by Jesse Reynolds on December 2nd, 2008

Better Babies contestants at the Indiana State Fair, 1929

The leading newspaper in Canada's capitol city published an essay by ethicist Margaret Somerville on the social implications of widespread genetic screening. In "A New Eugenics," she asserts that the clear message is that certain groups of people don't make the genetic grade, and should not have been born:

As harsh as the language is, we must ask ourselves: "Are we on a search-and-destroy mission to wipe out certain groups of people?"...

[A]re we implementing a new eugenics and, if so, what are its dangers? To respond we need to take heed of history....

Whether or not we like it, the message we will be delivering at the societal level is: "We don't want you in our society unless you measure up to a certain genetic standard. You are only a potential member, until you've passed the admission test that we are willing to pay for with our tax dollars and implement."

The unavoidable collective impact of these decisions is the implementation of negative eugenics with respect to disabled people and it's disingenuous to deny that.

Negative eugenic practices have historically taken various forms, from infanticide, on to prenatal testing and selective abortion, and then to preimplantation genetic diagnosis (PGD) in the last two decades. With the price of genetic sequencing plummeting, the next step becomes apparent. The technology behind the wide genetic scans offered by companies such as 23andMe could feasibly be used on an entire batch of blastocysts in a fertility treatment, enabling prospective parents and clinicians to pick the genetically "best." Such a process was just described by the assisted reproduction and stem cell company Reprogenetics, at a recent meeting of the American Society for Reproductive Medicine.

What might be the cost of a wide-scanning PGD? Traditional PGD presently costs a few thousand dollars over the price of basic in vitro fertilization, and has been used to select against a single gene at a time, generally one related to a serious disease that is known to be carried by one or both of the parents. As a baseline for some "back of the envelope" calculations, the service of 23andMe, which tests for 91 genetic variations, currently costs $400. At this price, applying it to an entire cohort of a dozen blastocysts, even with additional costs for extracting a single cell from each and amplifying their DNA, may become competitive.

If the additional cost of such a procedure were just a few thousand dollars, then prospective parents who already are using IVF may find it hard to resist. But could this become even more widespread? I would not rule out the future use of wide genetic scans for natural pregnancies. This would sometimes be followed by selective abortion, just as it now sometimes is for sex selection. In fact, there's a good chance genetic testing could be done using a pregnant woman's blood at just five or six weeks gestation, as is currently done with prenatal sex determination and possibly soon for monogenetic diseases such as cystic fibrosis.

But wide adoption may hinge on the cost-benefit analyses of insurance providers. In jurisdictions where a new baby is likely to have the same insurer for much of its life, such as nations with single payer health care, some may argue that the cost of a wide genetic scan plus IVF would warrant coverage in order to ensure a "genetically healthy" baby, even if there is no indication of genetically-related disease in the parents.

Of course, IVF remains a physically unpleasant process, and many parents would decline the service, even if free. At what point, though, might they face pressure from their insurer, government, or society at large to be sure their child will be the healthiest possible?

Previously on Biopolitical Times:

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