3.21.2006

What's wrong with the FDA?

In short: they approved this device, but not this. And read this if you really want to get angry.

"Plan B," which is the brand name for this kind of emergency contraception, is not the same thing as RU-486, also known as Mifepristone, which can be fatal if administered incorrectly. Note that it is considered contraception because it works before implantation, that is, before the pregnancy begins. I think implantation occurs sometime around the 16-32 cell stage of a zygote (it becomes an embryo after implantation), but I wouldn't swear by it.

If you know me in real life at all, and possibly if you only know me online, you know that I take mental health very seriously and would heartily support approval for any drug or device proven to be both safe and efficacious in treating depression, manic depression, OCD, or any other intractable affliction of the mind. It just seems clear that no reputable (that is, double-blind, controlled, not-financed-by-manufacturer) studies have been done that show that this device is any good at all, and the claim that someone is suffering so something must be done is specious if what you choose to do is implant an electrical device in his or her body. I feel like the makers of VNS are messing with the minds of people who are at their wit's end and feel that they have no other medical options left to them. This is a truly sucky place to be in, and I really, really don't want to minimize that, but the solution is not to offer unproven treatments.

I think that this is evidence enough that the national distrust of, ignorance of, and disregard of science is now negatively impacting our lives far beyond the public school classrooms where "intelligent design" (a.k.a. "theology") may be taught alongside science.

Grrrrr...

1 comment:

Courtney Love/Martha Stewart said...

Sorry I've been too busy to reply sooner. Your post is based on false assumptions about the statutory powers and the inner workings of the FDA and clinical investigations, a few of which I'll outline below. Writing about the "Food and Drug Administration" is like talking about "Africa" having problems: both are composed of many different complex governing entities that just happen to make up a whole. The FDA's Center for Drug Evaluation and Research is completely separate from its Center for Devices and Radiological Health.

When the Food, Drug and Cosmetic act was enacted, there were very few medical devices, but drugs had been used for a very long time. Therefore, the statutes for devices are much newer than those for drugs. The approval process and standards are different because devices and drugs pose very different therapeutic and clinical issues. Therefore, comparing drug and device clinical trials and approvals is like comparing apples and prime rib.

Understand that it is extremely difficult to recruit subjects for device clinical trials because most people are more comfortable swallowing a pill than having devices surgically implanted in their bodies. Therefore, Cyberonics sample size was acceptable by clinical norms. This alone presents a problem with accurate placebo outcomes. Second, you criticize that the study was manufacturer-financed. Every drug and device manufacturer conducts its own approval studies because they are testing a proprietary, investigational product. Later those firms might contract for studies run by outside investigators.

Finally, while double-blind, controlled studies are undoubtedly the gold standard, other types of studies are acceptable by the FDA as a condition of approval -- especially for a secondary indication, which Cyberonics was seeking (It was shown effective in controlling epilepsy, its original indication). The FDA does not have the legal authority to require double-blind trials. Sorry.

Remember that device approval comes down to a FDA reviewer and her team. She has significantly more data available to her than you or I read in a Washington Post Article.

As for the merits of the VNS stimulator, remember that it has been proven effective in treating epilepsy. Epilepsy drugs commonly are used to treat bipolar disorder and depression (e.g. Lamictal) and are quite effective in some people. Because epilepsy drugs have been shown to help depression, it makes sense the that CDRH reviewer and subsequently, the Advisory Committee, approved the VNS device for treating intractable depression. Mental health care is a black box, unfortunately. I'm sure you're right, that CDRH felt compelled to offer this because if it helps some patients -- and anecdotal experience has shown that it does -- it's worth the risk. This is not ignoring science, as you suggest; it is simply acknowledging that the data we get from clinical trials is extremely limited and making an educated decision about the approval of a product. I think it's ironic that you're angry because you think the FDA's decision was unscientific , because most of the drug approval studies for mental health products demonstrated pretty abysmal efficacy rates too. Thank God they're still available for the patients they work for.

Because the VNS device was approved without indisputable clinical evidence, doctors and patients must be well-educated about the risks and benefits of VNS treatment (and every other medical product). I would advise the FDA to set up one of its risk management programs, like it has for Accutane and other potentially very risky drugs.