Sunday, July 17, 2005

The Politics of the Birth Control Patch

I took a bit of a hiatus from blogging to finish up Healy's book, Let Them Eat Prozac so that I can finish the review. Luckily I finished the book and it seems just in time to use what I have learned to think about this AP story suggesting that the birth control patch may lead to deaths. I ran across this story this morning in the Hanover Evening Sun. I snatched the paper out of the hands of the owner of a local cafe that I visit. I was curious of the source of this story: was it an FDA finding? Was it a lawsuit? Was it the claims of a conservative preacher? Or, was it a consumer watch group. It turns out, curiously, that the AP did the study on "patch related" deaths by reviewing drug safety reports under the Freedom of Information Act. What we know, from this article, is that several families have filed lawsuits against Ortho McNeil and that reports made to the FDA (voluntarily by patch users) reveal a higher incidence of strokes (3 x higher) than the birth control pill. This last finding, however, was reported not from a Randomized Control Study (RCT), but from an AP analysis of drug reports.

When I finished this story, I tried to think of how to interpret this story. Because I have spent a lot of time learning about how Big Pharma fought plaintiffs' filing suits because their relatives committed suicide on SSRIs (thanks to Healy's book), I know that they are mighty powerful and likely to win cases. What makes Big Pharma even more powerful than the tobacco lobbies is its ability to have the physicians (most of them) in their pocket. Physicians are regularly recruited by pharmaceutical companies to speak at medical conferences that they sponsor, or "write" symposia articles (which have really been ghostwritten by pharmaceutical marketing deparments), or Big Pharma gives lots of money to clinicians to run clinical trials on the drugs or further research. Finding a doctor willing to speak against the hazards of a profitable drug is very difficult. If a law firm finds one, Big Pharma will spend a lot of money trying to discredit this expert witness (these are called Daubert trials).

Now, I know, you are thinking, "but certainly the FDA would report serious flaws with a drug compound." Alas, this is not true. And, this is so for a couple of reasons. First of all, the FDA is not really set up to be a consumer watchdog organization. The fact that many drugs are carefully regulated as "prescription only" was passed by Congress in 1962, after the Thalidomide disaster, to set up a "watchdog" for patients (the doctor). And, if you are quick, you can see the problem here. The FDA, furthermore, gets its working budget, from the "users," e.g. Big Pharma. So, clinical trials on drugs are sponsored by the very companies trying to get FDA approval (which means "yes" this drug seems to have an "effect").

So, I gave you this background info to let you into my thought process about the "patch." If the "patch" is a highly profitable drug, its unlikely that physicians or the FDA would blow the whistle. And, alas, they didn't. The AP did. Now, why? Is the patch more dangerous than the pill? Well, I turned to my mother for some insight here (she worked at the Office of Family Planning for several years in a BIG state). Mom was amazed that reports of danger were surfacing for the patch. "It is exactly the same chemical compound as the pill," she said. Moreover, she pointed out that the pill has been around for over 50 years. So, why would this be more dangerous?

I tried not to think the worse. But, it is starting to look suspicious people. Before saying what I think, however, let me also point out that taking the pill is NOT a good idea if you smoke--or have high blood pressure. So, it could be--if one were to do an epidemiological study of this--that women who died from strokes or suffered strokes while on the patch, were engaging in other behavior that put them at risk for a stroke. I dunno, maybe patch wearers are smokers? But, such a study has not yet been done, and I wonder what it would take to do this study.

If drug companies test for such a side effect (dropping dead from a stroke) then family planning clinics, OBGYNs etc. might be less likely to prescribe it. What Healy taught me is that doing a study is like admitting guilt, which hurts profits. Drug companies cannot afford to lose profits, since they are in a highly expensive business (it takes billions of dollars to bring a compound to trial) as well as beholden to stockholders. Now, if someone else wants to undertake this study, they are going to need big bucks, since epidemiological studies are really really expensive. Where is that money going to come from? Tax payers? (I would raise my eyebrows).

So, I think now to something else mom said. "The patch is really popular with teenagers, they get little tattoos around where their patch goes." Uh-oh, I think. Yes, conspiracy thinking begins. Hmmmm, could it be that some reporters are creating concern about the patch for political reasons. I dunno. But, lets remember that this administration has paid more than enough attention to right wing religious groups who would love to see young women denied access to birth control. We still haven't gotten a thumbs up or thumbs down on Plan B from the FDA. And, lets not forget Tom Coburn of Oklahoma, who is blocking Bush's nominee to head the FDA unless the FDA puts a warning on condoms that they do not protect against all STDs. Tom Coburn, btw, is the wacko who thinks you should give the death penalty to abortion doctors.

[Side note: I just went to the Washington Times to see what they reported on this story. They printed the AP story, but trimmed away the discussion where physicians point out that their own interpretation of the data suggests that the patch is safer or that it is not cause for alarm.]

Ok, so I don't want to leave this blog on a conspiracy theorist note. First of all, I am really really suspicious of the pharmaceutical industry. I do think that if a top selling drug had negative side effects, they are likely to bury it somehow. Secondly, the woman who wrote the AP story, Martha Mendoza, wrote a piece for Ms. Magazine on abortion, specifically how the partial-birth abortion ban negatively affected her (her fetus had died at 19 weeks and she was trying to find a doctor who would remove the dead fetus with much difficulty). I think its important to be suspicious of Big Pharma greed. And yet, we are facing a story about the birth control patch, which cannot be a politically neutral story in this era.

Let me end on one last note. I think that feminists are likely to find themselves in an odd relationship with Big Pharma in the next few years. The new birth control methods (the patch, the Nuva ring, etc.) are likely to be money makers. Moreover, if Plan B becomes over the counter, Barr Laboratories is likely to profit. Hence, the profit-seeking of Big Pharma is likely to work in the service of "proc-choice" and reproductive freedom. This uneasy political alliance needs to be carefully monitored. And yet, who else could pressure the FDA to approve of Plan B than big dollar pharmaceutical companies?