Friday, November 11, 2005

Scientific merit

Just this week, a Johnson and Johnson subsidiary, Ortho McNeil, put a warning label on their estrogen patch, Ortho Evra. It seems the Ortho Evra patch delivers a whole lot of hormone - use it and you get way more than you would on the pill. So? Well that means the nasty side effects associated with the estrogen compounds in the pill may be more likely to occur when you use the patch.

Today's news item says the AP announced 4 months ago that the rates of death and disability in women who used the patch were suspiciously high. Further, an internal memo at the drug company, Ortho McNeil, shows that in 2003 the company "refused...to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was 'too high a chance that study may not produce a positive result for Evra' and there was a 'risk that Ortho Evra may be the same or worse than Ortho-Cyclen'".

According to today's story, when questioned about the 2003 memo and the reasons for not conducting studies comparing the safety of the patch to the pill, Ortho McNeil released a written statement saying that decisions to fund studies, such as a comparison of adverse events between patch and pill using patients, "...are based upon scientific merit." (quote from a written statement by Ortho McNeil spokesperson)

Because they didn't conduct those studies, the company can get away with a watered down warning on their possibly deadly patch. Here's what it says on the website for the potentially lethal Ortho Evra patch:
"You will be exposed to about 60% more estrogen if you use ORTHO EVRA than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen exposure may increase the risk of side effects. However, it is not known if there are differences in the risk of serious side effects based on the differences between ORTHO EVRA and a birth control pill containing 35 micrograms of estrogen."
(red text mine)

Isn't that great? They can legitimately say "we don't know" here because they never did the study. My god I am just horrified. Why? It's not like I should be surprised to see a drug company acting in a highly unethical way. If it were that this sort of devil may care approach to R&D hardly ever occurred outside the tobacco companies, I might have an easy excuse to claim shock. Still, despite the corporate precedent, the level of carelessness for women's lives Ortho McNeil is displaying here is just staggering.

Some cynnical part of me is saying "well of course the makers of OrthoEvra patch don't care if women get sick and/or die from using the patch. The risk to women's health is less severe than the risk to company profits should a safety comparison between the new product (patch) and the old (bcps) turn out against the new".

But what is genuinely shocking and perhaps even more disappointing is the lack of any visible, public response by women's groups whose missions include advocacy for women's reproductive health and freedom. The absence of response (or the presence of positively skewed "neutrality") makes it seem as if women's health comes second to advocating for various forms of birth control. This pisses me off.

Understand that I consider myself a full on feminist. Relative to the topic of reproductive health and rights, I believe in a woman's right to make individual decisions about her body, her right to make decisions about when and whether to reproduce, and her right to privacy in those decisions. I believe that women's choices about any aspect of their health, including birth control/contraception/reproductive health falls under the universal issue of patient privacy, i.e., no one but a woman and her medical provider should be involved in ANY of that woman's health decisions - before, during, or after. I believe it is government's job to protect these individual rights and freedoms, not to limit or criminalize personal responsibility and liberty for half the population because some people with mommie issues can't stand to think of women not wanting tons and tons of babies (this is how I see most anti-choice folks, and I've seen them up close, outside women's health clinics, screaming in my face when I did clinic escorting and clinic defense).

However, I think abortion sucks as an option. I'd never want to have one. I don't wish them on my friends. I want other options. I want to have access to the means to lock the barn door before the horse gets out, so to speak. I think surgical or drug induced termination sucks just like I think it sucks that in order to "treat" my endometriosis I have the miserable options of surgery or drug therapy that will essentially make me an insane, fat, angry, hairy man. We can fucking clone kittens. We can transplant kidneys, livers, hearts, retinas, bone marrow. We can make little devices that slice plaques out of arteries. We can repair vessels in someone's brainstem. We can get 50 year old women pregnant with quintuplets. So why can't we have safe, good contraception that women can and will use without having to choose between fun satisfying sex or cerebral blood flow? If we could have more genuinely GOOD options, it would make the whole abortion thing a null issue. It has been frustrating to see NOW and NARAL (et al) seemingly not focusing the greater part of their members' time, energy, and money on lobbying to fund contraceptive research that would result in options that don't involve big health risks to women (e.g., how about some male contraceptives?!)

I would think that the women's groups would be pissed. Allowing corporations to ignore women's health to profit off birth control products only enhances some of the arguments of the anti-choice contingent who say birth control (abortion or other forms) are anti-woman. Yet of the big women's reproductive health advocacy groups, NOW, NARAL, and the Feminist Majority Foundation only one, NARAL, has a link on their site to this story
(it's linked from the main page by clicking "contraception" under "issues" on the side bar. On the page that opens from that link, under "latest headlines" there's a link titled "FDA issues warning against J&J's OrthoEvra birth control patch". That takes you to another page where there is a link to the story. Talk about a scavenger hunt!)


Then there is Planned Parenthood, who are supposed to be all about women making informed decisions in reproductive health. What do they have to say about Ortho Evra?
On the front page of the website is a feature called Ask Dr. something or another. Here's the text:
"I've been hearing lately that the birth control patch is dangerous. Is that true?"
No. More than four million American women have safely used Ortho Evra — the patch — since it was introduced... more »

If you click for "MORE" you get something annoyingly like an advertisement for the Ortho Evra patch:
"While all medications are associated with adverse events, medical authorities and health officials have yet to find evidence proving a causal relationship between recently reported adverse events and use of the patch."

Planned Parenthood actually italicized "causal". This rhetoric is just way too much like the line we used to get from tobacco corporations. "There is an association but no evidence of a causal link". Coincidentally, tobacco companies target women as consumers without regard for the health consequences of their product also ("You've come a long way baby").

I guess Planned Parenthood doesn't want women to stop using their birth control in a panic and end up preggers. I understand this concern, but I personally consider pregnancy a more curable condition than fucking death by pulmonary embolism.

As some defense, the Planned Parenthood "Ask Dr. whatshername" thing is old, it looks like it was last updated in 2004. There isn't an update based on the newest information, the recently disclosed 2003 Ortho McNeil memos which say they didn't want to run a study comparing patch to pill because they were afraid there was "too high a chance that study may not produce a positive result for Evra". I sure hope I see a response from the women's groups that takes the drug company to task.


All that said, I do quite strongly believe safe (relatively speaking), legal, affordable pregnancy termination options need to be ensured and protected as a form of birth control* for all women until we have guaranteed access to truly safe, legal, 100% reliable, affordable (free!), convenient, and fucking ubiquitous forms of contraception. But we are techonologically advanced enough now that this shouldn't be the focus anymore. The drug companies know this. They know there is a market for contraceptives that will allow women access to the same kinds of sexual freedom that men take for granted. They know the women who want these products want to be healthy, otherwise we'd still have the same old shitty pill we had in 1970, which was effective but had the precision of a hormonal bomb. Women need to insist on something better though, especially when it comes out that the makers of a contraceptive that was marketted on, among other things, its relative safety effectively hid information about the risks of their product. We need to demand better. When will the leaders of the women's groups stop living in the 60s and realize that if modern science can give us pills that allow 70 year old men to obtain rock hard erections, it can find a form of contraception that does not risk women's lives?

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