I know a lot of women who are dissatisfied with their birth control, especially the pill. Apparently, the body uses those hormones for a lot of things besides conception, like making you depressed and gain weight and totally uninterested in the activity with which the pill is supposed to help you.
"I think a lot of the last decades of work by the industry has been in taking hormonal methods and changing them a little bit, tweaking them, as opposed to huge leaps and revolutionary changes," says Jill Schwartz, medical director of CONRAD, a reproductive health research institution. Yet even she is not optimistic that women would be willing to try an experimental new method. "It's economic. It's going to cost so much to make a new product... But it's not going to be a huge market share. So for industry it's not enticing."
Are pharmaceutical companies so busy inventing illnesses and wooing doctors that they can't bother to invest in R&D for a product for which 99 percent of American women are potential consumers--not to mention the rest of the world? Have social conservatives made birth control so controversial that even the most forward-thinking university researcher can't find funding for this research and even the most profit-thirsty CEO doesn't want to go through the FDA approval process? Or is the human reproductive system really so complicated that we unlocked the only way of controlling it way back in 1951? My friends and I would like some answers.
I don't think the issue is that Pharma is too stupid, uncaring, or uninterested in the market. Birth control is a quite large market, in fact, nearly unique--you can get a bunch of motivated young people to take your product every day for a decade or longer. So lets consider what the er . . . barriers are:
1. There aren't unlimited ways of tinkering with the human body. When Friedman asks "is the human reproductive system really so complicated that we unlocked the only way of controlling it way back in 1951?" it sounds sarcastic. But the answer may be, well, yeah, we did. Estrogen and progesterone are the main sex hormones. That does make them the most likely targets for preventing conception.
2. Side effects are almost inevitable. When I was younger, I thought of the pill as something nearly perfect--almost no side effects, almost 100% effective. I think a lot of young women view it the same way. As Ann's friends and mine have learned, that isn't necessarily true. Over several billion years of evolution, the human body has learned to use hormones in multiple different pathways, the better to economize on DNA and productive capacity. What that means is that when you knock out the target you want, you very often (almost always?) run the risk of knocking something else out. For example, your body has apparently has pathways to make you more amorous and attractive when you're fertile; if you manipulate the hormones that make you fertile, it's not surprising that you may also knock out your libido.
3. It's harder to bring a new product into a crowded market. Obviously, if there's already a lot of competition, it's harder to make a profit--both your volumes, and the price you can charge, are probably going to be lower. But it's also a regulatory issue. It's easier to get a drug approved when you're comparing it to a placebo than it is when you have to prove that it is at least as effective as the existing treatments on the market (particularly if the treatments are pretty effective). In the latter case, you not only have a higher bar for what "effective" is, but also, you're probably trying to detect small differences in effectiveness or side effect profiles (rather than the large difference in effectiveness between, say, the pill, and praying.) If the effect you're trying to detect is small, you need to run larger, more expensive trials in order to get statistically significant results.
4. Liability and related risks are higher for "lifestyle" drugs. I know--birth control is important! I'm not trying to trivialize it. But the condition it prevents--pregnancy--is rarely fatal in this day and age. And birth control is used most heavily by young, healthy women. If a large group of young, healthy women take your drug, and there turns out to be some rare side effect that didn't show up in your 10,000 person trial, but did show up in your 5 million customer base, you are going to pay heavily for those problems. Horrified juries will deliver large awards, especially since those sorts of product liability cases are often based on the remaining years of health and income that were lost.
5. It used to be easier to get drugs approved. The FDA has gotten consistently more strict with its requirements over the decades, and pharmaceutical companies have responded by killing products that might be good, but have a high risk of flunking Phase III.
So I'm not optimistic that we'll get better birth control. The male pill faces the same barriers (look at the risks of Propecia), such that I'm skeptical that it will ever be approved or marketed even if someone manages to develop it.
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