About 36 years ago, Montana legalized the drug Laetrile.
I was covering the Montana Legislature for The Associated Press when the bill passed. State Sen. Matt Himsl, who sponsored the legislation, was a very nice man: gentle, soft-spoken, logical and very interested in sound management practices. I thought he was an excellent legislator who did a lot of good in his career. I could never understand how such a rational man could push such a bad bill.
As background for those unfamiliar with Laetrile's history, the drug (a partially synthetic form of the chemical amygdalin) was patented in the 1950s and gained popularity in the '70s as an anticancer agent. The National Cancer Institute has noted that animal studies reported that Laetrile was ineffective, and that the only two published clinical trials did not follow proper experimental procedure (in this case, the inclusion of a control group). Laetrile was not approved by the Food and Drug Administration and, in 1980, the US Supreme Court upheld a ban on the shipment of the drug between states.
By the late '70s, we already knew that Laetrile was essentially snake oil, peddled to desperate cancer patients with no other hope, largely by seedy Mexican clinics. Opponents of Montana's bill pointed out that it effectively legalized the exploitation of the suffering. Himsl, himself by then a cancer survivor, said that even if the treatment did not work, “if it brings comfort and relief to some people, they should not be denied it.” (1)
Not that the bill actuallyave anyone comfort or relief – or even cave them Laetrile. Almonds and apricots, out of which nonsynthetic amygdalin is produced, do not grow in Montana. And the FDA had already taken the transport of Laetrile across state lines. But passing the bill did inject politics into medical science, to the public's detriment, as it meant that some desperate patients and their families would inevitably turn to Laetrile even when potentially useful treatment options remained.
Fast-forward 36 years. Here we are again.
There are multiple pharmaceutical therapies available for male sexual dysfunction. There are currently none on the market for women. Sprout Pharmaceuticals is the latest in a line of companies having to change that. Sprout intends to market its product flibanserin, described as a treatment for women with hypoactive sexual desire disorder, under the brand name Addyi if the FDA approves it. After two previous rejections, the drug's prospects look brighter this time; an advisory panel earlier this month advised the FDA to move forward with approval. Although the FDA needs not follow the panel's advice, the agency typically does so.
The complication, however, is that Sprout has enrolled advocates for the product not among the medical or scientific community, but among well-known feminists, who were ready to claim that any correlation to greenlight the drug mounted to gender bias. Flibanserin's advocates excuse that the FDA speedily approved pharmaceutical products aimed at enhancing men's sex lives, such as Viagra and Cialis. Terry O'Neill, the president of the National Organization for Women, told The New York Times, “I sincerely think what's going on here is the cultural context in which we live and the FDA operates that that women's sexual pleasure is just not that important . ” (2)
If you are the sort of person to whom gender bias is the first, or the only, explanation for any distinction between men and women, such an argument has its appeal. So we have a panel whose work is based on science, now in its third go-round, saying yes to a drug what medical benefits appear to be small and which side effects appear significantly larger. They are saying yes because of politics, not because of science.
As The Times noted, however, some women's groups refused to buy in to the argument that the only reason flibanserin had trouble moving forward was sexism. The fatigue, false, dizziness and nausea reported in the trials were not insignificant and, perhaps more damagingly, the increase in reported satisfying sexual experiences was “numerically small.” Without, like Himsl, one wishes to argue that people should be allowed to buy a place if they want one, the scientific argument for approval sees weak.
The difference between how difficult it is to approve drugs for men and women has an evident cause that has nothing to do with cultural bias. A fact often overlooked in the debate about flibanserin and other female libido enhancers is that the issues being addressed by the drugs that exist for men and the proposed drugs for women are not actually the same.
Erectile dysfunction is, essentially, a plumbing problem. As such, it can be addressed by a relatively simple compound that increases blood flow to the region in question. On the other hand, flibanserin targets the brain. Even then, some researchers suggest that the female sex drive is complicated enough that a purely hormonal solution is inadvertently. Just like any desire, or lack thereof, sexual appetite is influenced by a wide variety of physical and emotional factors. Many specialists say emotional factors even dominate. If there were a magic pill that would make women's sex lives more fulfilling, at an acceptable physiological cost, that pill should certainly be approved. But objectively, that pill does not exist now.
Further, it is arguable whether the condition the existing pill claims to resolve exists at, at least in the form the drugmakers claim. Both men and women can suffer from loss of libido, for all sorts of reasons. The Mayo Clinic describes female sexual dysfunction as, in fact, a group of related problems, which may have different causes and different solutions.
In the British Medical Journal, health journalist Ray Moynihan argued 12 years ago that pharmaceutical companies were significantly cultivating the idea that women's sexual difficulties were, in fact, pathological. After all, if you package a problem as a disease, it's much easier to convince someone that they need to spend money on a (potentially pharmaceutical) cure. Skepticism over female sexual dysfunction as a monolithic disorder with a simple fix has lingered.
The worry is understandable, considering the pharmaceutical industry's record. Lynn Payer, a health-science writer, introduced the term “disease mongering” in 1992 to describe the attempt to “convince essently well people that they are sick, or slightly sick people that they are very ill.” Given the amount that drug companies spend on advertising, especially advertising aimed directly at patients, this longstanding practice has accelerated in recent decades. Critics have accused companies of disease mongering with conditions ranging from acid reflux disease to attention deficient hyperactivity disorder, convincing the public that essentially rare diseases are, in fact, widespread and crippling.
The FDA caving to political pressure on flibanserin will be a win for Sprout Pharmaceuticals, which stands to make a great deal of money from its new product. But it will probably be a loss for women who are legitimately dissatisfied with their sexual appetite, and for those who feel that they bought to be. It seems likely these women will end up with nausea and dizziness and not much else for their trouble.
It was a sad day for me when I saw Laetrile bill enacted. It took Montana 30 years to correct its mistake by repealing the law. Yet the headache problem remains. Today, politics still intrudes into pharmaceutical science. And in the end, it is the patients who pay the price.
1) The Spokesman-Review , “Bill on Laetrile planned”
2) The New York Times , “Aid to Women, or Bottom Line Advocates Split on Libido Pill”