Lybrel: A study in wasted resources

In its zealous effort to protect Americans from the alleged evils of drug makers, the FDA places strict rules on how a product may be marketed or sold. Inside every package containing a pharmaceutical product, the FDA requires that prescribing information be included. This prescribing information (shortened in industry parlance to "PI") is a document prepared by the drug company and edited by the FDA. The next time you buy a drug, open up the PI and look at the section called "Indications and Usage." This is the part of the PI that dictates exactly what the drug may be used for, according to the FDA. You'll probably notice that the "Indications and Usage" section is very specific, unless you are looking at a drug that was approved many years ago. For example, Avastin, a cancer drug, is not approved to treat "cancer." It's approved to treat only two types of cancer (non-small cell lung cancer and colorectal cancer), and only when those cancers have advanced beyond a certain stage -- according to the FDA, you may not use Avastin to treat breast cancer, even though it has been shown to have an effect on that disease, and you may not use it to treat colorectal cancer caught at an earlier stage.

Note that while the "Indications and Usage" section of the PI states the uses of a drug that the FDA has approved, once a drug has been approved, it can be prescribed by a doctor for other uses. So, plenty of breast cancer patients are already getting Avastin, even though approval for that use is not expected until early next year. However, while lack of FDA approval for a particular use doesn't have to stop a doctor from prescribing a drug, it can mean that insurers won't approve reimbursement for that drug, and more importantly, it means that the drug company is forbidden from marketing the drug for that purpose.

In practice, this means that drug companies must conduct large, expensive clinical trials each and every time they'd like to advertise a new use for their product -- even if that use is already well established. Perhaps the money and time spent on those clinical trials could have been used for innovation in another area -- why spend astronomical sums on trials merely to confirm something doctors already know, when that money could be used to develop an entirely new drug for some other condition?

There is no better example of this FDA-induced waste than Lybrel, a birth-control pill approved by the FDA in May. Lybrel joins a crowded market, with more pill brands and generics than I can count, plus patches, injections, and vaginal inserts. So what's "different" about Lybrel?

According to the FDA and Lybrel's marketing, Lybrel is the first and only oral contraceptive that is taken 365 days a year, with no breaks -- meaning no menstrual periods. Sounds great, doesn't it? Being female, I can say that there is nothing fun or convenient about menstruation, so why not get rid of it?

The problem is that women could already do this long before Lybrel showed up. Any of the existing brands of birth control pills will work -- simply omitting the placebo pills in the pack and taking active pills continuously will do the trick. Gynecologists have known this for years, but apparently years of successful experience aren't enough to satisfy the FDA; only an expensive clinical trial will do.

And so it is that only Lybrel can claim that it is capable of continuously suppressing periods; for women with health insurance, Lybrel may be the only pill brand that is covered for that purpose. (I always found it remarkably silly that my insurance company would not cover a generic pill brand purchased every three weeks instead of once a month, though they will cover the more expensive brand Seasonique, another "me-too" pill that claims it allows women to have four periods a year; covering the generic would save the insurance company money.) Why else would Wyeth bother to conduct clinical trials with nearly 2,500 women to prove something medical practitioners already know?

What a waste. Without FDA, Wyeth and other pharmaceutical companies could have simply continued to market its other Pill brands, letting women know that they can be used to continuously suppress periods. End the FDA, and this kind of waste will end, so that resources can be used for real medical innovation.