Pharmaceutical patents versus alternative medicine

There is often a great deal of criticism of pharmaceutical companies for how they operate and how they are protected by patent law, which allows them to have a roughly 17-20 year monopoly on new drugs. Alt-med advocates, in particular, like to bash the pharmaceutical industry. Certainly, sometimes the industry deserves it (the recent Vioxx debacle, for instance, shows Merck at the very least skating close to the edge of ethical behavior, if not going way beyond what should be acceptable), but a lot of the time the criticism is simplistic and overlooks the massive costs of bringing even a single drug to market. I found a nice couple of posts on the Becker-Posner Blog that discuss the issues involved here and here.

Key points: R&D costs for a new drug that obtains FDA approval and makes it to market can approach $1 billion. At the very least, it's hundreds of millions of dollars per drug. The costs come from the science, clinical trials, and the regulatory requirements for approval. That R&D time eats into the patent protection time, which means 17 years of patent protection are often, in effect, around 12 years, given that it can take 5 years or more for a drug to be approved. Even drugs that don't make it all the way to approval incur some of these costs. However, once a pharmaceutical is finally approved, usually the manufacturing costs are fairly small, which is why generics can be made so much cheaper. It is reasonable to grant pharmaceutical companies a monopoly for a time in order to recoup their costs. The questions become: How long is reasonable? Are 17 years too long or too short? How can we decrease R&D and regulatory costs without sacrificing patient safety? With Vioxx and accelerated approval, the FDA may have gone too far in the direction of speed, but the pressures for faster drug approval are not unreasonable for serious, life-threatening diseases. For example, AIDS and cancer patients, who understandably want the fast approval for drugs and are equally understandably willing to take more risks, might disagree that speeding the process up is a bad thing. The problem is, the law now doesn't seem to differentiate between drugs designed for such deadly diseases and drugs designed for more chronic or less severe diseases--or even for "lifestyle" drugs like Viagra or Cialis. It's a complicated issue that I'll try to address more in the future.

Now contrast this situation to alternative medicines, many of which are herbal. Alt-med advocates frequently complain that research into alternative medicine is not funded by pharmaceutical companies or the various companies that manufacture and sell herbal remedies because most of the treatments aren't patentable, being herbs or plants or whatever. They often use this observation as a way of absolving themselves of having to actually prove the efficacy of their remedies with actual clinical trials and scientific studies. However, this doesn't stop them from charging what seems to me like near-pharmaceutical industry prices for some of their products. For instance, about a year ago, one such person was using MLM methods to sell 150 g tins of Korean Ginseng powder for close to $300 each! (I note that he no longer publishes the price of his Ginseng on his website but rather simply lists contact information.) Clearly, alt-med can be quite profitable as well, and it has the advantage of (until recently) not actually having to prove the efficacy of any of its therapies.

Fortunately, that is changing. Scientists and doctors are becoming interested in whether any of this stuff actually works (and, if so, which specific therapies work) and the NIH has set up a center known as the National Center for Complementary and Alternative Medicine (NCCAM), which is now providing funds for well-designed basic research and clinical trials examining alternative medicine. The budget has gone from essentially zero to around $120 million in 12 years. Hopefully, in the future, research funded by NCCAM will help tell us which "alternative" medicines or therapies are efficacious, so that they can be added to the armamentarium of "conventional" medicine.