Today I tie up some loose ends (here is post 1 and post 2 in the series) beginning with an argument in favor of me-too drugs that I do not like and then moving on to an attack on Marcia Angell’s book The Truth About Drug Companies.
Many people argue that price competition is a benefit of me-too drugs. But recall the point I made yesterday, me-too policy is patent policy. If you think lower prices are a good idea then you really think that weaker patents are a good idea. Indeed, as far as price competition is concerned the ultimate me-too drug is a generic so the logic suggests we should get rid of patents. For obvious reasons, that is not a good idea. (Our current policy is actually quite good – strong patents for about 12-15 years of effective life followed by very sharp price competition from generics. Note that since profits are discounted the future competition doesn’t reduce R&D very much.)
I dislike Marcia Angell’s The Truth About Drug Companies not because of her conclusions but because it isn’t serious research. She has lots of citations to newspapers, for example, but not a single citation to Frank Lichtenberg the premier researcher on the value of new drugs. (I don’t agree with everything in Jerry Avorn’s Powerful Medicines, and he doesn’t cite Lichtenberg either, but I learned something from his book. If you are interested in these issues I recommend it highly.)
Concerning me-too drugs, on page 90 Angell says "there is little evidence to support the notion that…if one drug causes side effects, another one won’t." That’s odd because on page 81 when discussing the me-too statin’s (Zocor, Lipitor, Pravachol etc.) she notes "Bayer’s Baycol had to be removed from the market because, at the approved dose, it caused a deadly side effect." Hmmm. Similarly, early tests suggest that Celebrex may not have the same side-effects as Vioxx, despite the fact that both are Cox-2 inhibitors.
Angell is also skeptical that me-too drugs can have different effects in different people. Frankly, I was shocked at this argument. Every clinical trial that has ever been run demonstrates that the same drugs have different effects in different people – it’s hardly a surprise that different drugs have different effects. And me-toos are different – different enough not to violate the patent on the innovator drug almost certainly means different enough to have different effects in some people. My local supermarket carries at least a dozen different styles of peanut butter, a fact of which I approve, but Angell thinks two angiotensin-converting-enzyme (ACE) inhibitors may be one too many (p.90). Give me a break.
Finally, it’s important to recognize that small changes can actually make for important improvements. What could be more me-too than a once-a-day pill replacing a twice-a-day pill? Yet, to dismiss this change is to overlook the people factor. A once-a-day regime that people stick to is much better than a twice-a-day regime that people fail to follow. Forget the chemical structure the economics says a drug that people actually take is a better drug.