For the next 4 to 5 weeks, I am going to put together an educational primer for people interested in the Movie SiCKO, a political documentary film by Michael Moore, scheduled for release in the
United States on June 29, 2007. It will investigate health care with a focus on large American pharmaceutical companies and the Food and Drug Administration. I haven’t seen the movie yet however I intend to. What’s interesting is that Mr. Moore isn’t bring up anything new….pharmaceutical and health insurance companies have been behaving badlyfor years. In any case, by reading this blog the next few weeks, I hope that you will educate yourself about several concepts before seeing the movie.
The concept: “Me-too drugs”
The players: Pharmaceutical Companies
The Scoop: The pharmaceutical industry is not especially innovative or inventive. The great majority of “new” drugs are not new at all but merely variations of older drugs already on the market. These are called “me-too” drugs. The idea is to grab a share of an established, lucrative market by producing something very similar to a top-selling drug. For instance, we now have six statins (Mevacor, Lipitor, Zocor, Pravachol, Lescol, and the newest, Crestor) on the market to lower cholesterol, all variants of the first. As Dr. Sharon Levine, associate executive director of the Kaiser Permanente Medical Group, put it,
“If I’m a manufacturer and I can change one molecule and get another twenty years of patent rights, and convince physicians to prescribe and consumers to demand the next form of Prilosec, or weekly Prozac instead of daily Prozac, just as my patent expires, then why would I be spending money on a lot less certain endeavor, which is looking for brand-new drugs?”
Of the 78 drugs approved by the FDA in 2002, only 17 contained new active ingredients, of which seven of these were classified by the FDA as improvements over older drugs. The other seventy-one drugs approved that year were variations of old drugs or deemed no better than drugs already on the market. Only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH). Of the 7 drugs discussed above, not one came from a major US drug company.
Case in Point: Nexium, a “me-too” drug for stomach acid, has earned approximately $5 billion for its maker, AstraZeneca, since it went on the market in 2001. Nexium illustrates the drug makers’ strategy. Many chemicals come in two versions, each a mirror image of the other: an L-isomer and an R-isomer. (The “L” is for left, the “R” is for right.) Nexium’s predecessor Prilosec is a mixture of both isomers. When Prilosec’s patent expired in 2001, the drug maker was ready with Nexium, which contains only the L-isomer.
Is Nexium better? So far, there’s no convincing evidence that it is, says Stanford drug industry watcher Randall Stafford, MD, PhD.
The problem with Me-Too drugs is that they are always marketed as BETTER than what’s already available. However, the FDA approves drugs on the basis of their superiority to placebo, not their superiority to existing drugs,” Stafford says. “I think people misunderstand the nature of FDA approval and the criteria used to allow drugs to enter the market. So consumers feel compelled to leave their current regime–even if it’s working–for these drugs. Me-Too drugs also COST SUBSTANTIALLY more–forget about lowering prices.
1. The Truth About the Drug Companies ByMarcia Angell
2. “Me-too drugs, Sometimes they’re just the same old, same old” By Rosanne Spector.