How Pharmaceutical Companies Fool Consumers with Me-Too Drugs
Posted Jan 07 2013 12:00am
I recently listed to an excellent podcast interview of Dr. Marcia Angel l by Russ Roberts on Econtalk about the pharmaceutical industry. She is a former editor of the New England Journal and a pathologist by training (see: Angell on Big Pharma ). In the interview, she makes a strong case that these companies are not particularly innovative and often quite unscrupulous in their marketing practices. She is a long-time critic of the industry. To support her claim, she discusses "Me-Too" drugs. Here's an excerpt from another article that makes the same points as Dr. Angell (see: Sometimes they're just the same old, same old ):
It’s expensive to produce an innovative drug. On average, the bill runs to more than $400 million. So drug companies often take a less costly route to create a new product. They chemically rejigger an oldie but goodie, craft a new name, mount a massive advertising campaign and sell the retread as the latest innovative breakthrough. This strategy has shown great success for turning profits. Nexium, a “me-too” drug for stomach acid, has earned $3.9 billion for its maker, AstraZeneca, since it went on the market in 2001. The U.S. Food and Drug Administration classified three-fourths of the 119 drugs it approved last year as similar to existing ones in chemical makeup or therapeutic value....Many chemicals come in two versions, each a mirror image of the other: an L-isomer and an R-isomer....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.“Newer isn’t always better, when it comes to drugs,” says Stafford....
You may have a question about how the pharmaceutical companies fool physicians and the general public into thinking that a Me-Too drug is superior to the similar drug already on the market. The process starts with the clinical trials required by the FDA, according to Angell. In such trials, the protocol is written to only compare the Me-Too drug to a placebo and not to the original drug. This is allowed by the FDA. This problem could be avoided by requiring Me-Too drugs to only be tested with a "three-armed" trial with the new drug being evaluated against both a placebo and the older drug. Moreover, the drug companies have another trick up their sleeve in these clinical trials according to Angell: they modify the drug dosage such that the new drug is compared against a less effective dosage of the drug that is available in the market.
For the sake of balance, I came across an article by a pharmaceutical company researcher about this topic. He makes the point the most Me-Too drugs were developed in parallel with the first one that comes to market (see: Those Me-Too Drugs ) rather than afterwards. This may be true but it seems to me that the second drug then needs to be evaluated in clinical trials to determine whether it is superior to the first. Also, here's another link to an article in the New York Review of Books by Dr. Angell in which she presents more of her criticisms of the pharmaceutical industry (see: The Epidemic of Mental Illness: Why? ).