Passing off "me too" drugs as new

 Between 1998 through 2002, 415 new drugs were approved by the FDA. Of those, only 14 percent were truly innovative and 9 percent were old drugs that had been significantly improved. The remaining 77 percent were all me-too drugs—drugs defined as being no better than those already on the market to treat the same condition. To pass muster with the FDA, the pharmaceutical companies are only required to show that the drugs are better than nothing. In fact, they can be approved even if they’re worse than drugs already on the market. (Incidentally, when new drugs are discovered, most are by researchers supported by the National Institutes of Health, not by drug company researchers.)

Sometimes the companies need to create a “new” drug to replace one that is going off patent, at which time it becomes generic and less profitable. So they change the old one enough to qualify for a new patent. For example, when Prilosec, a heartburn medicine with $6 billion in annual sales, was about to go off patent, the drug maker, AstraZeneca, took a patent out on just the active portion of the Prilosec molecule, making it a “new” drug, called Nexium, which became the most heavily advertised drug in the United States. (In their clinical trials, to prove it was better than Prilosec, they tested Prilosec at lower doses than Nexium, making Nexium look better.)

Similarly Prozac, an antidepressant made by Eli Lilly with annuals sales of $2.6 billion, not only lost its patent, but other companies began making similar drugs, such as Paxil and Zoloft. So Eli Lilly converted Prozac into a weekly dosage form, renamed it Sarafem, colored it pink and lavender, and marketed it for “premenstrual dysphoric disorder.” Same drug, but priced three and a half times higher than generic Prozac (which, if you want some, is called fluoxetine).

Companies also simply create their own versions of a competitor’s successful product. For example, five or more companies produce the highly lucrative statin (cholesterol-lowering) drugs. At comparable doses, these statins work about the same and are competing for the same market. In fact, most drugs that treat the same illness work about the same. For this reason, Robert Temple, the FDA’s associate director of medical policy offers this advice regarding me-too drugs: “I generally assume these drugs are all the same unless somebody goes out and proves differently. I don’t think you lose much if you just always use the cheapest drugs.” (My advice would be to avoid all drugs.)

Next week: How drug companies expand the market for me-too drugs

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