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She turns her pen on drug makers

Former New England Journal of Medicine editor Marcia Angell criticizes costs, research and marketing.

August 09, 2004|Peter Jaret | Special to The Times

For more than a decade, physician Marcia Angell served as executive editor and then editor in chief of the New England Journal of Medicine, one of the country's most prestigious medical journals. Under her watch, the journal published hundreds of studies of new drugs. It also published blunt editorials harshly critical of the pharmaceutical industry and the way drugs are tested and approved in the United States.

Angell left the journal's editorship in 2000, and is now a senior lecturer at Harvard Medical School. She has written a scathing critique of the pharmaceutical industry, "The Truth About the Drug Companies: How They Deceive Us and What to Do About It" (Random House, 2004). In a recent conversation, she talked about why so many of the drugs on the market are so costly, and also about her contention that many of them are not as effective as they're promoted to be.

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Question: We all know drugs are expensive. But doesn't that reflect the high cost of researching and developing new drugs?

Answer: No. That's what the drug makers would like you to think. But it's simply not true. In 2002, the biggest drug companies spent only about 14% of sales on research and development and 31% on what most of them call marketing and administration. They consistently make more in profits than they spend in R&D. And their profits are immense. In 2002, the combined profits of the 10 drug companies in the Fortune 500 were $35.9 billion. That's more than the profits for all the other 490 business put together, if you subtract losses from gains.

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Q: The system may be flawed, but hasn't it generated hundreds of new medications?

A: That's another myth the drug makers would like you to believe. In fact, the number of truly innovative new drugs is quite small. True, many drugs are coming to market. But most of them aren't new at all. They are minor variations of bestselling drugs that are already on the market.

There are dozens of examples of these "me-too" drugs. There are now six different statins to lower cholesterol. The first, Mevacor, which was approved in 1987, was indeed an innovative drug. Other companies wanted to capitalize on this extremely lucrative market and they began creating other statins. Lipitor is now the biggest-selling drug in the world. But it's a me-too drug. There's little scientific evidence that any of them is better than the others in comparable doses.

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Q: Doesn't the Food and Drug Administration require new drugs to be safer and more effective than drugs already on the market?

A: It should, but it doesn't. Drug makers are only required to show that a new medication is more effective than a placebo, or sugar pill. If a drug works better than a placebo and is safe, the FDA approves it, and it can enter the market. The result is that doctors don't know if a new drug that comes along is any better or worse than the drugs they're already using.

A dark fear I have, in fact, is that drugs are getting progressively worse. There's some basis for that concern. The first drugs used to lower blood pressure were diuretics. Then new drugs for hypertension came along and were heavily marketed, and many doctors stopped using diuretics. In a study published in 2002, researchers compared the old drugs to the new ones, and guess what -- the old drugs turned out to be just as good for lowering blood pressure and even better than the new drugs for preventing some of its complications.

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Q: Why do drug makers churn out new drugs when older ones work perfectly well?

A: Because patents run out on older drugs and they can then be sold as generics at as little as 20% of the price [they sold at while still under patent]. Pharmaceutical manufacturers need a constant supply of new drugs that have patent protection so they can charge whatever they want.

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Q: Isn't it useful to have a variety of drugs to choose from, in case a patient doesn't respond to the first?

A: That's an argument the pharmaceutical industry makes -- that it's good to have six cholesterol-lowering drugs, or five selective serotonin reuptake inhibitors (SSRIs), the antidepressants that include Prozac, Zoloft and Paxil. But if that's true, then the companies should be required to test a new me-too drug in people who failed to respond to the first drug. And they don't do that. My guess is that if the first drug doesn't work, the second one won't work either, since me-too drugs are so similar. But no one can say for sure.

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Q: What about competition? Do me-too drugs help keep prices down?

A: Probably not. When did you see a drug company advertise that its drug is cheaper than another drug? You don't see ads that promote Lipitor as cheaper than Zocor. Or Zoloft as cheaper than Paxil. I can't think of any other industry where price is almost never mentioned. Drug companies compete by implying that their new drug is better. And also by making more people think they need drugs.

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