She turns her pen on drug makers

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.

Consider psychiatric drugs. If you can define everyone who has the blues as having depression that needs to be treated, you've created a huge market. If you define everyone who is shy as having social anxiety disorder, that enlarges the market. There's probably not a soul alive who hasn't felt shy. If you listen to the pharmaceutical industry, many of the ordinary discontents of life are medical conditions that require drugs.

You see the same thing with erectile dysfunction. Any episode of impotence, no matter how mild, how rare, becomes a condition, erectile dysfunction, that can be treated. It's no coincidence that the people in those ads tend to be middle aged or even younger. Pushing the disease is a big part of pushing the drugs. The result is that many Americans are probably on too many medications, with all the risks of side effects and drug interactions that implies.

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Q: If new drugs aren't necessarily better than old ones, why do doctors prescribe them?

A: Part of the answer is marketing. New me-too drugs are heavily marketed to patients and doctors. Look at the ads on television. Look at the endless parade of drug representatives marching through doctors' offices. Pharmaceutical companies spend billions and billions to make us think that new drugs are better than old ones. They have to. If you had a drug that was important and unique, you wouldn't have to advertise it very much. If you came out with a cure for cancer, the world would beat a path to your door.

So you have to ask, why are drug companies spending so much on marketing? The answer is that they have to convince us that their me-too drugs are better than the others. And that takes a heap of marketing, because there's usually no scientific evidence to back up the claim.

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Q: It's easier to imagine patients being fooled -- but doctors?

A: People don't realize that the pharmaceutical industry supports most of the continuing medical education programs in this country. These are the programs doctors are required to attend to update their knowledge. Drug makers fund the programs, so it's not surprising that they promote a drug-intensive style of medicine.

In their offices, doctors are visited by swarms of company sales representatives who bring packages of free samples -- about $10-billion worth a year -- of the newest brand-name drugs. The doctors get used to prescribing them, the patients get used to taking them, and when the free samples run out, someone has to start paying for the drug.

Whether these new drugs are actually better than older generic drugs never crosses the doctor's mind or the patient's mind. They confidently believe that newer is better.

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Q: What about clinical trials? Don't they provide evidence about how well drugs work?

A: Research is biased in favor of the drugs and drug makers. The pharmaceutical industry spends a great deal to influence people in academic medicine and professional societies. It does a super job of making sure [that] nearly every important person they can find in academic medicine [who] is involved in any way with drugs is hired as a consultant, as a speaker, is placed on an advisory board -- and is paid generous amounts of money.

Conflicts of interest are rampant. When the New England Journal of Medicine published a study of antidepressants, we didn't have room to print all the authors' conflict-of-interest disclosures. We had to refer people to the website. I wrote an editorial for the journal, titled "Is Academic Medicine for Sale?" Someone wrote a letter to the editor that answered the question, "No. The current owner is very happy with it." That sums up the situation nicely.

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Q: What can be done to fix the system?

A: The single most important change that should be made -- and it could be made tomorrow -- is for Congress to redefine what safe and effective means, to insist that the FDA require manufacturers to test new drugs not just against placebos but against existing drugs. After all, the relevant issue isn't whether a new drug works better than nothing; it's whether it's better than older drugs already in use.

That's why so many clinical trials published are of no use to doctors. Doctors don't want to know if this new drug is better than a sugar pill. They want to know if it's better than the drug they're already using. The FDA should require manufacturers to compare new drugs head to head, at equivalent doses. Only drugs that are safer, more effective, or significantly more convenient, should be approved.

We also need to make the FDA more independent. The FDA has 18 advisory committees, and many of the members of those committee have financial ties to the drug industry. That's wrong.

Finally, university medical centers and medical societies and the people who run them need to stop fooling themselves into thinking they can take huge sums of money from drug makers and still remain objective and independent.

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Q: Is there anything patients can do?

A: Ask questions. If your doctor prescribes a medication, ask about the evidence that shows it is effective. Ask why your doctor is prescribing this particular drug. Ask if there are older, less expensive drugs that might work just as well. A few questions from patients might begin to make [doctors] think about what they're doing. Finally, ask your doctor whether you really need a drug at all. Maybe a lifestyle change would be better, or maybe the illness is mild and will go away on its own.

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