Conversation with a Harvard expert

Dr. Jerry Avorn is chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital in Boston and a professor at Harvard Medical School. Avorn and his colleagues published research that helped identify the heart attack risk of rofecoxib (Vioxx). He is the author of numerous articles and the book Powerful Medicines (2004).

You've been critical of the pharmaceutical industry. Are drug companies behaving more responsibly these days?

They are somewhat more cautious, primarily because the FDA has become more vigilant. A 2007 law forced the agency to create a better system for monitoring and studying drugs once they are on the market. Our group is very involved with the collection and analysis of data from that postmarket surveillance system.

We get a lot of questions from readers about generic drugs and whether they really are just as good as brand-name drugs. Are they?

Yes they are. Generics are often made by the same companies that make the branded products. And if they aren't, they are usually made by equally large companies that the FDA subjects to the same degree of quality control as brand-name manufacturers.

We are collectively wasting billions of dollars on brand-name drugs when we can buy generics that are just as safe and effective, for as little as $4 a month.

We also get questions about the side effects of statins. Do you think they have been downplayed?

Statins have prevented enormous amounts of sickness and death from heart disease; they are fantastic drugs.

But it's also probably fair to say that we are not as good as we should be about studying side effects that don't land people in the hospital — or kill them. I think we have a good handle on statins and rhabdomyolysis, the muscle breakdown that can be fatal. But I don't think we have studied as carefully as we should have the extent to which statins sometimes make people ache. And making tens of millions of people ache — that's not nothing.

Is off-label use of drugs a bad idea?

The problem is not off-label use, but off-evidence use. I am comfortable with a drug being prescribed for a condition for which it may not have an FDA indication, as long as there are very solid trial data that the drug works for that condition.

Cancer drugs are getting to be a huge expense, aren't they?

Yes. While there are some important new discoveries, I'm troubled by the demagoguery that insists that every patient have access to any cancer drug they want, even if it has been shown not to work. We have to believe the clinical trial data, and if that shows the drug is ineffective, we can't say, "For you, we'll make an exception."

If there is some scientifically plausible manner for predicting whom a drug is going to help and whom it won't, that is a different story. Herceptin, the breast cancer drug, is an example of a drug for which there are genetic markers. But we're not there yet with most cancer drugs.

Do you think the relationship between academic medicine and the pharmaceutical industry has gotten too cozy?

We're getting better at identifying conflicts of interest in medical education and research, but this remains an important issue. Here at Harvard Medical School, for example, because of efforts by some students, faculty members are now required to disclose at the beginning of a talk from whom in industry they are receiving payments.

I do worry that potentially conflicted relationships are becoming more basic and accepted. Many academic researchers believe that they have to form alliances with drug companies because they can't be sure of National Institutes of Health funding. I'm concerned that there is sometimes a lack of appreciation that the goals and values of a company, which meet shareholder needs, will often differ from those of academic research.

Are you optimistic or pessimistic about the future of medications and their regulation?

I am optimistic. The examples of what happened with Vioxx and several other problematic drugs have had a bracing effect on how we understand and study medications that is analogous to the bracing effect that thalidomide had on drug regulation in the 1960s.

The other thing that gives me hope is that we have begun to pay more attention to the way existing drugs are used — and not used. The next big dent in heart disease, diabetes, and hypertension may come not from a new blockbuster drug but from understanding better how we can get people to take their medications and help them afford them.

Would you care to discuss any medications that you're taking?

I'd rather not get into specifics. I'm on the run-of-the-mill stuff for a 63-year-old. It's been a revelation to think about compliance, perceptions of side effects, and risks and benefits from the other side of the prescription pad. It reminds me of when I had some very minor surgery as a medical student. That was one of the most useful experiences I had in medical school — what it's like to lie there, waiting for the nurse to come around with pain medicine. If we could do this ethically, I think every doctor ought to have one minor hospitalization and one mild chronic illness requiring a daily medication, because we'd then understand much more how things feel from the patient's side.