5 Questions: Angell on big pharma

An occasional feature in which a medical expert answers five questions on a science or policy topic of interest to the Stanford community

Marcia Angell

The pharmaceutical industry is not shy about taking credit for advances inmedicine, but over the last few years there has been a growing drumbeat of criticism about the skyrocketing cost of prescription drugs in the United States. Few critics have presented as harsh an assessment as Marcia Angell, the former editor-in-chief of the New England Journal of Medicine and now a senior lecturer on social medicine at Harvard Medical School. Her latest book, The Truth About the Drug Companies: How They Deceive Us and What to Do About It, was published in August by Random House.

1. A couple of weeks ago, the pharaceutical firm Merck & Co. withdrew from the market its blockbuster arthritis and pain medication – Vioxx – which had been taken by more than 2 million people worldwide. A study indicated it doubled patients risk of heart attack and strokes. Is this move indicative of a larger problem?

ANGELL: I believe it is. We have known about a probable increased risk of heart attacks for about three years, but the company downplayed it, even while they exaggerated the marginal finding that the drug carried a lower risk of gastrointestinal side effects than over-the-counter arthritis drugs. That is to be expected, given the company’s obvious conflict of interest.

What’s less explicable is the U.S. Food and Drug Administration’s failure to mandate the larger, longer study that Merck eventually did. What needs to be done now is to conduct

similar studies of the cardiovascular effects of the other Cox-2 arthritis drugs: Celebrex and Bextra.

Given that these drugs offer nothing in terms of pain relief compared with over-the-counter drugs, the FDA should accept almost nothing in the way of serious side effects.

2. You write that drugs are the fastest-growing part of the U.S. health-care bill. Aren’t technological advances in medicine largely to blame for the rise in costs?

ANGELL: That is what the big drug companies would like us to believe. They imply that they are hard-pressed to cover their research and development costs. But R&D is a relatively small part of their budgets – less than half of what they spend on marketing and administration.

And after all their expenses, they have more left in profits than they spend on R&D.

In fact, until last year, the pharmaceutical industry was the most profitable in the United States for over two decades. (Last year, it fell slightly from first to third place.)

3. The pharmaceutical industry says that profits lead to reinvestment, reinvestment leads to research and research yields new medicine for patients. What’s your take on that scenario?

ANGELL: It isn’t true. Drug companies concentrate mainly on producing minor variations of top-selling drugs already on the market – called “me-too” drugs. Most of the R&D goes into clinical trials, the last stage of R&D. Innovative drugs are much fewer and stem from publicly funded research at university and government labs.

During the six years, 1998 through 2003, of the 487 drugs that came to market, 78 percent were classified by the FDA as unlikely to be improvements over drugs already sold, and 68 percent didn’t even contain new chemical compounds. It takes a lot of marketing to convince doctors and patients that one me-too drug is better than another at comparable doses, since companies rarely compare them head-to-head in clinical trials. That is why drug companies spend over twice as much on marketing and administration as on R&D.

4. A critic of your book said that the cost of medicine is much denounced, yet you don’t consider the value of medicine; that is, what’s it worth to you or a loved one not to suffer sickness and pain. How do you respond to this criticism?

ANGELL: The life of a loved one is infinitely precious, but that does not justify drug companies taking advantage of that dependency to charge exorbitant prices, particularly given their huge profits.

5. What’s the evidence that there is a pro-industry bias in academic drug research?

ANGELL: Much industry-sponsored clinical research is carried out at academic medical centers. Studies show that such research is more favorable toward the sponsors’ drugs than publicly funded research, and it is often biased in design – e.g., a clinical trial may compare a new drug with a placebo, when what doctors really want to know is how it compares with an old drug.

In addition, medical schools and teaching hospitals have also largely abdicated their responsibility to educate physicians, leaving that to drug companies. Doctors learn to practice a very drug-intensive style of medicine and to believe expensive new drugs are better than less expensive older ones, even when there is little evidence to support that belief.