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AUGUST 18, 2004


Drugmakers "Blackmail the Public"

Author Marica Angell says her research shows their huge influence over Congress, the FDA, and doctors is harming Americans

After she stepped down in June, 2000, as interim editor-in-chief of the New England Journal of Medicine (NEJM), Dr. Marcia Angell decided to write a book about biases in clinical trials. As she was doing her research and writing, she realized that "all roads led back to drug companies." Angell decided there was a bigger story to tell -- about the vast influence the pharmaceutical industry has over how medicine is practiced today.

During her 20-year career at NEJM, Angell had watched drugmakers expand their sway. They became the main sponsors of clinical testing and physician education and are also a critical source of funding for the Food & Drug Administration. "I finally decided just to bite the bullet and write about [the industry]." The result is The Truth about Drug Companies: How They Deceive Us and What to Do About It, which arrives in bookstores in late August.

The book provides a detailed account of the intimate interconnections between drug companies and every other player in the health field -- including medical journals, doctors, government agencies, Congress, universities -- and how such relationships harm the public. Dr. Angell recently spoke with BusinessWeek Online reporter Amy Tsao. Edited excerpts of their conversation follow:

Q: You give a very troubling account of the drug industry's practices. What, in your view, are the big truths that it doesn't want the public to understand?
I would say they're threefold. One, they spend relatively little on R&D -- less than they make in profits and far less than they spend on marketing and administration. What the industry does is essentially to blackmail the public. It says: "We're the source of your miracles, of your innovative drugs, and therefore don't mess with us."

The second truth is that they're not particularly innovative. Their major product is "me-too" drugs -- and even the innovative drugs that they do produce are almost always based on research that has been done at taxpayer expense [and] funded by the NIH [National Institutes of Health].

The third truth is that they have pretty much had their own way because of their control and influence over the institutions in society that really ought to be checking them. They have pretty much bought and paid for Congress. They have a lot of influence over the FDA through user fees they pay [to have their drugs reviewed by the agency], and they have way too much influence over doctors and the medical profession generally.

Q: You mentioned that in other countries drug companies can sell medication for a profit, [but] there are price controls. What's the difference between the profit margins in the U.S. vs. countries where there are price controls?
I don't know the answer to that. That's another way they're very secretive. We do know that they make a profit in other countries because they aren't charities. They don't give drugs away. But let's assume that they did.

Look at the year 2002 , when the profit margin for the 10 [drug] companies on the Fortune 500 list was 17% of sales, and sales in this country amounted to about half of their worldwide sales. You can calculate even if they made no profit whatsoever in the rest of the world, they would still come out with at least an 8.5% profit margin. And that would be higher than the median of the other Fortune 500 companies that year, which was 3.1%.

Q: What role should physicians play in curbing some of the industry's marketing influence?
I think my harshest criticism, perhaps, was not for the industry but for my fellow physicians and the medical profession. After all, the industry is in business to make money, but that isn't what doctors and medical schools should be doing. They don't have to be in bed with the drug companies. But they are.

Drug companies finance most of the continuing medical education of doctors, as well as meetings of professional societies. They lavish all manner of gifts on doctors in practice, including dinners in luxurious restaurants and trips (ostensibly for educational purposes) to exotic resorts. And they provide speakers and meals for interns and residents in teaching hospitals.

The profession should acknowledge that this is all a form of marketing, which adds to the prices of prescription drugs. Doctors should take responsibility for their own education and buy their own meals.

Q: What about medical journals? Are enough safeguards in place to make sure that the right research is published?
There are two issues in that question. One, is the research valid, and can we trust it? And I'm concerned that increasingly, we can't -- that the sponsors introduce all kinds of bias in the designs and analyses of the study and that some of the more interesting data are suppressed.

The second issue is whether journals are publishing the most medically and scientifically important research or whether they're publishing studies that are preferentially favorable to the industry. The answer depends a lot on the journal.

I don't think the big distinguished journals, the reputable journals, like the New England Journal of Medicine or the Journal of the American Medical Assn. are selecting papers to publish because they're favorable to sponsors. Not at all. [But] I think many journals are publishing papers that are favorable to the industry because they're totally dependent on the industry for advertising revenues.

Q: We're seeing many individuals -- even whole states -- buying drugs from abroad. What will be the impact of this?
I think the industry is going to use trade agreements to force other countries to let their prices rise. This is something that Mark McClellan, former FDA commissioner, talked about last year. Already, a recent trade agreement with Australia was designed to do that, and it gives the drug companies the right to prevent importing drugs from Australia. I think the intention is for other bilateral trade agreements do the same thing.

The real answer is to regulate prices here in some way, not to require them to go up [elsewhere].

Q: Is that a possibility?
Not as long as the pharmaceutical industry has the largest lobby in Washington and contributes so generously to political campaigns.

Q: What about legislative solutions?
The most important and most doable solution in many ways is to require that companies, to get FDA approval, have to compare [the new product] with older drugs already in the market, not just with placebos. The new drug should be shown to be superior in some way to existing treatments -- more effective, safer, or substantially more convenient. This would pull the rug out from the me-too industry.

Q: What about the recent talk of clinical-trial registries. Is that a solution?
All clinical trials should be registered in one central place. It should be a condition of enrolling human subjects. After all, human subjects don't sign onto clinical trials just for fun. They are hoping that this will yield knowledge. If that knowledge is suppressed, then they've been used in a misleading way.

Research must be registered, and it should be done so at the inception of the study. The reason for registering it at the beginning is that it doesn't allow companies to shift the goal post as the trial goes on.

Q: What can individuals do to fight back?
One recommendation is to be aware that this industry speaks through many voices, and whenever anyone makes a pronouncement about drug prices or anything else dealing with prescription drugs, people ought to ask themselves if there is a conflict of interest. Often there is.

Patients have to become much more skeptical about claims that drugs will cure whatever ails them. There's reason to believe that some new drugs are not nearly as good as they're claimed to be, that doctors believe the claims as much as their patients do, and we have to remember that almost any drug has a risk of side effects. This isn't to say that there aren't important drugs on the market. They can be very helpful and even lifesaving.

I'm not trying to say never take a drug -- but I'm saying that people should be reluctant to take drugs unless they're pretty sure that they're needed.

Edited by Thane Peterson

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