Friday, August 24, 2007

Epstein vs. Relman: A Debate to Overlook

All right, as the Old Testament might have put it, first Richard A. Epstein, a law professor at University of Chicago, begat a book called Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation (Yale University Press). That in turn begat a book review by former New England Journal of Medicine editor and frequent drug industry critic Arnold S. Relman (who also happens to be the husband of another NEJM former editor, Marcia Angell, author of The Truth About the Drug Companies). That begat a reply by Epstein, recently posted on

I have not read Epstein's book, and based on HOOKED you can presume that I would tend to disagree with most of what he says. Epstein also wrote a paper published last winter in Perspectives in Biology and Medicine on conflict of interest, and I disagreed with most of what he said in that paper. All of which is beside the point here, as the question is rather what one might learn from this exchange of views.

Alas, it is disappointing. Relman beats up on Epstein for two cardinal sins. First, Epstein is a frequent consultant for the drug industry and is also an economic disciple of Milton Friedman. Second, Epstein is a lawyer writing about health care matters. Both sins show that he is an idiot and that he cannot possibly therefore be correct about anything further.

Epstein replies in kind. Since Relman is a physician without any additional training, he clearly knows nothing about law, or economics, or corporations, so he's incompetent to pass judgment on any of these issues. And since Relman rejects Friedman, he must be an unreconstructed New Dealer (proof: he was born in 1923!) and is therefore completely unreliable on anything related to either economics or government.

Just how this pissing contest is supposed to enlighten the rest of us is never explained by either party.

Because Epstein assumes that Relman is an ignoramus, he proceeds to teach Relman (and the weary reader) a course in Econ 101 as he sees it. Industry must make a profit or else it will have to shut down. Regulation has costs as well as (purported) benefits. Advertising lets consumers know that there is a product out there that they might wish to consume. Drug companies spend a lot on research. Gee, thanks for all of these insights.

If we are going to keep score, I give the win to Relman. He accuses Epstein of being an unabashed apologist for the industry, citing all the arguments that support the industry position, selectively remaining silent on any point that is not in the industry's favor. Epstein, in his Econ 101 course, basically acts in such a way as to verify Relman's description of him. As my printout of his rebuttal runs 16 pages, single spaced, I can give only one example. Epstein says that as a consumer who has no special training in drugs, he naturally goes out and hires a professional--a physician--to advise him on medical matters. But in the next paragraph, he says that if he had a serious or terminal illness, he would not wish to wait for the randomized controlled trials to be finished. For such a person, he says, "the fetish over clinical trials is a death sentence." He goes on to praise the Abigail Alliance for demanding a legal right to access to any experimental drug that the patient and physician think might be life-saving.

Now, what Epstein never explains, and seems completely unaware of, is the contradiction between saying that he would hire a doctor to give him the good advice he needs on drugs, and depriving that same doctor of what is today considered the best possible evidence of what drugs work and for whom (that is, the randomized clinical trial). How is the doctor that he prudently hires supposed to get the information on which to base his advice--tea leaves?

Fortunately this is not about keeping score. It is about figuring out these thorny policy issues, and we cannot do so if we have a cardboard caricature of free-market worship on one side, and a cardboard caricature of anti-free-market attack on the other.

Instead, read two different books. First read Medicine and the Market by Callahan and Wasunna. You will find a careful analysis of both the ethics and the facts related to markets as a means of organizing medical care. Among other things you will read that in most of the civilized world, it is simply a given that we need both private markets and government regulation, and that regulation helps markets run well by leveling the playing field. Only in the U.S. do we find the ideological fervor that insists that we worship at the altar of the "pure" free market and the government be damned.

Next, read Leonard Weber's Profits Before People? Weber (an esteemed colleague of mine, who taught at University of Detroit-Mercy) has taught and written about business ethics in health care. His book on the pharmaceutical industry could be viewed as an ethics consultation, as if the industry had noted its poor PR lately and asked Weber for his ethical advice. Weber tries to give them the advice that he thinks a good business ethicist would. And his advice is markedly different from the Milton Friedman school. In fact, Weber ends up saying just about the same bad things about the drug industry as do its more strident critics like Angell (and me for that matter). I'd like to hear Epstein explain how it is that Weber knows nothing about corporations and markets and the realities of business.

Relman AJ. To lose trust, every day. The New Republic, July 23, 2007: 36.

Epstein RA. Cambridge v. Chicago: an answer to0 Dr. Arnold Relman's New Republic review of Overdose. August 22, 2007;

Callahan D. Wasunna AA. Medicine and the Market: Equity v. Choice. Baltimore: Johns Hopkins University Press, 2006.

Weber LJ. Profits Before People? Ethical Standards and the Marketing of Prescription Drugs. Bloomington, IN: University of Indiana Press, 2006.


Anonymous said...

You wrote --
"Now, what Epstein never explains, and seems completely unaware of, is the contradiction between saying that he would hire a doctor to give him the good advice he needs on drugs, and depriving that same doctor of what is today considered the best possible evidence of what drugs work and for whom (that is, the randomized clinical trial). How is the doctor that he prudently hires supposed to get the information on which to base his advice--tea leaves?"

I don't see the contradiction. Epstein is saying: 1. Under normal circumstance he would seek the counsel of a well trained physician, but 2. If he were terminal and no randomized control studies were yet available, he would not want to be deprived of access to experimental medications. How is that "depriving the doctor" of information?

Greg Scandlen
Consumers for Health Care Choices

Howard Brody said...

Mr. Scandlen's comment is quite reasonable. On its face, the position attributed to Epstein is a sensible one. In fact, which of us would not want such options for ourselves?

My problem was making several assumptions without taking the time to list all of them in the original post. Here are some:

1) If you read the entire Epstein commentary, he does not appear to be dismissing the value of clinical trials only for terminally ill patients. He says that clinical trials are a major burden for the drug industry because they cost so much and take so long. He says that the industry would be better able to produce new miracle drugs if they were not burdened by the FDA with having to do these trials. So I say--and just how, then, are we supposed to know with any confidence that these are "miracle" drugs?

2) Both Epstein and the Abigail Alliance people appear to have a vastly inflated view of what "experimental medicines" really can accomplish for MOST terminally ill patients. The medicines that are at the early stages of trials are, in fact, unproven, and are every bit as likely to hasten death as to promote a cure. Plus, even if one of these new medicines is a miracle breakthrough, most people, by the time they are declared to be "terminal," are beyond the stage at which even the best medicine could help. If we weigh what the vast majority of teminal patients give up by the present trial system on one hand, against what the present trial system contributes to medical knowledge on the other, it's no contest. (Which is not to say that occasional compassionate exceptions ought not be made and that the system for making such exceptions should not be re-examined.)

3)In HOOKED, I suggest that we reform the trials system so that the questions of real concern to physicians and patients can be better studied. A critical part of the reform I call for is taking control over the conduct of trials away from the companies and placing it in the hands of a neutral scientific agency such as a new NIH institute. Companies would then have to pay a tax to fund the trials that the new agency believes are scientifically necessary, but that no company today wants to fund (such as would be needed to find cures for rare sorts of cancer, and other "orphan" diseases). I have to assume that Epstein would be even more against this proposed reform than he is opposed to the current system since it would create a bigger government apparatus and further tax the industry (or the general public, or both).

I hope this explains my original intent a bit better.

Thanks, Howard Brody