July 26, 2004

NEJM -- "I read every word of this book"

The New England Journal of Medicine this week gave "The $800 Million Pill" its best review to date. Others have been more effusive in their praise (thank you Shannon Brownlee in the Washington Monthly). But the NEJM is the voice of authority in the drug development field, so its kind words are welcome news indeed.

The editors sent me an advanced copy several weeks ago. It's not a common practice, but we had been in touch because I was about to criticize them (in my role as director of the Integrity in Science project at the Center for Science in the Public Interest) for failing to report the conflicts of interest of some of the authors who had recently published primary research papers in their pages. Notwithstanding my boorish behavior, they still published the review.

The editors engaged an M.D. who is also a Ph.D. economist -- Allan Detsky of the University of Toronto -- to review the book. Like most in his field, he quarreled with the anecdote-driven methdology that I -- a mere journalist -- used. But when he turned to my major arguments, he had to admit that I made "a persuasive case." But best of all, he praised my writing! Hey, call me whatever you want. But if you say my writing engaged you, you've got a friend for life.

Here's the final sentences of the review:

"Although the approach Goozner uses in this book is not scientific, I think he makes a persuasive case. The passion of individual scientists pursuing an activity they truly enjoy, not the profit motive, has led to the major technological advances of the past century.

"I will end by saying that I am not one who enjoys reading books slowly. I often skim. In order to read a book from cover to cover, I have to find it truly interesting. I can tell you that I read every word of this book."

For a complete copy of the review, click here:

Volume 351:405 July 22, 2004 Number 4

The $800 Million Pill: The Truth Behind the Cost of New Drugs

By Merrill Goozner. 297 pp. Berkeley, University of California Press, 2004. $24.95. ISBN 0-520-23945-8.

The pharmaceutical industry claims that it can continue playing a key role in the development of new weapons against disease only if Americans pay prices for medicines that yield very high profits. It also claims that price controls would cause the stream of new products to dry up. Merrill Goozner, a former chief economics correspondent at the Chicago Tribune, comes to a conclusion that is very different from the views espoused by the drug companies. He does so on the basis of a detailed review of the development of drugs to combat cancer and the human immunodeficiency virus, a description of the early successes of therapies developed by the biotechnology industry, and a review of the economics of "me-too" products, such as H2 antagonists, proton-pump inhibitors, and allergy medications. He believes that the private sector's main role is to develop and commercialize therapies that are based on knowledge generated by independent researchers in academia and in government. In his opinion, high prices and big profits are not the key ingredients in pharmaceutical breakthroughs.

On one hand, this book gives the reader lots of interesting and useful background about the people and organizations involved in expanding medical knowledge and in developing drugs. On the other hand, it falls short of what I expected from the title. It is not a detailed forensic accounting of the true cost of developing individual drugs as compared with industry claims. Indeed, the only real discussion of the $800 million pill (the alleged average cost of developing a new drug in the United States) comes in a brief review of a study by the Tufts University Center for the Study of Drug Development that was first published in 1991 and then updated in 2001. There is a brief rebuttal from other organizations in the penultimate chapter of the book, but for a reader looking for definitive "proof" or data, this book falls short. Written in the typical style of investigative journalism, the book comes across as an author's attempt to prove a point, rather than an impartial scientist's effort to answer a question.

Goozner repeatedly comes back to one central theme: that medical innovations start with dedicated and passionate people, most of whom are not employed by the pharmaceutical industry, who are investigating scientific questions. Without these dedicated scientists, none of the innovations described in this book would have occurred. In other words, the development of drugs is not exclusively driven by high profits but, rather, is a collection of efforts. Goozner goes on to suggest some very useful methods for improving the process of drug development with the support of government-funded research (e.g., randomized trials comparing new and existing products, such as the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial, known as ALLHAT). Although the approach Goozner uses in this book is not scientific, I think he makes a persuasive case. The passion of individual scientists pursuing an activity they truly enjoy, not the profit motive, has led to the major technological advances of the past century.

I will end by saying that I am not one who enjoys reading books slowly. I often skim. In order to read a book from cover to cover, I have to find it truly interesting. I can tell you that I read every word of this book.


Allan S. Detsky, M.D., Ph.D.
University of Toronto

Posted by gooznews at July 26, 2004 06:14 PM