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

CSPAN Booknotes appearance

Can't sleep? Turn on CSPAN-2 for its Booknotes program at 5 a.m. on Sunday (EST) and see my appearance at The New America Foundation.

After a brief vacation, regular postings to this site will begin appearing again next week.

Next DC appearance

For those of you living in the Washington, DC area, I'll be appearing at a forum hosted by the New America Foundation on Thursday, July 8 at 12:15 p.m. Talk title: THE $800 MILLION PILL: WHAT DRIVES THE COST OF PRESCRIPTION DRUGS?

NAF is located at 1630 Connecticut Ave. (DuPont circle area) on the 7th floor. If you want to attend, send an r.s.v.p. to buntman@newamerica.net. Come on by!

And now for the good reviews . . .

The Copley News Service this week sent out a review of "The $800 Million Pill" to newspapers in the chain. Hopefully, some will run it in their weekend editions.

Click on to read the review:

Biotech and Big Pharma executives challenged about the high price of prescription drugs repeatedly defend themselves and their companies by citing the high cost of research and development. It costs about $800 million and takes a decade to bring a new drug to market, an industry-funded report from Tufts University found. The industry uses these findings like a shield to deflect criticism from consumers and the insurance lobby. In "The $800 Million Pill," Merrill Goozner, a former chief economics reporter for the Chicago Tribune, crushes the study and the executives' arguments like a tablet in a mortar and pestle.

Using his own analysis as well as public records, independent studies and even industry insiders, he shows that the cost is more likely in the range of $71 million to $250 million. The advertising campaigns for these new drugs, often hyping new versions of treatments already on the market, add millions to the cost of drugs while bringing nothing to the consumer, Goozner says.

"If the industry-funded academic economists at Tufts had factored out the half of industry research that is more properly categorized as corporate waste, their number would have been similar to that of the Global Alliance," a nonprofit that commissioned a team of former drug company executives to build their own model of what it costs to develop a new tuberculosis drug. The estimate: between $115 million to $240 million.

Many a businessman may scoff at Goozner's strident assertions. Ours is a capitalist society and drug companies, like any big business, must navigate competition and regulation while worrying about shareholders and the bottom line. But his book offers an eye-opening tour of the labyrinth that is drug discovery at a crucial time, for consumers traumatized by the wallop they receive with every trip to the pharmacy counter.

Goozner takes his readers into government and private industry labs and offers insights into the decisions made in corporate boardrooms. His heroes are the researchers who toil at the bench, sometimes for decades, driven more by the prospect of scientific breakthrough than the monetary reward of commercializing their discovery.

Eugene Goldwasser spent more than 20 years pursuing a single hormone that stimulates red blood cell production, a crucial discovery for anemia. The discovery paved the way for Amgen to become a biotech success story. It also set off a patent war that serves as an example of how drug prices can often reflect much more than the cost of research and development.

The villains in this tale are the corporate executives. They fund clinical trials simply to help sell yet another blood pressure control medicine, but don't want to spend resources on a long-shot treatment for HIV.

A government lab or researcher funded through taxpayer-supported grants can search for years before finding a molecule that effectively treats disease. Drug companies then sweep in, license the molecule and begin taking credit for all of the work and resources that went into its discovery.

In the end consumers bear the burden of research and development. And they are being double-billed: First, their taxes fund the government research grants, and, later, at the pharmacy, they pay again.

It's unlikely price controls will win Congressional support, Goozner said. He proposes that Congress create an independent institute on clinical practice within the National Institutes of Health, letting it conduct clinical trials that compare existing medicines. It would generate best-practice guidelines for physicians and help Medicare determine which drugs offer too little benefit for too high a price.

He suggests Congress address patent laws that impede research and drive up costs by allowing people to stake claim to products of nature. And he proposes the Food and Drug Administration's approval process for new drugs require new products to be measured against other therapies where they exist.

"Unless the government helps the pharmaceutical industry by reforming its drug approval process in a manner that fosters innovation," Goozner concludes, "the prognosis for the industry is grim."

- Terri Somers.