The $800 Million Pill: The Truth behind the Cost of New Drugs (Hardcover)

by Merrill Goozner (Author) "Eugene Goldwasser retired in 2002 after a forty-seven-year career as a biochemistry professor at the University of Chicago..." (more)
Key Phrases: recombinant manufacturing, protease inhibitor program, protease inhibitor candidate, United States, New York, Burroughs Wellcome (more...)

Editorial Reviews

From Publishers Weekly
In this fascinating critical look at drug and biotech companies, Goozner pulls back the curtain on the process of new drug development and answers two important questions: "where do new drugs come from?" and "what do they cost to invent?" Using case studies that recount the discovery, development and eventual commercialization of a number of significant drugs, including Epogen and the AIDS cocktail, Goozner dismantles the pharmaceutical industry’s assertion that drug prices must be kept high in order to stimulate cutting edge research. The cost of each new discovery averages $800 million, industry officials have claimed. But Goozner argues that citizens are already paying much of that bill: taxpayer-financed medical research, he finds, has played a major role in each important medical discovery. Goozner convincingly argues that new drugs get into the hands of the sick not thanks to drug and biotech companies, but to the passion of dedicated scientists—in both the private sector and the public. A former Chief Economics Correspondent for the Chicago Tribune and an award-winning journalist, Goozer writes with skill and elegance, incorporating anecdote and history in a way that enlivens his research and makes his book an engrossing read. Though the issue of drug costs has been discussed extensively in the media, Goozer’s study puts all the political chatter, news coverage and analysts’ reports into a context where they finally make sense.
Copyright © Reed Business Information, a division of Reed Elsevier Inc. All rights reserved.

From The New England Journal of Medicine
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 H(sub 2) 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.
Copyright © 2004 Massachusetts Medical Society. All rights reserved. The New England Journal of Medicine is a registered trademark of the MMS.

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Product Details

• Hardcover: 297 pages
• Publisher: University of California Press; 1 edition (April 22, 2004)
• Language: English
• ISBN-10: 0520239458
• ISBN-13: 978-0520239456
• Product Dimensions: 9 x 6.1 x 1.2 inches
• Shipping Weight: 1.2 pounds (View shipping rates and policies)
• Average Customer Review: 3.9 out of 5 stars See all reviews (13 customer reviews)
• Amazon.com Sales Rank: #594,482 in Books (See Bestsellers in Books)

Customer Reviews

Most Helpful Customer Reviews

48 of 52 people found the following review helpful:

4.0 out of 5 stars Masterful expose, but some blind spots., November 2, 2004

By	Joel M. Kauffman (Berwyn, PA United States) - See all my reviews (REAL NAME)

A masterful work on the exaggerations by Big Pharma on the cost of developing new prescription drugs. Tells detailed stories of the development of erythropoietin (Epo), Ceredase, Replagal, AZT and triple cocktail for AIDS, Cisplatin, Taxol, Erbitux, sulfanilamide, Tagamet, Zantac, Prilosec, Nexium and others. The stories are easy to understand and back up Goozner's contention that most real breakthroughs in drug development are the result of long years of work by academics or in government labs (NIH), and occcasionally by biotech firms, usually not by the Big Pharma companies.

Goozner confirms others in noting that about 4/5ths of "new" drugs, while being new molecules, are similar to others on the market. This consumes most of Big Pharma's research and sales dollars. He shows that simply purifying a drug to sell one of two isomers (left-handed, say, not mixed left- and right-handed) will get a new drug approval from the FDA (Nexium vs. Prilosec, I think). Sometimes this is valuable for patients, but not always. In ibuprofen it does not matter.

Goozner carefully works out the cost of a typical new drug launch at $100 to $200 million, a lot, but not $800. Many details are explained, such as orphan drugs, and access for compassionate use. Some of the perversions of drug trials are exposed, such as failure to compare a new drug with the best previous one. The limitations of newer NSAIDS (Celebrex, Vioxx) and many anticancer drugs are brought out.

This book has good good academic referencing and a good index. So why only 4 stars? The layout, some of the chemistry and some of the pharmacology.

Each paragraph is a gem of understandable prose. From p229: "As the twenty-first century dawned, the drug industry's search for new drugs to replace old ones coming off patent became frenzied. There were fifty-two drugs with more than $1 billion in sales in 2000, but forty-two were slated to lose their patent protection by 2007. The drugs that account for fully half the industry's sales were on the cusp of low-cost, generic competition. But instead of looking for truly innovative medicines, which are dependent on the maturation of biological understanding and even then are difficult to find, an increasing share of the industry's research and development budgets turned to the search replacement ["me-too"] drugs..." However, I found it hard to read this book for more than 20-40 mintues at a time. There are no tables, graphs, photos, section headings or sub-section headings; it is one continuous mass of text except for chapter headings, most of which are cute, but do not explain what is on the chapter.
Occasionally people are mentioned with no context (Kessler, p145).

Chemically, the most serious error was confusing positional isomers on a benzene ring with left- and right-handed forms of a drug, which depend on the positions of 4 different substituents on a carbon atom (p221). These are called "optical isomers". Only exact mirror image compounds are called enantiomers.

Pharmacologically, Goozner was not aware of the misleading effects of lead time bias (earlier detection on 5-year survival rates in cancer. He overstated the benefits and understated the risks of cisplatin and Taxol, not looking for all-cause death rates. Conversely, he took at face value the claims for anticholesterol and blood pressure drugs, which have very few benefits long-term. He missed that the ALLHAT trial of blood pressure drugs had no placebo (p248), so based on earlier trials that did, no standard drug treatment for moderately high blood pressures is worthwhile. See: Joel M. Kauffman, Bias in Recent Papers on Diets and Drugs in Peer-Reviewed Medical Journals, J. Am. Physicians & Surgeons, 9(1), 11-14 (2004).

Still, this book is a valuable reference to have.

15 of 21 people found the following review helpful:

5.0 out of 5 stars Definitely worth reading, April 29, 2004

By A Customer

I found this book fascinating, informative and thought-provoking. It examines how the current system for bringing new drugs to market works, what the short-comings of this system are, and how it could be improved to get more benefit from the money that tax-payers and users of health services (whether by paying directly for drugs or through insurance premiums)contribute.

Although this could have become a really dry exercise in economics or a political tirade agains drug companies, instead it contains a series of stories which track the development of some of the major "breakthrough" drugs in recent history. We are introduced to people who dedicated their lives to finding a cure for a single disease and read about the many set-backs and struggles that they had to go through to achieve this goal. The medical information that is explained in the course of these stories was, for me, one of the most interesting aspects of the book

0 of 1 people found the following review helpful:

4.0 out of 5 stars thoroughly researched, November 29, 2007

By	Paul J. Fitzgerald "author" - See all my reviews (REAL NAME)

This review is from: The $800 Million Pill: The Truth behind the Cost of New Drugs (Paperback)

This book is filled with detailed information on drug companies, development and marketing of drugs, federal regulation of drug companies, academic drug research, and some of the interesting characters involved in all of this. It comes across as slightly against big pharma, but not overly so. It may be a touch dry, with a touch more emphasis on the bureaucratic aspects of the drug development process, but definitely worth a read if you're interested in why prescription drugs cost so much in America and where this is all leading. Author of Adjust Your Brain: A Practical Theory for Maximizing Mental Health.