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United Kingdom: Cambridge University Press, 2001
Review by Kip Sullivan
The book is about how Bristol-Myers Squibb ripped off U.S. taxpayers and U.S. cancer patients and their insurers.
Since at least 1959, when Sen. Estes Kefauver opened his investigation into the high price of prescription drugs, the pharmaceutical industry has vigorously promoted the myth that drug research depends on high drug prices. The industry's effort to promote this myth went into overdrive in 1993 after President Bill Clinton called drug prices “shocking” and implied he might endorse drug price controls. In 1994, the industry even changed the name of its trade group from the Pharmaceutical Manufacturers Association to the grammatically tortured Pharmaceutical Research and Manufacturers of America.
The myth that drug research will dry up if drug companies do not charge high prices rests on two premises. The first is that the process of discovering a new drug is a hit-and-miss process. As drug industry apologists like to put it, drug researchers “drill” many “empty holes” before finding “oil.” The second premise is that most research leading to the discovery of new drugs is financed by the drug industry. The first premise is true, the second is not.
The discovery process—the process by which a particular “molecular entity” is determined to have a particular effect on human beings—is indeed hit and miss. But the bulk of this research, often called “basic” research, is financed by government agencies, notably the National Institutes of Health (NIH), not the drug industry. Of the tens of billions of dollars the drug industry claims to spend each year on research, most is spent on “me too” drugs and testing the safety and efficacy of molecular entities already discovered by tax-financed scientists. According to a study prepared by the NIH and obtained by Public Citizen under the Freedom of Information Act, basic research accounts for only 14 percent of all drug industry research and development expenditures.
Jordan Goodman and Vivien Walsh illustrate these truths—the trial-and-error nature of the drug discovery process and the dominant role of the NIH in that process—in The Story of Taxol. Taxol, a drug used to treat breast and ovarian cancer, is sold, hand over fist, by Bristol-Myers Squibb, the third-largest drug manufacturer in the U.S. and the fourth-largest drug manufacturer in the world. Goodman and Walsh offer a fascinating history of the work done by the National Cancer Institute (NCI), one of the institutes that make up the NIH, to determine that Taxol could shrink tumors. They also describe NCI's decision to hand Taxol over to Bristol-Myers on a silver platter. Taxol, originally derived from the Pacific Yew tree (Taxus brevifolia), was discovered by researchers working for a plant- screening program operated by the NCI. Between 1960 when the program began and 1981 when it was ended, the program tested the anti-carcinogenic effect of 114,000 plant extracts taken from approximately 15,000 species of plants collected from around the world. The plant-screening program greatly enhanced the world's knowledge of botany, but it produced only one drug-research success story—Taxol. Of the estimated 15,000 species tested, only Taxol received FDA approval. One drug on the market per 114,000 extracts tested amounts to a heckuva lot of dry holes per gusher.
In 1962, an NCI agent and three graduate students randomly collecting samples of plants in the Pacific Northwest encountered the yew tree in the Gifford Pinchot National Forest. They stuffed samples of its bark and needles into bags and shipped them back to the NCI for analysis. In 1966, NCI-financed scientists determined that an extract from the bark slowed tumor growth in mice; in 1967, the scientists named the compound “Taxol” (“tax” for Taxus and “ol” because the molecule contained the basic components of alcohol); and in 1970 they discovered Taxol's molecular structure. Still no sign of Bristol-Myers in this history of Taxol.
Over the next decade, NCI researchers wrestled with a host of problems, the most intractable of which was the enormous amount of yew bark needed to provide Taxol in sufficient quantities to sustain research on patients. Each yew tree produced about four pounds of bark, and by 1980 the NCI was issuing bids for 10,000-pound shipments of bark. By 1984, when the first small trials on humans began at Sloan- Kettering Cancer Center and six research centers affiliated with universities, NCI was asking loggers in the Northwest to bid on contracts for even larger quantities of bark. By 1987, researchers at Johns Hopkins were reporting that Taxol had a curative effect in some ovarian cancer patients. This announcement triggered a rapid increase in the demand for Taxol. The NCI was now convinced that the supply of yew trees was so limited that it would never be able to meet the demand if the drug were to win FDA approval. In 1988, worried about the supply problem and about the strain on its budget created by the burgeoning Taxol clinical trials and the growing costs of producing Taxol for the trials, the NCI began making grants to researchers to determine how to synthesize Taxol (that is, to create it from artificial sources). Nineteen eighty-eight was also the year, according to a source cited by Goodman and Walsh, that NCI began “putting out feelers” to the drug industry looking for a “partner” to take over the production of Taxol.
On August 1, 1989, the NCI announced in the pages of the Federal Register that it was looking for a private-sector partner to bring “taxol to a marketable status to meet the needs of the public and with the best terms for the Government.” (Note the small “t” in “taxol” in the Federal Register announcement. It wasn't until 1992 when Bristol-Myers' application to trademark taxol was approved that Taxol had to be spelled with a capital “T”). Inexplicably, the version published in the Federal Register did not contain a sentence that had been in the draft version, which had stated that the “United States Government will receive a reasonable share of income once the drug is marketed for general use.” In December 1989, almost two decades after NCI's agent first collected bark from the Pacific Yew tree, NCI announced that Bristol-Myers Squibb would get the contract. In January 1991, the NCI signed the agreement with Bristol-Myers.
The deal the NCI struck with Bristol-Myers raises two questions: Why Bristol-Myers? Why did the NCI fail to extract from Bristol-Myers a promise to return some of the profit from the sale of Taxol to the taxpayers who had financed three decades of research on Taxol? Goodman and Walsh make a reasonable effort to answer the first question; they make no effort to answer the second. They discuss the possibility that Robert Wittes, an NCI employee from 1983 to 1988, was the link between the NCI and Bristol-Myers who cemented the NCI agreement with Bristol-Myers. Wittes became a vice president at Bristol-Myers in November 1988 just as the discussions about finding a partner for NCI were beginning. He became an NCI employee again in August 1990. But, NCI denied any wrongdoing by Wittes. The authors conclude, “[T]he reasons why Bristol-Myers Squibb emer- ged as the successful contender remains hidden from public view.”
My chief criticism of the book is the authors' failure to give the reader any idea of just how badly Taxol patients are being ripped off by Bristol-Myers. For that information, one must turn to Jamie Love of Public Citizen. In an appearance before the U.S. Senate in October 1997, Love testified that Bristol-Myers' main contributions to the development of Taxol were “to provide NCI with 17 kilo's of Taxol for use in government-sponsored clinical trials, and to investigate methods for harvesting and manufacturing Taxol. The amount of money actually spent by BMS on Taxol prior to FDA marketing approval was very modest.” And yet Bristol-Myers is charging obscene prices to cancer patients. According to Love, industry experts say Bristol-Myers pays about 40 cents to manufacture a milligram of Taxol, but Bristol-Myers says it charges $4.87 per milligram to drug wholesalers. No wonder the U.S. drug industry was ranked first in Fortune magazine's list of the nation's most profitable industries for each of the last 20 years.
Instead of exploring the dimensions of the consumer rip-off and the NIH's disinterest in stopping it, Goodman and Walsh devote their last chapter to an uninteresting description of the everyday tactics environmental groups used to stop the extinction of the Pacific Yew tree and to a discussion of how environmental groups and yew tree loggers responded to the termination of the bark-collection program in 1993 when Bristol-Myers began using a synthetic process for manufacturing Taxol. Predictably, environmental groups fought excessive logging of the tree by holding meetings, appealing to the public, and lobbying Congress. Predictably, the loggers and the environmental groups had to find something else to do when the threat to the yew tree disappeared.
The opening and closing chapters of this book badly needed a good editor. These chapters are full of obvious statements (“events were shaped by the big players”) and painfully abstract sentences that say nothing (“The substance of the meeting might best be described as a continuation of past efforts but with an increasing presence”). But the authors deserve credit for writing a very useful and exhaustively researched book. It should be read by anyone who wants to understand how the drug industry has gotten away with extortion for so long. Z