The Truth About the Drug Companies: How They Deceive Us, and What to Do About It
- Book Review,
by Marcia Angell
Amazon.com
Many Americans have wondered why prescription drugs have become so expensive while advertising for those drugs seems to grow exponentially. Former New England Journal of Medicine Editor Marcia Angell has some answers. The pharmaceutical industry, according to Angell, is fraught with corruption and doing a disservice to customers, the federal government, and to the medical establishment itself. In The Truth About the Drug Companies, Angell explains how a huge portion of the revenue generated by "Big Pharma" goes not into research and development but into aggressive marketing campaigns to sell their product. She describes how, even though the drug companies claim that it costs them an average of 802 million dollars per drug to develop new medicines, that figure is obscenely inflated since it factors in marketing as well as expected interest the company would have received had they invested the money in the open market. Meanwhile, Angell says, most of the R & D work is done by colleges and universities funded by the government. There are also problems with the drugs themselves, Angell indicates, since a majority are "me-too drugs", slightly modified versions of existing products which meant to address concerns of consumers most likely to spend money on pharmaceuticals. Thus, the market is filled with remarkably similar drugs to treat depression and high cholesterol while potentially life-saving medicines for diseases afflicting third-world countries are discontinued because they aren't profitable. In the books most damning passage, Angell tells of the high-priced junkets offered to doctors, ostensibly offered as educational opportunities that seem to constitute little more than bribes. The prognosis for reform is a grim one, Angell indicates, due to the massive cash reserves and lobbying efforts of "Big Pharma." Indeed, that lobby was hard at work trying to discredit her claims immediately upon the book's publication. But for anyone who's paid a pharmacy bill, The Truth About the Drug Companies is a fascinating read. --John Moe
From Publishers Weekly
In what should serve as the Fast Food Nation of the drug industry, Angell, former editor of the prestigious New England Journal of Medicine, presents a searing indictment of "big pharma" as corrupt and corrupting: of Congress, through huge campaign contributions; of the FDA, which is funded in part by the very companies it oversees; and, perhaps most shocking, of members of the medical profession and its institutions. Angell delineates how the drug giants, such as Pfizer and AstraZeneca, pay physicians to prescribe their products with gifts, junkets and marketing programs disguised as "professional education." According to Angell, the cost of marketing, both to physicians and consumers, far outweighs expenditures on research and development, though drug makers invoke R&D as the reason drug prices are so high. In fact, says Angell, with combined 2002 profits of $35.9 billion for the Fortune 500's top 10 drug companies, the drug industry is America's most profitable by far, thanks to disproportionately high prices, generous tax breaks and manipulation of patents to extend exclusive marketing rights to blockbuster drugs like Prozac and Claritin. Angell mounts a powerful case (and offers specific suggestions) for reform of this essential industry—a case worth bearing in mind as "big pharma" continues to oppose importing cheaper drugs from Canada. Copyright © Reed Business Information, a division of Reed Elsevier Inc. All rights reserved.
From the New England Journal of Medicine, October 7, 2004
In this book, her most recent, Marcia Angell explores pharmaceutical research, deplores the rapidly expanding involvement (and distortion of truth) of Big Pharma, and implores us all (physicians, patients, politicians) to do something about it. The dust-jacket blurb asserts that Angell, "during her two decades at [the Journal] had a front-row seat on the growing corruption of the pharmaceutical industry." Perhaps, but since leaving the Journal, she's gone behind the curtains of Big Pharma, Big University, and Big Faculty. Drawing on her own work and on her thoughtful analysis of research, company financial statements, and investigative reports into drug development and marketing, Angell writes with the unambiguous and unyielding style that Journal readers came to expect and trust. By Angell's account, the current slide toward the commercialization and corruption of clinical research coincided with the election of President Ronald Reagan in 1980 and the passage of the Bayh-Dole Act, a new set of laws that permitted and encouraged universities and small businesses to patent discoveries from research sponsored by the National Institutes of Health (NIH). Research paid for by the public to serve the public instantly became a private, and salable, good, one that is producing drug sales of more than $200 billion a year. Commercialization had both specific and broad effects. Readers of this journal and others are familiar with investigations into the control that research sponsors at pharmaceutical companies exert on the design and analysis of clinical trials (including the distortion of primary outcome measures in trials) and the issue of reporting, nonreporting, and biased reporting of results. Angell reminds us of the increasingly cozy relationships between big industry and the faculties of universities. Not only are narcissistic donors renaming the medical schools; they are buying access to the best minds of their faculties. Angell's examples of the large consulting fees paid by industry to individual faculty members and to NIH scientists and directors are astounding. The broader effects are felt in the commercialization of universities, medical faculties, and our profession. In 2000, in a letter written in response to Angell's Journal editorial, "Is Academic Medicine for Sale?" a reader supplied the answer: "No. The current owner is very happy with it." The increasing intrusion of industry into medical education and the almost complete domination of continuing medical education (especially regarding drugs) by the marketing departments of large pharmaceutical companies are a scandal. The same companies also spend heavily to lobby governments. According to Angell, Pharmaceutical Research and Manufacturers of America, the pharmaceutical industry's U.S. trade association, has "the largest lobby in Washington," which in 2002 employed 675 lobbyists (including 26 former members of Congress) at a cost of more than $91 million. The result has been above-average growth in corporate profits during both Republican and Democratic administrations. The most recent and (at least to observers outside the United States) perplexing lobbying effort caused Congress explicitly to prohibit Medicare from using its huge purchasing power to get lower prices for drugs, thus opening up a dollar pipeline, in the form of higher drug prices, directly from taxpayers to corporate coffers. These changes, along with the cave-in by the Food and Drug Administration (FDA) in 1997 that permitted direct-to-consumer advertising to bypass mention in their ads of all but the most serious side effects, have further augmented profits. The overall effect has been a corruption not only of science but also of the dissemination of science. Angell documents that, contrary to what they claim, large pharmaceutical companies have "paltry output" in innovative research. In fact, as permitted by Bayh-Dole, pharmaceutical companies buy discoveries coming out of the basic-science enterprises, including universities and publicly funded granting agencies. The real costs of research on drugs by pharmaceutical companies are much less than the oft-quoted $800 million or so per new drug brought to market. Most of their research is on me-too drugs -- unoriginal, tax-deductible (and thus paid for in lost taxes by the public), and mostly unnecessary, except for corporate profits and executive bonuses. The Big Pharma companies are, in essence, manufacturing and marketing companies. Angell's concluding chapter, the least convincing one in an otherwise fascinating and penetrating book, contains the solutions, all of them predictable (and probably unattainable): control me-too drugs, re-empower the FDA, oversee Big Pharma's clinical research, curb patent length and abuse, keep Big Pharma out of medical education, make company financial statements transparent (so we can tell what the costs of research really are, as distinct from marketing), and impose price controls or guidelines. Granted, the problems are so prevalent and the corporate tentacles so entwined with our way of being that it is hard to see what else to recommend. But perhaps Angell is right. We must change the way we manage research and the development and distribution of new drugs. Not only are health and health care at risk, but so are the research enterprise and the reputations of universities and governments. The integrity of scientific research is too important to be left to the invisible hand of the marketplace. John Hoey, M.D.Copyright © 2004 Massachusetts Medical Society. All rights reserved. The New England Journal of Medicine is a registered trademark of the MMS.
From Bookmarks Magazine
Big Pharma “is taking us for a ride,” Angell contends. “And there will be no real reform without an aroused and determined public to make it happen.” This expose may arouse readers, but will it help the larger cause? Critics agree that Angell’s passionate, well-researched indictment of the industry’s practice raises important questions. The lack of new insight doesn’t diminish its power, but some critics who applaud Angell’s suggested reforms also see them as unrealistic. Only Dr. Miller of The Wall Street Journal—a former FDA official—condemns Angell for playing down the drug companies’ R&D investment, ignoring the FDA’s high bar of approval, and overemphasizing the industry’s involvement in politics. There might be gray areas, but general consensus is, “the author clearly points the way.” It’s just a question if anyone will “heed the warning” (Rocky Mountain News). Copyright © 2004 Phillips & Nelson Media, Inc.
From Booklist
Angell, former editor in chief of the prestigious New England Journal of Medicine, pulls no punches in her criticism of the big pharmaceautical companies. She profiles big "pharma" as one of the most bloated, secretive, self-serving industries--one that uses government payoffs, lures, bribes, and kickbacks to maintain its practice of grossly overcharging the public for products that are increasingly less than innovative. Under the current situation, the main pipeline of new products are mostly "me-too" drugs-- drugs very similar to successful ones already on the market yet patentable as new entities so that the companies can continue to charge premium prices for existing treatments as the older drugs move to generic status. The problem is that these new drugs may be less safe and effective than the older ones, since to get approval, drug companies only have to show that they work, not that they are better than an existing drug. Fortunately the public is angry about the current situation and is beginning to demand reform, to which Angell provides a sensible, enlightened approach. David Siegfried
Copyright © American Library Association. All rights reserved
Review
“Dr. Angell’s case is tough, persuasive, and troubling.”
—The New York Times
“In what should serve as the Fast Food Nation of the drug industry, Angell… presents a searing indictment of ‘big pharma’ as corrupt and corrupting.”
—Publishers Weekly
“The Truth About the Drug Companies is a sober, clear-eyed attack on the excesses of drug company power… a lucid, persuasive, and highly important book.”
—The Boston Sunday Globe
“Her prose is clear and readable… Angell does an excellent job [making] a convincing case against Big Pharma.”
—Chicago Sun-Times
“If you’ve ever suffered prescription drug sticker shock, Dr. Marcia Angell’s The Truth About the Drug Companies is the book for you.”
—Newsday
“In-depth and insightful”
—Rocky Mountain News
“Put your money on Angell. We need to know why drugs cost what they do, and we need to know how our physicians choose the drugs they give us.”
—St. Louis Post Dispatch
“Engaging and well-written”
—San Antonio Express-News
"Pharamceutical companies will need a new miracle pain reliever after the whipping they receive from Marcia Angell in her book….a starting point for serious discussion."
"If informed criticism contains the sharpest stings, author Marcia Angell's jolting indictument of 'Big Pharma' might just be enough to pierce the beast's hide."
From the Inside Flap
During her two decades at The New England Journal of Medicine, Dr. Marcia Angell had a front-row seat on the appalling spectacle of the pharmaceutical industry. She watched drug companies stray from their original mission of discovering and manufacturing useful drugs and instead become vast marketing machines with unprecedented control over their own fortunes. She saw them gain nearly limitless influence over medical research, education, and how doctors do their jobs. She sympathized as the American public, particularly the elderly, struggled and increasingly failed to meet spiraling prescription drug prices. Now, in this bold, hard-hitting new book, Dr. Angell exposes the shocking truth of what the pharmaceutical industry has become–and argues for essential, long-overdue change.
Currently Americans spend a staggering $200 billion each year on prescription drugs. As Dr. Angell powerfully demonstrates, claims that high drug prices are necessary to fund research and development are unfounded: The truth is that drug companies funnel the bulk of their resources into the marketing of products of dubious benefit. Meanwhile, as profits soar, the companies brazenly use their wealth and power to push their agenda through Congress, the FDA, and academic medical centers.
Zeroing in on hugely successful drugs like AZT (the first drug to treat HIV/AIDS), Taxol (the best-selling cancer drug in history), and the blockbuster allergy drug Claritin, Dr. Angell demonstrates exactly how new products are brought to market. Drug companies, she shows, routinely rely on publicly funded institutions for their basic research; they rig clinical trials to make their products look better than they are; and they use their legions of lawyers to stretch out government-granted exclusive marketing rights for years. They also flood the market with copycat drugs that cost a lot more than the drugs they mimic but are no more effective.
The American pharmaceutical industry needs to be saved, mainly from itself, and Dr. Angell proposes a program of vital reforms, which includes restoring impartiality to clinical research and severing the ties between drug companies and medical education. Written with fierce passion and substantiated with in-depth research, The Truth About the Drug Companies is a searing indictment of an industry that has spun out of control.
About the Author
Former editor-in-chief of The New England Journal of Medicine and now a member of Harvard Medical School’s Department of Social Medicine, Marcia Angell is a nationally recognized authority in the field of health policy and medical ethics and an outspoken critic of the health care system. Time magazine named her one of the twenty-five most influential people in America. Dr. Angell is the author of Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case.
Excerpt. © Reprinted by permission. All rights reserved.
Chapter 1
The $200 Billion Colossus
What does the eight-hundred-pound gorilla do?
Anything it wants to.
What’s true of the eight-hundred-pound gorilla is true of the colossus that is the pharmaceutical industry. It is used to doing pretty much what it wants to do. The watershed year was 1980. Before then, it was a good business, but afterward, it was a stupendous one. From 1960 to 1980, prescription drug sales were fairly static as a percent of U.S. gross domestic product, but from 1980 to 2000, they tripled. They now stand at more than $200 billion a year. Furthermore, since the early 1980s, this industry has consistently ranked as the most profitable in the United States—by a long shot. (Only in 2003 did it fall from that position to rank third among the forty-seven industries listed in the Fortune 500.) Of the many events that contributed to their sudden great and good fortune, none had to do with the quality of the drugs the companies were selling.
In this chapter I’ll give you an overview of the pharmaceutical industry—its meteoric rise and the recent, early signs of either a coming fall or an overhaul. I will not go into much detail here, I’ll leave that to later chapters. What I want to do now is provide a quick look at what’s under this rock when it’s lifted. It’s not a pretty sight.
Before I begin, a few words about the facts and figures I will use throughout the book. In most cases, I use data from the year 2001, because it is the most recent year for which information is reasonably complete for all the aspects of the industry I will consider. If I stick with one year, it will make it easier to see the whole picture. But for some important facts, I will use figures from 2002 and, whenever possible, 2003. In all cases, I will make it clear what year I am talking about.
I also need to explain what I mean when I say this is a $200 billion industry. According to government sources, that is roughly how much Americans spent on prescription drugs in 2002. That figure refers to direct consumer purchases at drugstores and mail order pharmacies (whether paid for out of pocket or not), and it includes the nearly 25 percent markup for wholesalers, pharmacists, and other middlemen and retailers. But it does not include the large amounts spent for drugs administered in hospitals, nursing homes, or doctors’ offices (as is the case for many cancer drugs). In most analyses, they are allocated to costs for those facilities.
Drug company revenues (or sales) are a little different, at least as they are reported in summaries of corporate annual reports. They usually refer to a company’s worldwide sales, including those to health facilities. But they do not include the revenues of middlemen and retailers.
Perhaps the most quoted source of statistics on the pharmaceutical industry, IMS Health, estimated total worldwide sales for prescription drugs to be about $400 billion in 2002. About half were in the United States. So the $200 billion colossus is really a $400 billion megacolossus, but my focus in this book will be mainly on how the drug companies operate in the United States.
You should understand, however, that it is virtually impossible to be precise about most of these figures. Before drugs reach consumers, they pass through many hands and are paid for in exceedingly complicated, often hidden, ways. It is easy to compare apples and oranges without knowing it. You need to ask, for example, whether a number refers just to prescription drugs or includes over-the-counter drugs and other consumer products made by drug companies; whether it includes revenues for middlemen and retailers or not; whether it refers just to outpatient consumer purchases or also to health facility purchases; and whether it includes mail order purchases.
Let the Good Times Roll
The election of Ronald Reagan in 1980 was perhaps the most fundamental element in the rapid rise of big pharma—the collective name for the largest drug companies. With the Reagan administration came a strong pro-business shift not only in government policies but in society at large. And with the shift, the public attitude toward great wealth changed. Before then, there was something faintly disreputable about really big fortunes. You could choose to do well or you could choose to do good, but most people who had any choice in the matter thought it difficult to do both. That belief was particularly strong among scientists and other intellectuals. They could choose to live a comfortable but not luxurious life in academia, hoping to do exciting cutting-edge research, or they could “sell out” to industry and do less important but more remunerative work. Starting in the Reagan years and continuing through the 1990s, Americans changed their tune. It became not only reputable to be wealthy, but something close to virtuous. There were “winners” and there were “losers,” and the winners were rich and deserved to be. The gap between the rich and poor, which had been narrowing since World War II, suddenly began to widen again, until today it is a yawning chasm.
The pharmaceutical industry and its CEOs quickly joined the ranks of the winners as a result of a number of business-friendly government actions. I won’t enumerate all of them, but two are especially important. Beginning in 1980, Congress enacted a series of laws designed to speed the translation of tax-supported basic research into useful new products—a process sometimes referred to as “technology transfer.” The goal was also to improve the position of American-owned high-tech businesses in world markets. The most important of these laws is known as the Bayh-Dole Act, after its chief sponsors, Senator Birch Bayh (D-Ind.) and Senator Robert Dole (R-Kans.). Bayh-Dole enabled universities and small businesses to patent discoveries emanating from research sponsored by the National Institutes of Health (NIH), the major distributor of tax dollars for medical research, and then to grant exclusive licenses to drug companies. Until then, taxpayer-financed discoveries were in the public domain, available to any company that wanted to use them. But now universities, where most NIH-sponsored work is carried out, can patent and license their discoveries, and charge royalties. Similar legislation permitted the NIH itself to enter into deals with drug companies that would directly transfer NIH discoveries to industry.
Bayh-Dole gave a tremendous boost to the nascent biotechnology industry, as well as to big pharma. Small biotech companies, many of them founded by university researchers to exploit their discoveries, proliferated rapidly. They now ring the major academic research institutions and often carry out the initial phases of drug development, hoping for lucrative deals with big drug companies that can market the new drugs. Usually both academic researchers and their institutions own equity in the biotechnology companies they are involved with. Thus, when a patent held by a university or a small biotech company is eventually licensed to a big drug company, all parties cash in on the public investment in research.
These laws mean that drug companies no longer have to rely on their own research for new drugs, and few of the large ones do. Increasingly, they rely on academia, small biotech start-up companies, and the NIH for that. At least a third of drugs marketed by the major drug companies are now licensed from universities or small biotech companies, and these tend to be the most innovative ones. While Bayh-Dole was clearly a bonanza for big pharma and the biotech industry, whether it is a net benefit to the public is arguable (I’ll come back to that).
The Reagan years and Bayh-Dole also transformed the ethos of medical schools and teaching hospitals. These nonprofit institutions started to see themselves as “partners” of industry, and they became just as enthusiastic as any entrepreneur about the opportunities to parlay their discoveries into financial gain. Faculty researchers were encouraged to obtain patents on their work (which were assigned to their universities), and they shared in the royalties. Many medical schools and teaching hospitals set up “technology transfer” offices to help in this activity and capitalize on faculty discoveries. As the entrepreneurial spirit grew during the 1990s, medical school faculty entered into other lucrative financial arrangements with drug companies, as did their parent institutions. One of the results has been a growing pro-industry bias in medical research—exactly where such bias doesn’t belong. Faculty members who had earlier contented themselves with what was once referred to as a “threadbare but genteel” lifestyle began to ask themselves, in the words of my grandmother, “If you’re so smart, why aren’t you rich?” Medical schools and teaching hospitals, for their part, put more resources into searching for commercial opportunities.
Starting in 1984, with legislation known as the Hatch-Waxman Act, Congress passed another series of laws that were just as big a bonanza for the pharmaceutical industry. These laws extended monopoly rights for brand-name drugs. Exclusivity is the lifeblood of the industry because it means that no other company may sell the same drug for a set period. After exclusive marketing rights expire, copies (called generic drugs) enter the market, and the price usually falls to as little as 20 percent of what it was. There are two forms of monopoly rights—patents granted by the U.S. Patent and Trademark Office (USPTO) and exclusivity granted by the Food and Drug Administration (FDA). While related, they operate somewhat independently, almost as backups for each other. Hatch-Waxman, named for Senator Orrin Hatch (R-Utah) and Representative Henry Waxman (D-Calif.), was meant mainly to stimulate the foundering generic industry by short-circuiting some of the FDA requirements for bringing generic drugs to market. While successful in doing that, Hatch-Waxman also lengthened the patent life for brand-name drugs. Since then, industry lawyers have manipulated some of its provisions to extend patents far longer than the lawmakers intended.
In the 1990s, Congress enacted other laws that further increased the patent life of brand-name drugs. Drug companies now employ small armies of lawyers to milk these laws for all they’re worth—and they’re worth a lot. The result is that the effective patent life of brand-name drugs increased from about eight years in 1980 to about fourteen years in 2000. For a blockbuster—usually defined as a drug with sales of over a billion dollars a year (like Lipitor or Celebrex or Zoloft)—those six years of additional exclusivity are golden. They can add billions of dollars to sales—enough to buy a lot of lawyers and have plenty of change left over. No wonder big pharma will do almost anything to protect exclusive marketing rights, despite the fact that doing so flies in the face of all its rhetoric about the free market.
Riding High
As their profits skyrocketed during the 1980s and 1990s, so did the political clout of drug companies. By 1990, the industry had assumed its present contours as a business with unprecedented control over its own fortunes. For example, if it didn’t like something about the FDA, the federal agency that is supposed to regulate the industry, it could change it through direct pressure or through its friends in Congress. The top ten drug companies (which included European companies) had profits of nearly 25 percent of sales in 1990, and except for a dip at the time of President Bill Clinton’s health care reform proposal, profits as a percentage of sales remained about the same for the next decade. (Of course, in absolute terms, as sales mounted, so did profits.) In 2001, the ten American drug companies in the Fortune 500 list (not quite the same as the top ten worldwide, but their profit margins are much the same) ranked far above all other American industries in average net return, whether as a percentage of sales (18.5 percent), of assets (16.3 percent), or of shareholders’ equity (33.2 percent). These are astonishing margins. For comparison, the median net return for all other industries in the Fortune 500 was only 3.3 percent of sales. Commercial banking, itself no slouch as an aggressive industry with many friends in high places, was a distant second, at 13.5 percent of sales.
In 2002, as the economic downturn continued, big pharma showed only a slight drop in profits—from 18.5 to 17.0 percent of sales. The most startling fact about 2002 is that the combined profits for the ten drug companies in the Fortune 500 ($35.9 billion) were more than the profits for all the other 490 businesses put together ($33.7 billion). In 2003, profits of the Fortune 500 drug companies dropped to 14.3 percent of sales, still well above the median for all industries of 4.6 percent for the year. When I say this is a profitable industry, I mean really profitable. It is difficult to conceive of how awash in money big pharma is.
Drug industry expenditures for research and development, while large, were consistently far less than profits. For the top ten companies, they amounted to only 11 percent of sales in 1990, rising slightly to 14 percent in 2000. The biggest single item in the budget is neither R & D nor even profits but something usually called “marketing and administration”—a name that varies slightly from company to company. In 1990, a staggering 36 percent of sales revenues went into this category, and that proportion remained about the same for over a decade. Note that this is two and a half times the expenditures for R & D.
These figures are drawn from the industry’s own annual reports to the Securities and Exchange Commission (SEC) and to stockholders, but what actually goes into these categories is not at all clear, because drug companies hold that information very close to their chests. It is likely, for instance, that R & D includes many activities most people would consider marketing, but no one can know for sure. For its part, “marketing and administration” is a gigantic black box that probably includes what the industry calls “education,” as well as advertising and promotion, legal costs, and executive salaries—which are whopping. According to a report by the nonprofit group Families USA, the former chairman and CEO of Bristol-Myers Squibb, Charles A. Heimbold, Jr., made $74,890,918 in 2001, not counting his $76,095,611 worth of unexercised stock options. The chairman of Wyeth made $40,521,011, exclusive of his $40,629,459 in stock options. And so on. This is an industry that amply rewards its own.
In recent years, the top ten companies have included five European giants—GlaxoSmithKline, AstraZeneca, Novartis, Roche, and Aventis. Their profit margins are similar to those of their American counterparts, and so are their expenditures for R & D and marketing and administration. Furthermore, they are members of the industry’s trade association, the misleadingly named Pharmaceutical Research and Manufacturers of America (PhRMA). Recently I heard Daniel Vasella, the chairman and CEO of Novartis, speak at a conference. He was clearly pleased with the American commercial and research climate. “Free pricing and fast approval secure rapid access to innovation without rationing,” he said, sounding like the most red-blooded of Americans, despite his charming Swiss accent. His company is now moving its research operations to a site near the Massachusetts Institute of Technology (MIT), a hotbed of basic research surrounded by biotechnology companies. I suspect the move has nothing to do with “free pricing and fast approval” at all, and everything to do with the opportunity to profit from U.S. taxpayer-funded research under the terms of Bayh-Dole, and from the proximity of U.S. medical scientists who do the research.
Buy from Amazon
Compare Prices
|
|
Home
