In her scathing review of the pharmaceutical industry entitled The Truth about the Drug Companies: How They Deceive Us and What to Do About it, Marcia Angell methodically rebuts industry positions on research, innovation, politics and intellectual property. Dr. Angell worked for The New England Journal of Medicine for 20 years, serving as its editor in chief. Currently she is a member of Harvard Medical School’s Department of Social Medicine. Her critique rebuffs common arguments that the industry uses to explain its exorbitant prices.
It is the National Institutes of Health, she explains, and not the drug industry, that is responsible for the research and innovation we see today. Legislation during the 1980s, most notably the Bayh-Dole of 1980, enables the industry to exclusively license and patent NIH work. Take, for example, the case of Taxol, which came from direct research of the National Cancer Institute within the NIH. After the discovery, Bristol-Meyers Squibb licensed Taxol, but because of a shortage of a key ingredient, were unable to manufacture it in large quantities. Florida State University, using an NIH grant, synthesized the necessary molecule, and Bristol-Meyers Squibb could continue making money. Dr. Angell relies on anecdotes like this one to drive her points home, but while they make her arguments vivid, they may not provide an accurate image of the bigger picture. It implies, for example, that the companies’ role is merely hat of manufacturing and distribution, which seems like an exaggeration.
The pharmaceutical industry and its trade group PhRMA do not like the idea that they only produce and distribute the drugs, as in the case of Taxol, and often point to their own massive Research and Development (R&D) budgets. They herald the magic figure of $802 million as the per-drug R&D cost. Dr. Angell explains that number, which was produced by an organization funded primarily by PhRMA. She dismantles the figure, explaining that it contains research that is really marketing or administration. For example, Direct-to-Consumer advertisements (the ones on TV) are considered educational, and therefore fall somewhere under the umbrella of R&D. It is impossible to determine where it falls, since drug companies are not required to disclose the details of their R&D budgets. Almost anything may be wrapped up in the broad category, and as of now there is no way to know. She takes information from the PhRMA website and calculates her own estimate, using an overly crude method. Still, her point that no one knows what is really in R&D is made clear.
Dr. Angell next points out the amazingly profitable yet entirely unoriginal production of “me-too” drugs. The FDA only requires that a new drug be compared with a placebo and not the current drugs in use for a disease, so that to be approved by the FDA, a drug need only be better than nothing. That opens the door for drugs which are not better and may be worse than what is currently available. Since the period a company can exclusively sell a drug is limited, companies use the relaxed standards of the FDA to maintain their monopolies on drugs. Dr. Angell looks at the popular heartburn drug Prilosec as an example. As the patent of its producing company AstraZeneca was about to expire, they got another drug approved. The new drug, Nexium, had the same active ingredient as Prilosec, yet the company marketed it as the newer, better Prilosec. Yet the two had never successfully been compared in a clinical trial. Or take Claritin, which was made an over-the-counter medicine as its patent ran out. That way, no other company could sell a prescription generic. Also, the makers of Claritin came out with Clarinex, which is just Claritin in the form it takes in the body. They marketed Clarinex as the better drug, since they had years left of exclusivity. The most striking example is Prozac Sarafem, which is Prozac, except that it has a pink shell, yet somehow the pink version sells for 3 times as much as Prozac generics. These anecdotes, unlike earlier, are so numerous that they manage to successfully illustrate the bigger picture of deceit and not innovation.
It may be surprising that the drug companies can get away with such obvious gimmicks, and Dr. Angell discusses a variety of techniques used to influence law, politics and the medical profession. The 88,000 sales representatives that follow doctors around, bringing gifts and contributing fancy dinners, help influence doctors across the country. So does the continuing education of doctors, which is mandatory and which gets 60% of its funding from PhRMA. Patent law protects companies for 20 years, and they can extend that 30 months at a time by suing other companies. Dr. Angell’s explanation of the medical profession is particularly scathing, yet she fails to address what she calls the cause, namely the greed of doctors. Her argument that doctors should not accept industry-funded education seems trivially impractical given current practices in the medical profession.
PhRMA’s biggest advantage, she argues, is that its members generally do not compete in prices. The FTC issued a report in 2003 detailing widespread anticompetitive activities in the industry. The FDA responded that it does not have the resources to oversee the industry, so it takes the companies at their word. The report did bring political attention, including a bill in the Senate by Senators Chuck Schumer and John McCain, but the bill died in the House, which Dr. Angell attributes to the PhRMA lobby, the biggest and most powerful in Washington. Despite the bleak pictures she paints, Dr. Angell predicts the downfall of the industry. She claims that the research pipeline has dried up, although her sources on that point are mostly unclear. Furthermore, the public seems to be getting skeptical of ever-rising prices, bringing the issue to the political arena.
In her grand finale, Dr. Angell tells the reader how to save the industry. She calls for sweeping changes that mainly involve a more powerful FDA. She would like to force drugs to be tested against other drugs and to approve only more effective drugs or treatments. She also suggests opening the “R&D black blox” to give the publicly-supported industry some transparency. Her advice seems sound, but her only suggestion for forcing the changes is to “write your congressman.” Her faith in democracy, while admirable, seems to go against her previous condemnation of the drug industry’s lobby and the stranglehold it has over American politics. Her tone, particularly in the section on politics, comes off as scolding. It is clear her personal politics shine through in her argument about what to do next.
In general, Dr. Angell makes the distinction between argument and fact clear. She cites rigorously, and draws from several types of sources. She uses governmental reports from the FDA, SEC and GAO, and several books and well-respected newspapers, including the New York Times, Boston Globe and Wall Street Journal. She also takes data from PhRMA itself, where appropriate. Occasionally, though she resorts to hyperbole and overstatement. For example, she writes “A third of big pharma’s drugs are now licensed or otherwise acquired from outside sources” but in the endnote, she explains “this is my best estimate.” While she explains how she arrived at that estimate, it demonstrates a more general tendency to write in extremes.
Her proposal and subsequent discussion ignore what would likely be the biggest objection, namely a commitment to free market ideas. Much of the political objection to her proposed solution stems from caution about governmental oversight. The market will, a critic might argue, take care of innovation like no regulatory body could. The closest she comes to addressing the point is to say that all other developed countries have price controls. She separately admits that most innovation comes from the work in the United States. It may be easy to imagine her response, yet the omission of a counter argument seems odd in comparison to her otherwise methodical style.
__
note: I wrote this for school for my class in History of Science History of Medicine 210: “Magic Bullets and Wonder Pills”.
Post a Comment