Kathleen Z. Rooney
As the second century of the FDA begins, consumer protections in pharmaceuticals are firmly established and largely successful. Cases like thalidomide have demonstrated the need for a government agency to weigh the profit-motive against the protection of consumers. The establishment of the clinical trial created an industry of science-based companies and an infrastructure of academic and industrial links that are focused on deriving treatments for human illness. The combination of public and private interests creates both a profit-motive to grow and support the industry along with more altruistic motives of alleviating suffering.
By limiting the right to market drugs without their approval the FDA is equivalent to the Patent Office in its control of the industry
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This control has centralized the power of the companies that hold these patents and created an enormous profit incentive and an accompanying drive to interpret statistics in favor of the products that the companies want to market. While that incentive is a legitimate and intended consequence of much legislation, it creates a strong temptation for inappropriate and misleading research, development and production of drugs.
There are two ways in which the approval process has been misused. One is simple deception to avoid potential losses by suppressing the negative findings during the trials process. The examples here are many and have led to the criticisms that the industry and the FDA are too close. Another is more vaguely unethical, and, in fact, a legal process by which these companies use federal money to produce less effective and costlier drugs whose only true beneficiaries are the shareholders of these companies.
When a company patents a successful drug, they can reap huge profits, by remaining the only source of this very much in-demand product. It is a monopoly that is accepted by the government as a trade-off for the humanitarian nature of the business to alleviate pain and suffering of patients. As the industry grew throughout the 1980's, further growth incentives were legislated to enhance the profits of these lucky few companies. Ostensibly, these incentives were to reward altruistic companies for furthering lifesaving research, in order to offset their financial risks in research and development. They were also intended to encourage the nascent bioscience industry. The meteoric growth of these industries shows just how successful these acts have been in encouraging work in developing pharmaceuticals. However, growth has been centralized, with more power in the hands of a few companies and an industry that has the power to influence those who try to control it.
In The Truth About the Drug Companies Marcia Angell, 20-year-veteran, and first woman editor of the New England Journal of Medicine, writes of the profit margins that zoomed in the 1980's following the enactment of the Bayh-Dole act in December 1980, " Before then it was a good business, but afterward, it was a stupendous one. From 1960 to 1980 prescription drugs were fairly static as a percent of the U.S. Gross Domestic product, but from 1980 to 2000 they tripled."
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This act encouraged the use and commercialization of government-funded research in order to spur research and create economic growth. It allowed NIH-funded researchers at universities to hold the title for their inventions. Previously, the government owned those rights. In turn the titleholders could sell the right to market the drug to pharmaceutical companies. This has become the dominant mode of research for these companies. Ironically, companies who have underpaid the NIH royalties on drugs they have licensed have charged the governments Medicare and Medicaid programs inflated prices on these same drugs. While there have been beneficiaries within universities and small biotech firms that have developed new technologies, an enormous amount of profit has gone to the licensors of these products, the Pfizers and Aventis, without their actually having to risk any capital on research and development.
The Hatch-Waxman act of 1984 sought to increase the production of cheaper generic drugs. In order to unburden the producers of generic drugs from their regulatory costs, this act allowed a streamlined approval process, where the generics could be approved on the basis of the clinical trials of the original drug. This was supposed to lower investment costs and in turn lower cost to the consumer. As a compromise to industry, name-brand drugs were given longer patents.
The clever producers of name brands have discovered ways to lower their overhead and extend their monopolies by using Hatch-Waxman. Angell writes that "in the five years 1998 through 2002, 415 new drugs were approved by the Food and Drug Administration (FDA), of which only 14 percent were truly innovative. A further 9 percent were old drugs that had been changed in some way that made them, in the FDA's view, significant improvements. And the remaining 77 percent? Incredibly they were all me-too drugs - classified by the agency as being no better than drugs already on the market for treating the same condition."
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These products were either slightly chemically altered, or repackaged in new doses or levels of time release enough to claim a patentable product, not enough to require a full set of new trials. This practice is ethically challenging along several fronts. The financial resources of the NIH and these companies are NOT being spent discovering innovative treatments for challenging health problems, but are maximizing profits through copycat drugs.
An even darker side exists to the practice. The trialing process only requires that a drug be better than a placebo, but not better than existing treatments. Therefore the risk/benefit calculation is invalid. The copy may be better than no treatment and this benefit may outweigh the side effects, but is it better than another possible treatment? An example is Crestor, the cholesterol-lowering drug approved in 2003. Hawthorne says, "… the problem wasn't merely that Crestor might be redundant: The consumer advocacy group Pubic Citizen Watch charged that it actually caused worse side effects than the other statins, including kidney damage and severe muscle deterioration, and called for it to be banned."
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There is no requirement for this side-by-side analysis to be made or to be reported.
This limitation of the trialing process can be outweighed by the prudence of the medical practitioners who prescribe and review medications. While drugs may be approved for sale, it is common practice for doctors and patients to decide which drug will be chosen for treatment. However, even this private arena is rapidly changing, as insurance and public/private pay options are reconfigured. The landmark prescription drug act of 2003 carried a provision that Medicare could not create a formulary or bargain with the drug companies for pricing. This is unheard of within the private insurance industry. All insurance carriers have formularies with tiered reimbursement for various levels of drugs and employ cost-saving practices such as substituting generics or even substituting completely different treatments for the same condition. How will these changes and the Health Care Act of 2010 affect the industry?
