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Mania for new rules imperils health
Mania for new rules imperils health
The Providence Journal
By Peter Pitts
Friday, May 4, 2007
NEW YORK
OVER THE PAST 50 years, the average American life span has increased by a full decade. Deaths as a result of cancer are slowly and steadily falling. Survival rates for any number of previously fatal diseases have never been higher. Americans are living longer, healthier, more productive lives than ever before. By and large, this progress is the result of innovative new drugs.
Yet at every twist and turn, those responsible for these life-saving medicines are under attack.
In recent weeks, several U.S. senators have pushed a measure designed to expand the Food and Drug Administration by creating a redundant office to oversee drug safety after a drug has already been approved. It already costs around $800 million to develop a new drug, however, and adding more bureaucracy will do little but increase that cost.
Meanwhile, at the state level, legislators are working feverishly to remove perceived potential conflicts of interest between doctors and pharmaceutical companies. Citing transparency as their goal, state lawmakers in Vermont, Minnesota and elsewhere have passed “marketing-disclosure” laws that require drug companies to divulge all payments made to doctors.
And last month, in an effort to preempt congressional action, the FDA announced tough new rules regarding who can serve on the advisory panels that recommend whether a drug should be sold. In a nutshell, the rules preclude any person with a financial conflict amounting to more than $50,000 from serving on these panels.
These directives have arisen amid accusations that drug manufacturers have usurped the FDA process, essentially paying doctors to get their drugs on the market before a drug’s safety can be guaranteed.
On their face, such measures may seem like a good idea. But, as the former senior FDA official in charge of advisory committees, I’m certain that they’re terribly misguided.
Imagine if the scientific community had ignored Louis Pasteur’s research on bacteria and fermentation simply because he had received funding from the wine industry. Science would have been set back immeasurably, and you might not be able to buy safe, pasteurized milk in your local supermarket today.
But $50,000 is a lot of money. If an academic or practitioner has a financial conflict amounting to more than that, isn’t his involvement hopelessly biased and unscientific?
Not necessarily.
First, the FDA’s new rule is too sweeping, as it groups together experts who receive consulting fees and research funding with those who have a direct economic stake in a drug’s success.
This is a mistake. Pharmaceutical companies pour billions of dollars each year into exploring new drugs — cancer-fighting treatments, Alzheimer’s medications, cholesterol-lowering statins.
Sure, these corporations seek to profit. But are the scientists who conduct research on their behalf inherently predisposed to support their work?
Furthermore, when it comes to the FDA’s advisory committees, the agency has historically recruited the best and the brightest. Therefore, it shouldn’t surprise anyone that the leading drug companies often call on the same experts. If the goal is drug safety, the agency should not have to depend on the almost best and the almost brightest.
What’s more, when it comes to the sale of pharmaceuticals, the U.S. Department of Justice strictly enforces fraud, abuse and anti-kickback laws.
Plus, the leading drug manufacturers already adhere to voluntary marketing guidelines that prevent unethical relationships from arising in the first place. For example, the guidelines specify that gifts to physicians must support a medical practice, and shouldn’t exceed $100. Further, the guidelines stipulate that all entertainment — including tickets to sporting events — is inappropriate.
In this regard, drug manufacturers were well out in front of Washington’s recent efforts to curtail the influence of lobbyists on politicians.
Although it may be politically fashionable these days to criticize drug companies, let us not forget that they are in the business of fighting death, pain and disease, and have had much success thus far. If we reject all of their money as tainted, we run the risk of rejecting their next miracle cure.
The next time you go to the pharmacy and pick up a potentially life-saving drug, ask yourself if you really care who funded the research that led to its development. Chances are it was a pharmaceutical company, but regardless of who footed the bill, you’re awfully glad the drug is for sale.
Peter J. Pitts, a former associate FDA commissioner, is president of the Center for Medicine in the Public Interest.
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