Biotech at risk for broadside hit - (Boston Herald 8/6/08)

August 6, 2008
Ethics bill would be malpractice.

On the last day of July, the Massachusetts Legislature passed the Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care. It's both a mouthful and a mess. If Gov. Deval Patrick doesn't veto the bill by Aug. 13, the law will put a needless chill on clinical research and pharmaceutical innovation in the commonwealth.

Among other provisions, the bill would require public disclosure when payments of $50 or more are made between pharmaceutical research firms and health-care providers. The information from these transactions - which includes physicians' names - would be posted on the Internet.

Transparency is generally a good thing. But publishing a list of doctors who have been involved in financial transactions through the state’s many academic research programs and clinical trials with pharmaceutical companies suggests that there is something wrong with these associations, even though the payments are neither illegal nor unethical.

According to the National Institutes of Health, there are currently 5,673 clinical trials being conducted in Massachusetts alone - and nearly 2,000 of them are recruiting patients. Many of these important programs could be threatened under the legislation. How many of the doctors and researchers already involved in trials might decide that the unwanted public attention is not worth their participation?

Also under such a regime, physicians and academic scientists who reside here - along with those who are contemplating a move to the Bay State - might decide to move elsewhere. If working with drug companies and biotechnology firms is viewed negatively, these folks could very well decide that Massachusetts’ research climate is too hostile.

Already, according to a Massachusetts Medical Society report, 24 percent of practicing physicians either have plans to leave the state, or are considering leaving, because of the practice environment.

Fears of biotechnology firms choosing to do business elsewhere are also real. And their absence would create a gaping hole. Biopharmaceutical companies employ nearly 55,000 people in Massachusetts, according to the Center for Labor Market Studies at Northeastern University. And that number has been growing. Whereas Massachusetts lost 100,000 private-sector jobs between 2000 and 2005, the biotechnology industry created 6,100 jobs.

When developing life-saving and life-enhancing medicines, drug companies depend on physicians and academic scientists. This legislation unwisely cuts into that indispensable relationship.cw-3

The legislation is also unnecessary, as when it comes to perceived conflicts of interest, the industry is already policing itself. Just this month, the pharmaceutical industry’s trade group issued a new code on interactions with health-care providers. It will take effect on Jan. 1.

Under the industry’s old guidelines, drug reps were allowed to give gifts of up to $100 to physicians. That’s why Lipitor post-it pads and Claritin letter-openers are so ubiquitous around doctors’ offices. The new rules, however, prohibit all but educational gifts.

And whereas the old rules allowed for drug reps to purchase “modest” and “occasional” meals for physicians, restaurant outings will no longer be permissible under the industry’s new plan. As if that weren’t enough, the pharmaceutical trade group is also instituting new regulations regarding the fees paid to doctors who work as industry consultants.

When a doctor decides which treatment to prescribe, free stationery and a burger at Applebees isn’t likely to be a major influence. Physicians are quite well paid, and they swear an oath to do what’s best for their patients. Even if they could be bribed, it would presumably take more than a few pieces of stationery. Doctors simply don’t base medical decisions on who gave the best paperweight.

Massachusetts lawmakers are apparently convinced that drug companies are in cahoots with academic scientists and physicians. But in this rush to regulate, they may inadvertently harm patients and one of the state’s most-bustling industries.

Sally C. Pipes is president and CEO of the Pacific Research Institute and author of "Miracle Cure: How to Solve America's Health-Care Crisis and Why Canada Isn't the Answer."

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