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With More Oversight Possible Under Obama, Drug Industry Works to Polish Its Image

Rep. Henry A. Waxman (D-Calif.), the incoming chairman of the Energy and Commerce Committee, supports legislation giving the FDA power to selectively ban direct-to-consumer advertising in the initial years a medication is on the market.

"It is in these first few years of a drug's life that drug companies often aggressively market their products," Waxman said in a recent speech. "This increases the number of consumers exposed to safety risks of new products, long before those risks are truly understood."

The drug industry supported a watered-down version of the Grassley bill and has opposed giving the FDA power over ads directed at patients. Instead, PhRMA members have adopted a voluntary marketing code.

As of the start of this year, about 40 companies agreed to stop distributing notepads, pens, T-shirts, soap dispensers, napkins and other tchotchkes festooned with product logos. Drugmakers describe the gifts as "reminder items" for doctors and nurses who may forget what cholesterol pill or diabetes medication they want to prescribe. But many consumers suspect that the goodies, as well as more extravagant gifts such as travel and meals, lead to medical decisions that have less to do with sound science than with clever marketing.

The voluntary code, which encourages but does not require companies to hire an independent auditor to monitor their compliance, also sets new restrictions on buying meals for physicians. Fancy restaurant dinners are out unless they include a substantive presentation from a medical expert. Food deliveries to a physician's office are still acceptable, as are some meals at conferences.

In 2005, the industry spent more than $6.8 billion on the goodies, meals and other office visits, according to a report in the New England Journal of Medicine.

Patient advocacy groups say the voluntary changes will fall short of altering the cozy relationship between doctors and pharmaceutical companies.

"I'm not sure it actually changes the number of meals the industry is providing all that much," said Allan Coukell, policy director of the Prescription Project, a Boston-based nonprofit that often finds itself pitted against drugmakers.

In March, drug companies will also begin following stricter advertising policies. Actors posing as doctors, as well as celebrity endorsers such as artificial-heart inventor Robert Jarvik, will be identified accurately in commercials. Suggestive ads for products such as the impotence drugs Viagra and Cialis will be pulled from day time slots when children are likely to be watching. And ads will contain information on programs designed to help patients understand and afford the medications.

"You're seeing a greater trend toward transparency and openness among pharmaceutical companies to let people know how we do business and what services are available," said AstraZeneca spokesman Tony Jewell. AstraZeneca's spots conclude with a plug for the company's prescription savings program, information that Jewell says helps patients.

Tauzin defended direct advertising as a means to not only educate patients about treatments but also alert them to illnesses they may not realize they have. Even so, he recognized the "perception problem" of the ads, a problem he characterized as "you're smoking in bed and the house is on fire."

In a speech last month, Roche Pharmaceuticals chief executive William Burns hinted that the Swiss company may go further than the PhRMA guidelines.

"Direct-to-consumer promotion was the single worst decision for the industry," he said. "When industry says, 'We're spending all the money on [research and development],' but actually it's spending it on DTC advertising to preserve margins, it doesn't get much credibility."

Grassley and consumer watchdog groups say they are far more troubled by sizable industry payments to doctors for activities often labeled as consulting, research or continuing medical education. In addition, they note that the PhRMA guidelines have no enforcement mechanism.

"People are less apt to violate a federal law than a code of ethics of its own profession," Grassley said. He also said companies making biotech drugs, including a number of very expensive new treatments for cancer and other diseases, should not be exempt. So far, the trade group BIO -- the Biotechnology Industry Organization -- has refused to adopt even the PhRMA code.

The industry's voluntary efforts are "a start, not an end," Grassley said in an interview. "You can't say it's a substitute for what I'm trying to do."


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