Profession

Legislation targets drugmaker gifts, incentives to physicians

Publicly exposing financial ties to industry will make doctors think twice about propriety, advocates say.

By Kevin B. O’Reilly — Posted Nov. 19, 2007

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Thirteen states this year have seen legislative proposals aimed at limiting financial relationships between physicians and drugmakers. Most bills failed to pass, due to heavy pressure from pharmaceutical lobbyists, experts said, but new efforts are afoot.

The latest proposals include a Michigan bill that would make that state the second in the nation after Minnesota to place a limit -- $100 -- on the total value of gifts a drugmaker can give a physician in a year. Michigan and Massachusetts are considering so-called sunshine laws requiring drug companies to publicly disclose any gifts, payments, subsidies or incentives worth more than $25.

The bills proposed this year exempt drug samples and payments for clinical trials from reporting requirements or gift limits. In September, a bipartisan U.S. Senate measure was introduced that would list gifts of more than $25 in a public, national database.

The American Medical Association's ethical code says gifts from industry should be of insubstantial value and primarily benefit patients. The AMA has not taken a position on the congressional or state legislation.

Drugmakers "spend a ton of money on TV, and they spend a ton of money in the field pushing prescriptions," said Michigan Rep. Mike Simpson, who co-sponsored the gift legislation as part of a package aimed at containing health care costs. "We hold doctors in the public trust, and we want to make sure physicians are prescribing the best medicine based on what's in the patient's interest, not on what they are getting from the pharmaceutical industry."

Simpson said that while he doubts most doctors base prescribing decisions on industry gifts, the new legislation would ease patients' concerns about physician conflicts of interest.

Medical societies offer views

The Michigan State Medical Society has yet to take a position on Simpson's legislative package, proposed in late October. Colin J. Ford, the society's director of state government affairs, said MSMS has opposed similar proposals in the past because they failed to "provide any sort of context for these expenditures."

He added that voluntary guidelines adopted by the Pharmaceutical Research and Manufacturers of America "have already addressed many of these issues." PhRMA has said repeatedly that reporting requirements and gift limits are unnecessary and could hinder appropriate physician interactions that benefit patients.

The Massachusetts Medical Society has come out in support of a proposed state sunshine law. The society said the bill reflects the AMA's ethical policy on gifts. Samples, payment for bona fide clinical-trial work and scholarships for medical residents selected by a professional association would be exempt from disclosure. Drugmakers could be fined $10,000 for failing to report gifts or payments, which the state attorney general would report on an annual basis.

"The Massachusetts Medical Society is very concerned about conflict of interest in the choice of prescription medications," the organization said in testimony submitted to a House Joint Committee on Public Health hearing in September. "The interest of our patients must always prevail over the economic interest of insurers, prescribers or the pharmaceutical industry."

Evidence from two states with reporting laws, Minnesota and Vermont, showed that thousands of physicians received payments of more than $100 over two years, according to a study in the March 21 Journal of the American Medical Association. Such widespread payments show the need for further legislation, said Joseph Ross, MD, the study's lead author.

"Many of these payments are appropriate, and many are inappropriate, based on the standard AMA and PhRMA guidelines," said Dr. Ross, instructor in geriatrics and adult development at the Mount Sinai School of Medicine in New York City. "The real way these laws work is by putting the sunshine in. I think physicians and companies will be more circumspect about what payments they both give and receive when they could be exposed publicly. If it's an appropriate payment, they shouldn't be embarrassed about it being made public."

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ADDITIONAL INFORMATION

Gift guidelines

More than a dozen states this year have proposed measures to limit industry gifts to doctors or require drugmakers to disclose presents, payments or other incentives. Here are some voluntary guidelines in place:

American Medical Association: Among its policy and guidelines: Acceptable gifts should primarily benefit patients and be valued at $100 or less. Cash payments are prohibited, but industry-subsidized CME is acceptable if doctors are not sponsored directly and physicians pay for travel, lodging and personal expenses.

Pharmaceutical Research and Manufacturers of America: The voluntary code for drug rep interactions with physicians tracks the AMA's guidelines. Among the rules: Modest meals are allowed, but only in the context of an educational presentation. Gifts of $100 or less that directly relate to the physician's work or primarily benefit patients are allowed. Stethoscopes are OK, golf bags are not.

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External links

American Medical Association's ethical guidelines for gifts to physicians from industry (link)

Pharmaceutical Research and Manufacturers of America code on gifts, in pdf (link)

National Conference of State Legislatures on marketing and direct-to-consumer advertising of pharmaceuticals (link)

"Pharmaceutical Company Payments to Physicians," abstract, Journal of the American Medical Association, March 21 (link)

"A National Survey of Physician-Industry Relationships," abstract, New England Journal of Medicine, April 26 (link)

Prescription Project fact sheet on regulating industry payments to physicians, in pdf (link)

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