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Written by Theresa Maher   
Thursday, 22 March 2007
Drug companies are taking advantage of certain loopholes present in Minnesota and Vermont laws and are not disclosing payments and gifts provided to doctors, says a new study appearing Wednesday in the Journal of the American Medical Association.

 

Minnesota and Vermont have disclosure laws that require pharmaceutical companies to reveal the nature of gifts given to doctors. Such laws are also in place in California, Maine, West Virginia and the District of Columbia. The intention of these laws is to inform the public about possible bias when a doctor prescribes any medicine or product.

However some ambiguity in the Minnesota and Vermont disclosure laws has allowed drug makers to hide information on the money paid out to doctors for promoting certain drugs or products. The study found most payments were related to promotional talks to other doctors, education, research, meals and for attending conferences.

Drug companies did not give other reasons and even hid payments made to doctors by citing them as trade secrets. he researchers believe the requisite information as asked for in the disclosure laws is inadequate and prevents the public from accessing complete information.

Lead author Dr. Joseph Ross, a researcher at Mount Sinai School of Medicine in New York suggests that the issue needs to be probed because doctors might be unduly influenced by the drug industry and not lookout for the patients' best interests.

Data on the disclosure clause in Vermont was examined from July 2002 to June 2004, while Minnesota information was collated from January 2002 to December 2004. The findings of the study are startling.

"In Vermont, 61 percent of payments were not released to the public because pharmaceutical companies designated them as trade secrets and 75 percent of publicly disclosed payments were missing information necessary to identify the recipient," the researchers write. "In Minnesota, only 25 percent of the companies reported in each of the three years."

Records were found to be poorly maintained and the drug companies often failed to disclose the exact nature of the gift given to doctors. Some records were handwritten and were barely legible. Specific names of doctors receiving payments were missing as well, the researchers said.

Minnesota introduced the disclosure law in 1993, while Vermont adopted the measure in 2001.

During the study period, researchers were able to access information on 7,000 payments totaling $30.96 million in Minnesota. Of the state's 17,000 doctors, 2,400 received payments above $1,000 each. In Vermont some 12,000 payments totaling $2.18 million were disclosed during the study period of which 2,416 payments of 100 dollars or more were made to physicians.

The American Medical Association recommends a limit to gift payments made by drug companies to doctors. "To avoid undue influence ... gifts (but not other payments) to physicians should benefit patients and should not exceed 100 dollars in value, a recommendation similar to those of other medical organizations and the Pharmaceutical Research and Manufacturers of America," it says.

However this rule was clearly flaunted in the study. Moreover $3.41 million was effectively hidden cited trade secrets in Vermont. The researchers struggled to get the proper data and had to negotiate with the State Attorney General to get access.

"The hoops that we had to jump through just to get the data in each state is enough to show these laws really aren't working," the researchers noted.

The disclosure laws in Vermont and Minnesota are ineffective to stop doctors from accepting large sums from pharmaceutical companies, the researchers concluded, adding that these vast sums of money could have a bearing on the medicines prescribed.

The results of the study were discouraging to Dr Troyen A. Brennan, of Aetna Inc, Hartford, Connecticut, and Dr Michelle M. Mello, of the Harvard School of Public Health, who wrote in an accompanying editorial that ethics were bypassed in such cases.

"Their primary commitment is to create shareholder value, not maintain an altruistic commitment to patients," they wrote in their piece titled "Sunshine Laws and the Pharmaceutical Industry."

"But at some point the leadership of the pharmaceutical industry and their boards of directors must begin to recognize that growing public and professional mistrust could substantially detract from that value."

Reacting to the study, Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said it mixed apples and oranges "because they combine the activities of pharmaceutical research company representatives who meet with health care professionals with separate physician contracts and grants to academic medical research centers."

While gifts from drug companies to doctors are fairly common, the public is unaware of this intimate link between the two. A poll by New York Times/CBS News last month found 85 percent of respondents to be against the notion of drug makers gifting cash to doctors. They felt such gifts would influence doctors' decisions when they write medications.
 

 
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