Study: Loopholes Weaken Drug Industry Payment Rules
Laws in Minnesota and Vermont that require pharmaceutical companies to disclose payments and gifts provided to physicians contain loopholes that can prevent the information from being publicly available, according to a study published on Wednesday in the Journal of the American Medical Association, Long Island Newsday reports. California, Maine, West Virginia and the District of Columbia have similar measures (Ricks, Long Island Newsday, 3/20).
Minnesota and Vermont were the first two states to adopt disclosure laws, in 1993 and 2001, respectively (Tanner, AP/Houston Chronicle, 3/21). For the study, lead author Joseph Ross of Mount Sinai School of Medicine and colleagues studied data collected under Minnesota's disclosure law from January 2002 through December 2004 and Vermont's disclosure law from July 2002 through June 2004.
In Minnesota, more than 7,000 payments totaling $30.96 million were reported during the examined period, the study found. Nearly 2,400 of the state's 17,000 doctors received disclosed payments, which averaged about $1,000, according to the study.
The American Medical Association and other medical groups recommend that gifts to doctors not exceed $100.
In Vermont -- where disclosures are required for payments of $25 or more, excluding prescription drug samples, funding for research and education-related travel -- about 12,000 payments were disclosed during the study period totaling $2.18 million, the study found. An additional $3.41 million in Vermont disclosure data were withheld from public release on the grounds of trade secrets, according to the study (AP/Richmond Times-Dispatch, 3/21).
The average disclosed payment in Vermont was valued at $177. The study noted that it was difficult to gain access to much of the information (CQ HealthBeat, 3/20).
Researchers said acquiring some of the data required a lawsuit in Vermont and photocopying individual disclosure forms in Minnesota.
Ross said, "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" (AP/Richmond Times-Dispatch, 3/20).
Peter Lurie, co-author of the study and deputy director of Public Citizen's Health Research Group, said, "The gifts may take the form of educational fees, cash, a check or a meal" (Long Island Newsday, 3/20). Lurie suggested that the actual number of pharmaceutical industry payment to Minnesota doctors was higher than the study found, but he added that the reporting was so poor and incomplete that researchers could not assess the extent of payments, the Minneapolis Star Tribune reports (Lerner, Minneapolis Star Tribune, 3/20).
Lurie said, "Despite the fact there is obviously enormous underreporting, there are still a significant number of doctors in Minnesota who are accepting large sums from pharmaceutical companies -- sums that could have an impact on the prescription of medication to patients." Lurie added, "This law could not have been less effective."
Public Citizen has recommended that the Minnesota Board of Pharmacy, which runs the state disclosure program, collect the information in an annual report and consider listing doctors who receive the highest payments by name (Olson, St. Paul Pioneer Press, 3/21).
Lurie said that the Board of Pharmacy currently "collects the information, and they stick it in a box and then they just ignore it" (Minneapolis Star Tribune, 3/20).
Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said that the laws in Minnesota and Vermont -- as well as the information analyzed for the JAMA study -- "mix apples with 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" (CQ HealthBeat, 3/20).
Richard Geier, president of the Minnesota Medical Association, said, "I think what [the study] is basically saying is that Minnesota and Vermont have attempted to find some information, but it hasn't been very effective." Geier added, "Public Citizen thinks everything is corrupting. (But) the idea that you can totally separate drug companies and doctors is ridiculous. Because you have to have doctors to even get the drugs on the market" (Minneapolis Star Tribune, 3/21).
Cody Wiberg, executive director of the Minnesota Board of Pharmacy, said he is taking steps to make the disclosures more publicly accessible and plans to monitor the payment list for possible violations of state law, including a law that prohibits gifts of more than $50 to physicians. Pharmaceutical companies that are occasional offenders will receive warning letters, and stronger measures might be taken against frequent offenders, Wiberg said (St. Paul Pioneer Press, 3/21).
In related news, the New York Times on Wednesday examined the Minnesota law, as well as concerns among some experts about the pharmaceutical industry's influence on research physicians.
The Times profiles National Kidney Foundation President Allan Collins, a Minnesota physician who, according to disclosure data, received at least $25,800 during 2005 from Amgen, primarily for consulting and speaking fees. During 2004, Amgen paid more than $1.9 million to research and education programs led by Collins, according to records obtained by the Times.
Collins in an e-mail said that he personally received less than $10,000 from Amgen in 2004, adding, "The contract amount of $1.9 million from Amgen was paid to the Minneapolis Medical Research Foundation for the research contract, on which I am the designated senior researcher." Collins added, "Just because I might do consulting work doesn't mean I don't press the agenda of the public health."
However, Daniel Coyne -- a physician at Washington University> in St. Louis who recently wrote an editorial in a medical journal criticizing guidelines written last year by NKF recommending wider use of Amgen drugs -- said, "Amgen's funding for Dr. Collins' MMRF is another huge financial connection to individuals at the National Kidney Foundation. The foundation's recent pro-industry anemia guidelines -- and the revisions due next month -- have to be viewed with great skepticism" (Harris/Roberts, New York Times, 3/21).