States have begun restricting the perks that drug and medical-device manufacturers can give doctors, aiming to keep the companies from influencing prescription habits and treatment plans. New Jersey could become the first to make doctors accountable.
State Attorney General Anne Milgram has recommended banning doctors licensed in the state from accepting gifts that don't directly benefit their patients, and requiring them to report consulting fees greater than $200.
The choice to put the responsibility on doctors, met with scorn from the Medical Society of New Jersey, was deliberate. The state has direct control over doctors through its licensing process. And, Milgram said, doctors should be conscious of how their relationships with manufacturers can influence care.
"It really is, at the end of the day, each individual doctor's conflict of interest as much as it is the industry's," she said.
The recommendations are subject to further review, and it could take six months or more for the Board of Medical Examiners to amend the rules, according to Lee Moore, a spokesman for the Division of Consumer Affairs.
New Jersey has one of the nation's largest concentrations of pharmaceutical firms. Milgram said she hoped the proposed rules would provide a model for other states.
Milgram assembled a task force in 2007 to look at ways to control conflicts of interest between doctors and manufacturers.
At the time, her office was involved in other conflict-of-interest issues, investigating the relationship between student-loan issuers and college financial-aid offices, among other issues.
Moore said the Division of Consumer Affairs used input from the task force, academia, and a 2007 public hearing to produce the report that Milgram released this month.
The report suggests setting limits on how much industry-funded continuing education doctors can receive and what kinds of meals the companies can provide to doctors in their offices or at events.
It also recommends requiring pharmacists to obtain consent from doctors before releasing prescription information to data-collection companies that sell the information back to manufacturers for marketing purposes.
The Medical Society of New Jersey, which represents the state's approximately 33,000 physicians, took issue with the report. Spokesman Daniel Klim said the task force's time could have been better spent on other issues.
"We don't believe that pharmaceutical gifts influence medical decision-making as much as, say, a patient's insurance plan," he said.
Klim said that physicians follow a code of ethics and that real conflicts were rare.
"I think in any industry you could find negativity," he said.
Some industry analysts scoffed at the idea that doctors can self-regulate when the influence of manufacturers has deep roots.
Small gifts lead to bigger benefits, such as free education courses, said Daniel Hoffman, a president of the consulting firm Pharmaceutical Business Research Associates in Glenmoore, Pa.
"It's sort of the opening gambit to a one-hand-washes-the-other relationship that I think has to be broken, to which this kind of ban can be useful," Hoffman said.
Dave Knowlton, president of the nonprofit New Jersey Health Care Quality Institute, said the state should be wary of putting new regulations on doctors who already have too many hoops to jump through.
"I really think that we should be diligent about saying, 'Let's not put another hassle on them unless we really think there's a need for it,' " he said.
Knowlton was on the task force and said he was frustrated that he and other members were left out of much of the process.
He wanted proof that the regulations were needed, arguing that many of the abuses of years past had been remedied through voluntary actions by manufacturers and federal regulations controlling such things as payments to physicians during drug and product trials.
Knowlton said he asked the Division of Consumer Affairs for that information and never received it. He said the task force was presented with a final draft of the proposal after not meeting for more than a year and was given little time to review it.
"The process was not transparent," he said.
Milgram said the proposed rules for pharmacists were important because many people don't know their prescriptions are used as marketing tools. Manufacturers can use the information to target specific doctors, perhaps plying them with gifts or promotional lunches to change their prescription habits, she said.
The measure is subject to further review before the Board of Pharmacy.
Hoffman, the consultant, said prescription-data mining should be checked to even the playing field in the drug market.
"If you've got good drugs on things that advance the standard of care and you're selling them at competitive prices, that will become known," he said.
Harvey Maldow, chief executive officer of the New Jersey Pharmacists Association, wasn't pleased with the proposed change. Prescription information is available to those data-collection companies from other sources, such as third-party prescription plans, and the process of obtaining consent from doctors would be "onerous," Maldow said.
California, Maine, Massachusetts, Minnesota, West Virginia, Vermont, and Washington, D.C., all have restrictions on gift-giving or a manufacturer-reporting requirement.
Congress is considering requiring manufacturers to report gifts or payments to physicians. Penalties would be $1,000 to $10,000 for each item not reported, for a total of up to $150,000. Intentional omissions could bring a total fine of up to $1 million.
The fate of the New Jersey proposal under Republican Gov.-elect Christopher J. Christie is unclear. Spokeswoman Maria Comella said Christie had yet to fully review it.
Milgram said New Jersey needs to act.
"We don't currently have strict enough federal regulations," she said. "To me, the argument of 'please just wait [for a federal plan]' isn't fair to the consumer, because people go to the doctor's every day."