While it's no secret that pharmaceutical companies lavish gifts on doctors -- everything from free notepads and pens to meals to the more extravagant paid trips or seminars -- most patients are in the dark about who, exactly, is courting their physicians. But Congress may be finally acknowledging this relationship, one important step toward creating a national gift registry so patients can track the perks Big Pharma is giving to their doctors.
In June, the nonprofit government watchdog Public Citizen testified before the Senate Special Committee on Aging in favor of federal legislation that would require drug companies to disclose payments to doctors. But the group urged lawmakers, before jumping on the proposal, to examine a Petri dish of existing disclosure laws. Although four states and the District of Columbia already have disclosure laws on the books, the group says they are "inadequate" and do not give patients a clear picture of how money is changing hands.
The pharmaceutical industry spent an estimated $25.3 billion peddling prescription drugs in 2003, and much of that money went to physicians in the form of free samples, meals, conference fees, air fares, and continuing medical education activities. The only reins on Big Pharma's giveaway are voluntary regulations set by the American Medical Association (AMA) and adopted by the trade association Pharmaceutical Research and Manufacturers of America. The AMA's ethical guidelines, which are supposed to "prevent inappropriate gift-giving practices," only sanction gifts valued at $100 or less.
The pharmaceutical industry is adamant that these gifts have no influence on which drugs physicians prescribe to their patients. But a growing body of evidence shows that drug companies' generosity may in fact be guiding the pen across the prescription pad.
"The drug industry doesn't spend $20 or $30 billion a year on advertising prescription drugs unless they believe it has an impact on doctors prescribing," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "You would probably like to know whether your doctor is getting no money, some money, a lot of money, or a huge amount of money, because it's going to influence what that doctor decides for you."
Public Citizen says a federal disclosure law would give patients the ability to track their doctors' financial ties to drug companies. "We need a strong, uniform national law that requires every state [to have] these kinds of disclosures," Wolfe said. "State laws are better than nothing, but filled with problems."
In March, Wolfe (along with three other physicians and one medical student) published a paper in The Journal of the American Medical Association (JAMA) that analyzed Vermont's and Minnesota's publicly available disclosures of payments made to doctors from 2002 to 2004. The researchers concluded that both states' laws failed "to provide the public with easy access to information about these payments," and were "insufficient for revealing the true patterns of payments."
In Vermont, patients can obtain an annual summary report detailing how much money drug companies have given to health-care providers, and the form and purpose of the payment. The report does not, however, list recipients by name, but rather uses generic terms, such as "family practice" or "oncology." Patients cannot search for their specific doctor, nor is the information available in an online database.
Vermont's reporting requirements have also been criticized for allowing pharmaceutical companies to claim a "trade secret" exemption, which protects them from disclosing many of their payments to doctors. Assistant Attorney General Julie Brill defended Vermont's report, saying it "does an analysis that we think gives the public a pretty complete picture of what is going on, although it doesn't name names."
Brill also said there were holes in the JAMA article, which she said "never discussed the reason for the trade secret exemption." Brill said Vermont's laws protecting trade secrets are broadly written, and the legislature feared drug companies would legally challenge the disclosure law if the trade secret exemption was not extended to them. "We would not like to see the [disclosure] law struck down, or be stuck in limbo, while this trade secret issue is being litigated," Brill said.
The JAMA authors recommended that disclosure statements be made available online, but Brill countered that in Vermont, "it was never envisioned that there was going to be a website where people could have access to data. That takes money; that takes time."
In Minnesota, researchers found that payment data was never compiled into a report or a database, and that to obtain the records, they had to physically travel to the state’s Board of Pharmacy's office and make photocopies themselves. Since then, the documents have been digitally scanned and are available online. Unlike in Vermont, the vast majority of the disclosure statements do contain doctors' names. But Cody Wiberg, the board’s director, said that patients wanting to find information about their doctors "may have to do a little work" because the documents have not been indexed by the doctor's last name. "Admittedly, it's not searchable," Wiberg said. "You actually have to go through document by document, and there are thousands of documents."
Wiberg said the state's poor showing in the JAMA article can be attributed to a lack of money and clear direction from the legislature. The board plans to hire additional clerical staff and expects to create a searchable database in the coming year, according to Wiberg.
During the Senate hearing last month, Public Citizen also offered analysis of disclosure laws in two other states, Maine and West Virginia, plus the District of Columbia. Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group, testified, "Although these statutes are undoubtedly intended to increase the transparency of the physician-pharmaceutical company relationship, it is clear that all fall well short of their aspirations."
And while these laws are falling short, the vast majority of states have no disclosure laws at all.
"One of the standards for [deciding if] it's appropriate to take a gift from a company is asking, 'What would my patients think if they knew out about this?'" Wolfe said. "Since most doctors don't even have to face the prospect of their patients finding out about it, they can evade that test. And none of them should be able to evade that test."
Wolfe said a federal disclosure law would offer patients better protection. "Ideally, patients should be able to go to some central, national, online database, put in the name of their doctor, and get all the gifts the doctor has gotten from all of these companies," he said. "We are nowhere near that yet. Slowly, it might happen at a state level, but ideally it should happen at a federal level so you can have the same requirements affecting doctors in Maine or Massachusetts or Montana or California."
Following Public Citizen's testimony, Democratic Sens. Claire McCaskill of Missouri and Herb Kohl of Wisconsin said they intended to push for a national registry. McCaskill's press office would not give details about any forthcoming legislation, but said the senator has "moved in the direction of a national disclosure registry for gifts to physicians."
''If it becomes a public record, it will have a cleansing effect on what I think is an insidious practice,'' McCaskill told the Miami Herald in July.
To avoid the same pitfalls as the state laws, Wolfe said Congress has to "be serious" about creating legislation that does not shield drug companies and doctors. But with lawmakers remaining mum about it, it is too early to tell if possible legislation will have any teeth.
But even as Public Citizen is advocating for a national disclosure law, it admits that such measures are simply a Band-Aid for a more systemic problem – that pharmaceutical companies are allowed to give gifts to doctors in the first place. As Lurie told the Special Committee on Aging, "Payment disclosure laws are a first step toward addressing the problem, but they are not the only method or even necessarily the most effective one."