By Stephen Cha
Sunday, July 24, 2005
NEW HAVEN, Conn.
When it comes to accepting gifts from the marketing reps of pharmaceutical firms, the American College of Physicians-American Society of Internal Medicine suggests that its members apply a simple litmus test: "What would the public or [our] patients think of this arrangement?"
Most patients never find out. If they did, they'd probably go into shock over the goodies doctors accept, like meals, travel, gift certificates or parties. The pharmaceutical industry estimates that it spends about $5.7 billion a year on marketing directly to physicians, which works out to about $6,000 to $7,000 per doctor.
Three years ago, Vermont enacted a groundbreaking law intended to remedy the situation by requiring the drug companies to publicly report promotional gifts and payments to physicians. As in many areas of government and business, the law was tailored with the idea that sunshine is the best cure for the ethically questionable practices that thrive in secret. If shame alone fails to curtail excesses, then at least information about gifts and contributions can empower voters, investors or consumers to make more educated choices, aware of potential conflicts of interest.
Yet in the world of medicine, this is a new concept and, judging from Vermont's experience, legislation about it may require further surgery. Not only have pharmaceutical companies and doctors circumvented the disclosure rules, but it's virtually impossible for patients to find the information.
"It's not surprising that this extraordinarily well-financed industry circumvented the law," says Peter Shumlin, the former Vermont legislator who sponsored the bill. "The surprise is that we consumers still take it."
The scope of the problem in medicine is well known -- at least among doctors.
As a medical student, a colleague of mine once walked into the offices of a practice where she was working and unexpectedly found herself at a party. Food, trinkets, pens and coffee mugs were being handed out to the whole office staff, about 20 people including med students and doctors -- all courtesy of Merck & Co. And to the physician who was the number one prescriber of Vioxx in the entire region that year, a marketing rep of the company awarded a pair of Philadelphia Eagles season tickets.
That was almost five years ago, and the party for Vioxx has ended -- the painkiller got yanked from the market because it could cause heart problems. Recent congressional investigations revealed that Merck marketers had misled physicians, wrongly suggesting that Vioxx was better for the heart than other pain relievers, even after research suggested possible dangers.
Did Merck's perks encourage that doctor to prescribe a drug that he might otherwise have avoided? It's difficult to judge. Like political contributions, these gifts are not necessarily improper, and some industry-physician collaborations can lead to important advances. But research shows that such largess affects physicians' prescribing practices and may compromise their objectivity.
Certainly if I knew that my doctor was getting $5,000 to $20,000 a year from the maker of Vioxx, I would wonder why the doctor was prescribing it.
"I think the public would be outraged if it knew the extent of the industry's influence in prescribing decisions," says Shumlin. "We hoped to force industry to show the extent of these practices, and hoped to embarrass doctors into changing their own practices." Hoping that these changes in practice would help stem the rising costs of prescription drugs, 23 states have since considered, and a handful have adopted, similar legislation.
So far, however, industry has exploited loopholes in the Vermont legislation to avoid full public disclosure. For instance, the law says that gifts under $25 or grants for "research" need not be reported. And even when those gifts are reported to the government, the disclosure can be withheld from the public if the industry designates its own reports as "trade secrets." And the reports of gifts are made to the state attorney general's office, which doesn't keep a public database with real-life physicians' names and gift descriptions.
Instead, the attorney general issues annual overviews. In the May 2005 report, the most recent, the industry reported about $3.11 million in gifts in Vermont. None of the state's 2,200 doctors are named.
Nancy Chard, a Vermont state senator on the conference committee that forged the legislation, says, "Doctors' names should be out there. But the bill got toned down to a point where it's just a happy memory. I'm proud of having done it, but it's not a viable piece of legislation. There are so damn many bad guys in this thing."
Worried that Congress might spoil the party, some organizations have begun self-regulation. The American Medical Association and the pharmaceutical industry issued a set of voluntary guidelines on gifts. For instance, gifts should be under $100 in value unless they are payments as part of a formal consulting relationship. This gesture, and $91 million in campaign contributions the two industries made during the 2004 election cycle, have been enough to keep Congress out of this dogfight.
Given the amount spent on marketing per physician, it's clear that many gifts are not within the AMA guidelines. In Vermont, many reported payments to individual physicians ran into the thousands of dollars. "I'll tell you one thing," says Chard. "There are still plenty of [pharmaceutical] dinners going on at the local fancy restaurants."
"It's unconscionable that they're spending $3 million on trinkets here in Vermont when my patients can't afford to pay for the medications to treat their high blood pressure," says Benjamin Littenberg, director of general internal medicine at the University of Vermont. Littenberg accepts no gifts, no drug detailers and no materials from drug companies or their sales reps. (He's also never written a single prescription for Vioxx.)
Legislators in Vermont started with the simple idea that the billions of dollars industry hands to physicians should be public knowledge. And there are some simple ways to fix the rules the law established.
· Remove trade secret exemptions that subvert the entire point of the law. Allowing a drug company to decide what is a trade secret is like permitting John McEnroe to make his own line calls.
· Require disclosure of the identities of gift recipients. Imagine if all political contributions had to be disclosed, but the public never learned who received them.
· Improve data quality. More than half of the "name-identified data" in Vermont contained only a last name and amount of gift.
"Do-not-call" lists that are made public could provide broad recognition and encouragement for physicians who rebuff drug reps. No Free Lunch, an organization that advocates a complete ban on promotional gifts, also collects commitments to spurn industry gifts. Already, more than 250 physicians have taken the pledge.
Littenberg says, "Taking anything from drug companies violates a trust. They shouldn't be allowed to offer [gifts], and we shouldn't be allowed to accept them, and it's appalling it's even an issue. It would be like Consumer Reports taking money from the washing machine manufacturers."
While people have criticized the pharmaceutical industry for promoting less-than-desirable drugs, the fact is that for every dangerous or inappropriate drug prescribed, there is a prescribing physician -- one who may have been unduly or unconsciously influenced by these quiet billions in gifts. Physicians should serve as patients' trusted intermediaries, but that trust must be built on openness; the public has a right to know about potential biases. Public disclosure may not stop the distorting influence of money in medicine, but it should be the first step.
Stephen Cha is an internist and a Robert Wood Johnson clinical scholar at Yale University School of Medicine.