Your doctor just put you on a new medication — the latest, cutting edge drug, he says.
Does it make a difference that the company that makes it just bought him lunch?
The answer to that question lies at the heart of a contentious national debate that is now playing out at the state Capitol. Lawmakers are considering a proposal that would outlaw most gifts — including meals — to health care providers from drug or medical-device makers and require the disclosure of any drug or device company payments to physicians exceeding $1,000.
The proposal comes as the ties between doctors and drug and medical device companies, once an accepted hallmark of medicine, face increased scrutiny. Several states, including Vermont, New Hampshire, Maine and Massachusetts, have already clamped down on the financial relationships, banning most gifts outright or requiring drug companies to disclose payments to doctors.
Now Connecticut has joined the fray, with a proposal that has touched off a fierce fight.
On one side: consumer advocates, health care watchdogs and some doctors who say industry gifts, no matter how small, can influence doctors to prescribe expensive, new drugs instead of less-costly generics. This drives up health care costs and potentially harms patients, they say.
"Patients need to know that their doctors are writing prescriptions based on the best scientific evidence and in the patient's best interests, and not because of pressure from drug companies," Dr. Stephen R. Smith, a New London physician, said in written testimony on the bill.
On the other side: the Connecticut Pharmacists Association, and pharmaceutical and biotech industry groups, who say existing federal rules and industry ethics make a state law unnecessary. A new pharmaceutical industry code of ethics, for example, has prohibited gifts like sporting event tickets or trips to Las Vegas, leaving the industry to give small gifts, like meals, that representatives say are simply a way to fit drug company representatives into a doctor's busy schedule.
"It's preposterous that a physician would advise against his best professional judgment because of a free sandwich," said Paul Pescatello, president and CEO of Connecticut United for Research Excellence, a trade group for the state's bio-pharmaceutical and life science companies.
Extensive Ties
There's little question that the interactions between doctors and the pharmaceutical industry are extensive.
The industry spends billions of dollars a year on marketing to doctors, and studies have indicated it reaches nearly all of them. A survey of physicians, reported in the New England Journal of Medicine in 2007, found that 94 percent said they had some type of relationship with the industry. Most of the relationships involved receiving meals or free drug samples, but doctors also reported receiving tickets to sporting events, payments for serving as a speaker and reimbursement for travel and meeting admission costs.
The dispute is whether the gifts affect the decisions doctors make when it comes to patient care.
Critics of the gifts say the implications are enormous: doctors may feel pressure to prescribe the drugs pitched during a free lunch, even if they are no more effective than cheaper generic drugs or not the best for a particular patient.
The proposed marketing limitations have drawn the support of state Attorney General Richard Blumenthal, the Connecticut Center for Patient Safety and the Consumers Union, the publisher of Consumer Reports.
State Senate President Pro Tem Donald E. Williams Jr. sees the proposal as a way to lower health care costs, which he said is critical to making the system more accessible and affordable.
"When we look at the gift ban, what we're really talking about is finding ways that can discourage the prescribing of more expensive prescription drugs where less expensive generics could be just as effective," he said.
Supporters of the bill cite studies that show relationships with drug companies may influence doctors to prescribe the company's drugs — even if other drugs may be more beneficial.
Citing that research, the prestigious Institute of Medicine last month offered a set of wide-ranging recommendations aimed at eliminating the influence of industry marketing on medicine. The institute recommended, among other things, eliminating all gifts from the industry to doctors and having Congress create a national reporting program to require all pharmaceutical, medical device and biotech companies to make public all payments to doctors and medical groups.
Reforms Unneeded
But opponents of the proposed bill say state action is unnecessary, in part because federal anti-kickback rules and voluntary professional and industry codes of ethics already address payments to doctors. A new code of ethics by the Pharmaceutical Research and Manufacturers of America took effect in January and limits the types of gifts allowed, they say.
In testimony on the bill, the trade group, known as PhRMA, characterized meals provided to health care providers as "professional courtesy" and a way to make sure that pharmaceutical representatives and their educational materials can be fit into doctors' busy schedules.
Pescatello said additional regulations could be cumbersome for smaller biotech companies that might have to hire a law firm or assign an employee to make sure they are complying. It would hit particularly hard at a time when the industry is facing a tough economy, less money from venture capitalists and the uncertainty of potential federal health reform.
"They don't see having another regulatory scheme to comply with as useful," he said.
PhRMA has argued that the bill could potentially discourage drug development and access to clinical trials in Connecticut.
The Connecticut State Medical Society has also raised concerns with the bill. Dr. William A. Handelman, the society's president, said it was somewhat insulting to imply that small gifts like pens or meals would corrupt doctors, but that banning such trivial items was not something to fight over.
But Handelman said he had concerns about the disclosure requirements, which he said could add significant workload to medical practices and may not give the public a complete picture of how the money is used.
It's not clear whether or when the legislature, saddled with a massive budget mess and nearing the end of the session, will take action on the proposal, which passed the public health committee by a vote of 21-9 in March.
Smith, a family physician at the Community Health Center of New London and a board member of the National Physicians Alliance, which is campaigning to reduce marketing influence on the profession, said he's concerned about the proposal's chances against the powerful PhRMA lobby in the waning days of the legislative session.
Smith sees the regulation as an important step in restoring trust in the profession, which he said has been eroded by cases involving doctors with conflicts of interest who may have financial stakes in products or tests they recommend for their patients.
"I think there's been a recognition on the part of medicine as a profession that we have lost our credibility with the public," he said.
