Vt. testimony sharply divided on free drug samples

Medical practitioners on Tuesday presented ardent as well as disparate views to a Vermont state panel reviewing the merits of free medicine samples provided at doctors' offices.

Curbing or even eliminating the free samples could be the next stop for Vermont, a state that already holds drug companies accountable for their marketing efforts.

The Vermont attorney general's office held the hearing, part of a broader study to be submitted to the Legislature in December.

It was supposed to be a discussion about the prospect that Vermont might require drug company to disclose when representatives provide free samples of the wares to doctors and other providers.

If this were to happen, Vermont would assert itself further nationally in efforts to loosen the grip of the pharmaceutical industry on health care delivery.

"No other state actually requires reporting samples of any kind of medical product," Marjorie Powell, senior assistant general counsel with the Pharmaceutical Research and Manufacturers of America, an industry group, said in an interview. "Vermont is in that sense standing alone among the states."

Testimony frequently drifted, though, from the question of disclosure to whether the free samples are a good idea at all - a boon to doctors trying to provide medicines to low-income patients and those without insurance, or a marketing ploy that distorts the way health care is delivered.

The hearing drew dozens of drug industry lobbyists who are paying rapt attention to Vermont's ongoing efforts to regulate drug companies' marketing efforts. This year, the state banned free lunches given by drug company representatives to doctors and other prescribers, which Powell called the toughest such law in the country.

The state also has been a leader in requiring disclosure of trips, fees and other things of value the companies give doctors. Some of those testifying worried that Vermont is creating too harsh a climate for drug companies and health providers. Others focused purely on the question of free samples.

"I personally have given samples to patients who did not have any other way of obtaining those medications. And in many cases patients received lifesaving treatments through the use of these samples," said Dr. Richard Pinckney, an internal medicine physician and assistant professor at the University of Vermont College of Medicine.

Dr. Steffie Woolhandler, a primary care physician and associate professor at Harvard Medical School, said the samples are most often new and expensive drugs, some of which have not been adequately tested, and end up later getting "black-box" warnings about unforeseen dangers.

"Four of the 15 top samples given to kids in 2004 got one of these new danger warnings, a new black-box warning within three years," Woolhandler testified by telephone.

"Among adults two of the most sampled drugs in 2002 were Vioxx and Celebrex, obviously found within a year or two to have very serious and lethal heart disease side effects," Woolhandler added.

Ken Libertoff, executive director of the Vermont Association for Mental Health, argued that free drug samples should be banned in Vermont.

"There are clinical studies that conclude that samples induce the use and reliance on the most expensive drugs when less expensive medications could and oftentimes would work as well," Libertoff said. He said prescribing decisions should be made "based on what is medically appropriate" and not which drugs are in best supply in the doctor's sample cabinet.

But others argued that free samples help fill in the gap when a patient can't afford a medication, is awaiting prior approval from a balky insurance company or faces a copay so steep it will cut into the grocery budget.

"I like to have a patient try a new medication that might have an expensive copay with a sample so we can be sure a patient tolerates the medicine before having to pay for it," said Dorothy Malone-Rising, a nurse-practitioner who works in the northern Vermont town of Johnson.

She said samples are especially important for diabetic patients, from whom preparing and giving themselves a first shot of insulin is often a traumatic experience.

"Having their provider at their side as they give their first injection is essential," Malone-Rising said.

The attorney general's office is to prepare a report for lawmakers by Dec. 15.

Attorney General William Sorrell said he expects the report will focus mainly on the disclosure issue, and leave the debate over whether free drug samples are a good idea to another day.