Life Science Compliance Update

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February 04, 2009

State Policy: Vermont Physician Gift Ban – Time to Leave the Maple Farm

With all the negative ramifications of the serious restrictions on manufacturers’ and physicians' interaction in Massachusetts, Vermont has decided to get into the act. 

According to the Barre - Montpelier Times Argus (that’s right the newspaper is named after a cow), and Vermont Public Radio, the bill S 48 has near unanimous support from members of the Vermont Senate, according to the backers of the legislation (all 30 state senators are sponsors of the bill).  The bill also has support of the Vermont Medical Society (which promotes insurance company services on their website).

The bill calls for a ban on all Food and Drug Administration (FDA) FDA-regulated promotional talks, marketing research, and consulting (which will probably get it thrown out in court, due to that bothersome free speech thing). 

The fine for violations is $10,000 per incidence and also requires reporting of all payments or transfers of value to physicians with no floor, so it would still be enforced if the revised Physician Payment Sunshine Act were enacted.

This bill defines “gift” as any payment, food, entertainment, travel, honorarium, subscription, advance, service, product sample, or anything else of value provided to a healthcare professional.

In addition, they have three definitions of clinical trials: FDA-approved, bona fide, and clinical trial.  Bona fide means that even with FDA–approval, the results have to be able to be published freely and of interest to scientists and health professionals in that particular field.  So, if some crazy “Pharmed out” doctor thinks that a study is not interesting to them, a company stands the possibility of fines.

The bill excludes continuing medical education (CME) from the ban, but they define CME as:

“Significant educational, scientific, or policy-making conference or seminar” means an educational, scientific, or policy-making conference or seminar that:

(A)    is accredited by the Accreditation Council for Continuing Medical Education or a comparable organization; and

(B)    offers CME credit, features multiple presenters on scientific research, or is authorized by the sponsoring association to recommend or make policy.

This definition is especially problematic for rural Vermont as the bill outlaws support for grand rounds which feature one speaker.  Getting a panel of experts to travel to give grand rounds in Barre (population 9,291) or Brattleboro (population 8,289) would be all but impossible.  It will likely mean that Vermont physicians will have to go out of the state to get their required CME hours. 

This bill disclosure of “gifts,” includes research (I surmise they do not want to do research in Vermont).  It also has restrictions on what one can pay a Vermont physician for research and education.

What I find particularly bothersome about all these “gift” bills is that they define payment for service (speaking, consulting, and/or research) as a “gift.” 

Since when is it a “gift” to have to fly to Boston and drive three-to-four hours to some remote town in rural Vermont and give a medical talk (the largest city in Vermont is Burlington -- population 38,899).  These are the same geniuses who gave us Howard Dean, M.D. (remember his scary scream when he lost the Iowa democratic caucus).

One particularly ridiculous quote is from John Brumsted, M.D., President of the Vermont Medical Society in support of the bill: “Patients need to have confidence in the prescribing actions of doctors.”  Perhaps a better statement would be: “patients need to have confidence in the knowledge, education, and informed objectivity of the prescribing actions of doctors.”

The rationale behind all of this was well stated by Senator Kevin Mullin, R-Rutland, a main sponsor of the legislation.  Senator Mullin said state healthcare programs are saving $10 million a year by encouraging the use of generic drugs.  “There are savings to be had.”  This is not exactly an argument for improved patient care or better patient outcomes, but rather, that the state saved money. 

If this bill passes, the patients of Vermont should leave their Maple Farms and go to a real city for medical care.  The doctors and politicians of Vermont believe that the only thing that matters is saving money, but then when they get sick, they all go to New York City.

Vermont Legislature: S48

Barre - Montpelier Times Argus: Bill would expand rules for drug gifts to doctors

Vermont Public Radio: Legislation would limit drug company gifts to physicians

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