After years of debate, the Massachusetts legislature yesterday weakened portions of a controversial law that bans drug and device makers from providing gifts to doctors. Lawmakers voted to allow doctors to receive free meals and they also repealed a disclosure rule that requires all financial arrangements between drug and device makers with prescribers to be posted on a website maintained by the state Department of Public Health.
The changes were included in the fiscal budget that must be approved by Massachusetts Governor Deval Patrick within 10 days, which sources say he is expected to approve. Currently, drug and device makers can only pay for meals offered in conjunction with an educational presentation - otherwise known as continuing medical education - if the meeting occurred in a hospital or office setting.
What will the rollback allow? Doctors can receive “modest meals and refreshments” in connection with non-CME educational presentations about the “benefits, risks and appropriate uses of prescription drugs or medical devices, disease states or other scientific information.” And these must occur in a venue and manner “conducive to informational communication,” according to the bill, although that is not the same thing as accredited continuing medical education.
However, there are reporting requirements. Drug and device makers must file quarterly reports detailing all educational presentations, which must include the location of the presentation; a description of any pharmaceutical products, medical devices or other products discussed at the presentation; and the total amount spent on the presentation and an estimate of the amount spent per participant on any meals, refreshments or other items of economic value provided (see sections 108 through 114 of the proposed budget).
The 2008 law, which you can read here, was seen as a way to limit undue industry influence over medical practice. Similar concerns sparked a US Senate investigation into financial relationships between drugmakers and physicians, and ultimately led to the Sunshine provision in the Affordable Care Act that, next year, requires payments for consulting and grants, among other things.
"The trust at the heart of the patient-doctor relationship is in danger," according to a web site run by the American Medical Student Association, which mounted a campaign against changing the Massachusetts law. "What is clear is that patients disapprove of 'free lunches' and 'wining and dining' for doctors, and they worry about the objectivity of medical decisions."
But the ban has upset some doctors (read here), and pitted various consumer and patient groups against restauranteurs and the pharmaceutical and device industries ever since. Those in favor of repeal argue the ban has stifled business seeking to expand in Massachusetts and robbed the state of revenue, such as a pair of medical industry conventions that were to have been held in the state.
“The gift ban has been devastating to restaurants and thousands of middle-class employees,” according to a statement on the Massachusetts Restaurant Association web site (read here). However, state tax receipts on meals increased last year and the same trend continued through the first five months of this year, according to the state Blue Book (see here and here).
State coffers aside, some eateries maintain the ban has had real consequences. The Chocolate Truffle, for instance, is not selling as many chocolate shoes, a popular corporate gift, since the ban took effect. “We have closed a store in Lynnfield, we have drastically cut the number of employees we have,” Erin Calvo-Bacci told a Boston television station last week (look here). “If that gift ban was gone then we could increase our production.”
Four years ago, the move to enact the ban prompted industry threats to curtail investments and meetings in the state. Four years ago, Sanofi ceo Chris Viehbacher, who then headed the GlaxoSmithKline North American pharma biz, sent harsh letters to Massachusetts lawmakers (read here) and several trade groups similarly issued warnings that clinical trial work may be curtailed (see this). Just the same, the Biotech Industry Organization just concluded its annual gathering this month... in Boston.
One proposal contained in the budget that heartened the American Medical Student Association is the creation of an academic detailing program, which would receive $500,000 in funding. This would provide an evidenced-based outreach and education program on the therapeutic and cost-effective use meds to physicians, pharmacists and other health care professionals authorized to prescribe and dispense prescription drugs.