Over the past few years, we have covered issues and stories regarding the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, which was enacted in 2008. When the Code went into effect on July 1, 2009, it required reporting of all payments or economic benefit over $50.00 and not aggregated, made from manufacturers to doctors, similar to the Physician Payment Sunshine Act. The Massachusetts Department of Public Health collects the payment data and publishes it on its website.
The Code also prohibited certain payments, such as those for entertainment, complimentary items (e.g., pens, mugs, etc.), and even restricted meals. Additionally, the Code required all manufacturers to adopt a marketing code of conduct and to provide training to their employees about such code.
Numerous stakeholders in Massachusetts raised concern over the Code of Conduct. In fact, one study conducted by the Massachusetts Institute of Technology found that “physician-industry collaboration related to physician education and technology development was impaired by the Massachusetts regulations, with evidence of a larger negative impact on physician education.” The study also found that a “majority of physicians claimed that physician education has been impaired as a direct result of the Massachusetts regulations, and a majority of company representatives stated that their ability to keep physicians updated had been impaired as a result of the law.”
In response to these concerns, and several attempts to repeal the legislation, the Massachusetts legislature finally amended the Code this past summer. The changes include allowing for payment of expenses for medical device training, meals for non-CME presentations at locations beyond hospitals, medical offices and training sites, elimination of state reporting for physicians that duplicates federal Sunshine Act reporting, and the addition of quarterly reports for the non-CME events by manufactures.
Then, just last week, the Massachusetts Public Health Council passed the first round for emergency regulations to allow companies to provide modest meals for healthcare providers for product education.
In response to our story, a Massachusetts physician contacted us about a recent experience involving the Massachusetts code. The physician was at a work/research meeting to discuss the design of a multi-center a clinical trial of a new small molecule. The company needed input on which subgroups of patients had the greatest need for the specific type of compound.
Lunch was served during the meeting, and although the physician received his lunch, his plate was soon taken away because the supporter’s lawyers had determined that no physicians from Massachusetts could eat at scientific advisory boards. All the other physicians received food. The physicians insisted to no avail that this was an incorrect interpretation of the rules, given the recently passed repeal and emergency regulations regarding modest meals for non-CME presentations.
Nevertheless, the physician had to leave the meeting to get food himself, which he then submitted as an expense to get reimbursed. The sad part, the physician explained, was that this was not the first time this had happened.
While transparency is a laudable goal, shaming physicians for no wrongdoing and embarrassing them in front of their colleagues, is one of the significant consequences and costs that come with it. Placing a physician in an embarrassing situation like this, for a simple meal, so that he and his colleagues could continue planning a clinical trial that will eventually lead to a cure or treatment is shameful. Continued actions such as this will discourage researchers and physicians from participating in such activities, which will only throw sand in the gears of innovation, slow medical progress, and hurt patients.
Physicians and researchers give up their free time, their weekends, and their time with their families, so that important breakthrough research can be conducted and science can move forward. While transparency in any research relationship may be considered by some important, stigmatizing a physician for being hungry is nonsensical and truly shows the potential harm the Physician Payment Sunshine Act may really have on physician-industry collaboration.
Is this really what we want to be spending a quarter of $1 billion on? Do patients really find value in knowing everything their physician has ate during lunch while trying to improve their knowledge and competency about a certain disease, or trying to conduct research? How will knowing what this doctor ate, or prohibiting from eating lunch with his colleagues when they would be discussing research improve a patient’s healthcare?
We have asserted for years that the unintended consequences of transparency are chilling innovation, and while this doctor gave no indication of his desire to stop doing research with industry, his message to us clearly shows his dissatisfaction and disgust.
This situation truly underscores the significant need to educate patients and consumers about such payments when they are made public and the tremendous amount of context that will be necessary to ensure that doctors such as this one do not have to walk with their heads down to McDonalds for trying to improve the lives of millions of Americans.