Massachusetts Code of Conduct: Impairs Local Biotech Industry
Earlier this month, Carey Kimmelstiel, MD, director of the adult cardiac cath lab and interventional cardiology at Tufts Medical Center, gave a presentation at the Society of Vascular Surgery (SVS) annual meeting in Boston. During his presentation, he asserted how “the proliferation of policies that have sought to distance the relationship between industry and healthcare providers could reduce medical innovations and ultimately, stunt improvements in patient care.”
In a follow up interview with Cardiovascular Business, he noted how these policies are contrary to what patients want and need because “most people operate under the assumption that an educated and informed physician provides patients with the best care, and patients benefit from innovative medications and devices.” Informing physicians and providing them with education means maintaining the relationships between industry and healthcare providers that have led to numerous achievements and better results for patients. Enacting regulations governing “what physicians do and how they do it,” with regards to the interactions of physicians with industry does not accomplish this.
Likewise, laws such as the Sunshine Act, federal and state policies, and the National Institutes of Health (NIH), which make corporate consulting almost nonexistent, do little in the way of making sure physicians remain educated for the benefit of innovative medicines and devices to treat their patients with.
For example, a law in Massachusetts enacted a gift ban, which applies to Massachusetts physicians not only when they are in the state, but also wherever they may travel to, and also placed “strict limits” on continuing medical education (CME) and academically professional presentations. Dr. Kimmelstiel noted that these regulations not only “made illegal practices that are not illegal elsewhere, but also elucidated a double standard because lawmakers are not adhering to these stipulations.” As a result, he acknowledged how “current regulations like those in Massachusetts and Minnesota, threaten the academic mission in terms of post-graduate medical practice.”
Another negative consequence from these kinds of laws in Massachusetts is that companies such as “Pfizer pulled back grant funding for a visiting professorship program in Massachusetts.” This kind of company response is problematic because although “companies would not actually be breaking the law by continuing funding, they just don’t want to worry about compliancy issues.” That creates a huge problem for states like Massachusetts because companies “are just walking away from the state instead of having to worry about liabilities due to compliance.” As a result, jobs go elsewhere, taxes are lost, and surrounding businesses (e.g. restaurants) suffer.
This type of problem is also being seen by a “huge decline” in CME-funded meetings. Such a decrease is particularly problematic since there is very little data showing industry support can lead to bias in CME or non-CME presentations. Instead, Kimmelstiel noted a reported from the Accreditation Council in Continuing Medical Education released in June 2008, which found that there is “no empirical evidence to support or refute the hypothesis are biased, and there is limited evidence to suggest that CME activities funded by commercial interests can be effective in changing physicians’ prescribing practices.” This kind of evidence was also supported in three other studies (Cleveland Clinic, Medscape, and UCSF).
Dr. Kimmelstiel also noted the negative impact the Massachusetts law has had on “the clinical benefit that results from innovation.” For instance, he cited a Boston Business Journal article, which clearly showed that “in the year following the gift ban enactment in Massachusetts, jobs were being lost in the state, and fewer pharmaceutical companies and medical device makers are willing to host clinical trials in states with such laws.” This kind of loss is significant considering the cost and huge investment companies have to make to produce innovation.
Assessing closer the impact of the recent gift ban in the year since its enactment, a recent Massachusetts Institute of Technology thesis paper “found that 70 percent of industry respondents reported an “impaired ability to collaborate” with Massachusetts physicians and 83 percent reported a “decreased interest” with Massachusetts physicians. The results also showed that 83 percent of physicians reported an “impaired ability” to collaborate with industry to develop new devices and new technologies, and that 79 percent of physicians reported that their education had been impaired. In addition, over half of the respondents said they perceived a negative long-term impact on patient care through impaired physician education.
In the end, Dr. Kimmelstiel noted that “increasingly tight restrictions on free trade and interaction between manufacturers and prescribers will truly reduce innovation, efficiency and productivity.” At present, leaving understaffed and under resourced governmental agencies to wait years to approve drugs that sit in the “valley of death” is unacceptable to patients and physicians.
What we need instead is for policymakers to determine “what method of innovation delivers cures to patients in a timely manner, and whether policies serve those characteristics.” Since it is clear that prohibiting interactions with industry will make delivery of new medicine and devices difficult, what we need now are policies that encourage such relationships and foster collaboration to its fullest because patients expect and deserve the most educated and informed physician for their treatment.