They that giveth are now taking away. Much fanfare was made about Deval Patrick and the Legislature’s Biotech bill. Which Deval has said will create a quarter of a million jobs over the next decade in Massachusetts. That number aside, it seems that due to an obscure provision in a health care bill waiting for the Governor’s signature, all the fanfare could be for naught.
According to an op-ed in yesterday’s Boston Herald a provision contained in the Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care, could have the affect of stopping clinical trials in Massachusetts dead in their tracks.
Among other provisions, the bill would require public disclosure when payments of $50 or more are made between pharmaceutical research firms and health-care providers. The information from these transactions – which includes physicians’ names – would be posted on the Internet.
Transparency is generally a good thing. But publishing a list of doctors who have been involved in financial transactions through the state’s many academic research programs and clinical trials with pharmaceutical companies suggests that there is something wrong with these associations, even though the payments are neither illegal nor unethical.
According to the National Institutes of Health, there are currently 5,673 clinical trials being conducted in Massachusetts alone – and nearly 2,000 of them are recruiting patients. Many of these important programs could be threatened under the legislation. How many of the doctors and researchers already involved in trials might decide that the unwanted public attention is not worth their participation? ……….
……Fears of biotechnology firms choosing to do business elsewhere are also real. And their absence would create a gaping hole. Biopharmaceutical companies employ nearly 55,000 people in Massachusetts, according to the Center for Labor Market Studies at Northeastern University. And that number has been growing. Whereas Massachusetts lost 100,000 private-sector jobs between 2000 and 2005, the biotechnology industry created 6,100 jobs.
When developing life-saving and life-enhancing medicines, drug companies depend on physicians and academic scientists. This legislation unwisely cuts into that indispensable relationship.
They that giveth taketh away. I’ve been part of a clinical trial for a topical dermatological agent. It worked better than anything I had previously taken. That drug and countless others which save lives are developed and tested in the Commonwealth. This proposed law, which still has the chance of being vetoed, could crush that innovation. All the tax breaks in the world don’t matter if clinical trials are stopped in their tracks, due to doctors not wanting to participate in them.
more after the break—
Lest you think this is all hyperbole and Chicken Little language, read this letter from Anil Nair a clinical neurologist from Boston University, to Governor Patrick.
Dear Governor Patrick,
As a practicing neurologist and a clinical researcher at Boston University Alzheimer’s Disease Center, I’d like to thank you for the leadership you’ve exhibited to build upon the Commonwealth’s already strong presence in the life sciences. I was proud and deeply encouraged when you signed the related legislation into law less than two months ago.
This amazing commitment to create the nation’s premiere environment for the advancement of life sciences provides optimism to those of us who have a vested interest in a strong and vibrant research community. And importantly, it offers great hope for patients who anxiously await new cures and treatments for Alzheimer’s disease and other devastating ailments.
However, I am deeply concerned that the great promise afforded by this initiative could be endangered by subsequent healthcare legislation (S 2683) awaiting your signature. While I fully endorse the underlying intent of the legislation – lowering healthcare costs in the state – Section 14, which requires disclosure of payments valued at $50 or more by pharmaceutical companies to physicians and other healthcare professionals, is troublesome.
Posting this information – essentially a list of companies, dollar figures and doctors’ names – on a public Web provides a one-dimensional window into the existence of a professional partnership. It offers little if any useful information and threatens to raise unnecessary suspicions and misinterpretations.
Of particular concern is the fact that those who access and make judgments on such information may lack the context to understand the true nature of the payments.
For example, in many cases a payment provided by a pharmaceutical company to a physician is used to cover the hospital and staff expenses necessary to conduct the research, as opposed to being actual compensation to the individual physician. Some hospitals or academic research centers even insist that the physician take the payment in his or her name, so that the institution can avoid the appearance of having received payment from a company.
The disclosure requirement disregards such complexities and nuances in the partnerships between researchers, institutions and companies. If enacted, it is possible – perhaps even probable – that an entire grant will be linked to an individual physician’s name, creating misimpressions in the public eye as to the level and purpose of the compensation. Such misperceptions could unfairly impact the physician’s reputation, and more alarmingly, could jeopardize the relationship shared with his or her patients.
If Massachusetts adopts this disclosure requirement, I fear future research, patient access to clinical studies and the state’s life sciences program would suffer irreparable harm. I urge you to return S 2863 to the legislature with an amendment to eliminate Section 14.
Anil Nair MD.
Assistant Professor, Department of Neurology Boston University School
Governor Patrick should veto this bill.