When you take money from everyone, is it no longer a conflict of interest?
I only raise the question after reading the latest in the ongoing dust-up over implanted defibrillators, where the latest company on the hot seat for selling flawed devices (St. Jude Medical) has accused the scientist who brought the situation to light–Dr. Robert Hauser of the Minneapolis Heart Institute Foundation–of undercounting the deaths associated with their main rivals’ devices. Why does the metaphor “falling out among thieves” come to mind?
St. Jude and Medtronic are not thieves, of course. They merely take advantage of a flawed Food and Drug Administration process for approving new devices, where updated devices can enter the market without extensive clinical trial testing because they are only minor variations from earlier technology. When the “minor” variation turns out to be flawed electronic leads that cause the device to repeatedly misfire, leading to the equivalent of a mule kicking the non-patient in the chest (see this excellent New York Times story by Barry Meier), then perhaps we have a problem with our regulatory system. Those pre-marketing approval regulatory flaws are compounded when the FDA still has no adequate system for post-marketing surveillance, although its planned Sentinel System is under construction.
And that’s exactly what Dr. Hauser pointed out in this excellent commentary in the New England Journal of Medicine last month that shed light on the St. Jude situation. He wrote:
Why are we placing patients at risk when the tools and technology are available to monitor vital medical devices such as ICDs, heart valves, and coronary stents? The problem is that our current passive postmarketing surveillance system fails to detect significant device defects before large patient populations have been exposed. Consequently, we repeatedly find ourselves reacting ineffectively, even dangerously, to big problems with devices by subjecting patients to care strategies that are not supported by solid clinical evidence.
Hauser and his colleagues in Minneapolis have been on the front lines of exposing both St. Jude’s and Medtronic’s problems. Both companies are headquartered in Minnesota. So I was interested to see how the $11 million-a-year organization keeps body and soul together. Hauser reported no conflicts of interest, including none for the institution that employs him, on his disclosure forms filed with NEJM.
Yet if one goes to the donors page of the institute’s annual report, one finds a different story (the most recent year on its website is for 2010). There it is reported that Medtronic has given over $1 million to the organization over the years, while St. Jude’s and Boston Scientific have given between $250,000 and $999,999. Not to be outdone, the trial lawyers who sued Medtronic (reported as the “Co-Lead Counsel and the Plantiffs Steering Committee for the Medtronic ICD Products Liability Litigation, MDL # 1726”) also gave over $1 million.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
So here I think we have finally found the solution to the vexing conflict-of-interest problem. Rather than banning people with conflicts of interest from writing editorials and commentaries in leading medical journals (which, if properly reported, might have caused NEJM editors to pause before letting Dr. Hauser write his piece), editors should simply insist that they take money from everyone. It clearly hasn’t dissuaded Dr. Hauser from doing yeoman-like work on behalf of the public health and safety, for which he is to be congratulated.
