Sen. Charles Grassley fired off the latest in a series of letters aimed at the healthcare bureaucracy, this times asking Food & Drug Administration chief Dr. Margaret Hamburg how her agency handles physicians’ potential conflicts of interest.
The Iowa Republican, citing financial disclosure forms filed by Medtronic Inc. (NYSE:MDT) and ethical guidelines for physicians who are on medical device and pharmaceutical firms’ payroll, Grassley asked Hamburg to describe how the agency treats “financial interests that may present a conflict.”
Noting that FDA rules require the disclosure of “significant financial interests” of the clinical investigators companies employ, Grassley asked Hamburg to specify how the agency decides whether those interests affect “the rights and welfare of human subjects” or the integrity of trials.
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“Assuming there are no compelling circumstances, are there financial interests that the FDA would consider too significant a conflict to be appropriate for a clinical investigator to be involved in a study?” Grassley asked. “Does FDA advise manufacturers on specific steps that should be taken to minimize potential bias? Are there actions that FDA expects companies to take to manage potential conflicts of interest?”
The Medtronic filings covered 32 doctors “who may have conducted studies on behalf of Medtronic” between January 2007 and April, according to Grassley. Seven of the docs received “significant payments,” from the company. For example, Medtronic doled out consulting fees ranging from $40,000 and $2 million to some, $1 million in royalties to other and “several thousand” in MDT stock, according to the letter.
Fifty docs received “significant” payouts from the Fridley, Minnesota-based medical device giant.
“Almost all of these investigators received significant payments from Medtronic. Two of the investigators met three of the four criteria for disclosure to the FDA. Not only did they receive ‘significant payments of other sorts,’ but they also had a proprietary interest in the product tested and a financial arrangement where the value of compensation could be influenced by the outcome of the study,” Grassley wrote.
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.
The senator has long been interested in how federal bureaucracies administer healthcare. He was the driving force behind the inclusion of a so-called “Physicians Payment Sunshine Act” provision in the healthcare reform legislation, which requires medical device, biotech and pharma firms to disclose their financial arrangements with physicians. This year alone Grassley has quizzed the Centers for Medicare and Medicaid Services about how it polices its contractors; asked the FDA about adverse events connected with electronic medical records systems; and probed a U.S. Veterans Administration official’s past ties to Medtronic.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
