[1]thx to colin dun on flickr creative commons
In 2013, the American Heart Association issued new guidelines [2] for treating cholesterol, causing a stir that more patients may wind up being treated with medicines. As part of that process, the expert panel members who oversaw the document disclosed their financial ties to drug makers. But one large payment was not divulged.
The panel vice chair, Jennifer Robinson, a University of Iowa professor of epidemiology and internal medicine, did not disclose nearly $110,000 in research grants that she received from Eli Lilly for running tests for an experimental cholesterol treatment. The grants, however, can be viewed on the federal Open Payments database [3] that tracks payments made by drug and device makers to physicians.
In a statement, an AHA spokeswoman called the failure to report the payments an “oversight,” but acknowledged that it “does not comply with our disclosure policy.” And so, the AHA is updating the guidelines documentation to correct the record. The failure to disclose the payment was first noted [4] by Unite Here, a labor union.
There is no indication of any wrongdoing or that the failure to report the Lilly payment has had an effect on medical practice. The Lilly drug is still not available, because the drug maker placed further development on hold. But the episode highlights ongoing concerns over financial ties between researchers and the pharmaceutical industry – and what some experts say is a need to ensure disclosures are complete.
“Transparency is critical to ensure that the American public gets medical advice that is clinically relevant and free of corporate marketing,” said Paul Thacker, a former aide to US Senator Chuck Grassley of Iowa, who investigated ties between physicians and industry that led to the creation of the Open Payments database.
In an e-mail, Robinson wrote us that the decision not to disclose the Lilly payments was, essentially, a timing issue. She began work on the Lilly study shortly after the AHA panel completed the guideline recommendations and submitted them for publication. This submission also occurred before she received any payments from the drug maker.
“The Eli Lilly study started after the guideline recommendations were completed, so it was not on my radar to report,” she wrote. She added that the funds were paid to the university to cover the cost of the research she was conducting, which is a standard price. “They are not direct payments to me,” she added.
The AHA further explained that Robinson abstained from voting on the recommendations because of her financial ties to several other drug makers, which had been disclosed. The organization also said that Robinson did not believe it was relevant to disclose the relationship with Lilly, because the type of drug involved in the testing was not included in the recommendations.
The Lilly drug being developed is a PCSK9 inhibitor, a new type of injectable treatment that, at the time this episode occurred in 2013, was not yet available because it was in mid-stage testing. However, the medicines were already starting to generate interest, since clinical tests run by other drugs makers indicated the treatments could greatly reduce levels of LDL, or bad cholesterol.
As a result, there was also growing chatter the drugs could become big sellers. This past summer, the Food and Drug Administration approved two of them – Repatha from Amgen and Praluent from Sanofi and Regeneron Pharmaceuticals. Both drugs were priced at between $14,100 and $14,600 per year, substantially more than statins, older drugs available for pennies a pill.
Given the growing buzz in the medical and financial communities, one disclosure expert says the payments should have been reported, regardless of the specific timing.
“A person who knows they are going to be on a guideline panel may already have in mind that they will be useful to a company,” said Sheldon Krimsky, a Tufts University professor who has studied conflicts of interest. “That [type of] anticipation and eventual affiliation with the company can affect their role in developing the guidelines, especially if there are drug therapies involved.”
One labor union, which is critical of financial ties [5] between industry and the AHA, worries such relationships can raise health care costs. “The AHA should prohibit its authors and leadership from accepting industry payments,” said Arthur Phillips, a research analyst at Unite Here. The union, which represents workers in the hotel, gaming, food service and textile industries, among others, recently began a campaign to end industry funding of continuing medical education, which are programs that doctors are often required to attend to maintain their licenses.
However, industry and some researchers argue completely severing ties is not practical, because they say the most qualified experts often have relationships with drug makers.
The episode should also be seen as a warning for professional medical societies that issue treatment guidelines, according to Thacker. “AHA is doing the right thing by publishing an erratum, but they should tighten their disclosure requirements in the future,” he intoned. “It shouldn’t take a call from a reporter to let them know that something went awry.”