Dr. Robert Califf, President Obama’s nominee to head the Food and Drug Administration, has been the target of serious criticism in recent weeks over his close ties to the pharmaceutical industry. He has received hundreds of thousands of dollars from Big Pharma. Furthermore, his prestigious post at Duke University was underwritten by some of the biggest names in the industry, including Bristol-Meyer Squibb, Eli Lily, Merck and Novartis. Now, there are new questions being raised over a clinical trial that was overseen by Califf in 2011.
That trial is known as “ROCKET-AF.” The purpose of that trial was to compare the effectiveness of the anticoagulant Xarelto (rivaroxaban) with warfarin, an anticoagulant used since the early 1950s. There were serious concerns at the time over the clinical trial for this dangerous medication. ROCKET-AF, conducted at the Duke Clinical Research Institute (DCRI), was funded by the drug’s own maker, Bayer AG, and marketing partner Janssen Pharmaceutica, a division of Johnson and Johnson. In retrospect, it shouldn’t be surprising that an FDA advisory committee found evidence showing that ROCKET-AF was biased in favor of Xarelto. Recently, however, records at DCRI indicate that a device known to be defective was employed for blood tests during the ROCKET-AF study.
The Alere INRatio was designed specifically to measure levels of clotting agent in a patient’s bloodstream. The device was found to give inaccurate results when compared to those obtained from a professional medical laboratory, and was subject to a Class I recall in 2014. Since then, it has been cited as a cause of action in numerous lawsuits.
The INRatio monitoring system was the subject of two warning letters from the FDA in 2005 and 2006 – years before the ROCKET-AF study was started. For some strange reason, the FDA advisory board reportedly knew nothing about the warning letters. Dr. Vasilios Papademetriou, who was on the advisory board and voted to approve Xarelto, said, “This information should have been available to us.” In an email communication with the Project on Government Oversight (POGO), he expressed concerns that faulty readings from the INRatio device may have compromised the results of ROCKET-AF. “It all depends on how often it happened and in how many patients,” he added.
The primary reason for the concern revolves around the manufacturer’s claim that Xarelto is a “one-size-fits-all” solution, requiring no ongoing blood monitoring or adjustments in dosage – unlike warfarin. By providing false readings in warfarin patients, researchers may have given those test subjects higher amounts of warfarin than was necessary. This in turn would have caused higher rates of bleeding in warfarin patients – making Xarelto to appear more effective than it really was.
When questioned by POGO, the response from the DCRI was essentially, “We’re looking into it.” In a written statement, spokesperson Susan Landis wrote the Institute is “conducting an independent analysis of the trial data to understand what effect, if any, the potential device malfunction might have had.” She assured POGO that “results of the Institute’s independent analysis will be shared with the public.
Meanwhile, Califf and the DCRI – which he helped to establish – are facing some difficult questions about the Alere INRatio and its role in the ROCKET-AF study. Califf’s nomination is already being questioned because of his financial ties to Big Pharma. The current investigation by the DCRI is likely to further hinder his chances at being confirmed as new head of the FDA.
Regardless of why Dr. Califf chose a defective testing device and whether or not he was aware of its problems, the entire issue illustrates one of the core problems with the profit-driven health care industry. The main concern of the privatized health care industry is to maximize profits and shareholder dividends. As a result, too many medical devices and prescription medications are rushed through the testing phase and put on the market. The results have been disastrous.
The other part of the equation is the intimate relationship between government and corporations. As a result, agencies charged with protecting the public interest too often wind up serving those of Corporate America instead. “It’s a combination of the revolving door you see between industry and the regulators,” says Levin Papantonio attorney Ned McWilliams, who is heading up the firm’s Xarelto litigation. He adds, “But also, [it’s] the captive agency…we have this agency where they just do not have the power, or they’re just enamored of the power of these drug companies.”
It’s a state of affairs that will only get worse if corporate insiders like Robert Califf continue to be placed in key positions at regulatory agencies.