Fresenius in Hot Water with FDA for Poor Communication

Fresenius in Hot Water with FDA for Poor Communication

June 19th, 2012 // 12:09 pm @

Source

Consider this scenario: A company runs the largest chain of dialysis centers in the US and is also the leading supplier of products that are used not only by its own clinics, but my many rivals. In 2010, the company discovers a potentially lethal risk is associated with one widely used product. Last fall, the company sends a lengthy memo to its own centers, but waited five months to send an abbreviated note to rival clinics that lacked much of the same crucial safety information.

This chain of events is now causing difficulty for Fresenius Medical Care, a unit of the large German health care company that treats some 400,000 Americans who receive dialysis. The company is now being investigated by the FDA for its actions, or lack of action, as the case may be. And the episode is causing outrage among dialysis patients, including one prominent patient web site that believes the Fresenius explanations are “morally indefensible.”

Here is the background: Last November, Fresenius sent an internal memo to doctors in its dialysis centers indicating a significant risk of cardiac arrest and death appeared to occur during treatments in which its GranuFlo concentrate product was improperly administered, according to RenalWeb, a patient web site. “In light of these troubling findings,” the six-page memo stated. “…This issue needs to be addressed urgently.”

By contrast, the two-page memo issued in late March is much less detailed – there is little in the way of the background, summary findings or statistical analysis, which also included two charts, that appear in the lengthier memo that was distributed last fall to its own personnel (you can read that here).

“This 6-page internal FMC memo shows that for at least 15 months, FMC did not share this information with the thousands of non-FMC physicians and clinics that were using the Granuflo product,” according to RenalWeb. “It then appears that FMC received an inquiry on March 27, 2012, from the FDA specifically about Granuflo-related products and alkalosis. Only then did FMC provide a scientifically-ambiguous, 2-page memo with far less actionable information to its non-FMC customers on March 29, 2012. The March 29 memo did not mention any patient blood levels. The most at-risk population of all, ‘acute’ dialysis patients, are not mentioned in either memo.”

And so, the FDA is now investigating. “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern,” Steven Silverman, director of compliance for the FDA medical devices division, tells The New York Times. “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.” One Fresenius customer agreed. “If the data was sufficient to warn their doctors, then all users…should have been made aware of it,” Tom Parker, chief medical officer at the Renal Ventures dialysis chain, tells the paper. The agency subsequently issued a safety alert.

So how does Fresenius explain its actions? Franklin Maddux, the chief medical officer for Fresenius in North America, tells the Times that his office, which wrote the memo, was in charge of its own centers and had no way of communicating with other clinics except through papers in medical journals. He adds that the findings of the internal memo were too preliminary to warrant a publication, the Times writes. “I felt that it was not in a condition for general consumption,” he tells the paper.

Of course, Fresenius operates a large sales and marketing apparatus, which could have been deployed to communicate with customers. Sales reps, after all, are expected to be aggressive about promoting products and closing deals. Even so, this would not account for the discrepancy between the amount of information allegedly contained in the different memos. A Fresenius spokesman, meanwhile, tells the Times that no one thought it necessary to send a notice because the internal memo did not contain specific reports of adverse events related to GranuFlo.

GranuFlo contains an ingredient that the body converts to bicarbonate, and it contains more of this ingredient than rival products, the Times writes, adding that some doctors “apparently have not been accounting for extra bicarbonate” when deciding how much bicarbonate to prescribe separately. “The result can be, in effect, an overdose of bicarbonate, which some recent studies have suggested could lead to heart problems.”

“This is what happens in a vertically-integrated company when physicians in the clinic division and physicians in the products division both report to non-physicians,” RenalWeb writes in an editorial. “This situation presented obvious conflicts of interest… with their concerns for profits appearing to take clear precedence over concerns for patient safety. Dr. Frank Maddux’s assertion that he had no way of communicating with noncompany clinics clearly demonstrates his conflict of interest within Fresenius’s corporate structure for doing what is right for all dialysis patients. Ultimately, however, this position is morally indefensible.”

[UPDATE: A Fresenius spokesman sends us this: “Fresenius Medical Care had received an informal inquiry from the FDA concerning the November 2011 Fresenius Medical Services circular and, in response, engaged in cooperative dialog with the FDA that we understand to be used to reiterate and emphasize the need for physicians to consider total buffer. We have understood that the FDA sought to add, and has added, its authoritative voice to the reminders to physicians about the need to consider total buffer, which FMC has issued multiple times over the years. Our understanding was confirmed by the FDA’s own recent publication addressed to the medical community. We are not aware of ongoing investigative activity by the FDA.]


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