NJ Settles with Synthes in Landmark Deal over Prodisc Conflicts

Synthes, a <"http://www.yourlawyer.com/practice_areas/defective_drugs">medical device Them! hd company based out of New Jersey and Pennsylvania, just reached a settlement with prosecutors in New Jersey over alleged financial conflicts of interest, reports NJ.com.

Last year, we reported that Prodisc, an artificial spine disc made by Synthes, was at the center of a congressional investigation into the close financial ties between doctors and drug and medical device makers. In 2008, Senator Charles Grassley (Republican-Iowa) wrote to Synthe’s American headquarters citing concerns over the possibility of “a dangerous conflict of interest” posed by the financial ties many doctors involved in Prodisc clinical trials had with the company. The Food & Drug Administration

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(FDA) also received a similar letter from the Senator.

In Grassley’s letters to the FDA and Synthes he wrote, “Clinical investigators play a critical part of the FDA approval process. These physicians are expected to act objectively in testing the safety and effectiveness of the drug or medical device under consideration. But when they stand to profit from FDA approval of the product they are testing, the investigator’s objectivity is called into question.”

Also in 2008, the New Jersey attorney general’s office began an investigation into Synthes aimed at determining if it was benefiting from conducting clinical trials on its products, said NJ.com. Now, as part of what is considered a “landmark deal,” Synthes will not be compensating trial doctors with company stocks, will release information on payments to physicians, and will release information if involved doctors have a financial claim in the trial results, said NJ.com.

New Jersey attorney general Anne Milgram noted that these conflicts of interest are not unusual in the medical community, reported NJ.com. “It is outrageous that doctors who are testing and, in many cases, recommending the use of certain high-risk medical devices are being compensated with stock in the very companies that make the devices,” said Milgram. “All patients—but especially those considering high-risk devices such as spinal disc replacements—deserve honest, objective clinical trial information about the products available,” quoted NJ.com. Milgram also criticized the FDA, saying it was not as diligent as it should have been monitoring
Synthes saying, “Medical device makers have a duty to make certain that clinical trial results are accurate and unbiased. In creating these financial incentives for doctors, Synthes and the rest of the industry have done the exact opposite. Going forward, if the industry will not address this problem voluntarily, we most certainly will,” quoted NJ.com.

Prodisc was approved by the FDA in 2006 and was developed by Spine Solutions, which was eventually sold to Synthes. According to a prior New York Times piece, a New York investment firm, Viscogliosi Brothers, helped found Spine Solutions and financed the disk’s development and research through a number of investment funds in which many of the clinical trial doctors were also investors. As a result, the very doctors charged with overseeing the clinical trials that would determine its approval had a high stake in Prodisc’s success.

Meanwhile, Lee Moore, spokesman for the attorney general’s office, said New Jersey just issued subpoenas to five “major medical device manufacturing companies,” reported NJ.com. Moore did not name the companies.

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