Study of Artificial Spinal Disk “Prodisc” – Guided by Physicians’ Finances or Concern for Patients?

When patients are considering treatment options, there is often”blind faith” in the doctor’s recommendations, as he is viewed as a concerned, educated and neutral provider. Perhaps, this view is nave. In reality, doctors are often financially motivated in the varying courses of treatment offered. Instead of acting as neutral gatekeepers of potentially harmful drugs and procedures and “neutral scientists “investigating a procedure’s safety, at times they are in actuality financially motivated advocates for the same.

For instance, Dr. Joseph E. Zigler, a well known spine specialist, and an advocate of Prodisc, an artificial spinal disk for the lower back, has been found to have a financial stake in success of the same. In fact, The New York Times has reported that doctors at about half the research centers involved in the study of Prodisc had a direct financial interest in the devices success. Lawsuits have been commenced against a multitude of physicians similar to Dr. Zigler who have pushed for the Prodisc, in light of financial incentives and have ignored its adverse effects. In fact, many patients are complaining they have been detrimentally affected by Prodisc and some patients actually said that they are worse off from having this procedure.

It is claimed that the research study that was performed falsely advertised and glorified Prodisc. In the study results submitted to the F.D.A., an unusually large number of patients were not included, and some of those patients have said they fared poorly. For instance, Calvin Timberlake’s artificial disk failed and had to be removed. Currently, he has to take medication to control the pain and suffering he must now endure.

It is alleged that the surgeons were not adequately critical over the research and products they were developing, instead being guided by their investments in the success of the same. While the doctors and researches state that their financial interest did not guide their research findings, there is concern that they did not adequately inform the FDA of their financial interest and potential conflict of interest.

The FDA is currently investigating this matter. It appears that the physicians may have not been forthright about their financial interest in Prodisc and whether the research studies performed were candid and an honest look at the benefits of Prodisc on patients with lower back spinal problems.

The issue may have criminal implications as well. The New Jersey attorney generals office issued subpoenas to two companies involved in the development of the Prodisc, Synthes Spine, a unit of the Swiss device manufacturer that now owns the Prodisc, and to the Viscogliosi Brothers, the New York investment firm that helped found the original maker of Prodisc in the United States. The firm operated several funds in which the clinical researchers were investors.

Additionally, U.S. Senator Charles E. Grassley, the ranking Republican member of the Senate Finance Committee, has sent letters asking the F.D.A. and Synthes to provide accounts of what the company had disclosed to regulators about the researchers before the disks approval in 2006.

The inquiry is part of a broad look by Mr. Grassley and others in Congress into the close financial ties between doctors and the makers of drugs and devices. Last year, Mr. Grassley introduced legislation that would require corporations to disclose any money they give to doctors.

Also last year, Senator Clair McCaskill, Missouri Democrat, and Senator Herb Kohl, Wisconsin Democrat and chairman of the Special Committee on Aging, said that they will work to create legislation creating a national registry that would list the payments and gifts made by companies making medical devices and drugs to doctors.

If you believe that you have been harmed by a dangerous drug, please contact our office to speak with a personal injury attorney who will try to help.

The personal injury lawyers at Levine & Slavit have decades of experience in handling personal injury claims involving dangerous and defective products Levine & Slavit has offices in Manhattan and Long Island, handling cases in New York City, the Bronx, Brooklyn, Queens and surrounding areas including Westchester County.

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