Recent disclosures have again uncovered direct financial ties between orthopedic surgeons and device manufacturers. A well-known spinal surgeon and some of the nation’s most prominent orthopedic surgeons, reporting their results in peer-reviewed journals, hailed Prodisc, an artificial spinal disk as superior to conventional spinal fusion. Dr. Jack Zigler, one of the lead researchers in a study of almost 240 patients made the claim, as did doctors at almost half of the 17 major and academic research centers involved in the study. Unfortunately, 11 of these researchers had more than a scientific interest in the study results; they stood to profit financially if the Prodisc succeeded, according to The New York Times (Jan. 30, 2008) and information from a patient lawsuit settled last year.
The field of spinal surgery continues to foster controversy, particularly in the treatment of back pain, where significant debate continues over how many patients actually benefit from spinal fusion and other operations. As artificial disks become a growth industry, more skepticism is unleashed. Thousands of patients worldwide have received the Prodisc, which costs about $10,00 in the U.S. Yet Medicare and several commercial insurers generally refuse to pay for the surgeries which can cost additional thousands of dollars. The legal and clinical aftermath of Prodisc continue in the courts, and includes patients who had the device implanted only months after the FDA approved it. The FDA is now checking to see whether there was adequate financial disclosure information about the Prodisc researchers during the clinical trial and when the the application for official approval was submitted.
New spinal devices are only the tip of the iceberg. Five companies that account for nearly 95 percent of the lucrative market in hip and knee surgical implants have avoided criminal prosecution over financial inducements paid to surgeons to use their products by agreeing to new corporate compliance procedures and federal monitoring under 18-month agreements with the U.S. Department of Justice.
According to the above Government web site, four companies, have executed Deferred Prosecution Agreements (DPAs), which will expire in 18 months if they meet all of their respective reform requirements. Criminal Complaints were also filed against those four companies, charging them with conspiring to violate the federal anti-kickback statute. Those Complaints will be dismissed at the conclusion of the DPAs if the companies comply with their terms. The fifth company, Stryker Orthopedics, Inc., voluntarily cooperated with the U.S. Attorney’s Office before any other company