Did Ethical Standards Slip In Disc Trials?
Researchers Had Financial Interest in the Subject of Their Study
The Food and Drug Administration said last month that it is investigating whether several orthopedic surgeons failed to properly disclose their financial investments in the manufacturer of an artificial spinal disc that the FDA approved in 2006. The surgeons, who were conducting clinical trials that ultimately led to FDA approval of the ProDisc-L lumbar replacement disc, were also investors in a venture capital fund that invested in the development of the product. As investors, the physicians stood to gain financially from the success of the clinical trials. "We are looking at the issue," says Karen Riley, a spokeswoman for the FDA.
As investors in a venture capital fund that specialized in spine products, the physicians had already profited when the developer of the artificial disc, Spine Solutions, was sold to the Swiss medical device manufacturer Synthes in 2003 for $350 million, according to documents from a lawsuit filed in 2004 in the Pennsylvania Court of Common Pleas.
One surgeon-investor involved in the clinical trials, Richard A. Balderston, MD, chief of spine surgery at Pennsylvania Hospital in Philadelphia, earned about $100,000 based on a $500,000 investment when Synthes bought Spine Solutions, according to court documents. Dr. Balderston didn't return a phone call for comment.
In 2004, a woman who had participated in ProDisc-L's blinded clinical trial filed a malpractice suit against Dr. Balderston and Spine Solutions. The confidential settlement of the lawsuit, reports the New York Times, says that researchers at about half of the 17 research sites had a financial interest in the success of the ProDisc trial, the paper notes. Other surgeon-investors included Jack Zigler, MD, of the Texas Back Institute and Kevin Foley, MD, of the University of Tennessee, according to the paper.
Dr. Balderston's financial disclosure wasn't in the clinical trial records, according to a 2006 affidavit provided by GPCA, a clinical auditing firm that reviewed the clinical trial records for the lawsuit in Philadelphia. Patricia Kennedy, who sued Dr. Balderston and Spine Solutions, settled in April 2007. Another patient who received a ProDisc implant is suing Synthes in federal court in Texas. Synthes did not return a phone call for comment.
Some orthopedic surgeons seem ambivalent about the issue of conflict of interest. At the American Academy of Orthopedic Surgeons' annual meeting in April 2007, 71 percent of the surgeons attending a session on ethical issues said that there is a perceived, and real, conflict of interest between orthopedic surgeons and manufacturers in the $5 billion spinal implant market. However, 87 percent of the surgeons said they believe that collaboration between device manufacturers and surgeons generally benefits patients, according to an article in the March/April 2007 edition of AAOS Now.
This isn't the first time that the issue of conflict of interest has been brought up regarding clinical trials for lumbar replacement discs, according to California spine surgeon Charles D. Rosen, MD, who founded the Association for Ethics in Spine Surgery. An executive at DePuy Spine, the manufacturer of the Charit?? disc, participated in AAOS recommendations to the FDA in 2005 for creating guidelines for clinical trials of discs, wrote Dr. Rosen in a letter to the court in the Kennedy lawsuit. Dr. Rosen noted that the guidelines are sympathetic to positive evaluation of artificial discs. "Industrial influence encouraged, and was successful in achieving, FDA approval and dissemination of artificial disc replacements."
Implants Linked to Surgery Site Infections in Breast Surgery
Average Infection Increases Cost by More Than $4,000
Surgical site infections after breast surgery are more than twice as common as previously believed, according to a study by researchers at the Washington University School of Medicine in St. Louis, Mo. More than 5 percent of patients developed SSIs after breast surgery, compared to previous CDC estimates of nearly 2 percent. Each infection also added an average of more than $4,000 in hospital-related expenses.
Cancer patients fared the worst, according to the study published in the January issue of the Archives of Surgery. SSIs jumped to 12.4 percent for mastectomies that were immediately followed by breast reconstruction with an implant and to 6.2 percent for mastectomies followed by reconstruction with abdominal tissue.
"The reason for the [higher] rates is due to the compromised immune system of the [cancer] patients, not the type or length of the procedure," says co-author, Keith E. Brandt, MD, FACS, a professor of plastic and reconstructive surgery at the Washington University School of Medicine.
Another reason for higher infection rates after surgery, cited by surgeons and infection control experts, may be the fact that implants introduce surface area where bacteria can grow. "Any time you put in a foreign body, that increases your risk of infection," says Kathleen Kohut, RN, BSN, CIC, CNOR, an independent infection control expert in Baltimore.
The study, sponsored in part by the CDC's Prevention Epicenter Program, looked at 949 mastectomy and breast reconstruction including breast reduction and augmentation surgeries in women and men performed at the Barnes-Jewish Hospital in St. Louis.
In the Know
Hand Gels Alone May Not Curb Infections. You'd think that the more your staff used alcohol-based hand gels, the lower your patient infection rates would be. Not so, according to an infectious disease specialist at the University of Nebraska Medical Center. Mark Rupp, MD, found that staffs that nearly doubled their use of alcohol-based gels had no bearing on the rate of infections among patients. "Hand hygiene is still important, but it's not a panacea," says Dr. Rupp, who pointed to other culprits: rings and fingernails that are too long and hard to clean; the prescription of antibiotics only when necessary; the poor handling of catheters and improperly sanitized treatment areas. Dr. Rupp says bacteria showed up when fingernails extended just beyond the fingertip. According to Dr. Rupp, your fingernails are too long if you can see them over the skin of your fingers when looking at your palm. Study results appear in the January issue of Infection Control and Hospital Epidemiology
Mandatory State Licensure for Mass. ASCs? A bill in Massachusetts would require all ASCs to be licensed by the state and contribute into a free-care pool to help cover expenses for patients who can't pay for regular care. Under the current state rules, ASCs must contribute to the free-care pool, but they seldom meet the thresholds of caseload volumes and numbers of procedures that would require them to contribute, says Ronna Wallace, legislative consultant for the Massachusetts Association of Ambulatory Surgery Centers. The bill also includes a strict determination-of-need rule that would prevent centers from changing specialties.