MASSDEVICE ON CALL — Medtronic Inc. (NYSE:MDT) faces new heat over the Infuse bone growth product, this time for allegations that the therapy caused excess bone growth in the spinal canal of 70 percent of patients in an independent clinical trial.
In what has become a familiar cry against the Infuse product, doctors on the company’s payroll were accused of concealing vital information from published studies.
A 2004 paper written about a clinical trial conducted by MDT’s paid consultants maintained that no harm was done to patients and that any excess bone growth, known as ectopic bone, didn’t cause any ill effects.
Just a few months ago, a clinical trial found that nearly three quarters of patients had unwanted bone growth in their spinal canals, and the trial was cut off after only 34 of hundreds of enrolled patients had received the implant, the Milwaukee Journal Sentinel reported.
The allegations continue to stack the deck against the Infuse implant, which has been widely used to fuse spinal vertebrae during surgeries since 2002.
A study published last month accused the Fridley, Minn.-based company of concealing that the bio-engineered bone growth protein can increase the risk of infertility in men. Last week two U.S. Senators demanded that the medical device giant turn over documents relating to internal correspondence with paid consultants and researchers who worked on product trials, expanding the investigation into whether physicians on the company’s payroll concealed the infertility risk.
A critical review of Infuse’s complications will be published in the Spine Journal this week.
Breast cancer update: Nearly half of affected don’t get life-saving treatment
Almost half of all U.S. women with advanced breast cancer didn’t receive postmastectomy radiation therapy, despite evidence that the treatment may save lives.
Of nearly 5,000 women diagnosed with advanced breast cancer between 1999 and 2005, only 55 percent received PMRT. Women with intermediate stage breast cancer tended to receive the treatment more often.
"The findings add to the debate on the effectiveness of standardized treatment guidelines," said Dr. Benjamin Smith, lead author and assistant professor in the dept. of radiation oncology at the University of Texas M. D. Anderson Cancer Center in the release. "There’s a clear gap between the scientific evidence demonstrating PMRT’s benefits and the proper use of the therapy in everyday clinical practice."
Better strategies may be necessary to bring clinical evidence into practice, researchers argue, offering several tactics to ensure more consistent use of the PMRT.
Among their recommendations are that medical accreditation should be tied to compliance, as tracked by organizations like American College of Surgeons Commission on Cancer and the National Quality Forum.
Docs turning away privately insured patients the most?
While doctors have been accepting fewer and fewer patients on government health insurance programs, the biggest slide in acceptance was for patients with private insurance, researchers at Weill Cornell Medical College found.
Medicare patients experienced a drop in acceptance from 95.5 percent to 92.5 percent between 2005 and 2008, but privately insured patients, who were accepted 93.3 percent of the time in 2005, were accepted only 87.7 percent of the time in 2008.
The change may lead back to two main factors, researchers said: inadequate reimbursement levels and the labyrinthine administrative issues that go with private insurance.
"At a moment when the country is poised to achieve near-universal coverage, patients’ access to care could be a casualty of the collision between the medical profession and the insurance industry," said Dr. Tara Bishop, lead author and assistant professor of public health at Weill Cornell Medical College.
The Obama administration is currently embarking on a project to determine acceptance and rejection of new patients using "mystery shoppers" to pose as consumers and call practices to try to obtain appointments.
Boston Scientific lauds patent reform
Boston Scientific Corp. (NYSE:BSX) applauded the recent decision to revise the U.S. patent system which passed through the U.S. House of Representatives this week after passing through the Senate in March.
"As one of the largest patent holders in America, we have directly experienced the challenges facing our current system. The America Invents Act is critical to ensure the U.S. Patent and Trademark Office has the available resources to upgrade procedures within our system, review applications in a timely manner and provide the means to strengthen protections on issued patents," company officials said in a statement.