Efforts to correct biased and dangerous medical studies are making more headlines.
Shortly after I posted about a new idea to correct missing and misreported research, I got an email from AHCJ member John Fauber, an investigative reporter at the Milwaukee Journal Sentinel.
His latest story for the Journal Sentinel and MedPage Today involves an extensive undertaking coordinated by Yale University to correct the record on a product made by Medtronic called Infuse. The project is called YODA, for Yale Open Data Access. (Read more..)
Infuse — officially a device — consists of a metal cage fitted around a sponge that is soaked in a genetically engineered protein. The protein is supposed to promote bone growth and healing. It works, but perhaps too well. Side effects linked to its use include bone overgrowth that can trap and irritate nerve roots causing chronic pain. It has also been tied to a complication called retrograde ejaculation, which leads to sterility in men. Patients who receive infuse also experienced more problems with wound healing and more cancer.
All in all, pretty devastating outcomes for patients who were hoping to feel better after their back surgeries. Continue reading
Readers of Covering Health are likely familiar with medical device manufacturer Medtronic and John Fauber’s coverage of conflicts of interest surrounding the company’s Infuse product.
It seems that U.S. Senators Max Baucus (D-Mont.) and senior member Chuck Grassley (R-Iowa) also are aware of the coverage.
The two, leaders of the Senate Finance Committee, have demanded “an extensive trail of documents, including financial records and communications between the company and doctors who have received millions in royalties and other payments.” [See the letter.]
Over the past year, Fauber, of the Milwaukee Journal Sentinel (see update), has reported that the company made payments to surgeons “involved in the clinical testing of Infuse or who wrote positive medical journal articles that failed to link the product to serious complications.” Those complications include unwanted bone growth outside the fusion site and sterility in men.
Infuse is a biological agent used in spinal fusion surgery that stimulates bone growth.
A professor of orthopedics at Dartmouth Medical School is pleased the Finance Committee is investigating, saying it is doing public health work because his profession and the FDA failed to prevent this circumstance.
It appears there is more news to come about Infuse:
Next week, independent researchers are expected to publish more papers revealing additional serious complications with Infuse that were not reported in numerous articles published over the last decade and co-authored by doctors with financial ties to Medtronic. The independent researchers said their research also was prompted in part by Journal Sentinel reports.
This post should have mentioned that the Medtronic coverage is a joint project between the Milwaukee Journal-Sentinel and MedPage Today.