Now that your children have completed the school year, and your college students have come home, hopefully to a summer job, TSB hopes that each one enjoy great quality time with your family. Life is short, seize the moment, and every now and then, smell the roses. Now back to the blogging world.
On Tuesday June 28th, 2011, John (God, am I a pain in the ass to Medtronic) Fauber from the Milwaukee Journal Sentinel publish an article entitled; "Researchers Sound Alarm on Medtronic's Infuse Years Ago." A journey back in time brings the reader to 1999 when clinical reports began to surface that a new biological product had surfaced that was going to herald a new modality of treatment that would safely regenerate bone in patients that were subject to back fusions. Then something naughty happened. CT scans were starting to reveal unwanted bone formation in the spinal canal. As TSB has asked on numerous occasions, how many of us heard those stories from various surgeons? The clinical trial that was set to enroll hundreds of patients had to be stopped. Unfortunately, it would be five years before Medtronic would publish a paper on the halted study. As the results of ectopic bone formation was published, the paper downplayed the significance of this occurrence. Based on these findings the question must be asked of our bloggers; "has monetary and commercial progress skewed the medical communities ability to report clinical outcomes in a regulatory and transparent manner?"
David Malone M.D., a Tulsa, Oklahoma surgeon reported that he had two patients that had required multiple surgical revisions. One patient's biological response was so explosive that he needed a second revision because the boney ingrowth was larger than before the first revised surgery. Dr. Malone was quoted as saying that the secretaries in the clinic could even identify which patients received INFUSE by assessing the post-op x-rays. Good ol' Ronnie Pickard, a then top excutive at the Evil Empire agreed to a confidential settlement with the patient. Obviously, Mr. Pickard was unavailable for comment for the article. Dr. Malone goes on to report that in 2002 he sent a letter to the FDA making them aware of his experience with INFUSE. The FDA read the letter into the record and then gave INFUSE its stamp of approval in late 2002.
The 2004 paper has drawn much criticism from the spine community. Was there a systemic failure by the medical and scientific community by not reporting the various medical complications associated to INFUSE? As in any battle to conquer the market, collateral damage occurs. Could Medtronic and the surgeons involved have taken a mercenary attitude in the commercialization of INFUSE, accepting the fact that there would be casualties? In addition to the many questions surrounding the politics and financial implications surrounding INFUSE, one must ask the question whether ethics, good science and medical advancements take a back seat to commercial interests, especially when the potential of hundreds of millions of dollars are at stake?
Marybeth Thorsgaard, the Mouthpiece of Medtronic, issued a statement on behalf of Medtronic, stating, the patients that were enrolled in the original study, were made aware of potential adverse events related to ectopic bone formation. The article goes on to identify the usual suspects that have been involved with Medtronic over the years, Reggie Haid, Ken Burkus, and Charlie Branch. None of the aforementioned surgeons responded to e-mails from the Milwaukee paper. In closing, it looks like the INFUSE saga is just beginning to pick up some momentum. Considering that Medtronic has experienced flat growth and downsized its workforce, are they in a position to be broadsided by a potential torpedo? As INFUSE continues to get bad press, will this affect their estimated revenue stream of $1 million dollars per day for this product? And, did the FDA commit a major faux pas when they failed to acknowledge that INFUSE was a pharmaceutical and not a device? You know what Joni Mitchell once sang;
"And the seasons they go round and round, And the painted ponies they go up and down,
We're captive on the carousel of time, We can't return, we can only look behind from where we came
And go round and round and round in the circle game."