Do these guys work at Medtronic?
The Zen philosopher, Basho, once wrote:"A flute with no holes is not a flute......and a doughnutwith no hole is a Danish."
A company with alleged falsified data is a..............POS.
Apprently I am not the only one thinking that this is about to lead to really big problems for Medtronic.
Please note points 3 through 5 in the article.
Read for yourself
I truly agree with both previous posters.
It is becoming apparent that not all adverse events in the clinical trial that gained product approval for infuse were properly reported.
What has changed from 2008 till now? Now we have a physician that works in the field or orthopedic surgeon who is now pointing out the issue. A colleague has turned on his own field. Basicly a whistleblower.
So the next question is ......Is it criminal? A physician signs what is called an investigator's agreement with the sponsor prior to starting a given clinical trial. This is mandated by the FDA. This is normally an 8 or so page long document writing by a lawyer employed by the sponsor. It is designed to make sure everyone knows their legal responsibilities in the clinical trial. In that document it states "I the physician will report any and all adverse events in a timely manner"
Once a physician signs this document prior to the clinical trial this is the point that the physician becomes an investigator.
I have not seen the actual investigators agreement for this particular trial. But that language is in all investigators agreements. Either written like I wrote it or something like that. It is FDA mandated that it has to be in there. The sponsor has by law a given number of days to report serious adverse events to the FDA. This is designed to protect the public from investigational products that are not functioning as they should.
So the legal framework for a lawyer to go after the sponsor or the investigator is there. Legal documents were signed prior to the clinical trial that gained product approval.
"expired..." is correct. Adverse INFUSE events were not reported.
The reason––Investigators apparently were paid (Influenced) to conceal them. This isn't difficult. The DoJ has been on this for some time (2008). Hawkins resignation was on Dec 20, right? Hmmmm. Meanwhile, the investigator receiving the most money ($20 Million) stonewalls on the issue of conflict of interest––making things look even worse.
Mr. Ishrak can only hope something will surface elsewhere in the device sector to remove this issue from the front pages.
Abstract BACKGROUND CONTEXT: Increasingly, reports of frequent and occasionally catastrophic complications associated with use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion surgeries are being published. In the original peer review, industry-sponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP-2 use. Some authors and investigators have suggested that these discrepancies were related to inadequate peer review and editorial oversight.
PURPOSE: To compare the conclusions regarding the safety and related efﬁcacy published in the original rhBMP-2 industry-sponsored trials with subsequently available Food and Drug Administration (FDA) data summaries, follow-up publications, and administrative and organizational databases.
STUDY DESIGN: Systematic review.
METHODS: Results and conclusions from original industry-sponsored rhBMP-2 publications regarding safety and related efﬁcacy were compared with available FDA data summaries, follow-up publications, and administrative and organizational database analyses.
RESULTS: There were 13 original industry-sponsored rhBMP-2 publications regarding safety and efﬁcacy, including reports and analyses of 780 patients receiving rhBMP-2 within prospective controlled study protocols. No rhBMP-2–associated adverse events (0%) were reported in any of these studies (99% conﬁdence interval of adverse event rate !0.5%). The study designs of the industry-sponsored rhBMP-2 trials for use in posterolateral fusions and posterior lateral interbody fusion were found to have potential methodological bias against the control group. The reported morbidity of iliac crest donor site pain was also found to have serious potential design bias. Comparative review of FDA documents and subsequent publications revealed originally unpublished adverse events and internal inconsistencies. From this review, we suggest an estimate of adverse events associated with rhBMP-2 use in spine fusion ranging from 10% to 50% depending on approach. An-terior cervical fusion with rhBMP-2 has an estimated 40% greater risk of adverse events with rhBMP-2 in the early postoperative period, including life-threatening events. After anterior inter-body lumbar fusion rates of implant displacement, subsidence, infection, urogenital events, and ret-rograde ejaculation were higher after using rhBMP-2 than controls. Posterior lumbar interbody fusion use was associated with radiculitis, ectopic bone formation, osteolysis, and poorer global outcomes. In posterolateral fusions, the risk of adverse effects associated with rhBMP-2 use was equivalent to or greater than that of iliac crest bone graft harvesting, and 15% to 20% of subjects FDA device/drug status: not applicable.
Trauma Society (A), OREF (B), AAOS (A), NASS (A), The Spine Journal
First I would like to compliment Jacosa and Ma for a great discussion. The information that is important is being narrowed.
We know the following:
During a "clinical trial for FDA approval" reporting any and all "events" is required. I will leave it up to everyone to know what is meant by "event."
That is known and clear.
What is not clear here is this is a post market trial. In a post market trial the rules and "reporting structure" is different. I will leave it up to the board to decide and define that structure.
Here is the first question. During the post market trials were all "events" and I mean all "events" reported to the FDA?
Second we know that there was a under reporting in the final published literature these "events" that is clear.
Who knew of these "events" that should have been reported to both the FDA and reported in the publication?
Last did Caragee's analysis look at actual reported "events" that did go to the FDA vs what was in the articles? The key item is what is out and reported to the FDA vs what shows up in the articles?
Who can clear all this up. From there you can determine what may happen next.
It just dawned on me what you meant in your last post. "therefore I do not have to fill out an adverse event form"
For you and other readers I apologize for making a poor assumption The assumption was that you understood the basics of clinical trial research. The physician in the hypothetical scenario that I spoke of earlier does not have the right to make the call "therefore I do not have to fill out an adverse event form" If an infection occurred during a clinical trial the investigator or commonly know as the physician has an obligation to report an infection that occurred as a result of a surgery when an investigational product was used that adverse event form then goes to an adjudication committee which is a team of experts and they decide if the infection is the result of the investigational product.
This is how investigational medical device trials work. The physician or investigator that was unduly influenced by the fact that he is getting paid millions by the sponsor is considered severly biased in the clinical trial world. So therefore his research is suspected to be biased and not of sound clinical science.
I should have explained that in the post of the hypothetical patient. An adverse event form definitely should have been filled out in that scenario.
Sorry for the poor assumption I made
I think that the point that you are missing is the fact that what Carragee found was the FDA reports of adverse evewnt rates post approval are severly out of wack when compared to event rates in trials. All medical device adverse events have to be track even in a market release scenario. Carragee compared those rates to what was reported in the initial clinical trials that gained product approval. That is were he found the mismatch of much higher rates post approval.
Jocosa Your back pedaling my good man. Why? You have gone from the stance that and I quote "all adverse events were PROPERLY reported to the FDA" to "the legal waters are muddy."
They look pretty clear to me! And I bet to lawyers like the Becker law group that a few months back were running adds on TV search for patients that had DePuy joint implants made by JnJ. Remember that?
Yeah I am willing to bet that the hypotehical patient that I spoke of in previous posts that for arguement sake we will say is a patient of Dr. Zdeblick that the article spoke of. You know the guy that got 21 million from Medtronic for being the arthur on some of Infuse studies and participated in the clinical trial. I am willing to bet that as Dr. Zdeblick was writing his e-mail to Forbes, he was thinking about that patient that had a complication in an Infuse study. He can either sign his mansion over to the patient now and agree with Carragee that all adverse events were not reported PROPERLY or he can wait for his day in court. Zdeblick has no choice now but to take that position. The check has been cashed and the money spent. But the damage to the patient still remains. If you really think that in any case that an Infuse product was used and an adverse event was not reported or a complication occurred that there is no evidence of that complication in any medical record across the country. Let's be real!
The Becker law office is probably at the hypothetical patients door right now. The lawyers are foaming at the mouth. This is what they live for. Blood is in the water and it was spilled by these articles. The sharks are circling. The legal path is pretty clear to me. Hire Dr. Carragee as your expert witness for the patient that had complications. If he won't do it then hire the Doctor from Vanderbilt that called the clinical trial that gained product approval for infuse "A Folly"
The legal path looks pretty clear to me!
You miss the weird part of this one. Medtronic didn't falsify data. What's been shown is that articles summarizing the data which had been properly reported in very dull ways misrepresented the results in bright, punchy, lying summaries. And while Medtronic doean't seem to have paid extra on the spot to have the sawboneses lie, the company hired them to do other things, later, for suspiciously high compensation.
It seems that adverse events should have been reported that were not in the clinical trial that gained FDA approval for the product. This is criminal. DOJ is coming.
Adverse events had to have happened in the trial but no side effects reported???????????