Where's Steve MacMillan when you need him? Considering that Stryker finally sold off OP-1 to Olympus in a deal that smelled fishy and included the V Brothers, once again Stryker just can't rid itself of its Albatross, also known as OP-1. On July 25th, 2012, it was reported in various media outlets that more than a dozen patients may have be the subjects of secret medical experimentation (that sounds nefarious) alleged to have taken place at Pomona Valley Hospital, in Pomona California. A letter dated July 24th, 2012 was issued by the attorney for the plaintiff, April C. Cabana to the Office for Human Research Protection at the United States Department of Health and Human Services.
Based on the aforementioned complaint, once again, we are revisiting the off-label use of OP-Putty and Calstrux. Even though the complaint seems to absolve Stryker, it seems that the Almighty Stryker can't get rid of that dog OP-1. The allegations in this complaint center around the truff, as Mike Tyson would say, regarding Pomona Valley Hospital at first denying that an IRB had not been approved by the hospital. Unfortunately for Pomona and the surgeon involved, recently obtained documents suggest that there was a "secret research project" taking place at the hospital regarding OP-1 and Calstrux. It seems that the hospital's Vice-Chair person asked the lead investigator "if efficacy is obvious should the research project and randomization be continued."
At issue are State and Federal laws and regulations that mandate that researchers receive informed consent of subjects or patients prior to enrolling them in a research project. The complaint states that Ms. Cabana was never informed that she was going to be enrolled as a subject in this project. As many of you are aware, surgeons can use their professional discretion for off-label use. The smoking gun seems to be the correspondence between the hospital and Ms. Cabana's surgeon. So how did Pomona, the surgeon, and Ms. Cabana get to this point? OP-1 a potent bone morphogenic protein supposedly delivered the knock out blow by accelerating boney growth in and around her nerves resulting in remedial surgery that was not successful. Not only does Ms. Cabana suffer agonizing pain, she is on permanent disability. But this raises a greater concern. If Ms. Cabana was made aware of being enrolled in the so-called "research project,"and that OP-1 and Calstrux would be used, would she had the acumen to make an educated decision about the use of these products during her initial surgery? Consumer Medicine? Bah Humbug! Once again, the Cabana case brings to light the complexities that exist in modern day spine surgery, successful fusion no matter at what cost. How many Ms. Cabana's exist that we never hear of? Based on this complaint, there are potentially a few more to be reckoned with since Pomona had at least 16 other patients enrolled in the OP-1/Calstrux project.
So TSB must ask the proverbial question, what happens to Pomona? What happens to Dr. Famous? Does the government have the "chutzpah" to take action or will they attempt to quietly deal with this, sweeping it under the rug. TSB doesn't know about our readers, but knowing what we know, if this was my loved one, there would be some serious ass kicking going on.
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Some people got to have it,
Hey, hey, some people really need it
Hey listen to me, y'all do thangs, do thangs, do thangs, bad things with it
Talkin' 'bout cash money, dollar bills y'all come on now.