"but the FDA doesn't take anecdotal evidence into consideration when clearing devices"
Dr. Golish is one of the FDA reclassification panel members. Listen to his question and Dr. Strauch's, one of the public testimonial speakers, reply. Dr. Strauch is well respected and when he says that he has used PEMF therapy for 15 years, reducing use the use of narcotic pain killers, sending patients home from the hospital days early, and " no complications or adverse effects " it leaves an impression on panel members.
DR. GOLISH: "Yeah, briefly. I found all the testimonials compelling, and I appreciate them. The question is for Dr. Strauch, whose leadership I'm certainly familiar with, having published in the Journal of Reconstructive Microsurgery on free fibula transfers, also something with the high donor site morbidity, like a TRAM flap.
The testimonial you gave is very compelling, about your 360s. You said at the end, that to preserve this treatment modality, it ought to be down-classified. What makes you think, sir, that the companies will not be able to provide it unless it's down-classified?"
DR. STRAUCH: "I can't speak for all of the companies, but I think they're all in the same pot. I don't think they're going to be able to afford it now because they're not making a lot of money out of this, and they can't afford $1 million to $4 million to do extensive double-blind studies at this point. And the alternative is to go out of business. I really think it's going to take this modality away if we don't.”
