For example Garden - in the last 3 paragraphs of the National Center for Health Research negative comments, one can see the crescendo of desperate panic to make trashy points. . . . .
QUOTE
"The FDA has stated that it “has been reviewing these devices for many years, and their risks are well known.” We disagree. A tiny percentage of adverse reactions are reported to the MAUDE database, making it impossible to know how frequently adverse reactions occur.
Pain management is serious business. The FDA has approved several prescription drugs with clear risks of addiction. If the FDA is willing to clear unproven medical devices aimed at reducing pain rather than requiring evidence of effectiveness, the unintended consequence will be more prescriptions for pain medication, including the drugs that have been proven to be most addictive.
We urge the FDA to keep nonthermal SWT devices as class III devices and require a PMA as FDA originally recommended in its 2012 proposed rule. General and special controls cannot compensate for a lack of safety and effectiveness evidence. Downgrading these devices to class II is not justified. By requiring a PMA, companies would be required to prove that their products are safe and effective." UNQUOTE
My thoughts:
In the first quoted paragraph above, the author begins the serious bad-mouthing, but without legitimate basis. How can one refute the FDA statement that the FDA has been reviewing the devices for years and the risks (or lack of them, as is the case) are well known. The writer is therefor saying the FDA has not been reviewing them for years and the risks are not well known. Rubbish. Makes zero intellectual or scientific sense. The next sentence is equally ill-founded rhetoric and, who is "we"?
In the second paragraph above, the author makes a correct statement in saying that pain management is serious business. Then seriously shoots himself in the foot when he states that the consequence of the FDA approving such devices will be more prescriptions for pain medication etc. What? The author is therefor stating that the efficacy of such devices is zero, in which case the number of prescriptions would be the same as if there were no such devices. Creative sitcom nonsense.
The last paragraph is best - urging the FDA to stay where it was in 2012, when it admitted magnanimously that it did not have enough horsepower in its devices division and did something about it and here we are! The, the author states that general and special controls cannot compensate for a lack of safety. Nonsense when one considers that the only negative side-effect of an ActiPatch is experienced if one eats the damn thing! And the author concludes authoritatively, based on the foregoing nonsense, "Downgrading these devices to Class II is not justified.". Wow, now that shows deep scientific research! And finishes up with "by requiring a PMA, companies would be required to prove that there products are safe and effective.". Already been done and facts are found in the comments by the coalition of companies that made its comments at the same time. I love it when script writers tell the FDA it is nonsensical. It would appear the comment is designed to stretch time, or to create noise adverse to the inevitable - that the devices work well and will help tens of millions of Americans currently suffering from varying levels of chronic pain to deal with it better and more safely.
