Way to go Fuj - Mr. Brown's message actually provides great ammo to make it for easier for the folks at the FDA to grant BIEL approvals across the board - all products!
I have read up to 27112 and here is my feedback as you have requested.
Mr. Brown shoots himself in the foot (needs ActiPatch) and if I were you I would not write to him. Suggest you write instead to the FDA, since Brown's letter was addressed to you. If you write to Brown, you cannot win as he will only manipulate whatever you say to his own ends, which are continuing to be paid and feeding his amateurism as a self-appointed watchdog for the FDA. What? I wager this man is a huge thorn in the side of the FDA.
The Evidence:
"Members of the Coalition strongly support"? Scientific evidence?
"We strongly oppose the petitions"? No scientific evidence!
"Adverse events.......confirm the panel's concerns.....blisters, third degree burns, shock sensations, interference with a pacemaker" no scientific evidence, reckless, manipulative rhetoric! It gets better as he tightens the noose on himself.
“We agree with the FDA that they are Class III devices because they can have serious adverse health consequences, such as third degree burns or shocks to patients with pacemakers or implanted”. On what basis does Mr. Brown qualify himself to agree with the FDA on anything, particularly given that the FDA is wisely assessing the whole category? Mr. Brown is unqualified scientifically and without the clinical data the FDA has to agree or disagree with anything.
“We appreciate BioElectronics sending us data on their device. We were glad to see that the device had clinical data, but the number of patients evaluated is very small, and therefore can’t provide conclusive evidence of safety for most patients likely to use this device.”
Why can’t it be conclusive and who is Mr. Brown to determine what conclusive is? Mr. Brown comes a long way toward agreeing with BIEL, but of course he cannot go all the way to agreeing because that would conflict with his platform and mission, which is to dissent.
Brown goes on - “Even if BioElectronics had more conclusive data for its devices, that would not justify down-classifying an entire category of devices from Class III to Class II (moderate risk), because other devices in that category need to be proven safe and effective as well.“
So, he shoots himself in three additional ways. He does not have any problem with BIEL’s scientific data except with its quantity, which does not defeat or negate its credibility at all. Two, BIEL’s status as an individual product line has nothing to do with Brown’s nonsensical statement – “that would not justify down-classifying an entire category of devices from Class III to Class II (moderate risk), Three, BIEL products have nothing to do with other devices. Each product is assessed on its own merits. If BIEL products are different as suggested by iHub contributors, the FDA will indeed create a standalone category for them.
Brown’s last paragraph combined with his title and role as Government Relations Manager of the Cancer Treatment & Prevention Fund makes history – thereby placing his entire message in the proper round file – he’s a PR guy – how can he possible make the gigantic and impossible scientific leap from PR guy for the Cancer Prevention & Treatment Fund to scientific peer group commenter on BIEL PEMF therapy? He can’t and thus the reason why his message is nonsensical. The folks at FDA are very bright and will see through this guy’s complete and total blah blah in a nano-second. It’s about science and he said nothing about that.
Do the BIEL products work? Are they harmful? No. Is there one iota of evidence indicating one negative side-effect? No. I suggest Mr. Brown should stick to cancer, if he is qualified, and stop wasting the money his contributors have donated on matters about which he knows nothing. How about, oh, let’s see, commenting on the many atrocious side-effects of Temodal (Temozolomide) or Tarceva (Erlotinib) which are both prescribed in the treatment of astrocytoma, brain metastases from solid tumors, glioblastoma multiforme and melanoma, all of which are instantly understood by FDA personnel in the cancer treatment field. Stick to your field Mr. Brown.
Don’t write to him Fuj, he will only defend his blah blah statements with more blah blah statements and he has the time and other people’s money to do it forever. If it weren’t so repugnant, it would be laughable.
AI
