1. FDA requires written submissions and signups for oral submissions before it posts the agenda and the actual issues to be presented to its advisory committee. How can you formulate a comment for the advisory committee when you do not know what it is being asked to consider? Thus the ability to make relevant public comments is greatly reduced
2. The crochety and financially conflicted New Yorker, Dr. Arnold Monto has been the acting chair for all the Covid vaccine VRBPAC meetings, and this will be no exception. He has been a physician since 1958! His singular strength is cutting off discussion, and refusing to entertain questions that stray into areas he doesn’t like. He is back this week to no doubt do more of the same. It is clear why he was chosen.
3. Acting FDA Commissioner Janet Woodcock has a history, well documented by an expose in the Lancet 20 years ago, of crooked backdoor dealings while ostensibly following the rules. The Covid meetings look to me like more of the same. This is probably why she is heading the FDA at this time–she is known commodity, a dirty fighter, and can be counted on to do whatever it takes to keep the Covid vaccine agenda on track.
4. Here is another example of how Janet Woodcock controls FDA doings with an iron hand. She threw Sidney Wolfe off an advisory committee for the invented crime of intellectual conflict of interest. Yet those with real financial conflicts of interest are allowed in:
An article in USA Today in September 2000 shows, however, that the FDA granted so many waivers—800 between 1998 and 2000—that 54 percent of the experts on these all-important Advisory Committees had “a direct financial interest in the drug or topic they are asked to evaluate.” And this 54 percent figure does not take into account that FDA rules do not even require an Advisory Committee member to declare receipt of amounts less than $50,000 per year from a drug company as long as the payment is for work not related to the drug being discussed.