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President Joe Biden’s nominee to head the Food and Drug Administration definitely brings experience and credentials to the post, although some might say he also brings baggage.
As reported by The New York Times on 12 November, if approved it wouldn’t be the first time that Dr. Robert M. Califf served as commissioner of the agency that regulates all food, medical products and tobacco, the agency at the forefront of the COVID War, and one that is itself no stranger to controversy.
Dr. Califf was one of seven different FDA commissioners since 2015. Dr. Califf succeeded fellow Obama appointee Margaret Hamburg and headed the agency for 11 months, in the last year of the Obama administration.
Dr. Califf is not President Biden’s first nominee for the post; previous nominees were dropped in response to complaints of them being too close to the pharmaceutical industry. But Dr. Califf is hardly different in that regard; his biography from Duke University (where he ran a research center funded by the drug industry) indicates he is a member of the drug lord mobs while acting as a consultant to Merck, Amgen, Biogen, Genentech, Eli Lilly and Boehringer Ingelheim.
In addition, he’s on the corporate board of the biopharmaceutical company Cytokinetics, and has been a senior advisor to Verily Life Sciences and its sister company Google Health.
The NYT explains his nomination by noting that “In the end, White House officials might have concluded that they could not find a suitable candidate with no industry ties.” See “AMERICANS GETTING SCREWED: FDA IN BED WITH BIG PHARMA” (28 Sep 2021).
The NYT also notes that, when Dr. Califf ran the FDA, he proposed permitting drug companies to advertise off-label uses of agency-approved products, contrary to existing rules for drug advertising. His idea was considered dangerous and was blocked by other Obama administration officials.
TRENDPOST: Current examples of “off-label” use would be the use of ivermectin or hydroxychloroquine as therapeutics against COVID-19. Apparently off-label use can be good or bad, depending on the politics of those recommending it. The NYT article about Dr. Califf notes that the FDA has been “widely criticized” for “not standing up to Mr. Biden’s predecessor,” who “promoted unsafe and unproven treatments.”
One of the FDA’s “controversies” involved Biogen, one of the companies for whom Dr. Califf consulted, and its Alzheimer’s drug Aduhelm, which the agency approved despite objections from its own independent advisers, and which costs users $56,000 per year; see “ALZHEIMER’S DRUG? FORGET ABOUT IT” (15 Jun 2021) and “FDA APPROVES NON-EVIDENCE BASED DRUG” (29 Jun 2021).
That episode may account for why the agency’s acting commissioner, Dr. Janet Woodcock, is considered out of the running; she acknowledged that her agency’s interactions with Biogen “may have occurred outside of the formal correspondence process.”
Three members of a select FDA advisory committee resigned in protest over the agency’s approval of Biogen’s Alzheimer’s drug; one of them, Dr. Aaron S. Kesselheim, said it was “probably the worst drug approval decision in recent U.S. history.”
But the NYT quotes the same Dr. Kesselheim as believing that Dr. Califf’s background is not “necessarily disqualifying,” and would make Dr. Califf an asset to the agency. But Dr. Kesselheim still views Dr. Califf’s drug advertising rule changes as “a red flag” and “a terrible idea” that he hopes Dr. Califf has now “moved past.”
TREND FORECAST: The relationship between the FDA and the industry it’s charged with regulating is hard to describe without using the term “incestuous”; for example, another former FDA commissioner, Scott Gottlieb, who served from 2017 to 2019, now serves on Pfizer’s board of directors; see “FDA & BIG PHARMA: ONE BIG CLUB” (29 Jun 2021).
The prospects for any meaningful change look bleak. The situation is hardly different from what Trends Journal has drawn attention to many times regarding the financial industry and its supposed regulators: see “BANKSTER BANDITS: CRIME SYNDICATE COVER UP” (16 Nov 2021).