Dr. Robert Califf, the 70-year-old cardiologist, was confirmed by the U.S. Senate last week to lead the Food and Drug Administration despite bipartisan concerns about his close ties to drug companies.
Sen. Bernie Sanders, I-Vt., voiced his opposition to Califf’s nomination because he owns millions in pharmaceutical stock and is a senior advisor at Google Health and Verily.
CNBC reported that Califf, last year, pulled in $2.7 million from Google and $5 million in Verily, the life science arm of Alphabet. He also serves on the board of Centessa Pharmaceuticals and Cytokinetics, the biopharmaceutical company. (See “FDA AND BIG PHARMA: ONE BIG CLUB.“)
The report said he has up to $5 million in unvested stock options at Contessa and owns stock in Amgen, Gilead, and Bristol-Myers Squibb. He agreed to resign from his board jobs and divest his stock holdings within 90 days of taking the role.
The Senate passed his nomination with a 50-46 vote. He is expected to be sworn in sometime this week.
Dr. Scott Gottlieb, who was once commissioner of the FDA and now sits on Pfizer’s board of directors, praised the selection of Califf to lead the agency.
He joined five other former commissioners in a statement that read, “Confirming Dr. Califf is critical not only for moving beyond the Covid-19 emergency, but also to help meet FDA’s many other major regulatory responsibilities where Senate confirmed leadership is essential for the nation’s wellbeing.”
Califf already has a docket of major items to consider ranging from COVID-19 vaccines for children under 5 and a review of e-cigarette applications.
The Biden administration was reportedly considering keeping the acting head of the agency, Dr. Janet Woodcock, in place. But she was seen as damaged due to her time as the head of the FDA’s Center for Drug Evaluation and Research in the 1990s, when opioids were approved.
Sen. Joe Manchin, D-WVa., urged President Biden to withdraw Califf’s own nomination in an op-ed published in USA Today. He pointed to Califf’s “significant ties” to the pharmaceutical industry and pointed to how drug-related overdoses surged in the U.S. during his previous tenure as head of the agency.
“In 2016, then-Commissioner Califf announced the FDA’s plan to overhaul its opioid policies. But between 2016 and 2017, the FDA approved five new opioids and only removed a single opioid from the market.
Dr. Califf also commissioned a report on opioids, but the report failed to review the flawed enriched enrollment randomized withdrawal (EERW) methodology used to approve new opioids,” he wrote. (See “BIDEN PRESIDENCY=OBAMA 2021.”)
On 23 November 2021, the Trends Journal reported that Califf is no stranger to controversy. He was one of seven different FDA commissioners since 2015.
He’s from Duke University, where he ran a research center funded by the drug industry, which could indicate that he is a member of the drug lords mobs while acting as a consultant to Merk, Amgen, Biogen, Genentech, Eli Lilly, and Boehringer Ingelheim. (See “NEW FDA HEAD STUCK IN REVOLVING DOOR.”)
Manchin gave an impassioned speech in the Senate and said he has “never been more profoundly confident of a vote.”
“We need people who want to protect us, not people who allow drugs to destroy us,” he said.
Sen. Edward Markey, another Democrat, also accused the agency of becoming the “country’s biggest pill pusher.”
At the time of his previous tenure as head of the agency—during the Obama administration—he called for all data that is submitted to the FDA during the drug development process to be made public, StatNews reported.
“Making nonclinical and clinical data submitted to the FDA as part of the drug development process publicly available in a way that protects identity and trade secrets is the big idea that will accelerate the development of treatments for Covid-19 and many other diseases that continue to ail the global population,” Elizabeth Baker, the regulatory policy director at the Physicians Committee for Responsible Medicine, wrote in the online magazine.
TRENDPOST: As the late-great comedian George Carlin noted, “It’s one big club and you ain’t in it.”
The FDA claims collaboration with the drug industry is necessary and helpful. But the critics believe that such closeness constitutes a breach of an ethical barrier between the regulators and those they are supposed to regulate.
Need proof? As we had noted in the above article, the former commissioner, Scott Gottlieb is now on the board of directors of Pfizer, the Big Pharma drug dealer that made nearly $1 billion in vaccine profits in the first quarter of this year.