The Biden administration has nominated Dr. Robert Califf to head the Food and Drug Administration. Peter J. Pitts, a former FDA Associate Commissioner, had published at the International Business Times an enthusiastic essay about Califf’s nomination because Califf is a proponent of accelerated approval for drugs. However, that one factor, while it can be beneficial, ignores myriad other problems with Califf.

You can read the IBT article here, which focuses on Califf’s approval history. This essay is about all the problems with the rest of Califf’s history.

COVID has revealed that the FDA, the CDC, Fauci, the White House, and “science” are at odds with each other. The FDA desperately needs major reform and transparency surrounding hiring, drug safety, and new drug approvals. As commissioner under Obama, Califf made few or no noteworthy changes to the FDA and shows no signs of improving the record if re-appointed.

Califf arrived at the FDA in 2015 determined to modernize how the agency reviewed drug and device study data, but there is little evidence he achieved that goal:

• When he learned that Obama had proposed him as commissioner, Califf removed his name from scientific articles he had written. Even if they were controversial and assuming they were truthful, he should have stuck by them. America needs an FDA commissioner who will stick to evidence-based science, even in the face of controversy.
• Dr. Califf currently works full-time for Google’s “Alphabet” company (Google being the most evil company in the world, according to Ted Cruz). In 2019, he became head of medical strategy at Google parent company Alphabet Inc.

Dr. Califf in Bed With Big Pharma:

• Dr. Califf has deeper ties to the pharmaceutical industry than any FDA commissioner in recent memory, and he lacks a public health background.
• Dr. Califf founded the Duke Clinical Research Institute, which runs research trials for pharmaceutical companies and today has more than 1,200 employees.
• At Duke, Dr. Califf actively solicited funding from Big Pharma and no record exists of Dr. Califf ever saying “no” to any pharmaceutical company that offered him money. America needs an unbiased, science-based commissioner without these conflicts, and someone who can stand up to Big Pharma and say “no.” Some of the drug companies he accepted money from have FDA violations and questionable or even upsetting behaviors when it comes to their claims and when it comes to their safety /regulatory records.
• Hillary Clinton and the Clinton foundation have been heavily criticized for doing the same thing. She solicited significant donations as Secretary of State from anyone and everyone. Some of the countries from which Hillary Clinton accepted donations have appalling human rights records and even ties to terrorism. The Republicans threw a fit about Clinton but they didn’t seem to care about the appointment of Califf the first time around and haven’t yet raised these issues since his second appointment was proposed.
• Bernie Sanders is opposed to Califf’s appointment because of his Big Pharma ties.
• More than half (~63%) of Califf’s $320 million funding at Duke came from Big Pharma and has had decades-long ties to almost every big pharma company.
• He has served as a paid consultant with (1) Merck Sharp & Dohme, (2) Johnson & Johnson, (3) GlaxoSmithKline, (4) AstraZeneca, (5) Eli Lilly (6) Amgen, (7) F. Hoffmann-La Roche AG, (8) Janssen Pharmaceutica, (9) Daiichi Sankyo, (10) Sanofi-Aventis, (11) Bristol-Myers Squibb, (12) Proventys, Inc, (13) Regado Biosciences, Inc, and (14) Corgentech Inc. (15) Genentech
• Forbes wrote that his close ties to the drug industry were the reason for him not being nominated for the FDA Commissioner position in 2009.
• Due to Califf’s big pharma conflicts, he would be unable to serve on an FDA advisory committee, yet democrats are proposing Calif for a third tour of duty at the FDA, where he previously served as the deputy commissioner and then the commissioner.

Image: Robert Califf (cropped). Public domain.

Califf and the Opioid Epidemic—Bipartisan Disapproval

• Given the pressing need for a permanent commissioner, Califf is expected to again win confirmation. This is despite the fact that he has presided over highly questionable approvals at the FDA (including high-dose highly addictive hydrocodone preparations, Oxycodone use in children as low as 11, and female sexual dysfunction drug Addyi among several others). On every single one of these FDA approvals, the FDA decided to override its own advisory committee of experts, yet Califf still gave his approval.
• Joe Manchin has repeatedly stated that he would refuse to support Janet Woodcock’s appointment as FDA commissioner because of her inaction of the opioid epidemic. Under Woodcock, the FDA allowed Purdue to claim on Oxycontin’s insert that its delayed absorption was “believed to reduce the abuse liability.” The drug’s label declared that addiction “is rare.” That freed Purdue’s marketing team to push their drug as much safer than any opioid competitor. While OxyContin’s maker Purdue hadn’t performed clinical trials to prove that the drug was less addictive than other opioids, the FDA allowed the drug to carry a label that said addiction ‘is rare.’ Califf permitted the use of OxyContin in little kids as young as 11 years old.
• Moderate West Virginia Democrat Senator Joe Manchin called Biden’s choice of Califf an “insult to the many families and individuals who have had their lives changed forever as a result of addiction.”
• Califf was a cheerleader for Vioxx, which was reported to have caused 50,000 heart attacks.
• It has been reported by Freedommag.org that “while at Duke, the research operations over which Dr. Califf presided resulted in major fraud.”

Ineffectual assistance to terminally ill patients:

• Right-to-Try legislation exploded under Califf’s last FDA appointment because terminally ill American patients could not obtain access to potentially life-saving drugs that they needed. Right-to-Try now exists in 41 states.

Today’s FDA is not the same FDA of 20 or even 10 years ago. The FDA has become a lot more political and has made some highly questionable approvals and safety decisions in the very recent past which include, but are not limited to, vaccine/booster approvals. The FDA and CDC regularly ignore their own independent expert panels’ advice which they solicit and that includes, but is not limited to, decisions related to Covid-19 vaccines and boosters.

While Califf has put out voluminous amounts of research, he has a list of conflicts dozens of pages long. He clearly knows a lot about drug development and drug research but there are other individuals who are equally or more qualified than he is out there who don’t have Califf’s conflicts and baggage.

It is even further evidence of Joe Biden’s presidency being nothing more than an Obama 3rd term.

Greg Daniels (a pseudonym) is a former long-time FDA official.

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