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Last week, former FDA commissioner Scott Gottlieb took on a new position – on the board of pharmaceutical giant Pfizer.
Mr. Gottlieb will now profit from a company that he was responsible for regulating less than 3 months prior. The move has been widely criticized, and for good reason. The revolving door between government regulators and the pharmaceutical industry has completely eroded the public’s faith in the FDA.
Pfizer is a massive company worth billions. Since Gottlieb was nominated as FDA commissioner, Pfizer’s market value has exploded from $200 billion to $240 billion. For the first year as commissioner, Gottlieb was forced to recuse himself from making decisions involving nearly 20 pharmaceutical companies with whom he had relationships. These companies included Vertex Pharmaceuticals, GlaxoSmithKline, and Bristol-Myers Squibb, among others.
Before becoming commissioner, he also did work for Pfizer.
The announcement has received much criticism, with one U.S. Senator calling for his resignation, saying that the move “smacks of corruption.” Leigh Turner, a bioethicist at the University of Minnesota, tweeted the following:
The next chapter of Scott Gottlieb’s career will be played out in the inner sanctums of Big Pharma — forever reinforcing the FDA’s critics of the revolving door between the agency and the industry.”
Is Pfizer Rewarding Gottlieb’s Loyalty?
Though Gottlieb has said that he is “proud” of his relationship with Pfizer and that he’s “very confident” about his record at the FDA, his dealings with the massive pharmaceutical corporation were sketchy to say the least. When it came to concerns about Pfizer’s rheumatoid arthritis medication, Gottlieb was notably soft.
In February, a safety trial run by Pfizer found that higher doses of the drug Xeljanz resulted in a “statistically and clinically important difference” in the instances of blood clots and death. While Gottlieb’s counterparts in the European Union quickly put restrictions on the drug, the FDA simply warned doctors of the study’s results.
In addition to rheumatoid arthritis, the drug was marketed for the treatment of ulcerative colitis and psoriatic arthritis. But the safety study required by the FDA did not focus on these other conditions, even though the dangerous higher doses were already recommended for patients with ulcerative colitis. Patients with inflammatory bowel disease like colitis have a higher risk of clots – as much as 3 times higher. Nevertheless, these patients continue to receive the dangerous higher dose.
“It sounds like a reward for a job well done,” said Carl Elliot, another bioethicist from the University of Minnesota. While Gottlieb denies any involvement in the decisions about Xeljanz, his prior involvement with Pfizer and quick appointment to the board following his resignation certainly raise doubts. “It sure does look suspicious,” Elliot said in an interview.
A History of Corruption
Unfortunately, the unseemly relationship between Big Pharma and the FDA is nothing new. For nearly 40 years, every FDA commissioner but one has joined the board of a pharmaceutical company after leaving the agency.
Scott Gottlieb’s predecessor, Robert Califf, was a consultant who was paid tens of thousands of dollars by the pharmaceutical industry. His clients included Merck, AstraZeneca, Eli Lilly, and Johnson & Johnson, the last of which paid him over $78,000 in 2012. Following his tenure as commissioner, he took a job with the publicly traded pharma company Biokinetics.
Before Califf, Margaret Hamburg was in charge of the FDA. She was charged in a racketeering lawsuit shortly after leaving the office. The suit accused Hamburg of collusion, conspiracy, and racketeering involving Johnson & Johnson’s drug Levaquin. Hamburg and J&J allegedly withheld the risks of the drug, which ended up killing over 5,000 patients and leaving tens of thousands injured by life-threatening disease.
During her tenure, Hamburg’s husband made hundreds of millions thanks to her work with Johnson & Johnson. She also approved the opioid painkiller Zohydro ER, manufactured by Zogenix Pharmaceuticals. An advisory panel voted 11-2 against approving the drug, citing its risk for abuse and overdose. They were joined by law enforcement agencies, anti-addiction groups, and addiction experts who voiced the same concerns.
Hamburg’s husband’s hedge fund held stock in the drug and made tens of millions on its approval. After stepping down as FDA commissioner, she took a lucrative job with Alnylam Pharmaceuticals.
Andrew von Eschenbach
Before Hamburg was appointed, Andrew Von Eschenbach was the FDA head. After leaving his post, von Eschenback took a position on the board of BioTime, a publicly traded biotechnology company that develops stem cell therapies and cancer drugs. Von Eschenbach took over the FDA suddenly, after a 2-month stint by his predecessor, Lester Crawford.
Lester Crawford served only a few months before resigning in the wake of allegations that he had failed to disclose conflicts of interest. A year later, he pled guilty to conflict of interest and false reporting of information about stocks he owned in agricultural and pharmaceutical companies – the very industries he was meant to regulate.
He was given 3 years of probation and a fine.
He soon joined Policy Directions, a lobbying firm that represents companies regulated by the FDA, including Merck, Nestle, and Alpharma Inc., a pharmaceutical company specializing in morphine-based painkillers.
Mark McClellan and Jane Henney
Before Crawford, the FDA was run by Mark McClellan, who went on to work for Johnson & Johnson. McClellan was preceded by Jane Henney, who followed her FDA appointment by becoming a director at Amerisourcebergen Corp, a wholesale drug company. The cycle is virtually endless.
It’s Time to Shut the Door
The influence of major companies is not limited to the FDA, nor is it limited to leadership. Just look at Ajit Pai, the FCC chairman with a storied career in the telecommunications industry. Or Sonny Perdue, who spent years working in agricultural sales before becoming Secretary of Agriculture in 2017.
If these conflicts weren’t enough, consider this: 75% of the FDA’s drug review budget comes from the biopharmaceutical industry. This has led to hundreds of risky drugs being rushed to market without adequate proof of safety. Even independent advisors often receive payments from the industry after drugs are approved.
How can we trust federal regulators to protect consumers when they are beholden to Big Pharma?
There’s only one way to stop the revolving door, and that’s to become vocal and active when it comes to our representatives. Scott Gottlieb, like those before him, was nominated and confirmed by elected officials. We need to make sure that the people receiving our votes are looking out for our best interests instead of continuing to let companies like Pfizer and Johnson & Johnson call the shots.
If we don’t stand against this kind of corruption, no one will. It’s time to shut the door between industries and their regulators.