By Jefferey Jaxen
Scott Gottlieb, who stepped down as Food and Drug Administration (FDA) Commissioner prematurely in April, will join Pfizer’s board of directors the company announced Thursday. With an American opioid crisis still blazing and a growing public body questioning the FDA’s purported ‘gold standard’ in pre-licensure vaccine safety testing, Gottlieb’s revolving door step down to Pfizer shouldn’t be a surprise.
Every FDA commissioner over the past 38 years has joined the board of a pharmaceutical company after leaving the agency, except for one — David Kessler, according to Walid Gellad, an associate professor of medicine and head of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
Attempting to normalize Gottlieb’s move, the Washington Post reported:
“The vast majority of former FDA commissioners join the boards of drug or health-care companies at some point after leaving the agency, according to Walid Gellad, an associate professor of medicine at the University of Pittsburgh. He said a notable exception was David Kessler, the FDA commissioner during the George H.W. Bush and Clinton administrations. Mark McClellan, who was the head of FDA during the George W. Bush administration, is on the board of Johnson & Johnson. Robert Califf, who was commissioner during the Obama administration, is a board member for Cytokinetics and advises Alphabet’s Verily life sciences unit.“
Pfizer, the world’s largest drug maker, manufacturers an array of both meningococcal and pneumococcal vaccines along with popular drugs Enbrel and Lipitor. Gottlieb’s former FDA agency has licensed nearly all vaccines added to the U.S. Center’s for Disease Control and Prevention’s (CDC) recommended schedule without proper and thorough safety testing. Lack of double blind, inert placebo testing, dangerously short adverse event reporting windows and statistical manipulation has marred the FDA’s credibility in the eyes of the public. Gottlieb’s current move will do nothing to help repair it.
The former FDA head was outspoken in media appearances during the U.S. measles cases. Before stepping down to Pfizer, Gottlieb made his bid for a federal bill to force vaccines across the board by removing all exemptions.
Gottlieb warned that states might “force the hand of the federal health agencies” if they continue to allow vaccine exemptions. “You could mandate certain rules about what is and isn’t permissible when it comes to allowing people to have exemptions,” he added. Although his mandatory vaccination dreams never materialized under his watch, it didn’t stop his from weighing in publicly on vaccine injury.
The former FDA head did admit that he thinks “people have some casual fears about putting…a complex medical product into an otherwise healthy child.” When asked by the CNBC reporter why parents claim that their children developed autism or “something on the spectrum” right around the time they received their shots, Gottlieb blamed coincidence by saying:
“Children who are gonna display symptoms of autism and other developmental disorders, those start to manifest and become self-evident right around the time kids are getting vaccinated.”
The CDC’s schedule requires kids to get vaccinated from birth to 18 years. In other words, in Gottlieb’s world, during anytime “kids are getting vaccinated” is the window when a certain cross-section of them will naturally have “language and motor skills not developing properly.”
Watching the American opioid crisis continue to claim the lives of record numbers of people, a quadrupling in overdose deaths over the last two decades, has left onlookers wary of both drug companies and FDA who caused it. The current parallels of improper safety science and accelerated government endorsement with respect to vaccines can no longer be avoided.
In a 60 Minutes exclusive, CBS News reports:
“In 2001, after Dr. Kessler [FDA commissioner in the 1990s] left the agency, the FDA officially relabeled the powerful opioid OxyContin to be used for an ‘extended period of time’ by chronic pain suffers. Originally approved based on science that showed it safe and effective only when used “short-term”, the label was changed without adequate scientific study. “We don’t know whether the drugs are safe and effective for chronic use,” Kessler says. “The rigorous kind of scientific research the agency should be relying on is not there.” The right to market for the new indication was ultimately granted to a whole class of opioids.”
Kessler: “There are no studies on the safety or efficacy of opioids for longterm use.”
CBS Reporter: “But there’s a law that says that a drug cannot be promoted as safe and effective unless it’s proven to be safe and effective. But yet, with FDA sanction, these opioids are being used in that way that you say have not been proven.”
Kessler: “That’s correct. The rigorous kind of scientific evidence that the agency should be relying on is not there.”
Gottlieb released a statement to 60 Minutes admitting, “…we at the FDA include ourselves among those who should have acted sooner.”