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Scott Gottlieb M.D.

Dr. Scott Gottlieb Was A Pfizer Board Member, As Of November 15, 2021. According to their Pfizer board member page, Dr. Scott Gottlieb is a member of Pfizer’s board of directors.

Gottlieb Was The Commissioner Of The Food And Drug Administration (FDA) Under The Trump Administration. “President Donald Trump’s pick to lead the Food and Drug Administration, Scott Gottlieb, is a physician, a cancer survivor, a venture capitalist and a government insider who has long said he wants to tear down the wall of FDA regulations he believes is holding back innovation.’” [CNN, 4/4/17]

Gottlieb Served As FDA Commissioner From 2017 To 2019. [Pfizer, accessed 11/19/21]

Gottlieb Was A Senior Fellow At The American Enterprise Institute (AEI), As Of November 15, 2021. “Scott Gottlieb, MD, is a senior fellow at the American Enterprise Institute (AEI). He returned to AEI in 2019 after serving as the 23rd commissioner of the Food and Drug Administration (FDA). At AEI, he continues his work on improving public health through entrepreneurship and medical innovation and on expanding regulatory approaches to maintain patient and physician autonomy. Dr. Gottlieb is also a special partner with the venture capital firm New Enterprise Associates and serves on the boards of Pfizer, Illumina, and Tempus.” American Enterprise Institute

AEI Is A Conservative Think Tank. “The Prince-ton basketball player was a key figure on welfare policy for both New York state and NYC, where he became known nationally as a vocal proponent of work requirements and ran the city’s mammoth Department of Human Resources. This month, he takes over as head of the American Enterprise Institute, the august conservative think tank on Massachusetts Avenue.” [Washington, 7/8/19]

Gottlieb Was The Former Deputy Commissioner Of The FDA Under President George W. Bush. “Scott Gottlieb, President Trump’s choice for head of the Food and Drug Administration, was confirmed by the Senate on Tuesday in a 57 to 42 vote. The former deputy commissioner of the FDA under George W. Bush will come to the job with strong views about what FDA reform might look like — unlike many of Trump’s other nominees.”[Vox, 5/10/17]

Gottlieb Had An “'Unprecedented'” Amount Of Conflicts Of Interest Tied To The Pharmaceutical Industry And Had Been Paid “Millions Of Dollars” By Industry Interests He Would Oversee At The FDA. Experts Warned Of Gottlieb’s “Myriad Conflicts Of Interest” Due To The “Millions Of Dollars” He Had Been Paid By Industry In The Years Before Trump Nominated Him To Lead The FDA. “President Trump has repeatedly slammed pharmaceutical companies for 'getting away with murder' on soaring drug prices, but he and his nominee to head the Food and Drug Administration have pledged to ease industry regulations and speed approvals for medicines and other consumer products. The nominee, Dr. Scott Gottlieb, has spent the bulk of his career working in the drug and health care industry, which experts say raises the potential for myriad conflicts of interest. If confirmed to head the F.D.A., he would wield considerable power over companies and investment firms that have paid him millions of dollars over the years.” [New York Times, 3/19/17]

2013-2015: Gottlieb Was Paid $413,700 In Consulting Fees From Pharmaceutical Companies That Were All “Likely To Have Regulatory Business With The FDA” During Gottlieb's Tenure. “From 2013 through 2015 — the extent of a database maintained by the Department of Health and Human Services — Gottlieb received some $413,700 received from drug companies for consulting, speaking or other services. In 2015 alone, he collected $199,951 from eight drug companies, including GlaxoSmithKline, Squibb, Valeant. All are likely to have regulatory business with the FDA in coming years.” Los Angeles Times, 3/16/17

2005- After Taking His Position At The FDA, Gottlieb Had To Recuse Himself From Participating In Matters Involving Nine Drug Companies. “This wouldn’t be the first time that Gottlieb’s conflicts of interest raised eyebrows. Upon taking up his FDA post in 2005, he had to recuse himself for up to a year from participating in matters involving nine drug companies, including Eli Lilly, Roche, Procter & Gamble and Sanofi-Aventis.” Los Angeles Times, 3/16/17

Public Citizen's Health Research Group’s Michael Carome: “Gottlieb Is 'Entangled In An Unprecedented Web Of Big Pharma Ties.'” “’Gottlieb is 'entangled in an unprecedented web of Big Pharmaties,’ Michael Carome, director of the Health Research Group at the advocacy organization Public Citizen, told me.” 1)|Los Angeles Times, 3/16/17 2)

Revolving Door Career

F.D.A. Nominee Details Millions in Payments From Drug Firms

New York Times - By KATIE THOMAS - MARCH 29, 2017

Dr. Gottlieb was just 33 years old when he became a deputy at the F.D.A. in 2005 during the Bush administration. At the time, he had little government experience beyond a handful of previous stints at the F.D.A. and the Centers for Medicare and Medicaid Services. Before that, he had held jobs as a financial analyst and consultant to the pharmaceutical industry. He also wrote newsletters chronicling the biotech industry: the Gilder Biotech Report and the Forbes Gottlieb Medical Technology Report.

Those industry ties soon became a headache. In late 2005, he was forced to recuse himself from discussion of a defense plan for the avian flu, the Boston Globe reported at the time, because of his consulting work for some of the major players in the vaccine market, including Roche and Sanofi. Around the same time, emails that were leaked to Time Magazine showed him questioning career F.D.A. employees over a decision to halt a trial for a multiple sclerosis drug, and expressing surprise when the agency turned down an osteoporosis drug.

At the time, Dr. Gottlieb defended his actions, saying his job required that he ask questions to understand how the agency worked, and that he deferred to career staff on drug approvals.

“The agency was being highly politicized by the Bush administration, and he certainly was part and parcel of that politicization,” Dr. Wood said. “I think for that subset of F.D.A. career staff, the physicians who worked there, I think there was suspicion of everyone in leadership at the time.”

Dr. Gottlieb left the agency in 2007, and quickly returned to the health care industry. He became a partner at New Enterprise Associates, working on the firm’s portfolio of health care investments, and took consulting work at a range of companies, from pharmaceutical giants like Bristol-Myers Squibb and GlaxoSmithKline to start-ups like Cell Biotherapy, an early stage cancer biotech firm that he helped found. Dr. Gottlieb also held seats on a number of corporate boards, including Tolero Pharmaceuticals, a Utah company working on cancer treatments, and MedAvante, which assists pharmaceutical companies with clinical trials. 3)

Gottlieb Advocating for Opioids

Wall Street Journal - The DEA’s war on pharmacies — and pain patients

Doctors and patients would suffer less if medical regulators were put in charge of monitoring opiate consumption and abuse

March 23, 2012 by Scott Gottlieb M.D. Senior Fellow American Enterprise Institute

Last month, the Drug Enforcement Administration abruptly revoked the narcotics license held by the distributor Cardinal Health, preventing that firm from shipping prescription pain drugs to thousands of Florida pharmacies and hospitals. It’s the latest tactic in the DEA’s struggle to stem the illicit use of prescription painkillers like OxyContin and Vicodin.

The agency is going after professed “chokepoints” in the drug-supply system, including pharmacies and, now, drug distributors.

This approach is burdening a lot of innocent patients, including those with legitimate prescriptions who may be profiled at the pharmacy counter and turned away. Others have in effect lost access to care, because their doctors became too wary to prescribe what their patients need. But the DEA tactics aren’t stemming the illegal activity.

“What can be done? We should free the DEA from the dual mandate to be both regulator and cop.” — Scott Gottlieb

A good line of demarcation would be at the point of care. Doctors prescribing narcotics, drug distributors and pharmacies could come under the supervision of HHS. The department would also take responsibility for apportioning active ingredients to manufacturers of narcotics, educating doctors on proper prescribing, and investigating pharmacies and providers who appear to have gone rogue.

HHS would need authority to bring civil and criminal cases against bad practitioners. Yet this is consistent with the impending, if long overdue, expansion of HHS’s oversight of Medicare and Medicaid fraud. It combines many of the same methods, including sophisticated clinical data mining and provider-claims analysis. These competencies are beyond the reach of an already overburdened DEA.4)

Revolving Door Industry Influence

House Investigators Point to Purdue Pharma Influence With Trump FDA Commissioner Scott Gottlieb denies pharma manipulation, but ties to opioid industry have dogged him for years.

April 19, 2022 The Disinformation Chronicle by Paul Thacker

If not for the COVID-19 virus, the American media would be consumed by the opioid pandemic. Since 1999, more than 500,000 Americans have perished due to opioid overdoses—100,000 just in the last year. While denying culpability for decades, the pharmaceutical industry is finally paying a price, although a minor one. Purdue Pharma is now in bankruptcy, but the Sackler family who fueled the epidemic will escape legal accountability and walk away with billions.

Still, many are pushing to hold those responsible to account, the latest being a House investigation into the consulting firm McKinsey, which advised the FDA on drug safety at the same time that it was advising Purdue on ways to increase Oxycontin sales.

Just think about that for a moment—for years McKinsey played both cop and robber. Of course, this is absolutely heinous, and should not have happened. And of course, nobody will be prosecuted. But buried down in the House’s 53-page report5) are a few paragraphs on McKinsey employees emailing that they had influenced a 2018 speech on opioid safety by FDA Commissioner Dr. Scott Gottlieb.6)

Face The Nation

Transcript: Dr. Scott Gottlieb on “Face the Nation,” Oct. 23, 2022 The following is a transcript of an interview with Dr. Scott Gottlieb, former FDA commissioner and a member of the Pfizer board, that aired Sunday, Oct. 23, 2022, on “Face the Nation.”7)

Full transcript of “Face the Nation” on Nov. 6, 2022 Laura Meckler, Dr. Scott Gottlieb and Emily Oster 8)

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