The Legacy of Scott Gottlieb, MD, Commissioner of FDA – Watchdog or “Lapdog”

After a stint of less than two years as Commissioner of the FDA, Scott Gottlieb, MD has announced his resignation to “spend more time with his family.”

On February 24, CBS 60 Minutes aired a segment on the opioid epidemic featuring a high-ranking executive from the pharmaceutical industry, Ed Thompson.  Thompson has many years experience in the industry and, in fact, produces opioids for pharma and bravely accused the FDA of opening the floodgates on the opioid epidemic.  He went so far in the interview as saying “the root cause of this epidemic is the FDA’s illegal approval of opioids for the treatment of chronic pain.”

In the telecast, David Kessler, MD former FDA Commissioner when the maker of OxyContin, Purdue Pharma had their highly addictive opioid first approved in the early 1990’s was also featured.  When Kessler left the FDA, the labeling on OxyContin was changed to “long-term use” which according to Kessler was a mistake.  He further stated there were never studies conducted on the safety or efficacy of opioids for long-term use.

Under the tenure of Dr. Gottlieb, an opioid 1,000 times more powerful than morphine and 5 to 10 times stronger than fentanyl was approved.  It is a dissolvable sufentanil also known as Dsuvia.  This approval was given during an ever raging opioid crisis in every town and city in the country.

Raeford Brown, MD, as Chairman of the FDA Drug Safety Advisory Committee reviewed the safety and need for the dangerous opioid and warned it would be abused and fuel overdose deaths as well as be diverted to the black market. Dr. Gottlieb overrode Dr. Brown’s warning and sufentanil or Dsuvia was approved.  Dr. Brown was quoted as saying the FDA “is having a direct impact on the mortality rate from opioids in this country by continuing to approve new high-risk drugs.”

As informative as the CBS 60 Minutes broadcast was on the FDA fueling the opioid epidemic, there is another crisis brewing in our country and Dr. Gottlieb has taken quite an interest in it — or rather may have quite an interest in it.  Vaping or e-cigarettes seemed to be the focus of Gottlieb’s stay with the FDA and he was quite vocal on his promise to increase efforts to keep kids from getting hooked on e-cigarettes and even went on record as saying the FDA was considering a temporary ban on them.  Quite commendable of Dr. Gottlieb and quite a legacy to leave in the wake of just under two years as Commissioner of the FDA, but there is a problem here.

In April 2013, Gottlieb was made a managing director of T.R. Winston and Co., a merchant bank. One of Winston’s clients, Kure, is a manufacturer of vaping products. Gottlieb was on Kure’s board from March 2015 to May 2016 and had a financial interest in the company as well as a financial interest in 13 Winston clients. Winston-related income made up 60% of Gottlieb’s earnings of $3 million since the beginning of 2016.

Quite a legacy Dr. Gottlieb is leaving the country with as watchdog for the safety and lives of the American people.  With his financial interest in the vaping or e-cigarette industry, he should be able to live a rather comfortable life — as a lapdog.