Is the FDA Really the Watchdog of the American People or Foxes in the Hen House?

Article posted with permission from the author, Marianne Perez.

In 2020, I had the below article published by several newspapers questioning long-term FDA employees in high-ranking positions starting their own companies. My focus was on Sharon Hertz, MD and Ellen Fields, MD who formed Hertz and Fields Consulting, Analgesic Drug Development — while employed by the FDA. With combined decades of experience and contacts with the pharmaceutical industry, it was puzzling that red flags were not raised as to huge conflicts of interest.

After over four years, I looked into the Hertz and Fields website. Who were their clients? Had they relocated from a one-bedroom condo used as their headquarters?  Were they really offering 1,000 shares of stock at $1,000 per share?

There is no Hertz and Fields website and there is no list of clients — although they have well over 500 unnamed contacts.

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Wonder why Health and Human Services (HHS), Department of Justice (DOJ), Drug Enforcement Agency (DEA), Attorneys General and elected officials don’t ask questions and conduct investigations calling it “conflict of interest?”

I do. But then I also question another FDA head named Bob Rappaport, MD who may have been an even bigger fox in the henhouse.  Stay tuned.

Jan-09-2020
Problematic Employment Move for FDA Heads
Marianne Skolek-Perez Salem-News.com Investigative Reporter

Why are FDA division heads allowed to approve dangerous opioids, killing and addicting in the hundreds of thousands, and then start their own consulting businesses?

Ellen Fields, MD and Sharon Hertz, MD Photos: LinkedIn

(MYRTLE BEACH, SC) – Two long-term heads of the FDA in the Division of Anesthesiology, Addiction Medicine, and Pain Medicine have recently terminated their employment with the FDA to start their own consulting business.

The two are promoting their availability to successfully and efficiently “bring pharmaceutical products to market” utilizing their FDA expertise.

Below is a Linkedin synopsis of Sharon Hertz, MD and Ellen Fields, MD collaborating in the lucrative private sector using their FDA tenure to help bring new pharmaceutical products forward.

Sharon Hertz
Ellen Fields

A few interesting details:

Hertz and Fields Consulting, Analgesic Drug Development, was incorporated on September 24, 2019 while both Hertz and Fields were still employed by the FDA.  The registered address of the consulting firm is a condo located at 7981 Eastern Avenue, #416, Silver Spring, Maryland 20910. The FDA headquarters is also in Silver Spring, Maryland.

This is not the first time the FDA has violated the trust of the American people. There was the sordid employment of Curtis Wright, MD by the FDA.

For those not familiar with Curtis Wright, MD, he was employed by the FDA from 1989 to October 1997, including multiple senior scientific positions in the Center for Drug Evaluation and Research as Deputy Director and subsequently Acting Director of that division.

Dr. Wright was involved in the review and approval of OxyContin, an opioid manufactured and marketed criminally by Purdue Pharma headquartered in Stamford, Connecticut.

After OxyContin’s approval by the FDA, Dr. Curtis subsequently went to work for Purdue Pharma — violating FDA protocol, although no action was ever taken against Wright by the FDA.

When I questioned the FDA about their lack of pursuit in the matter, they cited they were not aware that Dr. Wright was working for Purdue Pharma and the statute of limitations had passed for the FDA to take action against Wright.

Strange that it was all over the Internet that Wright was an employee of Purdue Pharma, but the FDA denied knowledge of Wright first approving a drug and then going to work for the drug company. Conflict of interest? Obviously not to the FDA.

Oh, and there was a patent when Wright was employed by Purdue Pharma.  Interested in the details of that patent? It was for a tamper-resistant oral opioid agonist formulation.

Two of the inventors on the patent were Benjamin Oshlack and J. David Haddox, MD who, when OxyContin was launched, tried to convince the medical profession that there was no such thing as “addiction” — it was “pseudo-addiction”.

“Pseudo-addiction” is a term Haddox coined and then pushed the medical profession to over-prescribe opioids by minimizing the dangers. The third individual named on the patent was former FDA employee, Curtis Wright, MD.

Is the FDA unaccountable to the Secretary of Health & Human Services, Attorneys General or the Department of Justice?  They certainly have proven not to be the watchdog of the American people.

Their disconcerting contribution to the opioid epidemic should have taught them something, but the further blatant conflicts of interest by Drs. Hertz and Fields show that is simply not the case. Outrage?  There should be.

Article posted with permission from The Washington Standard