Another FDA Whistleblower, a Predatory CEO and Regulator Revolving Door Spin

Medical Monopoly Musings #59
Another FDA Whistleblower, a Predatory CEO and Regulator Revolving Door Spin

Got one more FDA whistleblower to share with you. For this one, I want to go into a bit more detail to show how this fits in with other critical aspects. This gives you a bigger picture of how the FDA and Big Pharma operate in all their shady glory.

The majority of this comes from Robert Whitaker over at MadInAmerica.com. For even more details go and read his lengthy piece.

It is centered around the antipsychotic drug, asenapine, made by Schering-Plough (SP) with the trade name Saphris.

SP later merged with Merck in 2009. This merger made CEO of SP, Fred Hassan, and other executives over $100 million. Earlier, Hassan had great success at Pharmacia, which got bought out by Pfizer, largely based on Celebrex and Bextra, drugs that would come under lawsuits and criminal charges for false marketing later.

Hassan, named by Financial Times CEO of the Year in 1999, would take that position at SP in 2003. At SP he also led the false marketing of Vytorin and Zetia which Merck later paid $688 million for. He was in charge during the approval of asenapine as well.

He’s held various positions and board seats of other pharmaceutical companies since then up through the present day. Hassan was a chairman at PhRMA, the industry trade group, including working on the Affordable Care Act in 2009.

Our drug in question centers around Ron Kavanagh, an expert in clinical pharmacology at the FDA turned whistleblower. His case is still not resolved despite him turning whistleblower 12 years ago.

Kavanagh had worked at the FDA since 1998 and led to several drugs not being approved, and others such as Lotronex, being recalled.

The pharma companies started hating him because of this. So did others at the FDA. In 2005, he started talking to the Senate Finance Committee about “corruption in the psychiatry division and in the Office of Clinical Pharmacology and other FDA offices.”

He mentioned the off-label marketing of psychiatric drugs, particularly in children. (See #40 for examples.) For this he was suspended and told to stop blowing the whistle if he wanted to keep his job.

In 2007, Kavanaugh looked at the data behind asenapine. He warned that asenapine and related drugs would be responsible for 5000 or more deaths per year. And his research showed they weren’t even effective for mild to moderate bipolar symptoms they were approved for.

Some alarming details stood out. Whitaker wrote that Kavanaugh found safety concerns about neonatal deaths “where a possible toxic risk had been deliberately obscured” by SP and “a cardiac arrest in a healthy volunteer had morphed into a fainting episode.” Unfortunately, this is often how drug science is conducted and modified by drug companies. In May 2008, Kavanaugh recommended non-approval.

By June, receiving pushback from his superiors, he wrote to the Office of the Inspector General and senator Charles Grassley. He said his colleagues at the FDA were “complicit” with SP in criminal activity.

Superior to Kavanaugh was the director of the psychiatry division at the FDA’s Center for Drug Evaluation and Research, Thomas Laughren. Laughren started at the FDA in 1985. His first review as a team leader was Prozac (see #10, #40 and #58).

During his FDA tenure, Laughren recommended off-label use of psychiatric drugs in children. He co-authored a book with chief medical officer of Eli Lilly (maker of Prozac), Leigh Thompson. He served on panels at conferences paid for by drug companies. In other words he had conflicted interests.

FBI agents looked into the whistleblower complaint but labeled it a difference of opinions in the agency.

In August, Laughren wrote a report approving of asenapine. That month Kavanaugh was fired.

Despite approval, asenapine didn’t do particularly well in the marketplace (perhaps because it didn’t work). In 2013, it was only making sales of $150 million.

In 2012, Laughren left the FDA to form Laughren Psychopharm Consulting. One of his first clients was AstraZeneca, working to get Seroquel approved for more uses including in adolescents. Laughren was successful in navigating these new uses through the FDA’s approval process, despite data of sudden cardiac death. (This was also the drug that AstraZeneca paid Wikipedia editors to write positively about covered in #47.)

Within two years, the FDA received reports of 220 deaths due to cardiac events for Seroquel. A warning label was added.

A PDF of a presentation of Laughren found online lists clients including AbbVie, Eli Lilly, Pfizer, Roche and many others.

Meanwhile he is also consultant to National Institute of Mental Health, under the NIH.

Laughren is also a part time employee at Massachusetts General Hospital Clinical Trials Network and Institute which states on their home page, “Making Your Clinical Trial Programs SUCCESSFUL – Smaller and Faster.” He holds a leadership position there.

In this document he summarizes, “Regulatory agencies are not fundamentally opposed to
considering alternative approaches to carving up the psychiatric illness space” by showing studies that show clinical benefits which “have a way of overcoming initial regulatory reluctance.”

In other words, hire me! I have the network to help get your drug studied in a way it will get approved because of my insider knowledge and connections.

In summation, Hassan and Laughren are laughing all the way to the bank. Meanwhile, Kavanaugh has still not made any traction on his whistleblower case. Welcome to our FDA.

References:
https://www.madinamerica.com/2020/08/fda-whistleblowers-documents-commerce-corruption-death/
https://en.wikipedia.org/wiki/Fred_Hassan
https://isctm.org/public_access/Feb2014/Presentations/140219_Laughren.pdf
https://mgh-ctni.org/