Blowing the Whistle on the FDA

Medical Monopoly Musings #58
Blowing the Whistle on the FDA

How many FDA whistleblowers would you require before you realize it is safer to assume the FDA is not fulfilling it’s intended role than to assume they are?

Here’s five of them!

Renee Dufault showed that lye used in the production of high fructose corn syrup left trace amounts of mercury. Mother Jones reported that based on average consumption, “individuals could be ingesting as much as 200 micrograms of the neurotoxin per week—three times more than the amount the FDA deems safe for children, pregnant women, women who plan to become pregnant, and nursing mothers.”

When Dufault showed her superiors at the FDA these findings she was told not to investigate. The FDA claimed it was safe without actually investigating further.

So she left in 2008 to make her research public. While I knew corn syrup was bad for you, I had never heard about this fact until I sought out FDA whistleblowers.

Rosemary Johann-Liang was an FDA deputy director. She recommended a strong warning on the product label for the drug Avandia (by GSK) causing congestive heart failure. She was reprimanded, and the review transferred to her supervisor and out of her hands.

Later, the NEJM published similar results vindicating her. She resigned from the FDA.

"I really advocate for drug safety, and a lot of times the agency doesn't want to hear that there are problems,” she said. “I think, in general, there is a culture of 'The drug is always innocent.'"

She also points out the level of proof required by the FDA for drug effectiveness is far lower than that of drug safety, when it should be the opposite if health is actually what is important (rather than money).

What do you expect when the agency is paid for, in part, by the industry they regulate? In 1992, Congress passed the Prescription Drug User Fee Act. This made it so pharma companies would fund the FDA’s New Drug Applications reviews.

This law gave Big Pharma even more leverage over the FDA.

Dr. David Graham, associate director in the FDA's Office of Drug Safety turned whistleblower, testified to the U.S. Senate regarding Merck’s Vioxx risks. He was reprimanded…and later smeared and discredited.

(Smearing anyone who says what you don’t like is the standard industry strategy. For example, Victoria Hampshire was an FDA veterinarian. She found a popular heartworm medication for dogs was often deadly. Her analysis got the drug pulled off the market. In return, the drug’s maker Wyeth Pharmaceuticals conducted a smear campaign against her. They even used their influence with the FDA to have her criminally investigated! That’s what you get for truly following the science. Wyeth was later acquired by Pfizer. After all, company culture is important!)

In Dr. Graham’s testimony he said, “I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless...Vioxx is really a symptom of something far more dangerous to the safety of the American people. Simply put, FDA and its Center for Drug Evaluation and Research are broken.”

(If you remember our pharma-friends at the American Council on Science and Health, they named Dr. Graham the “Whiny Whistleblower of the Year” the year before Pfizer whistleblower Peter Rost. Also going back to Eli Lilly’s Prozac as covered in #40, Dr. Graham pointed out deadly side effects of that one too. Of course, it still made it to the market. Profits overs safety!)

Right around this time Kaiser Health News reported, “Former FDA Commissioner Lester Crawford is under criminal investigation by a federal grand jury over allegations of financial improprieties and false statements to Congress…Crawford left FDA in September 2005, two months after his Senate confirmation.”

That’s the head of the FDA because the corruption is top down.

The FDA is in charge of making sure the upcoming COVID vaccines are safe. Bill Gates called the FDA the “gold standard” and said they would do their job properly as long as political pressure didn’t get in the way.

… Such as politics pressuring the FDA back in 2005 with the Bush Administration. Dr. Susan Wood was FDA Assistant Commissioner for Women’s Health back then. Here the administration tied up approval for Plan-B, the “morning-after pill,” regardless of the safety or efficacy. She resigned in disgust.

Oh and the FDA has been caught spying!

The New York Times reported in 2012, “A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama, previously undisclosed records show.”

Senator Grassley said "Secret monitoring programs, spying on Congress and retaliating against whistleblowers -- this is a sad commentary on the state of affairs at the FDA.”

When the FDA has been always been involved in politics, is criminally complicit at worse, or just bureaucratically inept at best, so many times…do you really want to trust anything they touch?

References:
https://www.motherjones.com/environment/2009/08/corn-syrups-mercury-surprise/
https://usatoday30.usatoday.com/news/health/2007-06-10-fda-insider_N.htm
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534432/
https://www.nytimes.com/2005/02/25/politics/10-voters-on-panel-backing-pain-pills-had-industry-ties.html
https://whistleblower.org/timeline-us-whistleblowers/
https://www.finance.senate.gov/imo/media/doc/111804dgtest.pdf
https://www.madinamerica.com/2020/08/fda-whistleblowers-documents-commerce-corruption-death/
https://khn.org/morning-breakout/dr00036941/
https://www.acsh.org/news/2005/12/30/whiny-whistleblower-of-the-year-award
https://www.youtube.com/watch?v=gvqsYRhQ-DY
https://www.nytimes.com/2012/07/15/us/fda-surveillance-of-scientists-spread-to-outside-critics.html?pagewanted=all
https://abcnews.go.com/Politics/OTUS/fda-insists-spied-scientists/story?id=16808223