Former FDA head turns whistle-blower about industry he once shielded

Maybe the guilt over all the dangerous drugs approved on his watch eats away at him.

Or maybe he realizes he was also lied to…deceived…tricked…

But whatever the reason, Dr. David Kessler, the former head of the FDA has gone from being Big Pharma’s BFF to public enemy #1.

Turning the tables

Over 17 years after leaving the top job at the FDA, Kessler is out to prove just how much Big Pharma lies, cheats, and steals. And drug companies have fired back, calling him a “hired gun” who’s no better than an ambulance-chasing lawyer.

And this is what has them so riled up:

One of the drugs approved under Kessler’s watch was the antipsychotic Risperdal, made by Johnson & Johnson.

And it wasn’t long after that the drug was being promoted and pitched “off label” to doctors for kids.

Risperdal is bad enough for adults to take. But where children are concerned, it’s a hundred times worse.

One of its side effects is a condition caused “gynecomastia.” That’s the development of fully-formed breasts in boys. Some boys who grew breasts as big as a “D” cup.

Ignoring the physical dangers for a moment, we’ve all been teenagers. And we know that anything that makes us stand out or different can be crippling.

Just imagine what have D-cup breasts would mean for a teenage boy in America. So it shouldn’t come as a surprise that this would lead to lawsuits.

Well over a thousand lawsuits, in fact.

And it was one of those lawsuits that brought Dr. Kessler to Philadelphia at the end of January. He testified on behalf of the parents of an autistic boy, one who developed large breasts after taking the drug. The boy who now needs a double mastectomy.

Dr. Kessler filed a scathing 92-page report about the case. He testified that Johnson & Johnson knew all about the risks to young boys taking the drug. And that the company hid the information from patients, doctors and even the FDA, keeping it secret for years.

Also revealed in this trial was how aggressively the company promoted the drug for kids “diagnosed” with ADHD and autism. The boy’s pediatrician said that sales reps hounded him about it constantly, visiting his office over 20 times in two years to pitch Risperdal and bring samples.

Dr. Kessler called it a “corporate strategy to illegally promote” the drug, taking advantage of the fact it had been allowed on the market by the FDA for adults.

Johnson & Johnson has been busy settling these Risperdal cases for several years now, most confidentially. Dr. Kessler was supposed to testify in others, too, but the drug maker managed to settle them and keep him off the stand.

But they failed in this case.

I, for one, am glad to see Dr. Kessler finally standing up to Big Pharma. Too bad he didn’t do it when you and I were paying him to – and when it could have made a real difference to these young boys – and millions of other Americans.

Source:

“J&J lawyers aim to discredit ex-FDA chief in Risperdal breast-development case” Tracy Staton, February 2, 2015, FiercePharma, fiercepharma.com

“Former FDA chief testifies for plaintiff in Risperdal case” David Sell, January 28, 2015, Philadelphia Inquirer, Philly.com