Type 2 diabetics lose when the FDA chooses between drug safety and drug profits

Your pain, their gain

If you have type 2 diabetes, FDA officials have an important message for you. When it comes to drug safety, they want you to know that drug company executives are under great pressure to generate revenue.

Wait. What?

Yes, you read that right. Drug safety goes on the back burner. Drug profits? Front burner all the way!

I wish I were exaggerating. I wish I could tell you that FDA officials bend over backward to protect type 2 patients.

They don’t. In fact, quite the opposite. And you might not believe how despicable it gets.

It’s hard out there for a drug company

In 2010, I mocked FDA officials for approving the type 2 diabetes drug Victoza. (That’s right. Me mocking the FDA! Hard to believe, isn’t it?)

They completely deserved it, of course.

Several members of an agency review panel said Victoza wasn’t safe. In animal studies, Victoza caused thyroid tumors. In human studies, many patients developed pancreatitis — a dangerous inflammation.

In addition, the market has no shortage of type 2 drugs. Nobody was clamoring for a new one. Except, of course, Novo Nordisk, the maker of Victoza. Oh, and also maybe Paula Deen. She promoted Victoza when she announced her type 2 diabetes.

So the agency gave Victoza the green light, dismissing the advice of panel members.

And to nobody’s surprise, just one year later, FDA officials issued a warning. They linked Victoza use to an increased risk of pancreatitis, thyroid cancer, and kidney failure.

Recently, Public Citizen petitioned the FDA to ban Victoza immediately. And their petition includes a little surprise. You might not believe these two stunning comments from the director of the FDA’s Office of Drug Evaluation.

The director explained why he dismissed the safety warnings. He started by noting the pressures on drug company executives to generate revenue. And he added, “With most classes of drugs, there are similar drugs in development from competitors which places even more pressure to generate profit.”

Have you ever heard anything so clueless? Here’s the head of drug evaluation candidly revealing that the focus on profits overrides safety. It’s beyond despicable!

But Novo Nordisk must have found this encouraging.

They quickly moved ahead with even bigger plans. Already, two trials have been completed that tested Victoza as an anti-obesity drug. In both trials, Victoza dosage was significantly higher than the dosage given to diabetics. No surprise that gastrointestinal adverse effects were also higher.

Would you care to guess how the FDA will respond when Novo applies to the agency for Victoza anti-obesity approval?

I’ll give you a hint. Novo profits will rise.

Sources: 
“Public Citizen to FDA: Pull Diabetes Drug Victoza From Market Immediately” Public Citizen press release, 4/19/12, citizen.org