$60 million Victoza settlement leaves millions of patients still at risk

Type 2? The cancer risk you won’t hear from your doc

When it comes to selling its drugs, it doesn’t look like any devious plan is off limits for Big Pharma.

The most recent exposé concerns Novo Nordisk and how the drugmaker schemed to make its blockbuster type 2 med a bestseller despite its link to thyroid cancer.

The Justice Department filed a complaint to take away, as it said, some of the company’s “ill-gotten gains” for putting “vulnerable patients at risk.” To settle, Novo has just forked over close to $60 million.

Considering, however, that the drugmaker raked in over two billion in sales on this dangerous med last year, that’s really nothing more than a slap on the wrist.

But despite how many complaints are filed and how much Novo pays to settle them, a whole lot of vulnerable patients are still at risk.

Approve first, ask questions later
When Victoza was OK’d by the FDA back in 2010, it didn’t exactly come out of the gate with a clean bill of health.

This type 2 drug, called a GLP-1 (a fairly new class of diabetes meds), had already been shown to cause medullary thyroid carcinoma (MTC), a type of thyroid cancer, in lab animals — and the FDA thought that risk could extend to people as well.

So, as a condition of Victoza’s approval, Novo was instructed to follow something the FDA concocted for dangerous drugs it wants to approve, called a “Risk Evaluation and Mitigation Strategy” (a.k.a. REMS).

That is supposed to ensure that a drug’s risks don’t outweigh its benefits. Only it’s done after a med is approved, prescribed, and taken by millions!

Call me crazy, but shouldn’t that be what the FDA figures out before it releases a drug on unsuspecting patients?

Well, it looks like even REMS was too much for Novo to comply with. The company did everything possible to underplay any potential risks when selling Victoza to doctors.

The DOJ complaint tells about a full-scale plot on Novo’s part to “counter and neutralize” the cancer risk for this drug by arming its sales force with messages that would make docs believe there was nothing much to worry about.

Sales reps were coached in how to make the danger seem unimportant by “sandwiching” the information about thyroid cancer between promotional brochures, and even performed “skits” to have it appear as if the cancer connection was “irrelevant” and didn’t apply to people, just lab animals.

But even before all this came out, experts were saying this drug was bad news.

Several years ago, the consumer group Public Citizen even tried to get Victoza banned. It filed a petition with the FDA — not because of thyroid cancer, but about its off-the-charts risk of pancreatitis.

On top of that, four years ago researchers from UCLA and the University of Florida found something that should send shivers down the spine of any doctor who prescribes Victoza (or any GLP-1 drug, for that matter).

And that was abnormal cell growth — precancerous changes — found in the pancreases of diabetics who had been taking these meds.

As Public Citizen noted, those findings aligned perfectly with the “rapidly increasing number of reports” submitted to the FDA of pancreatic cancer in patients using these GLP-1 diabetes meds. And allowing drugs that are linked to pancreatic cancer to stay on the market is “extraordinarily reckless.”

Well, guess what? Victoza and all its GLP-1 friends are not only still on pharmacy shelves, but still being prescribed as if nothing had happened. Big surprise, right?

Certainly, if you have type 2 diabetes, you’ve got enough on your plate already without adding pancreatitis, thyroid cancer, or the horror of pancreatic cancer.

And that’s why you need to do what the FDA has failed to do: Tell your doctor that as far as you’re concerned, Victoza and other GLP-1 drugs (such as Trulicity or Lyxumia) are simply far too risky to take.

“Novo to pay nearly $60M to settle Victoza marketing suits with DOJ, whistleblowers” Eric Palmer, September 6, 2017, FiercePharma, fiercepharma.com