Makers of risky asthma med dodge accusations of fraudulent marketing
Imagine a drug so dangerous that it can only be given in a doctor’s office — and then you have to wait two hours to make sure nothing goes terribly wrong.
A drug that has been linked to heart attacks, mini-strokes and blood clots and carries a black box warning about life-threatening allergic reactions.
With a drug that risky, even the FDA didn’t want it overused. So it only approved the asthma med Xolair for patients who couldn’t get relief with other, safer meds.
So how in the world did Xolair end up being handed out like candy to people with mild asthma symptoms — and maybe even to a child or grandchild you love?
It’s a case that involves accusations of cheating, lying, deception and… death. A story that could only come out of Hollywood — or Big Pharma.
You see, Xolair is one of those pricey, injectable “biologic” drugs that Big Pharma can sell for a fortune. In fact, Xolair can go for up to $24,000 per year, per patient.
Forget treating asthma! That’s like taking out a mortgage!
But on their way to getting filthy rich, it looks like something happened that Novartis and Genentech probably never expected.
The FDA decided the drug was too risky and shot down almost all proposed uses for it, except one — “moderate to severe asthma.”
And according to former sales reps who have turned whistleblowers — and who have spent years trying to bring the truth about Xolair to light — that’s when the shenanigans began.
They claim that the drugmakers devised a plan that included bribes, kickbacks, and insurance fraud to make sure docs handed out Xolair to as many folks with asthma as possible.
And that includes kids and other patients who probably shouldn’t have been allowed within 100 feet of the stuff.
For example, they claimed, by substituting the term “active asthma” for the FDA’s much narrower “moderate to severe asthma” in their sales pitches, the manufacturers were able to extend its use to patients even the FDA didn’t think it was safe for.
But it didn’t stop there.
Their complaint claims that doctors were rewarded with free equipment, and sales reps even volunteered to help with time-consuming insurance paperwork.
They also used things like concert tickets, American Express travelers’ checks and getaways to events at country clubs and casinos, so doctors would write more Xolair prescriptions, the whistleblowers charged.
Meanwhile, back in the real world — you know, the world of patients who were prescribed Xolair, things weren’t going so well.
An analysis of 11,503 Xolair users found at least 347 deaths while on the drug.
And a government review found five deaths of children up to 16 years of age on Xolair in 2011 alone, as well as 81 “serious” pediatric reactions.
But despite all the testimony and evidence, and after a judge even declared last year that “fraud was probable,” it doesn’t look our government is going to do a thing about Xolair.
In fact, the FDA just gave Xolair an additional approval for chronic hives in kids 12 and up.
The Feds aren’t lifting a finger to protect us from drugs like Xolair, so we’re going to have to look out for ourselves.
If you or someone you love (especially a child) is taking Xolair, have a talk with your doctor about whether it’s appropriate — or even approved — for your condition.
Because the fewer people who take this drug, the more easily we’ll all be breathing.
Sources:
“Major pharma scandal: Whistleblowers claim popular asthma drug was marketed illegally” Martha Rosenberg, March 3, 2016, Alternet, alternet.org
