Big Pharma’s latest offer is one the regulators can’t refuse twice

“I just couldn’t defend the risk-benefit advantage here.”

That comes from Dr. Stuart Rich, a world-famous professor at the University of Chicago’s Pritzker School of Medicine. He knows more about pulmonary heart disease than just about anyone on the planet.

And he’s talking about a drug the FDA is about to approve.

Cangrelor, a new, risky blood thinner, is now moving at light speed through the agency’s approval process.

The drug’s trials have been called disturbing and unethical. A leading cardiologist warns cangrelor may be just as likely to cause serious internal bleeding as save a life.

And it’s just months from being stocked at hospitals and clinics near you – all thanks to the oldest trick in the Big Pharma playbook.

For blood or money

The FDA is expected to green light the blood thinner cangrelor sometime this summer. And that will be a sad day for the untold numbers of patients who will be given the drug.

Because forgotten will be what got it into doctors’ hands in the first place. And that’s one of the most devious trials in the history of Big Pharma. One that FDA committee members even called “unethical.”

But that’s probably quite an understatement.

Desperate to get cangrelor on the market, its manufacturer The Medicines Company apparently tried every trick in the book to make it look good.

And that started with the cangrelor trials. More than 11,000 people were used as guinea pigs – and many may have been put directly in harm’s way.

The goal was to prove that cangrelor is somehow better and safer than existing treatments. And to do that, researchers may have intentionally delayed administering competing drugs to patients – waiting until those medicines couldn’t deliver much of a benefit.

Experts who analyzed the study claimed these trial participants received “substandard care” that put them at greater risk for life-threatening heart attacks and clots.

All to make cangrelor look good.

That should have been enough to put the brakes on cangrelor right then and there. And it nearly was.

Just last year, an FDA advisory panel initially recommended against approving cangrelor. One expert called the trials “very disturbing.” Dr. Milton Packer, another of the country’s top cardiologists, warned that cangrelor was just as likely to cause potentially life-threatening internal bleeding as it was to save a life.

But that was then. Now the same advisory panel that was ready to scrap cangrelor just months ago is recommending its approval – and all it took was a promise from The Medicines Company to limit how the drug was used.

They didn’t do a single new test. They didn’t present any new data. And it’s the same formulation that Dr. Packer and Dr. Rich warned was too risky.

It’s the oldest trick in Big Pharma’s playbook. Agree to whatever limitations you must to get a drug approved – and then all bets are out the window.

But, hey, if you can’t trust a company accused of running unethical clinical trials, who can you trust?

Of course, not everyone is falling for the ruse. Public watchdog groups submitted testimony opposing cangrelor’s approval. They pointed out the “ethical lapses” in the trials and how research hasn’t proven cangrelor is any better or safer than drugs currently used.

But all that will be ancient history once cangrelor is approved. And all your doctor may know is that the FDA thought it was safe enough and effective enough to be allowed to use.

Once approved, cangrelor will be administered to a patient before they undergo a cardiac stent procedure or angioplasty to prevent clots and heart attacks.  And it would be administered in a hospital or clinic setting – a situation where it’s often difficult to keep track of the drugs you’re being given.

I’ll be following the FDA’s actions on cangrelor, and keep you informed when it gets officially approved later this year (as no doubt, it will be), so you’ll be able to discuss it with your doctor.

And don’t be surprised if you know more about this drug than he does.

Source:

“Medicines Co.’s cangrelor finally lines up for FDA approval” Damian Garde, April 16, 2015, FierceBiotech, fiercebiotech.com