Brilinta: More likely to kill you than prevent a heart attack

There are two things Big Pharma will never run out of – money and gall.

And right now, they’re using both to try to try to turn a potentially deadly blood thinner into the next billion-dollar blockbuster.

Drug giant AstraZeneca has quietly asked the FDA to dramatically expand the market for its controversial blood thinner Brilinta.

Brilinta has been called one of the worst drugs ever submitted to the FDA. It may be more likely to kill you than prevent a heart attack.

And in five short weeks, the FDA may start asking us to take three times as much of it.

Back in September I told you the appalling story of how Brilinta got to market. AstraZeneca sought the FDA’s approval based on a study called PLATO that compared Brilinta to another blood thinner, Plavix.

AstraZeneca claimed that PLATO proved Brilinta patients had fewer coronary events. But Dr. Thomas Marciniak, who led the review team for the FDA, called PLATO the “worst submission” he’d ever encountered for collecting data on serious side effects and even deaths.

According to the PLATO results, 12 people even called in their own deaths by phone – apparently that’s how desperate they were to get out of the trial.

And with good reason. When Dr. Victor Serebruany from Johns Hopkins took a second look at the PLATO data, he found that patients on Brilinta had a 27 percent higher rate of heart attacks and strokes.

This pill wasn’t thinning blood – it was thinning out the herd.

Dr. Serebruany was so outraged by how AstraZeneca had allegedly misrepresented the PLATO data that he even filed a complaint with the U.S. Department of Justice. But the company was able to make the DOJ investigation disappear and force through Brilinta’s approval.

Now, less than a year later, AstraZeneca is back with more shady Brilinta science. They’re asking the FDA to triple the amount of time heart patients can spend on the drug, from one year to three – and they’ve even wrangled a “priority review” that would force the FDA to act as early as July 1.

AstraZeneca is pinning its latest request on a new study called PEGASUS. But just like the winged horse for which the study was named, the science behind Brilinta is a myth.

Nearly 8 percent of patients taking Brilinta during the PEGASUS trial suffered a heart attack, stroke, or cardiovascular death – compared to 9 percent of people on placebo.

That’s hardly a difference at all – but the patients on Brilinta were a whopping two-and-a-half times more likely to suffer serious and life-threatening bleeding.

Brilinta may be more likely to cause a potentially fatal bleed than save your life. Or, at best, it’s what the editors of the New England Journal of Medicine called “close to an even proposition.”

But close shouldn’t be good enough. Not when our lives are at stake.

Sources:

“AstraZeneca scores fast-track FDA review for big new Brilinta use” Tracy Staton, April 29, 2015, FiercePharma fiercepharma.com