Popular heart drug wins approval on highly suspect study
Big Pharma talks to the dead — and still fudges the data!
You know it’s something serious when the Department of Justice gets involved.
After all, Eric Holder is a busy man. He certainly wouldn’t waste his precious time if he didn’t have to.
But this was big.
An expert was accusing a big drug company of using manipulated data — even fraudulent — to get a drug approved by the FDA.
And while patients were still unknowingly popping these pills, a drama was taking place behind the scenes. Something that brought serious scrutiny to the safety of this drug.
Something you, and your doctor, never heard a word about.
It only took AstraZeneca two years from application to approval of its “investigational” blood-thinning drug Brilinta.
Brilinta was approved based on the results of a big study called PLATO that compared it to another blood thinner called Plavix.
And many at the FDA didn’t trust the PLATO results from the get-go — for good reason.
This is what Dr. Thomas Marciniak, who was the team leader for the PLATO review group at the agency, had to say about it: “Literally this submission is the worst submission I have encountered for collecting — or at least submitting — information on SAEs.” (That’s the industry-speak for serious adverse events.)
Dr. Marciniak also said that the drug shouldn’t get an FDA okay based on that trial.
And he had good reason…
AstraZeneca stated that 12 patients who died during the PLATO trial reported their own deaths by phone!
That was the final straw for Dr. Marciniak.
So he brought in a well-respected expert in blood-thinning drugs from Johns Hopkins, Dr. Victor Serebruany, to help make the argument.
Even more blind and deaf to the facts than usual, the FDA approved Brilinta in 2011.
Apparently none of those issues troubled the FDA too much. Things like that, it said, were likely “too minor” to have any real meaning.
Astra must have been really excited that all those concerns were brushed aside and went away.
But they weren’t brushed very far.
Because Dr. Serebruany wouldn’t go away.
Now, don’t think this doctor was just concerned because of some crazy things like people calling Astra on the phone to report they had died. No, there were other big problems with PLATO.
The number of people who died taking Plavix, which Brilinta was tested against, were oddly very high. And for the people who had heart attacks during the study, well, somehow that managed to be slanted in favor of Brilinta too.
But if you actually looked at the study results, they showed that those taking Brilinta had a 27 percent higher rate of heart attacks and stoke.
In other words a lot more people died taking Astra’s drug then the Plavix!
But that wasn’t what Astra submitted to the FDA with their application.
So Dr. Serebruany filed a complaint under a provision in the law called the federal False Claims Act.
That’s when the U.S. attorney’s office in Washington got involved. By then Eric Holder’s DOJ had no choice: it had to step in. But not for long.
Because at the end of August, the DOJ quietly closed its Brilinta “investigation,” taking no action.
Many experts said that Dr. Serebruany’s charges were strong enough to require the FDA to add more warnings to the drug’s label, or, maybe have it taken off the market altogether.
But nothing changed, and Brilinta continues to be prescribed “as is.”
But “as is” is dangerous — and more dangerous than the alternative, Plavix. Despite Holder’s looking the other way.
Sources:
“U.S. DOJ closes probe into AstraZeneca’s heart drug Brilinta” Hester Plumridge, August 19, 2014, The Wall Street Journal, online.wsj.com
“Doctor Challenges testing of AstraZeneca’s Brilinta” Thomas M. Burton, The Wall Street Journal, online.wsj.com
