FDA researcher questions approval of dangerous blood thinner

Lester Baldwin, Jr. had only been taking the blood thinner Eliquis for two days when it nearly killed him.

It started with numbness — and then he couldn’t use his right hand. If emergency doctors hadn’t quickly diagnosed his brain hemorrhage, he probably would have died.

Baldwin and his doctor had no idea just how dangerous Eliquis could be. And it looks like they’re not alone.

Because an exposé just published in the Milwaukee Journal Sentinel has revealed some shocking details about how Bristol-Myers Squibb and Pfizer got Eliquis approved in the first place.

Now some of the country’s top doctors are claiming that the science behind the drug may have been little more than a dangerous fraud.

One that could put your life in danger.

The missing 300For patients like Lester Baldwin who have Afib and are on blood thinners, Eliquis was supposed to be a breakthrough.

They were promised that the pill doesn’t require routine bloodwork and you don’t even have to watch what you eat.

But when it comes to Eliquis, what you’re having for dinner should be the least of your worries.

Because what Baldwin and his doctor didn’t know was that this drug should never have been allowed on pharmacy shelves — and one top FDA scientist even tried to stop it.

Dr. Thomas Marciniak, who works at the FDA as a medical team leader, told the Journal Sentinel that when Bristol-Myers Squibb and Pfizer submitted clinical trial data on Eliquis, some critical safety information had completely vanished.

In fact, data on around 300 patients who participated in the trial had gone missing. And the more we learn about these 300 patients, the clearer it becomes that this may have been no accident.

You see, Dr. Marciniak claims that if there had been just one more death among Eliquis patients — or one less death in the warfarin group they were being tested against — the drug would not have been able to demonstrate any statistical benefit.

There would have been no reason for the FDA to approve Eliquis. Case closed.

And it sure seems possible that the missing data on these 300 patients could have been bad news for Eliquis — and maybe even included additional deaths. That’s because, unlike with warfarin, Eliquis has no antidote if you start bleeding uncontrollably.

That’s something that patients like Lester Baldwin, Jr. learned firsthand.

But it turns out that wasn’t the only problem with the Eliquis studies. Dr. Arnold Relman, former editor of the prestigious New England Journal of Medicine, told a shocked audience at Harvard that the big Eliquis trial called ARISTOTLE was heavily skewed in the drug’s favor.

Around 35 percent of the warfarin patients weren’t given the right amount of that drug in the study, causing them to have more clots than the Eliquis ones. These patients may have had their lives put at risk, just to make Eliquis look better.

But, of course, the FDA ignored the problems with the Eliquis research — and the warnings of one of its top scientists — and unleashed this monster on all of us.

And now, instead of working to keep Eliquis away from patients, the mainstream is trying to give it to a million more people with AFib instead.

Last year, Dr. Gregory Lip — a British cardiologist — developed a scale that tells doctors which patients should be put on blood thinners like Eliquis, based on their stroke risk.

And it didn’t matter that Dr. Lip has been taking money from Big Pharma for years — or that this was a blatant attempt to increase the use of these dangerous blood thinners by one-third.
The scale has still been adopted by doctors all across the country, who now have permission to dole out Eliquis prescriptions like never before.

And most of these patients will never know the true dangers of Eliquis or the story of how this drug should never have seen the light of day. It’s a story that probably still has some ugly and heartbreaking chapters to come — and you don’t want to be part of it.

Sources:

“Eliquis claim about reduced deaths questioned by FDA reviewer” John Fauber and Coulter Jones, August 1, 2015, Milwaukee Journal Sentinel, jsonline.com

“Doctor with financial ties to drug-makers at center of sales boom of new anticoagulants” John Fauber and Coulter Jones, August 1, 2015, Milwaukee Journal Sentinel, jsonline.com