Will the FDA let Big Pharma strip the warnings from this dangerous med?

FDA Alert: Pfizer’s hush money could put thousands more at risk

When Billy Bedsole Jr. decided he wanted to stop smoking, he turned to a man he trusted — his doctor. So when his doctor prescribed Chantix, Billy thought it was finally the answer he’d been hoping for.

But instead of kicking the habit, Billy started having memory loss, depression, and thoughts of suicide. His behavior became so erratic that he had to be hospitalized.

These horrible side effects put Billy and his family through, what his lawyer describes as an “incredible ordeal.”

And they were side effects, he said, that Pfizer knew might happen, but never bothered to warn about.

Billy sued Pfizer, and when his lawsuit finally got scheduled for trial this year, it was said to be the lead test case — the first of thousands — against Pfizer and Chantix.

But it looks like we’ll have to wait a little longer to get the brass at Pfizer under oath. Because it would appear that when its CEO, Ian Read, was subpoenaed to take the stand, Pfizer started making deals.

Rather than risk having to tell “the truth, the whole truth and nothing but the truth,” they settled with Billy.

In fact, Billy’s case was only one of the thousands Pfizer would “confidentially” settle. It did so with almost all of the other 2,700 Chantix lawsuits. To the tune of over $275 million.

So we will never hear about the specifics of those nearly 3,000 cases. And, if Pfizer has its way (as it usually does), we will hear even less about the horrible side effects of this dangerous drug.

But it’s critical that you know the truth. Because this drug messes with your brain more than Dr. Frankenstein would.

In preparing for the lawsuits against Pfizer, many documents concerning Chantix became part of the court record.

Those documents were sealed, and Pfizer plans to keep it that way.

In fact, the drug giant is planning to do everything in its power to make sure no one hears about these side effects again.

To that end, it’s asking the FDA to strip that black box warning from its Chantix package. The warnings about “hostility, depressed mood,” and “suicidal behavior.”

These warnings, which were added three years after Chantix hit the market, are precisely the ones that Billy and thousands of others never saw.

Now Pfizer wants a whole new group of Chantix users not to see them again. Drug experts Thomas Moore and Dr. Joseph Glenmullen were hoping a judge would let them bring those sealed court documents on Thursday to the FDA meeting. But the judge denied their motion.

Moore, who is the senior scientist at the Institute for Safe Medication Practices said that this “public debate about the psychiatric side effects of Chantix” needed to include a “balanced scientific record.”

Moore also said that Pfizer had subpoenaed him for documents about his research as well as personal emails just to “harass and intimidate” him.

Another trick Pfizer used to keep the public from seeing those court files was to stamp them “confidential.”

And that’s not because they contain any trade secrets or personal information, Moore says.

But it’s a good thing that Moore and Dr. Glenmullen weren’t counting only on getting hold of those court documents for the FDA meeting.

They’re also coming with plenty of other evidence about just how dangerous Chantix is.

Of course none of the 2,700 cases will be cited since Pfizer required confidentiality agreements. But there is more proof…proof that comes straight from the FDA’s files.

Armed with that evidence –they’re planning on asking the agency to not only keep that warning on the Chantix box, but to make it twice as big.

While the public is apparently welcome to attend, you won’t be allowed to make any comments at the meeting. So they are counting on us not wasting our time sitting by and watching the FDA in “action.”

That leaves us holding the bag again. Since we know the FDA never considers its mission statement before its bank statement.

Sources:
“Pfizer preps its case for FDA pulling Chantix’s black-box warning” Tracy Staton, September 25, 2014, FiercePharma, fiercepharma.com