Combining two dangerous drugs doesn’t make either any safer
What’s old is new again — and twice as deadly as ever
Quietly, behind the locked doors of a government shutdown last October, the FDA approved a dangerous “double” drug.
One that puts us women at serious risk.
Somehow, despite fudged studies, horrific side effects, missing reports, lackluster data andthe fact that the FDA has yet to approve the second half of this drug combo, this toxic twofer is coming to market this month.
And, since the PR push is in full swing, you can only avoid it if you know what to look for.
Out of the horse’s…
The approval of Duavee for hot flashes marked a new low at the FDA.
The drug, first called Aprela, had been in the works since ’99, first from Wyeth, and now Pfizer.
At first, it didn’t seem likely that the FDA would approve another estrogen drug.
After all, we all know the dangers of hormone replacement therapy by now. The bad news about estrogen pills started coming out in the ’90s. And by 2002 the Women’s Health Initiative proved how incredibly dangerous they are.
The conclusion, that estrogen can significantly up the risk of breast cancer, strokes and heart attacks, caused the study to end prematurely and millions of women to stop taking these hormone pills.
But now Pfizer wants us to believe that this “new” drug is somehow safer than that old estrogen.
How? Here’s the shocker: by adding another dangerous drug to the mix!
Only the FDA could do this kind of math — one deadly drug plus another deadly drug equals a safe one!
Duavee is nothing more than a mixture of Premarin (you know, PREgnant MARe urINe) and a drug called bazedoxifene. This second part of the Duavee mix has its own horrible side effects — stroke, deep clots, hot flashes (unbelievable!), leg cramps, and — worst of all…cancer.
Talk about a whole being worse than the sum of its parts!
This second half of Duavee also goes by an alias, Viviant. It’s one Pfizer had been trying to get approved by the FDA for osteoporosis since 2006 without success. The drug company has yet to address FDA’s “concerns” about its safety.
But why beat a pregnant horse over the head trying to prove Viviant is safe when you can just mix it with another drug, call it something else, and come back to the FDA with a “new and improved” version?
And even the “cost” of its old stand-alone estrogen, Premarin, hasn’t stopped Pfizer from pushing forward with Duavee. It has already set aside over $800 million to cover future lawsuit settlements over that hormone replacement therapy drug.
Despite all the pages of documents for Duavee on file with the FDA that have had large sections redacted like a classified CIA document, I was able to see this:
The FDA told Pfizer that the usual way “adverse events” are reported will not be enough for this dangerous drug. To figure out the “serious risk” it might pose for cancer of the uterus will require a full-scale “clinical trial.” One to be reported back to the FDA over a year from now!
So let me get this straight. They approve a drug, admit they don’t know enough about how many cancers it might cause, and then, after it’s flying off of prescription pads for over a year, they will take another look-see?
But even Pfizer’s closest friends couldn’t keep the Duavee label free of black box warnings. Warnings about cancer, heart damage and “probable dementia!”
And this is mostly a treatment for hot flashes! Yes, they can be horrible. But they are temporary. And they are certainly not dangerous. Most importantly, they will stop.
The same can’t be said about cancer or heart disease. And certainly not about “probable” dementia.
Sources:
Letter, FDA to Birming Wong, Pfizer, October 3, 2013, accessdata.fda.gov
“Big Pharma wins again: FDA approves Aprela under new name” Jane Allin, November 8, 2013, Tuesday’s Horse, tuesdayshorse.wordpress.com
“Pfizer targets approval for new menopause drug” Ryan McBride, FierceBiotech, fiercebiotech.com
