What if there were a common health problem… and no known way to cure it? Would you rush a poorly proven drug through trials to deal with it? Even if you suspected the drug could result in many unnecessary deaths?
That seems to be the case with a new Parkinson’s drug called pimavanserin.
The drug is meant to deal with psychoses linked to Parkinson’s disease. A problem the FDA has no approved drugs to handle.
Pimavanserin (PVS) appears to be a bad gamble… one that’s cost many lives, thanks to the FDA’s fast-track process.
Here’s how desperation led to destruction with PVS.
Filling a Gap vs. Filling a Gap Safely
PVS was approved on the basis of one six-week study.
Let’s allow that to sink in for a moment.
People with a serious health condition – Parkinson’s disease – suffered from various psychoses. The situation was so dire; Uncle Sam approved a drug on the basis of a single 6-week study.
A study that had no other drugs to use as comparisons… that flunked three previous trials… and that still required a warning for it’s higher risk of death.
According to Uncle Sam’s own calculations…
- PVS didn‘t have enough trials to qualify for approval
- PVS barely reached 2/3 of the number of human “exposures” for consideration for approval
- The study in question showed “minimally improved” status among participants.
And here’s a comforting fact: People taking PVS are 2.38 times more likely than those taking a placebo to have a “serious” adverse event – including death.
Which seems to say, patients may experience minimal relief… but run maximum risk. Not exactly an ideal situation.
In fact, the finding of the Medical Review for the FDA was “Do Not Approve.”
Don’t Worry… It Gets Even Worse
The FDA’s statistical review found that having 25% of the subjects ineligible to take part in the study was no big deal.
In spite of there not being enough studies… having only 2/3 the minimal number of human “exposures” required… and a significant number of adverse events.
The drug was approved. But only barely.
In spite of the FDA’s approval, members of the committee voiced reservations.
- The committee chairperson noted there were safety concerns.
- A University of Florida member of the committee noted she only voted “yes,” because there were no safe alternatives to the drug.
- The FDA reviewer noted that 7 of every 91 patients could expect to respond to the drug treatment. Another five would experience severe side effects. And, of those five, one would die.
Reviewers classified benefits as “modest.” And many were worried with the small number of subjects in the one positive study.
CNN recently broke this story… noting the risk of death that’s more than doubled among those who take this drug. CNN reported one of the FDA’s committee members said, “I guess I’m hoping that the risks are going to be small…”
CNN reported, “In November, an analysis released by a nonprofit health care organization, the Institute for Safe Medication Practices, warned that 244 deaths had been reported to the FDA between the drug’s launch and March 2017.”
In less than a year, this “miracle” has proven to be a disaster. And the FDA (Food and Drug Administration) has proven to be at the forefront of every misstep along the way.
Your takeaway? You can’t trust Uncle Sam when it comes to your health. The FDA will side with Big Pharma more often than not. And you’ll be left hanging with “miracles” that turn into disasters faster than you can count.
About the Author: Jason Kennedy is a celebrated investigative health writer and the author of The X-Factor Revolution and Beyond the Blue Zone. With over 10 years of experience working with today’s leading alternative and anti-aging doctors, Jason shares his insider status and access to the latest breakthroughs with thousands of readers from around world.
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Fiore, K., “FDA Advisors Lukewarm on PD Psychosis Drug,” Medpage Today. Mar 29, 2016.
Ellis B. and Hicken, M., “FDA worried drug was risky; now reports of deaths spark concern,” CNN. Apr 9, 2018.
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