Leave it to Big Pharma to take a bad situation and make it a thousand times worse.
Around 40 percent of those with Parkinson’s disease are said to suffer from hallucinations and delusions. So, enter Nuplazid, a drug that was recently approved to lessen “Parkinson’s psychosis.”
But here’s the trouble: It doesn’t work. And that may be the least of it, because the FDA has compiled a list of over 700 people who died while on it. And in 500 of those deaths, Nuplazid is the only “suspect” medication those patients were taking.
Giving the green light to Nuplazid represents the worst of the worst when it comes to the slipshod, fast-track drug review process that the FDA conducts.
And despite the current “safety” review that the agency claims to be doing, this med is still being prescribed as if it were some magic potion and as safe as a lollipop.
Knowing the Nuplazid story is something that all caregivers for Parkinson’s patients urgently need to be aware of.
And even if this terrible disease hasn’t hit someone in your immediate family, please share this very important eAlert with your friends and relatives. It could well mean the difference between life and death.
Talk about delusional!
Nuplazid was given the go-ahead despite so many red flags that it’s almost unbelievable that the drug’s manufacturer, the San Diego company Acadia, had the gall to present it to the FDA in the first place.
For starters, Acadia had been trying to find a use for this med, known generically as “pimavanserin,” for over a decade. Back in 2005, it even conducted a trial on patients suffering from schizophrenia, which must have turned out to be a complete dud, as the results were kept a deep, dark secret.
Then, the drugmaker set its sights on Parkinson’s patients.
For that, Acadia conducted three trials, none of which found any evidence that this med could do a thing to help those with Parkinson’s psychosis, which is characterized by hallucinations (seeing or hearing things that aren’t there) and delusions (believing things that aren’t true).
In fact, one of those trials was ended early due to “futility.” In other words, it was going so badly that there was no reason to even finish it!
There were also more than double the number of serious side effects and deaths in those taking Nuplazid versus a placebo.
So, instead of ditching this worthless and incredibly risky med, the drugmaker asked FDA officials if the agency would consider approving Nuplazid if it tried one more time to find any shred of benefit.
Surprise, surprise! Not only did the agency agree to that… but it gave Acadia a speed pass to zip through the FDA, saying that this drug deserved “breakthrough status.” On top of that, it lowered the bar for practically everything that was done during that trial, from how symptoms were measured to what “benefits” were considered acceptable.
In the end, it looks like when FDA officials gave Nuplazid their blessings less than two years ago, they were the ones believing things that weren’t true and seeing things that weren’t there.
Because the hundreds of reports of patients who have died while taking Nuplazid is, according to Diana Zuckerman of the National Center for Health Research, “almost unheard of” – especially for such a new drug.
And remember, since many of those reports are submitted voluntarily (only the drugmaker is required to tell the FDA about adverse reactions), they’re just the tip of this deadly iceberg.
Yet as I write this, the drugmaker is doing everything in its power to sell as much Nuplazid to Parkinson’s patients as it possibly can — from disguising scary drug ads as public service announcements to providing checklists about delusions and hallucinations for patients to print out and take to their doctors.
But it gets worse, because those at risk aren’t just Parkinson’s patients.
Unbelievably, Acadia is now looking at other applications for this drug, perhaps as a general antipsychotic or even specifically for those with Alzheimer’s!
And regardless of what it finds, as it stands now, any doctor can prescribe this med off label for any condition whatsoever.
That’s why we need to do everything we can to stop them.
And you can do that by making sure anyone you know who’s caring for a patient with Parkinson’s is warned about Nuplazid.
Whatever the FDA decides to do when it completes its so-called safety review probably won’t be worth a wooden nickel. So, it’s up to us to step up to the plate and sound the alarm as loud as we can.
“FDA re-examines safety of controversial new drug” Blake Ellis and Melanie Hicken, April 25, 2018, CNN, cnn.com