Hundreds of deaths possibly linked to Parkinson’s disease drug made by San Diego’s Acadia
Hundreds of patients have died while taking a Parkinson’s disease drug from San Diego’s Acadia Pharmaceuticals, according to a story by CNN. In addition, the story said many other patients weren’t benefiting from the drug, meant to control Parkinson’s disease psychosis.
A total of more than 700 patients taking the drug, Nuplazid, have died in the most recent tally by the U.S. Food and Drug Administration, the story said.
Shares of Acadia lost nearly a quarter of their value at Monday’s close.
The CNN article didn’t compare the rate of death among patients who took Nuplazid to that among patients who didn’t. So whether the drug was associated with a higher death rate, a lower one, or didn’t have any association at all, wasn’t made clear.
Acadia replied to CNN with a statement indicating that deaths among Nuplazid patients were, if anything, lower than the average among those with Parkinson’s disease psychosis. A complication in about 40 percent of Parkinson’s patients, the condition causes hallucinations and delusions.
Nuplazid is Acadia’s flagship drug. It was approved by the FDA in April 2016. The FDA gave it “breakthrough therapy” and “priority review” designations, helping expedite its review. These designations are given to drugs treating severe diseases without adequate existing treatments.
The CNN story quoted industry observers who said approval appears to have been unduly rushed.
Nuplazid was taken by 244 patients who died between the drug’s launch in 2016 and March 2017, CNN said. The article gave as its source a report from the non-profit Institute for Safe Medication Practices. The report was issued in November.
These deaths and the most recent tally were reported to the FDA among the drug’s potential “adverse events,” the report stated. It doesn’t mean the drug caused their deaths, but may have been a factor.
In its response, Acadia said the rate of death was less than half that of all Parkinson’s disease psychosis patients. The rate of death was measured in “patient-years,” as recorded in the Medicare Claims Database from 2012 to 2015.
Patient-years represents the total amount of time patients have been on a drug, multiplied by the total number of patients. So if 3,000 patients have taken a drug for three years, that would represent 9,000 patient-years.
Acadia shares closed at $16.50 Monday, down about 23 percent. At that price, Acadia still has a market value of more than $2 billion, making it one of the biggest biomedical companies in San Diego County.
The CNN story didn’t contain any news to those who followed Acadia closely, said Bud Leedom, president of Leedom Asset Management in San Diego. The story’s effect came from its aggregation of previous reports and the emotional impact of those interviewed for the story, said Leedom, a financial adviser who follows San Diego public companies.
Acadia shares have performed poorly in recent months, Leedom said, and this latest controversy may have convinced shareholders who were on the fence to sell.
On Oct 9, Acadia closed at $37.59, more than twice Monday’s close.
Originally posted on SanDiegoUnionTribune.com