Tag Archives: Drugs

Hahn Defends Using Less ‘Robust’ Data During COVID, But Critics Contend It Has Gone Too Far

Sarah Karlin-Smith, Informa Pharma Intelligence: June 04, 2020


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Anecdotes Are Not Data Sets

The regulatory flexibility touted by Hahn was embraced to some degree by even some of the agency’s most notable critics, who agreed that the nature of the COVID-19 pandemic should allow for a different pace of decision making than under normal circumstances. However, they said they were concerned that FDA is misusing such flexibility, particularly when it came to the emergency use authorization (EUA) for hydroxychloroquine and chloroquine.

“I agree with Dr. Hahn that in emergency situations it makes sense to move quickly and change course quickly if the evidence is different from what was hoped for. But the only justification for making [hydroxychloroquine] immediately widely available was that President Trump had ‘a good feeling about it,” said Diana Zuckerman, president of the National Center for Health Research.

The EUA was granted based on laboratory data and anecdotal clinical reports. (Also see “FDA’s Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments” – Pink Sheet, 30 Mar, 2020.)

Zuckerman described this not as datasets but as anecdotal evidence. “Scientists don’t call anecdotal evidence datasets. As any scientist can tell you, the plural of anecdote is ‘anecdotes’ not ‘data,”” Zuckerman said.

In an emergency situation “making decisions on the fly and using the best data that you have is inevitable,” but the agency should follow certain principles when it does this, said Aaron Kesselheim, the director of the Program on Regulation, Therapeutics and Law at Harvard Medical School and Brigham and Women’s Hospital.

Kesselheim’s third principle was that the FDA should revisit or revise these decisions just as quickly as they made them when new information emerges. He said the FDA has done a good job in some circumstances of adhering to these principles and done less well in others.

As Hahn mentioned in his speech, the agency has reversed some of its early EUAs for COVID-19 tests. (Also see “FDA Yanks Potentially Faulty COVID-19 Antibody Tests – And More May Be On The Chopping Block” – Medtech Insight, 22 May, 2020.)

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Read the full article here.

Medical Professors are Supposed to Share Their Outside Income With the University of California. But Many Don’t.


For nearly two decades, Dr. Neal Hermanowicz has led the movement disorders program at the University of California’s Irvine campus, where he earns more than $380,000 a year in salary and bonuses. The widely respected expert on Parkinson’s and Huntington’s diseases adds to his income by consulting for drug companies.

Since 2014, 11 pharmaceutical companies have paid him a total of at least $588,000 for consulting, speaking and honoraria, according to federal data. For example, he has received more than $225,000 in speaking and consulting fees from San Diego-based Acadia Pharmaceuticals, manufacturer of a controversial drug for Parkinson’s-related psychosis. In 2017, he was the company’s highest-paid physician consultant in the U.S. That year, he prescribed the drug more than 180 times, costing patients or their insurers more than $445,000.

Under University of California rules aimed at discouraging excessive moonlighting, Hermanowicz should not only have reported his outside income to UC Irvine; he should also have turned over more than $200,000 to the school from 2016 to 2018, according to UC Irvine policies. His academic department would then have decided how much to keep and how much to return to him. That didn’t happen. From 2014 to 2018, Hermanowicz didn’t report any payments from pharmaceutical companies on his annual “outside professional activity” forms, which ProPublica obtained through a public records request.

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Approved in 2016, the drug, better known by its trade name, Nuplazid, has been associated with more than 2,000 patient deaths and 10,000 other adverse events, according to FDA data — figures that one expert has called an “important warning signal.” But for Hermanowicz, those concerns were overblown.

Nuplazid “got some attention in CNN recently with maybe an increasing risk of death, which I don’t think is valid,” he told the crowd. “They didn’t really do a careful analysis. They just said people took this medication and then they died.”

When Hermanowicz first connected with Acadia, as early as 2012, it was a relatively unknown firm, with no drugs on the market. But biotech insiders had high hopes for the company, which for over a decade had been developing Nuplazid to treat severe psychosis associated with Parkinson’s.

Hermanowicz became one of the drug’s primary advocates. Besides serving as an investigator in the trials, he also published several studies on its safety and efficacy.

In August 2015, he co-wrote an Acadia-funded study in the American Journal of Managed Care on how to manage the symptoms of Parkinson’s disease, emphasizing the need for effective treatment options. The next year, a study that he co-wrote called the drug “an important advancement” and a “first choice for treatment of Parkinson’s disease psychosis,” and he said it had a “better safety profile than current treatments.” In both studies, Hermanowicz disclosed his ties to Acadia.

The FDA’s clinical review reached a different conclusion. Conducted in 2016 by Dr. Paul Andreason, it found an increased risk of harm and death. Nuplazid failed two clinical trials, and patients experienced double the rate of adverse events of those on a placebo. Based on reviews of similar drugs, Andreason determined that Nuplazid’s safety profile was “not adequately safe” for treating Parkinson’s-related psychosis.

“We needed more controlled trial data to identify what the risk was,” said Andreason, who has since left the FDA.

When Nuplazid came before the FDA’s approval committee, Hermanowicz testified at the meeting, expressing the hope that the drug “will be available to me to provide to my patients.” In the company’s press release celebrating the approval, Hermanowicz said he was “delighted.” He was the only nonemployee quoted.

After Nuplazid hit the market, reports of deaths associated with the drug surged. “It’s a very high number” of deaths, said Diana Zuckerman, president of the National Center for Health Research. While it’s difficult to determine why there are so many fatalities, she said, the drug’s benefit isn’t worth the risk. In hundreds of cases, patients’ hallucinations, which are supposed to subside with the drug, were instead aggravated.

“This is not a particularly effective drug,” she said. “So what is the risk you are going to take?”

Last year, an FDA analysis found no “new or unexpected” safety risks related to Nuplazid. Acadia has maintained that the drug is safe for patients, and that the multitude of adverse events reflects its patient population, which is mostly elderly and in an advanced stage of Parkinson’s disease. “Our top priority is patient safety and we stand by the established efficacy and safety of Nuplazid,” said Maurissa Messier, a senior director for corporate communications at Acadia, in an emailed statement. Acadia is now seeking approval for Nuplazid to treat the millions of people who suffer from dementia-related psychosis, such as Alzheimer’s disease.

Hermanowicz has continued to publish studies supporting Nuplazid, lead medical education courses sponsored by Acadia and receive large consulting payments from the drugmaker without disclosing them to the university.

Some faculty members do take pains to comply with the university’s policy on outside income. Dr. Anjay Rastogi, a professor and clinical chief of nephrology at UCLA medical school, meticulously tracks all payments he receives from industry in a centralized spreadsheet — and remits the required portion, which he said funds academic enrichment, teaching or research.

“We need to disclose everything, I disclose more rather than less,” he said. “In my opinion, it’s fair that we help the university, and they help us as well.”

Read original story here.