FDA bars critic from review panel of Biogen’s controversial Alzheimer’s drug

By Deena Beasley

(Reuters) – The U.S. Food and Drug Administration, citing conflict of interest, has recused a member of an 11-person advisory committee set to review Biogen Inc’s experimental Alzheimer’s drug aducanumab on Friday.

Mayo Clinic neurologist Dr. David Knopman confirmed on Monday that he was recused from the scheduled meeting of outside advisors to the FDA. Expert advisory panels often play an important role ahead of FDA approval decisions, although the agency is not required to take their advice.

Knopman, who said he was recused because of his involvement in conducting clinical trials of aducanumab, has been a vocal critic of the drug, including in a paper published on Sunday in the journal Alzheimer’s & Dementia.

“Aducanumab’s efficacy as a treatment for the cognitive dysfunction in Alzheimer’s disease cannot be proven by clinical trials with divergent outcomes,” he wrote.

The FDA, which is slated to decide by early March whether to approve aducanumab, did not immediately respond to a request for comment.

If approved, aducanumab would be the first drug to treat an underlying cause of the fatal, mind-wasting disease, a field that has for decades produced nothing but failure. By 2025, the number of people age 65 and older with Alzheimer’s dementia is projected to reach 7.1 million in the United States alone, according to the Alzheimer’s Association.

Biogen has said aducanumab, an antibody designed to remove harmful plaques from the brain, was shown in one of two major studies to significantly slow cognitive and functional decline. A second trial, however, showed a benefit only for a subset of patients who were given a high dose for at least 10 months.

Biogen abruptly ended a pivotal trial of aducanumab last year after an early look at results suggested it did not provide a desired benefit. Months later, the biotech company shocked many by reversing course, saying it had decided to seek FDA approval after all.

Shares of Biogen were down about 0.5% at $250.78.

(Reporting By Deena Beasley; Editing by Bill Berkrot)

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UK launching controversial vaccine trials where volunteers will be infected with the coronavirus

In a bid to speed up the race to find a vaccine for the novel coronavirus, the U.K. government announced Tuesday morning that it will be launching some controversial vaccine trials known as challenge trials.

The experiment will take place in a quarantine ward of a north London hospital. After inhaling a diluted dose of the virus, the trial participants will be closely monitored, thus enabling scientists and doctors to better understand the disease and how a vaccine can fight it.

“Human challenge studies can increase our understanding of COVID-19 in unique ways and accelerate development of the many potential new COVID-19 treatments and vaccines,” explained Dr Chris Chiu, from the Department of Infectious Disease at Imperial College London and lead researcher on the human challenge study.

The 1Day Sooner advocacy group, which has been petitioning the government to allow challenge trials, hailed the announcement. “We are glad the U.K. government is embracing the altruism of the thousands of our British volunteers who want these studies,” the group said.

The advocacy group says these trials “will be key to making multiple safe and effective COVID-19 vaccines available for the whole world, including those in low-income countries bearing the brunt of this pandemic.”

It says it believes these trials will not only accelerate research into vaccines but “will also answer essential questions about COVID-19 immunity that are broadly applicable to the development of treatments and public health policy.”

Alastair Fraser-Urquhart, 18, a spokesperson for 1Day Sooner, explained to ABC News his motivation to volunteer for these trials. Brushing aside the fact that he’s putting himself at risk, he said, “I’m convinced that challenge trials will save thousands of lives and billions of pounds, and if I didn’t do something and I wasn’t advocating challenge trials I would regret it.”

Andrew Catchpole, the chief scientist of hVIVO, the company that will be running the trials in conjunction with the British government, Imperial College University and the Royal Free Hospital, stressed to ABC News that as much risk as possible has been removed from the process.

Only people ages 18 to 30, proven to be healthy, will be taken as volunteers, according to Catchpole, and the dose of the virus that they will be exposed to will be very carefully calibrated.

“So just like any other clinical trial, what you would expect is that any product we put into a human needs to undergo very tight regulations, and this is no exception to that,” Catchpole said.

“So the virus, which we would inoculate them with, has been manufactured to the very high standards, a medical grade version of the virus that undergoes very high regulatory

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