Drugmakers' secrecy alarms experts

Few details of trials is common; but scientists want openness now.

The morning after the world learned a closely watched clinical trial of a coronavirus vaccine had been halted last week over safety concerns, the company’s chief executive disclosed that a person given the vaccine had experienced serious neurological symptoms.

But the remarks were not public. Instead, the chief executive,

Pascal Soriot of AstraZeneca, spoke at a closed meeting organized by J.P. Morgan, the investment bank.

AstraZeneca said Saturday that an outside panel had cleared its trial in Britain to begin again, but the company still has not given any details about the patient’s medical condition, nor has it released a transcript of Soriot’s remarks to investors, which were reported by the news outlet STAT and later confirmed by an analyst for J.P. Morgan.

Another front-runner in the vaccine race, Pfizer, made a similarly terse announcement Saturday: The company is propos

ing to expand its clinical trial to include thousands more participants, but it gave few details about its plan, including how it would determine the effectiveness of the vaccine in its larger study.

It is standard for drug companies to withhold details of clinical trials until they are completed, guarding their intellectual property and competitive edge. But these are extraordinary times, and now there is a growing outcry among independent scientists

and public health experts who are pushing the companies to be far more open with the public in the midst of a pandemic that has

killed more than 193,000 people in the United States.

These experts say American taxpayers are entitled to know more since the federal government has committed billions of dollars to vaccine research and to buying the vaccines once they are approved. And greater transparency could help bolster faltering public confidence in vaccines at a time when many Americans fear President Donald Trump will pressure federal regulators to approve a vaccine before it is proved safe and effective.

“Trust is in short supply,” said Dr. Harlan Krumholz, a cardiologist and health care researcher at Yale University, who has spent years prodding companies and academic researchers to share more trial data with outside scientists. “And the more that they can share the better off we are.”

Last week, nine pharmaceutical companies, including AstraZeneca and Pfizer, pledged to “stand with science” and rigorously vet any coronavirus vaccine — an unusual pact. But researchers said the joint statement was missing a promise to share more details about research with the public and the scientific community.

None of the three companies with vaccines in advanced clinical trials in the United States have made public the protocols and statistical analysis plans for

those trials — the detailed road maps that could help the independent scientists better understand how the trials were designed and hold the companies accountable if they were to deviate from their plans.

NEW YORK TIMES 2019 While CEO Pascal Soriot said in a closed meeting a patient had neurological issues during an AstraZeneca COVID-19 vaccine trial, the company has released no public statement.