Doctors and Researchers Criticize Non-Transparency of Hydroxychloroquine Study

June 1, 2020

The highly politicized debate over whether hydroxychloroquine is or is not useful to COVID-19 patients appears to be far from over. A coalition of more than 180 doctors and researchers have signed an open letter questioning the findings of a study showing that hydroxychloroquine and chloroquine have no benefit in treating COVID-19 patients.

The letter comes against the backdrop of allegations that FDA Commissioner Stephen Hahn personally intervened on behalf of a small doctor’s practice in New York to help it obtain hydroxychloroquine for its patients.

The study referred to in the letter was of 96,032 hospitalized COVID-19 patients from six continents in the past few months. Results were reported in The Lancet and found that the anti-malaria drugs offered no benefit and caused deaths and cardiac arrhythmias (DID, May 26).

But the coalition questioned the lack of transparency in not listing the countries or hospitals that contributed data for the study. It also claimed the data needed more error-checking, that data from Australia, for example, was not compatible with government reports of COVID-19 cases.

In addition, the coalition noted “implausible ratios” of chloroquine to hydroxychloroquine use in Australia, where chloroquine is not readily available.

The coalition called for Surgisphere, which holds the data for the trial, to provide aggregated patient data at the hospital level. It also called for the World Health Organization (WHO) or another institution to independently validate the study.

Surgisphere defended the study’s findings and said it had “clearly outlined the limitations of an observational study.”

France issued an order on May 27 banning hydroxychloroquine as a treatment for COVID-19 because of the study’s findings, shortly after the WHO suspended the hydroxychloroquine arm of its multinational Solidarity trial to conduct a safety review (DID, May 27).

Meanwhile, the FDA is defending Hahn’s alleged intervention in April to a rural New York family practitioner, Vladimir Zelenko, who said he had seen positive results in COVID-19 patients to whom he had prescribed a combination of drugs, including hydroxychloroquine.

The commissioner’s alleged personal involvement in helping to supply a single clinical trial — especially when that trial involves a controversial, potentially ineffective and unsafe drug 3 — has garnered criticism for being outside of his role as chief of the agency.

Peter Lurie, an ex-associate FDA commissioner for public health strategy and analysis, and executive director and president of the nonprofit Center for Science in the Public Interest, said the main issue with the communication was that Zelenko’s clinical trial went beyond the agency’s Emergency Use Authorization (EUA) for hydroxychloroquine, which only authorizes the drug’s use in hospitalized patients.

“By reaching out to Dr. Zelenko, Dr. Hahn was facilitating the evasion of the very EUA his agency had just issued,” he said.

He also felt that the communication was significant given that Zelenko had received attention from the White House.

“It’s hard to understand why an FDA commissioner would choose to spend his valuable time in the midst of a pandemic concerning himself with an individual doctor’s needs,” he said. “But in an administration that values demonstrations of loyalty above almost everything else and knowing that Dr. Zelenko had captured the president’s attention, maybe this makes some kind of sense.”

The FDA defended Hahn’s actions, sayingthat both Hahn and the agency have interacted with a variety of people both inside and outside of the research community during the pandemic.

“Throughout the pandemic, Dr. Hahn and the FDA have heard from people from all levels of government, Congress, academia, industry and the public on issues related to combating COVID-19,” an agency spokesperson said. “The agency is approaching all of these requests with a sense of urgency and responsibility during this public health emergency and has provided information and facilitated connections for follow-up.”

Read the coalition’s letter here: www.fdanews.com/05-29-20-Letter.pdf. — Jordan Williams and James Miessler