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Hahn: FDA does not make regulatory decisions based on pre-pressures or press releases

The COVID-19 pandemic has rocked the long-standing model of clinical data publishing as researchers and drug makers race to share the latest findings on treatment and vaccine candidates at a time when the number of deaths and deaths is still increasing .

Many of the medical and scientific findings during the pandemic have been published in press releases or in pre-printed format, meaning they have not been peer-reviewed on sites such as bioRxiv and medRxiv, both of which were founded last year by Cold Spring Harbor Laboratory and the medical journal BMJ.

This kind of research is being watched closely by Wall Street as much of the early findings on experimental drugs and vaccines can shift the stocks of the companies developing these products.

Also see: Why Virus Shares Boost Market Volatility

Yet Dr. Stephen Hahn, Commissioner of the Food and Drug Administration (FDA), clearly states that the emergence of the prepress culture is not part of regulatory decision making.

“What we saw during the pandemic is a lot of preprints and press releases,” Hahn said in an interview with the medical journal JAMA last week. “We can’t make a decision based on a pre-print or a press release, and that’s because we insist on seeing all the raw clinical trial data.”

Traditionally, medical science research goes through a peer review research process before it is published in medical or scientific journals. Preprints have been questioned, as well as the speed with which medical journals publish research and the amount of press releases from companies developing treatments or vaccines.

Each manufacturer who placed a COVID-19 vaccine candidate in the U.S. clinic has taken a slightly different approach to publishing data from their Phase 1 clinical trials.

Moderna Inc. MRNA,
first one press release with interim results on May 18 and a study was published a month later on July 14 in the New England Journal of Medicine. Inovio Pharmaceuticals Inc. INO,
+ 3.65%
so far only has one news item, on June 30. When BioNTech SE BNTX,
and Pfizer Inc. PFE,
published the first data from the phase 1 clinical study of their COVID-19 vaccine candidate on July 20, they published a prepress and gave one news item at the same time.

Do not miss it:Dr. Osterholm: Americans will live with the coronavirus for decades

That said, the rate at which information is being discovered and shared in the unprecedented time is tremendous. As of June 1, at least 42,000 papers on COVID-19 have been published, 272 patents have been issued, and more than 3,100 clinical trials have been initiated, according to the Digital Science platform.

The Chan Zuckerberg Initiative, a company founded by Facebook Inc. FB,
+ 0.25%
founder Mark Zuckerberg and his wife Priscilla Chan gave medRxiv $ 2 million in June. The company said more than 7,000 preprints about COVID-19 have been published, including 5,500 about bioRxiv and medRxiv.

But it’s not just the amount of research, it’s how fast the scientific or medical consensus is shifting. There was more concern about the virus three months ago spread on surfaces. Now that focus has shifted to the dynamics of air transmission and growing concerns about transmission through the eye. Once-hyped drugs like Roche Holding AG’s ROG,
+ 0.29%
rheumatoid arthritis drug Actema has failed to successfully treat COVID-19 patients and others such as hydroxychloroquine in clinical settings because evidence has shown that they do not work.

Read: Dr. Fauci recommends wearing safety glasses to avoid contracting the corona virus

For example, JAMA received at least 7,000 additional entries during the pandemic, said chief editor Dr. Howard Bauchner during the interview with Hahn. He also suggested Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, raised a similar question during a live streamed interview this week.

“Do you even consider it reasonable to ask that they refrain from press releases about early investigation of data?” Bauchner asked.

“I actually think that’s a very good idea,” said Fauci. ‘[But] the companies, sometimes, [they] tell us to do that. They have to make something public, even if it’s not in the normal academic circles that you and I work in. ‘