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FDA urged to follow science, not hope, in quest for COVID-19 cures

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Former FDA Commissioner Margaret Hamburg and FDA’s former Acting Chief Scientist Luciana Borio Thursday cautioned the agency to put science ahead of hope when responding to the COVID-19 pandemic.

They spoke with BioCentury following public statements from President Donald Trump calling for widespread use of unapproved drugs under compassionate use to treat COVID-19.

“The magnitude and urgency of the threat creates tremendous pressure to accelerate product development and availability, even when these candidates remain unproven with respect to safety and efficacy,” Hamburg told BioCentury. “However, we cannot allow the desire to do whatever we can in the face of a tragic pandemic to divert us from making science-based decisions.”

Trump blamed “red tape” at FDA for delaying the availability of COVID-19 therapies.

Hamburg, however, said that “in response to serious past epidemic threats, FDA has been able to mobilize rapidly and effectively -- working with government agencies and the private sector -- to make new diagnostics available for use through Emergency Use Authorizations, to study and assess candidate drugs and vaccines, and to make promising candidates available as swiftly as possible when appropriate.”

“The American people deserve a lot more than hope from the FDA. They deserve cures.”

Luciana Borio, In-Q-Tel

Borio called for caution in making claims about untested drugs, or in making drugs available based on preliminary or anecdotal data.

“The American people deserve a lot more than hope from the FDA. They deserve cures,” said Borio, who is VP at In-Q-Tel, a non-profit strategic investor for the U.S. intelligence and defense communities.

She assailed the notion that distributing medicines under compassionate use can substitute for randomized, controlled trials. “Thinking that data collected under compassionate use is valuable to assess efficacy demonstrates a lack of understanding of fundamental scientific concepts. Thankfully, the NIH and academic partners are conducting adaptive, randomized clinical studies to find cures. These types of studies brought us treatments for HIV, Ebola and countless of other diseases, as well as Ebola vaccines.”

Hamburg and Borio were responding to a press briefing from the White House Coronavirus Task Force at which Trump made a number of confusing and incorrect statements about the strength of the evidence for chloroquine as a treatment for COVID-19 and about its regulatory status.

Right to try

Trump said chloroquine and hydroxychloroquine have “shown very, very encouraging early results.” He ended the briefing by stating: “We are very excited about chloroquine” and added that “it could have a very positive effect, or a positive effect, maybe not very, but maybe positive.” Trump also expressed optimism about chloroquine dramatically shortening the duration of the COVID-19 pandemic.

He said FDA is “going to be able to make that drug available almost immediately.”

Trump said chloroquine “has gone through the approval process, it has been approved” for COVID-19. He praised FDA, saying the drug was “approved very, very quickly.”

In fact, FDA has not approved chloroquine or hydroxychloroquine for COVID-19.

Trump touted the success of federal right-to-try legislation, suggested it could be applied to COVID-19 therapies, and said FDA is going “beyond right to try.” He said that “people are living now who had no chance of living” because of right-to-try, he said.

There is no documented case of a life being saved or extended as a result of right-to-try legislation.

Trump falsely suggested that in the absence of right-to-try patients would be unable to receive unapproved treatments for COVID-19. “In past administrations you wouldn’t even be able to even think about getting many of the drugs that have been showing great promise now,” he said.

In fact, FDA’s expanded access, or compassionate use, pathway is decades old.

“FDA’s responsibility to the American people is to ensure that products are safe and effective.”

Stephen Hahn, FDA

FDA Commissioner Stephen Hahn attempted to correct some of Trump’s assertions at the press conference, stressing the importance of establishing the safety and efficacy of therapies. “The FDA is committed to continuing to provide regulatory flexibility and guidance but let me make one thing clear: FDA’s responsibility to the American people is to ensure that products are safe and effective.”

Hahn said chloroquine will be made available to treat COVID-19 on a compassionate use basis, and said FDA is considering a “large pragmatic clinical trial.”

The FDA commissioner said data will be collected from any compassionate use access for COVID-19. “The important thing about compassionate use, and that’s that the president meant by this is beyond right-to-try, is that we get to collect the data. One of the things I promise the American people is that we will collect the data and then make the absolute best decisions based on those data about the safety and efficacy of treatments.”

The agency issued a statement Thursday afternoon that was far more restrained in its commitments than the comments made by Trump or Hahn.

FDA said it “has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine, which is already approved for treating malaria, lupus and rheumatoid arthritis, to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy in using chloroquine to treat COVID-19.”

While chloroquine and hydroxychloroquine have both been shown to block SARS-CoV-2 replication in cell culture, clinical data so far in COVID-19 patients are scant.

In mid-February, China's Ministry of Science and Technology (MOST) announced chloroquine had "fairly good efficacy" in COVID-19 patients, and reported that patients receiving the drug exhibited fever reduction and pulmonary improvement. However, detailed data haven't been disclosed.

Data from an open-label, non-randomized trial of hydroxychloroquine in COVID-19 patients were reported in March. In the 36-patient study led by a researchers at Aix-Marseille University, administration of hydroxychloroquine four days after symptom onset led to significant increases in the percentage of patients who had undetectable virus 3-6 days after treatment vs. those who did not receive the drug.

On Thursday, Mylan N.V. (NASDAQ:MYL) said it has ramped up production of hydroxychloroquine sulfate tablets and Bayer AG (Xetra:BAYN) announced that it is donating 3 million tablets of Resochin chloroquine phosphate to the U.S. government.

While other companies have received approval to sell chloroquine in the U.S., Bayer has not. The company said it is “working with appropriate agencies on an Emergency Use Authorization for the drug’s use in the U.S.”

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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