World Health Organization Warns Against Untested Drugs for COVID-19
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“Small, observational and non-randomized studies will not give us the answer we need,” stated WHO Director-General Tedros Adhanom Ghebreyesus. “Using untested drugs without the right evidence could raise false hope and even do more harm than good and cause a shortage of essential drugs that are needed to treat other diseases.”
The World Health Organization (WHO) is organizing the SOLIDARITY clinical trial to create data that can be leveraged to decide which treatments are most effective, if they decrease mortality and hospital stays. It will have five arms: one standard of care; one Gilead Sciences’ remdesivir; one a combination of lopinavir/ritonavir; another a combination of lopinavir/ritonavir/interferon beta; and the fifth of chloroquine. Ten countries are participating to date.
“That’s why WHO had launched the SOLIDARITY trial, to generate robust, high-quality evidence as fast as possible. The more countries sign up to the trial and other large studies, the faster we will get results on which drugs work and the more lives we will be able to save,” Tedros said.
This may be partly in response to attention paid to the malaria drug hydroxychloroquine for treatment of COVID-19. This was largely based on a study published in 2005 that found that chloroquine prevented the replication of the SARS-CoV-1 virus that caused SARS in laboratory studies.
In the midst of the China outbreak, production of the drug was ramped up for use in treatment. President Trump has touted it as a “game-changer,” but drug and public health experts have been more conservative in their praise, saying that the drugs, chloroquine and hydroxychloroquine, have not been approved as treatments for COVID-19 and that for the most part, their effectiveness for treating COVID-19 are largely anecdotal. However, because the drugs are approved for malaria, lupus and rheumatoid arthritis, physicians have broad latitude for using them “off-label” for COVID-19.
French researchers have published an article in the International Journal of Antimicrobial Agents describing the potential use of a combination of hydroxychloroquine and the antibiotic azithromycin, which is better known as Z-Pak. The FDA is also evaluating the drugs but have not yet made recommendations.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, is taking a more cautious, scientific approach. “As the Commissioner of FDA and the president mentioned yesterday, we’re trying to strike a balance between making something with the potential of an effect available to the American people, at the same time that we do it under the auspices of a protocol that would give us information to determine if it’s truly safe and truly effective,” he said in a Friday, March 20 press conference. “But the information that you’re referring to specifically is anecdotal, it was not done in a controlled clinical trial. So you really can’t make any definitive statement about it.”
Gilead announced that it was placing compassionate use requests on temporary hold for its experimental antiviral remdesivir for COVID-19 because of the increased demand—what is has called “an exponential increase in compassionate use requests for emergency access to remdesivir.” It is continuing to provide patients with access to it but wants to make sure it is available for ongoing clinical trials and for the most severely affected patients under a “compassionate use” program.
“We are focused now on processing previously approved requests and anticipate the expanded access programs will initiate in a similar expected timeframe that any new requests for compassionate use would have been processed,” the company stated. “As an exception, compassionate use requests may still be made for pregnant women and children less than 18 years of age with confirmed COVID-19 and severe manifestations of disease.”
In a related topic, the U.S. Federal Bureau of Investigation (FBI) also warned last week to be particularly wary of so-called cyber-attacks scams, especially in three states in the U.S. that have the highest rates of COVID-19 cases. Those are California, New York and Washington, although they are certainly not the only targets.
Herb Stapleton, Section Chief of the FBI Cyber Division, told CBS News that there had been a significant increase in coronavirus scams.
“Be aware that you might start getting a lot of phishing emails. You might also get texts asking you to sign in,” said Pali Surdhar, chief security officer at nCipher Security. “Articles about coronavirus are going to be interesting to anyone, and it’s a great way for attackers and hackers to get into your system and get some information about you.”