RESEARCH BRIEFING

More studies on hydroxychloroquine, same “iffy” results

Once obscure, known mainly to patients with rheumatoid arthritis and lupus, hydroxychloroquine is now quite famous, despite limited data supporting its use for covid-19. Nevertheless, President Trump recently hailed (on Twitter) hydroxychloroquine as a potential cure for covid-19. So far, no high quality data supports this claim. Numerous low quality studies have been published on this topic though. The few well-designed “randomized” studies that have been published are also seriously flawed. Now another study has been published assessing hydroxychloroquine in a “preprint” non-peer reviewed medical journal medRxiv. In this double-blind, randomized clinical trial, researchers in Wuhan, China enrolled patients with covid-19 to either receive 400 milligrams of hydroxychloroquine per day for 5 days or just “supportive care” (treating symptoms and any other treatments that are needed such as oxygen). Patients were included if they had confirmed SARS-Cov-2 infection and signs of pneumonia on CT scan. However, the patients included in this study were not severely sick. The primary goal of the trial was to measure how long it took patients to recover (both overall and with respect to lung health). Although the statistical analyses were not sophisticated enough to account for differences between the patients who received the drug and those who did not, the patients who received hydroxychloroquine were slightly less likely to get sicker. However, the scientific methods used in the study were so seriously flawed that the results are almost impossible to take seriously. Epidemiologist Lucas Morin posted a highly informative thread on Twitter describing the numerous problems of this trial. Sadly, this trial does not provide the answers we need.

Does your blood type make you more susceptible to SARS-Cov-2?

Another paper published in the preprint medical journal medRxiv looks at the relationship between ABO blood types and covid-19 susceptibility. Researchers from Wuhan, China looked at the blood type of 2,173 patients with confirmed SARS-Cov-2. Individuals with blood group A were more likely to have become infected than other groups. Type O individuals were at lowest risk for infection. Are these results meaningful? Possibly, but not necessarily. Many alternative explanations for these results remain likely. For example, people with blood group A might also live in more crowded areas or with families. While the blood group O is more prevalent in China, it is uncertain what the prevalence of blood group A in Wuhan is. These data will need to be repeated before we can take them “seriously” enough to warrant a change in our diagnostic approaches.

Research Section Editor

POLICY BRIEFING

FDA Authorizes First Serology Test for SARS-CoV-2

Under its emergency use authorization (EUA) authority, the FDA authorized the first serology test for detection SARS-CoV-2. Previously approved tests for covid-19 have detected viral SARS-CoV-2 genetic material from specimens taken from the respiratory tract. The new serologic assay, made by Cellex, detects antibodies produced by the body against the SARS-CoV-2 virus and can deliver results in approximately 15 minutes. However, the detection of these proteins does not necessarily correlate with having covid-19, the disease caused by the virus, nor does the presence of antibodies imply that a person has adequate immunity to the virus. The antibodies the new test detects usually take several days for the body to produce after someone becomes infected. This means the antibody tests are less likely to be helpful in diagnosing people who do not yet have symptoms, which is when people are now believed to have the highest rates of transmission. New York Times.

Relaxed restrictions for controlled substances

The US Drug Enforcement Agency (DEA) has established new guidelines for prescribing controlled substances during the SARS-CoV-2 pandemic. Previously, in-person evaluation by licensed providers was required before prescribing medications known as schedule II-IV drugs. (Schedule II medications include morphine and fentanyl; Schedule III includes buprenorphine --one of the active substances of “Suboxone”--and ketamine; Schedule IV includes benzodiazepines such as valium and Xanax (alprazolam). However after coordination between the Department of Health and Human Services (HHS) and the DEA, telemedicine evaluations by a DEA-registered practitioner are now sufficient. The policy is expected to remain in effect for the duration of the declared national emergency. The DEA has also relaxed its requirements around medication assisted therapy (MAT, or opioid-agonist therapy) for opioid use disorder. In addition to permitting an initial evaluation via telemedicine, registered providers may initiate therapy with new or existing patients solely through telephone interviews. US Department of Justice.