The U.S. Food and Drug Administration (FDA) on May 1 granted emergency use authorization for Remdesivir, an anti-viral drug developed by Gilead Science already being used to treat Ebola.
With hospitals expressing concerns they won’t receive enough Remdesivir to handle their caseload, Gilead has pledged to donate 1.5 million doses, enough to treat 190,000 cases, by the end of May, The Wall Street Journal reported on May 8. Gilead expects to produce enough doses to treat one million patients by the end of the year, the Journal reports.
New Look at Old Drugs
While awaiting results from long-term efforts to come up with an effective vaccine, health care professionals have been combating the deadly novel coronavirus by using existing drugs developed for other purposes, known as off-label use.
Any new vaccine must clear the FDA’s rigorous testing protocols, a process that can take years and cost millions of dollars. This is why some existing pharmaceuticals, while not providing immunity to COVID-19, are gaining consideration as ways to shorten the illness of patients stricken by the pandemic.
The off-label drugs with antiviral properties that have received the most attention—from supporters and critics alike—are chloroquine (CQ) and, particularly, hydroxychloroquine (HCQ). Commonly used in Africa and on the Indian subcontinent to treat people with malaria, HCQ also serves as a prophylaxis in India to protect medical workers, first responders, household contacts, and others at risk of exposure.
The Association of American Physicians and Surgeons (AAPS) notes the COVID-19 mortality rate in India is only two per million, compared with more than 200 per million in the United States. HCQ has also been used in treating autoimmune disorders such as lupus and rheumatoid arthritis.
Governors Say No
Governors in several states, including Michigan, New York and Nevada, have issued executive orders restricting how doctors can prescribe CQ and HCQ to treat COVID-19.
The AAPS sent a letter to Arizona Gov. Doug Ducey on April 27 expressing concerns about his order forbidding prophylactic use of CQ and HCQ until peer-reviewed evidence becomes available.
“To date, the total number of patients treated with HCQ with or without zinc and the widely used antibiotic azithromycin is 2,333 in observational data from China, France, South Korea, Algeria, and the U.S.,” AAPS wrote. “Of those, 2,137 or 91.6 percent improved clinically. There were 63 deaths, all but 11 in a single retrospective report from the Veterans Administration where the patients were severely ill.”
AAPS further points out pharmaceutical companies have donated tens of millions of doses of HCQ to federal and state health agencies. At least 14.4 million doses of HCQ have been distributed to 14 city governments, according to the Federal Emergency Management Agency (FEMA). Yet New York (the state hit hardest by COVID-19 by far), Arizona, and Nevada are stockpiling HCQ, arguing more clinical trials to determine its efficacy are necessary.
Claims that off-label drugs are “unproven” miss the point, says John Goodman, president of the Goodman Institute for Public Policy Research and co-publisher of Health Care News.
“[FDA]-approved drugs work for you only about half the time and in some cases only 20 percent of the time,” said Goodman. “Almost all drugs have side effects, and these side effects, by law, are stated when the patient purchases a drug.”
Goodman says as many as one in five drugs sold in the United States are used off-label, and for cancer drugs the figure is one in two.
Addressing concerns that HCQ can have side effects in people with cardiac problems, Dr. Michael Robb, M.D., physician at the Phoenix-based Robb Oto Neurology Center, says doctors can screen out such patients while administering the drug safely to other COVID-19 patients. Robb says there are 148 studies on HCQ posted on clinicaltrials.gov.
Jane Orient, M.D., president of the AAPS, says HCQ “was approved for use against malaria decades ago, and its use today is perfectly legal.” By issuing an advisory against using the drug except in hospital settings, Orient says the FDA “is trying to squelch its use.”
Use of the drug “could drastically reduce the carnage,” said Orient. “Why is the government restricting the use of medicine?” (see related story, page 13).
Bonner R. Cohen, Ph.D., (firstname.lastname@example.org) is a senior fellow at the National Center for Public Policy Research and a senior policy analyst with the Committee for a Constructive Tomorrow (CFACT).