What President Trump called a potential “game-changer” in the battle against COVID-19 — a safe, cheap, effective treatment, available NOW — is suddenly seen as a highly dangerous drug. Of the fake news and misinformation that has proliferated in this pandemic, the most harmful is the claim that hydroxychloroquine (HCQ) is a serious heart hazard. That incorrect claim has been supported by prestigious medical journals.
This negative message contradicts 65 years of experience of safe, worldwide use of HCQ for malaria, lupus, and rheumatoid arthritis. Hundreds of millions of patients have taken it without difficulty and without serious side effects. Recent studies in several countries have shown that if used early, within the first week of symptoms, HCQ is safe and highly effective for COVID-19.
Yet the Food and Drug Administration is severely restricting its use to hospitalized patients, and doing nothing to counter the fearmongering.
On May 27, Yale professor of epidemiology Harvey S. Risch published an article in the American Journal of Epidemiology entitled: “Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis.”
Dr. Risch referred to five clinical trials, including two controlled trials, which showed “significant major out-patient efficacy” of hydroxychloroquine plus azithromyxin (HCQ+AZT). No cardiac problems were noted in these trials. He concluded: “Evidence about use of hydroxychloroquine alone, or of hydroxychloroquine+azithromycin in inpatients, is irrelevant concerning efficacy of the pair in early high-risk outpatient disease. Five studies, including two controlled clinical trials, have demonstrated significant major outpatient treatment efficacy.”
Dr. Risch concluded that theoretical fears of cardiac events were not borne out in real-world usage and were vastly overshadowed by lives saved. He writes: “These medications need to be widely available and promoted immediately for physicians.”
The FDA in its drug evaluation database has only 62 cardiac deaths attributed to HCQ out of 50 MILLION prescriptions for HCQ, an actual risk of 1.2 per one million people. You have a TEN-fold greater risk (1/74,000) of dying in a fatal car accident on a 1000-mile road trip than dying from a heart arrhythmia if you take HCQ.
The combination HCQ+AZT has been in widespread standard-of-care use in the U.S. and elsewhere for decades in older adults with multiple comorbidities. A large Oxford-based record-linkage study involving more than 300,000 patients with rheumatoid arthritis led to an estimate of only 47/100,000 cardiac arrhythmias attributable to these drugs, most not fatal.
But the media are ignoring this Yale report, instead hammering on studies of critically ill hospitalized patients that show no benefit when HCQ is used far too late in patients in whom severe organ damage has already been done — often to the heart. One study performed in Brazil and published in JAMA on Apr 24 used double the known lethal dose of chloroquine in debilitated, critically ill patients, many with multiple other diseases. Brazilian scientists have demanded JAMA immediately retract this study. The Brazilian government has launched a judicial investigation into the authors’ ethical and legal violations of approved dose guidelines, yet JAMA has still refused to retract the publication.
The recent Lancet data-mining report, also heavily covered in the news, again only included severely ill hospitalized patients, including those in that Brazilian study. Leading scientists from several countries are questioning the validity and accuracy of the data.
To put HCQ safety in perspective, consider the risks of common over-the-counter medicines (OTC) that most people don’t think twice about using:
• Tylenol (acetaminophen) is the number 1 cause of acute liver failure in the U.S., ahead of hepatitis, with a death rate of 20-40 percent. It is also the second overall cause of liver failure requiring liver transplant.
• Common pain relievers Aleve and Advil account for 21 percent of U.S. adverse drug events. They lead to a 50 percent increase in risk of acute kidney failure, and significant risks of life-threatening gastrointestinal bleeding.
• OTC proton-pump inhibitors (“acid-reducers”) cause a 31 percent increased risk of hip fracture, and 54 percent increased risk of spine fracture.
Other countries, which use HCQ prophylactically or early, have dramatically lower COVID-19 death rates than the U.S. The U.S. death rate is nearly 20 times that of India, and 265 times the FDA’s estimated rate of HCQ-related heart problems!
The President has the legal authority under the Defense Production Act in the Presidential Emergency Powers to bypass the FDA and change HCQ to over the counter during this National Emergency. Its long safety record supports that as a reasonable option when compared to risks of common current OTC medicines.
It is time for people to light up the switchboards at the White House, governors’ offices, and legislatures. Americans deserve accurate risk information and the right to choose whether or not to take HCQ. All Americans, not just the elite, should be able to access this life-saving, inexpensive, safe medication.
