We promised we would keep you informed about the latest developments in the ongoing hydroxychloroquine and azithromycin controversy. Is this drug combination a breakthrough or a disappointment against the coronavirus? Preliminary studies produced mixed results. Some suggested benefit. Others were discouraging. The latest and largest study reveals hydroxychloroquine harm and no benefit.
New Research about Hydroxychloroquine Harm:
Here’s the background on the study that was published in The Lancet (May 22, 2020). The investigators collected data from 671 hospitals in six continents. Patients who tested positive for SARS-CoV-2 between Dec. 20 and April 14 were eligible to participate.
There were four groups. Of the 96,032 patients hospitalized with the coronavirus, 14,888 received drug treatment. 3016 received hydroxychloroquine alone; 6211 received hydroxychloroquine [HCQ] plus a macrolide antibiotic (azithromycin [AZM] or clarithromycin); 1,868 received only chloroquine and 3,783 got chloroquine plus an antibiotic. 81,144 received no antiviral medication. This is by far the largest study of these drugs to date. Patients who received medications started therapy within 48 hours of diagnosis.
The Envelope Please:
The researchers took into account a number of underlying factors. They controlled for things like age, race, weight, cardiovascular disease, diabetes, lung disease, smoking history and immune system function.
Over the roughly four months of the study period, 10,698 people died in the hospital. The study looked for two key outcomes: 1) serious irregular heart rhythms (arrhythmias) and 2) deaths.
Data Break Down for Hydroxychloroquine Harm:
Serious Heart Rhythm Changes
Control Group (no HCQ or AZM) 0.3%
HCQ alone 6.1%
HCQ + AZM (or CLR] 8.1%
Chloroquine alone 4.3%
Chloroquine + AZM (or CLR) 6.5%
Control Group (no HCQ or AZM) 9.3%
HCQ alone 18.0%
HCQ + AZM (or CLR] 23.8%
Chloroquine alone 16.4%
Chloroquine + AZM (or CLR) 22.2%
Interpreting Hydroxychloroquine Harm:
Here is how the investigators summarized their results:
“In this large multinational real-world analysis, we did not observe any benefit of hydroxychloroquine or chloroquine (when used alone or in combination with a macrolide) on in-hospital outcomes, when initiated early after diagnosis of COVID-19. Each of the drug regimens of chloroquine or hydroxychloroquine alone or in combination with a macrolide was associated with an increased hazard for clinically significant occurrence of ventricular arrhythmias and increased risk of in-hospital death with COVID-19.”
The authors conclude:
“These findings suggest that these drug regimens should not be used outside of clinical trials and urgent confirmation from randomised clinical trials is needed.”
People’s Pharmacy Perspective:
We were disappointed with these results. We were hoping that the antiviral activity of hydroxychloroquine along with its immunomodulatory effects might improve outcomes. The preliminary pilot studies offered a small ray of hope in that regard. But there were also other disappointing results.
We still need randomized controlled trials (RCTs) to determine whether hydroxychloroquine alone or with azithromycin might prevent people from developing COVID-19. Such studies remain the gold standard. That’s because there is a placebo arm that is compared to the drug arm of the trial.
Monitoring the Electrocardiogram:
It is clear from the latest research that people should get an electrocardiogram (ECG) before they are given HCQ or AZM. That’s because both drugs can prolong the QT interval on an ECG. If both drugs are taken together that is likely to increase the risk for dangerous heart rhythm abnormalities. The data from The Lancet study reinforce this concern.
You can find out what the QT interval is and why it is so important at this link. You will get a crash course on ECG interpretation and learn why hydroxychloroquine and azithromycin pose a significant threat to the heart.
Reports of Hydroxychloroquine Harm Will Rile Readers:
We know that many of our readers will be upset about this new research in The Lancet. They do not want to hear about hydroxychloroquine harm.
Here are just a few comments from readers who were disappointed about two other negative hydroxychloroquine studies published in the New England Journal of Medicine and JAMA:
Dawn does not believe patients need to be hospitalized or participate in a clinical trial to get hydroxychloroquine:
“Physicians could be allowed to more freely prescribe the medication to patients in the outpatient setting. The number of physicians who have attempted to speak out via social media or mainstream media have been silenced by so-called ‘fact checkers’ and, in some instances, even by their professional organizations.
“Data could be collected from physicians regarding the efficacy of Hydroxychloroquine in combating COVID-19, but ONLY IF physicians are allowed to prescribe the medication in the outpatient setting and earlier in the disease process. There are ways and means to coordinate such a study if the physicians were allowed to do it.”
Don says it’s all about the money:
“There’s no profit to be made from wide distribution of this low cost and not patentable drug. This is why testing is rigged to show that it is ineffective: 1. Test primarily on people who are already very ill. 2. When testing on those who are not yet seriously ill, do not combine with zinc and azithromycin, which is the clinical treatment found to be most effective. 3. Use the media to discredit it, and censor dissenting voices.”
“The testimony of dozens, if not hundreds of doctors and thousands of patients who have been helped with this drug count for nothing.”
Linda says HCQ only works with azithromycin and zinc:
“I have seen many doctors say they’ve had major success treating patients with hydroxychloriquine together with azithromycin and zinc. The drugs have to be administered early and before patients need hospitalization. It was already too late for these patients.”
Laurie agrees that early treatment is best:
“Several comments suggested the need to start HCQ early for it to be effective, to which you replied that it was given within 24-48 hours of patients being hospitalized, implying that it had indeed been given early enough. Everything that I have read from credible sources on the subject shows that once someone has become ill enough to warrant being hospitalized, it is already too late. I’d call that a flawed study.”
Faye says we’re “hacks”:
“You are just another hack going against a drug that has been used for years and is cheap. I read your articles for advice, but I don’t know If I can trust anything you write on any drug now.”
Mary says that side effects are minimal:
“If ever I faced this virus, I would most gratefully welcome the opportunity for this drug with azithromycin. My husband has had two friends through his line of work in different parts of the country who took this drug with azithromycin and recovered beautifully. I would hope that those afflicted with this virus would have the opportunity to try these and other drugs rather than wait until it’s too late, especially when the side effects are minimal.”
Claudia says that the drugs save lives:
“Having seen numerous patients on television who asserted that this protocol saved their lives, I am skeptical of this study.”
James is questioning our objectivity:
“There are so many real-life examples of HCQ working that you are causing many of your readers to start wondering about the accuracy and legitimacy of other articles you have written. This is the first time I am seriously considering blocking your newsletter. It is really sad to see what is happening to the media these days. Money and politics seem to control things now.”
We wish that the latest research would have demonstrated a positive effect. We take no satisfaction in reporting on hydroxychloroquine harm. And we await other large observational trials to confirm or refute The Lancet data.
Most important, we look forward to randomized placebo-controlled trials. They will ultimately tell the full story about the benefits and risks of these drugs, especially when it comes to the question of prevention. Will hydroxychloroquine prevent people from getting sick with the coronavirus? Only RCTs will be able to answer that question.
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