Hope For "Bending the Curve" in Defeating the Novel Coronavirus Pandemic
I've spent days searching the internet in an attempt to separate fact from fiction when it comes to finding drugs or other measures that may help us in dealing with covid-19. Specifically, we need to find ways to minimize infections and substantailly lower the rate of death without killing our economy.
It appears to me that not everyone wants to rescue the economy, nor do they appear to want to lower fatalities. These actors seem like they want the most devestation possible to achieve one purpose: cause the current president to lose the coming presidential election. Does anybody doubt that this is the case? Really? Then how do you explain all the doom-and-gloom, worst case scenario stories that continue to be told and written by one loud segment of the American press?
After watching their tactics unfold it certainly appears that this part of our press corps would be willing to sacrifice thousands of American lives if it meant that our current president would lose the next election. It seems obvious to me. Maybe I'm reading too much into it. Of course, nobody will actually say this in public.
What do you think?
However, recently there have been major breakthroughs with promising medications that already exist on the market. These meds have been around for decades and are used in the treatment of lupus, malaria and other autoimmune or viral diseases. The drugs are also relatively cheap, safe and well known by physicians the world over.
If you have been watching the news you will know that Trump has brought up these drugs in a favorable manner for a couple weeks. Because of this he has been universally lambasted by one segment of our media. They accuse him of encouraging "false hope" to the American public.
But is it really "false hope"? What if he is right and the treatments make a huge difference? What will the attacking press say then?
Let's move on to the information I want to use to convince you that we are on the cusp of a turnaround in our fight to beat this scourge.
I decided that the most reputable source of information I have access to is the Wall Street Journal. Though I do not agree with their opinions all the time, at least they do not write in a manner that is obviously politically biased in one way or the other. The WSJ is one of the few outlets that routinely bashes and/or applauds the actions of the current administration.
The same cannot be said for most of the other news outlets on the internet, on TV or at the news stand.
I've been waiting for a clear sign that we are "over the hump" in identifying the potential of these treatments. The WSJ provided to me what I was waiting for on March 29, 2020.
Here is a copy of the WSJ editorial. I'll add clarification and emphasis as needed.
An Update on the Coronavirus Treatment
Hydroxychloroquine and azithromycin continue to show results for patients.
By Jeff Colyer
March 29, 2020 3:23 pm ET
Boxes of Plaquénil hydroxychloroquine and Zithromax azithromycine in France, March 24.
In the fight against Covid-19 though we might look forward in doom, one day we will look backward in awe. In an article last week, I discussed a promising drug combination to treat the disease. There is now new data supporting this treatment. Since then, Kansas City area physicians, including Joe Brewer, Dan Hinthorn and me, continue to treat many patients, and some have shown improvement. Major medical centers including the University of Washington and Mass General have added hydroxychloroquine to treatment options. So here’s an update, a response to some questions that have come up, and suggestions based on the latest information.
What is the treatment?
Physicians are using two drugs in combination—hydroxychloroquine and azithromycin, which I’ll abbreviate HC and AZ—to treat patients with advanced Covid-19 symptoms. We use a regimen reported in a recent open-label trial in Marseille, France, which was updated March 26, and which doctors may modify in any given case.
What is the evidence?
For HC, two bodies of evidence support its potential in treating Covid-19: in vitro (test tube) studies and initial clinical reports from the field. After the 2002-03 global outbreak of SARS, a coronavirus related to the one that causes Covid-19, an in vitro study (test tube) conducted by doctors from the Centers for Disease Control and Prevention identified chloroquine (a relative of HC) as an attractive option for prevention and treatment. If added before the virus was introduced, the drug was highly effective in preventing cellular infection. Even later application markedly inhibited infection. Another contemporaneous study showed similar results. As for Covid, a Chinese study published March 9 showed HC has excellent in vitro effects. Other recent information suggests potential antiviral mechanisms of HC and chloroquine.
The bedrock of all infectious medicine, from developing treatments for specific infections to treating individual patients, is in vitro laboratory testing and patient trials. Covid-19 is no exception. Current laboratory data suggest that HC should work.
Clinical information has also emerged from Covid treatment. During the initial Chinese outbreak, Wuhan doctors observed that patients with lupus—a disease for which HC is a common treatment—did not seem to develop Covid-19. Of 178 hospital patients who tested positive, none had lupus and none were on HC. None of this Wuhan hospital’s dermatology department’s 80 lupus patients were infected with the novel coronavirus. The Wuhan doctors hypothesized that this may be due to long-term use of HC. They treated 20 Covid-19 patients with HC. Their result:“Clinical symptoms improve significantly in 1 to 2 days. After five days of chest CT examination, 19 cases showed significant absorption improvement.”
Second, consider AZ—the antibiotic marketed as Z-Pak—combined with HC. The French study showed that 57% of 14 Covid-19 patients receiving HC without AZ tested negative for the virus on a nasal swab on day six. But 100% of the six patients who received both HC and AZ tested negative on day six. Compare that with 16 infected patients at another hospital who didn’t receive either treatment: only 12% tested negative on day six. These are small samples, but significant.
The authors of the French study last week published the results of an additional 80 hospitalized patients receiving a combination of HC and AZ. By day eight of treatment, 93% showed a negative nasopharyngeal swab for the virus. “This allowed patients to rapidly be discharged from highly contagious wards with a mean length of stay of five days,” the authors write. “Other teams should urgently evaluate this cost-effective therapeutic strategy, to both avoid the spread of the disease and treat patients as soon as possible before severe respiratory irreversible complications take hold.” I agree.
What are the risks?
The World Health Organization lists both HC and AZ as essential medicines, “considered to be the most effective and safe to meet the most important needs in a health system.” These drugs have been in use for many years—HC since 1955 and AZ since 1988. Only the combination is new. For now it isn’t well understood why the mix is so effective.
All drugs have side effects, and HC’s overall record is safe. Yes, this is an “off label” use. But that isn’t unusual, either. One study showed 21% of U.S. prescriptions were for off-label use.
These drugs are still needed to treat malaria, lupus and other diseases, which makes it important not to exhaust supplies treating Covid-19 patients. Yet this is a historic pandemic, and treatment with HC and AZ shows considerable promise. That is reason to increase supplies quickly.
What are the next steps?
New York state has started a large controlled clinical trial, and there are reports of others. Many believe that patients who can’t be in a trial should be allowed to decide, in consultation with a physician, whether to use this treatment. This is happening in some U.S. practices.
In a perfect world with unlimited supplies, any infected patient could receive treatment. With limited supplies, we should treat the sickest first and be strategic about it. We should consider this regimen for highly exposed people such as health-care workers and first responders. These heroes in the war against Covid-19 deserve protection.
Early treatment is always better, whether for cancer, diabetes or infection. The in vitro results, field experience and French trial suggest Covid-19 is no different. If this regimen’s promise is borne out by more data, and if supply is ramped up, then we can expand treatment.
For my entire career, I have taken a conservative approach to medicine. I don’t want to give false or premature hope. All of this is subject to further refinement as more information arrives. But likewise I can’t ignore the available evidence. This appears to be the best widely available option for treating Covid-19 and not merely easing the suffering from the disease. It would be irresponsible not to pursue this option aggressively.
Dr. Colyer is a practicing physician. He served as governor of Kansas, 2018-19.
[Note: The next day the WSJ Editorial Board released the following recommendation.]
An FDA Breakthrough on Treatment
The agency finally approves anti-malarial drugs for Covid-19.
By The Editorial Board
March 30, 2020 7:10 pm ET
The Food and Drug Administration on Sunday green-lighted two malaria medicines that have shown some promise treating the novel coronavirus, and the emergency approvals couldn’t come soon enough. Expanding their use could bring quicker relief to patients and hospitals while allowing scientists to better assess their efficacy.
The malaria drugs hydroxychloroquine (HC) and chloroquine have been around for more than five decades, so their safety is well documented. New evidence suggests that they could also help fight the novel coronavirus, as op-eds by Dr. Jeff Colyer on these pages have reported. Both chloroquine and HC in vitro block the replication of RNA viruses like the novel coronavirus.
Hydroxychloroquine nowadays is often prescribed for the autoimmune conditions lupus and rheumatoid arthritis that result from the body’s immune system attacking its own cells. Scientists have also documented an overreactive immune response in severely ill coronavirus patients.
Notably, a study in France of 80 coronavirus patients given HC and azithromycin, an antibiotic for upper respiratory infections, documented “a clinical improvement in all but one 86 year-old patient who died, and one 74 year-old patient still in intensive care unit.” Doctors have also reported anecdotal evidence of the malaria drugs’ efficacy.
More study is needed, and a clinical trial of the two drugs involving 1,100 patients started last week in New York. But the FDA’s emergency authorization will let more doctors prescribe the drug outside of clinical trials, and hospitals will be required to maintain data on drug dispensation and patient outcomes. This will allow a larger review than possible in a controlled clinical trial.
Production of the drugs will need to increase so patients with autoimmune conditions can maintain their treatments, and the emergency approval covers only drugs supplied by the National Strategic Stockpile. The Department of Health and Human Services reported Sunday that Novartis has donated 30 million doses of HC, and Bayer has contributed one million doses of chloroquine to the federal government, which can distribute the drugs to areas with the highest need.
Some are attacking President Trump for giving patients “false hope” by encouraging the emergency drug approvals. They quibble that the French study lacked a control group, but are flogging a smaller Chinese study that found no statistical benefit from HC. That study’s control group received other antiviral drugs.
Effective drug treatments would reduce the strain on hospitals and in the long term will be more important and less costly than government quarantines in defeating the pandemic.
[Note: On April 2 the Washington Times released the following.]
An international poll of more than 6,000 doctors released Thursday found that the antimalarial drug hydroxychloroquine was the most highly rated treatment for the novel coronavirus.
The survey conducted by Sermo, a global health care polling company, of 6,227 physicians in 30 countries found that 37% of those treating COVID-19 patients rated hydroxychloroquine as the “most effective therapy” from a list of 15 options.
The U.S. Food and Drug Administration gave chloroquine and its next-generation derivative, hydroxychloroquine, emergency-use authorization Monday for treating the novel coronavirus, although the drug was already being used off-label by some doctors and hospitals for COVID-19 patients.