Hydroxychloroquine, marketed under the name Plaquenil, is a drug used to prevent malaria. It is also a pill used for patients with rheumatoid arthritis and also lupus. It has been on the market since the 50s.
But, for months, private doctors have been prescribing HCQ for patients in the early stages of the Wuhan virus with what they report as great success.
Controversy began to rage around this drug when President Trump began to speak about HCQ following a series of positive reports from doctors in a number of global locations.
Adverse effects were discovered when treating hospitalized patients suffering in advanced stages of the virus disease, including those on ventilators, with HCQ alone or in combination with other drugs.
Reports claimed that the drug had caused heart rhythm problems among patients receiving higher doses of chloroquine. The United States National Institute for Health (NIH) issued new guidelines for the use of the drug but added, “there was insufficient evidence for or against chloroquine or hydroxychloroquine for COVID-19.” But it also advised against using HCQ with azithromycin because of the potential side effects.
Researchers analyzed medical records of 368 male veterans hospitalized with confirmed coronavirus infection at Veterans Health Administration medical centers who died or were discharged by April 11. About 28 percent of those who were given HCQ died versus 11% of those who received routine care alone. About 22% of those getting the drug plus azithromycin died too, but the difference between that group and usual care was not considered large enough to rule out other factors that could have affected survival.
A Brazilian medical trial of a drug that had been stockpiled by Israel as a potential treatment for COVID-19 was stopped due to patients developing irregular heartbeats. Another trial in Sweden was halted when patients reported migraines, peripheral vision loss and cramps. But both the Brazil study and the Swedish one were found to have used Chloroquine (not the safer HCQ).
HCQ and CQ are two different drugs, though both have been used to fight Malaria. The equivalent is akin to damning both for the sins of only one. That would be like saying Tylenol causes stomach bleeding, as can Aspirin, so ban them both.
Dr. Ramin Oskoui, Cardiologist and CEO of Foxhall Cardiology, said on the Laura Ingraham show about the FDA limiting access to HCQ, “You've got to wonder. We know that Tylenol can cause liver failure, but it's available over the counter. So the FDA's recommendations are really schizophrenic. The instance rate of cardiac toxicity is vanishingly low. It's not 5 percent, it's probably 0.05 percent. We used this drug in pregnant women. We used it in children. We use it without monitoring in countries for malaria prophylaxis. The FDA package insert never mentions EKG as a baseline. All the patients - somewhere close to a dozen that I've treated - are established patients with EKGs that I know their heart history. I've had no problems except for one patient who had persistent nausea, a small price to pay for avoiding the ICU.”
So why suddenly did the FDA insist that HCQ must only be used in a hospital environment which restricts the virus patients to those in late advanced stages of the disease when it has been shown to work well in early stage patients? Many medical specialists, such as Dr. Oskoui are puzzled.
Israel has stockpiled both chloroquine and hydroxychloroquine on the assumption that if trials find that it is beneficial in the treatment of COVID-19 this would spark a buying war for the drugs.
Speaking to the financial daily Globes, Prof. Ronni Gamzu, a former director general of the Health Ministry who now heads the Ichilov Hospital in Tel Aviv, said the hospital had used chloroquine, but had seen no evidence of its efficacy in treating COVID-19.
Jacob Moran Gilad, a member of the Health Ministry’s Epidemic Management Team, said that the Epidemic Management Team discussed whether to give hospitals any directions regarding hydroxychloroquine, and decided not to. “At the moment there is no official guidance or endorsement by the Health Ministry that it should be used for COVID-19,” he said. “We discussed this in the national management team and we decided not to give guidance as there is no data to support the use of this drug.”
Speaking to The Times of Israel in mid-April with regard to chloroquine, Moran-Gilad said, “In a few weeks’ time if there is official data to show it is beneficial it will be very difficult to secure the drug.”
He said that doctors are allowed to prescribe hydroxychloroquine to their patients, and some are doing so. But this is on patients in advanced stages of the virus damage. What of early to mid-stages of the virus infection?
Dr. Vladimir Zelenko from New York announced that over 400 of his high-risk patients with COVID-19 have recovered.
All were treated with his 3-drug regimen of hydroxychloroquine, azinthromycin, and zinc. The doctor said two patients died, but the other 403 recuperated completely from COVID-19, the disease many in the US call the CCP (Chinese Communist Party) virus.
“And by the way, it’s not magic, I mean there’s a reason behind it,” said Zelenko. “The virus is inside the cell, the zinc cannot get inside the cell for biochemical reasons, so the hydroxychloroquine opens the door and lets the zinc in. That’s all it does, in this context. Meanwhile, the antibiotic, azithromycin, protects the patient from secondary infections.”
As one GP stated, “They also find a much higher benefit if you take those medications as soon as symptoms are present. The higher deaths are skewed because they are talking about intubated patients who pretty much had nothing left to lose.”
A French Doctor, Didier Raoult, said he conducted a study of 80 patients that showed that four out of five of those treated with the drug had “favorable” outcomes. He had earlier reported that after treating 24 patients for six days with HCQ and azithromycin, the virus disappeared in all but a quarter of them. The research has not been formally published in a medical journal.
It really seems like much of the mainstream media is against this drug, despite promising results. Dr. Raoult just published a more recent study on outcomes of over 1000 patients, but the media chose to only mention the initial study with 80 people.
The drug is supposed to stop the virus entering cells so perhaps it should be given earlier before any damage to the lungs has taken place. It is most successful early on as it is targeting viral entry into host cells and viral replication, one or the other or both. But they have been applying this drug to people in trials with acute respiratory disease where another set of drugs, perhaps Remdesivir, may have been more effective.
On May 14, The National Institute of Health announced that the National Institute of Allergy and Infectious Diseases (NIAID) had launched a clinical trial testing hydroxychloroquine and azithromycin in 2,000 patients with mild and moderate cases of COVID-19.
Teva Pharmaceutical Industries Ltd. donated the hydroxychloroquine for the trial, evaluating whether the drug combination can prevent hospitalization and death. "Although there is anecdotal evidence that hydroxychloroquine and azithromycin may benefit people with COVID-19, we need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes," NIAID director Dr. Anthony Fauci said in a statement.
Dr. Bright signed a recommendation for HCQ. In a contradictory claim, Bright said, “I rightly resisted efforts to provide an unproven drug on demand to the American public. I insisted that these drugs be provided only to hospitalized patients with confirmed Covid-19 while under the supervision of a physician.”
These drugs were not being provided to the public but to a specific research within the confines of the NIH where he works, and a project in which he had been selected as a leading participant.
Alex Azar, the Health Secretary saud that the NHS is looking closely at HCQ and if it passes the NHS testing it will be prescribed as part of the virus treatment.”
Dr. Bright wrote a letter to the New York Times in which he hinted that Trump was promoting HCQ as one of the drugs being tested, for personal financial gain.
Fact-checker website, Vox, concluded that “Trump has been accused of many crimes – but doesn’t seem to be doing anything wrong this time.”
Bright claims he was pushed out of his previous job because he resisted efforts by HHS leadership to promote HCQ. Azar told reporters Thursday: "On hydroxychloroquine, Dr. Bright literally signed the application for FDA authorization of it. Literally, he's the sponsor of it."
Asked about this during his testimony, Bright said that he supported the use of HCQ under the supervision of a physician.
There are dozens of other clinical trials underway to evaluate HCQ in COVID-19 patients both in the US and abroad.
The University of Minnesota plans to test HCQ to prevent COVID-19 infections in the nation’s frontline health-care workers.
Thousands of health care workers around the globe have been laid low by the virus, including at least 3,300 health care workers in China, 20% of the frontline clinicians in Italy, and more than 12,000 health care workers in Spain.
The Patient-Centered Outcomes Research Institute, a government agency created by the Affordable Care Act, said Wednesday it is putting up $50 million to fund a registry and a randomized, placebo-controlled clinical trial examining if HCQ can prevent COVID-19 infections in 15,000 health care workers. The trial will be led by the Duke Clinical Research Institute.
Similar trials are under way in Australia where they are testing a tuberculosis vaccine in health care workers. In France, where a hospital near Lyon is also testing AbbVie’s HIV drug Kaletra. In Spain, and the Netherlands, according to ClinicalTrials.gov.
Hydroxychloroquine isn’t approved by the Food and Drug Administration (FDA) to treat or prevent COVID-19 infections. However, the regulator recently used its emergency powers to allow chloroquine and hydroxychloroquine to be used in clinical trials for COVID-19 and to treat some patients who have been sickened by the virus given the lack of proven therapies available to treat the disease.
So at this point Hydroxychloroquine sulfate is approved by the US Food and Drug Administration (FDA) for the treatment of malaria, lupus erythematosus and rheumatoid arthritis. The Teva-manufactured drug is not approved for use in treating COVID-19. However, it is under investigation for efficacy against the novel coronavirus and has been requested by US government officials to be made available for testing purposes.
Although there have been health problems in certain patients being treated with a mixture of the two drugs in hospital patients with advanced symptoms of the coronavirus, there are endless reports of success in the use of HCQ on early to mid-stage virus patients. But on April 30, the FDA warned against its use outside hospital confines or clinical trials.
This is strange and somewhat contradictory. While it is admitted that there have been a number of negative effects over the application of HCQ and CQ in advanced hospitalized patients, it does not look as if the FDA has been listening to private practice physicians in the United States and abroad who have been treating their patients with “amazing” results in their surgeries.
There are now reports that the drug, HCQ, is being withheld from local doctors who have been successfully treating their patients with this drug.
Texan doctor, Ivette Lozano, appeared on Fox News with Laura Ingraham, to tell how she has been successfully treating early stage patients with HCQ. Recently, the Texas State Board demanded that she disclose her patients’ medical history which, in America, is an infringement of doctor-patient confidentiality and against the law.
Dr. Lozano sent HCQ prescriptions for fifteen of her patients to the pharmacy and was told they would no longer provide her with this drug. She protested that they could not do that, but the pharmacist told Dr. Lozano, “I have the right to deny this prescription to you.”
The pharmacist admitted having supplies in stock but would not supply this doctor with an inexpensive well known drug with a thirty-year history.
She complained, “I have patients with pneumonia that have been turned away from clinics and hospitals. I have patients with temperatures of 102.9, all successfully treated with HCQ. Now physicians are concerned they will be in trouble with licensing boards. Now pharmacists are refusing to provide this medication. I have a huge problem on my hands. Every patient I have treated in serious and moderate condition improves within five hours, and some have been completely cured within 24 hours to two days. It’s incredible!”
Perhaps the highest profile person who responded well with the use of HCQ was Detroit Democratic representative, Karen Whitsett, who was invited to the White House after thanking President Trump for speaking about HCQ.
She had originally been diagnosed with pneumonia, but by the time her Covid-19 test came back positive her health had plummeted.
"It went from the headaches being severe to fluid building up in my lungs, to sweats breaking out, to the cough and my breathing being labored," Whitsett said. "It all happened in a matter of hours."
"If President Trump had not talked about this it wouldn't have been something that would be accessible for anyone to be able to get right now.” Within a few hours of taking the drug, she said she was already in recovery.
As a result of publicly thanking the President, the DNC, instead of celebrating her recovery from a near-death experience, censored her and expelled her from the Democratic Party.
On May 12, researchers at NYU Grossman School of Medicine found that patients given HCQ along with zinc sulphate and the antibiotic azithromycin were 44 percent less likely to die from the coronavirus.
"Certainly we have very limited options as far as what we have seen work for this infection so anything that may work is very exciting," said Dr. Joseph Rahimian, Infectious Disease Specialist at NYU Langone Health.
The study looked at the records of 932 COVID-19 patients treated at local hospitals with HCQ and azithromycin. More than 400 of them were also given 100 milligrams of zinc daily. Researchers said the patients given zinc were one and a half times more likely to recover, decreasing their need for intensive care.
One theory is that HCQ may aid a cell’s ability to absorb the zinc which has antiviral properties and responds to the infection.
"It sort of boosts the zinc activity which is one of the reasons we thought to look at zinc here and in this observational study we did see a difference suggesting that maybe that boosting activity of the HCQ with the zinc helps the zinc to work better and lead to a benefit," Rahimian said.
Confirming the case that HCQ alone or in combination with certain other drugs may not do so well in advanced virus cases, Dr. Rahimian says patients in the more critical stages of infection did not fare as well.
As if to confirm the efficacy of the HCQ and zinc combination, a study in the Journal of the American Medical Association on Monday found that treating advanced patients only with HCQ, azithromycin, or both did not reduce hospital deaths.
In France, 400,000 people signed a petition to their government to allow more doctors to prescribe HCQ for virus patients even as experts debate the efficacy of the drug.
France has recorded over 180,000 cases of infected people. Over 28,000 people have died from or with the virus. And there is no known drug that successfully solves the problem.
At the end of April, a clinical trial of a thousand patients with the drug Remdesivir, from Gilead Science, produced favorable results with patients recovering 31% faster than patients given a placebo.
In Israel, the covert Biological Research Institute, announced it had developed an antibody that could be used to develop treatments against the Covid-19 virus.
In a rare statement, the Institute announced, “As far as we know, according to comprehensive scientific publications from around the world, the Biological Research Institute is the first in the world to achieve this breakthrough in these three parameters at the same time.”
Prof Shuki Shemer, the head of Israel’s Assuta Medical Center and a former director general of the Health Ministry, said, “This is a real breakthrough involving scientific and technological capabilities of the first order. They’ve produced an antibody that neutralizes the virus. There’s still a long way to go, but no other country has done this.”
There are many more trials. The race is on to find a cure for the Wuhan virus pandemic.
The media was quick to trash President Trump when he said he was hopeful that HCQ could be used successfully in the treatment of virus patients. It will be interesting to see if the same anti-Trump media give Democratic NYS Governor, Andrew Cuomo, the same short-shrift treatment, after he said the New York based research was “promising.”
And we will end with Trump.
On the day that Moderna announced promising results on its preliminary testing of a new virus vaccine on humans -did they test it first on animals? - at a White House press briefing on May 18, Trump surprised many by admitting he is taking HCQ on a daily basis.
“You’d be surprised at how many front line workers are taking hydroxychloroquine before they catch it. I’m taking it. I started a couple of weeks ago.”
At this briefing Trump spoke of a Westchester doctor who had contacted him after prescribing HCQ to his patients. “He had hundreds of people. He hasn’t lost one. He just wanted me to know the success of what he is doing.”
While it is not recommended that a 72-year-old overweight President should take this drug prior to exhibiting symptoms, Trump clearly wants to project himself as being out in front of the issue of the use of hydroxychloroquine.
Time will tell if his instincts were right about HCQ.
Barry Shaw, Israel Institute for Strategic Studies.