Is This Medicine A Magic Bullet?

‘Battlefield Medicine’: NY, NJ Doctors and Patients See Anecdotal Evidence of Hydroxychloroquine Benefits in Fighting Coronavirus

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NIAID-RML via AP

AARON KLEIN

1 Apr 20206,070

18:06

Doctors who have treated a combined total of over 425 confirmed or presumptive Chinese coronavirus patients with the drug hydroxychloroquine told Breitbart News they are finding the medication to be helpful.

The doctors stressed that more long-term studies are needed to draw concrete scientific conclusions about hydroxychloroquine and Chinese coronavirus. But they said they decided to act because they felt it was safe and because the coronavirus pandemic does not leave any time to wait for what could be months or even years of clinical trials.

Their experiences are not meant to be taken as controlled scientific trials. Studies are clearly required to more conclusively determine whether the hydroxychloroquine indeed played a role in patient recovery or whether those same patients would have recovered anyway without the medication.

Even if hydroxychloroquine is found to be helpful, more research is needed to determine whether the drug needs to be combined with other medication, and which amounts should be used. Some of the doctors interviewed for this article prescribed hydroxychloroquine along with zinc sulfate, and in many cases combined the drug with an antibiotic regimen.

There are also concerns about the supply chain for hydroxychloroquine. Hospitals are reportedly seeking to stockpile the drug in anticipation of a flood of coronavirus patients and many pharmacies say they are experiencing a massive number of prescription requests for hydroxychloroquine sulfate.

Hydroxychloroquine sulfate is a Food and Drug Administration (FDA)-approved prescription arthritis medicine that is also used to prevent malaria, and has been prescribed to treat lupus symptoms. It is also known by the brand name Plaquenil. The extra demand could cause a shortage for lupus and arthritis patients already using the medication regularly.

Two days ago, the FDA issued emergency approval to distribute millions of doses of hydroxychloroquine to hospitals across the country for use in treating coronavirus.

The FDA’s chief scientist concluded that “based on the totality of scientific evidence available to FDA” it is “reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective for the treatment of COVID-19.”

The FDA noted the medication is currently being used in several countries to treat Chinese coronavirus and said the “known and potential benefits of chloroquine phosphate and hydroxychloroquine sulfate” outweigh “the known and potential risks” of these drugs in treating COVID-19.

‘Battlefield medicine’

The hydroxychloroquine sulfate is thought to serve as a key to force open internal cell channels, including those susceptible to coronavirus, allowing the zinc to penetrate and help line the intracellular walls to protect against coronavirus penetration. The antibiotic is meant to act against any secondary infection brought on by the coronavirus attack.

The doctors interviewed for this article practice in the hard-hit areas of New York or New Jersey. They say none of their patients experienced strong side effects from the medication cocktail.

The hydroxychloroquine treatment is not believed to kill coronavirus. Instead it could protect cellular lining from further penetration.  This could mean that if it does work, the drug cocktail would likely have more success in patients who are in the early or middle stages of infection and would be less effective in those who are already in critical condition. Indeed, that is what the doctors say they have been finding.

Also, doctors affiliated with other practices or with hospitals who are using the hydroxychloroquine and antibiotic combination say they are aware of positive results.

Breitbart News also spoke with numerous patients treated by the doctors, who claim the drug helped them to recover.

“This is battlefield medicine and the use of real time frontline assessment,” said Dr. Vladimir Zelenko, who practices family medicine with mostly ultra-Orthodox Jewish patients near the Orange County, New York, village of Kiryas Joel. The tightknit community has seen a deluge of coronavirus cases in recent weeks.

Zelenko has been prescribing a treatment plan of 200mg of hydroxychloroquine twice a day for 5 days, Azithromycin 500mg antibiotics once a day for 5 days, and 220mg of Zinc sulfate once a day for 5 days.

Zelenko has become one of the faces of hydroxychloroquine use for coronavirus patients after he shared his regimen with the White House, which is reportedly evaluating the plan.

Rudolph W. Giuliani, the president’s personal attorney, has been promoting Zelenko’s hydroxychloroquine plan, and Fox News’s Sean Hannity read from the doctor’s regimen during an interview with Vice President Mike Pence, who is leading the White House Coronavirus Task Force.

As of this writing, Zelenko said he has seen nearly 700 coronavirus patients since the outbreak, with each diagnosed either clinically or via coronavirus testing.

He said that he selected about 200 high-risk patients to receive the hydroxychloroquine cocktail and about nearly 150 took the drugs. Six of his patients were admitted to hospitals. Two of those admitted were intubated, and four are recovering on intravenous antibiotics.

“This is better outcomes than what is being reported by other physicians,” he said.

Zelenko said that the lack of testing has been a factor, explaining that during the initial days he had to act clinically and that in recent weeks he needed to prescribe in large part based on symptoms, since he didn’t want to waste valuable time for the test results to return three days later. He said that the instant tests currently in development would be a gamechanger.

Zelenko provided a sampling of specific outcome data sets on 55 of his patients, the vast majority of whom had the outcomes of “better” or “a lot better.” He is still compiling more data sets.

While some of the treated patients did not receive coronavirus tests due to limited availability and result times, Zelenko noted the Kiryas Joel area is flooded with coronavirus patients and he has seen many patients who fit the specific symptom profile or coronavirus as opposed to a cold or the flu.

Dr. Rosy E. Joseph is a nephrologist in Hackensack, New Jersey, and has been practicing for 30 years. She graduated from Columbia University medical school. Like most area doctors, Dr. Joseph in recent weeks has experienced a surge in coronavirus patients.

As a kidney specialist, Joseph has been using hydroxychloroquine to treat lupus patients for decades.

Joseph told Breitbart News that she treated between 50 and 60 presumptive and confirmed coronavirus patients with hydroxychloroquine. Her regimen differs somewhat from that of Zelenko in that she combines the drug with Vitamins C and D, along with zinc.

Joseph said that she believes the regimen is most likely helping. She said only one patient was hospitalized, an elderly individual who was already seriously ill by the time hydroxychloroquine was administered. That patient went to the hospital the next day.

Joseph said she has not seen evidence of serious side effects from the prescribed cocktail.

A third doctor, Hillel Isseroff, is an internist in Brooklyn, New York, affiliated with NYU Langone Hospitals and Mount Sinai Beth Israel Hospital. He has been treating coronavirus patients in the Crown Heights section of Brooklyn, which has also experienced a massive influx due to the pandemic.

Isseroff told Breitbart News that he is currently analyzing data from the more than 225 coronavirus patients that he treated using hydroxychloroquine. His overall assessment is that he feels the medication might be effective if it is started early, from onset of the symptoms.

Isseroff had been prescribing hydroxychloroquine along with Azithromycin 250mg tablets in select coronavirus patients who were considered high risk. He has also been suggesting zinc early in the illness.

Patients recount taking cocktail

Besides the doctors quoted in this article, Breitbart News is aware of other physicians and even New York hospitals treating coronavirus patients with hydroxychloroquine.

Some of the doctors asked that their names be withheld from publication. They each reported generally positive results from prescribing hydroxychloroquine, but stressed that their cases do not represent controlled scientific trials.

One doctor, a renowned oncologist on the upper east side of Manhattan, has admitting privileges to hospitals in that area.  He told Breitbart News he is aware of one major upper east side hospital that is officially using the hydroxychloroquine and azithromycin combination to treat coronavirus patients. He says that the hospital is finding the cocktail to be working “quite well” in patients who are not admitted in critical condition.

The oncologist asked that the name of the hospital be withheld from publication since he is not an official spokesperson for the facility.

A pulmonary specialist affiliated with a second New York hospital using hydroxychloroquine reported positive results, but asked that Breitbart News wait for an official comment from the hospital before printing the name of the major health institution.

Both hospitals have been asked for official comment.

Meanwhile, numerous coronavirus patients recounted their experiences taking hydroxychloroquine.

Joel Rubin of Woodbury, New York, has been a patient of Dr. Zelenko’s for 16 years. Rubin and his elderly father tested positive for coronavirus. His father had a serious case of secondary pneumonia and he himself was in bed for a few days with coronavirus symptoms.

Rubin said that after taking the cocktail for a few days, his father is “doing amazing,” and he personally is nearly recovered.

Rubin works in the healthcare industry, and says he knows several other patients in the area who were treated by Zelenko and got better after taking hydroxychloroquine.

Another patient of Zelenko’s, Joseph, age 48, says that he has experienced coronavirus symptoms and was put on the drugs.

“I got better every day,” said the patient, Joseph, who asked that his last name be withheld to protect his privacy.  “I didn’t have any side effects.”

Those experiences were echoed by other patients who detailed their cases to Breitbart News.

Media playing deadly politics?

Numerous healthcare workers and patients contacted by this reporter expressed concern that media outlets and some anti-Trump politicians are playing politics with hydroxychloroquine simply because Trump has been touting the drug.

“Lives are at stake. It’s terrible that this isn’t a cold scientific issue and instead people who hate Trump are trying to go against the drug just because Trump said that it works,” said one physician who spoke on condition of anonymity for fear of professional retaliation.

The same sentiment was expressed by other interviewees.

The phenomenon has led to an unusual situation in which a drug that could impact the coronavirus pandemic has turned into a political discussion instead of an analysis of the facts.

Hydroxychloroquine has been discussed on Fox News and conservative media while many left-leaning news media outlets have been repeatedly singling out one case of an Arizona man who attempted to self-treat with a toxic fish tank cleaner that contained poisonous ingredients such as chloroquine phosphate, a different form from the prescribed drug, and reportedly died as a result.

The implication is that hydroxychloroquine, which has been prescribed for decades, is somehow deadly.

When covering Trump touting the drug, many media outlets also repeatedly restate the fact that hydroxychloroquine is an “unproven” drug for coronavirus.  Hydroxychloroquine is obviously unproven given that the pandemic only began less than three months ago. Holding enough clinical trials would take many months or even years.

In a notable reversal, Michigan Gov. Gretchen Whitmer (D) is now reportedly asking the federal government to send shipments of hydroxychloroquine to help during the pandemic after first threatening “administrative action” against doctors who prescribed the drug for Chinese coronavirus patients.

“We want to ensure that doctors have the ability to prescribe these medicines,” the governor said. “We also want to make sure that the people who have prescriptions that predated COVID-19 have access to the medication they need. And so all of the work that we’ve done is trying to strike that balance.”

Government trials

New York State began clinical trials of hydroxychloroquine last Tuesday along with zithromax and chloroquine.

The federal government awarded PPD Inc., a North Carolina pharmaceutical company, $750,000 for a one-month study on the use of “hydrochloroquine and chloroquine in patients with coronavirus disease (COVID-19), positive for SARS-COV-2 virus exposure, or pre-exposure and post-exposure prophylaxis,” BuzzFeed reported.

In addition to approving the drug for emergency distribution to hospitals, the FDA announced it is “working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine, which is already approved for treating malaria, lupus and rheumatoid arthritis, to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy in using chloroquine to treat COVID-19.”

Speaking today on SiriusXM’s Breitbart News Daily with host Alex Marlow, Housing and Urban Development Secretary Ben Carson said the Trump administration was hurrying  drug approval and testing protocols and was allowing patient access to promising treatments going through clinical trials.

The fear of drug hoarding during the pandemic, however, prompted a New York state executive order last week that banned pharmacies from dispensing hydroxychloroquine for non-FDA approved indications, or for patients who are not in clinical trials for coronavirus treatment.

The executive order does not ban doctors from prescribing hydroxychloroquine for coronavirus patients, but doctors say that it has been making New York pharmacies more selective about filling prescriptions. The order caps the prescription period to 14 days per patient and doesn’t allow refills.

The potential shortage has already led the Israeli drug company Teva Pharmaceutical Industries Ltd. to donate 10 million hydroxychloroquine tablets to U.S. hospitals.  Teva is one of the world’s largest makers of hydroxychloroquine.

According to Drugs.com, common side effects of hydroxychloroquine include:

• headache, dizziness, ringing in the ears;
• nausea, vomiting, stomach pain;
• loss of appetite, weight loss;
• mood changes, feeling nervous or irritable;
• skin rash or itching; or
• hair loss.

Patients are urged to call their doctor if they develop:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
• very slow heart rate, weak pulse;
• muscle weakness, numbness or tingling;
• signs of low blood sugar or low blood cell counts.

This week, a small study reported by Chinese doctors documented that hydroxychloroquine helped the recovery of mildly ill coronavirus patients.

In advocating for hydroxychloroquine sulfate, many have pointed to a limited French study that had positive results.

The AP reported:

The French study has attracted the most attention. Doctors gave hydroxychloroquine to 26 people with confirmed coronavirus infections, including some with no symptoms. Six also were given the antibiotic azithromycin.

Some of the 26 were not counted in the final results because they didn’t complete the study — what’s known as “lost to followup” — but that included three who worsened and were sent to intensive care, one who died a day after later testing negative for the virus, and one who stopped treatment because of nausea.

After six days, no patients given hydroxychloroquine plus azithromycin had virus detected in swabs from the back of the nose, versus 57% of those given the malaria drug alone and 12.5% of some other patients who received neither drug.

The journal Nature Medicine reported on lab tests that demonstrated the drug blocked the coronavirus’s ability to enter cells, but it doesn’t mean the same would be repeated in human trials.

New York Gov. Andrew Cuomo’s office announced the state obtained 70,000 doses of hydroxychloroquine, 10,000 doses of zithromax and 750,000 doses of chloroquine in the last few days for trial use.

“We hope for optimistic results,” Cuomo said during a press conference last Tuesday about the tests. “The president and the FDA accelerated that drug coming to New York so the hospitals will start using that drug today.”

“I’ve spoken with a number of health officials and there is a good basis to believe that they could work,” Cuomo said. “Some health officials point to Africa, which has a very low infection rate and there’s a theory that because they’re taking these anti-malaria drugs in Africa, it may actually be one of the reasons why the infection rate is low in Africa. We don’t know, but let’s find out and let’s find out quickly.”

Aaron Klein is Breitbart’s Jerusalem bureau chief and senior investigative reporter. He is a New York Times bestselling author and hosts the popular weekend talk radio program, “Aaron Klein Investigative Radio.” Follow him on Twitter @AaronKleinShow.