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 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 damn 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 last week, 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.
Moran-Gilad 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, Jacob Moran-Gilad, a member of the Health
Ministry’s Epidemic Management Team, 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 caused by 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 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 a lot of 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 Institutes 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.
The trial was announced during Dr. Rick Bright's testimony
before a House of Representatives committee.
Dr. Bright has a chip on his shoulder. Part of that chip is
apparently political, part professional. Dr. Bright was transferred to the new
diagnostics research study. For reasons unknown he took umbrage at the move.
Bright hired the team of lawyers that represented Christine
Blassey Ford in her failed Congressional complaint against Judge Brett Kavanagh,
Trump’s choice for a seat on the Supreme Court, on flimsy sexual harassment
charges.
Originally, Dr. Bright signed a recommendation for HCQ. In a
strangely 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
with a reported annual salary of $285,000.
Alex Azar, the Health Secretary, blasted Bright by saying that “had
Dr. Bright turned up to work at his new job he would know that that NHS is
looking closely at HCQ and if it passes the NHS testing it will be prescribed
as part of the virus treatment.”
Azar added, "Whose job was it to actually lead the
development of vaccines? Dr. Bright. So while we're launching Operation Warp
Speed he's not showing up to work to be part of that. This is like somebody who
was in a choir and is now trying to say he was a soloist back then. What he was
saying then is what every member of this administration and the president
was saying."
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.
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 Laura Ingraham, to tell how she has
been successfully treating early stage patients with HCQ. Recently, the Texas State
Board demanded that she discloses 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 admitting 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 improve 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 expel 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 case,
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 obese 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.
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