Fda Continues to Withhold Drug
A wave of new evidence from studies in Italy, Belgium and the United States showing the effectiveness of hydroxychloroquine (HCQ) in reducing death from Covid-19, is spiking public demand for the drug even as the FDA continues to block its release and Americans die.
As a result of FDA policy, state supplies of the drug are becoming depleted. Dwindling allotments, along with FDA disparagement of the drug, have prompted governors to issue executive orders severely restricting doctors from prescribing it. Pharmacists are advised not to dispense it except in tightly defined circumstances.
The language used in many of these executive orders warns against doctors and patients seeking to “hoard” or “stockpile” the drug, which would cause a shortage of HCQ for people who take it for malaria, rheumatoid arthritis and other conditions.
Meanwhile, a million and a half HCQ tablets are lying unused in the National Stockpiles, with the FDA insisting the drug has not shown benefit in treating Covid-19, and poses significant health risks to the heart, kidneys, liver and other organs.
In virtually the same breath, the FDA insists the (“dangerous”) drug must be kept available to lupus and arthritis sufferers.
Making assertions that contradict each other or run counter to reality is almost becoming a norm for the FDA. Commissioner Hahn has publicly avowed that the FDA does not interfere with physicians’ ability to prescribe HCQ. Yet, as is well known, the agency routinely denies millions of Americans access to the national stockpile of the drug.
Shouldn’t a Historically Safe Drug Have been the First Line of Defense?
Dr. Hahn as a cancer specialist surely knows early treatment of any disease is critical, especially viral illness. This became clear in 2005 when the CDC and the National Institute of Health, which then employed Hahn, published their studies from the 2002 outbreak of SARS-Cov-1, a virus genetically related to Covid-19.
The studies appeared in the Virology Journal on August 22, 2005. They demonstrated potent antiviral effects of chloroquine (a close cousin of HCQ) to block the SARS-Cov-1 infection at the earliest stage.
“These inhibitory effects are observed when the cells are treated with the drug either before or after exposure to the virus, suggesting both prophylactic and therapeutic advantage,” the report summed up.
If the NIH knew that this drug cured a strain of coronavirus back in 2005, why did their experts and those at FDA sit on this information in 2020? Shouldn’t a historically safe drug have been their first line of defense? Especially since scientists have said Covid-19 is significantly similar to the SARS-Cov of 2005.
Dr. Jane Orient, executive director of Association of American Physicians and Surgeons (AAPS), views this dropping of the ball as non-accidental; it is indicative of what she calls “the corruption of the scientific establishment.”
In an interview with the Yated, she cited another example of the erosion of scientific ethics and standards: The May 1st Emergency Use Authorization (EUA) which the FDA granted to the experimental drug remdesivir, based on a single controlled clinical trial that was terminated early.
In that study, remdesivir showed only minor improvement in hospitalized Covid patients, and no reduction in overall mortality. In addition, it caused serious side effects. Yet none of this seemed to matter. The emergency use authorization “came from the FDA with unprecedented speed,” Orient said, “a half hour after the request was filed.”
The Leading Contender Had to Eliminated
When it came to HCQ, on the other hand, the FDA explained that the already-approved drug still required a “higher standard” of a randomized controlled clinical trial before it could be used for Covid-19. This demand was not about a new untested drug but a trusty old friend, safely used for the past 65 years. Does such a position make any sense?
It does, says Dr. Orient, “if you consider that according to disclosure statements in JAMA, (Journal of American Medical Association), most of the NIH panel members providing Covid-treatment advice have financial connections with Gilead Sciences, maker of remdesivir.”
“To clear the way for remsdesivir, an exorbitantly-priced drug, the leading contender—cheap, widely available HCQ—must first be eliminated.”
Dr. Orient points to another example of cynical moves by federal agencies regarding HCQ. “Two million doses of HCQ were sent by the Trump Administration to Brazil to help medical practitioners there safeguard themselves against the spread of the virus,” she said. “But in the United States, it is virtually impossible to obtain HCQ as a Covid prophylaxis.”
In many states, even securing the medicine for early Covid treatment is almost impossible; one needs to first be hospitalized with a later stage of the disease. This is despite the fact that it’s been conclusively demonstrated that the drug’s curative properties are primarily effective in the first few days after the onset of symptoms.
“What’s happened with hydroxychloroquine is that the system has gone mad,” Dr. Scott Atlas, a member of the White House coronavirus task force, told an audience at a conference in Colorado last week.
“I sort of make the analogy that we all know objective journalism is basically dead in this country,” Atlas added, as reported in the Washington Times. “I’m very cynical about that. And now what we’re seeing is that objective science is nearly dead.”
The Hospital Pleaded for HCQ to Save Lives
The following events bear out Dr. Atlas’ grim assessment. On August 10, ignoring the wealth of new HCQ-supporting data coming out of studies in Italy, Belgium and New Jersey, the FDA denied Henry Ford Hospital’s urgent request for emergency use approval (EUA) for HCQ.
The Hospital made the request after its clinical trials found an impressive 51% reduction in deaths if HCQ was begun within 24 hours of admission to hospital. These findings were supported by studies led by Dr. Peter McCullough’s team from Balyor Cardiac and Vascular Hospital in Dallas. The Baylor data showed prophylactic benefits of HCQ given to hospital workers who were exposed daily to Covid during the course of their work.
Administrators at Henry Ford Hospital petitioned the FDA for the EUA on July 1, as doctors were scrambling to save lives in the wake of fresh coronavirus outbreaks.
The FDA dragged its feet for six weeks before ultimately issuing a denial. By that time, 49,000 more Americans had died of Covid or Covid-related complications, in Michigan and throughout the country.
These were needless deaths caused not by lack of available treatment for the virus, but by political and financial agendas hoping for the lucrative “magic bullet” of a vaccine.
The FDA’s denial of the EUA for hydroxychloroquine for early-stage Covid-19 patients enabled the agency to falsely claim outpatient harm from HCQ based on inpatient data in critically ill patients. Attributing any late-stage cardiac effects to HCQ that was clearly caused by the virus and inflammatory damage is dishonest, critics say.
Citing these and other arguments, the Association of American Physicians and Surgeons (AAPS) sued the FDA in June to ends its interference with the use of HCQ.
Infringing on First Amendment Rights?
“There is no legal or factual basis for the FDA to limit use of hydroxychloroquine,” stated AAPS General Counsel Andrew Schlafly. “The FDA’s restrictions on HCQ for Americans are completely indefensible in court.”
The brief noted that many foreign nations, including China, India, South Korea, Costa Rica, United Arab Emirates, and Turkey, use HCQ for early treatment and prevention of COVID-19.
The mortality rate from Covid-19 in countries that allow access to HCQ—even countries with inferior medical healthcare systems—is only one-tenth the mortality rate in countries where there is interference with this medication, such as the United States, the brief asserted.
The lawsuit stressed the anomaly that citizens of the Philippines, Poland and Turkey all have greater access to HCQ than American citizens do. In Venezuela, HCQ is available over the counter without a prescription, while in the United States pharmacists are prevented from filling prescriptions for HCQ.
The brief also accused the FDA of infringing on First Amendment rights by preventing Americans’ use of HCQ as a prophylaxis. In the absence of preventive medicine, many important activities were unnecessarily shut down such as attending religious services or participating in political events such as political conventions, town halls, and rallies in an important election year.
Appeal for Emergency Injunction
After a Michigan district court ruled in favor of the FDA on technical grounds, AAPS followed up with an appeal to the Sixth Circuit. The appeal seeks an emergency injunction that would compel the FDA to release HCQ from national stockpiles, “while it is still timely to save lives and alleviate injuries from the disease.”
“In a scenario that future historians might compare to the withholding of grain from millions of Ukrainians by Josef Stalin in 1932, or the withholding by the U.S. federal government of penicillin from African American men in the rural South, Defendants withhold and waste more than 60 million doses of potentially life-saving medication for Covid-19,” the brief argued.
“The withholding and wasting of medication by Defendants while nearly 200,000 Americans die from the disease for which the medication was donated, is senseless and utterly indefensible,” the brief contended. “HCQ has proven to be very safe with more than a 65-year track record, while studies, experts, and individual recipients praise it as being life-saving.”
FDA’s duplicity ignores ethics, its own safety data, basic science, clinical studies, and common sense, the brief said.
New HCQ Studies in Europe Challenge The Status Quo
Similar to restrictions on HCQ for Covid-19 in the United States, HCQ in many European countries is currently still blocked by European health regulatory agencies taking their cue from WHO, the organization that has done the most worldwide to discredit HCQ as a treatment for Covid-19.
Physicians leading the Italian study by IRCCS Neuromed, which will soon be reviewed in the European Journal of Internal Medicine, told France Soir they hope their findings will ignite a change in the current status quo.
Peter D’angelo, writing for France Soir, noted that “to better understand how the recent Italian study that found HCQ lowered deaths from Covid was carried out, we interviewed the study leader, Dr. Licia Iacoviell, Director of the Department of Epidemiology and Prevention at IRCCS Neuromed.” Excerpts from that interview follow below.
France Soir: How many patients were affected by your study?
LI: Our study was carried out on a cohort of 3451 patients admitted to 33 clinical centers across Italy.
FS: Which institutions were involved in collecting clinical data on patients?
LI: The study focused on 33 hospitals, among the most recognized and important in Italy: Gemelli, Humanitas, San Matteo di Pavia, San Donato, San Gerardo di Monza, Spallanzani, Cotugno di Napoli, Miulli di Acquaviva delle Fonti, Monzino. University of Napoli Federico II, Catania, Palermo, Cagliari, Chieti.
FS: Can you tell us about the conclusions you’ve reached?
LI: We’ve seen a 30% decrease in the risk of death in patients receiving hydroxychloroquine.
FS: What were the mortality rates in the hydroxychloroquine and control groups?
LI: The mortality rate of patients receiving HCQ was 8.9 / 1000 patients / day; the mortality rate of those not receiving HCQ was 15.7 / 1000 patients / day. Treatment began on the first day of admission in most clinical centers, at a dose of 400 mg once a day, for an average of 10 days. 76% of patients were on HCQ treatment.
FS: Did the drug have statistically significant side effects?
LI: Our study did not collect information on adverse effects. However, the studies already published by the different centers participating in our study did not show significant cardiovascular clinical events.
FS: Could hydroxychloroquine have a significant impact on the treatment of Covid19?
LI: We believe that HCQ given early after the diagnosis of Covid-19 at low doses of 400 mg per day can be an effective and safe drug, inexpensive and easy to use, and not just in Italy.
Our study is currently being reviewed in the European Journal of Internal Medicine. Its results can make an important contribution to the debate on the use of HCQ in Covid-19.
In an emergency situation such as a pandemic, the “gold standard” of intervention studies cannot be used and even randomized clinical trials (RCTs) cannot be performed under the best conditions. Therefore, all data from both retrospective and RCTs should be considered, provided they are conducted appropriately.
FS: The main European medical agencies have blocked the use of hydroxychloroquine. Yet there are currently many publications that support the efficacy and safety of hydroxychloroquine. What are the prospects for the drug in the fall?
LI: Other European studies already published have shown the effectiveness of treatment with HCQ in reducing the risk of mortality.
In particular, a study carried out in France on more than 3,100 patients with COVID-19 showed that treatment with HCQ reduced the risk of hospitalization and death. A study from Portugal suggests that HCQ treatment protects against the Covid-19 infection.
Today’s debate on HCQ is hampered by the difficulty that positive studies face in getting published. In the fall, when these studies are available, we’ll have a clearer picture of the effectiveness of HCQ, which could hopefully lead to the reopening of the prescription of the drug in low doses and in specific situations.
House Arrest, Ankle Monitors
How far will local governments go in enforcing quarantines? In a cautionary tale about the expanding power of government, a Kentucky couple said they were placed under house arrest and fitted with ankle bracelets after they refused to sign a self-quarantine order over a positive coronavirus test.
Elizabeth Linscott said she got tested for Covid-19 as a precaution because she was planning to visit her family in Michigan. The next day, she received a “positive” along with an email from the health department containing a form to sign, the New York Post reported. The document asked that she check in daily with her symptoms, self-isolate and inform officials if she has to seek hospital treatment.
Linscott said she opted not to sign because she worried about whether she would have time to contact health officials in the event of a health emergency. At such a time she would not be likely to check in as required before leaving her home.
“My reasoning was if I have to go to the ER, if I have to go to the hospital, I’m not going to wait to get the approval to go,” Linscott told a news correspondent.
The couple was shocked when local authorities came knocking at their door. “I open up the door and there’s like eight different people,” Mr. Linscott said. “This guy’s in a suit with a mask, it’s the health department guy and he has three different papers for us. For me, my wife and daughter.”
The couple was placed under house arrest for two weeks and ordered to wear ankle monitors that will notify law enforcement if they travel more than 200 feet from the property, the reports said.
“We didn’t rob a store. We didn’t steal something,” Mrs. Linscott said. “We didn’t hit and run. We didn’t do anything wrong. Why were we treated like criminals?”
Without fanfare, without any change to the Constitution, Americans seem to have stumbled into a new era of increasing government power. The Fauci-Hahn strategies of suppressing the positive studies of HCQ for prophylactic use, while focusing on mask regulations and shutdowns of businesses, schools, and houses of worship, are supposed to control the pandemic. But will they? And at what price?
These measures have eroded constitutional freedoms and devastated the public’s financial, psychological and spiritual well-being—while costing 1,000 American lives every day.