Physicians Sue FDA For Blocking Access To Life-Saving Drug

Hydroxychloroquine (HCQ) as a cure for Covid-19 continues to ignite fierce debate as a jumble of falsehoods, misconceptions and rumors collide with positive findings about the drug.

Raising the tempo of the debate, a lawsuit filed by the American Association of Physicians and Surgeons against HHS (Health and Human Services) and FDA accused the federal agencies of “unlawfully” impeding access to HCQ by physicians who want to prescribe the drug to prevent or treat Covid-19.

The FDA, led by Obama-holdover Stephen Hahn, revoked its Emergency Use Authorization (EUA) for HCQ in June, citing the risks of cardiac arrhythmia, and severely tightening the EUA’s restrictions. The FDA now permits HCQ to be administered only to patients in hospitals who are unable to join a clinical trial.

The lawsuit asked a federal court in Michigan to remove the EUA’s sweeping constraints, which it says are based on falsehoods about HCQ. The brief sharply challenges the FDA’s assertions that the drug is unsafe for broad public use, claiming that its safety profile is long-established and for the past 65 years unchallenged.

The lawsuit accuses the federal agencies of deliberately misleading the public and discriminating against millions of Americans by blocking access to a life-giving drug.

It also accuses the FDA and HHS of manipulating the presidential election by withholding the public’s access to HCQ, indirectly stoking Covid-19 fears to force the cancelation of the Republican presidential election in Jacksonville, Fla.

The Stakes Could Not Be Higher

Weighing in on the controversy, Dr. Harvey Risch, an epidemiology professor at Yale School of Public Health and one of the country’s foremost experts in infectious diseases, told Newsweek this week that “hydroxychloroquine could save 75,000 to 100,000 lives if the drug is widely used to treat coronavirus.”

“An outpatient treatment that prevents hospitalization is desperately needed,” he said, adding that based on his extensive research and clinical experience, the drug is entirely safe if used as directed.

Risch, who identifies himself as normally on the side of “mainstream medicine,” said he finds himself in an astounding position of having to fight “on behalf of a treatment that the data fully support but which, for reasons having nothing to do with…science, has been pushed to the sidelines.”

The Yale expert noted that “tens of thousands of patients with Covid-19 are dying unnecessarily,” casualties of a “propaganda war” being waged against the use of the drug for political purposes.

A groundbreaking article by Dr. Risch in the prestigious American Journal of Epidemiology (AJE) contributes a great deal to understanding in what situations HCQ can be effective in treating a patient, and when it is of little benefit and possibly toxic.

In “Early Outpatient Treatment of High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis,” Risch analyzed several clinical studies that showed “significant major outpatient efficacy” of hydroxychloroquine plus azithromycin. In these trials, early treatment was decisive in the patient’s recovery.

Highly Effective When Administered Early

“When this inexpensive oral medication is given very early in the course of illness, before the virus has had time to multiply beyond control, it has shown to be highly effective, especially when given in combination with azithromycin or doxycycline and the nutritional supplement zinc,” Risch summed up his research in the Newsweek article.

Referencing evidence from numerous large studies, “the combination should be prescribed in high-risk patients immediately upon clinical suspicion of Covid-19 disease, without waiting for results of testing,” the Yale epidemiologist urged. “Delays in waiting before starting the medications can reduce their efficacy.”

Addressing the claim that studies have not shown a benefit from the use of HCQ, Risch noted that the timing of the treatment is critical.

“Hydroxychloroquine has shown major success when used early in high-risk people,” he elaborated, but as one would expect for an antiviral, much less success when used late in the disease course.”

HCQ given within the first week of symptoms, especially with zinc, can prevent the virus from entering the body’s cells and taking over. Waiting until you are in the ICU is like installing an alarm system after burglars have invaded, vandalized your home, and stolen all your valuables.

At that stage, the drugs cannot reliably undo the damage from the exaggerated immune response, or “cytokine storm,” triggered by Covid-19.

Evidence Continues to Mount in Favor of HCQ

Shortly after the publication of Risch’s May 27 article, another study published by the Henry Ford Health System in Michigan found that treatment with hydroxychloroquine cut the death rate significantly even in sick patients hospitalized with Covid-19 without heart-related side effects.

“A surprising new study found the controversial anti-malarial drug hydroxychloroquine helped patients better survive in the hospital,” CNN reported in June.

“A team at Henry Ford Health System in southeast Michigan said Thursday their study of 2,541 hospitalized patients found that those given hydroxychloroquine were much less likely to die.”

“Dr. Marcus Zervos, division head of infectious disease for Henry Ford Health System, said 26 percent of those not given hydroxychloroquine died, compared to 13 percent of those who got the drug,” the article continued.

Patients at Henry Ford were treated with HCQ as soon as possible after admission. “82 percent were treated within 24 hours and 91 percent within 48 hours of admission,” attested Dr. Zervos.

The study was published in the peer-reviewed, open-access online publication of the International Society of Infectious Diseases (ISID.org).

Surprising? Not to those who have been able to see through the cloud of hysteria and misinformation and take a look at the facts.

In addition to the Henry Ford studies, seven additional studies on HCQ have recently yielded positive results. In a follow-up letter, also published by AJE, Risch reports on these findings with a renewed call for the immediate early use of hydroxychloroquine in high-risk patients.

The seven studies include 400 high-risk patients treated by Dr. Zev Zelenko with zero deaths; four studies totaling almost 500 high-risk patients treated in nursing homes and clinics across the U.S., with no deaths; and a controlled trial of more than 700 high-risk patients in Brazil, with significantly reduced risk of hospitalization and two deaths among 334 patients treated with HCQ.

Acknowledging the accumulating evidence about HCQ’s benefits coming in from an increasing number of clinical trials, the New York Times observed that “the anti-malarial drugs have continued to generate controversy, as new research prompted some scientists to petition for expanding their use against the coronavirus, despite Food and Drug Administration warnings against them.”

[This sounds a bit like the Times looking for an “insurance policy” for when the truth about HCQ’s great importance in the pandemic will be impossible to deny. All those who derided it and scorned its advocates will then try to prove that they kept an open mind all along.]

Risch’s findings about HCQ coincide with the 3-pronged treatment for Covid-19 urged by Dr. Zelenko, who reached national prominence when President Donald Trump announced that he was taking HCQ as a prophylaxis upon the advice of “a doctor from Monsey, NY.”

Like Trump, the president of El Salvador, Nayib Bukele, freely admitted to using HCQ as protection against Covid-19, as has Brazilian President Jair Bolsonaro, according to the South China Morning Post. “I use it, and most of the world’s leaders use it as a prophylaxis,” said President Bukele,” as cited in court papers by the AAPS lawsuit.

For those whose curiosity is piqued by the striking fact that no deaths have as yet been reported within the ranks of the world leaders, the disclosure by El Salvador’s Bukele offers a fascinating insight.

How HCQ Became a Dirty Word

In May, the United States and Brazil issued a joint statement regarding health cooperation that is posted on the White House’s website, stating that “the American and Brazilian people stand in solidarity in the fight against the coronavirus. Today, as a demonstration of that solidarity, we are announcing the United States Government has delivered two million doses 10 of hydroxychloroquine (HCQ) to the people of Brazil.

“HCQ will be used as a prophylactic to help defend Brazil’s nurses, doctors, and healthcare professionals against the virus,” the White House statement continued. “It will also be used as a therapeutic to treat Brazilians who become infected.”

Then, on May 22, the two now-debunked studies trashing HCQ appeared in leading medical journals and flipped the world on its head. Almost immediately, the World Health Organization announced that it was suspending clinical trials of the drug (now resumed).

This was soon followed by bans on the use of HCQ to treat Covid-19 by France, Belgium, and Italy.

A few weeks later, on June 15, citing the negative HCQ findings, the FDA revoked its Emergency Use Authorization permitting doctors to prescribe the drug to hospitalized Covid-19 patients.

“You almost can’t say the word ‘hydrochloriquine’ anymore,” Dr. Risch said in a Fox News interview, describing how the drug was maligned.

The study’s findings, that HCQ allegedly led to a 30 percent increase in deaths as well as the occurrence of cardiac arrhythmias in Covid-19 patients, stunned doctors, whose collective experience with thousands of patients contradicted these claims.

An open letter by almost two hundred physicians slammed the study’s glaring inconsistencies. How, people wanted to know, could this database of 100,000 patient records crossing four continents and going back to the earliest days of the virus be authentic? No one even knew the world was dealing with a pandemic at the time. Studies and trials had not yet been launched.

And how could a drug in use for 65 years have such lethal side effects that no one had previously identified?

As is well-known, the HCQ studies were hastily retracted less than two weeks after publication. Surprisingly, there was no outrage, no cries for reform in the peer-review system, no announcements of an investigation into who engineered the fake studies and for what purpose.

The discovery of the fraud further eroded public confidence in science’s “voice of authority” that seems forever mired in self-contradiction or falling prey to obvious conflicts of interest.

Two months later, hints of foul play surrounding the retracted HCQ studies have begun to surface with a New York Times article that interviewed past and present associates of Dr. Sepan Desai, CEO of Surgisphere, the company with the “giant global patient database.”

The article cast Desai as a slippery character with a history of untrustworthy dealings, dogged by malpractice lawsuits. The article invites readers to believe he had apparently conned all the doctors who collaborated with him in the fabricated HCQ study, to the point that none of them ever asked to see his raw data. Sound reasonable?

The ripple effects of the medical fraud and its negative message about HCQ continue to impact world policy. They are egged on by anti-Trump political agendas and by those with vested interests in promoting expensive drugs and vaccines in place of the cheap, readily available HCQ cocktail.

Billions of dollars have already been invested in a Covid vaccine, analysts say. That the disease appears to be treatable without a vaccine is good news for world health, but less than exciting for investors in companies such as Gilead Moderna, AstraZaneca, and many others million dollar drug companies, all racing to produce a vaccine.

The FDA Has Always Allowed Drugs to be Used for Off-Label Purposes

Ironically, even as the FDA debunks hydroxychloroquine as “unsafe,” the Centers for Disease Control and Prevention, FDA’s sister agency within the HHS, attests to precisely the opposite on the CDC website:

“How long is it safe to use hydroxychloroquine?” the question is posed. Answer: “CDC has no limits on the use of hydroxychloroquine for the prevention of malaria.”

The FDA “is falsely pretending that a medication approved as safe for treating one disease can somehow not be safe for treating another disease,” the AAPS lawsuit charges.

“It further misleads the public by falsely implying that medication approved as safe for one use requires additional studies of safety before it may properly be used to treat a new disease. In this way, the agency justifies its policy of severely restricting HCQ’s use to hospitalized patients.”

Throughout its history, attorneys for the lawsuit note, the FDA policy has been to permit physicians to freely prescribe drugs off label for any condition they feel is beneficial. These regulations have been in place since World War II.

For example, namenda, approved for treatment of Alzheimer’s disease, is also used for OCD. Clonidine, a common high blood pressure medication, has a number of off-label uses, including treatment of ADHD. HCQ should be treated no differently, the lawsuit argues. It’s either safe or it isn’t. It can’t be safe for use for lupus but suddenly cause heart problems when used for Covid-19.

The AAPS lawsuit protests the government’s intrusion into physician autonomy, saying its use of the EUA to block access to an FDA-approved drug is “disingenuous” and “unlawful.”

In addition, the lawsuit also charges the FDA with discriminating against tens of thousands of Americans by demanding that people enter clinical trials in lieu of having their physician prescribe HCQ.

“Defendants lack the authority to [selectively] limit access to medicine that way. Significantly, not everyone who participates in a “randomized controlled clinical trial” even receives the drug in question, as usually half of participants in a clinical trial receive a placebo and thus would not receive any HCQ,” contends the lawsuit.

Those receiving a placebo are being wrongfully deprived of a drug that could spell the difference between life and death.

“Countries with underdeveloped health care systems are using HCQ early and attaining far lower mortality than in the United States, where the government impedes access to this drug. Citizens of the Philippines, Poland, Israel and Turkey all have greater access to HCQ than American citizens do,” observed AAPS attorney Andrew Schlafly.

Similarly, in Venezuela, HCQ is available over the counter without a prescription, while in the United States pharmacists are prevented from filling prescriptions for HCQ, leaving Americans without badly needed medical protection and cure.

Heroic

“Physicians who have been using these medications in the face of widespread skepticism have been truly heroic,” writes Dr. Risch in Newsweek. “They have done what the science shows is best for their patients, often at great personal risk.”

Risch laments the case of two doctors he knows “who have saved the lives of hundreds of patients with these medications, but are now fighting state medical boards to save their licenses and reputations.” The cases against them, he says, are completely without foundation.

Thanks to this type of government harassment, most Americans are still unable to obtain HCQ for early treatment of Covid-19, and while some 60 million HCQ dosages are stockpiled in federal warehouses, virtually no Americans are able to access the drug as preventive medicine.

“In the future, this misbegotten episode will be studied as a classic example of how extra-scientific factors overrode clear-cut medical evidence. But for now, reality demands a clear, scientific eye on the evidence and where it points,” urges Dr. Risch.

“For the sake of high-risk patients, for the sake of our parents and grandparents, for the sake of the unemployed, for our economy, and especially those disproportionally affected, we must start treating immediately.”

*****

 

“Natural Experiments” with HCQ Involving Large Populations

Leading epidemiologist Dr. Harvey Risch noted in Newsweek that beyond the many studies involving individual patients that show the benefits of HCQ, it’s instructive to look at “what happens in large populations when HCQ+azithromycin+zinc are used to treat Covid-19.”

“In the northern Brazil state of Para, Covid-19 deaths were increasing exponentially. On April 6, the public hospital network purchased 75,000 doses of azithromycin and 90,000 doses of hydroxychloroquine,” he attested.

“Over the next few weeks, authorities began distributing these medications to infected individuals. Even though new cases continued to occur, on May 22 the death rate started to plummet and is now about one-eighth what it was at the peak.”

The exact reverse “natural experiment” unfolded in Switzerland. On May 27, following the uproar over the fraudulent studies in Lancet and NEMJ, the Swiss national government banned outpatient use of hydroxychloroquine for Covid-19. Around June 10, Covid-19 deaths increased four-fold and remained elevated.

“On June 11, the Swiss government revoked the ban, and on June 23 the death rate reverted to what it had been beforehand. People who die from Covid-19 live about three to five weeks from the start of symptoms, which makes the evidence of a causal relation in these experiments strong,” wrote the Yale epidemiologist in Newsweek.

“Both episodes suggest that a combination of hydroxychloroquine and its companion medications reduces mortality and should be immediately adopted as the new standard of care in high-risk patients.”

*****

Does HCQ Cause Cardiac Arrhythmia?

In his opinion piece in Newsweek, Risch responded to the FDA’s claims that HCQ causes cardiac arrhythmia in Covid patients, noting that the public was told only half a story.

The full story, attests Risch, is that the FDA based its comments on data in its Adverse Event Reporting System according to which patients and doctors are required to report adverse drug effects to the FDA. The system claims to have captured up to a thousand cases of arrhythmias attributed to hydroxychloroquine use.

But what the FDA did not announce, says Risch, is that these adverse events were drawn from a gigantic pool of 50 million prescriptions for HCQ, often used by patients for extended time periods for the chronic treatment of lupus or rheumatoid arthritis.

Of these thousand cases of arrhythmias attributed to HCQ in the FDA database, 62 (out of 50 million) allegedly led to cardiac deaths. This is an actual mortality rate of 1.2 per one million people, signifying a death risk far below that associated with common over-the-counter medications such as Tylenol (acetaminophen) and aspirin.

For perspective, experts familiar with this subject ask us to consider that Tylenol is the number one cause of acute liver damage in the United States and has been known in severe cases to cause liver failure and death (Medical News Today, Drug Watch). Yet, it’s deemed safe by the FDA and people don’t hesitate to use it.

Prolonged use of Aleve and Advil account for 21 percent of U.S. adverse drug events. Sustained use can lead to heart attack, stroke and life-threatening gastrointestinal bleeding. (Medical News Today, Mayo Clinic). Yet, these risks are not considered significant enough by the FDA to ban the drugs.

The theoretical dangers of HCQ (to those with no previous cardiac trouble) are so minuscule, they are not borne out in real-world usage, Dr. Risch explains.  “In view of the mortality occurring right now in inadequately treated high-risk COVID-19 patients, these life-saving medications need to be widely available and promoted immediately for physicians.”

Dr. Risch and others familiar with the defects of many of the large trials sponsored by WHO note that HCQ has not been used properly in many studies. Sick patients were given dosages four times the recommended size, causing toxicity and death in countless cases.