States Bow to Pressure to Reverse Course on HCQ

By  Debbie Maimon, YATED  Sep 9, 2020

As Covid-19 continues to burn its way across previously unscathed regions in the country, public pressure in ten states has forced governors and pharmaceutical boards to lift or ease restrictions on HCQ to fight the disease.

Of the 44 states that had strict regulations in place since March, New York, Idaho, Kentucky, Minnesota, Mississippi, Ohio, Oklahoma, Oregon, South Dakota and Texas have all seen significant changes and even complete reversals in HCQ policy in recent weeks and months.

In some states where HCQ policies were rescinded, months of lobbying by legislators and public health activists paved the way behind the scenes.  In New York, for example, Gov. Andrew Cuomo suddenly announced on May 21, on Sean Hannity’s radio show, that there are now no restrictions in New York on HCQ, except for a 14-day limit on a prescription.

This was a drastic shift from previous limitations on the drug—among the most restrictive in the country. Although the announcement appeared spontaneous, it came about amid sustained criticism of Cuomo’s handling of the pandemic, although the press muted a great deal of it.

In Ohio, events that led to an HCQ policy reversal received more media attention.  An Associated Press article offers a tantalizing glimpse into some of the behind-the-scenes drama that contributed to that outcome.

They Didn’t Try to Burn Down the City 

According to the article, hundreds of Ohioans, furious over the Ohio Pharmaceutical Board’s issuing of restrictive regulations against the use of HCQ, forced Governor DeWine and the board members to rescind the restrictions just 24-hours after they went into effect.

It was a stunning example of how ordinary Americans overturned what they considered harmful state policy overnight, but without resorting to violence and property destruction in the kind of scenarios Americans have lately become used to.

In the midst of a pandemic with the fear of “I can’t breathe” gripping the populace, and the sense that authorities were literally withholding the “oxygen,” Ohioans accomplished what they did without rioting, looting or trying to burn down the city.

The AP article captures their outrage, while peppering the piece with reminders that HCQ does “more harm than good,” and “can cause heart complications.”

“COLUMBUS, Ohio (AP)–Hundreds of Ohioans reacted swiftly and angrily to news that the Ohio pharmacy board blocked the use of a malaria drug for patients with Covid-19, according to an AP review of comments received by the board,” the article begins.

“At issue was the prescribing of hydroxychloroquine for the coronavirus, despite scientific studies showing the drug can do more harm than good when used to treat symptoms of COVID-19.  On July 29, the pharmacy board banned prescriptions for hydroxychloroquine’s use, noting that the FDA previously revoked the emergency use of the drug, citing reports of heart complications.”

Yet, “one day later,” the article goes on to report, “the pharmacy board reversed itself based on reaction from the public and the medical community…The board was flooded with furious messages, receiving more than 1,400 emails and more than 400 voicemails in about a day,  according to a review of the reactions by The Associated Press.”

“How many lives may you save? How many lives will you lose by not allowing physicians to try?” Valerie Lydic, a school nurse from Perry, Ohio, wrote on July 29.” 

The article noted that pharmacists and doctors were among those slamming the restrictions and urging the board to reverse its decision.

“The thought that a pharmacist or pharmacy board can supersede a physician’s order or medication prescription, is frightening to me,” Dr. Michael Yaffe of Columbus, Ohio wrote.  “I completed medical school, internship and residency to earn the privilege and the right to make clinical decisions regarding patient care.”

 Paul Madachik, a retired industrial chemist, told the board its job was “to protect us from defective or substandard drugs, not to limit my physician’s treatment possibilities.”

Many Ohioans harshly criticized the board for interfering with the doctor-patient relationship and allowing pharmacists to usurp the physician’s role. Others accused the board of allowing partisan politics to override an issue of life and death; accepting money from drug companies hoping to push their own medications and vaccines, or trying to make President Donald Trump look bad.

A cross-section of voices coming from different sectors of the state, all with the same impassioned demand, “It’s our lives. We have the right to try!” won the day in Ohio.

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The original regulations in all but a few states tightly restricted HCQ treatment to patients suffering from malaria, lupus, or rheumatoid arthritis, or hospitalized patients testing positive for Covid 19. Doctors were required by law to specify a diagnosis code on the script and pharmacists were empowered to override the physician if they deemed the prescription for HCQ “inappropriate.”

In practice, that means that patients testing positive for Covid-19 but not sick enough to be admitted to the hospital were to be denied HCQ, according to regulations in many states.

They were sent home to simply wait it out, or to re-seek hospital admission only if their fever shot up or their breathing became labored—signs that the disease had progressed to the inflammatory, life-threatening stage.

The stated rationale in almost all administrative orders limiting public access to HCQ was to ensure that “the supply chain of the drug not be depleted” by a panicky public rushing to “hoard” the drug, leaving lupus and arthritis sufferers without their medication.

How bizarre. In the midst of a severe pandemic, lupus and arthritis sufferers were prioritized over Covid patients, when leaving these people untreated enhanced the rapid spread of a disease that is particularly deadly to people with underlying health conditions.

Pointedly ignored is the fact that no shortage of HCQ would exist if the FDA would release its own stockpile of tens of millions of dosages. In addition, governors have the authority to obtain additional supplies of the drug from other sources, as Governor Ron DeSantis of Florida proved in April.

DeSantis told Gray Media Group, Inc. that the U.S. Ambassador for Israel put him in contact with the Israeli company, Teva Pharmaceuticals, one of the big producers of HCQ. “We now have thousands of shipments of the drug coming to Florida hospitals in Miami-Dade, Broward, Orlando and Hillsborough counties,” DeSantis said.

Under pressure from various quarters, DeSantis later dropped HCQ, claimed he never endorsed it and began pushing remdesivir as a key treatment for Covid-19, although the drug is not FDA-approved and no one claims it’s curative.

To the governor’s credit, Florida is one of the nation’s few states that have no restrictions on HCQ. According to Sun Sentinel, hospitals across South Florida continue to use the drug as their frontline treatment.

Administrative Rules Threatening Doctors and Pharmacists

In language almost reminiscent of Soviet-era persecution, some states in their administrative orders regarding coronavirus went so far as to instruct doctors to inform on colleagues who violated the rules. “It is also important to be mindful that licensed health professionals are required to report inappropriate prescribing practices,” the administrative order in Michigan reads.

In Illinois, particularly dire warnings were issued to pharmacists who are suspected of filling too many prescriptions for off-label HCQ.

“Pharmacists are reminded that the Illinois Department of Financial and Professional Regulation has an online compliant form to file complaints against any registered professionals (including physicians, nurse practitioners, physician assistants and pharmacists), the new regulations said. “We take any allegations of unprofessional prescribing seriously and may levy discipline, up to revocation of their license, against any prescriber found to be in violation…”

Citizens in Montana are urged to inform on anyone they suspect of “inappropriate” prescribing of drugs labeled “scarce” including HCQ.

“If you are aware of inappropriate prescribing or dispensing… please contact the respective board by email at DLISBSDHELP@MT.GOV or go to HTTP://BSD.DLI.MT.GOV for more information. You may also report suspected fraud with respect to the sale or acquisition of supplies designated “scarce” by the HHS, to the National Center for Disaster Fraud hotline established by the United States DOJ by calling (866) 720-5721 or emailing DISASTER@LEO.GOV.

With the newly amended regulations in the above-mentioned ten states, the most draconian measures have been repealed, including rules that denied treatment to patients suffering early-stage Covid 19, and ominous passages warning doctors and pharmacists of severe consequences for “hoarding” HCQ.

Treating Doctors Like Criminals?

 It may have dawned on state bureaucrats that if legislation is indeed necessary to prevent doctors across the country from “stockpiling” the drug for themselves and their loved ones, that speaks volumes about their confidence that the drug works. Shouldn’t the collective knowledge and experience of thousands of frontline professionals be allowed to guide us?

Just as crucially, instead of treating the nation’s health providers like criminals for trying to shield themselves from Covid-infection as they treat the sick, doesn’t it make more sense to aid them in staying safe?

In the midst of a pandemic, do we really want doctors on the front lines to be cut down by the virus, leaving no one to man the clinics and hospitals?

In what many hope will be a state-by-state domino effect, the new policies in the ten states where HCQ policies have been amended now allow doctors to use their discretion in prescribing HCQ for off-label uses. Directives that encouraged pharmacists to refuse to fill prescriptions for HCQ aimed at treating the virus have been rescinded.

This is a tremendous breakthrough for public health activists demanding the “the right to try” a medication that holds out any possibility of benefit, a right enshrined by law.

Given the media’s maligning of the drug and the suppression of the most recent studies highlighting HCQ’s safety and efficacy, countless Americans have been left in the dark about the facts. To take just one example, searching online for recent articles on HCQ in the local Illinois press, one finds only articles that are 50-60 days old.

All the more reason to celebrate the fact that despite all the hurdles, hundreds of thousands of citizens in the states of NY, Idaho, Kentucky, Minnesota, Mississippi, Ohio, Oklahoma, Oregon, South Dakota and Texas have powered through the confusion and lack of information, compelling authorities to lift restrictions on a life-saving medication.

Texans Overturn HCQ Restrictions

In another example of individuals refusing to bow to irrational restrictions on a life-saving drug, Texans were challenging new regulations on HCQ imposed by their state’s Board of Pharmacy succeeded after many weeks in having the new mandates reversed, reported The Texan.

The new rules stated that no prescriptions for hydroxychloroquine could be dispensed without a diagnosis “for a well-known and FDA-approved purpose,” adding that the regulation was meant “to prevent hoarding of the medications during the coronavirus crisis.”

The mandate included a 14-day supply limitation with no refills, unless the patient was previously established on the medication as in the case of lupus and rheumatoid arthritis patients.

The Texan interviewed Dr. Izette Lozano who said she was seeing 5-6 Covid-19 patients a week. Her treatment protocol consisted of a prescription of about ten pills each of hydroxychloroquine, azithromycin and zinc, to be taken for five days.

Dr. Lozano said she learned about the treatment from one of President Trump’s press conferences, and began investigating it, eventually incorporating it as her standard of care with Covid-19 patients

After hitting a brick wall in her efforts to negotiate with the Texas Board of Pharmacy for the right to continue the protocol for Covid patients, and to prescribe them without listing a diagnosis, Lozano reached out to Republican State Senator Bob Hall.

Lozano was deeply concerned about the violation of patient privacy in having to specify a diagnosis, but Sen. Hall was more concerned about the rule that restricted the dispensing of potentially life-saving prescriptions.

“In a few months, we may discover situations where this combination of drugs could have saved a significant number of lives, but we had all these deaths because it was not used,” Hall told The Texan.

He shared with the reporter that he was also wary of possible “collusion between the pharmacy board and pharmaceutical companies who want to prevent the use of an inexpensive drug while they develop a new, expensive one.”

Sen. Hall said he contacted the Board of Pharmacy commissioners, executive director, and attorney about having the restriction on HCQ removed. In the ensuing weeks, public awareness grew about the issues at stake.

Six weeks later, “in response to outrage from grassroots Texans, state bureaucrats backed down,” The Texan reported, without elaborating on the details. The Board first reversed itself on the issue of prescribing HCQ off label for Covid-19, and shortly afterward, on the requirement to list a diagnosis code.

The Texas State Board of Pharmacy website now asserts: “The rules do not prevent a physician from prescribing one of these drugs for an off-label use. Please note, the intended use for the drug is not required [to be listed on the prescription], if the practitioner determines the furnishing of this information is not in the best interest of the patient…”

When asked in correspondence with The Texan what triggered the change in the administrative guidelines, CEO Allison Benz said that they had been receiving “inquiries” (read “outrage”) from pharmacists, health practitioners and the general public.

Despite the progress in many states in unshackling doctors and allowing them to treat patients as they deem proper, it is still impossible to legally obtain HCQ in the United States as a prophylaxis (which is how doctors say it works best). In stark contrast, in some areas of Central America, officials go from door to door to distribute HCQ. In some third world countries, the drug is sold over the counter.

In the United States, where almost two million doses of HCQ lie unused in federal warehouses, people have to be infected with the virus, test positive, show symptoms and in most states be hospitalized before they can be treated with it.

Perhaps with increased understanding and public pressure, this incomprehensible deadlock too might soon loosen up. With HCQ available as preventive medicine, Covid-19 would be as serious as a mild flu, experts say. Society could forego masks, social distancing, quarantines and lockdowns, and perhaps recapture a lost world.

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HCQ In South Florida Hospitals

In a Florida Roundup interview conducted by a panel of journalists with Dr. Marlow Hernandez and Dr. Dave Lacknauth, two health care administrators overseeing medical facilities in South Florida, discuss their experience treating hospitalized patients with HCQ.

 An excerpt from the conversation follows below:

Melissa Ross: Dr. Hernandez, are you seeing success with Plaquenil (brand name for HCQ) at your facilities at Cano Health? Are you using it?

Dr. Hernandez: Yes, we are using it across our 45 facilities in the state. We have over 60,000 patients, and we are using it selectively for those who have high-risk symptoms, and who do not have contraindications [for this drug.]

Melissa Ross: Can you elaborate on what is considered high-risk?

Dr. Hernandez: Those who seem to be going into the inflammatory stage of the disease, following the viral phase that lasts about a week. It’s what causes a lot of the mortality…That inflammation can build up in your lungs, can build up throughout your body. And if we have a medicine that can prevent that inflammation from going amuck, we can improve outcomes.

Hydroxychloroquine is not a panacea, but we’ve used it against immune system overreactions for decades. It’s safe for most patients. I’m very supportive of using it because it’s one of the important tools that we have in this terrible pandemic.  We cannot be in a position where we have some type of treatment and withhold it from our patients.

Tom Hudson: Dr. Lacknauth, are doctors at your health care system prescribing this drug for Covid-19 patients?

Dr. Lacknauth: Yes we are, as a health care team. We’ve assembled a group of infectious disease physicians, intensivists, pulmonologists, and our chief medical leadership. We meet three times a week. Hydroxychloroquine is a medication that after looking at a lot of data, we decided to use it.  And right now, we’re trying to get this initiated earlier on with our patient treatment, once we get a confirmed positive case. Because the effects of decreasing viral load will have a bigger impact if we can get patients started on this medication earlier. Of course, only in clinically appropriate situations.

Hudson: Tell us what those clinically appropriate conditions are. What are the conditions for the patient, for the primary care physician or the emergency room doctor in this case? What do they have to agree on for you to fulfill a prescription for hydroxychloroquine?

Dr. Lacknauth: The big thing we’re looking at, the big risk point is the possible cardiac complications. So, in our health care system, we are looking at cardiac monitoring of a patient prior to initiating therapy and making sure the rhythms on that patient are appropriate, and that we decrease risk when we do apply hydroxychloroquine.

Hudson:  And how do you do that?

Dr. Lacknauth: In the hospitals we have methods to monitor heart rhythm through EKG. We also have cardiologists who are part of our teams who have reviewed all relevant data, and they give our physician team guidance on the appropriate use of medications based on those rhythm rate readings.

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*A note of thanks to Dr. Jane Orient of the Association of American Physicians and Surgeons, who shared with this writer important documentation about the restrictions on HCQ state-by-state.

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