Open Letter to Governor Abbott- Please, let Texas doctors treat our patients. Board of Pharmacy over-reached on you Executive Order.

March 31, 2020

 

Dear Governor Abbott,

 

I wrote you last week regarding a 3rd generation Texas pharmaceutical company that could make millions of hydroxychloroquine doses for treatment of the COVID-19 infection for Texans in short order, if the active pharmaceutical ingredient can be purchased and red tape cut. We know of a supplier in Mexico, a mere six-hour drive from the plant. I have not yet received a response. You may not have received my letter. I am sure you are aware of the findings from studies in South Korea, France, and now, New York, showing extraordinary results in patients treated with hydroxychloroquine in conjunction with zinc and often azithromycin. I just concluded an hour long discussion with physicians across the country and Vladimir Zelenko, MD, who has treated over 700 patients in his high density community of 35,000 patients in one square mile in New York, with zero deaths and only 4 patients admitted to the hospital. I implore you to instruct the Texas Board of Pharmacy to remove the restrictions on prescribing hydroxychloroquine and azithromycin. From a medical standpoint, as Dr. Zelento says, this is World Ward 3, a race between this virus and humanity, and Texas physicians need the freedom to treat our patients in ingenious, empiric, evidence-based ways. We do not have the luxury of waiting, twiddling our thumbs, rationing ventilators for a year, waiting for randomized prospective studies and a vaccine. We must act now. There is no rationale or excuse for these restrictions.

  1. Hydroxychloroquine (HCQ) is safe, inexpensive, and has rare side effects. It has been used for over 60 years and used to be over the counter (OTC). It is FDA approved- just not for the precise indication of COVID-19, because this is a new virus. It is standard practice for physicians to use FDA approved drugs for off-label uses. This happens more than 20% of the time, and the FDA acknowledges this as standard of care and does not discourage off-label use. HCQ costs pennies per dose and can be taken orally, while newer biologics cost tens of thousands of dollars per treatment and must be administered intravenously. Additionally, among other antiviral and anti-inflammatory effects, HCQ inhibits the cytokine effect that causes the lethal lung damage caused by COVID-19. The science and experience exists.
  2. Zinc, inexpensive and OTC, is a mineral that inhibits the COVID-19 virus from replicating, but zinc cannot enter the patient’s cells, because it is a positively charged ion. HCQ is an ionophore that opens channels allowing zinc into cells, so it can inhibit virus replication, and thus, stop damage from and spread of COVID-19.
  3. Azithromycin is an inexpensive, widely used antibiotic that helps prevent secondary bacterial pneumonia and has other ancillary effects as well.
  4. HCQ combined with azithromycin and Zinc, a mineral with antiviral properties, available OTC at low cost, is extremely promising.
  5. India has stopped exportation of HCQ, reserving it for its own patients’ treatment, as are other countries. Israel, including Prime Minister Benjamin Netanyahu himself, Belgium, Brazil, France, and Ukraine have been in direct communication with Dr. Zelenko regarding his protocol. Prominent New York physicians and others across the country are using this protocol on out-patients who present with early symptoms with positive results, including a 90% decrease in hospital admission, eliminating the problems with shortages of hospital beds, ICUs, PPE, and ventilators. Today, the FDA approved HCQ for COVID-19, but with caveats- for New York inpatients with positive tests. The US has acquired and donated 30 million doses of HCQ from our National Strategic Stockpile to New York, and 6 million doses were donated to New York by Teva Pharmaceuticals. What about Texas? Is the US stockpile now depleted? Will other drug companies donate HCQ to Texas? We Texans are generous, kind and compassionate, but should we be equally as concerned about securing HCQ for fellow Texans as we are funneling our supplies to New York City, a city with a dangerously high population density and poor supply of hospital beds, ventilators, and personal protective equipment for front line health care workers?
  6. We know that by the time the test turns positive the viral load is high. We need to start treatment earlier, to diminish spread and need for hospitalization and intubation in the scare ICU beds. On a positive note, Abbott Laboratories has developed a new rapid test that will give results in minutes instead of days. But Texas patients who fall into high risk categories- age over 60, those with chronic illness, those who are immunosuppressed or on immunosuppressive medications, and those presenting with shortness of breath- deserve the right to try this treatment that costs $20.00 with minimal side effects that decreases the problems and cost of hospitalization, shortage of PPE, ICU, intubation, and death, before the test turns positive, or they are already so sick they must be hospitalized.

This is battlefield medicine, not medicine as usual. We should not have to wait for a test to turn positive when we could begin this treatment out-patient in at-risk patients who present with symptoms. I would love to discuss this with you in detail. The science and evidence exists. I implore you to remove the restrictions you have placed on physicians and patients through the Texas Board of Pharmacy restrictions on hydroxychloroquine and azithromycin dispensing. If you will not, please, at least allow physicians to dispense these medications at cost to appropriate patients before it is too late. Physicians must not be restricted from treating our patients, and patients deserve the right to try time-tested, inexpensive, low-risk medications that empiric, evidence-based medicine is showing to be highly effective. Let Texas lead; let Texans live. The virus is so catching that half of all Americans (160,000,000) may develop the infection- some asymptomatic, some dying. Interestingly, George Washington ordered Cinchona, made from Peruvian bark containing Quinine, the predecessor of HCQ, to protect himself and his troops from malaria. The British did not have this, and many attribute the victory at Yorktown in part to Quinine-containing cinchona. Sir William Osler, MD, wrote in an 1896 edition of Journal of the American Medical Association that the discovery of cinchona is one of he greatest benefits conferred upon mankind in relation to the fevers. I can fathom no ethical reason to withhold the right for patients to try and the right for physicians to provide HCQ to Texas patients. Texas can make its own supply as the US replaces what it preferentially funneled to New York. Let’s take action, not make restrictions. Let’s keep patients out of the hospital, not shut down society and destroy the Texas economy while scrambling to build more hospitals, waiting over a year for a vaccine or expensive meds.

 

Sincerely and Prayerfully,

Kristin S. Held, M.D.

San Antonio, Texas

President, Association of American Physicians and Surgeons (AAPS)

 

P.S. AAPS General Counsel and friend Andy Schlafly sent this email to a top aide of VP Pence, Paul Teller, today, expressing what he thinks needs to be done to help patients obtain effective treatment, such as hydroxychloroquine, in the face of political forces so strongly against freedom (which is not to build new hospital beds or tell people that hundreds of thousands will inevitably die, so just get used to it). I am sharing this with you with Andy’s permission. He believes maybe people wouldn’t be in such a panic if there were not so much interference with their obtaining effective medicine, rather than being warehoused in hospital beds and told that nothing can be done for them.

 

Paul,

 

Really appreciate all your work over the years.

 

Physicians nationwide are being intimidated and prevented from prescribing, or having their prescriptions filled, for hydroxychloroquine to treat coronavirus (COVID-19).  The recent statement by the FDA is inconsequential.

 

I specialize in advising physicians and I’ve been hearing about these problems all day long.  Blue states and red states, from Maine to Virginia to Ohio to Michigan to Texas to Nevada:  physicians are being bullied away from providing effective treatment.  Some even face discipline by their medical boards on this issue, which can be a career-ender.

 

Our mortality per capita from COVID-19 is already higher than China’s, where physicians have been encouraged to prescribe hydroxychloroquine to treat the disease early there.  In India, this treatment is being used effectively as a prophylactic to protect health care workers, unlike here.  At the end of this crisis, everyone is going to bitterly complain if our per-capita numbers are much higher than China’s and India’s.

 

An Executive Order is needed immediately to prohibit interference, even by state officials, with the prescription and dispensing of hydroxychloroquine in connection with COVID-19.  Waiting until patients are hospitalized is often too late, and very costly.  Keeping people out of hospitals with early treatment is essential.

 

Thank you and please let me know if you’d like any proposed language for an Executive Order, or a signed letter about this from the Association of American Physicians & Surgeons and other medical groups.

 

Andy Schlafly

AAPS General Counsel

908-719-8608

 

3 thoughts on “Open Letter to Governor Abbott- Please, let Texas doctors treat our patients. Board of Pharmacy over-reached on you Executive Order.

  1. Fantastic letter Kris! Thank you for stepping up for Texas and trying to protect our state. Maybe this should be published in some of the newspapers. Very disappointed in Abbott for not responding – I guess pharmacy boards have more power and prestige than physicians.

    Love, Mary

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