Recommendations are Not Edicts. Texas Medical Board out of control- power grab threatens Texas patients and physicians.

April 2, 2020

 

Dear Texas Patients, Physicians, and Governor Abbott,

 

“The nine most terrifying words in the English language are: I’m from the Government, and I’m here to help.”- President Ronald Reagan August 12, 1986, News Conference.

 

Never before in U.S. history have patients and physicians faced greater danger from bad policy generated from good intentions of governments trying to help. The United States of America is a Constitutional Republic, so we must deal with multiple layers of government “help” ranging from local communities- city, district, and county councils and boards- to state and federal governments replete with their branches and respective agencies and boards. Amidst the COVID-19 pandemic and associated economic crisis, the consequences of too much governing and too much “help” are proving to be threatening for individual patients, physicians, and the future of Hippocratic medicine in the United States. One size fits all general federal recommendations are being seized upon by various entities to issue drastic orders at odds with common sense and available evidence. Federal recommendations are being construed by states as a charge to take sweeping action with no regard for differences in each of the individual states and total disregard for the concept of federalism. Idaho is very different than Illinois, and New York City is very different than San Antonio. In Texas, Loving County (population density 0 people per square mile) is very different than Harris County (population 2702 people/ square mile, 2018).

 

On March 19, 2020 I received an email from the hospital system that runs the ambulatory surgery center where I operate on my patients, informing me:

“Methodist Healthcare is committed to implementing a thoughtful approach to elective surgical cases.  On 3/18/20, CMS released new adult elective surgery and procedure recommendations.   In their guidance document, CMS recommends that in order to preserve PPE and other healthcare resources, as well as limit exposure to the COVID-19 virus, that hospitals and health systems limit non-essential surgeries and procedures.

CMS is recommending that physicians make the determination on a case by case basis if the surgery or procedure is needed urgently.”

Centers for Medicare and Medicaid Services  (CMS) is a federal agency within the United States Department of Health and Human Services. CMS released recommendations, not edicts, mandates, orders, or rules.

In response to a federal agency’s recommendations, Texas Governor Abbott issued an Executive Order GA-09 lasting through April 21,2020. The Texas Medical Board then created and adopted emergency rules on the provision of non-urgent surgeries and procedures in all licensed inpatient and outpatient facilities and medical settings. The Texas Medical Board (TMB) published a press release on March 24, 2020, TMB Passes Emergency Rules to Enforce Gov. Abbott’s Executive Order GA-09. The Texas Medical Board’s Executive Committee amended Texas law to amend the definition of “Continuing Threat to the Pubic Welfare,” to include surgeries and procedures that are “not immediately medically necessary to correct a serious medical condition of, or to preserve the life of, a patient who without immediate performance of the surgery or procedure would be at risk for serious adverse medical consequences or death, as determined by the patient’s physician.” Read the TMB rules for yourself as well as the Texas Medical Association’s (TMA) White Paper and FAQs pertaining to the TMB rules.

The TMB amended Texas law to facilitate temporary suspension and restriction of physicians’ licenses and require reporting to the National Practitioners Data Bank. Per the TMA’s interpretation, “The Board also amended the rule relating to peer review and hospital reporting in order to require immediate reporting rather than after the peer review process… and allow the Board to more immediately utilize the disciplinary authority granted by Texas Occupations Code, 164.059.” In response to criticism of its actions, the TMB says it cannot put physicians in jail; yet, they have created a rule of law that mandates reporting of physicians, eliminates peer review and due process, takes away physicians’ medical licenses, reports physicians to a national data bank, and can accuse and convict physicians of crimes punishable by 180 days in jail and/ or $1000 fine. Subsequently another entity, like the Attorney General, could then sentence physicians to jail. This is career and in many ways life ending for physicians who simply want to take care of their patients.

Don’t think this couldn’t happen? Here is today’s reality. A highly respected, established orthopedic surgeon, colleague and friend, informed me last night that he had just officially received a letter from the TMB investigating him for operating while the governor’s order is in effect on cases he deemed necessary. (So, this investigation has to be based on something that happened in the week spanning 3/24 and 3/31). He wanted to share with me and our surgical colleagues that the TMB “has been weaponized by this order.” He has never been sued in 16 years of practice and has never had any complaints filed with the TMB or judgments made against him. He has been head of orthopedic sports medicine at a prestigious Texas institution and with a major hospital corporation. He has been the surgeon for professional athletes and their team and has a glowing, untarnished resume. He is calling for Texas physicians to ban together to help our patients. He wrote me, “I feel like I’m in a communist country.”  One patient he operated on had a dislocated fracture and the other was a medically necessary operation in a patient who had been medically maximized for a month in order to be strong enough to undergo the medically-necessary operation, so he felt ethically obligated to proceed.  He continued, “The TMB orders and FAQs say it’s ultimately the doctor’s decision, or if it doesn’t deplete Personal Protective Equipment (PPE) it’s OK. CMS recommendations say most of what we do as orthopedic surgeons is OK and even total joint replacements are listed as category 2a, Consider Rescheduling, not you have to reschedule. This is truly crazy and dangerous.” He emphasized, “My hospitals here have had zero COVID patients and therefore no PPE issue, and as you know, we don’t use the same PPE in the OR as would be needed in the ICU for COVID patients. This rule likely requires me to violate my Hippocratic oath.”

I asked him how the TMB found out about these two cases. Did someone report him, or is the TMB collecting data on surgeons and their activities? For example, is TMB looking at CPT codes submitted by billers or received by insurance companies? He replied, “I have no idea where it started. The TMB won’t say. They don’t list any patients, just general accusations. I bet no patients understand that surgeons are being threatened and now investigated for helping them.” He has had all his patients sign special consents in this precarious time, and he has been compulsive with documentation and rule-following. He dictates and writes in the History and Physical portion of operative notes justification for proceeding with the operation including quoting from the Governor’s Executive Order. He concludes, “Our colleagues should know what TMB is doing to us.” We need to unite and rectify this situation.

Fortunately, this esteemed surgical colleague is not only allegiant to the Hippocratic oath, but he is a man of God. He left me with these words: “I’m not worried. God is in control and Jesus is on the throne. Not sure if these are the last days, but evil is called Good, and Good evil. I do think our colleagues need to know that surgeons have a target on them. Could there be some agenda to destroy doctors’ practices using this COVID crisis as justification? We need to unite and support our colleagues, targeted, as we are just trying to help our patients.”

We will get to the bottom of this, but to do so will take starting at the top. Federal bureaucratic recommendations intended to help us resulted in draconian Texas Medical Board rules that will harm physicians and patients alike. We call on Governor Abbott to call out the TMB for over-reaching on his well-intended executive order and stop these totalitarian actions being taken against Texas surgeons.

Among entities that stand to benefit from such reporting and punishment of physicians for providing care are insurance companies, who during this period of time are continuing to collect premiums and subsidies from employers, government, and individuals alike. While patients shelter in place going without care, insurers’ expenses for surgical care drastically decrease.

It will be very helpful to see where the TMB got its information to pursue investigation of this Texas physician. In the meantime, dear colleagues, stand up for your patients and yourselves. Contact your state legislators and the governor’s office to fight for your rights to practice Hippocratic medicine, and pray.

P.S. Since I started writing this piece, my colleague operated to reattach a patient’s severed limb. He left the O.R. only to find a second letter from TMB, this time more accusatory and aggressive. I bet many other surgeons have too. Time to rise up.

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