04/10/2020 | Press release | Distributed by Public on 04/10/2020 13:07
WASHINGTON - After spending the last weekend talking to agency heads helping to break the logjam holding up the distribution of 30 million tablets of hydroxychloroquine (HCQ) donated by Novartis to the Strategic National Stockpile, Sen. Ron Johnson (R-Wis.) turned his attention this week to helping give patients the right to try this drug early in the course of their COVID-19 diagnosis.
Senator Johnson quickly determined that absent guidance from the FDA and the CDC encouraging its use, far too many doctors and hospitals were reluctant to assume the liability 'off label' use of HCQ posed. In fact, he heard reports that some state medical licensing boards were actually threatening doctors with sanctions if they prescribed HCQ 'off label.'
In order to break this prescribing logjam, Senator Johnson has spearheaded a campaign to solicit support for a letter urging President Trump to take two specific actions:
1. Issue a presidential directive to remove the FDA Emergency Use Authorization restriction that states hydroxychloroquine (HCQ) and chloroquine (CQ) from the Strategic National Stockpile are only approved 'for certain hospitalized patients,' and to direct the FDA to include the option of early outpatient use of these medications.
2. Issue a presidential directive or executive order to a) prohibit governors from arbitrarily restricting hydroxychloroquine (HCQ) to only hospitalized patients, and b) prohibit state medical boards and state pharmacy boards from threats of disciplinary action (now occurring in multiple states) against doctors and pharmacists legally prescribing and dispensing HCQ and CQ off-label for early treatment or prophylaxis for COVID-19 in outpatients or at-risk or exposed persons.
That letter began circulating among practicing physicians Thursday evening at 10 p.m. ET. By noon ET, 776 practicing physicians had already agreed to sign the letter. Having obtained that level of support in only 14 hours, Senator Johnson submitted the letter to the White House.
Until the president has taken this action, Senator Johnson is asking practicing physicians around the country to add their voice to this effort by reviewing and signing the letter showing their support for giving patients the right to try HCQ early in the treatment of COVID-19 when it is believed to be most effective.
Text of the letter is below. CLICK HERE TO SIGN THE LETTER.
Dear Mr. President:
We, the undersigned practicing physicians, urgently ask that you take two steps to help us treat patients according to our best ability and medical judgment, using the clinical and basic science data we already have on the effectiveness of certain established medicines in this war against COVID-19:
1. A Presidential Directive to remove the FDA Emergency Use Authorization restriction that states Hydroxychloroquine (HCQ) and Chloroquine (CQ) from the Strategic National Stockpile, are only approved 'for certain hospitalized patients,' and to direct the FDA to include the option of early out-patient use of these medications.
2. A Presidential Directive or Executive Order to a) prohibit Governors from arbitrarily restricting hydroxychloroquine (HCQ) to only hospitalized patients, and b) prohibit State Medical Boards and State Pharmacy Boards from threats of disciplinary action (now occurring in multiple states) against doctors and pharmacists legally prescribing and dispensing HCQ and CQ off-label for early treatment or prophylaxis for COVID-19 in out-patients or at-risk or exposed persons.
Restricting use to hospitalized patients means loss of the critical early window of opportunity to: (1) prevent the virus attaching to host cells, (2) reduce viral replication that prolongs time of infectivity and spread, (3) reduce the number of hospitalizations and need for intubation and mechanical ventilators, and (4) reduce risk of multi-organ damage and death or permanent lung impairment after recovery.
Evidence of successful treatment in thousands of patients is accumulating from many countries as well as U.S. physicians; it is far beyond 'anecdotal.'
HCQ has been FDA-approved for malaria since 1955, and it is now also approved for treating lupus and rheumatoid arthritis, with an impressive safety record.
When World Health Organization and U.S. academic experts say there is 'no evidence that any medicine can prevent or cure' COVID-19, they correctly mean that we don't yet have a randomized, placebo-controlled, doubleblind clinical trial (RCT). But designing, setting up, conducting, and analyzing any RCT takes many months or years.
We can't wait months for a completed RCT or a vaccine. People are dying every day. Staggering numbers of people have lost jobs, incomes, and ability to live life normally, all of which lead to loss of life that could quickly exceed losses from the virus.
Physicians taking care of patients in our communities across the country must be free to use the medicines at hand free of politicians and bureaucrats' second-guessing and threats. It is unprecedented-and lethal-for state governors and medical boards to forbid physicians' freedom to prescribe long-approved and safely used medications.
In a war to save lives and our country, we must fight with all the weapons we have at hand.