Distributed Denial of HCQ to COVID-19 Victims

Summary

On March 19, at a White House briefing, President Trump “touted” chloroquine (hydroxychloroquine is chloroquine metabolite) for possible use against COVID-19. The very next day, a media operation was launched to deny this treatment to the public. Several fake news outlets published articles, saying things like this (NYT, March 20):

Trump’s Embrace of Unproven Drugs to Treat Coronavirus Defies Science

Doctors and patients also worry that the president’s rosy outlook for the treatments will exacerbate shortages of old malaria drugs relied on by patients with lupus and other debilitating conditions.

Referring to this as a media operation is appropriate because multiple outlets repeated the same false talking points. At that time

  • The use of hydroxychloroquine for COVID-19 already had scientific support, although not to the level required for FDA approval of a new drug; but HCQ was already approved.
  • The fact that hospitals had already been increasing their supply of HCQ and CQ before President’s briefing was an additional indication that medical professionals believed in the drugs’ usefulness against COVID-19.
  • There were no shortages of HCQ or CQ for lupus & RA patients at that time.
  • Multiple pharma companies announced an increase in HCQ manufacturing and substantial donations of HCQ.
  • Even without these increases, the HCQ amounts required for COVID-19 patients were too small to impact the supply for other users.

This false alarm had all the behavioral characteristics of the Democrat-Socialist operatives: pitting groups of citizens against each other, sowing fear and division, and hoping that the conflict would damage President Trump. In this case, they incited lupus and rheumatoid arthritis patients against current and future COVID-19 victims. Google, Facebook, Twitter, and Microsoft support the fake new media financially, send web traffic to them, and endorse them to some extent. Amplified by Big Tech, the announcement of HCQ shortage caused a vicious spiral: panic buying by lupus patients, which led to actual shortages, which amplified the panic buying and so on. Then the blame was directed at COVID-19 patients and their physicians prescribing HCQ for them.

Consequences of the anti-HCQ Media Operation

The situation was aggravated by actions of some state governments, which started restricting access to HCQ for COVID-19 victims. The Governor of New York outright denied HCQ to COVID-19 victims, except for inpatient treatment and clinical studies. Physicians felt pressured to postpone HCQ treatment for COVID-19 patients. Instead of beginning HCQ treatment as early as possible, they postponed its use the late stages of the disease.

Late treatment with HCQ was frequently used as compassionate care for the most desperate causes.  Delaware’s HCQ policy illustrates this thinking in late March: “This drug is used in very limited instances for very critically ill patients with COVID-19, in a clinical setting.” This led to statistics in which use of HCQ was correlated with worse outcomes. Bad actors exploited the correlation-as-causation fallacy to advocate against HCQ.

Apparently, in the early April the medical establishment in the North East (inclusive of NY, NJ, MA, CT, PA, MD, and DC) decided against the use of HCQ as a COVID-19 treatment. Coincidentally or not, this area became the main COVID-19 death cluster, responsible for more than 60% of the US COVID-19 deaths.

Why shortages were not caused by COVID-19 use

The HCQ shortages were not and could not be caused by the drug’s demand as a COVID-19 treatment. HCQ is a prescription drug taken regularly by 1.5-2 million people, at approximately the same doses used for COVID-19. The majority of those taking the drug are lupus patients (there are 1.5M lupus patients in the US, and most of them are on HCQ), followed by rheumatoid arthritis patients (there are 1.3M RA patients). HCQ is manufactured by dozens of companies in the US and abroad in standard 200 mg HCQ sulphate tablets. An estimated 20-30 million HCQ tablets are purchased weekly.

An HCQ-based treatment course for COVID-19 is 5-7 days and requires only 10-15 tablets. On March 21, there were only 24,000 people who had tested positive for COVID-19. Most of them did not need HCQ and could not find a doctor who would prescribe it, anyway. Even if a quarter of them bought 15 tablets each, that would only amount to 90,000 tablets – a drop in the ocean of HCQ supplies. Even if we multiply that number by ten – to include those who were not tested, hypochondriacs, and people who would need it within a couple of weeks – it is still less than one million. Double that number to incorporate lack of knowledge about treatment time and some people using smaller HCQ dosage for prophylaxis, and it is still less than two million tablets, or only about 10% of a regular weekly’s supply. Such increase in demand was easily covered by pharma companies’ existing stock. Additionally, pharma companies were ramping up their manufacturing and announcing donations of tens of millions of tablets. Clearly, purchase of HCQ for COVID-19 treatment likely had no impact at all. All the shortages were caused by the operation using Internet and social media to create achieve results in the physical world. It was the first distributed denial of a life-saving drug in the history.

Stockpiling was the actual cause of shortages

Because HCQ is safe, it is frequently prescribed for 90 days. Because it is cheap, insurance companies may allow patients to refill the whole 90-day supply at one time. Many lupus patients do not adhere to their regimen (see below) and thus often have unfulfilled prescriptions. Due to the fear sowed by the media, some of these patients rushed to fill their long term HCQ prescriptions, even though they had plenty of unused tablets at home.  If we estimate only 5% out of the 1.5 million lupus patients filled their 30 or 90-day prescriptions, it created a sudden demand for 9 million tablets – enough to cause shortages in the distribution channels. Even so, it seems that HCQ supply from manufacturers was not interrupted at any time. Some manufacturers always had HCQ for sale, although not in all packaging options.  Following data is from the ASHP page, tracking HCQ shortages.

March 19, March 24:  HCQ tablets are available from Concordia, Sandoz, Zydus; Prasco (current customers), Amneal (“on allocation”). Teva promises availability in late March. April 16: HCQ tablets are available from Concordia, Mylan; Amneal (“on allocation”), Sandoz (current customers and through HHS), Zidus (current customers), and Prasco (limited supply).

HCQ State Orders

Lacking the authority to completely ban doctors from prescribing HCQ, some governors restricted pharmacies from fulfilling prescriptions to COVID-19 patients, but not to other patients. Notice that the rational policy to deal with shortage would have been to limit dispensed quantities of HCQ to everyone. This would have ensured that all patients receive the drug. The effect of the inverted policy was suffering of COVID-19 victims, stockpiling of the drug by users with 90-day prescriptions, and increased shortages. New York and Michigan outright banned dispensing HCQ to COVID-19 victims, with rare exceptions, and allowed stockpiling by other users. Apparently, when pharmacies in New York ran out of HCQ, lupus patients raided neighboring states.

Some states did not ban, but created obstacles for COVID-19 victims, like the requirement that the patient tested positive for COVID-19 (when the availability of tests was limited). In the best case, the result was delay of HCQ treatment, sharply decreasing its anti-viral efficiency.

NY’s policy on HCQ fulfillment was probably the worst (score: 10):

No pharmacist shall dispense hydroxychloroquine or chloroquine except when written as prescribed for an FDA-approved indication; or as part of a state approved clinical trial related to COVID-19 for a patient who has tested positive for COVID-19, with such test result documented as part of the prescription. No other experimental or prophylactic use shall be permitted, and any permitted prescription is limited to one fourteen-day prescription with no refills.

MI’s policy was probably the second worst. NJ’s policy was not much better.

DE adopted one of the best policies (score: 0):

New prescriptions are being limited to a 14-day supply, unless the patient is previously established on the medication. Patients previously established on the medication are limited to a 30- day supply. This should ensure that patients with chronic disease can get their medication and ensure there is adequate drug available in the clinical setting to manage the critically ill. The Division of Professional Regulation encourages prescribers, pharmacies, and pharmacists to adopt similar policies.

The policies are from AMA Statement and List of Related Laws, April 27.

Deaths Clusters

This map shows the states with higher than average US COVID-19 mortality rates. Darker red indicates states with more than 500 deaths per million. Lighter red indicates more than US average, or 250-500 deaths per million. New York, a few surrounding states, and DC create a cluster, which accounts for more than 60% of US COVID-19 deaths. This cannot be explained by residents’ traffic. While people from NJ and CT commute to NYC, there is not much regular traffic between NY and MA or PA. It is likely that the unreasonable HCQ policies in NY and NJ caused shortages of HCQ, which spilled over to the neighboring states. This suggests that lack of HCQ for COVID-19 patients was a factor in increasing COVID-19 mortality rates.

Supporting Information

Immediate Increase of HCQ Supply

From an article about HCQ donations by pharma companies (FiercePharma.com, March 20, 12:47pm):

Novartis has pledged a global donation of up to 130 million hydroxychloroquine tablets, pending regulatory approvals for COVID-19. Mylan is ramping up production at its West Virginia Facility with enough supplies to make 50 million tablets. Teva is donating 16 million tablets to hospitals around the U.S. On Friday afternoon, Amneal pledged to make 20 million tablets by mid-April. 

The pledges follow Bayer’s Thursday [actually, Wed, March 18] donation of 3 million tablets [of Chloroquine].

Teva press release, March 19, 08:23 pm EDT

Teva will donate 6 Million tablets through wholesalers to hospitals by March 31, and more than 10 Million within a month

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today the immediate donation of more than 6 million doses of hydroxychloroquine sulfate tablets through wholesalers to hospitals across the U.S. …

Mylan press release, March 19

Mylan has restarted production of hydroxychloroquine sulfate tablets at its West Virginia manufacturing facility in the U.S. to meet the potential for increased demand resulting from potential effectiveness of the product in treating COVID-19.

Novartis press release, March 20, 12:00 ET

Novartis intends to donate up to 130 million 200 mg doses by the end of May, including its current stock of 50 million 200 mg doses. The company is also exploring further scaling of capacity to increase supply and is committed to working with manufacturers around the world to meet global demand.

Amneal press release, March 20, 4:17pm

Amneal is ramping up production of hydroxychloroquine sulfate at several of its manufacturing sites and expects to produce approximately 20 million tablets between now and mid-April. Those tablets will be made available nationwide through Amneal’s existing retail and wholesale customers, as well as through direct sales to larger institutions in need.

Note that the increase in manufacturing and donations were announced before the fake news media published articles predicting imminent HCQ shortages.

Lupus Patients’ HCQ Needs

After HCQ accumulates in tissues, its half-life in the body is 30-60 days, so its users are able to skip it for a week or two without adverse effects. There is an interesting article in the Journal of Rheumatology:

One of the most common questions from patients was whether they should stop taking their lupus medications … Then, on Thursday, March 19th, President Trump, in a White House briefing, stated that antimalarials “showed tremendous promise” and “could be a game- changer”. Suddenly, the rumblings became a roar. The questions about stopping HCQ turned into ‘I can’t get HCQ, my pharmacy is out’ from lupus patients trying to access refills.

Dr. Raoult, the author of the French study at the heart of the current furor: “It is difficult to find a product that has a better established safety profile. Furthermore its cost is negligible”. One final and ironic possibility: is it possible that one outcome may be improved adherence to HCQ by lupus patients? For years, rheumatologists have been trying to convince lupus patients of essentially the same thing. The risk benefit ratio for HCQ is excellent, and the potential benefits significant. Yet adherence to HCQ is universally low.

The paper says that 20%-50% of the lupus patients had poor adherence to HCQ, sometimes not taking it at all. This is not surprising, given the long half-life of this medication in the body. This also explains why some lupus got COVID-19. More info:

Hydroxychloroquine on Lupus.org:

Given the drug’s many and varied beneficial effects and its excellent long-standing safety profile, most rheumatologists believe that hydroxychloroquine should be taken by people with lupus throughout their lifetime.

Hydroxychloroquine on RheumatoidArthritis.org:

The medication [HCQ] is generally well-tolerated, and has even been found safe overall for women who are pregnant or breastfeeding. … Like all medications, there is the risk of side effects. Fortunately, the problems seen by people taking this medication are usually very mild. Serious side effects are rare.

Examples of Fake News Anti-HCQ Articles

Washington Post, March 20, 2020 (5:07 pm CDT)

Hospitals and doctors are wiping out supplies of an unproven coronavirus treatment

This was the initial title. As suits fake news, WaPo surreptitiously changed it to even more alarmist title later:

As Trump touts an unproven coronavirus treatment, supplies evaporate for patients who need those drugs

The byline:

The U.S. has all but exhausted its supplies of two anti-malarial drugs that are being used by some doctors in the U.S. and China to treat the coronavirus, but which lack definitive evidence as effective treatment or approval from the Food and Drug Administration.

Note the phrases “all but exhausted” and “lack definitive evidence” indicating intentional deception.

The sudden shortages of the two drugs could come at a serious cost for lupus and rheumatoid arthritis patients …

Notice the “could come”.

Data gathered in the first 17 days of March by Premier Inc., a large group purchasing organization for 4,000 U.S. hospitals, showed a 300 percent week-over-week increase in orders of chloroquine and a 70 percent week-over-week boost in orders of hydroxychloroquine.

Hospitals are sophisticated buyers. They know what might help patients.

The NY Times, March 20, 2020 Updated 7:34 p.m. ET

Trump’s Embrace of Unproven Drugs to Treat Coronavirus Defies Science

Doctors and patients also worry that the president’s rosy outlook for the treatments will exacerbate shortages of old malaria drugs relied on by patients with lupus and other debilitating conditions.

Fake news par excellence! The NY Times insinuates that there are HCQ shortages, contrary to the facts, but in a way that sounds as if it was commonly known information.

“Rheumatologists are furious about the hype going on over this drug,” said Dr. Michael Lockshin, of the Hospital for Special Surgery in Manhattan. “There is a run on it and we’re getting calls every few minutes, literally, from patients who are trying to stay on the drug and finding it in short supply.”

Hydroxychloroquine is especially important for people with lupus, which can be life-threatening, Dr. Lockshin said. 

This is an attempt to stir up conflict between lupus/RA patients and COVID-19 patients.

ProPublica, March 22:

Lupus Patients Can’t Get Crucial Medication After President Trump Pushes Unproven Coronavirus Treatment

Trump’s unproven claim that hydroxychloroquine could be used to treat COVID-19 has led to hoarding, putting Lupus patients and others at even greater risk. As of Saturday afternoon, Anna Valdez had 27 pills left. That number is now down to 25.

Valdez called her local pharmacy and ordered a refill to treat her autoimmune disorder, thinking a 90-day supply would help her ride out the coronavirus outbreak.

Valdez is angry at Trump for recommending a drug that is unproven for COVID-19, upending the way medicine has been practiced and taking a medicine that works away from her.

Anna Valdez, if she ever existed, had enough HCQ for twelve days, and would be able to refill it on time, possibly for less than 90 days, if not for the axis of resistance. More on ProPublica.

Lupus.org published tips for stockpiling HCQ:

Try to refill your prescription before the refill date

If the medication is out of stock at a particular pharmacy, the pharmacists there may still be able to help you find a reputable place to refill. They may know of pharmacies that ship across state lines — if that is the case, ask your prescribing doctor to write you a prescription for that location.

If you believe you have been unfairly denied a prescription fill or refill, find your state board of pharmacy’s phone number or email address to file a consumer complaint. 

Ask your doctor to prescribe a 90-day supply, instead of a 30 day supply, to make sure you have enough in case it becomes more difficult to access later. 

Data behind the Map

The following table shows the number of deaths, deaths per million of population, and the level of damaging HCQ policy of the state.  HCQ policy is assigned a number from 0 (DE) to 10 (NY), based on its level of damage (by withholding or obstructing HCQ) to COVID-19 patients. States without a HCQ policy in the AMA Statement and List of Related Laws are assigned the number 1.

[Could Governor Cuomo, whose anti-HCQ regulations caused many thousands of deaths, be considered a mass murderer?  –Bob]

State Deaths Deaths/M HCQ policy derangement Cluster?
New York 26,812 1,378 10 NY cluster
New Jersey 9,264 1,043 6 NY cluster
Connecticut 2,967 832 1 NY cluster
Massachusetts 4,979 722 1 NY cluster
Louisiana 2,286 492 1
District Of Columbia 328 465 8 NY cluster
Michigan 4,551 456 9
Rhode Island 430 406 3 NY cluster
Pennsylvania 3,823 299 1 NY cluster
Maryland 1,683 278 1 NY cluster
Illinois 3,406 269 4
USA Total 80,931 245

(Worldometers snapshot, May 11, 2020)

Most of the states with the highest number of deaths per million are Democrat governed. On the other hand, California and Washington, who are also Democrat governed but have reasonable HCQ policies, have a low number of deaths per million. Washington, having a HCQ policy score 1, was at a disadvantage, as the first epicenter of the epidemic and because it receives less UV sunlight than NY, yet they fared much better.

Google Blocked Access to an HCQ Paper on  Author’s Google Drive

On March 17, Anthony wrote a post An effective treatment for #Coronavirus #COVID-19 has been found in a common anti-malarial drug. It linked to the paper An Effective Treatment for Coronavirus (COVID-19)by James M. Todaro, MD and Gregory J. Rigano, Esq., and its Spanish version, both shared on Google Drive. Since that time, both have been blocked by Google because of violation of its ToS (but remain in an archive).

Elon Musk tweeted about that paper a day earlier. When viewers click the link, Twitter shows them a “warning” that the destination page might be unsafe. I encounter such things all the time.

CONTINUE READING –>

 

2 thoughts on “Distributed Denial of HCQ to COVID-19 Victims

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