AAPS News May 2020 – Virus and Resistance

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Volume 76, no. 5  May 2020

Until now, an essential tool has been missing from the toolbox of total control by a ruling class: quarantine and curfews, stated progressive journalist Harry Vox in a videotaped interview on Oct 21, 2014 (tinyurl.com/y7gpfq3y). This was at the time of the Ebola epidemic, which faded before an effective treatment or vaccine was found. Readers may recall the pushback against limited travel restrictions and quarantines, though Ebola is far more deadly and transmissible than today’s demon, COVID-19.

Vox quoted from a 2010 Rockefeller Foundation document, Scenarios for the Future of Technology and International Development (https://tinyurl.com/tg2mnyy). The scenario named Lock Step described “a world of tighter top-down government control and more authoritarian leadership, with limited innovation.” This was enabled by a  pandemic, which “also had a deadly effect on economies: international mobility of both people and goods screeched to a halt, debilitating industries like tourism and breaking global supply chains…. Normally bustling shops and office buildings sat empty for months.” National governments “flexed their authority and imposed airtight rules and restrictions, from the mandatory wearing of face masks to body-temperature checks at the entries to communal spaces.” The pandemic faded, but “this more authoritarian control and oversight of citizens and their activities stuck and even intensified.” Was this prescient?

Unlike in the yearly influenza season, citizens hear daily media reports of global confirmed cases and deaths, and scary forecasts from computer models. Unquestionably, SARS-CoV-2 can cause respiratory and multi-organ failure; occasionally strikes down young, healthy individuals with terrifying speed; has overwhelmed intensive care units in some areas; and is highly contagious. Told that there are no “approved” treatments or preventives, most Americans have, so far, obediently accepted, out of fear or concern for others, unprecedented and economically devastating intrusions into their lives and even suspensions of civil rights.

How long can this continue, as markets crash, businesses fold, unemployment soars, tax revenues shrink, and government borrowing surges to unthinkable levels? Leading expert Dr. Anthony Fauci said that we could “relax social distancing” once there are “no new cases, no deaths,” but the real turning point won’t come until there’s a vaccine (tinyurl.com/sllqec4). Dr. Ezekiel Emmanuel said the U.S. could be locked down for 12-18 months until there’s a vaccine (https://tinyurl.com/sfuglgw).

Resistance to Disease

The choices are not vaccine vs. lockdown until the pandemic stops. The possibility of containment no longer exists. A close study of circulating viral genomes (PNAS 4/8/20, tinyurl.com/r49fj6e) suggests that the first infection and human-to-human spread occurred between mid-September and early December 2019, writes Bobby Scott, Ph.D., of Lovelace Respiratory Research Institute. Antibody tests of a random sample of 200 people in Massachusetts showed that 30% were positive (tinyurl.com/y7eqp3oq). At one hospital in Chicago, 30–50% of those who show up for testing have antibodies (tinyurl.com/y84wl63j).

The vast majority of people, especially children, recover uneventfully, as their immune systems defeat the virus. Some argue that it is best to let all but the most vulnerable live normally so that population (“herd”) immunity develops as quickly as possible. U.S. official policy is to “flatten the curve”—to delay but not necessarily reduce the ultimate death toll—so as not to crush the medical system when the epidemic peaks. Decades of outsourcing the supply chain and inattention to preparedness have left us vulnerable to the ever-present danger of a pandemic.

Policies are imposed based on computer modeling, opinion, and political agendas—not scientific evidence. In retrospect, Professor Yitzhak Ben Israel of Tel Aviv University, who plotted the rates of new coronavirus infections of the U.S., U.K., Sweden, Italy, Israel, Switzerland, France, Germany, and Spain, concluded that coronavirus peaked and subsided in exactly the same way, irrespective of whether the country quarantined like Israel, or used moderation like Sweden (tinyurl.com/ua2grsd).

A physician’s intuition favors reducing the dose of exposure and strengthening the immune system, then treating symptomatic disease while patients make antibodies—instead of betting the country’s health and prosperity on a vaccine that may never materialize. International studies are planned, taking a cue from HIV, of pre-exposure prophylaxis, using hydroxychloroquine (HCQ) or chloroquine (CQ), and a study of post-exposure prophylaxis began in Spain in March. India is not waiting for trials to treat medical workers or household contacts with HCQ (Science 4/10/20). In some American states, prophylaxis is forbidden, although about 10,000 medical workers have been infected (tinyurl.com/y7hc4sur).

Resistance to Tyranny

In America, impoverishment and enslavement are being imposed as governors unilaterally hand down despotic orders that could instantly destroy a person’s livelihood. High priests robed  in a mantle of Science attempt to control access to information about the unseen demon, even blocking diagnostic tests, as well as  treatments available in Brazil, Costa Rica, India, and many other countries. CDC, WHO, AMA, and their ordained functionaries will dispense only “approved” vaccine or drugs—unless Americans develop some antibodies to tyranny.


Government Responses

CDC laboratory contamination: The failure of the Centers  for  Disease Control and Prevention to quickly produce a test kit for SARS-CoV-2 was traced to violation of sound manufacturing practices, resulting in contamination of a key test component (Wash Post 4/18/20, https://tinyurl.com/y96uwbx5).

FDA and masks: The reason why masks have not been flooding the market is that no company not already heavily invested in surgical masks can jump through FDA hoops in time to mitigate the shortage. Step 1: Do a compositional side-by-side analysis of your mask versus all other masks currently sold. Hire a few materials scientists…. (https://tinyurl.com/yas498fj).


“Evidence-Based” Medicine

In an article on the Centre for Evidence-Based Medicine website, epidemiologist Tom Jefferson and Carl Heneghan, centre director and editor of BMJ, write: “There can be little doubt that covid-19 may be far more widely distributed than some may believe. Lockdown is going to bankrupt all of us and our descendants and is unlikely at this point to slow or halt viral circulation as the genie is out of the bottle. What the current situation boils down to is this: is economic meltdown a price worth paying to halt or delay what is already amongst us?” (tinyurl.com/s3rjhwx).

The computer model that “terrified our largely scientifically illiterate politicos and therefore killed the world economy” has been described by the same metaphor as other oversimplified models of complex phenomena: “assume a spherical cow of uniform density in a frictionless vacuum” (tinyurl.com/t8xhsxc).

COVID-19 could be the nemesis of EBM, stated Prof. Trish Greenhalgh at an Apr 21 Royal Society of Medicine videoconference. There is no reliable evidence to back recommendations for fabric masks, 6-ft distancing, and other policies.

EBM is “about integrating individual clinical expertise and the best external evidence,” write David Sackett et al. in BMJ (https://tinyurl.com/y7ywxfhl). “By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice….  By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine.”

EBM, they write, “is not restricted to randomised trials and meta-analyses…. [S]ome questions about therapy do not require randomised trials (successful interventions for otherwise fatal conditions) or cannot wait for the trials to be conducted.”

If there has been no RCT for “our patient’s predicament, we must follow the trail to the next best external evidence and work from there,” they advise. EBM is not conducted only in ivory towers. Audits from the front lines “show that busy clinicians who devote their scarce reading time to selective, efficient, patient driven searching…can practice evidence based medicine.”

Galileo said, “In questions of science, the authority of a thousand is not worth the humble reasoning of a single individual.”


“Any revolutionary change must be preceded by a passive, affirmative, non-challenging attitude toward change among the mass of our people. They must feel so frustrated, so defeated, so lost, so futureless in the prevailing system that they are willing to let go of the past and chance the future.”

Saul Alinsky, Rules for Radicals


Variables That Could Affect Death Rates

UK vs. Germany: In the UK, which has a much higher case-fatality rate, paracetamol (acetaminophen) is widely available over the counter even in supermarkets, but is a prescription-only drug in Germany. Antipyretic treatment might result in a dysregulated cytokine cascade, according to an article in the Journal of Thermal Biology (https://tinyurl.com/y8mwatqu).

Sex and ethnicity: While Anthony Fauci and the AMA deplore the higher COVID-19 mortality in American blacks as “unacceptable,” men and persons of African, Asian, or Mediterranean ancestry have a higher prevalence of the X-linked recessive gene for G6PD deficiency. In Italy and Spain, case mortality rate is also higher than the global rate. These patients may be more severely affected by oxidative stress (tinyurl.com/ycqghuox). CQ, HCQ, sulfonamides, aspirin, and some NSAIDs may cause hemolytic anemia in G6PD-deficient patients.


Lockdown Casualties

Cancer: Richard Sullivan, director of the Institute of Cancer Policy at King’s College London, said: “The number of deaths due to the disruption of cancer services is likely to outweigh the number of deaths from the coronavirus itself over the next five years.” Cancer screening has stopped (tinyurl.com/y7s5dsko). In the U.S. treatments are being altered, and cancer research will be set back at least a year (NEJM 4/17/20, tinyurl.com/ydau2wv7).

Cardiac disease: Delayed “elective” procedures with possibly fatal results include transthoracic aortic valve replacements and implantation of left ventricular assist devices (ibid.).

Livelihoods: If the COVID-19 crisis lasts 4 months, 65% of small retailers may be forced to close permanently by the end of the year, and 70% of restaurants and bars expect to go out of business if social-distancing orders last into July (tinyurl.com/ydau2wv7). “Lockdowns do not kill the virus; they kill the poor,” writes Australian economist Sanjeev Sabhlok. He believes all will  come to the same conclusion as Sweden—that well-managed development of population immunity is the only way out—after having first wiped out half their nation’s wealth and destroyed the future of millions of children and youth.

Lives Traded: If $3 trillion ($1T in losses plus $2T in stimulus spending) prevents (or postpones) 100,000 COVID-19 deaths, $30 million/life “saved” cannot be spent saving other lives. Medicare spends $121,000 on dialysis per QALY (quality-adjusted life-year) (tinyurl.com/y7eyyh6f). Most COVID deaths are in persons with a short life expectancy. N.Y. has 91.3 untimely deaths/y  per 100,000 persons under 50; only 4.9 per 100,000 from COVID.


AAPS Calendar

Sep 30-Oct 3. 77th Annual Meeting, San Antonio, TX

Sep 29-Oct 2. 78th Annual Meeting, Pittsburgh, PA


Lockdown Overreach

Giving arbitrary power to police predictably leads to oppressive absurdities: In Scotland, police search shopping bags for “nonessential” items and fined a woman who had purchased only wine and snacks. Persons suspected of hosting guests are reportedly being subjected to house searches. Videotaped incidents are appearing on social media (https://tinyurl.com/y9m8nkya).

Government filled in a skatepark near Los Angeles with 37 tons of sand to prevent anyone from violating social distancing orders (tinyurl.com/ydyl5gs9). Citizens, using buckets and shovels, turned it into a dirt bike track (tinyurl.com/yanx7otw). Antibodies?

In Elizabethtown, N.J., police are using drones donated by the Chinese company DJI to spy on back yards and other places patrol cars can’t reach, to look for social distancing violations penalized by $1,000 fines. It is claimed that the drones are not taking pictures or collecting evidence (tinyurl.com/yav9362w).

A mother was arrested and handcuffed in Idaho for allowing her children to play in a park (https://tinyurl.com/y9s52hwx).

Is there evidence that SARS-CoV-2 is transmitted outdoors? Chinese scientists could find only one of 318 outbreaks of three or more cases that occurred in an outdoor environment (https://tinyurl.com/y8vrla7l). So why are there orders to wear a mask when leaving your home for a safer environment?

How many infections will be prevented by closing an office building, shopping mall, or park for weeks for “disinfection”? Are we seeing good hygienic practices or compliance rituals? Is the main event a pandemic or a controlled demolition rehearsal?


Flipping the Commerce Clause

The original purpose of the Commerce Clause, to ensure free trade between the states, was flipped into an unlimited power to prohibit commerce shortly after the failure and repeal of alcohol prohibition. There was a dangerous shift in how Congress interpreted its powers. Vast prohibitive powers like those that the FDA exercises were no longer thought to require a constitutional amendment. Journalist James Bovard has documented for decades how the FDA has killed medical innovation and driven industries offshore, at least since 1990, when David Kessler became FDA Commissioner. His top enforcer described Kessler’s tactics:

The old way is over. We used to say that if a company made certain changes, then we would probably not take any action…. Now, even if they make the changes, they might end up in court. We want to say to these companies that you don’t know when or how we’ll strike. We want to eliminate predictability.

An American Electronics Association survey showed that  “40% [of medical device companies] reduced the number of U.S. employees because of FDA delays, 29% increased their investment in foreign operations, and 22% moved U.S. jobs overseas.” Kessler also ordered that manufacturers could not inform doctors about the discovery of additional uses for approved drugs.

The FDA effectively wields legislative, executive, and judicial power, with almost no real accountability. COVID-19 is exposing how it increases Americans’ risk of sickness and death.

“America must rid itself of the bureaucracy that has slowly choked out the greatest medical industry in the world,” writes Gavin Wax (https://tinyurl.com/yxxnhdbt).


Tip of the Month: Strings attached to relief fund payments. Medicare is automatically sending a “relief fund payment” to all physicians who billed Medicare for services in 2019. “Not returning the payment within 30 days of receipt will be viewed as acceptance of the Terms and Conditions. If a provider receives payment and does not wish to comply with these Terms and Conditions, the provider must do the following: contact HHS within 30 days of receipt of payment and then remit the full payment to HHS as instructed” (https://tinyurl.com/vnn6wkn). Conditions include extensive documentation and reporting. Also, “for all care for a possible or actual case of COVID-19, Recipient certifies that it will not seek to collect from the patient out-of-pocket expenses in an amount greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network Recipient” (tinyurl.com/y7jtwnhu).


Most States Restrict HCQ Prescriptions

Although the FDA does not have the authority to prevent physicians from prescribing approved drugs for an off-label use, almost all states have restricted the ability of physicians to prescribe CQ or HCQ for out-patients for treatment or prophylaxis (likely to be early treatment) of COVID-19 (tinyurl.com/y7oc65gn). At this time, only four states lack such restrictions: Florida, Nebraska, North Dakota, and Wisconsin.

The Texas Board of Pharmacy §291.30 Medication Limitations states:  “No prescription or medication order for chloroquine, hydroxychloroquine, mefloquine, or azithromycin may be dispensed unless the prescription or medication order bears a written diagnosis from the prescriber consistent  with the evidence for its use.” Georgia similarly requires “evidence for its use,” and pharmacies are claiming that there is no evidence sufficient to justify a prescription, so they are not dispensing.

A family physician in Georgia cannot get HCQ for his nursing home patients although one has died of COVID-19.

In Arizona, Gov. Doug Ducey’s executive order states that “prophylactic prescriptions [for CQ and  HCQ] for the prevention of COVID-19 are strictly prohibited unless peer-reviewed evidence citing prophylactic effectiveness becomes available.” AAPS has received no response to our letter concerning the E.O. (https://tinyurl.com/y9sxvpck).

On Mar 28, the FDA issued an Emergency Use Authorization (EUA) to allow use of CQ or HCQ from the Strategic National Stockpile (SNS) in hospitalized adult and adolescent patients “for whom a clinical trial is not available, or participation is not feasible” (https://tinyurl.com/umg25a9). Although the FDA’s EUA only restricts use of the supply from the SNS, the Federation of State Medical Boards (FSMB) issued a statement suggesting that the EUA applies more broadly and that physicians’ licenses would be at risk for off-label use.

Taking credit for attempts to suppress use of HCQ is Rick Bright, Ph.D., just this week ousted from his position as director of the U.S. Biomedical Advanced Research and Development Authority  (BARDA). He has spent his career in vaccine development (https://tinyurl.com/y82svstv).

HCQ and CQ have disappeared from the McKesson website, and azithromycin and ivermectin, recently mentioned as having anti-viral properties, are only available to physicians who have purchased them previously.


Correspondence

Physicians Treating Family Members. There have been concerns about physicians prescribing hydroxychloroquine (HCQ) to family members to treat COVID-19 or to protect them as the physician is working on the front lines. It is claimed that treating family members violates AMA Ethics Opinion 1.2.1: “In general, physicians should not treat themselves or members of their own families”—with six specific exceptions. Instead of a risk-benefit analysis, the AMA cites only what it calls “concerns” about  “professional objectivity, patient autonomy, and informed consent.”  There is no consideration of potential benefits.

In the early 1900s, physicians routinely treated themselves and their own families, without any concerns about “ethics.” Why should that change? All physicians have an ethical duty, anchored in Hippocratic principles, to “use treatment to help the sick according to my ability and judgment” and to provide only treatments that they are qualified to give. Why should family members not be free to choose the family member physician, who likely knows and cares more about the patient than anyone else, and who might be the best qualified  physician available?

 Lawrence R. Huntoon, M.D., Ph.D., Lake View, NY


A North Carolina Epidemic. In our state we have an epidemic of elected officials unilaterally revoking the constitutional rights and civil liberties of their “subjects.” The epidemic has spread from one public official to the next. As Daniel Horowitz writes, state legislatures must restrain the prerogatives that governors and local officials feel they possess. For example, they should require that “any violation of the Constitution under the guise of stemming an epidemic expire after seven days. In order to renew it, the governor would need to submit clear findings to the legislature and publicize them online articulating why this is the least restrictive means necessary to achieve the goal” (tinyurl.com/vcpgg9h). 

Joseph Guarino, M.D, Reidsville, NC


Let Us Treat Our Nursing Home Patients. After the tragedy at the Kirkland Nursing Home in Washington State, where approximately 47 of the 125 patients died of coronavirus, I have been researching for what I might do to help prevent such an occurrence locally. Last week, I learned a physician in Texas treated the patients in a nursing home there with HCQ. Of 135 patients in that facility, only one died of COVID-19. A French study as well as reports from India have supported the benefits of using HCQ in patients with coronavirus infections.  

Dr. Anthony Fauci does not support use of HCQ because there has only been “anecdotal” evidence that it might help. “ Anecdotal” refers to what has been “only observed” to occur; e.g. Sir Isaac Newton observed an apple drop from the tree and anecdotally surmised that something must have caused it to fall.

We’re all complying with the recommended social distancing, handwashing, and protective gear, yet none of these have been proven by a randomized, double-blind, controlled trial to actually be effective against transmission of the coronavirus! Why does Dr. Fauci recommend these measures, based only on anecdotes or opinion, while we are not allowed to treat our patients promptly with this cheap, long-used medication, although their condition could deteriorate rapidly while we await test results.

George L. Smith, III, M.D., Covington, GA


Gates and Vaccines. Bill Gates, the second largest donor to WHO, appears to be running the world response to COVID-19. No HCQ—you must get sick and die waiting for the vaccine that Gates will fund and profit from. Ignoring requests for other types of aid, Gates has peddled his vaccines as the cure of all the ills of developing countries while violating human rights and informed-consent laws (tinyurl.com/yabetwr2) and sidelining other effective solutions.  He crippled Eritrea while looking for a malaria vaccine. It is impossible to say just how many hundreds of thousands, maybe millions of lives could have been saved in the 2 years or so since Bill Gates announced his multibillion dollar “donation” to vaccine research if just a small percentage of his “gift” had been spent on implementing the Eritrean model of malaria mortality prevention. Eritrea had nearly eliminated malaria with a program of prompt treatment, insecticide-treated nets, larval habitat management, and indoor residual spraying (tinyurl.com/ybfvt3bp).

Marilyn M. Singleton, M.D., J.D., Redondo Beach, CA


Observations on HCQ. Over decades of practicing dentistry I have treated numerous sickle-cell patients. Sickle cell trait is associated with low cholesterol levels. The exterior coat of the malaria parasite contains cholesterol, which it cannot synthesize for itself; it may have a tougher time surviving in the blood if the host has low cholesterol levels. Hypocholesterolemia also happens to be an effect of HCQ. A Pubmed search reveals that chloroquine (CQ) was shown to be an effective treatment for coronaviruses as far back as 2005. Moreover, coronaviruses need cholesterol to enter a host cell [e.g. https://tinyurl.com/y6uttq4y]. So, in addition to other complex antiviral mechanisms, CQ/HCQ may make it harder for the virus to obtain cholesterol molecules. In any event, if exposed to SARS-CoV-2, I might ask my doctor for a 3-week course of a strong statin drug. This may be one of those rare situations in which a low cholesterol may be of benefit.

Henry Lorin, D.D.S., Florence, SC