Volume 76, no. 7 July 2020
The current front in the war against science and medicine, and hence against doctors and patients, is the war to suppress available, affordable, safe preventives and treatments for COVID-19, as patients continue to die and economic carnage continues.
Ironically, “anti-science” is the accusation hurled at any who question the narrative: We cannot live normally but must mask, isolate, and practice “social distancing” until we have effective treatment, proved by accepted peer-reviewed randomized controlled trials (RCTs), or the just-around-the-corner vaccine.
Science requires honest data, honest scientists, replication of results, ethical methods, and open discussion.
The “Second Wave”
Just as still-surviving businesses were beginning to re-open, a surge in “cases” has caused governors to “scale back” permission to work (intensify restrictions). And what is a “case”? The Texas Dept. of Health has changed the definition of a probable case (tinyurl.com/y84kowy7) to include someone who meets certain clinical criteria and epidemiological links, without an FDA-approved test. Revised definitions could result in a spike of reported cases of the virus, according to Aisha Souri, an epidemiology department official for Collin County (tinyurl.com/y6ugmrtu).
As testing increases, more positive tests will inevitably be found—although the percentage of positive tests is near an all-time low (tinyurl.com/yab4tavy, tinyurl.com/yd6rzbky). Confusing the issue is the report that the Centers for Disease Control and Prevention (CDC) has been conflating polymerase chain reaction (PCR) tests for active infection with antibody tests that determine whether a person has ever had the virus (https://tinyurl.com/y92ea59f), as have Texas health department officials. The validity and accuracy of the tests is also in question (tinyurl.com/yd2dg4pn). One AAPS physician stated that unused swabs had been reported positive by PCR.
The COVID-19 mortality rate includes nonconfirmed presumptive diagnoses, and some suggest it could also be understated. One indisputable figure—all-cause mortality—is probably the most reliable measure for assessing the status of the epidemic (https://tinyurl.com/ybghp8vk).
Until early April, all-cause mortality in the U.S. was no higher than in recent years. Then the numbers spiked, with excess deaths reaching a peak around Apr 15, and total daily deaths declining to normal by mid-June. According to a Financial Times analysis, the excess U.S. mortality during this outbreak was 38,750, a 25% increase. The excess mortality in New York City was 25,600, a 251% increase, accounting for all but 13,150 of the excess deaths in the whole country. Thus, one city accounts for 85% of the increase in U.S. all-cause deaths. The U.S. pattern is the same as elsewhere: a sharp rise then decline to normal over a few months.
According to FT, there have been no excess deaths in Iceland, Israel, Norway, or South Africa (tinyurl.com/rnzmwpr).
An increased number of cases in younger age groups has not thus far been accompanied by a rise in deaths. According to CDC figures, the weekly provisional death count for COVID-19, pneumonia, and influenza for all age groups was down to about the same level for the week of Jun 27 as it had been for the week of Mar 21 (https://tinyurl.com/y7gbmjlw).
Memorial Day festivities and Trump rallies are cited as concerns, but far more people were involved in “protesting” with shouting and chants, with little to no attention to mask-wearing and distancing. Notable but not noted in the media is that states with surges—California, Arizona, and Texas—border Mexico, which is very hard-hit. A California AAPS member reports to us that hundreds of COVID-positive patients from Mexico are being sent all over the state. The Border Patrol observes but cannot stop boats from Mexico landing illegally on the beach in San Diego.
Internationally, death rates are higher where governments ban or discourage use of hydroxychloroquine (tinyurl.com/ybfqbyck). Deaths may climb when HCQ treatments are stopped (tinyurl.com/yclkvezc) and begin to fall soon after they are started (tinyurl.com/y9pdeznq).
War on a Drug
This drug is not addictive, or a controlled substance under federal law. Overdoses are possible, but much less frequent than with acetaminophen, aspirin, ibuprofen, diphenhydramine, and many other over-the-counter drugs. So why the war on HCQ waged by the administrative state (see AAPS News, June 2020), with no pushback from most of organized medicine?
A victor in the war on HCQ is remdesivir, called the “standard of care” by Anthony Fauci. A price of $3,120 has been set for a 5-day course of treatment, and the U.S. government has bought up Gilead’s anticipated 3-month production of 500,000 doses. The price is “outrageous,” said Rep. Lloyd Doggett (D-Texas). “Without a taxpayer investment of $99 million, this drug would have been…on the scrap heap of failures.” Gilead claims it will have invested $1 billion and that the drug might save $40,000 per patient it keeps out of the ICU (tinyurl.com/yal8leh5).
A vaccine that could be given to nearly all healthy persons, instead of just to hospitalized patients, developed with huge subsidies, and free from manufacturer liability, would have still greater profit potential. The main purchaser might be the government. It could cost a fortune, states the LA Times (tinyurl.com/y9dgylq7).
South Africans Protest Vaccine Trials
Angry protesters have burnt face masks near the site of Africa’s first trial for a coronavirus vaccine in Johannesburg, claiming that the continent is being used as a testing “dumping ground.” Protest leader Phapano Phasha accused scientists of “manipulating the vulnerable” by selecting volunteers “not qualified enough to understand.” Protesters’ signs read: “We are NOT guinea pigs.” “NO unsafe VACCINE.” “Gates we are not your lab rats.” “No to gates [sic] poison.”
Seth Berkley, chief executive of the Gavi vaccine alliance, which promotes “immunisation for all,” described the anti-vaccine sentiment in Africa as “the worst I’ve ever seen” (The Times 7/2/20, https://tinyurl.com/y8sdlqp7).
The African Centre for Biodiversity raised many concerns about the Oxford vaccine being developed in partnership with AstraZeneca. The application to trial the vaccine in South Africa redacted crucial safety information. Preliminary studies in six rhesus macaques protected all from pneumonia, but some developed other symptoms, and the vaccine did not reduce the viral load in their noses. The trial protocol contains no method to assess the threat of Antibody Dependent Enhancement (ADE), which has occurred with previous SARS-CoV vaccines.
The vaccine uses a chimpanzee adenovirus that has been genetically engineered to remove elements required for it to replicate, and has been further modified to produce the coronavirus spike (S) protein. The defective virus, however, can be “rescued” by a double infection with a competent adenovirus.
It is unclear how health complications will be addressed after the 12-month study period (https://tinyurl.com/y9fwd93f).
COVID-19 Epicenters
According to a report by House Ways and Means Committee Republicans (tinyurl.com/yar9lysw), nursing home residents account for 42% of nationwide COVID-19 deaths but only 0.6% of the U.S. population. New York has seen 6,448 deaths in nursing homes, New Jersey 6,626, and Florida 1,867. On a per-capita basis, nursing home deaths in New York have been 400%, and New Jersey’s 1,000% higher than Florida. On Mar 13, CDC issued guidance to avoid discharging COVID-positive patients back to a nursing home that is unable to properly treat and quarantine them. Florida followed the guidance, but five governors instead issued “must admit” orders: Andrew Cuomo (NY), Tom Wolf (PA), Phil Murphy (NJ), Gavin Newsom (CA), and Gretchen Whitmer (MI).
Downstate New York has one of the worst COVID-19 death rates in the world, >143 deaths per 100,000 (tinyurl.com/y9w2lkxc), compared with 1.5 for India and 40 for the U.S. as a whole (tinyurl.com/ub9gvyc). Rates for downstate New York alone are worse than for any European country. Excluding downstate N.Y., the U.S rate drops to 23, better than in most European countries (https://tinyurl.com/yahug959).
Curiously, nursing homes and hardest-hit European nations share high uptake of influenza vaccine (tinyurl.com/yae5mj4m).
“The advanced societies of the future will not be governed by reason. They will be driven by irrationality, by competing systems of psychopathology.”
J.G. Ballard
Nominating Committee Report
The Nominating Committee submits the following slate:
President-elect: Jenny Powell, M.D., Osage Beach, MO
Secretary: Lawrence Huntoon, M.D., Ph.D., Lake View, NY
Treasurer: Tamzin Rosenwasser, M.D., Venice, FL
Directors: Chandrasekhar Doniparthi, M.D., Yuma, AZ; Jane L. Hughes, M.D., San Antonio, TX; Sheila D. Page, D.O., Aledo, TX; Tracy Ragland, M.D., Crestwood, KY.
HCQ Cuts Mortality by Half in Detroit Hospital
In a recently reported study at Henry Ford Health System (https://tinyurl.com/ybuwv3yk), COVID-19 patients who received HCQ had a mortality of 13% vs. 26% for patients who did not. Adjusting for variables related to propensity for death, the hazard ratio reduction was 66% for HCQ and 71% for HCQ + azithromycin, compared to neither treatment (p < 0.001). No patient had documented torsades de pointes.
Cases Up, Deaths Down
In the Sunbelt states, cases are soaring, but deaths are stable or down (tinyurl.com/ycbnvuvm). From Apr 17 to the first week in July, Florida’s new cases (positive tests) per day soared from 1,222 to 8,675 (7.2X), while daily deaths went from 53 to 48 (0.9X). In Oklahoma, scene of the Tulsa Trump rally, cases went from 108 to 495 (4.6 X) and daily deaths from 5.0 to 2.5 (0.5 X). In new hot spot Arizona, cases have soared. Gov. Ducey has re-closed gyms and bars, and New York Gov Cuomo will quarantine returning travelers from Arizona and 18 other states. In the first week of July, Arizona daily COVID deaths ranged from six to 24. How many lives can city-wide masking requirements save?
Controlled Human Infection Models Proposed
To speed vaccine development, in case the natural infection rate falls too low, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Vaccines Working Group is proposing controlled human infection models (CHIMs). In the past, CHIMs, which require deliberately infecting healthy persons, have involved organisms that pose minimal risk or have effective treatments. The “public health imperative” caused by the “unprecedented” mortality and economic disruption caused by SARS-CoV-2 is driving consideration of whether the risk of CHIMs, including community spread of the infecting organism, is justified by the societal benefit (NEJM 7/1/20).
AAPS Calendar
Sep 30-Oct 3. 77th Annual Meeting, San Antonio, TX
Sep 29-Oct 2. 78th Annual Meeting, Pittsburgh, PA
“Cooperation” Mandatory
Officials in New York’s Rockland County are issuing subpoenas to people who were allegedly at a party where people were infected with COVID-19, to compel them speak to contact tracers. Failure to comply will cost $2,000 per day (https://tinyurl.com/y9sm6bf5).
Citizens Sue over Mask Requirement
Four Palm Beach County (Fla.) residents have signed onto a lawsuit to block the county mandate requiring masks in public (https://tinyurl.com/y98gx8nw). The complaint claims that the county “recklessly required countless American citizens and Florida residents…to submit to dangerous medical treatments with well-known risks and potential for serious injuries and death, including being forced to wear harmful medical devices like masks.” The mandate was enacted by a 7–0 vote of county commissioners despite overwhelming citizen opposition. The fine is $250 for the first episode of noncompliance and $500 for each subsequent violation. Although the duration of a state of emergency is limited by law to 7 days, renewable as needed, top county officials expressed a desire to extend the mandate to one year, or perhaps indefinitely.
Hillsborough, Orange, Miami-Dade, Leon and Seminole counties have also been sued.
Freedom Foundation Sues in Washington
Citizens are suing Washington Secretary of Health John Wiesman for his order requiring “(E)very person in Washington state (to) wear a face covering that covers their nose and mouth when in any indoor or outdoor public setting” (Sehmel v. Weisman in the Superior Court in Lewis County, WA, # 20 2 0045321, https://tinyurl.com/y8c44aqx).
“The Washingtonians represented by the Freedom Foundation argue that by requiring them to wear face masks the state is essentially compelling them to support junk science in violation of their freedom of conscience, which is prohibited by the state constitution” (https://tinyurl.com/yazazu55). “The science on the efficacy of mask wearing in preventing the spread of COVID-19 is tentative and contradictory,” states the Complaint.
Plaintiffs point out that since May 2, the daily COVID-19 death count has been below 10. “To date, nothing about COVID-19 has been extraordinary except for the panicked and panic-inducing response from the government and the media.”
COVID-19 Vaccine Mandates Contemplated
Authors from Stanford’s law school and medical school are concerned about a poll that found that only 49% of Americans planned to get vaccinated against SARS-CoV-2. So, assuming that a vaccine is approved, and various criteria for imposing a mandate are met, including an unsuccessful time-limited trial of voluntary vaccine provision, Michelle Mello et al. discuss possible penalties.
“Because of the infectiousness and dangerousness of the virus, relatively substantive penalties could be justified, including employment suspension or stay-at-home orders for persons in designated high-priority groups who refuse vaccination. Neither fines nor criminal penalties should be used, however; fines disadvantage the poor, and criminal penalties invite legal challenges on procedural due-process grounds. Both are bad public health policy for a Covid-19 vaccine because they may stoke distrust without improving uptake” (NEJM 6/26/20, tinyurl.com/yawlr5lc). [Note that house arrest is not considered a criminal penalty.]
Intense clashes are expected over “what people owe to one another in the fight against the pandemic.”
Who’s in Charge?
New CDC director Robert Redfield, his former assistant Deborah Birx, and Anthony Fauci, who lead the White House coronavirus task force, were boosted into high government positions as a result of their work early in the AIDS epidemic. Redfield and Birx were accused of research misconduct in work on an over-hyped HIV vaccine (https://tinyurl.com/yd6uu872).
New vaccine czar Moncef Slaoui, a venture capitalist, has had deep connections with the drug and vaccine industry, including Moderna, but claims now to be divested (tinyurl.com/y9v8n3ou).
Stanford Accused of $468 Million Billing Fraud
The Department of Justice alleges that Stanford Health Care exploited its EPIC medical payment system by habitually upcoding and unbundling major surgical codes as well as by charging exorbitant fees, in United States vs. Stanford et. al. (Case No. CV 17-08726-DSF). According to the complaint, “Stanford egregiously instructed and required that its medical billers and coders always bill at the maximum level and fees, regardless of medical necessity, lack of substantiating medical records, and failure to adhere to national Correct Coding Initiatives.” The complaint further alleges that Stanford failed to cease the conduct once put on notice. When patients detected the upcoding, Stanford allegedly sent refund checks or unlawfully wrote off certain patient balances (https://tinyurl.com/y97sqsdh).
Court Rules for Physician in ERISA Case
In a 3–0 decision, the Ninth Circuit Court of Appeals ruled that ERISA plans may not deny fair payment for surgery on the basis of an anti-assignment clause after agreeing to assignment in order to get surgery done (California Spine and Neurosurgery Institute v. Blue Cross of California, Case No. 19-15192). (See AAPS News, October 2019). This should help other physicians who are battling ERISA plans for payment. AAPS filed an amicus brief in support of the physician.
Tip of the Month: Diagnostic code for COVID-19: Many pharmacies continue to interfere with filling prescriptions for COVID-19, despite studies showing that treatment is more effective as early as possible, as in treating influenza. Pharmacies have been demanding a positive COVID test result, which can take days or even more than a week in some places. But pharmacies might fill prescriptions for hydroxychloroquine based on a diagnostic code. ICD-10 code U07.2 (clinical/epidemiological diagnosis not confirmed by a lab test) may be used pre-test result if there is documented clinical support. ICD-10 code U07.1 requires laboratory confirmation of a COVID-19 diagnosis.
Correspondence
More Flaws in Negative HCQ Study. A study deemed “influential” by the WSJ and Medpage Today shows that having “randomized trial” in the title of an article published by NEJM (tinyurl.com/y92dpqyk) does not necessarily mean that it is a good study. The data in this case is so poor that it is essentially useless in answering the question of whether HCQ is effective as post-exposure prophylaxis for COVID-19. Participant selection criteria and eligibility threshold were changed after the study began. Some may have already been infected. Participants “enrolled themselves,” data was subjective and collected by surveys, and testing was often unavailable. The outcome was “ illness that was compatible with probable COVID-19.” Despite the high doses—800 mg, followed by 600 mg 6 to 8 hours later, then 600 mg per day x 4 days—there were “no serious intervention-related adverse reactions or cardiac arrhythmias.” [Also see AAPS News, June 2020.]
Lawrence R. Huntoon, M.D., Ph.D., Lake View, NY
Help Not Wanted. According to The Hill, 60,000 primary care physicians, almost 29% of the 209,000 in the U.S., may be forced to close their practice by the end of June (tinyurl.com/yank9uaq). Profit-seeking hospitals and insurance companies will not allow anyone to throw these physicians a lifeline even though patients will suffer, but will absorb these physicians to control their medical decision-making and to augment profits.
Gene Izama Dorio, M.D., scvphysicianreport.com/
The Communist Control Face Mask. The mask has a different symbolism for those who lived under communism and yearned to escape to the freedom of the West. It is like the façade most citizens had to adopt in order to cover their real feelings and to survive the oppressive regime. The COVID-19 mask has gone past the utility of protecting us from a potentially harmful virus; it has become the mask that muzzles biting dogs. When we were forced into harvesting grapes for free every fall in high school, we had to wear masks that prevented hungry and thirsty students from eating any grapes. Masks were used in other cultures to control and enslave people, to diminish, and demoralize them. Masks were and still are worn as a form of obedience. Has the virus been weaponized as a weapon against American freedom? Will we have to wear them indefinitely, or every flu season?
Ileana Johnson, Ed.D., https://tinyurl.com/y7keosap
The Catalyst to End Privacy. At its core, contact tracing is the government collecting data on everyone’s friends, family, associates, and colleagues. This is some of the most intimate personal data we have. Americans need to know they do not have to answer or respond to a contact tracer, but some state government agencies can charge you with a crime and forcibly quarantine you if you refuse. The COVID-19 crisis has accelerated the advance of “Big Tech” initiatives to grab Americans’ private health data.
Twila Brase, R.N., P.H.N., tinyurl.com/y98rt9th
Discriminating Virus? After a local Memorial Day, the Triad City Beat judgmentally reported that Reopen NC attendees were not sufficiently attentive to public health requirements. The Winston-Salem Journal then judgmentally reported that attendees at the Ace Speedway in Alamance County were flouting health protocols. Then came Minneapolis. The leftist press cheered, apparently deciding that masks and lockdowns and social distancing are no longer necessary—for certain protests.
Joseph Guarino, M.D, Reidsville, NC
Changing Ethics Rules for COVID-19. The Nuremberg and Helsinki rules for human experimentation prohibit exposing human subjects to what might harm them. In dire circumstances the experimenters are allowed to expose themselves to harm, but the ethics codes prohibit recruiting people to be guinea pigs. The reason is that even a consenting adult potentially might be under duress or inappropriate influence. The proposed solution to the more than 10-month period for testing a COVID-19 vaccine in a setting of natural exposure is a challenge trial, in which volunteers are vaccinated then challenged with a dose of the virus (tinyurl.com/yayt9384). In setting up a trial with known harm as an outcome, socialists are breaking ethics rules on a scientific pretext for the good of the herd.
John Dale Dunn, M.D., J.D., Brownwood, TX
COVID-19 Confirms Lessons from Lyme.
- Healthcare policies often fail with emerging diseases.
- CDC disease statistics can be misleading.
- Many disease guidelines are flawed.
- Peer-reviewed articles in prestigious journals can be fraudulent.
- Flawed randomized controlled trials can create a fool’s gold standard.
- Politicians make catastrophic, fatal errors with health policies.
- Money and politics corrupt science and medicine.
- Community doctors who treat patients know more than bureaucrats.
- We can learn the most from our patients.
- Trust your clinical judgment.
- Chronic infection occurs and must be recognized.
Robert C. Bransfield, M.D., Red Bank, NJ
