Guest post by Leo Goldstein
- The use of Remdesivir for COVID-19 was authorized by the FDA based on a single RCT, conducted by NIAID with the participation of Gilead Sciences, the exclusive manufacturer of Remdesivir. A final report from this study was published on October 8, five months after the drug’s authorization.
- The final report shows that at least 35% of the patients were treated with Hydroxychloroquine, probably with Azithromycin. The data in the final report suggests that Hydroxychloroquine, not Remdesivir, was the main factor benefitting the patients in this study.
- Nothing in the study supports the hypothesis that Remdesivir is an effective antiviral for SARS-COV-2.
- The study’s own numbers show an association between RDV and increased mortality in the most severe patients. It is also possible to conclude that RDV is net harmful for most hospitalized patients.
- The trial was conducted and reported with multiple defects, including:
- The study was not double blind, but was reported as such
- The pre-registered protocol was changed multiple times over the course of the trial
- The primary outcome was changed in the middle of the trial, apparently because the researchers noticed a lack of effectiveness of their drug as tried
- The outcome measures were subjective and not reliable
- The study was marred with conflicts of interest, aggravated by the design giving NIAID and Gilead leverage over the hospitals and physicians treating patients
- At least three of the study researchers-authors failed to report grants and/or personal fees received from Gilead recently.
Introduction
This study, also known as Adaptive COVID-19 Treatment Trial (ACTT-1), was registered as NCT04280705, and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), headed by Dr. Anthony Fauci. The study started as “A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults,” but quickly became a Phase 3 trial for Remdesivir. It was reported under the title “Remdesivir for the Treatment of Covid-19 — Preliminary Report,” (Beigel – Lane PR, 2020). The most important author is H. Clifford Lane, a Co-Chair of the NIH COVID-19 Treatment Guidelines Panel, and the deputy director of the NIAID.
This study was the only trial that supported the emergency authorization of Remdesivir (RDV) for COVID-19 treatment. Its updated version “Remdesivir for the Treatment of Covid-19 — Final Report” (Beigel – Lane FR, 2020) (also, “the paper”) was published on October 8, and is reviewed here.
The assumption that Remdesivir is effective against SARS-COV-2 is probably based on the similarity of its in-vitro effect with that of chloroquine, without taking into account that chloroquine and hydroxychloroquine accumulate in lungs, while RDV does not (Goldstein, 2020).
Unless stated otherwise, table and figure numbers refer to (Beigel – Lane FR, 2020) Supplementary Appendix, downloaded from https://www.nejm.org/doi/suppl/10.1056/NEJMoa2007764/suppl_file/nejmoa2007764_appendix.pdf on October 11, 2020.
Analysis
Fatal Methodological Defects
Each of the several study defects described below invalidate this study’s results.
Not Double Blind
The paper’s Abstract incorrectly claims that the study was double blind. In actuality, the study was not double blind. Doctors in the European site and “some” of the other sites were unblinded and knew what they were administering.
Too Many Sites
Contrary to common sense and best methodological practices (Kraemer, 2000), the trial was conducted in 60 sites, plus 13 sub-sites. Such a multi-site design is a potentially misleading “centralized multicenter collaborative RCT,” per (Kraemer & Robinson, 2005).
Notice that less than 600 courses of Remdesivir were distributed among 73 sites, with an average 9 RDV course per site – a small sample, sufficient to tease the appetite, but not sufficient for hospitals to draw their own conclusions about its efficiency.
Taking into account the intentional unblinding of the treating physicians and the limited drug supply, the sites could have been incentivized to compete against each other for the best results from RDV, and be rewarded with a prioritized supply of the drug in the future. RDV was believed to be a miracle cure, and the access to it was priceless.
Arbitrary Removal of Sites from Final Statistics
Two sites were removed from the Registry in the May 6 update:
Rocky Mountain Regional Veteran Affairs Medical Center – Department of Infectious Diseases, Aurora, Colorado, United States, 80045
University of Florida Health – Shands Hospital – Division of Infectious Diseases and Global Medicine, Gainesville, Florida, United States, 32610
These two sites started enrolling patients between April 2 and April 15, as indicated by the status Recruiting on April 16. Enrollment in all sites ended on April 19. Neither site was mentioned in the Beigel – Lane (both versions, including appendices), and their removal was not explained. This raises suspicions that these sites were removed because of undesirable results.
Concomitant use of other treatments
Administration of HCQ before and/or after RDV treatment was permitted. Co-administration of RDV with HCQ was also permitted in some sites (which had a written policy of HCQ use for COVID-19) but forbidden in other sites.
~35% of the patients in both Remdesivir and placebo groups also received Hydroxychloroquine (Table S3). ~80% of the patients received antibiotics, but the paper does not specify which patients. 93% of the patients were recruited on March 22 or later, after President Trump tweeted about HCQ & Azithromycin. In late March – early April, HCQ + AZ was the standard of care in some countries (Sermo, April 15). New York state required patients to be hospitalized in order to receive HCQ based treatment. Even before the President’s tweet, it was commonly known that Azithromycin has some effect against the coronavirus, and thus, its purchases had sharply increased at the expense of other antibiotics (Vaduganathan et al., 2020).
The paper gives no information regarding the use of Zinc and vitamin C, both of which were frequently used in COVID-19 treatments (Sermo 2020, April 9).
Substantial Changes of the Registered Protocol
The protocol was changed many times during the study. The primary outcome was changed on April 8 from “Percentage of subjects reporting each severity rating on an 8-point ordinal scale” to “Time to recovery”.
The relevant part of the ordinal scale is:
8 – death (appropriately removed from the scale and counted separately)
7 – hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
6 – hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices
5 – hospitalized, requiring any supplemental oxygen
4 – hospitalized, not requiring supplemental oxygen but requiring ongoing medical care
“Recovery” is defined as getting a score below 4, usually discharged from the hospital.
Defective Outcome Measure
There is a problem with the outcome measurements on this scale. The scores reflect subjective decisions by the doctor, such as “receiving invasive mechanical ventilation,” “requiring noninvasive ventilation” (here, requiring is the equivalent of receiving) and similar. These scores are not objectively measurable, like blood oxygen level or heart rate. And the doctor is likely unblinded and incentivized to evaluate RDV as superior to a placebo. Most secondary outcomes were also defined by the scores on this scale.
Lack of Baseline Information
The paper did not report statistics of baseline conditions of patients. Instead, it reported subjective scores on the same ordinal scale. It also reported selected comorbidities.
Unexplained Data Mismatch between the Preliminary and Final Reports
Referring to the data supplement, the numbers in the Final Report are substantially different from the numbers in the Preliminary Report.
No Benefits of RDV were Shown
The average mortality in the RDV arm appeared much lower than in the placebo group only on the first measurement date – 15 days after the start of treatment. The mortality rates reversed after that. By the end of the study (day 29), the total reported mortality was 11% in the RDV group vs 15% in the placebo arm (per table S12). This difference can be attributed to the differences in the initial conditions and data manipulation by the authors. Tables S13 and S15 support this conclusion.
Table S13
Table S15 displays the differences in scores between the Remdesivir and placebo arms on pre-selected days. Here, a small difference in favor of RDV develops immediately after randomization and stays almost the same for some time. This suggests not patients’ improvement due to RDV, but initial selection or scoring of patients, manipulated favorably to RDV. After changing only 0.1 points over eight days of the treatment (RDV treatment is given up to 10 days), the difference jumps 0.3 points (from day 11 to day 15) within four days without treatment – just in time to measure the outcome on Day 15!
| Day | 1 | 3 | 5 | 8 | 11 | 15 | 22 | 29 |
| Difference | Baseline | 0.2 | 0.3 | 0.3 | 0.3 | 0.6 | 0.6 | 0.5 |
This table does not consider deaths, discharges, and withdrawals.
Table S15
Table 15 shows results according to the objective National Early Warning Score. According to it, at the beginning of the treatment, symptoms of the RDV arm are better than the placebo arm: 5.7 : 6.1 (the higher score, the worse the symptoms). Similarly to the previous table, the difference increases in the first few days, mostly due to worsening in the placebo arm, becoming 5.6 : 6.6. Then the difference starts to decrease, becoming 6.3 : 6.6 (worse for RDV than at Baseline) on day 11, then increases by day 15. This table does not consider deaths, discharges, and withdrawals.
It is possible that RDV does have measurable antiviral effect against SARS-COV-2 in humans when administered early, but that was not demonstrated in this trial.
RDV Increased Deaths among the Sickest Patients
Even the manipulated data cannot conceal the harm that RDV has inflicted on the sickest patients. Unfortunately, Remdesivir was authorized and recommended for treatment of the sickest patients before the completion of the trial.
The following is the reported mortality by the Day 29 (from Table S5):
RDV Placebo
Score 7 21% 19%
Score 6 20% 20%
The actual odds are even worse for RDV. The following picture is Graph E from Figure S5. It is a Kaplan–Meier Estimate of Survival in the Score 7 group (the most severe group), by day.
The trick is easy to see. RDV patients appear to have slightly better chances of survival by Day 15, the first reporting measurement day. After day 15, their chances drop sharply and become much worse than the placebo arm. The difference narrows again on Day 26, just before the second measurement day.
Of even greater concern is that this graph is very different from the graph published in the preliminary report, (on May 22 and corrected on May 26), which depicted the RDV arm performing even worse.
This graph shows not only the sharp reversal of mortality odds after Day 15, favoring the placebo arm, but also a sudden narrowing of the gap on Day 26, three days before the final reporting Day 29. No explanation to this post-study data changes was given.
Hydroxychloroquine + Azithromycin
Table S8
Table S8 purports to analyze the patients that did not take Hydroxychloroquine. Only 46% (486 out of 1062, both arms) of the patients recovered by Day 29 without the use of Hydroxychloroquine. This percentage is much more significant than any Remdesivir percentages.
Table S6
This table shows median “time to recovery” (MTTR) organized by how soon RDV or placebo was administered after symptom onset. The First Quartile (“Q-I”) of patients were randomized and treated 6 days or less after the onset of symptoms, the Fourth Quartile (“Q-IV”) were randomized and treated 13 days or later. Only patients, who recovered by Day 29 are included. The rest (~30%) are those who died, quit, or not recovered by Day 29.
The Q-III (10 to ≤ 12 Days) had the shortest recovery time – 7 days. If RDV were an effective antiviral for SARS-COV-2, the Q-I would have the quickest recovery because they got it early. The recovery would be significantly longer in the Q-III, when the viral stage is over in most patients. However, the Q-III has the shortest MTTR for RDV. This contradiction alone refutes the hypothesis that RDV is an effective antiviral.
Another remarkable thing is that the MTTR for the placebo group in the Q-I is 24 days, which is 1.5-2x longer than for other quartiles. For placebo, one would expect similar times to recovery, or a monotonous change.
Both contradictions are resolved by accepting that many patients received effective anti-viral treatment, other than RDV.
- Most patients who were randomized in Q-I did not receive this other antiviral treatment and thus, had the longest average recovery time.
- Patients who were randomized in Q-II and Q-III were more likely to receive the other antiviral treatment early, upon symptom onset, and before receiving Remdesivir. Therefore, both RDV and placebo arms in Q-II and Q-III recovered the quickest.
- The RDV arm of Q-III had the shortest MTTR of only 7 days, this means that most of this group’s patients did not receive the full 10-day course of toxic RDV. This effect, stemming from receiving less Remdesivir, created the gap between it and the other groups.
- Q-IV was less likely to receive the other antiviral treatment, or received it too late, and had longer MTTR
- In each quartile, RDV arm reported results than “placebo” arm because of patients’ selection or another manipulation
Notice that somebody, convinced that HCQ has no effect, might misinterpret this statistic as evidence that HCQ interferes with the action of RDV.
Remarks
HCQ and RDV
Gilead claimed incorrectly and dishonestly that HCQ interferes with RDV antiviral effect, and the FDA slavishly repeated those claims. It is explained above how the statistics of trials using both HCQ and RDV might be misinterpreted this way.
In addition, Gilead presented results of a lab trial in a cell culture, in which chloroquine phosphate interfered with conversion of RDV into what Gilead called “Remdesivir triphosphate” (GS-441524 triphosphate, or GS-443902). This result is not related to HCQ, which is taken as hydroxychloroquine sulfate.
WHO Solidarity Trial
WHO has just published a preprint of the preliminary report (WHO, 2020) from the Solidarity trial of four antiviral drugs for COVID-19. It confirmed the lack of efficacy of RDV, which was administered as recommended by Gilead. This is, even though Gilead is well connected with WHO and makes substantial contributions to it.
The Solidarity report has also alleged a lack of efficacy of HCQ, but HCQ was administered in toxic doses, using the same regimen as in the RECOVERY trial – 2,400 mg in the first 24 hours (6x recommended dose), 800 mg for the next 9 days (2x recommended dose). These doses are 4-5x higher than the recommended doses for COVID-19 (and even for malaria).
Disclosed and Undisclosed Conflicts of Interest, related to Gilead
Undisclosed
- Thomas F. Patterson, M.D. – Consultant to Gilead (Personal Fees) in 2019
- William R. Short, M.D., M.P.H., – Consultant to Gilead (Personal Fees) (reported in 2019 and 2018)
- Norio Ohmagari, M.D., Ph.D., – One of the researchers in another Gilead-sponsored study of RDV for COVID-19 (Grein et al.), which completed in early March. This counts as a research Grant.
Disclosed
The following grants and personal fees, received from Gilead over the prior 36 months, have been disclosed by the following report authors:
- Anu Osinusi – Employee of Gilead Sciences, Inc.
- Thomas Benfield – Grants and Personal Fees
- Gerd Fätkenheuer – Grants and Personal Fees
- Roger Paredes – Grants and Personal Fees
- Anne Luetkemeyer – Grant(s)
- Sarah Pett – Grant
- Giota Touloumi – Grant
Unexplained Late Start of Treatment
It is surprising that a drug that is meant to act as an antiviral was given much too late. Only 25% of patients started the RDV treatment within 6 days from the onset of symptoms. 75% of patients started it between 7 and 34 days from the onset of symptoms, too late for antiviral.
With a couple exceptions, the named NIAID/Gilead researchers who conducted this study appear to have most of their experience in HIV, and in attempts of using RDV for Hepatitis C or Ebola, rather than acute respiratory tract infections. Thus, some of the decision makers could be not fully aware of the two-stage dynamics of COVID-19. The viral phase is followed by the immune response phase, and the immune response overreaction is more dangerous than the virus. Immune response decreases the viral load and impact, so these phases overlap. Their overlap is frequently classified as its own phase (Siddiqi – Mehra, 2020, Fig. 1).
It should be noted that early administration of RDV cannot be done routinely because RDV is administered by an infusion (not an injection), thus requiring a hospitalization. RDV is not safe, and its dangers are unknown, thus justifying its use only when the diagnosis is certain, and the patient is sick enough. Finally, one cannot charge $3,000 for treating cough and fever.
RDV & COVID-19 Severity
In COVID-19, the phase and severity of the disease are routinely confused. Patients in the early (viral) phase are routinely classified as mild. Patients with a strong immune overreaction in the late (immune response) phase are routinely classified as severe.
Antivirals are useless after the viral phase. Hydroxychloroquine is useful in all phases of COVID-19 because it is both antiviral against SARS-COV-2 and immunomodulator.
Even if RDV were an efficient antiviral, its only effect in the immune response phase is toxicity (Zampino et al., 2020). It is expected to be especially dangerous to severe patients. Even the manipulated data shows higher mortality rates in the RDV arm of the most severe subgroup.
Suspicion of Differential Care
The placebo arm was reported slightly worse than the RDV arm at the baseline: 30% vs 24% patients on invasive mechanical ventilation (IVM, also called intubation) or ECMO, per Table S1.
Table S3 shows that the percentage of placebo vs RDV patients that received ECMO or intubation in the process of treatment was 45.5% : 34.6% (as-treated vs intent-to-treat population; slightly smaller). This is an increase of 52% in the placebo vs 44% in the RDV group, which cannot be explained by properties of RDV in this trial.
Most of the increase of ECMO patients was due to intubation. Intubation is a controversial procedure in the COVID-19 treatment. It is believed to have been used excessively in the pandemic and has sometimes caused avoidable deaths. The percentage of intubated patients (“need for invasive mechanical ventilation”) is part of the measured outcomes. Given lack of positive effect from RDV and the incentives of the sites, disproportional intubation of placebo patients raises the suspicion that some of them were intubated unnecessarily to improve results for Remdesivir and Gilead. Some of the patients might have died as a result.
More
- Many hospitals have concluded that RDV is not what was promised, according to Reuters.
- This study was published in NEJM on October 8, the same day as another paper reporting old news on the tragicomic RECOVERY trial, and a shrieking anti-Trump editorial “Dying in a Leadership Vacuum”. This is not an accident, but a pattern. The PR version of this paper was published on May 22 – the same day as the infamous (Mehra et al., 2020) was published in The Lancet. Of note, Mehra was affiliated with Brigham and Women’s Hospital, which was contracted by Gilead for an RDV for COVID-19 clinical trial, possibly another one.
- It is strange that the research of a potential treatment for pandemic disease started at Phase 3, which is needed for FDA approval of a novel drug. Phase 3 trials do not allow flexibility necessary for research, especially in time of emergency. It seems like the pandemic was used as an opportunity to shortcut the drug’s approval, which could not pass scrutiny under normal circumstances.
- Contrary to the principles of scientific archiving, the Final Report re-uses the DOI number and the URL (doi: 10.1056/NEJMoa2007764, https://www.nejm.org/doi/full/10.1056/NEJMoa2007764) of the Preliminary Report, despite massive changes in the text and appendices.
- The Preliminary Report claimed that the study outcome measure was changed on April 2, 2020 “without any knowledge of outcome data from the trial and before any interim data were available.“ This subsentence is removed in the Final Report, essentially admitting that it was changed with the knowledge of the outcome data.
- The unusually large number of sites and their selection by Gilead might indicate an attempt to co-opt influential institutions. (Roussel & Raoult, 2020) found a nearly perfect correlation between the amounts received from Gilead and public opposition to hydroxychloroquine in France.
- If anybody wants to test the hypothesis that HCQ and HCQ + AZ are effective for COVID-19 treatment, re-analysis of the raw data from this study would work.
- This analysis does not cover reporting of adverse events from the study
No Competing Interest
The author declares no competing interest.
No funding was provided for this work.
All relevant ethical guidelines have been followed.
References
John H. Beigel, M.D., Kay M. Tomashek, M.D., M.P.H., Lori E. Dodd, Ph.D., Aneesh K. Mehta, M.D., Barry S. Zingman, M.D., Andre C. Kalil, M.D., M.P.H., Elizabeth Hohmann, M.D., Helen Y. Chu, M.D., M.P.H., Annie Luetkemeyer, M.D., Susan Kline, M.D., M.P.H., Diego Lopez de Castilla, M.D., M.P.H., Robert W. Finberg, M.D., Kerry Dierberg, M.D., M.P.H., Victor Tapson, M.D., Lanny Hsieh, M.D., Thomas F. Patterson, M.D., Roger Paredes, M.D., Ph.D., Daniel A. Sweeney, M.D., William R. Short, M.D., M.P.H., Giota Touloumi, Ph.D., David Chien Lye, M.B., B.S., Norio Ohmagari, M.D., Ph.D., Myoung-don Oh, M.D., Guillermo M. Ruiz-Palacios, M.D., Thomas Benfield, M.D., Gerd Fätkenheuer, M.D., Mark G. Kortepeter, M.D., Robert L. Atmar, M.D., C. Buddy Creech, M.D., M.P.H., Jens Lundgren, M.D., Abdel G. Babiker, Ph.D., Sarah Pett, Ph.D., James D. Neaton, Ph.D., Timothy H. Burgess, M.D., M.P.H., Tyler Bonnett, M.S., Michelle Green, M.P.H., M.B.A., Mat Makowski, Ph.D., Anu Osinusi, M.D., M.P.H., Seema Nayak, M.D., and H. Clifford Lane, M.D. for the ACTT-1 Study Group Members, Remdesivir for the Treatment of Covid-19 — Final Report, NEJM, 2020, https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
Beigel, …, Lane for the ACTT-1 Study Group Members, Remdesivir for the Treatment of Covid-19 — Preliminary Report, NEJM, 2020, available from https://www.nejm.org/doi/suppl/10.1056/NEJMoa2007764/suppl_file/nejmoa2007764_preliminary-report.pdf (without appendices)
Goldstein, Leo; Remdesivir has only insignificant antiviral effect against SARS-COV-2 but dangerous adverse events, defyccc.com, 2020, https://defyccc.com/wp-content/uploads/RDV-ineffective-in-COVID-19-Final-Draft.pdf
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But there’s not enough profit to be made from prescribing hydroxycloroquin. So it MUST be demonized to clear the way for a patented and profitable vaccine or other marketable treatment. If that takes the investment of grants, etc as incentives, so be it. That’s just the cost of doing business.
I don’t think profit is the motivator here. It is 100% based on Trump Derangement Syndrome.
HCQ plus ACZ given early stops the virus from replicating.
The Left wing side is letting people die, letting people suffer long term health effects from covid, and letting our countries suffer the economic effects from Covid isolation…
…And actively hiding this information and fabricating papers to hide the benefit of HCQ because of the Trump Syndrome.
The above is evil, not politics.
Is there anyone in this forum who does believes it is not evil to hide lifesaving cheap cures for covid and cancer?
Does the Trump Syndrome make Liberal become evil Zombies?
The Trump Syndrome does not explain the population’s Vit D deficiency and the fact that research which has been out for a decade shows that correcting the population’s Vit D deficiency
82% of the US ‘black’ population, 68% of the US Hispanic population, and 42% of the US general population and (roughly 30% of the US white population) is deficient in ‘Vitamin’ D which in this study is defined as a Blood serum level of active ‘Vitamin D’ of less than 20 ng/ml.
Prevalence and correlates of vitamin D deficiency in US adults.
https://tahomaclinic.com/Private/Articles4/WellMan/Forrest%202011%20-%20Prevalence%20and%20correlates%20of%20vitamin%20D%20deficiency%20in%20US%20adults.pdf
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3585561
Patterns of COVID-19 Mortality and Vitamin D: An Indonesian Study
Vitamin D Insufficient Patients, those patients that had a blood serum 25(OH)D of between 21 to 29 ng/ml died at a rate that was 12 times greater than those patients who had a blood serum level greater than 30 ng/ml.
Vitamin D Deficient Patients, those patients that had a Vit D active blood serum level that was lees than 20 ng/ml died at a rate that was 19 times greater, than those patients that had a blood serum level that was greater than 30 ng/ml.
Regardless of sex or age, Vit. D deficient people are 19 times more likely to die from covid or have serious organ damage than those who are Vit. D normal.
For Vitamin D status, cases were classified based on their serum 25(OH)D levels:
(1) normal – serum 25(OH)D of > 30 ng/ml,
(2) insufficient – serum 25(OH)D of 21-29 ng/ml, and
(3) deficient – serum 25(OH)D of < 20 ng/ml. This classification was based on existing literature.
Right on, Jeff.
In support of your characterization that actual evil is afoot here… is the WHO stopping all ongoing HCQ Studies based on claims of HCQ harm reported in a fraudulent (Lancet) Study. Those studies were not resumed after that study was withdrawn. Fauci lied to our faces repeating the lie of HCQ danger. Multiple Retrospective Studies including over 50,000 patients receiving HCQ with zero serious side effects… let alone fatalities.
Leftists have bern the world’s most prolific killers (120 million and counting)… and they are still at it killing people by the thousands as we look on.
The history of the scumbaggery perpetrated by the Democrat party since its inception to current time.
========================================================
1828: The Democrat party was founded by slave holders for the express purpose of expanding slavery northward, and has worked from its inception to thwart the advances in civil liberties being put forth by the Republican party and its predecessors.
October 13, 1858: During Lincoln-Douglas debates, U.S. Senator Stephen Douglas (D-IL) states: “I do not regard the Negro as my equal, and positively deny that he is my brother, or any kin to me whatever”; Douglas became Democratic Party’s 1860 presidential nominee.
April 16, 1862: Conservative president Lincoln signs bill abolishing slavery in District of Columbia; in Congress, 99% of Republicans vote yes, 83% of Democrats vote no.
July 17, 1862: Over unanimous Democrat opposition, Republican Congress passes Confiscation Act stating that slaves of the Confederacy “shall be forever free”.
January 31, 1865: 13th Amendment banning slavery passed by U.S. House with unanimous Republican support, intense Democrat opposition.
April 8, 1865: 13th Amendment banning slavery passed by U.S. Senate with 100% Republican support, 63% Democrat opposition.
November 22, 1865: Republicans denounce Democrat legislature of Mississippi for enacting “black codes”, which institutionalized racial discrimination.
December 24th, 1865: The Democrat party starts the KKK, commemorated by a plaque in Pulaski, listing the six founders, commemorates “Ku Klux Klan organized in this, the law office of Judge Thomas M. Jones.”
February 5, 1866: U.S. Rep. Thaddeus Stevens (R-PA) introduces legislation, successfully opposed by Democrat President Andrew Johnson, to implement “40 acres and a mule” relief by distributing land to former slaves.
April 9, 1866: Republican Congress overrides Democrat President Johnson’s veto; Civil Rights Act of 1866, conferring rights of citizenship on African-Americans, becomes law.
May 10, 1866: U.S. House passes Republicans’ 14th Amendment guaranteeing due process and equal protection of the laws to all citizens; 100% of Democrats vote no.
June 8, 1866: U.S. Senate passes Republicans’ 14th Amendment guaranteeing due process and equal protection of the law to all citizens; 94% of Republicans vote yes and 100% of Democrats vote no.
January 8, 1867: Republicans override Democrat President Andrew Johnson’s veto of law granting voting rights to African-Americans in D.C.
April 1867: The Democrat party formally reorganizes the KKK as their para-military terroristic wing to violently oppose the civil rights advancements being put forth by the Republicans. The Pulaski Den called a reorganizational meeting in Room 10 of the Maxwell House in Nashville, General George Gordon composed the Prescript or pamphlet of rules. This meeting was also a public nomination meeting for Democratic candidates for the fall election. The Democrat party formally adopts the slogan “The Party Of White Supremacy”, which they would keep for the next 110 years.
July 19, 1867: Republican Congress overrides Democrat President Andrew Johnson’s veto of legislation protecting voting rights of African-Americans.
March 30, 1868: Republicans begin impeachment trial of Democrat President Andrew Johnson, who declared: “This is a country for white men, and by God, as long as I am President, it shall be a government of white men”.
September 12, 1868: Civil rights activist Tunis Campbell and 24 other African-Americans in Georgia Senate, every one a Republican, expelled by Democrat majority; would later be reinstated by Republican Congress.
October 7, 1868: Republicans denounce Democratic Party’s national campaign theme: “This is a white man’s country: Let white men rule”.
October 22, 1868: While campaigning for re-election, Republican U.S. Rep. James Hinds (R-AR) is assassinated by Democrat terrorists who organized as the Ku Klux Klan.
December 10, 1869: Republican Gov. John Campbell of Wyoming Territory signs first-in-nation law granting women right to vote and to hold public office.
February 3, 1870: After passing House with 98% Republican support and 97% Democrat opposition, Republicans’ 15th Amendment is ratified, granting vote to all Americans regardless of race.
May 31, 1870: President U.S. Grant signs Republicans’ Enforcement Act, providing stiff penalties for depriving any American’s civil rights.
June 22, 1870: Republican Congress creates U.S. Department of Justice, to safeguard the civil rights of African-Americans against Democrats in the South.
September 6, 1870: Women vote in Wyoming, in first election after women’s suffrage signed into law by Republican Gov. John Campbell.
February 28, 1871: Republican Congress passes Enforcement Act providing federal protection for African-American voters.
April 20, 1871: Republican Congress enacts the Ku Klux Klan Act, outlawing Democratic Party-affiliated terrorist groups which oppressed African-Americans.
October 10, 1871: Following warnings by Philadelphia Democrats against black voting, African-American Republican civil rights activist Octavius Catto murdered by Democratic Party operative; his military funeral was attended by thousands.
October 18, 1871: After violence against Republicans in South Carolina, President Ulysses Grant deploys U.S. troops to combat Democrat terrorists who formed the Ku Klux Klan.
November 18, 1872: Susan B. Anthony arrested for voting, after boasting to Elizabeth Cady Stanton that she voted for “the Republican ticket, straight”.
You get that, libtards? Susan B. Anthony voted Republican. LOL
January 17, 1874: Armed Democrats seize Texas state government, ending Republican efforts to racially integrate government.
September 14, 1874: Democrat white supremacists seize Louisiana statehouse in attempt to overthrow racially-integrated administration of Republican Governor William Kellogg; 27 killed.
March 1, 1875: Civil Rights Act of 1875, guaranteeing access to public accommodations without regard to race, signed by Republican President U.S. Grant; passed with 92% Republican support against 100% Democrat opposition.
January 10, 1878: U.S. Senator Aaron Sargent (R-CA) introduces Susan B. Anthony amendment for women’s suffrage; Democrat-controlled Senate defeated it 4 times before election of Republican House and Senate guaranteed its approval in 1919. Republicans foil Democratic efforts to “keep women in the kitchen, where they belong”.
February 8, 1894: Democrat Congress and Democrat President Grover Cleveland join to repeal Republicans’ Enforcement Act, which had enabled African-Americans to vote.
January 15, 1901: Republican Booker T. Washington protests Alabama Democratic Party’s refusal to permit voting by African-Americans.
May 29, 1902: Virginia Democrats implement new state constitution, condemned by Republicans as illegal, reducing African-American voter registration by 86%.
February 12, 1909: On 100th anniversary of Abraham Lincoln’s birth, African-American Republicans and women’s suffragists Ida Wells and Mary Terrell co-found the NAACP.
May 21, 1919: Republican House passes constitutional amendment granting women the vote with 85% of Republicans in favor, but only 54% of Democrats; in Senate, 80% of Republicans would vote yes, but almost half of Democrats no.
August 18, 1920: Republican-authored 19th Amendment, giving women the vote, becomes part of Constitution; 26 of the 36 states to ratify had Republican-controlled legislatures.
January 26, 1922: House passes bill authored by U.S. Rep. Leonidas Dyer (R-MO) making lynching a federal crime; Senate Democrats block it with filibuster.
June 2, 1924: Republican President Calvin Coolidge signs bill passed by Republican Congress granting U.S. citizenship to all Native Americans.
October 3, 1924: Republicans denounce three-time Democrat presidential nominee William Jennings Bryan for defending the Ku Klux Klan at 1924 Democratic National Convention. The Democrat party invited the KKK to the convention, turning the Democratic National Convention into the largest KKK rally in history, known as “The Klanbake Convention”.
June 12, 1929: First Lady Lou Hoover invites wife of U.S. Rep. Oscar De Priest (R-IL), an African-American, to tea at the White House, sparking protests by Democrats across the country.
August 17, 1937: Republicans organize opposition to former Ku Klux Klansman and Democrat U.S. Senator Hugo Black, appointed to U.S. Supreme Court by FDR; his Klan background was hidden until after confirmation.
{NOTE: It was Hugo Black who also penned the legal validation of Roosevelt’s Executive Order of internment of over 120,000 Japanese Americans during WWII… yet another instance of Democrat’s xenophobia and racism.}
June 24, 1940: Republican Party platform calls for integration of the armed forces; for the balance of his terms in office, FDR refuses to order it.
August 8, 1945: Republicans condemn Democrat Harry Truman’s surprise use of the atomic bomb in Japan. The criticism goes on for years, especially after it was learned that the Japanese were ready to surrender after the first atomic bomb had dropped, but Truman’s racist hatred of the Japanese and his desire to intimidate the Russians by letting them know that the US had more than one atomic weapon led him to annihilate an additional 80,000 innocent people. It begins two days after the Hiroshima bombing, when former Republican President Herbert Hoover writes to a friend that “The use of the atomic bomb, with its indiscriminate killing of women and children, revolts my soul.”.
July 11, 1952: Republican Party platform condemns “duplicity and insincerity” of Democrats in racial matters.
September 30, 1953: Earl Warren, California’s three-term Republican Governor and 1948 Republican vice presidential nominee, nominated to be Chief Justice; wrote landmark decision in Brown v. Board of Education.
December 8, 1953: Eisenhower administration Asst. Attorney General Lee Rankin argues for plaintiffs in Brown v. Board of Education.
May 17, 1954: Chief Justice Earl Warren, three-term Republican Governor (CA) and Republican vice presidential nominee in 1948, wins unanimous support of Supreme Court for school desegregation in Brown v. Board of Education.
November 25, 1955: Eisenhower administration bans racial segregation of interstate bus travel.
March 12, 1956: Ninety-seven Democrats in Congress condemn Supreme Court’s decision in Brown v. Board of Education, and pledge to continue racial segregation.
June 5, 1956: Republican federal judge Frank Johnson rules in favor of Rosa Parks in decision striking down “blacks in the back of the bus” law.
October 19, 1956: On campaign trail, Vice President Richard Nixon vows: “American boys and girls shall sit, side by side, at any school – public or private – with no regard paid to the color of their skin. Segregation, discrimination, and prejudice have no place in America.”.
November 6, 1956: African-American civil rights leaders Martin Luther King and Ralph Abernathy vote for Republican Dwight Eisenhower for President.
You get that, libtards? MLK voted Republican. LOL
September 9, 1957: President Dwight Eisenhower signs Republican Party’s 1957 Civil Rights Act.
September 24, 1957: Sparking criticism from Democrats such as Senators John Kennedy and Lyndon Johnson, President Dwight Eisenhower deploys the 82nd Airborne Division to Little Rock, AR to force Democrat Governor Orval Faubus to integrate public schools.
June 23, 1958: President Dwight Eisenhower meets with Martin Luther King and other African-American leaders to discuss plans to advance civil rights.
February 4, 1959: President Eisenhower informs Republican leaders of his plan to introduce 1960 Civil Rights Act, despite staunch opposition from many Democrats.
May 6, 1960: President Dwight Eisenhower signs Republicans’ Civil Rights Act of 1960, overcoming 125-hour, around-the-clock filibuster by 18 Senate Democrats.
July 27, 1960: At Republican National Convention, Vice President and eventual presidential nominee Richard Nixon insists on strong civil rights plank in platform.
May 2, 1963: Republicans condemn Democrat sheriff of Birmingham, AL for arresting over 2,000 African-American school children marching for their civil rights.
June 1, 1963: Democrat Governor George Wallace announces defiance of court order issued by Republican federal judge Frank Johnson to integrate University of Alabama.
September 29, 1963: Gov. George Wallace (D-AL) defies order by U.S. District Judge Frank Johnson, appointed by President Dwight Eisenhower, to integrate Tuskegee High School.
June 9, 1964: Republicans condemn 14-hour filibuster against 1964 Civil Rights Act by U.S. Senator and former Ku Klux Klansman Robert Byrd (D-WV).
June 10, 1964: Senate Minority Leader Everett Dirksen (R-IL) criticizes Democrat filibuster against 1964 Civil Rights Act, calls on Democrats to stop opposing racial equality. The Civil Rights Act of 1964 was introduced and approved by a staggering majority of Republicans in the Senate. The Act was opposed by most southern Democrat senators, several of whom were proud segregationists – one of them being Al Gore Sr. Democrat President Lyndon B. Johnson, after failing to get the bill killed, relied on Illinois Republican Senator Everett Dirksen to get the Act passed, as means of passing the “blame” for the bill to Republicans.
August 4, 1965: Senate Republican Leader Everett Dirksen (R-IL) overcomes Democrat attempts to block 1965 Voting Rights Act; 94% of Senate Republicans vote for landmark civil right legislation, while 27% of Democrats oppose.
August 6, 1965: VRA of 1965, abolishing literacy tests and other measures devised by Democrats to prevent African-Americans from voting, signed into law; higher percentage of Republicans than Democrats vote in favor.
April 4, 1968: Martin Luther King, Jr. fatally shot in a conspiracy hatched by the democrat party. Democrat James Earl Ray was the locator, democrat Loyd Jowers was the money man, and democrat police Lt. Earl Clark was the trigger man. A jury finds the democrat party complicit in the conspiracy in 1998 King v. Jowers.
February 19, 1976: President Gerald Ford formally rescinds Democrat President Franklin Roosevelt’s notorious Executive Order authorizing internment of over 120,000 Japanese-Americans during WWII.
April 1977: The Democrat party finally grudgingly votes to do away with their official motto: “The Party Of White Supremacy”, which it had used since 1867.
September 15, 1981: President Ronald Reagan establishes the White House Initiative on Historically Black Colleges and Universities, to increase African-American participation in federal education programs.
June 29, 1982: President Ronald Reagan signs 25-year extension of Republican 1965 Voting Rights Act.
August 10, 1988: President Ronald Reagan signs Civil Liberties Act of 1988, compensating Japanese-Americans for deprivation of civil rights and property during World War II internment ordered by Democrat FDR.
November 21, 1991: President George H. W. Bush signs Civil Rights Act of 1991 to strengthen federal civil rights legislation.
August 20, 1996: Bill authored by U.S. Rep. Susan Molinari (R-NY) to prohibit racial discrimination in adoptions, part of Republicans’ Contract With America, becomes law.
March 14, 2016: The KKK Grand Dragon Will Quigg endorses Democrat Hillary Clinton for president, stating “the KKK has always been a Democratic organization”, and contributing $20,000 to her campaign. Hillary Clinton never disavowed this endorsement.
September 03, 2016: The Communist Party USA chair John Bachtell endorses Democrat Hillary Clinton for president. Hillary never disavowed this endorsement.
November 08, 2016: After the surprise defeat of corrupt Democrat candidate Hillary Clinton, the Democrats protest democracy, call for the electoral college to be abolished, call for the assassination of the president-elect, and start destructive paid protests, causing loss of life and widespread property damage. Evidence of Democrat vote rigging, pay-for-play, child exploitation, campaign contribution illegalities and more are found in a laptop belonging to Clinton aide Huma Abedin and her husband Anthony Weiner, in a directory titled “Life Insurance” and a subdirectory titled “Italy Child Sex”. The Democrats tried and failed to cover up the corruption.
November 16, 2016: After the suspicious death of a staff member of the Human Trafficking Center investigating Clinton ties to child abduction in Haiti, it was further found that Clinton-connected convicted child trafficker Laura Silsby was caught trying to abduct a child. Emails between the Clintons and Silsby show them discussing the price of transporting the abducted children.
July 23, 2020: Flight logs prove Bill Clinton visited Jeffrey Epstein’s island 26 times. In addition, the Clintons are now tied to slavery in the Morne Bossa mine (run by Hillary’s brother) and the Caracol Industrial Complex.
There’s more recent events, of course… I’ll leave it to those who are interested to add to the list.
Excellent post LOL@Klimate Katastrophe Kooks.
Optimum immune function requires Vit D levels ofat least 60-80 ng/ml. This was proven in a study conducted by the University of South Carolina Hospitals and Grassroots Health. They found that breast cancer rates declined by 80% as blood levels increased from 20 to 60 ng/ml. No further decline with higher levels. Also reduced recurrence by > 50%. Study of a hunter-gatherer tribe in Kenya found Vit D blood levels from 45-80 ng/ml w most 60-80 ng/ml. This represents evolutionary conditions. Dr Mercola and Dr Gundry have blood levels of 120 ng/ml w/o taking supplements – sun exposure only.
I agree with you, Jeff.
Why can’t it be both?
Spot on, Jeff in Calgary. Also, is it just coincidence that PDT, who has been taking HCQ, recovered so quickly and completely from COVID?
I know it’s mathematically impossible but I suspect that both potential profit at, say 100%, and Trump Derangement Syndrome at, say 75%, are motivators. And what about those who “trust the science” but only trust the scientists they think (or are told) they can trust, not realizing that not all scientists in a given field agree with the conclusions of any given study? Add in those who trust the media completely (I hope that group is growing significantly smaller) and you have a lot of reasons for people to be ignorant of the possibilities, leading to the current situation.
The reality is that its: “Trust the science” (that agrees with their preconceptions)
Ignore everything else.
Or maybe intensive care docs find the hard way it doesn’t work any better than a placebo supplemented by readily available steroids….
ref…Henry Ford study, table 1, second last tow……
That or they need to world to burn, for some reason.
It’s hard to know why they do what they do.
It isn’t hard to know they are capable for doing it. Just watch what the Dem twitteraty openly supports. It’s absolutely disgusting – I really mean absolutely.
It is more than that.
Zinc plus a zinc ionophore (HCQ, EGCG, Quercetin etc etc) BLOCKS the replication of RNA viruses by preventing them hijacking the cells RNA transcription process. These RNA viruses are many and include Influenza *all strains. Polio and a lot of others.
So by keeping sufficient in Zinc and drinking green tea or eating some vegetables for quercetin, you become immune to RNA viruses. That frightened big pharma and the CDC/FDA/NIH many of who have thousands of shares in pharmaceutical companies. The last thing that was wanted was that small dietary changes would stop RNA virus infections.
The Zelenko protocol and others that provide zinc then HCQ as the ionophore and add antibiotic against opportunist bacterial infections boost innate immunity and that is sufficient to stop the infection within a week for less than $30. The patient MUST start the regimen as soon as possible and it is an outpatient treatment.
Current medical practice approved by NIH/CDC/FDA is for the patient to self quarantine and go to hospital if symptoms get worse. This is like a fire department telling someone with a waste bin fire to leave it alone and call back if the roof catches fire. Long COVID is the result of this extra damage to lungs, blood vessels, kidneys, heart, brain etc etc., that could have been avoided with a prompt zinc/HCQ/antibiotic treatment. But the doctors are not allowed to show such treatment as that would remove the reason for vaccines <– Note that is plural.
The briefing on the Great Reset makes much play on the requirement for vaccine passports and control of the population – so showing that cheap therapeutics are better than vaccines is a little upsetting to the globalists.
There are politicians, medical bureaucrats, billionaires – that prefer that people die rather than show that some vaccines are not needed.
Exactly Ian.W. If HCQ with zinc is shown to cure covid it will do the same for all flu type RNA viruses as all need a low pH for entry and release of their gnome into cell, zinc ensures the virus cannot use rdrp for it,s replication. I am 80 next hcq, zinc, Doxycycline is my future flu remedy.
Gilead are the darlings of the US pharmaceutical community, they could dip a flask in a local pond and send it to the FDA and they would license it.
Gilead is to the FDA what Boeing is to the FAA. Way too close.
A regulatory landscape that is incestuous and corrupt.
Studies in the UK and elsewhere show it has little effect on outcomes
Nonsense! The dosage was excessive and the time of administration was wrong. In addition, almost no trials included zinc despite early indications that this was related to improved HCQ efficacy.
Isn’t the zinc the active ingredient that interrupts corona-virus replication process within the cells? Doesn’t HCQ help Zn enter the cells?
Optimum immune function requires Vit D levels ofat least 60-80 ng/ml. This was proven in a study conducted by the University of South Carolina Hospitals and Grassroots Health. They found that breast cancer rates declined by 80% as blood levels increased from 20 to 60 ng/ml. No further decline with higher levels. Also reduced recurrence by > 50%. Study of a hunter-gatherer tribe in Kenya found Vit D blood levels from 45-80 ng/ml w most 60-80 ng/ml. This represents evolutionary conditions. Dr Mercola and Dr Gundry have blood levels of 120 ng/ml w/o taking supplements – sun exposure only.
If you’re referring to the RECOVERY trial, that can only be described as an inexplicable screw up.
Apart from the ludicrously high doses used, HCQ was given at the later phase of the illness when the immune system has gone haywire. At that point the virus is an irrelevance. That’s when Dexamethosone is more appropriate.
Yes. Administering any anti-viral (cheap or expensive) when serious inflammation sets in is like making an appointment for a brake job – in mid-air after you drive off a cliff.
I’m sure that a big deal will be made about Remdesivir being the treatment for Trump, and his swift recovery – and it might very well be so. But it was administered LONG before any serious symptoms manifested.
Side note, on the idiocy of all too many people and drugs – I’m having a hard time finding famotidine in the stores. After the idiots included that in the list of what Trump was taking in Walter Reed. Sigh… (Famotidine is an OTC acid reducer. Which doesn’t work nearly as well as rinatidine, but the FDA banned THAT for levels of nitrosamine less than found in the typical BLT.)
You can’t find Pepcid?
And late night television is now saturated with ads to sue the makers of ranatidine
By studies, you mean “conspiracies to murder patient while producing fake data”. Wonder why the international court of justice is not doing anything about these obvious cases. Too preoccupied by Israel (which is not even a member) to care about UK (a member)?
Follow the money. Remdesivir is hugely expensive, and is potentially a big money-maker for those pushing it. HCQ, not so much. Shameful and fraudulent.
The steroids that have been found to cut the death toll in nearly half are readily available and reasonably priced so money motivation doesn’t seem to be totally the motive….seems the medical profession is trying to save lives as they should.
ref…steroids, Henry Ford study, table 1, second last row……
More fake news used to promote fake studies (used by fake history teachers like @CorentinSellin who don’t know a thing about medicine or politics).
The con is called “we need randomized studies”. Actually we don’t need these to have an informed opinion (and we can’t expect one f.ex. for contraceptives). It’s so bad even some French experts believe that EBM (Evidence Based Medicine) means randomized stuff. It does not.
The steroids were used before the results were published. No study caused any cheap drug to be used. People who claim it’s irresponsible to do anything not validated by randomized studies have been doing it or watching others do it.
You are the fish.
This is a high quality report, thank you Mr. Goldstein !
About 5 or 10 years ago I wrote a report on th pharma industry for my newsletter ECONOMIC LOGIC, and was surprised at what I found. I asked a friend in the industry to confirm my conclusion, and he said he’s been waiting for decades for people to wake up about this: The gold standard of two positive double blind tests that prove a new drug works sounds reasonable at first. But you can get a new drug approved that works no better than generic aspirin, has more side effects than aspirin, and is likely to have unknown side effects too. Then you can heavily advertise the drug and sell it for 10 or 100 times more than an aspirin. The double blind test sis against a sugar pill, rather than the product it is a substitute for: aspirin. This system results in spending on marketing and sales that can exceed spending on research and development. And some of the R&D is closer to marketing than to R&D. And I’m assuming everyone involved is HONEST, which is not real life!
I used to work for a well known pharma company, but not on drugs.
I had friends who would tell me the crazy stories.
In one case, a drug undergoing trials needed two studies to make the FDA happy.
The company ran three and threw away the worst of the three, which showed the drug began to cause kidney cancer after 90 days of use.
Imagine how surprised I was when year later the company went back for OTC status.
“But you can get a new drug approved that works no better than generic aspirin, has more side effects than aspirin, and is likely to have unknown side effects too. Then you can heavily advertise the drug and sell it for 10 or 100 times more than an aspirin. The double blind test sis against a sugar pill, rather than the product it is a substitute for: aspirin.”
Our FDA policy is established on: safety and efficacy.
Your example abides by this standard.
So, I develop a drug just as good as aspirin. Assume same side effects. It is a matter of freedom, not deception, for me to get approval for this drug to be approved and marketed.
Thus, no problem so far. Safe effective drug with marketing.
It is up to the experts to point out that this new drug is not worth the price tag relative to aspirin.
Here is the problem:
physicians are NOT “scientists.”
Generally, unless there is some special education provided to a doc or sought out by a doc, most any doc does NOT have the expertise to analyze the typical RCT for a drug.
Docs depend on others to review and make conclusions.
I actually have heard, in depth, how one large outpatient practice works to stay abreast of new drugs and determine whether they are worth it. but this network of docs is pretty big, and the docs reviewing data are trained to review these studies.
We did have a big movement to get new innovations tested relative to the status quo. That was “comparative effectiveness research.” Our Congress shut that effort down with the “death panels” story line.
Congress gets a lot of donations from Big Pharma; Big Pharma wants things the way they are.
Doctors are primarily trained to be diagnosticians – not dieticians and not pharmacists. I was told years ago (by a pharmacist) that doctors don’t know how drugs work – just that they do. It’s the pharmacist that is trained to know how drugs actually work and where there are contraindications for a particular drug.
However, you quote “has more side effects than aspirin”, then argue “Assume same side effects”. It would be better to NOT quote the original when you try to change the terms of reference. That is the sort of thing that Gilead seems to do!
“Here is the problem:
physicians are NOT “scientists.”
Categorically untrue. Trashcan physicians who do not take their profession seriously maybe fall in this category… but any true physician will constantly stay on the edge of specialty by staying up to date with easily accessible journals. Dogma runs deep, of course. But a diagnostician who is not a scientist is called a nurse practioner or a PA.
Which is why to this day the fake science around cholesterol and heart disease is resolved right?
If you didn’t figure that was sarcasm. Doctors are trained to prescribe, in many cases they are mandated to do so. An example would be returning a high LDL result from a blood panel. A Doctor was demanded a person be prescribed a statin, despite excessively weak results in those RCTs done of any positive results. Now if a person refuses then the doctor might ask to do a CAC score and then if a person returns a very low score or 0 they can hold off on prescribing said pharma trash.
If the Doctors had kept abreast of the RCTs done they might know that suggesting ‘heart healthy’ vegetable oils containing polyunsaturates were contra indicated. refer to Sydney Diet Heart Study and Minnesota Coronary Experiment for the results. The medical industry is still slow in moving towards better outcomes beholden to pharma for joint profit.
I am surprised how low are standards that the FDA has. Its primary duty is to ensure safety of a new drug. This cannot be done in a trial with a few hundreds patients. To discover dangers that happen to 1 in 1,000, they would have to demand a trial with at least 5,000 patients in the drug arm.
Good work, Leo!
I will keep your notes and analysis on hand when I read the paper itself!
We all know why there was a desperate effort to discredit Hydroxychloroquine and I’m sure any critical analysis of evidence to support its efficacy will be buried until after November!
So now the pushing of Remdesivir, and the elimination of HCQ for treatment both look like crimes against humanity. It is unconscionable that one of the primary actors in our response had the power to sponsor a product in which he has a vested interest, for special testing, and that anyone involved produced what sounds to be a faulty, fraudulent test. The people at NIAID and the FDA should be removed, and replaced with medical professionals.
Trump owns something like $1000 worth of stock (via a mutual fund) in a French company that makes HCQ – apparently THAT is what’s bad, not what you mention.
Yes
A good time to repost this graph. Reported CV19 US deaths have averaged around 800/day since this graph was last updated in late September.
Hydroxychloroquine + Azithromycin = $
Remdesivir = $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
No other reason needed.
It sounds to me like the MSM in collusion with the political left who denigrated the use of HCQ are responsible for 10’s of thousands of excess deaths. That the dismissal of HCQ was motivated by TDS makes this so much worse.
co2isnotevil,
Don’t ever forget that the lockdowns were a never before tried method of mitigation promulgated by the ChiComs to their hired shills in Western media and politics! No sane epidemiologist had ever advocated locking down healthy individuals until the Chinese pushed the method to the WHO and Western leaders during the early days of the “pandemic!” They only had to kill a few thousand of their citizens to “prove” the effectiveness of this insane cure that is worse than the disease!
I keep asking myself if Beijing Joe Biden and the other corrupt DemoKKKrats got paid to push this madness on our country and how many lives were lost or destroyed by their efforts! The drug companies were happy to jump on the bandwagon but the Dims and their Fake News sycophants did the heavy lifting!
#BigTech was interested in lockdowns
Amazon has certainly made out well as a result
Don’t forget Big Tech. It has literally deplatformed HCQ!
Leftists’ irrational hatred of Trump lead to the ban of Hydroxychloroquine based on a bogus (and later retracted) Lancet article…
10’s of thousands of Americans needlessly died due to Leftists suffering from Trump Derangement Syndrome..
How proud Leftists must be…
Samurai
Would it were so simple!
https://scitechdaily.com/aspirin-use-significantly-reduces-risk-of-death-in-hospitalized-covid-19-patients/
https://scitechdaily.com/new-research-finds-hydroxychloroquine-no-more-effective-than-placebo-in-preventing-covid-19/
While many are still flogging the HCQ horse, based on their belief in only political motivation, the fact remains that the person who started the debate did NOT use HCQ when he got COVID-19, despite being in the window of time supposedly optimal for its use. When his life was potentially at risk, Trump took advice that was counter to what many here claim to be beyond reproach. I suppose all those Leftists finally got to Trump!
Um, since Hydroxychloroquine is not an FDA-approved treatment for SARS-COVID-2, why would a doctor, much less a government-employed doctor, prescribe it?
Most prescribing is done “off-label.”
To be available by Rx in the U.S., a drug has to be approved for some “indication.” Headache, flu, HepC, depression, HTN, etc. One indication.
Once approved for one indication, it is in the pharmacies. Any doc can prescribe it for any condition he or she sees fit. The day after Prozac was approved for depression, a doc was trialing it in a patient for OCD.
Most of the “antipsychotics” prescribed are not for psychotic disorders. There really is only one psychotic disorder of any note: schizophrenia. When manic, people are considered “psychotic,” but are largely treated with anti-manics/anti-epileptics. Rx of antipsychotics far outstrips the number of people with schizophrenia or other “psychotic” disorders.
Most of the “antidepressants” are not prescribed for someone meeting criteria for Major Depressive Disorder.”
Most prescribing is done “off-label.”
The FDA does not practice medicine. It regulates manufacturers. It approves the text they print on the insert and packaging,
It has no say in what a doctor prescribes to a patient.
Trump’s physician is too young and inexperienced. This said, the antibody cocktail from REGN worked.
Your quoted HCQ study was pretty much useless. Zero hospitalizations in both arms shows the numbers were too small to draw any conclusions. HCQ if it works is supposed to reduce symptom severity, not prevent you from being infected. Hence comparing infection rates is hopeless unless total viral loads were compared. With zero overall hospitalisations, it’s clear that nothing could have improved the outcome since zero is hard to beat.
Yes, Trump did not go with HCQ when he came down with covid 19. So we can’t say whether HCQ would have been effective in his cure.
Back in May Trump announced that he was taking HCQ daily as a prophylaxis. Then all h*ll broke loose and the establishment trashed HCQ. Now, 5 months later, Trump comes down with covid 19.
An important question is: Did Trump continue with HCQ prophylaxis all that time and still caught covid? OR did he stop the prophylaxis due to bad media, and 5 months later get the virus??
Or, having used HCQ for so long he jumped out of the hospital after a few days, went to a big debate and then zigzagged thousands of miles to a dozen rallies in a few days. WUWT? Are we supposed to believe this was because of Remsdivir with the lackluster results just reported.
Did Trump continue with HCQ prophylaxis all that time and still caught covid?
He stopped taking it somewhere near the end of May (shortly after he mentioned he was taking it and “all h*ll broke loose” as you described it). He’d said, during a meeting with Arkansas Governor Asa Hutchinson and Kansas Governor Laura Kelly (on May 20th) “I think the regimen finishes in a day or two — yeah, I think it’s two days, two days,”
Clyde: Sci Tech Daily – they have all the end of world climate science studies, too. Ya know your default position has to be sceptical and then consider authoritativeness
Clyde Spencer
I see read the aspirin study. Being a quad bypass patient, I take 325 mg once per day. I have worked in the cafe, every day, since March 17th. No days off. I have not worn a mask. My staff have worn theirs about half the time. We were all exposed by one of my employees. None of us came down with any symptoms.
I wonder if the study included those that are taking a greater concentration of aspirin, on a daily basis?
Clyde,
Your link to study looks as if it was designed to fail. What did the fake study show?
That is the problem with double blind studies. The thinking in Medical ‘science’ is how to make more money from new drugs and how to hide effective cheap treatments.
All of the hospital workers had mild cases of covid. Fact. A mild case of covid is the best HCQ can do.
This test was designed to fail.
Why? What were the hospital worker’s ages?
Perhaps the hospital was in a sunny place and the workers were hence Vit D normal rather than Vit D deficient. That would also explain the results.
So Remesdivir doesn’t work very well, let’s just now focus on the next possibility….. But really the Henry Ford study that is purported to show that HCQ somewhat works…..actually second row from the bottom of their table 1, shows that is steroid treatment that consistently improved recoveries…..
What on earth is an ordinary person to believe?
I do know that Trump said positive things about Hydroxychloroquine and the news media pooh-poohed it the shortly thereafter. That told me back in March that Covid 19 had already become political. Since then what to believe is in question.
He also said positive things about Remdesivir in the same sentence, as he mentioned both.
I quoted two complete sentences.
Believe nothing. Demand proof.
Since the MSM are bought-and-sold, I suspect the better bet would be to adhere to the opposite of the MSM’s position.
In the case under consideration, since the MSM, Tony Fauci, and Bill Gates all say that HCQ is bad (“…will kill you…” – per Bill Gates), that sounds to me like high praise of HCQ. It’s a back-handed compliment at best, but since we’re all learning to read between the lines this year, I just check more into the opposite of what they say.
There was a good article in Tablet about this – by a Norman Doige (“Hydroxychloroquine: A morality tale”, August 14).
So, American medicine corrupt. No wonder the companies & doctors fight against anything they perceive as “Socialised Medicine”, as their profits will be slashed.
Perhaps you’re not inclined to notice, but “Socialised Medicine” has its own interested parties who have no higher regard for those needing care.
In a capitalistic medical system, profits go down when patients are harmed, and providers don’t have as much money to spend on their own needs and wants.
In a socialist medical system, it doesn’t matter whether patients are harmed, providers have just as much money to spend on their own needs and wants. Quite possibly more money, if they can just eliminate the more expensive ones – such as the elderly in nursing homes…
I just got myself from Covid 19 infection. I was using daily dosage of Zinc + 1dcl of Tonic with quinine + I got prescription to Azithromycin.
Antibiotics helped, that is for sure, but biggest relief I got myself by taking 3x500mg of Aspirin daily and 16g of Vitamin C daily.
Aspirin and Vitamin C are antioxidants which can prevent virus to enter cell and replicate. They are very important in first phase of sickness when there is no response of immunity yet and virus is replicating exponentially. In my case it was first 2 days. I had fever only on 2nd day, thanks to Aspirin and Vitamin C.
I have a lot of experiences to get from flu with C and Aspirin in one day and this virus responded to C and Aspirin too.
In second phase, where immunity kicked in and cleared lungs and blood from virus and virus stayed in smell and taste nerves Aspirin and C was not so helping. I think in this phase Zinc and Quinine was better.
But all lung damage was done in first phase, 1st and 2nd day, where Aspirin and C was helpful.
My wife was sick too and Aspirin plus Vitamin C helped her too in first phase.
So if you were taking each of these things every day, how can you know which things were helping what symptoms?
How can you know you would not have felt better after two days without anything but typical symptom relief?
Most cases are mild and many more moderate.
How did you assess “lung damage”?
What makes you think aspirin and vit C is “helpful” with lung damage?
Almost no one has lung damage until the later phases of illness, and doctors need to do x-rays to assess lung damage, so how did you have it in the first days or know which of several things helped?
The answer is that no one can discern such things.
And what, no vitamin D?
Immune cells must first attach to a molecule of D to function:
“When a T-cell encounters a foreign pathogen, it extends a vitamin D receptor. This is essentially a signaling device that allows the T-cell to bind to the active form of vitamin D, the steroid hormone calcitriol. T-cells have a symbiotic relationship with vitamin D. Not only does the T-cell extend a vitamin D receptor, in essence asking to bind to the steroid hormone version of vitamin D, calcitriol, but the T-cell expresses the gene CYP27B1, which is the gene responsible for converting the pre-hormone version of vitamin D, calcidiol into the steroid hormone version, calcitriol. Only after binding to calcitriol can T-cells perform their intended function. Other immune system cells that are known to express CYP27B1 and thus activate vitamin D calcidiol, are dendritic cells, keratinocytes and macrophages.”
https://www.nature.com/articles/ni.1851
No guaifenesin to enhance the mucociliary escalator, and prevent or treat lung congestion?
Vitamin C at the doses you talk of, taken orally, is not going to be absorbed and above a fraction of that amount, is passed rapidly in the urine unmetabolized.
High dose vitamin C as a therapy is given as an IV, since our digestive tract can only absorb a certain amount. Any excess above that is simply passed through or quickly excreted in urine.
Anyone wishing to make sure they have adequate nutrition in case of a viral infection is best advised to make sure you have all 30 essential nutrients, including all of the vitamins and minerals, and the two fatty acids that we need but cannot synthesize, and which are known to be important for proper immune functioning.
“The answer is that no one can discern such things.”
I agree, Nicholas. He also didn’t say if he was actually diagnosed with Covid.
Confirmation bias is a power thing.
re. Vitamin D
There is a Spanish study of Vitamin D that got amazing results. It compared two groups of hospitalized patients. Both groups got HCQ treatment. One got Calcifediol (Vitamin D) and one didn’t. Half the group that didn’t get Calcifediol ended up in the ICU. Only one (2%) of the group that got Calcifediol ended up in the ICU. Two of the untreated patients died. None of the treated patients died.
The effect size of the result is so huge that the study can’t be ignored. It blows my mind that some folks with a political agenda are doing just that.
Apparently colored folks are more likely to be Vitamin D deficient and therefore a lot more likely to suffer from the Wuflu. That doesn’t fit with the narrative that they are repressed and marginalized and therefore more likely to get the Wuflu. Accordingly, the activists trash Vitamin D studies.
I shared that study, and another one with similar results, on a forum I used to frequent.
The entire thread was filled with people complaining that they can’t get out in the sun for various reasons, and that they also can’t take Vitamin D supplements.
No positive reactions, just complaints and whining. It’s like they WANT C19 to make them miserable
And moreover I have UV arc lamp which I’m using during winter to get my Vitamin D. I was using it also during sickness. It is also producing a lot of ozone, which I’m breathing during exposing.
The heck guys,
Yes I was officially diagnosed as my whole 5 member family.
I took longer time before sicknes 2000IU daily of Vitamin D.
It had little use in first 2 days (my case) when immune system is not working yet. It is well known that coronavirus antibodies are produced few days later from start of sickness.
I was dissolving C and Aspirin into water. Sipping every hour. This way it is not straining digestive system and maximizing intake. If you put C into urine from blood it already did job. It is more less inert in in your blood, but is chemically reacting with radicals produced by virus to dissolve cell membrane. It is basically protecting your cell membranes from virus attack.
I was taking Guajacuran with guajafenesin.
Asses lung damage? I know from my coughing. From how deep it was coming. I don’t remember such depth from all my flu’s.
I felt viral pain, like burning on lungs second day, I know that this time virus was damaging my lungs. Later days I started with productive coughing, meaning lungs are working on damage.
Aspirin and C was directly decreasing this viral burning pain.
So you you can write what you want byt I know what I’m talking about.
“at the beginning of the treatment, symptoms of the RDV arm are better than the placebo arm: 5.7 : 6.1 (the higher score, the worse the symptoms).”
I’m not a epidemiologist (but an engineer and geologist), however a thinking dog catcher would reason that each human in this study differs in multiple ways physiologically, psychologically, variations in degree of illness even in a category. A statistical result like this for a medical treatment has to be regarded as showing no significant efficacy of RDV.
Good Lord, these post normal days, it is without question, essential for another level of management of drug trials and every other scientific use of experimental design and interpretation of statistical data where outcomes effect people. That new level is to pre-empt self-interested abuse in an amoral age. These trials should have to satisfy independent statisticians from design to interpretation. They should be managers of the project. These would be the likes of William Briggs, Ross McKittrick ….
Yes, external oversight of the study plan and how it progresses would be great.
It may have been / be in place.
It is normal for these types of studies to have a “DSMB” data safety and monitoring board. These are external firms hired per study by contract for these purposes. Usually.
What would be good to hear here is how the “fast track” approval path does or does not make use of a DSMB.
Q:What is an ordinary person to believe?
A: Evidence-based medicine means believing in patient outcomes reported by their caretaking physicians.
For Example:
rclutz.wordpress.com/2020/10/23/hcq-is-effective-for-covid-19-when-used-early-118-studies/
https://rclutz.wordpress.com/2020/10/22/truth-and-lies-about-hcq-covid-regimen/
“Evidence-based medicine means believing in patient outcomes reported by their caretaking physicians.”
But only the ones that have reached a certain conclusion, and not the ones that have reached the opposite conclusion?
There’s absolutely nothing to lose taking HCQ early as an outpatient and everything to gain. The medical establishment offers absolutely nothing at that stage of illness, so one really has to wonder about the ethics of those trying to stop early outpatient treatment with HCQ and other reportedly successful treatments.
I have been assured by people who only listen to MSM and don’t read studies that taking HCQ is a practical death sentence. Or at least you’ll go blind. And doctors who prescribe it are killing their patients and should have their licenses revoked.
Nicholas
Surely you aren’t suggesting that dyed-in-the-wool skeptics would resort to cherry picking! 🙂
When I have discussed HCQ with my physician, he just shakes his head and says, “Idiots!” I think it speaks volumes that physicians who recommend HCQ are in the minority. While commenters here have come up with lots of reasons for why HCQ should work, apparently their arguments aren’t convincing to the majority of practicing physicians. It is easy to rationalize that the people we often trust our lives with are easily swayed by Big Pharma — and yet we still turn to them when we are sick. Last time I checked, Walgreens and CVS didn’t give doctors a commission on the prescriptions they wrote. So, why would doctors care whether they prescribed something expensive or cheap? Actually, they would derive more goodwill from their patients if they prescribed something inexpensive, as long as it worked. Then, the man entrusted with the care of the president, doesn’t believe in it either. What does he know?
What early outpatient treatment does your doctor offer? If nothing I would have to call both him and those who employ such doctors “Idiots!”.
Clyde,
With all due respect, could you please explain the change in fatality rates that the Swiss documented? They stopped using HCQ at WHO recommendation and their rate rose by a factor of three to four fold. When they resumed using HCQ the rate fell back to the lower level! What was the cause of these changes if not HCQ?
While you may have a great doctor, I would caution you against believing everything he tells you! Most MDs are almost completely ignorant of anything to do with nutrition and they get lots of freebies and gifts from pharmaceutical reps! HCQ may not be the best treatment for the ChiCom-19 virus but it has certainly been proven effective in a large and growing number of studies!
The real question is what early outpatient treatments does his doctor offer that are better than HCQ? I’m pretty sure the answer is nothing.
Switzerland – With, Without & With HCQ
https://pjmedia.com/news-and-politics/stacey-lennox/2020/07/15/media-should-do-a-mea-culpa-as-french-analysis-offers-a-stunning-observation-about-hydroxychloroquine-use-n643181
Walgreens and CVS might not, but pharmaceutical companies have been known to shower Doctors with with gifts, promotional items, lunches with often-attractive drug industry representatives and, most notoriously, paid vacations to luxury resorts that were ostensibly for advanced medical education. Not surprisingly, Doctors who accept such gifts are more likely to prescribe the brand-name drugs from those companies.
Here’s a link to one study on that topic
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2528290
So call it a “rationalization” all you want, but the truth is big Pharma does attempt (and often succeeds) in swaying Doctor’s choices of prescriptions (they wouldn’t give out all those freebies if they didn’t think it was effective in driving business to their products. what? Did you think they gave those gifts out of the goodness of their hearts? how cute).
Gee Clyde even with all the things wrong with this Remsedivir study (I have a comment above on efficacy relative to placebos of 5.7 for RDV, 6.1 for placebo – lower is better). You are a scientist, are these numbers significantly different to you given the differences between people even in a narrow category – physiologically, psychologically.
In Canada, if you want to go to Africa you go to a tropical medicine doc. GPs have no idea about the safety of HCQ and I suspect your doctor calls people idiots only because he’s partisan in his sources of info after the controversy got started.
I joked in another thread that these days you have to ask a doctor who he voted for before choosing a family physician.
https://wattsupwiththat.com/2020/10/26/remdesivir-for-covid-19-study-accidentally-proved-effectiveness-of-hydroxychloroquine/#comment-3112221
Also note the author’s remark about the accidental proof of effectiveness of HCQ in the study!
Your faith in your doctor on this matter is not unlike the faith ordinary folk have upon consulting Jim Hansen about global warming armageddon. He’s an expert isn’t he? You also know that the experts at Lancet had to withdraw a fatally flawed article that by the time of withdrawal all HCQ trials were halted after the thing got published. You hinted at a possible motivation by big pharma to stack the deck- yeah this study seems to be one of those.
The doctors at Walter Reed. Are they immune to this kind of chicanery? Perhaps Trump who was (is) using HCQ made it possible to jump out of the hospital after a few days and go on an exhausting debate, cross country campaign trip with two or more rally’s a day. The article above doesn’t give confidence that RDV gave a 74 year old president wings.
Finally do I know that HCQ is the savior? No I don’t but I’m mad as hell that the ‘trials’ were compromised, discontinued and even made illegal in most US states and néomarxiste Europe. Colonel Sanders looking after our chickens for us, anyone?
Your faith in your doctor on this matter is not unlike the faith ordinary folk have upon consulting Jim Hansen about global warming armageddon. He’s an expert isn’t he?
I often find that my doctors have been far less informed about the latest studies and journal articles than I am, especially regarding MY specific health issues. I suppose it’s not unexpected, since they often don’t have time to keep up with everything, and I’m selectively reading based on my interests while they would have to read everything. But it has been the case where I have had to inform one of new information relevant to my treatment.
I “have faith” in my doctor to be an educated professional who helps guide my treatment, but I do not “have faith” that my doctor knows everything that’s going on in medical research.
I’ve noted that real Doctors who actually treat patients seem to choose HCQ and have excellent results.
The proponents of Remdesovir all seem to be bureaucrats who have been well lobbied by Big Pharma, and twist studies in order to make HCQ look bad and remdesovir look good
I would not go to your doctor – he has TDS.
Doctors do get paid vacations from Pharma (I’ve seen it). Pharmacy databases/archives trace every pill, patient, and doctor. Not too hard to imagine Pharma can query databases for the most productive doctors.
Nah, Nicky, that’s your method. Stop trying to project it onto others.
Bravo!
Ron Clutz October 26, 2020 at 7:47 am
Ron – thanks for the reply. Why should I believe your link over what the talking heads in the media tell me? When it’s political and this has been since March, you’re on your own.
For some reason the other link didn’t show up.
https://rclutz.wordpress.com/2020/10/23/hcq-is-effective-for-covid-19-when-used-early-118-studies/
As reported there, media have been biased against HCQ, especially in North America. Elsewhere in the world doctors have been treating patients successfully where not inhibited by medical bureaucrats. As FDA says, nothing stops doctors from prescribing off-label, but that FDA position puts family doctors at risk of liability, and effectively prohibits their use of the HCQ regimen.
For some reason the other link didn’t show up.
https://rclutz.wordpress.com/2020/10/23/hcq-is-effective-for-covid-19-when-used-early-118-studies/
As reported there, media have been biased against HCQ, especially in North America. Elsewhere in the world doctors have been treating patients successfully where not inhibited by medical bureaucrats. As FDA says, nothing stops doctors from prescribing off-label, but that FDA position puts family doctors at risk of liability, and effectively prohibits their use of the HCQ regimen.
Just before a week or two, I read in a news portal that Remdesivir is just not a gamechanger because of different sude-effects and non-efficiency.
Remdesivir is advertised at $3,120 for a five day treatment.
Hydroxychloroquine is advertised at $37 for 100 x 200mg tablets.
The effective medication is cheap as chips.
Good luck getting this published in a medical or scientific journal (which rely on page charges that come from federal and big pharma funding).
Sound familiar?
All these problems with this study seem to have become the new normal. Suggested reading on this subject, its causes and implications: Dr. Malcolm Kendrick – Doctoring Data:
https://www.amazon.com/Doctoring-Data-medical-advice-nonsense/dp/1907797467/ref=sr_1_1?crid=1HVZUKUFJADO&dchild=1&keywords=malcolm+kendrick&qid=1603725857&sprefix=malcolm+kendrick%2Caps%2C167&sr=8-1
I read that FauXi did the same thing with bactrim/AZT during the early days of AIDS that he’s now doing with HCQ/remdesivir. Doctors had good success treating pneumocystis pneumonia (one of the AIDS diseases) with the antibiotic bactrim, and AIDS activists petitioned FauXi to approve the drug for AIDS. But FauXi said he would only approve it with a RCT, then refused to fund an RCT, and worked for approval of AZT, a failed chemotherapy drug that is an extremely toxic DNA chain terminator that can ki!ll even healthy persons. No telling how many thousands of people died as a result. Sounds like an exact repeat today: work to thwart approval of a cheap effective drug in favor of a non-effective failed drug (remdesivir is a failed ebola drug). Big bucks for big parma in both cases, but the grave for many patients.
I Xi what you did there 🤔
There are two main issues to be seen here.
The first is that the quick, adaptive trial is, per the Kraemer citations and other points, not the best study design.
I say that this use of an adaptive trial, in itself, is OK, as long as we know what we are dealing with. We cannot let the “perfect” be the enemy of the “good.” We can trial a medication for a condition and get information that has value to our applied questions, such as whether a drug is good for patients with a specific clinical problem.
Adaptive trials have their place. I have heard Kraemer lecture on adaptive trials and their place. Web-search “Kraemer” and “adaptive trial” and see. Multi-site trials have their place. In fact, when we all started crying about the tyranny of the RCT, including how they fail to include participants reflective of patients in the real world, such as those with comorbidities, THE solution has been to have greater inclusivity, which requires greater study Ns, which often can ONLY be achieved by multi-site studies.
Further, we often cannot generate big study sample sizes QUICKLY unless we do a multi-site trial.
Therefore, it is obvious that adaptive trials and muti-site trials are inferior to optimal RCTS when examining a claim of causality (this drug cures this infection), but in certain circumstances, it is better to run decent trials that are not pristine RCTs.
All of this has been argued and explored extensively, including by Dr. Kraemer, in the recent 3 decades.
Cheating / Fraud is a totally different issue. It is totally possible to have a multi-site trial without being tainted by a drug company. I have helped develop such a protocol, and I have not yet seen Dollar One from the drug companies.
Here, yes, the rules were broken. Big Pharma support was not disclosed. The “Leo and Lacasse” episode has had a great impact on this conflict-of-interest topic, but with the time crunch here, those lessons were ignored.
Protocol changes seem to not make sense, and may be fraud conducted under the banner of “adaptive trial.”
The fraud should not be used to argue that we cannot use adaptive trials or multi-site trials.
Conclusion, RDV is a placebo.
Finally, something to agree on.
https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(20)30173-7/fulltext
“New” and “expensive” are very attractive properties that most humans are influenced by. What shocks me is how small the trial was – 131 and 154 patients distributed around umpteen centres.
The US health care system is a bone-fide, unadulterated mess and I have a hard time finding a way out.
Everything has consolidated into corporate entities. Hospitals and doctor practices are all giant corporations. Small practices just can’t operate anymore due to the massive overhead requirements forced by the governments (state and local). If your doctor belongs to a “practice” that doesn’t have an agreement with the hospital down the street, you are out of luck going to that hospital. We used to have 4 independent hospitals in our area and my doctor (then in a 2 doc practice) used to have privileges in all 4. Today he has but one.
Every patient is treated with the same protocols within a hospital or clinic. The doctor has very limited say. If you are a small company and have a new drug or medical device that will reduce costs and save lives, unless you have the money to pay off a clinic or hospital, it is next to impossible to get a clinical trial going because big pharma basically has all the patients bought and paid for. Hospitals (corporations) generally won’t accept your trial and even if they somehow do, qualifying patients that may benefit may not have the option to participate because a big pharma has paid the hospital to recruit the patients into their trials. The patients are the biggest losers.. a lot of times with their death. And quite frankly no one cares.
This remdesivir trial is so typical. It was showing no value before the trial but that doesn’t matter. Do the trial, come up with fudged numbers and get the FDA to approve its use anyway.
Case in point on the ‘Protocol’ thing.
I have type 2 diabetes and I get lab work done on a quarterly basis along with a doctor visit.
H1C is, generally, 6.1 – 6.3 on NO medication. Generally, considered pretty good numbers even on Meds.
BP is, generally, 132/70. A little high, but nothing to worry about.
Cholesterol HDL 88 Triglycerides 119 LDL 63 or there about.
Every visit I get the same recommendations for a blood sugar med, a BP med and a Statin. They’re recommended because those meds are PROTOCOL for Type 2 diabetes regardless of what the individual needs of the patient are. The doctor tells me I don’t need them and then recommends them so that he is following protocol. More than a little insane.
The quarterly lab work and visits are required as part of my insurance coverage and, while the doctor tells me I could get by with an annual physical, my employer is self insuring, administered through one of the big health networks, and quarterly visits for a chronic condition is their requirement for being covered.
On a side note. I paid for a Covid19 antibody test and came up positive. I’ve been told that I’m either, immune, or not immune. Seems there’s some question about that point along with whether I can be vaccinated safely, or not.
I was very ill the first week of January of this year and haven’t had so much as a sniffle since. I’m figuring I was an early adopter of Covid19. Thought I had the flu, did the usual C and Zinc thing, and had a miserable 5 days or so. Not the worst ‘flu’ bug I’ve ever had. The one in 79′-80′ kicked my ass as a teen. I was out of school for two weeks and didn’t have any sense of taste or smell for half a year afterward.
Cheers
Max P
That’s called the clinical pathway model, in which patients are channeled into slots and treated alike regardless of their individual pathophysiologies that might deviate from the norm for that slot. It turned doctors into cogs in a machine who really can’t think outside the box.
COVID-19: All the wrong moves in all the wrong places
https://stke.sciencemag.org/content/13/649/eabe4242
Clinical treatment protocols have been developed largely because of the extensive evidence that physicians fail to detect many treatable conditions, and when detected fail to treat sufficiently, including per current evidence.
An example is blood pressure. There is vast evidence that docs will medicate patients to a certain degree, but not further, to evidence-based clinical goals. Docs fail to go further either because they are afraid to cause the level of side effects that would occur, or because they do cause side effect complaints, and back off.
There is a Wikipedia entry for “therapeutic inertia” to get you started.
Clinical pathways can improve this.
Also, there are a fair number of situations where docs under-treat minorities relative to white patients. Clinical treatment pathways in some cases reduce this disparity since they reduce individual discretion in treatment decision-making, which is where these racial biases enter.
A lot of what physicians do is very routine and formulaic. So, why not follow a formula or a routine? Why pretend each patient is a blank canvas demanding an original work of art?
What was the role of Obamacare in this mess?
The article is well written. But I think it’s fair to ask who is Leo Goldstein? A Google search turns up a few hits but none of them is an expert in disease or drugs.
You inability to address any of the points in the article, or add anything of value to the discussion, as well as your use of the appeal to authority logical fallacy is noted.
1) The article is well written.
2) The author is not noted as an expert in disease or drugs.
3) What is your point?
From all I’ve read and listened to about this virus and the many medications that there are in helping to get over this illness — this is the way I see it, I may well be quite wrong.
At its basics this virus less to do with having a lung infection and more to do with the virus’s attack on red blood cells. This virus attack is two fold on the red blood cells, increasing the clotting, and lowering red blood cell’s ability to carry oxygen to the rest of the body. This virus changes the shape of the red blood cells (https://www.msn.com/en-in/health/medical/red-blood-cell-changes-could-help-identify-covid-patients-with-higher-death-risk-study-finds/ar-BB19nBmy ) — could this not be used for better diagnostic tests than the error prone PCR test? This virus binds to the ACE2 part of the cells.
So should it be that surprising to medical researchers that such medications as hydroxychloroquine should work in blocking this virus? Hydroxychloroquine also binds to the ACE2 part of the cells. Hydroxychloroquine as an anti-malarial drug interferes with the way the malarial parasite attacks/attaches to red blood cells while improving its oxygen carrying capacity.
Note — The three major co-morbidities are not lung problems – diabetes, cardiovascular disease, and kidney disease but these would be made worse by low blood/oxygen levels.
Maybe the success of HCQ treatment depends on where you live? /s
From hcqmeta.com “Significantly more studies in North America report negative results compared to the rest of the world” based on their study of 121 HCQ trials around the world.
Overall they report “HCQ is effective for COVID-19. The probability that an ineffective treatment generated results as positive as the 121 studies to date is estimated to be 1 in 27 million (p = 0.000000037).”
I haven’t seen hcqmeta.com praised or panned on WUWT yet, but I’m sure it will be shortly….
Dr John Campbell, who has a daily blog update on Covid-19, cites a new (8/24) pro-HCQ study:
https://www.youtube.com/watch?v=2uzXHnUViro&feature=share
Belgium Low-dose Hydroxychloroquine Therapy and Mortality in Hospitalized Patients with COVID-19: A Nationwide Observational Study of 8075 Participants (International Journal of Antimicrobial Agents, 24 August)
https://www.sciencedirect.com/science/article/pii/S0924857920303423
Campbell claims no-effect studies used too high a dose.
The Belgian study didn’t employ zinc. If it had, maybe its results would have been better.
Results
8075 patients with complete discharge data
HCQ group, n = 4,542
Deaths, 804, (17.7%)
no-HCQ group, n = 3,533
Deaths, 957 (27.1%)
Multivariable analysis:
Mortality was lower in the HCQ group compared to the no-HCQ group
Hazard ratio = 0.684
Estimated direct-adjusted mortality at 40 days
19.1% with HCQ alone
26.5% with supportive care only
Mortality in the HCQ group was reduced
Both in patients diagnosed in less than 5 days and more than 5 days
Conclusions
Compared to supportive care only, low-dose HCQ monotherapy was independently associated with lower mortality in hospitalized patients with COVID-19 diagnosed and treated early or later after symptom onset.
I am no expert on these trials, but if you are interested in looking at results of different studies, this page could be helpful. https://c19study.com/
SCANDAL:
The French Ministry of Health may be organizing the shortage of hydroxychloroquine putting pressure on Sanofi to stop delivering stocks of hydroxychloroquine to the central pharmacy of the University Hospital Institute in Marseille that so far as treated all patients to great results.
Professor Raoult explains in French:
https://www.mediterranee-infection.com/decision-de-lansm-sur-lhydroxychloroquine-ce-que-nous-en-pensons-ce-que-nous-allons-faire/
If this is confirmed, then it is utterly stupid from authorities:
1) without treatment, ICU and deaths, that were among the lowest in the world in Marseille, will rise demonstrating in spite of themselves the benefit of hydroxychloroquine associated with azithromycin
2) since the organization of this shortage is known, described and publicized, the double speak of French health authorities will be exposed and thus they would discrediting themselves.
It is very interesting that there is a cluster of communicable disease experts in French Marseille and that that cluster of communicable disease experts highly recommend HCQ plus AZ, based on months of clinical use treating covid patients.
Stupid is when people make a mistake due to a lack of care. What is happening is not ‘Stupid’, it is mass murder.
Stopping delivery of a drug (that was been used for more than two decades) that is highly effective to stop a pandemic is a criminal act.
When crimes are committed and there are no charges…. There is a reason why there are no charges.
Deep state corruption. Our government does not work (the government is not on the side of the people and our legal system is corrupt to the core) because of deep state corruption.
Deep state corruption ends when hundreds of people go to jail and lose all of their money.
Those people in our system FDA, CDC, who are implicated in the conspiracy. and the politicians need to be charged with conspiracy to commit mass murder. People died because of their actions.
There is an effective treatment even cheaper than HCQ – Vitamin D.
Trump was given that as part of his treatment.
This study from Spain is quite astonishing in its results:
https://www.sciencedirect.com/science/article/pii/S0960076020302764
Note also that their standard treatment id HCQ + Zinc. it’s only countries with rampant TDS that are willing to kill hundreds, if not thousands of people to satisfy their blind hatred.
Targeting the endolysosomal host-SARS-CoV-2 interface by clinically licensed functional inhibitors of acid sphingomyelinase (FIASMA) including the antidepressant fluoxetine
An anti-depressivum as “new” drug against Cov-19
When taken early enough garlic is at least as effective as any other “antiviral.
When enough is taken ‘social distancing’ is not a problem.
There is SO MUCH potentially interesting data missing in these studies that it defies explanation. For example, it would be interesting to know the blood type, race, and sex of patients. It would be interesting to have some kind of record of the use of Zinc, various vitamins, quinine, and other drugs and supplements. This allows data mining to look for patterns – one cannot assume that all blood types, races, and sexes have equal outcomes.
It does not surprise me that anti-virals are not given until after 6 days…it generally takes time for symptoms to become pronounced enough to seek a hospital.
The biggest problem uncovered so far with all these medical studies seems to be twofold – medical professionals seem unable to organize good studies that still help patients, and their biases seem to overwhelm their rational thinking. Add into this the outright fraud of liberal leaning organizations that just want to embarrass Trump and you have BAD SCIENCE.
It makes me wonder if any of this will ever be addressed once the crisis passes?
Chlorine Dioxide is all you need to overcome COVID-19 as well as a huge number of other illnesses. Thirty dollars will produce enough Chlorine Dioxide to treat hundreds of people, I know because I have produced it and used it to treat myself and was shocked by the results.
https://www.collective-evolution.com/2020/05/20/was-trump-right-new-study-shows-success-with-use-of-chlorine-dioxide/
Authorities in Guayaquil, Ecuador, which was particularly hard hit early in the pandemic, developed a treatment regimen of HCQ and azithromycin in the early stage of infection and nitazoxanide in the advanced stage of the disease. Their mortality rates fell sharply after implementing this treatment regimen.
The Oxford Recovery Trial exhibits a noticeable “design to fail”about it. Why such HUGE overdoses?
Hospitalised patients,already in serious condition.
See Prof Landray interview on France Soir. See him struggle when questioned about the doses received by patients.The french medical expert was dumbfounded by the Profs reply.
Right on!
Here is the interview of Landray link: http://www.francesoir.fr/politique-monde/interview-exclusive-martin-landray-recovery-hydroxychloroquine-game-over-uk
Here are other links from France-Soir
http://www.francesoir.fr/societe-sante/oxford-authors-british-clinical-trial-recovery-attempt-hide-deaths-overdose?
http://www.francesoir.fr/aglais-remdesivir-une-molecule-dinteret-therapeutique-tres-discutable-sur-le-covid-19?
One of the study’s flaws was: “Arbitrary Removal of Sites from Final Statistics.”
Reminds me of the what happened with the Surface Stations network and how NASA/GISS data have been (using unproven & inconsistent methods) adjusted to account for the retirement, miss-management, and relocation of Stations, as well as cherry-picking of data and other distortions of climate models and studies funded by federal grants (e.g., no clouds).
One common element is the involvement of government bureaucrats.
Ok.
Just trying a further contribute with my rumblings.
In consideration of all considered medications there, of any kind, the possibilities of the best application(s) and/or combos possible there, it is huge… and even mesmerizing.
When in some cases, some applications and combos look and seem and also really considered rightfully so as miracles…rightly so,
but, but but, this so till one comes to consider the danger and fatality of IDS.
The list of available medications that work or could work in the case of IDS, is far far too short.
Not only remdesivir will not work, but even the antibody plasma treatment will not be good enough… and will consist with a high potential of making things worse before it helping it.
HCQ, and the class that it belongs, a very very short and little class, does first no harm in consideration of IDS, makes not things worse and still assist possitively, even when in comparing with other medications not found to be so potential, still if applied properly and in time can be the only among very very few medications that makes a difference in consideration of an IDS condition… when and where a proper IDS condition happens to be a very or considerably a very very high risk health condition in severity or/and fatality.
In the modern times, we living in, with this whole evolution in technology and medications available there, we still fail to realize and acknowledge openly, that when it comes to a proper IDS condition the medical arsenal we posses for treatment is far too limited… far too short and far too little.
And the worse, we still keep ignoring it, even when so little there, and many times over and over keep failing to even apply it properly and correctly, that little there is.
Neither remdesivir or antibody treatment of any kind belongs in that very short least of medications that works in the case of IDS.
Neither vaccines or antibiotics work or help there at all, no any such treatments part of that very short list of medications that do work and could make a difference in the case of an IDS condition.
So, when it comes to COVID-19;
In one case, the soft normal one, the list of medications and treatments to help and assist, in combos also,
it is huge.
But in the other case, the very lethal “COVID-19” of hospitals, as it happened when it did, the list of medications that could help, if applied in time and correctly, it is still very very very short one indeed.
cheers
It appears there are other anti-viral cures for covid in addition to HCQ.
Invermectin and Annita… two broad spectrum anti-parasite drugs also ‘cure’/stop covid from replicating if give as soon as covid symptoms appear according to Brazil’s President Bolsonaro.
The standard approach for covid should be anyone that has symptoms receives early anti viral treatment with of probably a half dozen effective treatments.
The Covid mass murder scandal is only the tip of the iceberg.
Logically we should be using the cheapest, safest, medical treatments should be the first line of defense against covid. That would be correcting the population’s Vit. D deficiency. That would also reduce all medical costs by roughly 70%. It is 100% all about the money.
It appears the French have used anti virals to reduce the covid death rate by a factor of five.
France had 52,000 new covid cases, the highest ever recorded. The French covid death rate has dropped which explains why the French are no longer isolating at home.
The French response to high covid new cases, is to close bars and restaurants from 10 pm to 6 am.
Those responsible for fake medical ‘research’ papers to hide HCQ…
Senior FDA officials and senior CDC official who it appears are hiding other cures for covid…
… need to be charged with mass criminal negligence resulting in death, lose all of their money, and no longer be allowed to work in the medical industry.
Cure not vaccine says Bolsonaro Brazil President
Invermectin and Annita… two broad spectrum anti-parasite drugs.
https://news.yahoo.com/brazils-bolsonaro-says-cure-not-162937636.html
Brazil’s Bolsonaro says cure, not vaccine, way out of coronavirus crisis
“I’m an example, I took chloroquine, others took invermectin, others took Annita,” Bolsonaro said also referring to two broad-spectrum anti-parasite drugs.
“Everything indicates that everyone that took one of these three alternatives early on was cured,” he added without providing any scientific evidence to support his statement.
None of the drugs mentioned by Bolsonaro have been proven to work and none are authorized for the treatment of COVID-19 in Europe, for example.
Trump was berated for saying the drug worked and then was actively restricted from use.
Trump might have been a bit overly optimistic: “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. ”
Regardless of the final outcome, the hype was irresponsible
What was hyped?
The hype by who?
Interesting.
Unfortunately it’s all about politics and feelings (Trump said it’s good so its bad). Facts don’t matter anymore.
Leo Goldstein, thank you for the essay.
Hydroxychloroquine is useful in all phases of COVID-19 because it is both antiviral against SARS-COV-2 and immunomodulator.
Has that been shown? The supporters of HCQ that I have read have claimed that it only works when administered early.
It complements the body’s defenses. HCQ acts as a border guard. It’s most effective when administered early, and with smaller doses to reduce side-effects. It’s most effective when combined with Zn to inhibit reproduction and Az to reduce infections and inflammation.
The claim “only works when administered early” was Didier Raoult’s very first position; he admitted quite some time ago that HCQ is more useful that just in that case.
OTOH waiting as much time as possible and testing the drug too late to be useful is an old and tired strategy that has only impressed haters. But it really did impress haters!
Note that even in the criminal m u r d e r plot called RECOVERY – which is officially the best the UK medical institutions have to offer (which means the UK is just a thug failed state) – HCQ seems to have done some good. (Of course the protocol was designed to avoid being a scientifically useful experiment – it was a socially useful experiment, the same way a terror attack in France is.)
Here’s more:
https://www.washingtonexaminer.com/news/study-shows-hydroxychloroquine-may-be-effective-for-outpatients-with-covid-19
Early treatment study Source Study Page
Derwand et al., International Journal of Antimicrobial Agents, doi:10.1016/j.ijantimicag.2020.106214 (preprint 7/3) (Peer Reviewed)
COVID-19 Outpatients – Early Risk-Stratified Treatment with Zinc Plus Low Dose Hydroxychloroquine and Azithromycin: A Retrospective Case Series Study
79% lower mortality and 82% lower hospitalization with early HCQ+AZ+Z (~
No cardiac side effects. Retrospective 518 patients (141 treated, 377 control).
“The study was not double blind, but was reported as such”
->
Raoult was accused of not following the intended protocol in his trial of HQC
“The pre-registered protocol was changed multiple times over the course of the trial”
->
Raoult was accused for changing the measured value (once) during trial
“The primary outcome was changed in the middle of the trial, apparently because the researchers noticed a lack of effectiveness of their drug as tried
The outcome measures were subjective and not reliable”
->
The trial of HQC measured viral load at a given day (criticized as arbitrary) by RT-qPCR, a method widely criticized as not reliable and not reproducible… but not subjective.
“The study was marred with conflicts of interest, aggravated by the design giving NIAID and Gilead leverage over the hospitals and physicians treating patients”
Raoult was accused of having a conflict because of (past?) financing by maker of HQC – a lab that doesn’t want to be associated with any of that, that seems to hate that controversy, and that discouraged HQC use for COVID.
Among all accusation against Didier Raoult, that accusation of conflict of interest is one of the most stupid. These Raoult haters are usually extremely stupid, and are hated in France.
Nothing I wrote comes close to a defense of Didier Raoult. It’s just that his adversaries are too lame.