Aletho News

ΑΛΗΘΩΣ

Real Scientific Inquiry Requires Dissent. But That’s Not What the CDC and JAMA Want.

By Gilbert Berdine, MD | Mises Wire | March 19, 2022

Mendacity is worse than dishonesty. According to one essay on mendacity, “Mendacity connotes a mixture of dishonesty, hypocrisy and audacity.” Mendacity is an important theme of the play Cat on a Hot Tin Roof, by Tennessee Williams. “What’s that smell in this room? Didn’t you notice it? Didn’t you notice a powerful and obnoxious odor of mendacity? There ain’t nothing more powerful than the odor of mendacity!” I recently encountered this powerful and obnoxious odor in my email inbox with the arrival of a Medical News and Perspectives from the Journal of the American Medical Association (JAMA).

The title of this bit of medical mendacity is: “When Physicians Spread Unscientific Information about COVID-19.” Scientific information is curiously absent from the commentary. Instead, the words misinformation and disinformation in the body of the work are equated with unscientific information in the title. A number of people are accused of spreading misinformation, but no specific examples of scientifically incorrect statements are provided. The first specific claim of wrongdoing is “Ladapo continued to publicly contradict CDC recommendations on vaccines, masks, and testing.” The reader is required to accept that CDC (Centers for Disease Control and Prevention) recommendations are necessarily statements of scientific truth. This is religious dogma rather than the practice of the scientific method. The scientific method requires the free and open dissent from any scientific hypothesis by either empiric evidence contrary to the hypothesis or the logical extension of the hypothesis to an absurd conclusion. It is only by successful defense against dissenting opinions that scientific hypotheses become accepted as truth. By claiming that any dissent from CDC opinion is misinformation or scientific falsehood, JAMA has elevated the CDC to a divine source of infallible truth. JAMA further requests that medical boards become a new Inquisition to root out heresy and apostasy.

The JAMA commentary reserved special criticism of the organization America’s Frontline Doctors for the sins of opposition to “vaccination and mask mandates” and the promotion of “ivermectin and hydroxychloroquine for prevention and early treatment of COVID-19.” The JAMA commentary is dishonest by conflating opposition to mandates with opposition to the action being mandated. It is quite possible to agree with the decision to vaccinate yet be opposed to forcing others to agree with that decision. Furthermore, claims about vaccine efficacy and safety are always debatable, given that data have been withheld from the public and are necessarily incomplete about future events. The JAMA commentary is further dishonest in its implication that promotion of ivermectin and hydroxychloroquine is beyond the pale. The National Library of Medicine includes citations supporting the efficacy of ivermectin and hydroxychloroquine for covid-19. While the quality of the scientific information is always debatable, it is mendacious to claim that promotion of ivermectin and hydroxychloroquine is unscientific. The JAMA commentary is hypocritical in failing to note that CDC—the oracle of Delphi—has changed its position on the efficacy of masks multiple times during the course of the covid-19 pandemic. The JAMA commentary is dripping with audacity in asserting that anyone contradicting the CDC deserves excommunication from the practice of medicine.

Another specific citation of sin in the JAMA commentary noted: “A widely publicized January 23, 2022, march against COVID-19 vaccine mandates in Washington, DC, included physicians among its sponsors and speakers. A livestream of the event showed attendees shoulder to shoulder in front of the Lincoln Memorial, vanishingly few wearing masks.” Perhaps JAMA inquisitors should keep up with “The Science,” which currently questions the wisdom of masks during outdoor events. The history of science is full of examples where heresy and apostasy become generally accepted scientific truths.

The JAMA commentary is a typical authoritarian response to dissent. Authoritarians insist that people practice the logical fallacy known as appeal to authority. In this case, JAMA asserts that any statement from the CDC must be true, so any contradiction of CDC policy must be unscientific or misinformation. In this way, authoritarians relieve themselves of the difficult task of persuading people about the truth of their claims. The most common reason why people reject statements from authority is recent memory of lies from the same authority. The CDC has damaged its own credibility by admissions that it has withheld significant data on vaccines because the data might be misinterpreted. Rather than correct the mendacity of authority to increase trust in authority, the authoritarians demand that disagreement with authority be punished by some form of excommunication from civil discourse. In this case, rather than recognizing that the prevalence of people who disagree with statements made by the CDC is based on previous false or misleading statements by the CDC, JAMA asserts that any dissent from the CDC statements must be purged or silenced. True science with a small s welcomes dissent and agrees to debate dissent on the merits of the arguments rather than ad hominem attacks on the dissenters. The medical establishment is afraid to debate dissenters on the merits of the arguments demonstrating the weakness of the establishment narrative. JAMA does not even pretend to demonstrate that the heretics and apostates have made false statements. Instead, JAMA asserts that the CDC is infallible and any contradiction of CDC policy by physicians is de facto proof of heresy and should be punished by excommunication. The stench of mendacity emanating from the medical establishment has become powerful and obnoxious.

Gilbert Berdine is an associate professor of medicine at Texas Tech University Health Sciences Center and an affiliate of the Free Market Institute at Texas Tech University.

March 22, 2022 Posted by | Progressive Hypocrite, Science and Pseudo-Science, Timeless or most popular | | Leave a comment

Most authors of clinical trials published in JAMA and NEJM in 2017 failed to disclose industry payments

Authors of papers published in JAMA and NEJMreceived millions in undisclosed payments in 2017, an analysis finds.

By Natalia Mesa – THE SCIENTIST – January 24, 2022

A new analysis finds that 81 percent of authors whose work appeared in [two of the world’s most prestigious medical journals–SB] the Journal of American Medical Association and the New England Journal of Medicine in 2017 failed to disclose conflicts of interest in the form of industry payments.

The analysis reviewed 31 clinical trial reports from each of the two journals that were published in 2017 and identified 118 authors who, in total, received $7.48 million dollars in industry payments. The payment information came from Open Payments, a US government website where drug and device makers must report payments to physicians and health care providers. The analysis was posted as a preprint on medRxiv on January 1 and has not yet been peer-reviewed.

Of the 118 authors on the included papers, only a dozen did not receive any payments, according to the preprint. Of the 106 researchers who received payments, the payments ranged from as little as $6.36 to as much as $1.49 million. Researchers received payments for travel, food, speaking, and consulting services, among other things, STAT News reports. The 23 researchers that received the largest payments received a total of $6.32 million, of which $3 million was undisclosed.

The International Committee of Medical Journal Editors (ICMJE) recommends that researchers disclose payments they received in the three years prior to submitting a study for publication, so the analysis included all payments made to researchers between 2014 and 2017.

When publishing in ICMJE member journals, which includes JAMA and NEJM, researchers are required to follow the disclosure guidelines promoted by the ICMJE—which include disclosing payments. But this expectation was not met by many of the authors of the papers included in the analysis. According to STAT, the authors of the preprint say that their results suggest voluntary disclosure may not be adequate for avoiding financial conflicts or ensuring transparency.

“I’m not surprised, but really, I’m saddened and disappointed,” says Brian Piper, a neuroscientist and medical ethicist at the Geisinger Commonwealth School of Medicine, and one of the authors of the preprint, to STAT. “These are high-impact and highly influential journals. For many Americans, these are the centerpieces of evidence-based medicine. Many physicians subscribe to them. Many journalists turn to them for information.”

An NEJM statement to STAT says that the journal “follows the disclosure rules set by the ICMJE. The editors do review all of the more than 5,000 disclosure forms received each year but do not have access to primary records on which the information entered in the forms may be based. We expect the disclosure forms submitted by authors to be accurate and complete.”

JAMA has not yet responded to a request for comment on the preprint, STAT reports. 

According to STAT, Piper notes that disclosures that continue to rely on individuals may be a failed approach. Instead, he suggests that journals review Open Payments and provide a link showing payments made to authors.

January 28, 2022 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular | , | 1 Comment

Is there a Problem with the Lopez-Medina, Colombia-based Study Implicating Ivermectin?

Major Pharma Companies Including Merck Funding the Trial Site during the Study

By Michael B. Goodkin MD, FACC | TrialSite News | June 9, 2021

Although a great majority of ivermectin-based studies have indicated real promise, one particular study conducted by a small trial site in Colombia received unprecedented media attention when the study results indicated negligible impact. What hasn’t been disclosed by media is the seriously questionable pharmaceutical industry support of this one trial site. During the study, a handful of some of the largest drug companies in the world gave this site money. What’s not clear is why this occurred and whether the funds are correlated to some nefarious agenda. This author suggests that the publisher should have scrutinized this industry funding perhaps more carefully.

On March 4th, 2021, an article appeared in JAMA titled, “Effect of Ivermectin On Time To Resolution of Symptoms Among Adults With Mild COVID.” It concluded, “The findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the  effects of ivermectin on other clinically relevant outcomes.”

Dr. Eduardo Lopez-Medina et al. from Cali, Colombia, randomized 400 mildly ill patients, averaging 37 years old, to ivermectin 0.3 mg/kg or placebo. The time to resolution for ivermectin-treated patients was 10 days and placebo patients 12 days, which was not statistically significant.

Much has been written about the methodologic problems of the study but few read to the bottom of the article to see this:

Conflict of Interest Disclosures: Dr. López-Medina reported receiving grants from Sanofi Pasteur, GlaxoSmithKline, and Janssen as well as personal fees from Sanofi Pasteur during the conduct of the study. Dr. Oñate reported receiving grants from Janssen and personal fees from Merck Sharp & Dohme and Gilead outside the submitted work. Dr. Torres reported receiving nonfinancial support from Tecnoquímicas unrelated to this project during the conduct of the study. No other disclosures were reported.

Considerable press outlets noted this study, we suspect due to the fact that the ivermectin results were negligible, but none of the media addressed the possibility of conflict with industry.

Absolutely nothing has been written about the fact that the study was sponsored by Centro de Estudios en Infectogía Pediatrica and the authors were paid by 3 drug companies making COVID vaccines–Sanofi  Pasteur, GlaxoSmithKline, and Janssen– and two making COVID  therapeutics–Gilead and Merck.

We have some questions about this. Why did the authors disclose that they were receiving industry sponsor funds during the conduct of the study? Were these funds to actually direct the ivermectin study? That would most certainly be a conflict of interest material.

Merck’s expressed their intent on competing against the ivermectin generic approach. Why would this company be funding this small trial site operation in Colombia?

How could JAMA even think about publishing an article sponsored by 5 drug companies centering on a study targeting a generic competitor? Any layperson seeing this could think that this was highly suspect.  

The potential conflict of interest was so severe that no journal should have published it.

Why would anyone do this study?  

Was there a pressing need to know if 37-year-old patients got better sooner with ivermectin than placebo? There were a lot of resources put into this study. The only possible reason to do the study was for drug companies to have a vehicle to publish negative data about ivermectin. Is there anyone who believes the study was sponsored to add to the scientific knowledge about ivermectin for the treatment of COVID?

On February 4th, 2021, Merck, who had the original patent on ivermectin, put out a  statement regarding ivermectin for COVID:

• No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies;

• No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease; and

• A concerning lack of safety data in the majority of studies.

If Merck believed these statements to be true, why would they feel the need to go public with them?  

Merck’s vaccine had failed. Merck had bought a company, Oncoimmune, for $425 million and gotten $356 million from HHS in taxpayer money to develop a therapeutic agent, CD24c. They had a material conflict of interest. Later, the European Medicines Agency and World Health Organization both quoted Merck’s statement while ignoring the conflict of interest and science in recommending against the use of ivermectin for COVID, other than for research. Were they influenced by Merck? CD24c was dropped, and Merck has oral antiviral molnupiravir in a phase II-III trial. Why would Merck sponsor a trial of ivermectin?

Why would JAMA publish an article showing that young patients who are expected to recover quickly don’t get better much more quickly with ivermectin?  

This article did not warrant publication in JAMA. The only possible reason to publish it was to present false, negative information about ivermectin to readers.

Why was the age of the patients not mentioned in the key findings or conclusions? 

The age of the patients made the article irrelevant. It could not have been an accident that the age was not mentioned in the key findings and conclusions. That would never happen at JAMA. The authors anticipated that many readers would miss the age of the patients and conclude that ivermectin is ineffective in early COVID. Dr. Adfarsh Bhimraj at Cleveland Clinic who heads the committee writing COVID recommendations for the Infectious Disease Association of America spoke with Helio Medical News on ivermectin. He had a similar observation in the Washington Post.

“This was a well-done, but small trial in patients with mild or moderate disease,” Bhimraj said. He suggested that this is a negative study for a non-mortality outcome, but because the numbers were small, it might not have produced a statistically significant difference in effect size. The evidence is not enough to warrant a recommendation for the use of ivermectin. Other US experts who commented on the article have failed to notice the age of the patients and drug company sponsorship. It has crossed few American physicians’  minds that JAMA could be corrupted and knowingly publish a study with deceptive results in order to help drug companies.

Was the data fraudulent? 

If the purpose of the article was to make it appear that ivermectin was ineffective in mild COVID, there is no reason to believe the data was real. There is no published randomized data for comparison. In the Dominican Republic, Dr. Jose Natalio Redondo reported that in 1300 patients with all degrees of illness, the length of illness went from 21 days to 10 days with ivermectin treatment.

Was JAMA aware that there was concern they had been corrupted and the article unreliable?

Sixteen members of the AMA Board of Directors were emailed that it appeared that JAMA had been infiltrated and the article fraudulent on March 10th, 2021. Eleven JAMA editorial board members were emailed about it April 12th. And one was spoken to. The same email was sent to executive editor Dr. Phil Fontanarosa April 13th. This reply was sent:

“Your message was brought to my attention.    

I will look into these issues as outlined in your letter.    

Please bear with me, as this will take some time, given the number of issues and the complexity of the concerns you raise, as well as other urgent issues and priorities we are addressing right now.” 

As of 6/8/21, the article has been read online 759,000 times. How many of those readers concluded that ivermectin is ineffective for mild COVID and, as a result, did not prescribe it for their patients? To put things in perspective, Uttar Pradesh, India, with 210 million people, started ivermectin in August. By December, their mortality rate was 0.26 per 100,000. In the US, in December, it was 11 times higher at 2.8 per 100,000. Admissions in Mexico are down 75% due to ivermectin.

The JAMA article of 3/4/21 was a cleverly devised drug company creation designed to create the false impression that ivermectin was ineffective in mild COVID by claiming it didn’t shorten the duration of illness significantly. They knew people would miss the age of the patients and not read to the bottom of the article to see that it was sponsored by 5 drug company competitors. They knew people would leap to the conclusion that ivermectin was completely ineffective for COVID, not realizing that the article could not address its effects on hospitalization and death. An infectious disease doctor friend sent it to me as proof that ivermectin does not work. Drug companies would not have gone to these lengths if they did not fear ivermectin as a competitor.

JAMA reviewers could not possibly have missed the obvious conflict of interest. It was obviously their intention to spread misinformation. Leaving out the age of the patients was intentional to make readers think it was ineffective in everyone. The article has not only led to patient care being adversely affected but the article has been widely quoted as evidence against the use of ivermectin. WHO says it is the number one article in support of its position.

Doctors should contact JAMA to understand what is going on with the investigation. JAMA should report on their findings as they committed to this author to undertake an investigation.

June 9, 2021 Posted by | Corruption, Deception, Science and Pseudo-Science | , , | Leave a comment