- May 15, 2020
- Dr. Peter Breggin and Ginger Ross Breggin
An Analysis of the Science and Politics
By Peter R. Breggin, MD and Ginger Ross Breggin
May 14, 2020
We have found that remdesivir is a failed antiviral drug that will probably do more harm than good for many coronavirus patients. An earlier remdesivir trial for Ebola was stopped because the drug was causing significantly higher mortality rates than other antiviral drugs in the same trial. As one recent medical source noted, the remdesivir Ebola trial had to be aborted “because of an increase in death among patients taking it, meaning it did not help those patients”.
Remdesivir is not a specific anti-COVID-19 drug, as many people think. It is a general antiviral drug with a history of earlier failures, as well as adverse effects serious enough to kill patients. Dr. Anthony Fauci should never have made it his frontrunner for drugs desperately needed to treat the pandemic. We will describe very recent scientific data confirming these conclusions.
Fauci Cancels the NIH Remdesivir Trial for COVID-19
Dr. Fauci—Director of the NIH Institute for Allergy and Infectious Diseases—has clandestinely cancelled NIH’s remdesivir trial while he continues to audaciously promote the drug. Fauci signaled the end of the clinical trial when he announced that he had broken the double-blind by informing patients in the placebo group that they were not getting the antiviral drug remdesivir and allowing them to switch to taking it. In an interview, Fauci said that the results of the remdesivir trial were so promising, there was "an ethical obligation to immediately let the placebo group know so they can have access" to the drug.
Fauci had no ethical responsibility to break the double-blind to allow the placebo patients to get treatment. The drug was not saving lives, it has serious adverse effects from earlier trials, and its meager results were very disappointing and controversial. It is far more likely that he was ending the trial to cover up the disaster. In saving face for himself and the drug company, Fauci may have needlessly endangered the lives of the placebo patients by unleashing remdesivir upon them.
Like Tearing Up the Remdesivir Study in Front of Our Eyes
When Fauci announced he had broken the double-blind for his highly promoted remdesivir study, he basically tore up the study in front of our eyes, while telling us to take his word for everything. His actions left us wondering if he is hiding that remdesivir for COVID-19 is as disappointing and dangerous a failure as it was for Ebola. While touting the alleged positive results for remdesivir, Fauci has failed to announce the adverse effects profile. We simply do not know how dangerous the drug has proven to be in the aborted trial.
By breaking the double-blind, Fauci invalidated the NIH remdesivir study. We will never know what its conclusions would have looked like. Fauci’s remdesivir clinical trial will not even be eligible for publication in a reputable journal. Similarly, without the double-blind, the study could not have gained legitimate FDA approval if going through the agency’s normal approval process.
Once the double blind was broken, patients and researchers learned who was taking the medication and who was not. This turned Fauci’s “gold standard” clinical trial into the weakest kind of study, an open observational study—one in which highly biased researchers and analysts, such as Fauci, manipulate the unblinded data and offer their subjective opinions.
This is the study and the miracle drug that Fauci so highly touted two weeks ago, declaring “This will be the standard of care,” proving “that a drug can block this virus.” Now Fauci’s research is essentially worthless, except for the serious doubts it raises about the drug’s hidden safety profile.
Remdesivir Clinical Trial Published in Lancet Finds No Benefit and Very Serious Adverse Effects
Shortly before Fauci began touting his flawed and now-terminated study, strong peer-reviewed evidence from a genuine double-blind study was published indicating that remdesivir is both useless and dangerous in treating COVID-19. Together with the failed Ebola remdesivir trial, this new publication gives us two controlled clinical trials showing that remdesivir is probably doing more harm than good when treating viruses.
The recent multi-centered clinical trial was published in the world’s oldest and most prestigious journal, Lancet. In the study, remdesivir not only failed to demonstrate clinical improvement in COVID-19 patients, it inflicted potentially fatal adverse reactions on the patients in the form of increased damage to the lungs. Fauci may be killing unwitting patients by encouraging them, as he has done, to switch to the experimental and dangerous remdesivir.
The multi-center controlled clinical trial published in Lancet found remdesivir ineffective. It was devoid of any statistically significant clinical improvements.
Interpretation In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. (p. 1, bold in original).
In addition, despite the encouraging findings in non-clinical models, they found no antiviral effect for the drug in human patients:
Remdesivir did not result in significant reductions in SARS-CoV-2 RNA loads or detectability in upper respiratory tract or sputum specimens in this study.(p. 9)
Most importantly, Remdesivir produced very severe adverse reactions in the form of “respiratory failure” or “acute respiratory distress syndrome” in 5% of patients. In other words, 5 of every 100 patients taking remdesivir developed a life-threatening decline in their condition. The drug made their disease worse! This echoes the findings of the disastrous remdesivir Ebola trial.
Here is the Lancet study summary of adverse events serious enough to cause discontinuation of remdesivir:
More patients in the remdesivir group than the placebo group discontinued the study drug because of adverse events or serious adverse events (18 [12%] in the remdesivir group vs four [5%] in the placebo group), among whom seven (5%) were due to respiratory failure or acute respiratory distress syndrome in the remdesivir group. (p. 10)
Although the researchers were based in China, the publication of their scientific report had to pass the more rigorous Western standards imposed by the Lancet. By contrast, Fauci’s NIH remdesivir study has not passed peer review or been published anywhere—and because the double-blind has been broken, it should never be published in a legitimate journal. Now that Fauci has aborted it, scientists around the world will never know its real outcome. Instead, we are asked to take its meager, manipulated positive results on faith from Fauci without being told about its adverse event profile.
The study in Lancet was funded by numerous sources, including the Chinese government, the British government, the Bill and Melinda Gates Foundation, and by a drug company other than Gilead. Confirming Fauci’s biases, his Institute did not provide funding.
The gullible media has fawned over the NIH/NIAID press release of its unfinished, unpublished and aborted study on remdesivir while largely ignoring the completed remdesivir Chinese study in Lancet which found no statistically significant positive results for the drug and a very high rate of serious adverse effects.
Supporting an Unproven Financial Blockbuster Drug Over the Tried and True
As the Director of the NIH’s Institute for Allergy and Infectious Diseases, Fauci has been brimming over with enthusiasm for his clinical trial for remdesivir, claiming in advance that it was the greatest hope for stemming the epidemic coronavirus. At the same time, he has publicly criticized President Trump for promoting hydroxychloroquine without scientific clinical trials. This is a remarkable double standard.
Clearly, Fauci is a man on a mission—a mission to suppress one drug and to promote another. Because of Fauci, Trump has been ridiculed in the media for promoting hydroxychloroquine, an old and inexpensive drug with a great safety record in which he has no personal interest. But Fauci’s personal and professional interests drive him to promote a relatively untried experimental drug with two previously bad outcomes, including no clinical benefit and serious adverse effects.
Fauci chastised President Trump for showing enthusiasm for hydroxychloroquine in the absence of controlled clinical trials; but Fauci did nothing to conduct those much-needed trials. Instead, he rushed to sponsor remdesivir, and to boast about it, in the face of two existing negative clinical trials and before the drug had any positive clinical trials.
Fortunately, there are other physicians and scientists both in the news and on Twitter, who have spotted that Fauci is untrustworthy in his handling of the trials. Nonetheless, because of the way the media are hyping remdesivir, and with the fervent support of both NIH and the FDA, a new “blockbuster” drug is being created out of nothing. Remdesivir has little hope of genuinely helping people; and it can cause increased inflammation of the lung. However, unless the political tide turns on Fauci, remdesivir remains guaranteed to further enrich and empower the pharmaceutical empire and those who prosper within it, such as Anthony Fauci.
Remdesivir: A Cascading Failure from the Beginning
Fauci has been manipulating the remdesivir trials from the beginning. One example was highlighted by a May 1, 2020 headline in The Washington Post: “Government researchers changed metric to measure coronavirus drug remdesivir during clinical trial.”
Government clinical trial investigators changed the primary metric for measuring the success of Gilead’s experimental drug remdesivir as a coronavirus treatment two weeks before Anthony S. Fauci’s announcement that the drug would be the new “standard of care.”
When clinical trials are begun, the researchers are required to establish the “endpoints,” including a “primary endpoint,” which is the major measure of outcome and the main criterion for success. This is what The Washington Post was referring to as the metrics. The endpoints for remdesivir are listed in the original plan for the trials called the protocols. These initial endpoints for proving the success of remdesivir included truly meaningful criteria, such as the all-important lowered fatality rate and complete recovery.
Fauci Redefines Recovery to Included People Partially Disabled and Living at Home on Oxygen
As the trial continued, it must have become apparent to Fauci that his drug was not going to reduce mortality or even lead to complete recovery. When all the meaningful criteria for success were dropped, the one primary marker for success became “time to recovery”—except recovery included patients who remained hospitalized or who were at home requiring limitations on their activities and/or requiring oxygen. Here are the official criteria for “success”:
1. Time to recovery [Time Frame: Day 1 through Day 29 ]
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
What Fauci masterminded is so unbelievable that it needs repeating. Not only did recovery time become the single primary criterion for improvement, “recovery” was achieved even with the patient remaining in the hospital or returning home with limited activities and/or requiring oxygen. The miracle drug, by sleight of Fauci’s hand, had been surreptitiously reduced to a second-rate treatment that statistically does not save lives or lead to complete recovery.
Fauci’s NIH press release estimated that remdesivir shortened the recovery time for the COVID-19 illness by a mere four days (from 15 to 11). But as inadequate as that sounds for a wonder drug’s only achievement, it looks ridiculous when realizing that Fauci still had to reinvent the concept of recovery in order to get those limited results, ultimately stretching the concept of recovery beyond the limits of reason or sound medicine in order to fake effectiveness.
Although the NIH study for remdesivir failed to show a statistically significant reduction in deaths, NIH and the media have emphasized that there was a “trend” in a positive direction. That’s an unscientific pipedream. A “trend,” for example, is not a sufficient indicator of success for the FDA to approve a drug. If Fauci and his colleagues really thought the “trend” was going to be meaningful, they never would have prematurely ended the study before getting statistically significant evidence for this all-important failed result.
Finally, remdesivir must be given intravenously over a ten-day period. This procedure itself has risks. It also limits its use to patients sick enough to be hospitalized. As a result, it cannot be used as hydroxychloroquine is used around the world, as a prophylaxis and as a treatment to be given at the earliest signs of the disease before any need for hospitalizaton.
Good News from a Corrupt VA Study
Meanwhile, the corrupt Veterans Administration study that claimed to show that hydroxychloroquine was useless and dangerous instead documented that it was saving lives. When we re-evaluated the study, publishing a report and a video, we found that the hydroxychloroquine and azithromycin combination was lifesaving. The VA evaluated one group of patients who did so well that they did not require any specific medication or ventilation. They were the most well of the coronavirus patients with the very lowest death risk. The VA study then evaluated a group of the sickest patients, the ones most likely to die, who were given the more hazardous drug combination hydroxychloroquine and azithromycin.
How did the death rate of the sickest patients with combination drug treatment compare to the most well patients needing no drug treatment? There was no statistical difference in the death rates in the most well and the sickest groups. That is, the hydroxychloroquine and azithromycin combination was so astonishingly effective that it reduced the death among the sickest to the level of the most well patients. That’s a potential miracle drug!
A few days after we criticized the VA study, the Secretary of the VA made the TV rounds pointing out the inadequacy of the study, while praising the success of hydroxychloroquine in helping VA patients. He memorialized his opinions in a memo on April 29, 2020.
Valid studies of this combination drug regimen, perhaps with the addition of zinc, are needed. In the meanwhile, when a study aimed at discrediting a drug unintentionally turns out to show that in a combination it reduces the mortality rate of the sickest patients to the level of the most well patients, we need to take the finding seriously.
Frontline Physicians Around the World Oppose Fauci’s Viewpoint
Meanwhile, hydroxychloroquine, sometimes in combination with zinc and/or azithromycin, was already being widely used to treat COVID-19 around the world and had numerous clinical testimonials and informal studies supporting it. We have made some of these available in our Coronavirus Resource Center on www.breggin.com. Tragically, and mainly due to Fauci, governors in states like New York and Michigan continued to illegally limit the availability of hydroxychloroquine to doctors.
A May 7, 2020 survey of global physicians found that 55% were using hydroxychloroquine and 21% were using remdesivir. The survey concluded, “Remdesivir and Hydroxychloroquine are perceived as almost equally safe and effective.” But as noted, hydroxychloroquine is safer, has enormously greater treatment experience behind it, and it is given orally for prophylaxis and early treatment, while remdesivir is given intravenously to hospitalized patients.
Physicians around the world are resisting the growing political attacks on hydroxychloroquine. Unfortunately, we fear that fake promotionals from NIH and the FDA will make remdesivir a financial bonanza for Gilead and those associated with the company. For decades, this is how drug profiteering has worked. Better, safer, and much less expensive generic drugs are pushed aside by a deluge of advertisements, press releases, and positive news coverage for newly approved drugs, which too often are more dangerous and less effective.
Fauci’s Corrupt Treatment Panel
How deeply in bed was Fauci with Gilead, the powerful, wealthy drug company that makes remdesivir? Was Fauci bending over backward to favor Gilead?
Fauci’s institute has a panel for the purpose of developing treatment guidelines for the pandemic on an ongoing basis. It is called “NIH COVID-19 Treatment Guidelines.” Hundreds of drugs were coming up the pipeline seeking federal approval for treating the novel coronavirus. On a government treatment advisory panel, would you expect to find a dominant membership block that was financially indebted to one drug company with a single drug, while almost every other drug company and their drugs were left out?
Of the 50 members on Fauci’s committee to set treatment guidelines, only 11 had financial ties to drug companies. But nine of the eleven had financial ties to Gilead, remdesivir’s manufacturer. The ties consisted of “Research Support,” “Consultant,” and “Advisory Board.” Put simply, from the beginning, Fauci was stacking his treatment guidelines committee with Gilead.
It is no surprise that the stacked panel, before any clinical trials, came out strongly in favor of the highly experimental remdesivir and wholly against the commonly used hydroxychloroquine: “On the basis of preliminary clinical trial data, the Panel recommends the investigational antiviral agent remdesivir for the treatment of COVID-19 in hospitalized patients with severe disease” and “The Panel does not recommend remdesivir for the treatment of mild or moderate COVID-19 outside the setting of a clinical trial” (bold in original). Fauci’s outcome was predetermined or “fixed” from the start. This is not science and Fauci was acting like a promoter rather than a scientist.
What did Gilead get from Fauci? Everything. NIH organized and funded their trial, saving Gilead in the range of $100,000,000 dollars and, more importantly, years of time, while Fauci did his best to clean up any messy results. The remdesivir clinical trial was “sponsored by the National Institute of Allergy and Infectious Diseases (NIAID)” and was “the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19.” Gilead got what looked like a sure-thing bonanza from Fauci and Fauci is now desperately dancing around trying to keep it alive. His last-ditch magic trick was to pronounce the trial a success and then to cancel it before completion, so that the results could never be known.
Fauci was so comfortably intimate with Gilead that he dared to openly stack the treatment guidelines panel with people on the company’s payroll, while announcing the predetermined outcome in favor of remdesivir and against hydroxychloroquine in these same treatment guidelines. If Fauci can be so shameless about such obviously corrupt behavior, how many even worse offenses would he be willing to perpetrate in secrecy?
Dr. Fauci is treated with inordinate respect by the media and politicians. When challenged on one occasion by Rand Paul, a senator who is a physician, Fauci replied smugly that he relied wholly on the scientific data. He spoke as if he—Dr. Anthony Fauci—were the sole paragon of objectivity and scientific acumen. This was an arrogant way to speak to a fellow physician and besides nothing could be further from the truth. Fauci’s handling of the NIH trials for remdesivir, and his compulsive rejection of hydroxychloroquine, are more consistent with a master manipulator than an objective scientist. It no longer makes sense—and it is no longer safe—to listen to Fauci’s voice in the scientific and public discussion of the current coronavirus pandemic.