Can you trust the government’s medical “experts?”
Experts study their subject, continually narrowing their focus on individual aspects of their field as they grow their expertise. Over time they know more and more about less and less until they know everything about virtually nothing. That this hyper-specialized knowledge can be transferred to other areas, especially outside their narrow field of expertise, is highly doubtful.
Those experts who head institutions or individual departments within institutions become bureaucrats over time. Bureaucrats who are subject to outside forces to maintain their positions, advance to the next level of their career, to gain or avoid media attention, or to serve their self-interest agenda.
Those who operated within a bureaucracy controlled by politicians are those most likely to ignore data and the conditions on the ground as they struggle to maintain their position in a hostile political environment.
Which is why I wonder about Dr. Anthony Fauci, the physician/researcher who has served as the director of the National Institute of Allergy and Infectious Diseases since 1984 -- 36 years under both Democrat and Republican administrations.
Indeed, Dr. Fauci’s expertise does not extend to the economic, cultural, social ramifications of medical decisions driven by politics rather than objective science.
What I do not understand is this controversy over Hydroxychloroquine (Plaquenil), an anti-malarial drug used to treat several forms of malaria as well as lupus erythematosus and rheumatoid arthritis, and its use to ameliorate the effects of a coronavirus called SARS-CoV-2 which manifests as COVID-19 ('CO’ stands for ‘corona,’ ‘VI’ for ‘virus,’ and ‘D’ for the disease.) Hydroxychloroquine (Plaquenil) is a less toxic derivative of chloroquine (Aralen). There exist decades of experience with these drugs in clinical settings, both in-patient and out-patient. Side-effects are well-known and manageable. Whether or not it should be prescribed is a matter for physicians and their patients, not politicians and bureaucrats.
I question why various governmental agencies are inserting themselves into what is a physician-patient consideration of the risks and benefits of using hydroxychloroquine as a preventative or treatment for COVID-19? Especially when that treatment is widely available at pennies-on-the-dollar while pharmaceutical companies are charging thousands of dollars for their treatment products? Is this a case of politics and profits dictating public policy over science?
Again, the drugs and their side-effects are well-studied and have been known for decades. In many cases, it is both cheap and effective.
Effect of Chloroquine, Hydroxychloroquine, and Azithromycin on the Corrected QT Interval in Patients With SARS-CoV-2 Infection
The novel SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) is responsible for the global coronavirus disease 2019 pandemic. Small studies have shown a potential benefit of chloroquine/hydroxychloroquine±azithromycin for the treatment of coronavirus disease 2019. Use of these medications alone, or in combination, can lead to a prolongation of the QT interval, possibly increasing the risk of Torsade de pointes and sudden cardiac death.
Two hundred one patients were treated for coronavirus disease 2019 with chloroquine/hydroxychloroquine. Ten patients (5.0%) received chloroquine, 191 (95.0%) received hydroxychloroquine, and 119 (59.2%) also received azithromycin. The primary outcome of torsade de pointes was not observed in the entire population. Baseline corrected QT interval intervals did not differ between patients treated with chloroquine/hydroxychloroquine (monotherapy group) versus those treated with combination group (chloroquine/hydroxychloroquine and azithromycin; 440.6±24.9 versus 439.9±24.7 ms, P=0.834). The maximum corrected QT interval during treatment was significantly longer in the combination group versus the monotherapy group (470.4±45.0 ms versus 453.3±37.0 ms, P=0.004). Seven patients (3.5%) required discontinuation of these medications due to corrected QT interval prolongation. No arrhythmogenic deaths were reported. ‘
In the largest reported cohort of coronavirus disease 2019 patients to date treated with chloroquine/hydroxychloroquine±azithromycin, no instances of Torsade de pointes, or arrhythmogenic death were reported. Although use of these medications resulted in QT prolongation, clinicians seldomly needed to discontinue therapy. Further study of the need for QT interval monitoring is needed before final recommendations can be made.
Saleh, M., Gabriels, J., Chang, D., Soo Kim, B., Mansoor, A., Mahmood, E., Makker, P., Ismail, H., Goldner, B., Willner, J., Beldner, S., Mitra, R., John, R., Chinitz, J., Skipitaris, N., Mountantonakis, S., & Epstein, L. M. (2020). Effect of Chloroquine, Hydroxychloroquine, and Azithromycin on the Corrected QT Interval in Patients With SARS-CoV-2 Infection. Circulation. Arrhythmia and electrophysiology, 13(6), e008662. https://doi.org/10.1161/CIRCEP.120.008662 <Source>
Chloroquine is a potent inhibitor of SARS coronavirus infection and spread
Severe acute respiratory syndrome (SARS) is caused by a newly discovered coronavirus (SARS-CoV). No effective prophylactic or post-exposure therapy is currently available.
[OCS: Is this literally true today?]
We report, however, that chloroquine has strong antiviral effects on SARS-CoV infection of primate cells. These inhibitory effects are observed when the cells are treated with the drug either before or after exposure to the virus, suggesting both prophylactic and therapeutic advantage. In addition to the well-known functions of chloroquine such as elevations of endosomal pH, the drug appears to interfere with terminal glycosylation of the cellular receptor, angiotensin-converting enzyme 2. This may negatively influence the virus-receptor binding and abrogate the infection, with further ramifications by the elevation of vesicular pH, resulting in the inhibition of infection and spread of SARS CoV at clinically admissible concentrations.
Chloroquine is effective in preventing the spread of SARS CoV in cell culture. Favorable inhibition of virus spread was observed when the cells were either treated with chloroquine prior to or after SARS CoV infection. In addition, the indirect immunofluorescence assay described herein represents a simple and rapid method for screening SARS-CoV antiviral compounds.
[OCS: Can this study be extended? Perhaps yes, perhaps no?]
Vincent, M. J., Bergeron, E., Benjannet, S., Erickson, B. R., Rollin, P. E., Ksiazek, T. G., Seidah, N. G., & Nichol, S. T. (2005). Chloroquine is a potent inhibitor of SARS coronavirus infection and spread. Virology journal, 2, 69. https://doi.org/10.1186/1743-422X-2-69 <Source>
There are thousands of relevant studies, so many that no practicing physician has the time and energy to read, understand, and consider them all. It should be the duty of government panels to absorb this material and produce non-binding guidelines with the exception of instances when the drugs cause substantial and universal harm. And, in those cases, suitable warnings should be provided.
The science is growing day-by-day, now we need a neutral forum without political participants…
I am not saying that any of the studies offer conclusive proof of Chloroquine or Hydroxychloroquine’s effectiveness on the virus that causes COVID-19. What I am saying is to allow physicians and researchers, many of them as well-credentialed and experienced as Dr. Fauci, have their say in the scientific arena of debatable ideas and devoid of political consequences.
What I am saying is that the United Nations World Health Organization, the NIH, the CDC, etc. are all politically-driven entities, sometimes announcing helpful scientific advancements or warnings – and sometimes not. As we have seen in the past, these organizations can be affected by politics and lobbying by big pharma.
Do the bureaucrats sometimes get is wrong? (The AIDS/Bactrim Controversy)
Dr. Harvey Risch, a professor of epidemiology in the Department of Epidemiology and Public Health at the Yale School of Public Health. Dr. Risch has authored over 300 peer-reviewed publications.
RISCH: So the FDA is a very strange organization that has a history of not making science based rational based decisions about its approvals.
This was started, and most noticeably in 1987, when people with AIDS in New York City were dying of what is called pneumocystis pneumonia, PCP, and the clinical experience then had been amassed. A large number of cases who were prevented from dying by use of the antibiotic, Bactrim. This is even then was a generic medication and cheap.
And activists obtained a meeting with Dr. Fauci and 15 of his selected scientists at FDA, at NIH and asked Dr. Fauci just to make guidelines to physicians that they consider using Bactrim to treat preventively AIDS people so that they wouldn’t die of this pneumonia. Dr. Fauci refused.
He said, I want randomized, controlled, blinded, controlled trial evidence. That’s my gold standard. That or nothing. The activists left. The NIH did not fund any randomized trials. They raised money themselves from their own AIDS patients to collect the data to do a randomized trial.
It took them two years. They came back to Dr. Fauci.
During those two years, the FDA approved AZT as a treatment for AIDS, AZT works, but not completely. It needs other medications as well. And during the two years that it took them to get this data to come back to Dr. Fauci to support using Bactrim, 17,000 people with AIDS died because of Dr. Fauci’s insistence on not allowing even a statement supporting consideration of the use.
This has gone on before. Now, we have Dr. Fauci denying that any evidence exists of benefit, and that’s pervaded the FDA. The FDA has relied on Dr. Fauci and his NIH advisory groups to make a statement saying that there is no benefit of using hydroxychloroquine in outpatients.
And this is counter to the facts of the case. The evidence is overwhelming.
The FDA has also said that there is the harm of using these medications in outpatients overweighs the benefit; and in fact, they’ve said this with no information, no evidence whatsoever of any harm in outpatient use, and this is provable both by the fact that the FDA’s webpage says as a warning against outpatient use, but says it relies on inpatient hospital data, which means they don’t have any outpatient data.
As well as the fact that 90 percent of the cases of COVID this year have occurred since the time that the FDA restricted usage to inpatients only. So the FDA knows that it has no data for outpatients and no data on harm and yet, it denied the Henry Ford petition for outpatient usage.
Dr. Fauci and the FDA are doing the same thing that was done in 1987 and that’s led to the deaths of hundreds of thousands of Americans who could have been saved by usage of this drug. <Source>
Pneumocystis pneumonia can be prevented. Why did it take so long for well known preventative measures to be introduced in AIDS? <Source>
“Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and thus ultimate head of the ACTG (AIDS Clinical Trials Group), went as far as telling activists attending a 1987 meeting that there was no data to suggest PCP prophylaxis was beneficial and that it may, in fact, be dangerous.” Some years prior to 1987, Michael Callen, an AIDS patient advocate, received a similar response from Dr. Fauci, discouraging attempts to prevent PCP in people with AIDS on the grounds that there had been no controlled studies on the efficacy and safety of this intervention in this particular group of patients. Yet this same leadership did not feel there was any urgency to remove this obstacle by promptly conducting the appropriate trials.
[OCS: Treatment with Bactrim was cheap, appeared to be effective, and yet was rejected in favor of other more expensive treatment modalities.]
I am in the highest risk category, having multiple co-morbidities and a heart issue that can result in deadly arrhythmias. I believe in my team of world-class physicians -- not some bureaucrat, not some pharmacy benefits manager or druggist, and certainly not a socialist political clown-like, my governor, Gavin Newsom.
Anyone who watches television, listens to the radio, or reads the advertising in print publications is well aware of the numerous side effects (including death) of drugs that are being hyped to help you live a better life. Again, any drug use should be a question that should be asked of the physician who knows you and your conditions best – not some far-off “expert” or political hack.
We are so screwed.