Writing in the New England Journal, Dr. Fauci and his deputy, Clifford Lane tell us that despite “appropriate treatment with Remdesivir and dexamethasone, far too many people with Covid-19 will die.” And if Fauci keeps preventing the use of cheap, available and effective treatments, he will be correct. See “The Key to Defeating COVID-19 Already Exists. We Need to Start Using It” in yesterday’s Newsweek, by Harvey Risch, MD, PhD and Professor of Epidemiology at Yale, who does not want “far too many people” to die unnecessarily.
1. The Fauci article implies that so many people dying is partly the fault of observational studies and anecdotal evidence… whereas large prospective clinical trials can provide the answers we need. The authors list a variety of new drugs (all would be expensive) that hold promise for Covid and need to be tested. Fauci took the same approach to HIV treatment, preventing access to known effective drugs for years. He has not had much luck finding an HIV vaccine, despite spending a king’s ransom in taxpayer dollars looking for one. Yet he promises to produce a Covid vaccine at warp speed. Who is he kidding?
2. While congratulating the Recovery trial for its results, which allegedly prove that hydroxychloroquine does not work for Covid-19, the authors emphasize the importance of ethically conducted research, never mentioning the overdosing that characterized Recovery’s hydroxychloroquine arm, and no doubt contributed to the 396 deaths in that arm.
3. Nor do the authors mention that even the Recovery trial’s principal investigators only claim that their trial showed hydroxychloroquine did not work in hospitalized patients. Its benefit in early Covid-19 disease, and its value as a preventive for Covid-19 have yet to be proven in western clinical trials. India says its 3 clinical trials showed the drug worked, and it is now recommended prophylactically for all medical practitioners and first responders in India who may be exposed.
4. So why did Capos Fauci and Lane halt the long-promised NIAID trial of hydroxychloroquine in outpatients with early Covid-19 disease after enrolling only 20 subjects, a mere 1% of the 2,000 intended, according to the trial’s registration materials on Clinicaltrials.gov? Were they afraid that given the intense scrutiny this subject is now receiving, they would be unable to ‘fix’ the results of their very own prospective, randomized, controlled clinical trial? Frightened it would reveal more evidence that hydroxychloroquine actually works well against SARS-CoV-2?
Excerpts from Fauci/Lane’s NEJM opinion piece, with my comments in parentheses:
In the RECOVERY trial, the benefit of the glucocorticoid dexamethasone for patients with Covid-19 who were receiving mechanical ventilation at the time of randomization was clearly shown. A 28-day mortality of 29.3% was reported for patients in the dexamethasone group as compared with 41.4% in the usual care (i.e., nothing curative used–Nass) group. In contrast, no benefit for dexamethasone was seen in patients not requiring oxygen at the time of randomization, with 28-day mortality of 17.8% and 14.0% for the dexamethasone group and the usual care group, respectively. For the heterogeneous group of patients receiving oxygen without invasive mechanical ventilation, mortality was 23.3% in the dexamethasone group and 26.2% in the usual care group.
(The MATH+ protocol recommended steroids for late Covid-19 patients back in April. The patients treated with this protocol received other drugs as well, and reportedly have had much lower mortality rates, but so far the results have not been published. Mortality rates in the Recovery trial are among the highest reported in the world.–Nass)
These findings, while limited to patients with Covid-19, provides clarity to an area of therapeutic controversy and probably will result in many lives saved. (sic) The use of dexamethasone already has been endorsed by several treatment-guideline panels, including that convened by the U.S. National Institutes of Health.
(This is the guidelines group put together by coauthor Clifford Lane, who has financial COIs with Gilead, and who placed 15 others with Gilead connections on the guidelines committee, which included himself.–Nass)
The key to the success of the RECOVERY trial has been its pace of enrollment. The ability to rapidly enroll thousands of patients into the trial no doubt was facilitated by the National Health Service in the United Kingdom and the fact that the trial was available to essentially the entire patient population of the country.
(While the authors crow about the “availability” to patients of being a subject in the Recovery clinical trial, I would posit that being in the trial led to less individualized treatment, use of fewer therapeutic agents, and higher mortality rates.–Nass)
As noted by the authors, 15% of all the patients who were hospitalized with Covid-19 in the United Kingdom were enrolled in the trial.
Despite the decreases in death and complications that are likely to result from appropriate treatment of patients with remdesivir and dexamethasone, far too many people with Covid-19 will die.
Scientifically robust and ethically sound clinical research remains the quickest and most efficient pathway to effective treatment and prevention strategies for patients with Covid-19. It is our responsibility in the global medical research community to rapidly design, implement, and complete studies of the most promising therapeutic agents and vaccines against this disease. These agents include monoclonal antibodies, more selective immunosuppressive agents, and vaccines built on platforms ranging from nucleic acids to proteins to recombinant viruses.
(But if Fauci is to get the opportunity to trial those novel, expensive drugs and vaccines, some of which have yet to be invented, he would need to keep the pandemic going. Which is certainly not ethically sound, nor is it quick and efficient.–Nass)