CHINA REVEALS ITS FIRST CURATIVE MEDICATION
BEIJING, Feb. 17 (Xinhua) -- Chinese experts, based on the result of clinical trials, have confirmed that Chloroquine Phosphate, an antimalarial drug, has a certain curative effect on the novel coronavirus disease (COVID-19), a Chinese official said here Monday.
The experts have "unanimously" suggested the drug be included in the next version of the treatment guidelines and applied in wider clinical trials as soon as possible, Sun Yanrong, deputy head of the China National Center for Biotechnology Development under the Ministry of Science and Technology (MOST), said at a press conference.
Since the revelation of Xinhua, there was no need for the placebo arm in any trial on a new protocol, the placebo should have been chloroquine, and then HCQ. Doing that would have saved the eight people who died for science.
DYING FOR MERCK
KENILWORTH, N.J. & MIAMI--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death... Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/
Randomized controlled trial
Many papers discuss the disadvantages of RCTs.[77][95][96] Among the most frequently cited drawbacks are:
Time and costs[edit]
RCTs can be expensive;[96] one study found 28 Phase III RCTs funded by the National Institute of Neurological Disorders and Stroke prior to 2000 with a total cost of US$335 million,[97] for a mean cost of US$12 million per RCT. Nevertheless, the return on investment of RCTs may be high, in that the same study projected that the 28 RCTs produced a "net benefit to society at 10-years" of 46 times the cost of the trials program, based on evaluating a quality-adjusted life year as equal to the prevailing mean per capita gross domestic product.[97]
Emphasis on RCTs has blocked the use of repurposed medications.
There is no big money to be made selling such medications, thus it is difficult to find an honest RCT on a medication out of patent
Dr. Zelenko treated 2000 patients, with two deaths and four hospitalisations. He used additional medicines, such as ivermectin and quercetin and fluvoxamine, and published a study based on his previous work: that was a retrospective study.
Dr. Didier Raoult has rejected the idea of organising an RCT to determine the value of his Covid-19 protocol. He says it would be unethical to deny medication and cause grave illness or death, just to prove that his Protocol works.
Dr. Paul Marik: "You never recommend ivermectin alone; it is part of a package of medicines that work together. .. It's immoral to give people a placebo when there is a potentially effective therapy. It goes against the Hippocratic oath... You cannot give a placebo to who has... risk of dying... this complete obsession with randomized control trials in the midst of a pandemic... you are the doctor at the bedside... these are ivory tower people, they look at spreadsheets, not at patients. It's immoral and unethical not to provide the patient in front of you with the best care you have."
Fixation upon RCT's has even blocked the use of vitamin D in the prevention and cure of childhood pneumonia. Thus WHO doctors have for ten years been pleading for pneumonia prevention and treatment with vitamin D. but there is non money for RCT's on the use of cheap medications.
The conduct of an RCT takes several years until being published; thus, data is restricted from the medical community for long years and may be of less relevance at time of publication.[98]
Back in 2011, the WHO had published a report under the title “Vitamin D supplementation and respiratory infections in children”. Their conclusion was that "vitamin D deficiency in children has been strongly associated with risk of acute lower respiratory tract infections in a number of settings… During the winter months… acute lower respiratory infections are more frequent in children and adults. Vitamin D is thought to play an important role in immune system regulation, and can potentially protect against infections... vitamin D supplementation appears to reduce the incidence of and adverse outcomes from these conditions... reducing all cause mortality.”
The unnamed authors of the WHO report try to promote vitamin D, and offer in evidence 34 articles from medical publications; they do not appear pleased, when they note that "the recommended daily dose for children is still in debate." https://www.who.int/elena/titles/bbc/vitamind_pneumonia_children/en/
Where does this debate take place? Behind the scenes, at the WHO palace. Even more important, at the ministries of health of the great powers that fund the WHO. And let's not forget the headquarters of the big pharma companies. It will be there, that those who today head the ministries, tomorrow might find very well-paid positions.
Conflict of interest dangers[edit]
Some RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome.[100]
A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs "are more likely to be associated with statistically significant pro-industry findings."[101] These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials.[102] One possible reason for the pro-industry results in industry-funded published RCTs is publication bias.[101]...
If a disruptive innovation in medical technology is developed, it may be difficult to test this ethically in an RCT if it becomes "obvious" that the control subjects have poorer outcomes—either due to other foregoing testing, or within the initial phase of the RCT itself. Ethically it may be necessary to abort the RCT prematurely, and getting ethics approval (and patient agreement) to withhold the innovation from the control group in future RCT's may not be feasible.
Giving preeminent importance to RCT, we effectively prioritise new thus highly profitable medications over existing repurposed ones.
Agencies and organisations, from the WHO down to every health ministry, want to please the generous billionaires who have made big donations, while individual ministers look forward to have important position in industry, after retiring from public life. So they insist on the kind of lengthy trials that no one will ever pay for.
Ethics
Although the principle of clinical equipoise ("genuine uncertainty within the expert medical community... about the preferred treatment") common to clinical trials[24] has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs.[25] For another, "collective equipoise" can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective).[26]Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical "for most therapeutic trials."[27][28]
Although subjects almost always provide informed consent for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment.[29][30] Further research is necessary to determine the prevalence of and ways to address this "therapeutic misconception".[30]
The RCT method variations may also create cultural effects that have not been well understood.[31] For example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful.
WHY SCIENTISTS AND INVESTORS DEMAND RCT'S
We know that the gold standard for Pharma is the double-blind RCT. It is expensive, complicated, and tends to require such level of paperwork as to exclude immediate acting, upon appearance of symptoms.
Demanding RCT's has been the key method for excluding cheap out-of-patent medications. Thanks to the gold standard of medical research, mortality remains high, everywhere Pharma controls the discourse, talking softly and carrying a big stick.
Where medics are allowed to operate independently from the dictates of WHO, CDC, FDA, EMA and their great patrons from Pharma, Covid-19 has been beaten.