The Health Ministry is attempting to purchase a drug to treat COVID-19 patients, even though the manufacturer has said it is not an effective treatment and does not reduce mortality from the illness. The ministry has asked to buy more inventory of the medicine, Actemra (Tocilizumab), an immunosuppressant that is mainly used to treat rheumatoid arthritis. The Health Ministry wants to buy the drug, which is already in use in Israel, through an accelerated purchasing process at a cost of over 11 million shekels.
On Tuesday, the ministry’s pharmaceutical division asked for an exemption from the regular competitive bidding process to buy Actemra. “According to current professional literature, the medicine reduces the chance of death by 45 percent and [leads to] a clinical improvement in coronavirus patients,” states the purchasing request. Despite what the ministry wrote, the manufacturer of Actemra, pharmaceutical giant Roche, issued an update on Wednesday concerning the third stage of its clinical trial for the drug. Roche said the medication did not meet the primary goal of the trial in improving the “clinical status of patients with COVID-19 associated pneumonia or … reduced patient mortality.”
The phase 3 clinical trial of the drug was a “global, randomized, double-blind, placebo-controlled” study. This means neither the patients or the doctors knew who was receiving the actual drug and who received a placebo, and included a control group of patients. The study was coordinated with the U.S. Biomedical Advanced Research and Development Authority of the Department of Health and Human Services, and conducted in dozens of medical centers in the United States, Canada, Europe and Israel.
The Health Ministry was asked whether it would reconsider its plan to purchase Actemra in light of the results, but the ministry said it would not. The Health Ministry said that a number of hospitals in Israel “are using the medication successfully and are reporting positive results,” and the drug is in routine use in the health system for treating other patients – so it will be used in any case, even if not for coronavirus patients.
Actemra was highlighted at the beginning of the coronavirus pandemic as one of the most promising experimental drugs for patients in serious condition suffering from severe pneumonia. Many doctors, in Israel and around the world, used it over the past few months, sometimes in conjunction with steroids, while studying its scientific effectiveness. The drug acts on the immune system and is intended to rein in its overactivity – a reaction known as a cytokine storm – that also appears in some serious coronavirus patients.
In the cytokine release syndrome, the body is responding with large numbers of white blood cells and inflammatory cytokines – which leads the body’s immune system to overreact and cause serious harm – in the lungs and in other organs. Actemra suppresses the action of a type of cytokine (IL-6) and is supposed to help restrain this excessive immune response.
There is still no effective, official, scientifically proven treatment for COVID-19. The process of finding and institutionalizing the toolbox for the illness is complicated and elusive, and drugs that seemed to be suitable early on have been found to cause harm in certain situations. Treating the disease is extremely complicated; sometimes the timing of a particular medication regimen can be the difference between a case’s improvement or deterioration.
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Until a proven treatment can be found, patients are being treated with drugs meant for other diseases – while trials are being conducted around the world to test their effectiveness and safety. One of these drugs is Remdesivir, the antiviral drug from Gilead Sciences that in some cases has been reported to cut hospitalization time of patients in serious condition by up to a third. Remdesivir has also been reported to have improved the condition of patients in milder condition by lowering oxygen saturation in the blood. The Health Ministry recently bought 22 million shekels worth of the drug, and now wants to buy more Remdesivir for another 51 million shekels.
Other experimental treatments currently in trials include Dexamethasone, a corticosteroid anti-inflammatory and immunosuppressant used to treat a large number of illnesses. Preliminary results from a British study last month showed that a low dosage has reduced mortality among patients on ventilators by up to a third. The timing of the treatment with Dexamethasone is critical: While it helps patients in serious condition, it may be dangerous for patients in less serious condition.
Anticoagulant drugs are also now part of the COVID-19 treatment protocol, after the discovery that one of the most noticeable characteristics of the disease is over-coagulation. Some coronavirus patients in serious condition have been given a transfusion of antibodies from patients who have recovered, but the results of this treatment are still unclear, as the patients are still receiving other treatments at the same time.
The Health Ministry said that as part of the global attempts to find a treatment for the coronavirus, many treatments have been undertaken using drugs used to treat certain other diseases to examine their possible effectiveness on COVID-19 patients. “This is the case for Actemra too, because it acts in a manner that shows a possibility of effectiveness for coronavirus patients who are experiencing a cytokine storm,” the ministry said. “In addition to the company’s announcement, there are other recent reports that show a 45 percent reduction in mortality for patients on ventilators, among other things.”
The ministry added that a number of Israeli hospitals that are “using the drug with success and report positive results. The drug is still in trial stages as a possible tool for treatment that is available to doctors based on their judgment. Of course, additional clinical trials are still required with a larger number of patients in order to determine the effectiveness of the preparation and its place in the algorithm of treating the disease.” In any case, if it is not used for coronavirus patients, it “will not be wasted” because it can be used for treating other patients, said the Health Ministry.