Info Service on Health Issues (Apr20/03)
cautions against use of untested drugs for COVID-19
Geneva, 29 Mar (D. Ravi Kanth) — The Director-General of the World Health Organization (WHO), Dr. Tedros Adhanom Ghebreyesus, has called on individuals and countries to refrain from using therapeutics that have not been tested and demonstrated to be effective in the treatment of the COVID-19 pandemic, which has claimed thousands of lives around the world.
In his briefing on 27 March, Dr Tedros said “the history of medicine is strewn with examples of drugs that worked on paper, or in a test tube, but didn’t work in humans or were actually harmful.”
He said in “the most recent Ebola epidemic, for example, some medicines that were thought to be effective were found not to be as effective as other medicines when they were compared during a clinical trial.”
Countries, he said, must “follow the evidence”, as “there are no short cuts”.
More worryingly, he said, “using unproven drugs does create a shortage of those medicines to treat diseases for which they have proven effective.”
“As the pandemic evolves and more countries are affected, we are learning more and more lessons about what works and what don’t,” Dr Tedros emphasized.
Under the so-called “Solidarity Trail” launched for clinical trials on 27 March, the WHO DG said, patients in Norway and Spain have enrolled to use “four different drugs or drug combinations against COVID-19” that will indicate “the safety and effectiveness.”
Dr Tedros, however, did not indicate the names of the four drugs and/or drug combinations against COVID-19.
The Economist magazine in its latest edition of 28 March said the drug “remdesivir” developed by Gilead, a US drug maker, is being used for clinical trials by the WHO.
For the sake of transparency, the WHO must clearly inform the public at large which drugs are being promoted for clinical trials and the names of the companies that have developed these new drugs, said a health analyst, who asked not to be quoted.
Given the unusual urgency to conduct clinical trials of new therapeutics on a war-footing, it would augur well for informing the public about the new drugs and the developers of these drugs, the analyst suggested.
If The Economist magazine could know that the WHO is promoting remedesivir, which had already created a huge controversy following the patent rights it secured from the US Food and Drug Administration last week, it is incumbent on the part of the world’s health watchdog to remain transparent in all its actions.
Dr Tedros, however, expressed sharp concern over “the global shortage of personal protective equipment (PPE)”.
He said it is “one of the most urgent threats to our collective ability to save lives.”
The DG said “WHO has shipped almost 2 trillion individual items of PPE to 74 countries and is preparing to send a similar amount to further 60 countries.”
On the use of “untested medicines without the right evidence,” the US President Donald Trump said on 27 March that hydroxychloroquine, the anti-malarial drug, could be used for combating COVID-19.
President Trump’s statements without evidence have caused a shortage for Chloroquine and Hydroxychloroquine in the US and other countries for the actual users against malaria and arthritis, according to several news reports.
To combat the use of untested medicines, Dr Tedros said earlier that WHO has launched the SOLIDARITY trial, to generate “robust, high-quality evidence as fast as possible.”
Dr Tedros said he urged the leaders from the Group of 20 on 26 March “to fight, unite and ignite” so as to “fight to stop the virus with every resource at our disposal,” to “unite to confront the pandemic together” and “ignite the industrial might and innovation of the G20 to produce and distribute the tools needed to save lives.”
On 27 March, the WHO DG held a briefing with 50 health ministers at which China, Japan, Korea, and Singapore “shared their experience and the lessons they have learned.”
From the briefing with the health ministers, “several common themes emerged about what has worked”.
“The need for early detection and isolation of confirmed cases, identification and follow-up of quarantine of contacts, and the need to optimize care as well as the need to communicate to build trust and engage communities in the fight” are some of the major messages, he said.
Even in a country like Switzerland, which is the headquarters for global pharmaceutical behemoths such as Roche and Novartis among others, as well as a number of generic drug companies, there is a grave shortage of medicines because of the disruption of supply chains that caused acute shortage of raw materials, according to a report on the RTS, the Swiss broadcasting company.
More than ten days ago, the Big Pharma companies such as Eli Lilly, Johnson & Johnson, Roche, Sanofi Pasteur, and Takeda among others made promises that they will not impose any intellectual property commitments for sharing their technologies as well as pricing of new therapeutics or vaccines for COVID-19 on humanitarian grounds.
The Big Pharma representatives said during a press briefing on 19 March that “more than 80 clinical trials are underway to test new and existing medicines” while nine companies are researching new diagnostic tests, vaccines or treatments and testing existing medicines on those infected with the virus.
“Society needs to know it can count on the bio-pharmaceutical industry to work to rapidly bring forward therapies, vaccines, and diagnostics that protect humankind from this escalating pandemic and prepare the industry to better respond to future global health crisis,” IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) director-general Thomas Cueni claimed.
But, until now, the track record of the Big Pharma is anything but humanitarian. Given the ugly and obscene profit-oriented role in each epidemic, particularly the HIV/AIDS epidemic in South Africa, the Big Pharma’s promises and assurances have to be taken with a pinch of salt. There is an utter lack of confidence and trust in Big Pharma’s promises, according to various reports and studies.
In a report titled “Coronavirus Treatment Developed by Gilead Sciences” in The Intercept online publication on 24 March, reporters Sharon Learner and Lee Fang wrote that “this afternoon the Food and Drug Administration granted Gilead Sciences “orphan” drug status for its antiviral drug, remdesivir” and “the designation allows the pharmaceutical company to profit exclusively for seven years from the product, which is one of dozens being tested as a possible treatment for Covid-19, the disease caused by the new coronavirus.”
The report quoted experts to warn that “the designation, reserved for treating “rare diseases”, could block supplies of the antiviral medication from generic drug manufacturers and provide a lucrative windfall for Gilead Sciences.”
The Gilead Sciences, according to the Intercept reporters, maintains close ties with President Donald Trump’s task force for controlling the coronavirus crisis.
“Joe Grogan, who serves on the White House coronavirus task force, lobbied for Gilead from 2011 to 2017 on issues including the pricing of pharmaceuticals.”
The report, quoted James Love, the director of Knowledge Ecology International, a watchdog on pharmaceutical patent abuse, that “the Orphan Drug Act is for a rare disease and this is about as extreme an opposite of a rare disease you can possibly dream up.”
In the face of intense opposition from civil society, Gilead said on 25 March that it would no longer seek orphan- drug status for remdesivir, which is now being tested in Norway and Spain.
According to a report in the New York Times on 25 March, “the Food and Drug Administration had only granted the special designation on Monday – which gives drug companies a seven-year monopoly on sales, tax credits and expedited approval. Gilead said it asked the agency to rescind the status.”
The US Senator Bernie Sanders, who is seeking the Democratic presidential nomination, called it “truly outrageous”, noting that Gilead had received “tens of millions” of dollars from the federal government to develop the drug.
According to the New York Times, “Gilead recognizes the urgent public health needs posed by the Covid-19 pandemic, the drug maker said.”
“The company is working to advance the development of remdesivir as quickly as possible and will provide updates as they become available,” the paper said.+