NEW YORK – Dozens of experimental drugs that have shown promise in combating Ebola in humans remain in minimum supply because of a regulatory approval process that in the United States can drag on for years and cost tens, if not hundreds, of millions of dollars.
The drugs are held back with no promise regulatory agencies around the world, including the FDA, will ever give pharmaceutical companies the green light to take the product to market.
International medical experts, as WND has previously reported, warn the Ebola outbreak in West Africa is out of control after the WHO drastically underestimated its scope in the early stages.
Currently there are no FDA-approved vaccines for Ebola, according to a health advisory published on the Centers for Disease Control website.
Despite recent enthusiasm that a silver-bullet pill or vaccine is on the horizon that will put an end to the growing scare of an Ebola pandemic, the WHO, at best, remains cautiously optimistic.
“Recent intense media coverage of experimental medicines and vaccines is creating some unrealistic expectations, especially in an emotional climate of intense fear,” the WHO commented in an Aug. 15 media advisory.
“The public needs to understand that these medical products are under investigation. They have not yet been tested in humans and are not approved by regulatory authorities, beyond use for compassionate care.”
The WHO consequently has advised against concluding that certain alternative medical therapies or experimental drugs would prevent or cure the Ebola virus, if only government regulatory agencies got out of the way.
Nevertheless, this Thursday and Friday the WHO is convening a closed-door conference with some 100 top medical experts from around the world. The goal is to evaluate and possibly even recommend for the first time approval of the human use of various alternative treatments and experimental drugs designed to combat Ebola.
Accelerated tests underway
Last Thursday, the National Institutes for Health announced the initial human testing of two different vaccines developed to combat Ebola will begin this week. The National Institute of Allergy and Infectious Diseases, or NIAID, part of the NIH, is conducting Phase 1 clinical trials to investigate an Ebola vaccine co-developed by NIAID and pharmaceutical company GlaxoSmithKline. NIAID also is examining an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp.
In parallel, the NIH has partnered with a British-based international consortium that includes Britain’s Medical Research Council to test the NIAID-GSK vaccine among healthy volunteers in the United Kingdom and in the West African countries of Gambia and Mali.
Additionally, the CDC has announced the NIH is supporting the Crucell biopharmaceutical company and Profectus Biosciences in their development of Ebola vaccines, while the NIH at the same time is collaborating with Thomas Jefferson University to develop a candidate Ebola vaccine based on the established rabies vaccine.
Hope for ZMapp dampened
Momentum to push experimental Ebola drugs through the government regulatory process gained speed after Samaritan’s Purse, a Christian humanitarian organization, successfully treated two of its missionaries in Liberia infected with the Ebola virus with doses of the experimental drug ZMapp.
Initial enthusiasm for ZMapp cooled, however, when Liberian doctor Abraham Borbor, who contracted Ebola while treating victims, died after he was given ZMapp.
Demonstrating the difficulty of judging the success of experimental Ebola drugs, last week the Guardian in the U.K. reported a successful animal trial of ZMapp proved 100 percent effective, even though the animals were given the drug five days after being infected.
Even a quick review of the medical literature makes clear there is no medical consensus even regarding the type of alternative treatment or experimental drug that will be successful.
As the BBC reported Aug. 12, Tekmira Pharmaceuticals in Canada has tested an experimental drug, TKM-Ebola, on monkeys and a handful of healthy human volunteers with the goal of interrupting the genetic code of the Ebola virus to prevent it from making disease-causing proteins.
The BBC further reported the U.S.-based pharmaceutical company Sarepta Therapeutics has developed an RNA-based vaccine. Medical researchers, meanwhile, continue to examine a 1995 Ebola outbreak in the Democratic Republic of Congo in which seven out of eight Ebola-infected patients survived after being treated with blood serum from Ebola survivors that contained high levels of antibodies that proved to be effective curing others.
Insufficient funding
WND reported in April the attempt to manufacture a new drug, Cyanovirin-N, that appears effective in the treatment of Ebola and other hemorrhagic fevers, as well as HIV/AIDS, failed for lack of the multi-millions of dollars needed to conduct the tests required for FDA approval.
Cyanovirin-N is a microbicide that preliminary research had indicated was 100 percent effective in the treatment of HIV/AIDS and of all known strains of influenza. In the treatment of Ebola and other hemorrhagic fevers, it showed at least 90 percent efficacy.
Microbicides are chemical substances that reduce the infectious nature of various viruses or bacteria, compared to vaccines that use biological agents to improve immunity to a particular disease.
Simply understood, Cyanovirin-N is a protein that prevents viruses and bacteria from attaching to and infecting healthy cells.
Retired entrepreneur Jack Kneifl, in an interview with WND, said he obtained in March 2001 a $5 million commitment from an angel investor and co-founded a pharmaceutical company, OmniViral Therapeutics LLC, the developer of Cyanovirin-N.
The next step was to complete Phase 1 and Phase 2 clinical studies at an estimated cost of $8.5 million, he said.
“I went back to my angel investor requesting him to continue funding the operations. He turned into a chicken and pulled his funding, I believe because he was an industrialist, and this was his first venture investing in pharmaceuticals,” Kneifl said. “He didn’t realize how expensive FDA drug testing is during development phases.”
Had Cyanovirin-N passed Phase 1 and 2 clinical tests, Kneifl believed large pharmaceutical companies would have been interested in investing the $50 to $100 million needed to complete large-scale Phase 3 tests on human populations.
“Due to lack of funding, OmniViral, for all practical purposes, was closed down,” he said.
Japan to the rescue
Last week, the Japanese company Toyama Chemical, a pharmaceutical subsidiary of the photo giant Fujifilm, offered to deliver to the WHO at no cost a quantity of the experimental drug Favipiravir sufficient for 20,000 patients in an attempt to control the Ebola virus.
Favipiravir, originally known as T-705, is marketed by Toyama Chemical under the trade name Avigan.
Yoshihide Suga, a spokesman for the Japanese cabinet, affirmed Toyama Chemical is ready to ship the drug at any time to West Africa upon the approval of the WHO. Suga stressed that Japan’s health ministry approved in March the use of Avigan for use against influenza.
Fujifilm is in talks with the U.S. Food and Drug administration through a U.S. partner, Boston-based MediVector, to prepare for clinical testing in the U.S. of the drug according to FDA requirements.
While Toyama Chemical has yet to make good on its offer, Nigerian Health Minister Onyebuchi Chukwu confirmed last week that his country is the first in Africa scheduled to receive the Japanese drug.
Illustrating its cautious approach, the WHO commented on an offer by the Canadian government to donate several hundred doses of an experimental Ebola vaccine. The U.N. health agency said efforts to accelerate production of the vaccine will not be augmented for several months to come, and available supplies are too small to have a significant impact on the outbreak.
“WHO welcomes the decision by the Canadian government to donate several hundred doses of an experimental vaccine to support the outbreak response,” the media advisory continued, “but a fully tested and licensed vaccine is not expected before 2015.”
