Sunday, August 10, 2014
Pondering the answer to cruel questions
Is there an effective treatment for Ebola that would be worth fast tracking the production? Given that the human trials so far amount to three people who received top level standard treatments, did the serum actually work as expected? Would production of this or any other new treatment be experimenting of helpless African patients? While the medical community hashes out these questions, three emergency labs designed to quickly create vaccines and other drugs are ready and waiting if needed.
All three U.S. facilities established to quickly make vaccines and therapeutics in the event of a major public health threat say they are standing by to support any U.S. government effort to scale up a treatment for Ebola.If it works, fantastic! And if it fails the recriminations will be horrendous. And if nothing is done, the accusations will be bitter. And in the meantime, the disease waits for no man.
The facilities, called Centers for Innovation in Advanced Development and Manufacturing (ADM), were set up by the U.S. Department of Health and Human Services in partnership with private industry, to respond to pandemics or chemical, biological, radiological, or nuclear threats.
They have the expertise to quickly switch production lines to manufacture, for example, a smallpox vaccine if that scourge were to re-emerge, or an anthrax vaccine, and other life-saving compounds against both natural outbreaks and bioterrorism.
"They know our number and they can call us 24 hours a day," said Brett Giroir, chief executive of Texas A&M Health Science Center, site of one of the facilities. "We are prepared."
Global health agencies are only starting to consider whether to make experimental drugs, most of which have only been tested on monkeys, available to patients in West Africa, which is suffering the worst Ebola outbreak in history.
The World Health Organization is convening a group of bioethicists to consider such as issues as who decides which patients would receive the treatments or vaccines. U.S. officials have repeatedly emphasized the importance of public health measures such as quarantines to stop the spread of the disease.
Among the Ebola treatments that have shown promising results in lab animals is an antibody cocktail from Mapp Biopharmaceutical, a tiny biotechnology company in San Diego; a vaccine from Profectus in Tarrytown, New York; and an RNA-interference drug being developed by Vancouver-based, Tekmira Pharmaceuticals, which late last week got approval from the U.S. Food and Drug Administration to resume safety trials in human volunteers.
The decision to order any of the three advanced labs to begin making Ebola treatments would be made at the highest levels of the Obama administration.
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