The distribution of medicines derived from global drug research are favoring wealthy countries, a new study finds.
Although U.S. pharmaceutical drug and vaccine trials are often conducted internationally, a new study reveals "substantial gaps" between where these U.S.-approved products are tested and where they become available to patients.
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After undergoing trials abroad, new medicines and vaccines approved for use in the United States are often unavailable in the countries where clinical trials were hosted, a Yale University-led study published on Wednesday in the Journal of the American Medical Association found. The study suggests that some drug research in the U.S. is misaligned with a "bedrock" principle of research ethics – that the "benefits and burdens of research should be shared equitably by the people affected by it."
Five years after the drugs had been approved in the U.S., just 15% were approved in all of the countries where clinical trials had been hosted, the study found. Researchers surveyed 34 U.S. pharmaceutical company-sponsored drugs approved by the U.S. Food and Drug Administration in 2012 and 2014 in areas such as infectious diseases and neurology, among others, based on almost 900 trials performed in 70 countries. Of those countries, 7% received market access to the drugs tested within their borders within one year of FDA approval, while 31% gained access within five years.
[ MORE: Comparing COVID-19 Vaccination Rates by Country ]
Among the countries that participated in drug and vaccine trials, high-income countries such as Canada and European nations gained approval faster and at higher rates, while lower-income countries took longer to gain access, if they did so at all. African countries, such as Kenya and South Africa, had the lowest access of any region, followed by nations in the Middle East.
International research participation allows U.S. patients to benefit from new medications, according to the report, but "not often mentioned is that clinical research supporting U.S. medicine and vaccine approvals has been globalized and is largely conducted in other countries, increasingly lower-income countries."
The report notes that these trials have the potential to benefit both the U.S. and other countries involved internationally, "yet, for this to be true, the other countries would need to have access to the investigational products ultimately approved for marketing," the report says.
The findings come as low- and middle-income countries are pushing wealthy countries to temporarily suspend patent protections for COVID-19 vaccines, making them more easily accessible globally. In the U.S., the Biden administration on Wednesday announced its public support for the waiver idea, along with French President Emmanuel Macron, while other world leaders praised the move.
https://www.thewyco.com/general/a-global-gap-in-access-to-medicines-and-vaccines-07-05-2021
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Tags: coronavirus, vaccines, medicine, drugs, inequality, Africa, South Africa, Kenya, Middle East, Europe, Canada, United States, world, Best Countries