A biotechnology company headquartered in South Korea announced AstroStem, a new treatment for Alzheimer’s disease, became commercially available for use by patients at Fukuoka Trinity Clinic on March 20, after Japan’s Ministry of Health, Labour, and Welfare approved the product for use.
AstroStem, developed by Nature Cell, began the first phase of U.S. Food & Drug Administration (FDA) review for use in the United States in 2016. The FDA approval process can take as much as 10 to 12 years from a company’s initial application to government approval for use by consumers.
Says Human Costs Exceed Benefits
Edward Hudgins, research director for The Heartland Institute, which publishes Health Care News, says FDA’s regulatory processes do more harm than good.
“The overly cautious FDA approval process means that Americans suffer needlessly and often die waiting for treatments, already proven safe, to pass more and more tests to determine just how efficacious they are,” Hudgins said. “This red tape-laden process itself is anything but efficacious. Allowing patients to access such treatments would not only save lives and eliminate suffering, it would also produce real-world data on which medications work best, allowing patients to make informed choices about their health care.”
The costs of FDA’s excessive caution are incalculable, Hudgins says.
“An uncharitable way to describe it is that the FDA has adopted the philosophy that it’s good to let bad things happen somewhere else before we ever even try it,” Hudgins said. “My colleague who at one time worked at FDA estimated that probably millions of people have died or suffered needlessly because drugs were never released, were released too slowly, or were never even developed because the risks of going through the FDA process were simply too great to take on the financial burden of it.
“Another of my colleagues said there exists an invisible graveyard of people whose lives could have been saved but were not, because the FDA process is too slow.”
‘Steampunk Regulation’
Dr. Robert Graboyes, a senior research fellow and health care scholar at the Mercatus Center at George Mason University, says FDA’s regulatory model is outdated.
“In this country, we are still relying on that slow, twentieth-century regulatory framework, what I call ‘steampunk regulation,’ like an old factory from the early twentieth century,” Graboyes said. “The twentieth-century regulatory framework depended on an era when the government could monitor, could restrict behavior. The government controlled the capital necessary to develop a pharmaceutical.
“We live in a world now, thanks to technology, where some of these new treatments can be developed in a highly decentralized manner and at an extraordinarily low cost compared to the past,” Graboyes said.
‘We Shouldn’t Be Satisfied’
Hudgins says FDA’s rules are holding back medical progress in the United States.
“The FDA process helps keeps the U.S. behind other countries that are much more comfortable with innovation in this industry,” Hudgins said. “Those countries are releasing what could be lifesaving treatments, and we are not. We shouldn’t be satisfied with that.”
