It’s bad enough, as widely reported, that as the coronavirus has begun spreading rapidly beyond China, the United States finds itself reliant on the People’s Republic for a wide variety of medicines and, just as important, for the chemical building blocks of those medicines. It’s at least as bad, and much less widely reported, that the U.S. government still doesn’t know the exact extent of this dependence, and still uses an inspection system for checking the safety of these Chinese inputs that looks as leaky as the proverbial sieve.
Even worse, as I see it, these shortcomings have been way out in the open since at least last July, when the official U.S.-China Economic and Security Review Commission held a hearing on the matter.
Anyone with any doubts about how dangerous this dependency on China has become should check out the testimony of Rosemary Gibson of The Hastings Center, one of the world’s leading research institutes focusing on healthcare and healthcare and broader scientific ethics issues. Gibson has been investigating this situation for years, months before the corona virus outbreak, made the following claims at the Commission session to justify her conclusion that “The nation’s health security is in jeopardy”:
>”The U.S. can no longer make penicillin. The last U.S. penicillin fermentation plant closed in 2004. Industry data reveal that Chinese companies formed a cartel, colluded to sell product on the global market at below market price, and drove all U.S. European, and Indian producers out of business. Once they gained dominant global market share, prices increased.”
>”The U.S. can no longer make generic antibiotics. Because the U.S. has allowed the industrial base to wither, the U.S. cannot produce generic antibiotics for children’s ear infections, strep throat, pneumonia, urinary tract infections, sexually-transmitted diseases, Lyme disease, superbugs and other infections that are threats to human life. We cannot make the generic antibiotics for anthrax exposure. After the anthrax attacks on Capitol Hill and elsewhere in 2001, the U.S. government turned to a European company to buy 20 million doses of the recommended treatment for anthrax exposure, doxycycline. That company had to buy the chemical starting material from China. What if China were the anthrax attacker?”
>”Beyond antibiotics, the U.S. industrial base for generic drug manufacturing is on the brink of collapse. Generic drugs are 90 percent of the medicines Americans take. Examples of generic drugs made in China by domestic companies and sold in the United States include: antibiotics, anti-depressants, birth control pills, chemotherapy for cancer treatment for children and adults, medicine for Alzheimer’s, HIV/AIDS, diabetes, Parkinson’s, and epilepsy, to name a few. If past performance is indicative of future performance, China’s generic drug companies will engage in cartel formation and predatory pricing, and drive out U.S. and other western generic companies.”
>[T]he pharmaceutical and chemical industry’s successful requests to the U.S. Trade Representative not to impose tariffs on medicinal products made in China corroborate that much of the US industrial base, and our self-sufficiency in manufacturing products essential for life, has collapsed.”
And Gibson categorically stated that “The FDA [U.S. Food and Drug Administration] cannot fix the underlying cause of the proliferation of contaminated and potentially lethal medicines in the legal supply of America’s medicines.”
One reason for the FDA’s ineffectiveness is clearly a lack of good data. Not that the challenge of conducting adequate inspections is easy. Jennifer Bouey of the RAND Corporation, another leading think tank, told that Commission that on top of China’s foreign affiliated plants, “Researchers estimate there are 5,300 to 7,000 local manufacturers, each with a small share of the Chinese domestic market.”
Mark Abdoo of the FDA itself acknowledged to the Commission that because of “remaining gaps” in its data, the agency lacks “visibility of all Chinese manufacturers that produce drugs or active pharmaceutical ingredients of drugs that are ultimately shipped to the United States.”
Abdoo added that on top of drug building blocks (called “active pharmaceutical ingredients,” or APIs) that the FDA knows come into the U.S. market from China, such China-produced ingredients “also come to the U.S. as part of finished drug products manufactured in other countries, for example, India. Therefore, the percentage of APIs produced by China for the United States marketplace is likely underrepresented by our numbers as China is a major supplier of APIs for other countries.”
It’s worth mentioning at this point that relying on the main federal government system for slicing and dicing the U.S. economy – the North American Industry Classification System (NAICS) – can produce a highly misleading picture of American imports of drugs and their chemical ingredients from China.
For example, according to the NAICS data, although American purchases of finished drugs and their ingredients are up astronomically in absolute terms over the last 20 years, they still account for only 1.34 percent of such imports from the world as a whole. Similar trends have unfolded in “non-diagnostic biological products,” which are defined as “vaccines, toxoids, blood fractions, and culture media of plant or animal origin.” Despite soaring literally 80-fold from 1999 to 2019, imports of these goods equal only 0.34 percent of all U.S. imports.
But separate testimony to the Commission by journalist Katherine Eban, drawing on her recent probe of the foreign factories that supply so much of the U.S. drug market, identified numerous flaws in inspection procedures and broader policies that are much more easily corrected – and indeed, should have never been allowed to emerge in the first place. For example:
>”Most of the FDA’s investigators who are sent to China do not speak the language. They can’t read the manufacturing records. The FDA does not always provide independent translators. Instead, the companies provide translators who, more often than not, are company salesmen. Sometimes, FDA investigators simply give plants a pass, deeming them to be No Action Indicated because they have no way to tell otherwise. The investigators also can’t read street signs, which make them vulnerable to wild manipulations. Companies steer them to phony ‘show’ plants, where everything looks compliant, but the companies aren’t manufacturing there. Sometimes a group of companies pool their resources and invest in the same “show” factory, so that different FDA inspectors return to the same plant at different times, each one thinking they are inspecting a different facility.”
>”In the United States, in order to inspect drug plants, FDA investigators simply show up unannounced and stay as long as is needed. But for overseas inspections—due to the complex logistics of getting visas and ensuring access to the plant – the FDA has chosen to announce its inspections in advance. Overseas drug plants typically ‘invite’ the FDA to inspect and the agency accepts. Plant officials serve as hosts to the visiting FDA investigators, who become their guests. It is not unusual for manufacturing plants to arrange local travel for FDA investigators. This system has allowed manufacturing plants to ‘stage’ inspections, as one FDA investigator put it, and conceal evidence of data fabrication.”
>”According to the FDA’s own data, which I obtained, from 2013 to 2018, out of 864 inspections in China that FDA investigators recommended as Official Action Indicated, FDA officials downgraded 78 of those [that is recommended a milder response from Washington]. By contrast, in the same time period, out of 11,642 inspections that FDA investigators conducted in the U.S. and recommended as Official Action Indicated, only one inspection was downgraded in that time. This reflects the FDA’s willingness to give foreign plants, particularly in China, an opportunity to reform without sanctions.”
>The agency appears to discourage talented staff to deploy in China and elsewhere abroad because of “a lack of clear career progression and promotion opportunities. Right now, those who serve overseas often return to the FDA’s U.S. headquarters without a guaranteed job, and sometimes have to accept demotions.”
Alert readers will note that although most of the problems mentioned here are rooted in pre-Trump policies and practices, they’ve continued into the Trump era. All Americans should demand that the coronavirus outbreak be regarded by Washington as the most urgent possible wake-up call.
Incidentally, Rosemary Gibson’s latest findings are contained in her recent book, China Rx. Katherine Eban’s are available in her recent book, Bottle of Lies.
