At one time, decades ago, penicillin, vitamin C, and many other prescription and over-the-counter products were manufactured in the United States.
But now, antibiotics, antidepressants, birth control pills, blood pressure medicines, cancer drugs, among many others are made in China and sold in the United States.
The result – millions of Americans are taking prescription drugs made in China and don’t know it.
China makes essential ingredients for thousands of medicines found in American homes and used in hospital intensive care units and operating rooms.
In China Rx: Exposing the Risks of America’s Dependence on China for Medicine (Prometheus Books, 2018), Rosemary Gibson and Janardan Prasad Singh argue that there are at least two major problems with the United States relying on China for its medicines.
First, it is inherently risky for the United States to become dependent on any one country as a source for vital medicines, especially given the uncertainties of geopolitics. For example, if an altercation in the South China Sea causes military personnel to be wounded, doctors may rely upon medicines with essential ingredients made by the adversary.
Second, lapses in safety standards and quality control in Chinese manufacturing are a risk. Citing the concerns of FDA officials and insiders within the pharmaceutical industry, the authors document incidents of illness and death caused by contaminated medications from China.
How did you become interested in China Rx?
“I started looking at the contaminated blood thinner case – heparin. It resulted in unknown numbers of deaths,” Gibson told Corporate Crime Reporter in an interview last week. “There are reports to the Food and Drug Administration of deaths associated with contaminated heparin. But the reality is – nobody knows. And that’s because this is a perfect crime. It’s so hard for anybody to prove.”
“Yesterday, I was doing a radio interview. And a woman named Ann called in and said – I was taking Valsartan, this blood pressure medicine. It was recalled by the FDA because an ingredient in it was made in China. And it was found to have a carcinogen in it.”
“Then she said – I was just diagnosed with lymphoma. How would you ever know if those two things are connected?”
You open the book with the case of doctor who died after being given contaminated heparin.
“The story was a physician who walked into a hospital out west. He was a healthy guy. Four months later he was dead. The allegation was that he was given contaminated heparin.”
That case is currently in litigation?
There are reports that more than 80 people died as a result of this contaminated drug.
“I give a citation from the FDA website. But these are reports associated with heparin. The FDA doesn’t go and do autopsies. They don’t really know.”
Do we know what percentage of the U.S. drug supply is made in China?
“It’s very difficult to get a percentage. What we can say is that we are so dependent that if China shut the door tomorrow, within a couple of months, hospitals in the United States would cease to function.”
You cite medical newsletters as saying that up to 80 percent of all pharmaceutical ingredients are made in China.
“That’s a common number that is thrown out there. It’s not just the ingredients. It’s also the chemical precursors, the chemical building blocks used to make the active ingredients. Our dependence on China for the chemical building blocks to make a whole category of antibiotics. It appears there is only one non-Chinese manufacturer of that building block. This is for a whole class of antibiotics known as cephalosporins. They are used in the United States thousands of times every day for people with very serious infections.”
“We have a centralization of the global supply chain. And the FDA is unable to do in China the type of monitoring and inspection it does here in the United States.”
How much monitoring is the FDA doing in China?
“The FDA official Janet Woodcock came out and admitted – the FDA is stretched. The reality is that inspections in China and other countries are announced one or two weeks in advance of the inspection. In the United States, the FDA can walk in anytime. They are qualitatively different. Inspections would not have picked up the contaminants in this blood pressure medicine. The FDA had gone in and found problems in that facility in China a couple of years prior.”
“Who is accountable? Who does the public hold accountable for this blood pressure medicine that has a carcinogen in it?”
“The FDA is supposed to monitor every manufacturer of drugs coming into the U.S. wherever they are being manufactured in the world,” Gibson said.
Is the FDA looking at every manufacturer?
“It’s now doing what is called risk based inspection. It used to be that in the United States, every plant was inspected about every two years. In China, for decades, the FDA wasn’t even going into China. In an FDA memo from 1996, written by a dedicated FDA chemist, he wrote — we have no idea where these drugs are coming from and they could get to the President. Globalization has been a form of de facto deregulation.”
“Even though we have rules for when inspections are to take place, the reality is the supply chain is so complex, it’s almost impossible to insure that the products are safe.”
How did we move from a situation where we were supplying our own drugs to where we are so reliant on China?
“Two shifts. One is the 1984 Hatch/Waxman generic drug law. It was a bipartisan effort. It required companies to find a way to make cheaper generic drugs. In the beginning of the 1990s, we saw the outsourcing of the production of drugs to chemical firms in China. Not pharmaceutical companies, but chemical companies. And that’s when the FDA started seeing problems.”
That law itself wasn’t a bad law. But there should have been a Made in the USA requirement.
“The world would have been a different place right now.”
“The second thing that happened, and this was a big game changer as well, was the 2000 opening of free trade with China. We documented that within a couple of years of that happening, the United States shut its last penicillin fermentation plant up in New York. And that was after Chinese companies dumped product on the U.S. and global markets at below market prices and drove everybody out — the U.S., the Europeans and even the Indian penicillin fermentation plants. Drove them out. And then they increased the price. This is the playbook of China.”
“One of the important themes here is that trade policy has had a huge impact on this outsourcing. The second trend we noticed is that the last Vitamin C plant in the United States shut down. And China came in, formed a cartel, dumped the product on the U.S. market. The chapter on Vitamin C is incredible.”
“Penicillin, ascorbic acid, aspirin. Within four years of the trade law, Baxter Healthcare started buying active ingredients from China. And three years after that, the contaminated heparin was found.”
You also raise the national security aspect.
“The military population is dependent on China for their drugs, just as the civilian population is. Imagine you have young men and women in the South China Sea on those naval vessels. And they are dependent on the adversary for their antibiotics. Imagine that. Or imagine if there is an anthrax attack and China provides the active ingredients for the antidote. Medicines can be used as a strategic weapon, just like food was used in World War I and World War II to defeat the enemy. This would happen a lot quicker. You could degrade a product. You could contaminate it and kill a huge population.”
[For the question answer format with Rosemary Gibson, see 32 Corporate Crime Reporter 33, Monday August 27, 2018, print edition only.]