While Chinese manufacturing plants have been scrutinized for safety issues, American pharmaceutical companies have relied on them for sourcing cheaper ingredients for generic drugs since 2001. Now, this dependence is raising new concerns as a national security risk.
Thousands of prescription drugs found in the medicine cabinets of Americans such as antibiotics, blood pressure medications, Alzheimer’s drugs and ibuprofen are all made with ingredients sourced in China.
Potential Health Risks
In July 2018, the FDA voluntarily recalled several medicines used to treat high blood pressure containing the active ingredient valsartan. The drugs were contaminated by nitrosamine, a known probable carcinogen called NDMA.
NDMA has been used in the U.S. to make rocket fuel. The valsartan was supplied by Zhejiang Huahai Pharmaceuticals in China.
FDA official Janet Woodcock explains in a video posted to their website, “Nitrosamines are allowed in our food and water supply in small amounts, and we seldom give it much thought. But, they shouldn’t be in our drug supply, and the FDA is going to make sure they are removed completely from any drug that you might take.”
There is currently no law requiring drug makers or the FDA to identify the country where the drug or its ingredients are made.
In her book, China RX (2018) Rosemary Gibson warns Americans and government officials of the hidden potential dangers of continued drug outsourcing.
“Everyone should be able to find out where their medicines come from, and if they are made to the highest standards,” Gibson says. She and her co-author wrote China RX “ in the public interest, not for any special interest.”
I asked Rosemary about the recalled batches of valsartan. “The amount of MDNA per pill was more than 200 times the acceptable limit,” she said.
Impact of Trade Policies
Rosemary explains how our trade policies have had a profound influence on our medications. “China joined The WTO in 2001. Within a few years, we lost the last aspirin plant in the USA, our last penicillin plant closed. We don’t even make vitamin C anymore.”
“China’s aim is to become the pharmacy of the world,” Rosemary added.
As the years passed, American companies continued seeking cheaper routes to generic drugs overseas. Then came the Heparin recall.
In April, 2008, Baxter International voluntarily recalled batches of heparin after an FDA probe discovered contamination tied to the suspected deaths of 81 patients, according to Reuters. Baxter did not inspect its Chinese supplier before purchasing their heparin.
Heparin is a blood thinner widely used in clinics and hospitals and is made from pig intestines. “It is often collected from small, mostly unregulated farms in China.”
In June of 2008, Bloomberg News reported the number of U.S. deaths had climbed to 149.
In the midst of the investigation, Baxter and its ingredient supplier, Scientific Protein Laboratories revealed: “it appeared the chemical was deliberately added before either company received the ingredients.”
Chinese officials have acknowledged the presence of the chemical but said it was not to blame for the deaths.
CHINA RX uncovers what Chinese companies maintain about their responsibility, “we are not liable for consumer protection. If we were liable, the product would be very very expensive.”
Rosemary says the number of American deaths resulting from the tainted heparin was in the hundreds–well beyond the reported amount.
What is our Government Doing?
In 2008, Senator Sherrod Brown (D-OH) introduced a bill requiring transparency in prescription labeling. But it never became law. Rosemary said, “drug lobbyists got a hold of the first draft and killed it.”
On March 19, Senator Tom Cotton (R-AK) and Congressman Mike Gallagher (R-WI) introduced a bill intended to swiftly return manufacturing and safety to the U.S. drug supply.
Rosemary frequently testifies in senate committee hearings and is instrumental in exposing the potential security risks facing the U.S.
Potential Security Threats
In China RX, Rosemary warns, “without firing a missile or hacking the electric grid, China can take America down by disrupting access to essential drugs.”
I asked Rosemary how our government can reframe its response to this perceived threat. “We need to think of our medicines as a strategic asset,” she said.
America’s antibiotics supply is vulnerable right now. Concerns over a shortage grow as we fight the Covid-19 pandemic. Antibiotics (supplied by China) are crucial in treating secondary bacterial infections such as pneumonia caused by Coronavirus. The current crisis has amplified the national security concerns linked to our dependence on China.
What happens if China decides to cut us off?
Rosemary points to the leverage China holds over us in trade negotiations and the possibility of weaponizing our medication supply. She cautions, “China will continue to dominate the pharmaceutical market if we allow it.”
She encourages concerned citizens to call their lawmakers, spread the word and advocate for the manufacturing of our medications to return to America.
Does Rosemary think there is time to turn this around? “I hope so,” she said.