Time to act: Author warns of U.S. dependence on China drugs

Healthcare systems across the United States are already so dependent on China that “if China shut the door on exports of medicines and their key ingredients and raw materials, U.S. hospitals and military hospitals and clinics would cease to function within months, if not days.”

Rosemary Gibson

Imagine a world in which your hospital’s vital drug supply is critically understocked. In which clinicians are forced to choose which patients get those drugs and which ones don’t. In which the quality of the drugs in stock are suspect – perhaps tainted, toxic or containing less of the key medicinal ingredients than is indicated.

Then imagine your hospital – and your country – entirely at the mercy of another country to supply those drugs.

Imagine no more.

Healthcare systems across the United States are already so dependent on China that “if China shut the door on exports of medicines and their key ingredients and raw materials, U.S. hospitals and military hospitals and clinics would cease to function within months, if not days.”

That was the testimony of Rosemary Gibson , senior advisor at The Hastings Center, at a hearing of the U.S.-China Economic and Security Review Commission on July 31.

As co-author of the book China Rx: Exposing the Risks of America’s Dependence on China for Medicine , she explains China’s grand plans for international domination in the drug market – and the crippling ramifications of this endeavor on U.S. healthcare.

“When you control the supply of medicines, you control the world,” Gibson told the bipartisan commission. “The public and many policymakers have been kept in the dark about U.S. dependence on China for medicine and health security and national security risks of this dependence. It’s time to turn on the lights.”

In an effort to help enlighten physician leaders, Ms. Gibson sat down with Andy Smith, Senior Editor of the American Association for Physician Leadership, to discuss the subject and what leaders can do to address it:

Q: How did we as a nation reach the point where we no longer manufacture our own penicillin?

A: The last penicillin fermentation plant in the U.S. was located in upstate New York and it closed in 2004. That’s when a handful of companies in China began producing large quantities of the chemical material to make penicillin and sold it across the world at below-market price. U.S., European and Indian companies were driven out of business because they couldn’t compete. When they were gone, prices increased. That’s how we lost our ability to make penicillin and many other essential antibiotics. The New York plant was also making the chemical material for cephalosporins.

We can’t make doxycycline any longer. After the anthrax attacks in 2001, the U.S. government asked a European company to make 20 million doses, the company obtained the chemical starting material from a factory in China.

When it comes to generic antibiotics, we have virtually no ability to produce them anymore, which means we can’t make generic antibiotics for pneumonia, sexually-transmitted diseases and even last-resort antibiotics.

Q: What are other examples of medicines commonly used that are affected?

A: Heparin is a good example. The U.S. obtains most of the active ingredient to make heparin from China, as does the rest of the world. The raw material comes from pig intestines, and it takes one pig to make a vial of heparin. Right now, African swine fever is decimating the pig population there, a situation far worse than the disease that caused a heparin shortage in 2007 to 2008. Facing a shortage of the authentic ingredient at that time, a lethal and cheaper substitute, oversulfated chondroitin sulfate, was added to the active ingredient that mimicked the real one. Two hundred forty-six deaths were reported to the FDA associated with heparin. Looking ahead, severe heparin shortages are predicted for the U.S.

Q: How dependent are we overall?

A: Right now, we and the rest of the world are so dependent on a single country for thousands of key ingredients in antibiotics and many other medicines that if supply were interrupted, pharmacy shelves would be bare within months.

Q: You’ve talked about the ingredients in medicines, but what about the pills and finished drugs?

A: Millions of Americans are taking generic drugs made in China by domestic companies there and sold here. The first was the HIV/AIDS medicine nevirapine sold here in 2007. Since then, many generics are being sold here: antibiotics, anti-depressants, birth control pills, chemotherapies, medicine for Alzheimer’s, HIV/AIDS, diabetes, Parkinson’s and epilepsy, to name a few.

In the next five to 10 years, western generic companies will stop producing many of their products because they can’t compete with China since its government subsidizes its domestic companies. That will result in even fewer suppliers. And when we lose control over supply, we also lose control over price and quality.

Q: With the massive recalls of blood pressure medicines, some doctors and patients are becoming concerned about the quality of their medicines.

A: Yes, many Americans and their doctors are concerned about the quality and safety of their medicines and rightly so. Millions of people were sold blood pressure medicines that contained cancer-causing genotoxic impurities, and many manufacturers have recalled their products. The most troubling was a manufacturer in China whose blood pressure medicine, valsartan, contained per pill more than 200 times the acceptable interim limit for the carcinogen NDMA, far higher than any of the other products recalled. Even more concerning is the manufacturer knew its product did not meet U.S. standards but sold it anyway to unsuspecting U.S. hospitals and patients, according to the FDA warning letter sent to the company. The FDA banned all products from its facility from being sold here.

Q: You’ve conducted a root-cause analysis of the valsartan recalls. Tell us briefly what you found.

A: As the brand name product was going off patent, fierce competition ensued among generic companies to gain a large share of the world market for valsartan. It was all about who could make and sell the cheapest product. Manufacturers cut corners in a race-to-the-bottom on price. If you hammer down too hard on price or anything, eventually it breaks. That’s what happened to valsartan. Quality can’t be maintained when the companies that buy generic drugs from manufacturers buy them like big-box stores buy T-shirts, solely on cheapest price. Of course, that price is different from the price patients pay when they go to the drug store.

Q: What is the FDA doing to ensure the quality of medicines and what are the challenges?

The FDA conducts inspections of manufacturing plants around the world. Here in the U.S., inspectors can walk into a U.S. manufacturing plant on a Monday morning without notice. In other countries, FDA gives four to six weeks advance notice, although it can perform unannounced inspections. While inspections are essential, they can’t guarantee quality medicines. Inspectors are not on-site all the time. There has to be an ethos and culture of professionalism.

Q: Should healthcare leaders and patients be concerned about the quality of medicines?

A: Generic drugs have become commodities purchased on the global market at the cheapest price. They represent 90 percent of prescriptions dispensed, and that’s where quality problems are being found.

It was remarkable to learn that the FDA’s counterpart in Europe, the European Medicines Agency, has publicly stated that in some cases it allows defective medicines to be sold in Europe because it would be far worse to have no medicines at all.

The FDA is caught in this dilemma, too, although it doesn’t publicly say so. It’s in the unenviable position of weighing the relative risks of allowing defective medicines to be used versus having no medicines at all.

For example, an AMA resolution introduced by the American College of Cardiology in May 2019 said that the FDA was increasing the allowable nitrosamine contaminant level in blood pressure medicines because there wouldn’t be enough medicines to give to patients.

Q: What can healthcare executives do?

A: A solution is for hospitals is to use their enormous purchasing power to signal to the market that they want a safe and reliable supply of medicines. It’s worth watching Civica Rx, a non-profit formed by the Mayo Clinic and 900 hospitals which are trying a different approach.

It’s trying to solve the problem of perpetual drug shortages that cost hospitals nearly $400 million a year, and that’s just for the time pharmacists spend dealing with them. It doesn’t include the cost of physician time spent on ethics committees to decide who should get a medicine when there’s limited supply.

Civica Rx pays a fair and sustainable price, not a race-to-the-bottom price, to trustworthy manufacturers. The country-of-origin and manufacturers are transparent to the purchasers. Long-term contracts with manufacturers enable them to invest in their facilities and have back-up capability to assure an uninterrupted supply.

The first product Civica Rx is buying is injectable vancomycin that will be manufactured in Ohio. As Civica Rx ramps up to include more products in shortage, it expects that its hospitals will save 35-50 percent.

Q: What else can healthcare executives do?

A: I’m hearing from physicians and patients who are concerned about whether their medicines are working as they should. They might be right, and reports from clinicians should be included in adverse event-reporting systems to track them. An online pharmacy, Valisure, is testing every batch of medicines before selling them and has found that more than 10 percent of the batches it tests are rejected. There are issues with dosage, dissolution, and marketing claims related to dissolution or levels of probable human carcinogens.

Q: What solutions do you recommend nationally?

A: The first step is knowing who makes our medicines and identifying where we are at risk. The next step is providing incentives for domestic drug manufacturing for high-priority medicines. Also, advanced manufacturing technology is able to produce active ingredients for a number of essential medicines on a small scale much faster and at lower cost. Federal investment is needed to show proof-of-concept of commercial-scale domestic production. Once this technology

To contact Rosemary Gibson, email her at Gibsonr@thehastingscenter.org

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