FDA recalls are a reminder that China controls much of world's drug supply

If we were ever in an international incident with China, they would literally have their hands around our necks in terms of critical drugs.
By Maggie Fox

The Food and Drug Administration has broadened a recall of the common blood pressure drug valsartan, saying some batches have been contaminated with a potentially cancer-causing chemical.
While no product sold in the U.S. has been found to be contaminated, the FDA says the process used to make some generic versions of valsartan has the potential to generate a cancer-causing chemical called NDMA. 

Some batches sold in other countries were contaminated, said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
“These are present at very minute levels. But because they are toxic to the DNA, you have to control them,” Woodcock told NBC News.The Zhejiang Huahai Pharmaceutical Co. in Shanghai, China. The company has recalled valsartan, which is contaminated with a cancer-causing chemical.

The FDA has told patients to keep taking their drugs until they can be sure that they’re either using an unaffected brand or that they can be switched to a safer one. 

The threat is not immediate, Woodcock said.
“It is the lifetime exposure to this that is dangerous. It’s not like it would give you cancer tomorrow,” she said.
But the case does illustrate the challenges that FDA must overcome in regulating a drug market that’s increasingly outsourced to other countries, especially China.
While Woodcock says the FDA is on top of things, other experts say these cases illustrate just how vulnerable the U.S. is when it depends on other countries to make essential drugs.
“China doesn’t have anything like the consumer protection laws and product liability laws like the United States does,” said Rosemary Gibson, a health care expert at the Hastings Center who wrote a book titled “China Rx: Exposing the Risks of America’s Dependence on China for Medicine.”
A Chinese manufacturer was the source of contaminated heparin — a commonly used blood thinner — that killed at least 81 people in 2007 and 2008. 

An FDA inspection showed that the Chinese factory where the contaminated product was made had serious deficiencies in what’s known as good manufacturing practice.
Woodcock said the FDA has other ways of ensuring product safety. 

It regularly sends inspectors to scrutinize Chinese facilities, for instance.
“We have the exact same standards for drugs marketed in the U.S. regardless of where they are made,” she said.
But no inspection would have found the NDMA contaminant, which is a byproduct of processing foods such as bacon and is a water contaminant as well, Woodcock noted. 

It had to be discovered using a specific chemical test designed to find this particular compound.
“We are planning to test all the valsartan products in the United States for this impurity,” she said.
Woodcock said the FDA has issued new guidance to all makers of drug ingredients to make sure that NDMA and other potential cancer-causing chemicals that can be made as part of the manufacturing process stay out of any finished product.
Still, Woodcock said, it’s a big job.
“The field is stretched,” she said. 

FDA inspectors must keep an eye on U.S. makers of pharmaceuticals, including large and small outfits that make specialty compounded drugs. 

“But we do what we can. We get to the highest-risk places every year,” she added.
Outside experts point out that the FDA cannot control what manufacturers in other countries do, and say no amount of FDA inspection can ensure a reliable supply of vital medical products.
“It’s a major national security risk for us in two ways," said Mike Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota and an expert on biosecurity. 

"We are very concerned about the quality of these drugs.”
And the Trump administration has been engaged in months of verbal and bureaucratic battles with China over tariffs.
"Now we are caught up in an economic war in the sense of tariffs,” Osterholm added in an interview. "If we were ever in an international incident with China, they would literally have their hands around our necks in terms of critical drugs. They wouldn’t even have to fire a shot."
Gibson estimates in her book that 80 percent of the ingredients in U.S.-branded pharmaceuticals and over-the-counter drugs start out in either China or India.
“Food has been used as a weapon of war. Our medicines can be used like that, too,” she said.
China made a strategic decision to develop its pharmaceuticals industry and has succeeded, Gibson said, undercutting prices and grabbing market share from other countries.
“Penicillin is a good example,” she said. 

“We don’t make penicillin ingredients in this country anymore. That happened because Chinese companies came in and dumped it on the global market at a very low price. Now they are the largest producer of penicillin industrial ingredients in the whole world.”
The U.S. market is vulnerable to products that are contaminated but is even more vulnerable if some kind of accident, problem or disaster shuts down factories, Gibson said.
“Imagine if a major earthquake hit or civil war broke out in some of the major pharmaceutical-producing cities,” Gibson said.
“It would be disastrous. India still produces some of the drugs for us but most of the essential compounds for them come from China, so they would shut down too.”
Osterholm points to the damage done in Puerto Rico after Hurricane Maria last year. 

Medical supplier Baxter makes a large percentage of saline solution in Puerto Rico, and the 2017 hurricane shut down manufacturing for months, worsening an ongoing shortage of saline intravenous drip bags.
“If we think the IV bag situation in Puerto Rico was serious, it pales in comparison with what could happen with any kind of hiccup with China,” he said.
Gibson agreed.
“I can think of nothing that would make us more vulnerable than shutting off all these drugs we depend on every day,” she said.
“Hospitals would become centers of chaos and death. We are not talking about expensive designer drugs. You couldn’t do surgery. You wouldn’t have anesthesia. You couldn’t provide dialysis."

Poisoning the World

China recalls tainted heart medicine from stores worldwide

By Ben Westcott and Yong Xiong

A medicine manufacturer in China is undertaking an international recall of active substances used in a commonly-used heart medicine which were found to contain traces of a dangerous carcinogen, the government announced Sunday.
It is the second major Chinese medical controversy in less than a month, after hundreds of thousands of children's vaccines were revealed to be faulty, putting an unknown number of infants at risk.
Valsartan, a drug used to treat high-blood pressure and prevent heart failure, was recalled in 22 countries across Europe and North America earlier in July after batches were found to contain N-nitrosodimethylamine (NDMA), an organic chemical that belongs to a family of potent carcinogens.
The substances were supplied by Zhejiang Huahai Pharmaceuticals (ZHP), based in Linhai, in eastern China, who said they notified authorities as soon as they identified the impurity.
"We published our recall notice at midday on July 13 in China and overseas, and published the US market recall notice on July 14 Beijing time ... all the drug materials for the Chinese market were recalled by July 23," the company said in a statement to the Shanghai stock exchange Monday.
On July 16, ZHP said it had pulled all Valsartan products from US pharmacies, a market worth $20 million in sales for the company in 2017.
Animal studies using NDMA have shown it to cause liver, kidney and respiratory track tumors. Following the revelation, China's Food and Drug Administration said it had conducted a screening of all the country's suppliers of the Valsartan ingredients, including ZHP.
The early recall involved around 2,300 batches of the ingredient. 

Among the countries it was sent to were Germany, Canada, France, and Sweden.
According to Xinhua, ZHP has taken "needed measures" to put it back in line with regulations.

Chinese peril
The recent drug scandals come at a time when the Chinese government is attempting to rebuild trust, both domestically and internationally, in the quality of the country's products.
The government announced in mid-July it had discovered an estimated 250,000 doses of a diphtheria and tetanus (DPT) vaccine made by Changchun Changsheng Biotechnology and intended for young children were faulty, sparking widespread panic.
So far, 15 people have been detained, including the company's chairman, Gao Junfang, but the reaction on China's social media was fast and fierce before censors intervened.
"My home country, how can I trust you? You just let me down again and again," one user commented on social media.
Just days before the DPT vaccine announcement, more than 100,000 doses of a rabies vaccine produced by the same company were also found to be defective.
Major international scandals have badly damaged the country's reputation, such as the 2008 tainted milk formula scandal which put thousands of children at risk.
More recently in 2016, a criminal organization was found to be selling millions of improperly stored vaccines.
The Chinese government is still deeply reluctant to allow its citizens to criticize the handling of these scandals.
An initially open attitude to the vaccine crisis by the government, including a number of unusually vocal editorials in state media, was rapidly shut down as the outrage continued to grow.
Posts on the Chinese social media site Weibo were erased, as well as private chats on messaging application WeChat, while state media pivoted to act as a reassuring voice for confused parents.
The official mouthpiece of the Communist Party, the People's Daily, ran an interview in the past week with an expert alleging the vaccines were "safe," just ineffective.
Evidence in support of these claims has yet to be provided by authorities, nor has any estimate been given for how many children were injected with the faulty vaccines.