As Chinese companies have begun taking control of the pharmaceutical market in the United States, a hidden health crisis has been building.
The Food and Drug Administration (FDA) is inspecting only a small number of the Chinese companies that manufacture U.S. drugs, and those it does inspect are often found to have serious health violations. Meanwhile, the drugs that are making their way into the United States from China, either as finished products or as ingredients, are often falling far below U.S. safety standards. And some of these drugs are not being inspected at all.
The failure of Chinese drugs to meet U.S. quality standards is exacerbated by the volume of imported drugs. China has become the primary source of many crucial medical drugs, including penicillin, heparin, and medications essential for surgeries.
This supply would be placed in jeopardy if a dispute were to erupt between China and the United States. If the supply chains are cut, crucial medications would stop reaching Americans.
A new book, “China RX: Exposing the Risks of America’s Dependence on China for Medicine” by Rosemary Gibson and Janardan Prasad Singh, explains what led to the U.S. dependence of Chinese drugmakers. It details how the Chinese regime has overtaken, and in some cases, put out of business, many key drug industries by undercutting competitors, stealing from competitors, and cutting corners.
If China cut its supplies now, Gibson and Singh write, “Surgeries would be canceled, cancer treatments halted, kidney dialysis rationed. Infections would spread.” Global reliance on China for drug manufacturing is already becoming a reality.
It’s unclear just how many drugs in the United States come from China, since many drug companies choose to keep their sourcing under wraps or fail to take due diligence in identifying the sources of their ingredients. A short list of medications made in China and sold in the United States that the authors traced includes medications to treat HIV, Alzheimer’s disease, bipolar disorder, schizophrenia, cancer, depression, epilepsy, and high blood pressure, among others.
Even drugs not directly sourced from China often have Chinese chemicals as their ingredients. The authors state, “China is the largest global supplier of the active ingredients and chemical building blocks needed to make many prescription drugs, over-the-counter products, and vitamins.”
It wasn’t always this way. Gibson and Singh write, “In the 1990s, the United States, Europe, and Japan manufactured 90 percent of the global supply of the key ingredients for the world’s medicines and vitamins.” Now, according to industry newsletters cited in the book, 80 percent of active ingredients in medicines come from China and India.
While India also makes generic drugs for the United States, the authors note, “it, too, is dependent on China for key ingredients to make drugs such as penicillin.”
The impetus for this shift in the global supply chain can be traced back to 2000, when then-President Bill Clinton was in the final year of his second term. The authors write that “the White House went into overdrive to pass legislation to give China permanent normal trade relations,” granting the same trade advantages to China as other U.S. trading partners, including low import tariffs. This was done against public opinion, which overwhelmingly opposed the free trade deal.
As the doors opened, China had its own plans to dominate the markets. The authors note, “China pressured U.S. companies to lobby on its behalf or face economic retribution. It reportedly kept close tabs on chief executives who lobbied Capitol Hill. Companies that rebuffed the Chinese government’s expectations risked being barred from investing, manufacturing, and selling their products in the country.”
Just three years after Clinton’s U.S.–China Relations Act of 2000 was signed into law, the United States incurred a trade deficit with China totaling $124 billion.
Lack of Inspections
For drug industries—and for the health of average Americans, China’s command over drug manufacturingwould have a lasting impact.
The FDA was ill-prepared for that new reality. Gibson and Singh note, “The FDA was created in 1906 with the belief that America’s medicines would be made in the United States.” The FDA was not set up to inspect foreign facilities on a large scale—and Chinese drug plants went out of their way to make inspections exceedingly difficult.
“Drug company executives at home complained to the FDA about the uneven playing field. It was unfair that they were constantly inspected while businesses shifting production abroad to China were hardly ever inspected,” the authors write. These warnings, however, went largely unheard.
After Clinton eased trade restrictions, at least 714 Chinese plants began making drugs and active ingredients for the United States, with the FDA only inspecting around 15 of them a year, according to the book.
The situation only grew worse: In 2007, the FDA budget for inspection programs was cut, including the budget to inspect foreign plants making drugs for the United States. The authors write, “As the regulatory apparatus was being decimated, toxic products made in China flowed into the United States.”
The FDA was able to expand its inspections of Chinese plants in 2008, when it opened its first office in China, which was also the first FDA facility outside the United States. The reforms had mixed results. The book states that soon after, when FDA inspectors attempted to inspect Shanghai No. 1 Biochemical & Pharmaceutical Co., which sells the blood thinner heparin to the United States, they found that “the facility apparently never made any heparin and was a so-called ‘show’ factory.”
The company had been purchasing its heparin from an unknown factory and was merely putting its name on the aluminum drums that were shipped to the United States.
The FDA improved its situation in China somewhat, but remains under-staffed. As of April 2014, only two full-time FDA staff members were assigned to the agency’s China office in Beijing for inspecting drug-manufacturing plants. The Chinese regime also refused to grant visas to additional inspectors the agency had hired and forced the FDA to close its offices in Guangzhou and Shanghai.
Inspections also don’t guarantee safety. The FDA is required to give local government authorities advance notice when inspecting facilities. Additionally, FDA inspectors often have trouble communicating during sensitive negotiations, and long delays are common.
The book quotes an industry veteran who said data requests that would take 10 to 15 minutes in the United States will often take days in China. Furthermore, “you know they are scrubbing the data. They’re showing you what they want to show you, in many cases,” the industry expert said.
A High Cost
The poor quality of made-in-China medicine has already taken its toll. In March 2008, the FDA held a press conference in response to news that heparin made in China and sold through Illinois-based Baxter Healthcare Corp. was contaminated. The tainted heparin killed four people and injured 350. The full toll around the world was never reported, although federal officials determined that the contaminated product had been shipped to 11 countries.
When FDA inspectors traveled to the plant in Changzhou, China, that made the contaminated heparin, they discovered the heparin ingredient—made from pig intestines—was made in a dirty tank. Later, scientists conducted tests and identified the contaminant as oversulfated chondroitin sulfate.
In 2007, a similar contamination scandal occurred with Chinese-made pet food laced with melamine. Thousands of pet dogs and cats got sick, and hundreds died. A year later, the same toxic chemical was found in Chinese-made baby formula, which killed at least six babies and caused illnesses in more than 300,000 infants in China.
Among the problems with Chinese companies is that they often sell drugs at lower prices and drive out foreign competitors who do make medicines according to regulated standards.
“Noncompliance with U.S. standards is a deliberate competitive strategy. As long as they aren’t caught, they continue to win contracts. Lower prices discourage production in the United States and force worldwide sourcing, thereby risking poorer quality products,” Gibson and Singh write.
This was seen clearly in the vitamin C market. In the early 1990s, mostvitamin C (ascorbic acid) was made in Europe or Japan. China entered the market in the mid-1990s. By 2001, four major Chinese companies had cut their vitamin C prices in half. Other companies couldn’t compete.
After China controlled the market, its companies raised prices by 600 percent, according to the authors. A 2005 class-action lawsuit filed in New York found an “overwhelming evidence of collusion” among the Chinese companies.
The book states, “The companies admitted to price-fixing and acting under the direction of the Chinese government.” The Chinese regime used similar tactics to control the penicillin market.
The methods the Chinese Communist Party has used to seize control of global drug markets follows a similar model it has employed to control other sectors. The authors cite testimony from Jeffrey Johnson, president of cybersecurity firm SquirrelWerkz, before the U.S.–China Economic and Security Review Commission created by Congress.
Johnson said that “these campaigns consist of state-sponsored and supported criminal cartels” that have used a variety of dishonest tactics designed to “accelerate China’s entry and domination of each key global industry.”
Former FDA commissioner Dr. Margaret Hamburg explained, in a 2014 speech in Beijing, the consequences of relying on China to produce vital life-saving drugs. “The risks are greater at every step in our increasingly complex global supply chain networks today. Sometimes these hazards are the result of a lack of quality control … [or] intentional acts of diversion, counterfeiting, or adulteration.”
From - The Epoch Times - by Annie Wu and Joshua Philipp
Oh my God! Puritans Pride all the way now!
The US government trust China way too much.
I don’t for 1 minute think they “trust” them but the payoffs to look the other way are too great…..ALWAYS “follow the money.”
Donald Rumsfeld went to work for the FDA and kept push push pushing to have ASPERTAME approved…..THE sweetners in UNsweet products. In Splenda, Nutrasweet, Sweet and LO – yada yada yada. How many “DIABETICS” got and stayed thin over that product?
It is basically RAT POISON and does an awful number on one’s GUT.
Thanks you DONALD RUMSFELD. People still hang on his every word-sadly!
WAKE UP AMERIKA!
Well if this article and others that state we don’t manufacture parts for own aircraft anymore don’t scare you, you just aren’t paying attention!
Gosh I hope they do a better job with our medicines than they are doing with pet food. Many dogs died from eating dog food from China, mostly sold in dollar stores. I had a friend who lost two beautiful schnauzers. The problem was supposed to be cleared up but not long ago I read f another scare.
Slick Willie sold out America to China? Say it ain’t so! And Hillary was primed to carry on the Klinton tradition?
This post alone should have 1,000 LIKES.
Americans have GOT GOT GOT to wake up!
No one should be surprised at the revelations coming forth about china or other nations, who would love to see and actively perpetuate, the demise of AMERICA. The problem is? It’s difficult to separate facts from the lies. There are factions out here who want to see America destroyed. The lie is that our fate rests with politicians and the government. The truth is that the fate of “THE UNITED STATES OF AMERICA” remains in the hands of all law abiding citizens. But let’s face an important fact, “Nothing will change by you reading this post”. Win or lose you have to get of your ass and get out and vote. Not because someone told you this guy or that gal stands for this or that. Do your homework and find out who is the best candidate for American values. And most importantly, don’t be misled. Take the time to learn how and why America became free, and why no one will ever take away the freedoms we fought and will continue to fight for. “GOD BLESS AMERICA, OUR PRESIDENT, AND ALL LOVE US”!
This is one of the most important articles I have recently read. We need to address this very serious issue with our elected officials.
Much of the is happening because our elected representatives spend all their time focusing on politics and political objectives and not what they were elected to do. Hense, no one is watching the bureaucrats who’s main goal seems to be increasing their fifedoms and supporting their political interests. No one is watching the store and when they do the politicians simply protect their individual interests. I don’t think Americans have the will to throw the bums out.
The President has to do something about this. Simply BAN all medicines and food made in China. I don’t even buy straws made in China. I don’t trust them. This is their way of killing us without using bullets. Very clever…and we’re helping them. How dumb is that??
The problem with not buying Chinese products is that it is very difficult. Most of what is purchased on-line states “imported” but not from where. Its not until you get it home that you see it is made in China.
Why are many of our drugs so expensive if they are being made in China and much of it seems sub-standard? tells us whose side our government has been on in the past and the FDA has been OK with all this? they certainly must know what’s going on…..AMAC this needs to be an issue brought to the attention of Pres. Trump….we must bring the manufacturing of our drugs back here….should never have left….big bucks being made by CEOs and shareholders….but our lives have been worth risking and nary a word whispered…..sad
Well that’s alarming ?
Yet another mess arising in and from Asia that can be traced back to the former hedonist-in-chief. The left’s one time golden boy has left nothing at all laudable in his tracks. Who did he give missile technology again? Slick Willie…the gift that keeps on giving.
Sounds like China is controlling everything these days! And who’s to say that what’s in these drugs are substances made to kill off people so there won’t be as many to take over a country when they get ready to do so? I know this sounds like conspiracy theory but isn’t China’s end game to control the world? Until I read this I thought most of our medicines were still be produced here since we pay such high prices for prescription drugs. I’m going to do more research on the drugs I am taking and make sure, if I can, where they are coming from. I am getting to the place where I just don’t trust China!!!!
Let us know how you made out with your research on the drugs. Also see if you can see on the medicine made in China.
We have know for years that we cannot trust China to supply us quality safe products! — It is crazy that the FDA spends time and money hassling good healthy products produced in the U. S. and does not spend their efforts protecting us from the cheap unhealthy products of China!
President Trump MUST BE MADE AWARE OF THIS!!
I am appalled to hear that we have given the Chinese so much leeway to make our drugs…evidently due to our esteemed womanizer president Clinton. What can the government do to correct this situation? What can we do to get the government to look into this more closely and correct the situation?
This is a huge risk. In the past China has sent us dog and cat food that was poisoning our pets, hazardous drywall, toys painted with lead based paint, and in 2007 they sent Heparin marketed by the Baxter company. Heparin is a blood thinner often used in surgery to prevent blood clots. This Baxter Chinese Heparin was contaminated and killed five people. When I had by-pass surgery in January 2008 it was used in my surgery. I went into immediate anaphylatic shock, my blood pressure dropped to 50 and I broke out in hives all over. I had a fantastic surgeon who was able to control the reaction and was then able to proceed with the much needed surgery. About 2 weeks after my surgery, the FDA pulled the Baxter contaminated Heparin off the market. China should have been held accountable for the five people who died, but they were not.
I do not trust anything consumable that comes from China. I think we should ban any products such as medicines and vitamins that come from China.
Well, Pres. Trump already told us that we were in a trade war and others were winning.
Don’t forget in Clinton’s last term, Republicans were in control of Congress. They, together, Clinton and the Congress, presented us with GATT and then the WTO, all poised to put foreigners in control of not only our druggs and suppliments, but now even in our access to food–remember Smithfield? Once food is dependant on others, they can determine what and how much we are allowed to eat.
Control is the key, and the U.S. is no longer in control of its destany.
It’s about time the Rinos and Dems get out of the way and give our President the opportunity to do what’s best for America, for now and into the future.
Foods and medicines should be banned from China. I don’t trust these at all. Occasionally a few clothes I would buy, but nothing else. Maybe, this is why people are suffering from cancer because these products from China are doing the trick.