RX - USA vs Canada

FOX News: “America’s too dependent on China for its medicine”

 FOX reports AT LEAST 80% of the active ingredients found in All of America's Meds are sourced abroad, primarily in China. Experts warn America has become too dependent on China for its Meds … everything from painkillers, to antibiotics, even aspirin can all be sourced back to a country the Defense Dept. considers AN ADVERSAY.

"Imagine if China turned off that spigot," asks Rosemary Gibson, author of "China RX; The Risks of America's Dependence on China for Medicine."  "China's aim is to become the pharmacy to the world … China has said that.  It wants to disrupt, to dominate, and displace American and other Western companies." In 2015, China unveiled "Made in China 2025," its plan to make it the world's leader in 10 high-tech manufacturing sectors, including bio-medicine, by 2025. 

The new national security warning comes as China has already threatened to weaponize its dominance in mining of rare earth minerals against the US, in an escalation of the ongoing trade war. 

CHINA IS FIGHTING TO PROTECT ITS LEGITIMATE RIGHTS AND INTERESTS IN A TRADE WAR WITH THE US,  State Media says  … "I have no doubt that they would weaponizing their dominance of the pharmaceuticals market if they felt that that would give them an advantage over us strategically," retired Brig. Gen. John Adams told FOX News. Adams is president of Guardian Six, the defense research consulting firm

In a worst-case scenario, experts warn, China could withhold supply of Meds like important antibiotics, or degrade the quality of our medicines … even put lethal contaminants in them. Even when it comes to treating anthrax, China is the largest exporter of the building block to make ciprofloxacin, an anthrax antidote. The more probable threat from China, it can make America's Drugs more expensive.

"In 5 to 10 years, when China has a complete choke-hold over the US and its supply of Meds, it's going to be telling us how much to pay for our medicine," Gibson told FOX News. "We will lose control over how much we pay. We will be the price taker, not the price setter. And that's devastating."

Gibson said China wants to do with medicine what it’s done with steel. "China dumped its steel in the US at below-market price and it drove out so many factories and jobs that communities were devastated. We have the same story with a lot of our Meds and that has happened with penicillin," Gibson said. The last US plant making the penicillin antibiotic closed in 2004.

China is positioning itself to dominate at a minimum the generic drug industry; which accounts for 90% of prescriptions in many countries. Already, generic versions of high blood pressure Meds, anti-depressants, and cancer treatments, including chemotherapy, can be traced to China. Today, India is the generic drug manufacturing leader, however, China provides India with 80%+ of its raw ingredients.

Adding to the national security threat, generic drugs sourced back to China are used by America's military troops and veterans. The problem is health care providers, including military hospitals; do not know where all their drugs are sourced because Big Pharma is not required to publicly disclose the source of their active ingredients. [The FDA requires Country of Origin for Food-stuffs, but not pharmaceuticals.] "Knowing the scope of the problem," Adams said. "I think that's the start."

Sen. Sherrod Brown, D-Ohio, said to FOX News that pharmaceutical companies must be able to trace the origin of their ingredients. "American’s have a right to know where the ingredients in their medications are coming from, regardless of whether they are brand or generic," Brown said.

In a 2010 study of Big Pharma executives, 70% cited China as their Top Source for pharmaceutical ingredients. But Gibson said pharmaceutical companies don't want to disclose China as a source of their medicine because Americans are less trustworthy of their product

The FDA is Putting Americans at Risk with Chinese Drug Imports:  Where do the ingredients for your FDA Medicine come from? Chances are good that they are made in India, China, Hungary or some other country; however, the question is are they safe?                   

The FDA is caught between two hard rocks. On one hand the agency has been criticized for inadequate oversight of foreign drug manufacturing facilities, especially in China and India. On the other hand, the FDA has been hammered for allowing drug shortages to persist, especially when many of the drugs are essential for the public health.

The Latest FDA Boondoggle: According to the industry insider newsletter, FiercePharma, the FDA is ignoring its own cautions. The agency will allow importation of pharmaceutical ingredients from Chinese and Indian manufacturing plants that have been found to have problems; however…

To avoid shortages, FDA allows imports from 8 drug plants banned for quality  shortfalls" 

" Banned  Hisun plant in China gets   exemptions on 15 ingredients"

"Facing Cancer Drug Shortages, US FDA Relies on a Banned Chinese Plant"

Chinese Drug Imports from Problem Plants...  In the last few years the FDA has increased the number of inspectors it has on the ground in India and China. It hasn’t been easy. FDA inspectors have had a hard time getting visas to enter China. Unlike the unannounced inspections that occur in the US, the FDA must alert officials in China and India that they are coming well in advance of a visit.

Even with such obstacles, inspectors have found troubling lapses in quality: The more inspections, the greater the number of problems that have been uncovered. There has been out-and-out fraud, where companies have been found to fabricate data. In other cases there has been poor quality in manufacturing.

In the case of one of China’s major drug exporters, Hisun, the FDA revealed that there had been “broad data manipulation” at its factory in Taizhou. Despite an FDA ban on exports from the factory to the US, the agency has allowed the company to continue exporting various key ingredients to the US. That’s because those ingredients are considered essential to treat patients with leukemia, breast and ovarian cancer. Antibiotics and heart medicine have also been exempted from the ban.

This is like an elevator inspector saying that there were such significant problems with an elevator that it should not be permitted to carry passengers. Then, in the next breath the inspector allows the elevator to stay in service because it would be difficult for people to reach their floor without the elevator. Would you feel comfortable riding in such an elevator?

FDA Does Little to No Testing: You might imagine that if the FDA banned a pharmaceutical company in India or China from exporting its products to the US and then overturned its own ruling, the agency might test those products for quality… Au contraire: The FDA does virtually no testing itself. It relies on The Companies to do their own testing or hire outside companies to audit their products. To us that seems a bit like asking the foxes to guard the hen-houses..

Why Would We Accept the Honor System for Foreign Drug Manufacturers? We are not the first to suggest that the FDA relies on the honor system when it comes to drugs manufactured abroad. Companies are allowed to submit test results that the agency does not check. We would prefer Ronald Reagan’s approach: “Trust but verify.”

People with cancer deserve to know where their chemotherapy drugs are coming from and be assured that the FDA is guaranteeing absolute quality. Although the agency continues to reassure the American public that everything is fine with Indian and Chinese drug imports, we would like to know why there have been bans on the one hand and exemptions on the other.

 Was Your Generic Medication Made In China … Is It Safe [The Skeptical Cardiologist, Dr. Anthony, 7/29/18 The FDA recalled several versions of the generic blood pressure medication valsartan which were made in China and contained a carcinogen: I switched many patients from the bad valsartan to losartan or valsartan from presumably safe manufacturers: However, it didn’t really occur to me that this could be just the tip of the iceberg until I received a reader comment, which I copy below. As I thought about it, I realized that I have no idea where the generic ramipril I take is manufactured. It very well could be in China or India.

An article in  The Epoch Times confirms, Americans are becoming more and more reliant on Meds manufactured in China and that many researchers feel this poses a significant security threat.

‘The FDA inspects only a small number of Chinese companies that manufacture FDA Approved Drugs, and those it does inspect are often found to have serious health violations. Meanwhile, the drugs that are making their way into the US from China, either as finished products or as ingredients, are often falling far below US safety standards. And some of these drugs are not being inspected at all.’

The book, “China RX: Exposing the Risks of America's Dependence on China for Medicine” by Rosemary Gibson and Janardan Prasad Singh,” details the problem. It is very hard to find out how many US FDA Meds come from China since drug companies don’t make their sources apparent. In addition, even if the Drugs themselves aren’t manufactured in China, Gibson and Singh write. “China is the largest global supplier of the active ingredients and chemical building blocks needed to make many FDA Drugs, over the counter products and vitamins.” Below are the comments of my reader:

‘We have a horrible problem in the US; the infiltration of Chinese generics. I had no idea that this generic was being supplied by a Chinese maker. In fact, the bottles I got said “SOLCO” which is based in New Jersey. Now I’m painfully aware that SOLCO Healthcare US, based in New Jersey is owned by Zhejiang Huahai Pharmaceutical based in China’s Zhejiang Province. So this is the Chinese company’s subsidiary distributing this ‘FDA Med’ in the US. China has a long history of selling tainted products in the US - drywall, lead-based paint on toys, tainted pet foods, etc. It’s important to understand that in some cases 80% of prescriptions are generic: And some insurance companies will not pay for brand when generic is available.

 My valsartan was $30 for a 90 day supply; Diovan is $750... I get it. But when Chinese companies cut corners and endanger people something is wrong. I will never ever take another generic drug without first finding out where the product comes from. I know this is not perfect, but it is something. I think the US lawmakers need to do something to make this information transparent. It baffles me as to how this ‘FDA Drug’ could have been tainted with a highly toxic chemical for so many years (they say 4 years). This chemical is known to cause liver damage and cancer. Apparently the manufacturer changed the way it made the active ingredient which created this poison by-product. And now who do we hold accountable?

 How do we get to the bottom of what went wrong, and how to prevent this going forward? We have no way to compel anything in China. All that said, thanks for your information here it is helpful. I worry that the losartan is made by the same company - I will surely investigate.

 China’s pharmaceutical industry is poised for major growth: China’s become the world’s second-largest market for pharmaceuticals and the fastest emerging market for the sector.

China’s burgeoning middle-class and rapidly-aging society presents vast opportunities for the industry.

China wants to be the important innovator of pharmaceutical products.

China, the world’s manufacturing powerhouse is moving toward a more value-add economy  and there’s one major industry where the country could dominate both as a maker and consumer: HealthCare

That’s because China rocketed into its position as the world’s second-largest economy in a matter of mere decades under a strict one-child policy, contributing to a rapidly aging society with rising medical needs.

According to healthcare information company I QVIA, China was the world’s second-largest national pharmaceutical market in 2017, worth $122.6-Billion. It was the biggest emerging market for pharmaceuticals with growth tipped to reach $145-Billion to $175-Billion by 2022.

“The development of China’s healthcare industry is still in its infancy, evidenced by its low healthcare expenditure as a percentage of GDP... and a smaller proportion of its population aged 60 and over,” DBS analysts Mark Kong and Chris Gao said in a recent note. “That implies plenty of room to grow because as the population ages, the demand for medicines will increase.”

There’s still scope for growth, experts said, even though the Chinese pharmaceutical market’s compound annual growth rate from 2013 to 2017 was 9.4%. For comparison, the world’s largest healthcare consumer, spent $466.6-Billion in 2017 v $84.8-Billion spent in the same year.

Made in China 2025 - China already has ambitions for exporting generic medication. Last year, Chinese pharmaceuticals obtained US FDA  approvals for 38 generic drugs, up from 22 approvals in 2016. But, as part of  Beijing's  “Made in China 2025” industry plan,

 President Xi Jlnping  identified the pharmaceutical sector as one to push, with the focus on innovation and homegrown research and development. There’s some way to go. China’s largest listed pharma, Jiangsu Hengrul, has a market capitalization of $35-Billion, about a 10th of  Johnson & Johnson.

This year, at least, will be “promising” with potential new blockbuster therapies expected to be approved in China that will come with affordable price tags, said Credit Suisse in a sector note in January. As any delay in approval will cause declines in stock prices of the pharma companies involved, Credit Suisse advises investing in bigger names with strong near-term earnings support and new drugs or first-to-market generics in the works.

Here were Credit Suisse’s Chinese HealthCare stock picks for 2018: Sino Biopharm -  Hong Kong-listed Company had two blockbuster drugs on its roster; anlotinib for lung cancer and tenofovir for hepatitis B; and a few blockbuster generics aiming for approval before 2021. Credit Suisse’s top pick, Sino Biopharm was already the leader in the Chinese hepatitis medicine market with 22% market share in 2016. It also had a complete hepatitis drug portfolio. The company had more than 10,000 sales representatives in China, with half of them on the hepatitis team; the largest in China, according to Credit Suisse. In 2016, the company’s cancer drug franchise contributed 11% to the company’s sales. That will increase to 19% by 2020 after anlotinib is launched in the first quarter of 2018, said Credit Suisse. The product is likely to be competitive versus comparable drugs from multinationals, the bank added.

Jiangsu Hengrul Medicine -  Jiangsu Hengrui is the largest listed pharma in China. And, with industry consolidation in the cards due to government-led changes, it will be the best positioned to ride out that trend, said Credit Suisse.

That’s due, the bank said, to Jiangsu Hengrui’s effective drug portfolio, strong capacity in delivering products in the pipeline, its leading position in cancer treatment and a well-established sales team. The pharmaceutical firm was set to launch three blockbuster drugs in 2018, two of which are proprietary cancer drugs. The last is a generic product for respiratory conditions.

CSPC Pharmaceutical -  Hong Kong-listed CSPC was poised for near-term profitability and the strongest organic growth among large pharmaceutical names, the Swiss bank said. Inclusion of an injection used in stroke and cancer treatment under China’s healthcare reimbursement system will help drive growth, Credit Suisse added. 

The Asian giant’s control of world’s essential drugs complicates US desire to seek new trade deal. Two pillars of Trump administration policy - combating the soaring prices for prescription drugs and equalizing the US trade imbalance with China - appear to be on a collision course, drug and foreign policy experts say. That's because the key ingredients for so many essential drugs, from antibiotics and birth control pills to treatments for cancer, depression, high cholesterol and HIV/AIDS, are purchased from China, says Rosemary Gibson, co-author with Janardan Prasad Singh of  

'China - Rx: Exposing the Risk of America's Dependence on China for Medicine'

China has exclusive manufacturing agreements for drugs for anesthesia, cancer and HIV/AIDS, along with other medicines that "we use every day, not only in hospitals but in our own medicine chests," Gibson says, adding that China is now the world's only source of antibiotics, including the main ingredient in vancomycin, a treatment of last resort that is used by patients who are suffering from infections that are resistant to other treatment. 

Economic Power Moves East - "It's a huge dramatic shift and nobody knows about it," Gibson says. "And they're just ramping up. It's all part of a plan that China laid out in its 2025 initiative to become the pharmacy to the world."

President Trump h ad planned to deliver a long-anticipated speech on prescription drug prices, but news reports now suggest the administration will delay the address. It could not be determined whether the delay was prompted by the administration's discussions with Beijing over trade policy.

The US trade deficit with China hit a record $375-Billion last year, the Commerce Department reported. The US has called for China to reduce the surplus by $200-Billion and end state support for President Xi Jinping's  Made in China 2025 industrial policy.

If the Trump administration's import policies provoke a trade war with China, Beijing could retaliate by raising prices on or reducing supplies of components needed to make necessary drugs. Pressuring drug companies to find their supplies outside of China could also lead to higher prices, experts say 

"Imagine our being totally dependent on China, which could become our adversary, for all of our medicine including medicine for our military. Its lunacy," says Dan Slane, former member of the US-China Economic and Security Review Commission, created by Congress two decades ago to report on the national security implications on the US relationship to China.

The White House, the FDA and ‘Pharma’, the trade association that represents drug manufacturers, did not respond to US News & World Report requests for comment.

Multinational drug companies, many of them headquartered in the US, began buying ingredients for critical drugs in China after the US-China Fair Trade Agreement passed nearly two decades ago. State-owned Chinese companies, buoyed by heavy government subsidies, set their prices so low that they were able to undercut established manufacturers in the US and elsewhere, prompting them to shut down their plants and move their operations to China, the authors say.

"China offers (drug companies) incentives for transferring their production from here to there, and they're doing it," says Pat Mulloy, a trade lawyer and former assistant secretary of the Department of Commerce.

Gibson's and Singh's book offers examples of "companies pivoting east": Johnson & Johnson, based in New Brunswick, New Jersey, announced 4,800 job cuts in 2007 and 8,000 more in the US and abroad two years later, the authors say, as it was preparing to open a new Shanghai-based research and development center in 2009. "We see this as a way to move from bringing great products to China to actually discovering and developing things in China," the company's CEO, Alex Gorsky, told The Wall Street Journal in 2015.

·Pfizer laid off more than 2,000 researchers, more than half of whom were at the firm's research laboratory in Groton, Ct. "One of the casualties of the 2011 layoffs was Groton's antibiotic research program, which was reportedly moving to Shanghai," the authors write in "China Rx," citing local news reports that described it as "the first wholesale move of a major US pharmaceutical research unit to China.

Shifting production to China has made millions for the companies and their shareholders but hasn't trickled down to U.S. consumers, who are still paying more than consumers anywhere else in the world for their drugs. "The drug companies don't care about the US," Slane says. "They only care about profits."

The safety of the US drug supply is another concern, because the FDA lacks the funding and personnel to inspect Chinese factories, which may be forewarned of the inspectors' arrival. The most terrifying example involved a contaminated blood thinner, called Heparin, distributed by Baxter laboratories in 2008, which killed 81 people and sickened nearly 800 more.

The FDA identified Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated drug. 

Slane called the US dependence on Chinese drugs a national security concern, noting that recent Chinese militarization doesn't inspire confidence.

They're rapidly getting on parity with us in fighter jets, submarines and missiles," Slane said. "They have satellites that can take out our GPS systems. They have taken over islands in the East and South China seas that belong to Vietnam, the 

Philippines and Japan. 

They are militarizing the  islands with missiles. Their intent is to push us out of the eastern Pacific."

"You don't have to be a military expert to see where all this is going," he says. "In light of all that, now we're dependent on (the Chinese) for our drugs! Remember WW-II, Rubber and the Japanese