Chinese-made Pharmaceuticals Pose Risks

[Celebration]

http://economyincrisis.org/content/chinese-made-pharmaceuticals-pose-risks

Each day, tens of millions of Americans take medication to treat ailments and keep them healthy, but with more and more active pharmaceutical ingredients coming from China, some medicines could be having the opposite effect.

“With little realistic oversight, and more importantly, little ethos of business integrity in China, a major tragedy in the U.S. from a Chinese export is likely in the near future,” Roger Bate of the American Enterprise Institute writes.

..............snip

The lack of oversight poses a major problem for Americans that are required to take medicine. U.S. officials do not have the proper number of inspectors or the time to inspect and test all drugs entering the U.S. market. Oftentimes, they must take the word of suppliers that the drugs have been properly tested.

.................................

“Experts in China tell me that maybe a quarter of ingredients going to western companies come from unknown sources. Unfortunately, western purchasing habits are enabling this type of corner cutting.”

Beware the Risks of Generic Drugs

http://online.wsj.com/article/SB10001424052702303339904576406163574698214.html

Several pharmaceutical industry experts in China privately indicate that up to 25% of ingredients purchased in China by Western companies come from unknown sources. This is very worrying, because if any of these chemicals were substandard, the products made with them could fail to help patients recover from their illnesses, or even could be lethal.

Lower-quality products also mean more recalls, which can lead to dangerous shortages. The number of times when a desired life-saving drug was unavailable in U.S. hospitals and clinics tripled between 2006 and 2010, to a record 211 cases, according to the University of Utah Drug Information Service. In the first quarter of 2011, 89 incidents were reported.

In China, poor oversight, weak regulation and occasional gross negligence are likely to persist in compromising drug quality. The Chinese drug regulator has an overwhelming task in overseeing a rapidly expanding and already vast industry. The Food and Drug Administration has established an office in China and is increasing investigations of the plants that export to the U.S., but it is woefully understaffed. At best, it can assess each site only once every 13 years.

Deal in Place for Inspecting Foreign Drugs

http://www.nytimes.com/2011/08/13/science/13drug.html?pagewanted=all

The agreement will not affect the making of over-the-counter medicines or vitamins , whose global supply chains are even more vulnerable to tampering since government inspectors almost never visit their makers. Aspirin and vitamin C supplements, among others, are now made almost entirely in uninspected plants in China.

Nor will the agreement change the F.D.A.’s oversight of name-brand prescription medicines. Although branded drugs usually have more secure supply chains than those of generics, major pharmaceutical companies have moved aggressively into China in recent years and often rely on rarely inspected suppliers.

Federal officials for years have expressed concerns about the nation’s growing reliance on sometimes mysterious foreign drug suppliers, but they had largely despaired of fixing the problem. Congress has never given the F.D.A. the money needed to inspect these plants, and for nearly two decades the generic drug industry resisted proposals to pay inspection fees.

The industry changed its stance for several reasons. First, the heparin scandal scared everyone. The fake ingredient was good enough to pass a sophisticated test, so the conspirators probably knew that deaths would result, reflecting a callous level of greed. And the Chinese government refused to allow the F.D.A. to investigate, suggesting that the perpetrators were not only smart but politically well connected.

.............

Generic drug fees will be included in a package of industry fees — including those for branded drugs and medical devices — in legislation the Obama administration is expected to send Congress in January. Such fees were first approved in 1992 and have become a vital source of F.D.A. financing, although some consumer groups say they have led the agency to become too cozy with those it regulates.

[Sarah Ibarruri]

1. Every day there's a new horror story about Chinese-made products. nt

[MineralMan]

3. Oh, not really every day. That's an exaggeration.

But, there certainly are problems with some Chinese products. No question about that.

[Sarah Ibarruri]

4. Pine nuts is the latest. They're sending us the ones they use for animal feed. nt

[MineralMan]

5. Do they come from pine trees? Do they come in their shells.

I'm not sure what the difference between pine nuts might be from those sold for animal feed and those sold for other purposes. Do you know? I used to drive a couple of hours and harvest pine nuts from a forest near my old home in California. You spread blankets, then shook and knocked the tree. The nuts fell out of the pine cones and onto the blankets. Then, we'd roast them on cookie sheets in the oven and enjoy them until they were all gone. We'd repeat the process every year.

Do the Chinese pine nuts not come from pine trees? Do you have a link to share about this?

[MineralMan]

12. Ah, I found the information. Apparently, the shipment had seeds

from a different species of pine tree in it that cause a problem if consumed by humans. It caused a bad taste in people's mouths. I had that happen to me a couple of decades ago from some pine nuts I bought at a natural food store. I didn't finish the package of pine nuts. Wrong species of pine tree. I can see how that mistake might happen.

[Sarah Ibarruri]

24. It's always something with China. I'm sick of the trade with China. Since it began...

our products are trash.

[MineralMan]

25. It's true that some products from China are of poor quality.

Others aren't, though. China is not going away, you know. Their quality control is improving all the time. It's actually possible to buy some Chinese merchandise that will give good service over time. Even their gasoline engine-powered equipment is beginning to meet some reasonable standards.

If you think that trade with China is going to somehow end, I'm afraid you aren't looking at reality. As with some other expanding suppliers, the quality of their merchandise started out as abysmal, then moved to just poor. Now, it's starting to become acceptable in some fields, and will probably continue to improve. Market forces will force that to happen.

One area of interest to me in the China trade has been musical instruments. The first stuff sold here that was manufactured in China was, in a word, unusable. Cheap, but worthless. The second generation of musical instruments worked for a while, but had other problems like poor intonation. The third generation began to meet the standards for student instruments and gained some acceptance. Finally, in the past couple of years, some musical instruments from China are almost ready for the professional market. The next generation will be. It all takes time.

I wish we were still making all the stuff we need and want right here in this country. We're not, though, and we're not ever going to again. It's just not going to happen. But, China is learning how to make goods that meet standards. Not always, and some new startups are still suffering from poor standards. But, that's beginning to end.

The world is what it is. In large part, it's what we've made it. You can fight it, I suppose, but you'll lose in the long run. The answer is not to buy junk, and to buy only quality products, whatever their origin. But you're not going to get your choice of origin, I'm afraid. That day is gone.

[Sarah Ibarruri]

26. You're right. China products are of horrible quality. I remember when we manufactured here...

Now, almost everything is made in China, and even expensive things are of poorer quality than before we allowed our jobs and corporations to relocate and manufacture in China.

[MineralMan]

27. Did you even bother to read what I wrote?

It doesn't appear so.

[Sarah Ibarruri]

28. Yes. You said trade with China is not going to go away, and made mention of musical

instruments.

I'm old enough to have used products from before we began this everything-made-in-China trade, and I've yet to find one item that is made better or comparably in China.

I think the most important thing to take note of here is your comment that the everything-made-in-China trade is not going to end. Never is a long time. Things change all the time. People are beginning to get pretty pissed off with corporations, and this all-manufacturing in China could end as easily as it began. To say never, is to ignore all of history, and the primary lesson it teaches, which is that all things can and do change, and in the blink of an eye.

[MineralMan]

29. Yes, I'm old enough to remember that, as well.

What you appear to have missed was that I also said that the quality of Chinese goods has improved steadily, and is now approaching typical western quality. You are right. The very best products, manufactured by the very best companies, will probably always exceed the quality of the very best that China is able to create, or that it even wants to create.

So, I can pay over $8,000 for a tuba made in Germany. It will be the very best I can buy, if I can afford it. Or, I can buy the very best tuba made in China for $2000. In the hands of a good musician, you will not be able to tell the two apart if they are played behind a screen. The very best tuba players will be able to tell you the differences, and will never settle for less than that $8000 tuba. The college student studying the tuba at the university, on the other hand, will probably have the Chinese tuba. If he or she becomes a professional, then the $8000 tuba becomes more accessible. The difference is that there is nobody making anything much in between the two. You can buy a European tuba that is of the same quality as the Chinese $2000 tuba, but you'll have to pay $4000 for it. Which do you buy? Which is the better value? Very soon, the Chinese tuba, for $2000 will be considerably superior to the $4000 European tuba, and the Chinese manufacturer will offer a $4000 model that is superior to that $8000 tuba. When that happens, the professionals will buy two Chinese tubas, one in Bb and the other in C. Then, the $8000 tuba will no longer be available. That is the way it will go.

That's the marketplace.

[Sarah Ibarruri]

31. You said...

"What you appear to have missed was that I also said that the quality of Chinese goods has improved steadily, and is now approaching typical western quality."

That's not what I, my family, and my friends are seeing. Further, because there is the wonderful opportunity in China of previously-American manufacturers not being subject to ***ANY*** oversight, they can put any toxic products in anything they feel like.

I am dead set against the buying of articles made in China. In fact, I have begun to buy second hand. Not so much because I'm moneyless now (tho God knows our country is in the gutter thanks to the allowing all manufacturing to move to China), but because I want to make damned sure to give none of my money to corporations manufacturing in China.

[MineralMan]

32. You should do as you please, of course.

However, the truth of the matter is that Chinese manufacturing is improving in its quality. Chinese parts are in everything today, including "American" cars. More will be there soon.

You can buy used, if you wish. That's your privilege, of course.

[MineralMan]

2. There's certainly potential for problems in this.

There are, however, some protections, and the FDA requires thorough testing of each batch of ingredients, whatever their source, by the companies that actually manufacture the dose forms of these pharmaceutical drugs. That oversight is some assurance that you're not going to get poisoned.

Mylan is one of the larger generic pharmaceutical manufacturers in the US. They have an informative video on their site showing the entire process of manufacturing the actual dose forms of these drugs in their US factory, whatever the source for the ingredients is. You can see the video at this link:

http://www.mylan.com/about_us.aspx

I'm not saying that there are any guarantees that there won't be problems. Nobody can do that, but pharmaceutical drugs get a lot more oversight and have much higher standards for testing and manufacturing than supplements do. The video above is interesting to watch.

Disclaimer: I have absolutely no connection to any pharmaceutical company, other than being someone who takes one of the generics Mylan manufactures. It is almost certain that the main ingredient in that drug was made in China. But, the information I saw in the video is reassuring.

[Celebration]

6. well, good luck!

Inspections once every 13 years are not reassuring. Remember with the Heparin incident, the tests run did not show a problem. That showed intentional contamination due to cost cutting by the Chinese.

At least aspirin and Vitamin C don't require lots of different ingredients and are cheap to manufacture, so cost cutting is less of an issue. Not so with Johnson and Johnson's Tylenol products. What a debacle that was!

I honestly think everything made in China should be labeled as such, in LARGE LETTERS. The problems would most likely go away.

[MineralMan]

10. It is my understanding that every batch of the active ingredients

is tested using mass spectrography. That would detect any contaminants and positively identify the ingredient. I'm not concerned. It's certainly doing what it's supposed to do.

[NCarolinawoman]

7. They need to put a "made in China" label on vitamins and generics.

Many consumers would balk and in some cases "the market would dictate" to these companies what a poor investment they made by outsourcing.

It took me a while, but I found out that a drug I was taking was made in India. My pharmacist helped me get the information.

(On a side note: Recently I bought some Halloween stickers to put on envelopes. When I opened the package, I was overwhelmed with the smell of "burnt tires". The stickers were made in China--no surprise there.):mad:

[Celebration]

8. Amen!!

Labels would cure the whole issue.

BTW, problems are much less with Indian made drugs.

[SecularMotion]

9. Dead Babies Used to Make Pills in China, South Korean Network Says

HOSPITALS AND ABORTION clinics in China, together with pharmaceutical companies, have been engaged in a dark and grisly trade, according to a major South Korean broadcaster: turning dead babies into powdered medicine.

In an report aired on Aug. 6, the Seoul Broadcasting Station (SBS) say they uncovered the process by which the bodies of dead infants are turned into capsuled “stamina enhancers” for humans.

http://blog.theepochtimes.com/1/china/2011/08/06/dead-babies-used-to-make-pills-in-china-korean-network-says/

[MineralMan]

11. Stamina enhancers?

I don't know about you, but I don't take anything like that, and would never do so. Oriental medicine does have some really weird ingredients in some of its preparations. I don't go to a Chinese Herbalist, though, so I'd be extremely unlikely to come into contact with such a thing.

Was the stuff shipped to the US? I don't think so. So it's sort of off topic, really, since we're talking about pharmaceutical drugs in this thread.

[SecularMotion]

13. I guess you missed this part

"HOSPITALS AND ABORTION clinics in China, together with pharmaceutical companies"

[MineralMan]

14. Chinese pharmaceutical companies.

Look, the source you cite is an advocacy site. I'd need to read something from a more objective source. In any case, we don't use that product here, as far as I know. You might be able to buy it in a shop in some Chinatown area of a major city, but I doubt you'd know what to ask for. I have to admit that Chinese herbal shops are not the place I get anything at all, even though they're very interesting places.

[SecularMotion]

15. Is this a better source?

China’s New Lucrative Business: Dead Babies Turn into Stamina Booster Pills

A South Korean SBS TV documentary team accuses Chinese pharmaceutical companies of selling dead baby pills as stamina boosters.

The team reveals that the truth behind the dead baby pill is horrific and disturbing.

Chinese hospitals and abortion clinics that are connected to the business immediately notify pharmaceutical companies when a baby dies, mostly because of a still birth or an abortion.

http://sanfrancisco.ibtimes.com/articles/193371/20110805/china-dead-baby-pill-stamina-booster-cannibal-placenta.htm

[MineralMan]

16. Yes, that's a better source.

My comment is still the same. This stuff was aimed at consumers of Traditional Chinese Medicine. It wasn't coming to the US and it's way off topic in a discussion of the sources of prescription pharmaceuticals. It's another topic altogether. TCM doesn't interest me that much, frankly, and stories about preparations used in TCM are irrelevant when it comes to prescription pharmaceuticals.

As I said, Chinese pharmaceutical companies. This stuff wasn't heading here. I also noticed that you didn't boldface "Chinese" in that article. Why was that? Pharmaceutical is an adjective referring to medications. In this case, it's referring to medications used in Traditional Chinese Medicine, not in western pharmaceuticals. So your story is irrelevant to what is being discussed, just as is the story above about pine nuts. They were sold as food, not medicine. It's important to stick to the subject, really.

[HuckleB]

17. It appears that the term "pharmaceutical companies" is being applied with a wide swath.

Under this application, supplement companies and all alt med supplements would be considered to be pharmaceuticals. I'd actually be fine with that, if those companies also faced the same regulatory expectations given to pharmaceutical companies under the more narrow definition.

[MineralMan]

18. Yeah. Traditional Chinese Medicine has lots of very, very

strange incredients in its medications. And, yes, "pharmaceuticals" is a word that could be used to describe Chinese medications. However, it has nothing to do with the pharmaceutical industry as it is thought of here in the US. A traditional Chinese pharmacy is a wonder to behold. I visited one in San Francisco once, with a Chinese friend. He translated for me, and I learned a good deal. If your doctor ever prescribes cobra gall bladder powder, you'll have to find one of the Chinese pharmacies, I guess. It seems an unlikely prescription, though, just as dried human placenta seems something you'd be unlikely to see on your MD's prescription pad.

Misdirection is often used to derail a serious, informative discussion. It's a pity.

[HuckleB]

19. Exactly. -eom-

[SecularMotion]

20. The article speaks to ingredients used in pharmaceuticals in China

It's a pity that you refuse to consider the information as relevant.

[MineralMan]

21. It's interesting, and would make an interesting thread.

It has nothing, however, to do with the subject of this thread, which is about the use of Chinese ingredients in western pharmaceuticals. In this thread it is irrelevant.

In a thread about the medicinal products used in Traditional Chinese Medicine, it would be part of an interesting discussion. Maybe you should start such a thread. I'd love to participate, since I've recently been learning about TCM. The variety of ingredients in Chinese medicinal preparations is rather mind-boggling, and includes some very strange things indeed. We don't use them in western medicine, though. However, they may be a rich field for study, in the never-ending search for effective things to fight disease.

But, that's not the subject of this thread.

[SecularMotion]

22. Let me walk you through this, you seem to be having trouble on your own

Here's a quote from the article in the OP

"Today, 80 percent of pharmaceuticals contain ingredients from China or India.

“Far too many Chinese manufacturers cut the required corners. Even though all western pharmaceutical manufacturers are required to buy ingredients from audited and approved sites of good manufacturing practice, few check where those approved sites get their chemicals which may be from a shoddy, unapproved, unhygienic plant down the road,” Bate writes."

So, the point of discussion is the lack of testing on pharmaceutical ingredients from China or India.

I posted an article giving an extreme example of a questionable ingredient used by the pharmaceutical companies in China.

You argue that the questionable ingredient is not used to manufacture pharmaceuticals, but that's not the issue.

The issue is that these are the same pharmaceutical companies that export other ingredients to the US without testing or quality control.


Please stop trying to moderate this thread, if you have a problem with any posts use alert.

[MineralMan]

23. My DU friend, I can't moderate any thread. However, I can post

my opinion in replies to other posts. I have done so. You're free to ignore my opinion, disagree with it in a reply, or to do whatever you wish. I have no control over your posts, but I do have control over mine. In my opinion, you're writing about another subject than that of this thread. You apparently disagree with that opinion. I don't believe any DU rules have been broken, so I can't imagine why I'd click the alert button. I'm just participating in the discussion as you are. Please see my signature line for more information.

[HuckleB]

30. +1

[SecularMotion]

33. Seems to be an ongoing problem

"The State Food and Drug Administration is not responsible for regulating pharmaceutical ingredients manufactured and exported by chemical companies. This regulatory hole, which has resulted in considerable international news coverage unfavorable to China, has been known for a decade, but failure of Chinese regulatory agencies to cooperate has prevented effective regulation."

http://en.wikipedia.org/wiki/State_Food_and_Drug_Administration