The Safety Gap: Chinese Industry

[SteveGrenard]

Here is an important and realistic assessment of the problems associated with China's new industrial might, especially when it comes to pharmaceuticals and other products which are ingested. The asessment is well balanced by similar problems arising in other countries as well but focusses mainly on the situation in China. For China watchers it is worth reading.



http://www.nytimes.com/2008/11/02/magazine/02fda-t.html?hp=&pagewanted=all
The Safety Gap

The Safety Gap

By GARDINER HARRIS

Published: October 31, 2008

In the belly of an industrial district south of Lyon, France, just past a sulfurous oil refinery and a synthetic vanilla plant, sits a run-down, eight-story factory that makes aspirin, the first pharmaceutical blockbuster. The Lyon factory is the last of its kind. No other major facility in Europe or the United States makes generic aspirin anymore. The market has been taken over by low-cost Chinese producers. Even Bayer, the German company that created aspirin in the 1890s and has fought for more than a century to distinguish its product as the most trustworthy one, now has backup supplies from China.

 

[Beerina]

Do we have stats on rates of goofs and their severity for everywhere, and over time?

 

[CFLarsen]

Yet another thread from Steve about the Yellow Scare.

 

[Wolfman]

Yet another thread from Steve about the Yellow Scare.

Well, despite my well-known sentiments regarding Steve's posts in general, the article itself presents a relatively fair view of the situation in China. Let me point out that, even with relatively strict gov't regulation and enforcement in the U.S., we still have many bogus/dangerous products on the market (consider the whole homeopathic drug market, or the various drugs released on the market that subsequently turn out to have devastating side-effects). Then you have China -- which has much fewer regulations, and far less ability to enforce what regulations it has.

The article highlights a very important point that I've made consistently in regards to Steve's posts -- that any foreign companies using Chinese-made products have an implicit responsibility to verify the quality of those products for themselves. Failing to do so -- in full knowledge of the problems in China, and the reputation of Chinese pharmaceuticals -- makes them just as culpable as the Chinese side.

North American and European pharmaceutical companies changed to become more safe and reliable not as a result of any great humanitarianism on their own parts; they did so as a result of strict rules and regulations forced upon them by their respective governments. The same thing is true in regards to China.

The Chinese who knowingly make such tainted/fake products deserve full blame and condemnation for doing so (and, in many past cases, those responsible have face execution, or life sentences). But as this article very clearly argues (and as I have argued in the past), the responsibility and blame are not solely on the Chinese side.

On the Chinese side, you have people who due either to laziness, ignorance, or greed, produce products that are potentially dangerous. On the Western side, we have people who due either to laziness, ignorance, or greed, buy those products without taking adequate measures to inspect them, and ensure their quality.

Both sides are equally culpable. Both sides share equal blame and responsibility.

And, as this article argues very effectively, change will come only as a result of efforts by both sides -- on the Chinese side to improve regulation and control of the pharmaceutical industry; and on the foreign side, to actually inspect the facilities used in producing these products, and to verify the quality of the products they receive. In fact, this article focuses far more on the failings of the American side, than on the Chinese side; and places significant blame squarely in the lap of the FDA, and American companies, who have woefully failed in applying the same standards of due diligence towards Chinese producers that they do towards American ones.

Although I'm sure he didn't intend it, Steve has ended up giving us an article which, overall, is more critical of the problems in the U.S., than it is of the problems in China. And, unlike the majority of Steve's China-related posts (and, I'm sure, once again entirely unintentionally), it suggests strategies and solutions that lay equal responsibility on both sides. This isn't a "look at those terrible Chinese" article (no matter how much Steve may wish it to be); it is just as much a "look at those irresponsible Americans" article. It provides what so consistently lacks from the vast majority of Steve's posts about China -- a balanced perspective, and rational, logical solutions.

 

[gtc]

Although I'm sure he didn't intend it, Steve has ended up giving us an article which, overall, is more critical of the problems in the U.S., than it is of the problems in China. And, unlike the majority of Steve's China-related posts (and, I'm sure, once again entirely unintentionally), it suggests strategies and solutions that lay equal responsibility on both sides. This isn't a "look at those terrible Chinese" article (no matter how much Steve may wish it to be); it is just as much a "look at those irresponsible Americans" article. It provides what so consistently lacks from the vast majority of Steve's posts about China -- a balanced perspective, and rational, logical solutions.

If you read his post again you will see that Steve was being entirely objective in what he wrote. Unless we see evidence to the contrary, I think we should assume he has learnt something from the previous threads he posted.

Also, thankyou for your post. I agree entirely with what you wrote about China. All of what you wrote also applies to Western firms making products in China to sell to the Chinese market.

 

[Wolfman]

If you read his post again you will see that Steve was being entirely objective in what he wrote. Unless we see evidence to the contrary, I think we should assume he has learnt something from the previous threads he posted.

I'm gonna' remain skeptical in that regard. Will wait and see what kind of articles/OPs he makes in future.

Also, thankyou for your post. I agree entirely with what you wrote about China. All of what you wrote also applies to Western firms making products in China to sell to the Chinese market.

Yup, a simple but adequate demonstration of this is Coca Cola. In North America, Coke once made cans with those pull tab openers, that left you with a sharp-edged piece that had to be disposed of separately. There were safety issues with people getting cut, or ingesting the tabs when people dropped them into the can, and then drank them.

In Canada and the U.S., regulations were passed that forced companies like Coke to stop producing the pull tab cans, and instead make the kind we currently have (that opens the tab inwards, and leaves it attached to the can). I've seen a number of times where Coke (and other major soft drink producers) claim that they did this not as a result of regulation, but because of their own desire to produce a safer product. And by so saying, they are also acknowledging that the previous design was not as safe.

Yet, if you go to China today, and buy a can of Coke -- produced by an American company -- you will find it impossible to find a locally produced can of Coke that has the safe version. All of their cans (and those of most other soft drink producers) are the pull tab variety. And when the Chinese gov't talked about introducing regulations to make them produce the safer version, Coke invested significant money in convincing the gov't that it was not necessary. All because the pull tab cans are cheaper to produce, and switching machines to produce the safer kind of cans would cost them a lot of money.

Not as serious an issue as unsafe pharmaceuticals, perhaps...but demonstrates that "western companies" are every bit as motivated by greed and selfishness as Chinese companies, and are every bit as willing to sacrifice acknowledged safety issues in favor of the bottom line, unless they are forced to make those changes.

 

[Gurdur]

I'm gonna' remain skeptical in that regard. Will wait and see what kind of articles/OPs he makes in future.

Given your own rather rampant and abusive apologetics for the Chinese regime, it's rather funny, in a giggle sense, to see you criticising Steve Grenard for his own bias against the Chinese regime. Sheeesh, but it is rather hilarious.

 

[Wolfman]

Given your own rather rampant and abusive apologetics for the Chinese regime, it's rather funny, in a giggle sense, to see you criticising Steve Grenard for his own bias against the Chinese regime. Sheeesh, but it is rather hilarious.

Gurdur, you tend to pop into these things, and accuse me of things like this "rampant and abusive apologitics for the Chinese regime"; yet when I answer the questions you raise and demonstrate how wrong you are, you go quiet, until a new thread arises, and you can try the same thing again.

I have, in this and pretty much all other threads, acknowledged fully the problems in China. Hell, I've started threads that focused on negative aspects of the Chinese gov't (just check out the Forum Spotlight, and the thread I started discussing some of the abuses and wrongs committed by the Chinese gov't in the lead-up to the Olympics). I simply seek to provide balance, and to demonstrate that not all that happens in China is "bad", and that there's another side to the story.

The vast majority of people in this forum -- people of high intelligence and what I'd consider proven skeptical credentials -- consider my posts on China to be balanced, and to provide a much-needed perspective that tends to be lacking from people who have little or no actual experience of China, and base their opinions purely on second or third-hand information, and unsupported assumptions. And I am not aware of one single person in these forums who's had significant experience with China -- actually living here, or spending an extended time here -- who has had any significant disagreements with me. Ironically, the less actual personal experience people have with China, the more they are likely to accuse me of being an "apologist", and claim that they understand the situation better than I do.

Even in this thread, I've stated quite plainly that the Chinese share full blame, and are deserving of punishment. So please tell me how, exactly, this qualifies as "rampant and abusive apologetics". You seem to suffer under the rather ignorant delusion that anyone who does not simply condemn the Chinese gov't for anything and everything is an "apologist".

And I'll also point out that I at least responded specifically to the points and arguments raised in the OP. You have not done so at all; you simply posted a personal attack, with no reference whatsoever to the actual content of what is being discussed.

You, my friend, are an idiot.

 

[SteveGrenard]

If you read his post again you will see that Steve was being entirely objective in what he wrote. Unless we see evidence to the contrary, I think we should assume he has learnt something from the previous threads he posted.

Also, thankyou for your post. I agree entirely with what you wrote about China. All of what you wrote also applies to Western firms making products in China to sell to the Chinese market.

I always learn things on this forum. I bring up controversial subjects because I like to get other points of view and learn things. Insofar as the melamine/China thing which started with the dog food and has now spread to even eggs and other "foods" the only "yellow scare" (to quote Mr. Larsen) is the yolk of those eggs. Most if not all of these eggs would be consumed inside China or at best in bordering nations so my concern is for Chinese consumers.

I have learned a great deal from Mr. Wolfman and appreciate his responses to these subjects which appear in the world press. I am glad he found the NY Times article on the Safety Gap to be objective and balanced. I thought it was and I learned a great deal from this investigative report as well. And yes, the whole subject matter is scarey especially now for a person like myself who is on a dozen different prescription meds and who has to deal also with patients on many different drugs. But I appreciate the feedback and agree that foreign (non-Chinese) companies that buy Chinese products to relabel, repackage or sell as their own do need to take greater care. I wasn't actually sure if that function resides with the Chinese producers or the foreign buyers but see now why the foreign buyers need to take a role in this. Clearly with the infant formula it was principally Chinese babies who were most affected (before the melamine contamination was found in exports of other products as well as formula) and only China could police those products on behalf of its own people. Again my concern was and is for Chinese babies who are consumers of the formula whether they know it or not.

If I have any criticism it is with the source of the melamine being sold for the purpose of
adulterating proteinacious foods ... a "melamine mafia" if you will. I suggest that the
powers that be inside China go after these melamine-moguls and ban melamine from foods,
animal feeds and pharmaceuticals.

 

[SteveGrenard]

Its continuing, regular revelations that leads me to believe the problem lies somewhere within the melamine industry.

A product contaminated with melamine is still being sold in the US. Crispy Jacobina Biscuits in 3.88 oz packages tested positive for melamine by the Food and Drug Administration (FDA). The biscuits are sold through Everlasting Distributors Inc. of Bayonne, New Jersey, a major distributor of Chinese food products in the US. The company issued a press release through the FDA dated [29 Oct 2008] about the contaminated biscuits.

http://en.epochtimes.com/n2/united-states/melamine-contaminated-biscuits-sale-6
600.html

I live about 15 minutes from Bayonne NJ but had to find out about these biscuits in the online version of the Epoch Times. Wolfman and others interested in China may also be interested in this publication if they are not already aware of it:

The English edition of The Epoch Times launched in September 2003 on the web, and in August 2004 as a newspaper in New York. It meets a growing need for news reported and published independently, uncovering stories that have depth and meaning to people. In English, as well as in other languages, it serves a broad, international readership.

The Chinese-language Epoch Times started publishing in response to the growing need for uncensored coverage of events in China. The first newspaper was published in New York in May 2000, with the web launch in August 2000. Local editions published by regional bureaus soon followed, making it the largest of any Chinese-language newspaper outside of Mainland China and Taiwan.

http://en.epochtimes.com

 

[WildCat]

Then you have China -- which has much fewer regulations, and far less ability to enforce what regulations it has.

I find it difficult to believe that a country which is able to stifle free expression to the extent that China has is unable to regulate its industry. After all, it took them only a few years to wipe out the Falun Gong movement.

It's not a lack of ability, it's a lack of will.

 

[SteveGrenard]

I find it difficult to believe that a country which is able to stifle free expression to the extent that China has is unable to regulate its industry. After all, it took them only a few years to wipe out the Falun Gong movement.

It's not a lack of ability, it's a lack of will.

Excerpted from the Intl Herald Tribune of 11/12:

In late October [2008], newspapers in Viet Nam reported that tests on
240 tons of fish feed imported from China found traces of melamine,
but not high levels.

Last year [2007], thousands of pets in the United States were
sickened after eating melamine-tainted pet food ingredients imported
from China. That case led to the largest pet food recall in the United States.

China has blamed rogue food and feed dealers with intentionally
spiking milk and food supplies with melamine because the chemical
fools tests that measure protein levels. Some dealers use melamine as
a cheap feed substitute, perhaps not knowing its dangers.

But in interviews last spring, after the pet food scandal, melamine
scrap dealers -- who trade the melamine waste material to anyone who
will buy it -- openly admitted that melamine was often purchased by
feed companies and that it was widely used in the fish feed industry.

[Byline: David Barboza]
Date: 12 Nov 2008
Source: Herald Tribune [edited]
http://www.iht.com/articles/2008/11/12/asia/13chinafood.php

 

[geni]

Asprin is fairly cheap to make and fairly easy to make. It is also very trivial to check that the stuff is what it claims it is. I can't see it being a significant risk.

 

[SteveGrenard]

Asprin is fairly cheap to make and fairly easy to make. It is also very trivial to check that the stuff is what it claims it is. I can't see it being a significant risk.

While I am not saying nor do I know if true, yes, you and I can't think of any good reason to adulterate aspirin because it is so cheap. But I am reminded of a Law and Order episode based, I believe, on a true case, of a pharmacist who was caught diluting expensive chemotherapy drugs to increase his profit margins. On another level the incentive to dilute even aspirin at the manufacturing level is a possibility. Clearly it would be up to the importers, repackagers and wholesalers to insure that the dosage on the labeling is accurate.

How many millions of people could be taking 40 mgs of aspirin when they believe they are taking 81 mgs or taking 165 mgs when the labeling indicates 325 mgs? without ever realizing it?

 

[geni]

How many millions of people could be taking 40 mgs of aspirin when they believe they are taking 81 mgs or taking 165 mgs when the labeling indicates 325 mgs? without ever realizing it?

Workig out how much asprin there is in a tablet is chemicaly fairly trivial.

 

[Learning Phase]

Workig out how much asprin there is in a tablet is chemicaly fairly trivial.

Absolutely. For a manufacturer/importer.

For a consumer, no dice unless you happen to have a lab and training.

What is being suggested here is that food/drug imports from China should be tested and retested routinely with each lot, with the assumption that the products could easily be contaminated/dangerous/mislabeled.

If the companies in the U.S. are going to save cash by buying Chinese products, they have the responsibility to spend a bit of that cash making sure that the products really are as advertised.

It's not a bash of Chinese products or China, it's simple business sense, as it's been proven time after time that the Chinese government isn't going to fix these issues with a paradigm shift toward effective self-policing. They'll only provide individual "fixes" each time something appears:

"Oops, we're sorry that we sent you Lead-painted childrens toys, or propylene glycol in the cough syrup, or melamine in the pet food, or melamine in the milk. We'll fix that one. "

Until some big changes come in China, some of the products should be EXPECTED to have troubles.

 

[fuelair]

While I am not saying nor do I know if true, yes, you and I can't think of any good reason to adulterate aspirin because it is so cheap. But I am reminded of a Law and Order episode based, I believe, on a true case, of a pharmacist who was caught diluting expensive chemotherapy drugs to increase his profit margins. On another level the incentive to dilute even aspirin at the manufacturing level is a possibility. Clearly it would be up to the importers, repackagers and wholesalers to insure that the dosage on the labeling is accurate.

How many millions of people could be taking 40 mgs of aspirin when they believe they are taking 81 mgs or taking 165 mgs when the labeling indicates 325 mgs? without ever realizing it?

There were at least two and possibly three cases of chemo drug dilution in the last couple of years by pharmacists in the US. I have an idea about what to do with that kind of person. It involves plenty of dilution with water.