Skip to comments.Beware Chinese Pharmaceuticals, or, It's a Jungle Out Therre
Posted on 11/02/2007 4:31:04 AM PDT by grey_whiskers
China has been in the news a lot lately. First there were the stories about Intellectual Property theft (copyright infringements); then the discussions of the poisoned pet food; and now there are all kinds of recalls involving products containing unacceptable levels of lead.(*) But now the New York Times has printed a story which seems to contain the worst of both worlds unregulated Chinese manufacturing, not of consumer goods, which can be returned, but drugs, which are meant to be ingested. Forget the old saw How do you get the (diethylene glycol laced) toothpaste back into the tube? the problem here is how to keep the industrial chemicals, fillers, and by-products from getting into the tube in the first place.
The reason I am bringing this up is not to pick on Chinaalthough, realistically, this is still the same country which was behind Tianamen Square, and the same country which has threatened to nuke L.A. if we oppose an invasion of Taiwan. My concern is rather to sound the alarm in the same way Meryl Streep did over apples, except of course that she chose the wrong item to be alarmed over.
To quote from the article:
Pharmaceutical ingredients exported from China are often made by chemical companies that are neither certified nor inspected by Chinese drug regulators, The New York Times has found. Because the chemical companies are not required to meet even minimal drug-manufacturing standards, there is little to stop them from exporting unapproved, adulterated or counterfeit ingredients. (Does anyone want to do a 21st century remake of Upton Sinclairs The Jungle and investigate drug manufacture in China?)
This problem is made worse by two circumstances. First, there is the matter of the arcana of Chinese regulation. If you are a Chinese company, and you *do* get inspected, your inspection will be influenced by what you say you are in business to do. That is, if you advertise yourself as a drug company, you may be inspected or investigated by the safe-drugs people; but if you advertise yourself as a chemical company, but happen to sell chemical feedstock as raw materials for drugs, then you are free from inspection by the pharmaceutical regulators, and have to deal instead with the chemical inspectors. Different standards, different risks. And we all know just how safe, clean, honest, and efficient the chemical industry has been in China. The United States will approve certain end-product drugs for off-label uses if prescribed by a licensed physician; it appears that some Chinese industrialists recommend their own off-label uses for ingredients, even without a prescription!
But there is another problem too one which connects the problems in China to the United States. In the United States, the drug companies have come under fire, particularly from Democrats, for gouging the consumer. The drug companies complain in turn, that the costs of developing a new medicine, testing it for safety and efficacy, and bringing it to market are enormous and given the number of drugs which fail during the lengthy process of clinical trials and never make a penny, the prices are necessary. A particular bone of contention is that the same drugs made by the major manufacturers are sold at a much higher price in the United States than in (say) Mexico or Canada, right next door. Re-importation or even worse border jumping is frowned upon, as is the use of mail-order pharmacies from outside the country. The ostensible reason for this is the large number of counterfeit medicines out there and from the contents of this article, there seem to be plenty. Score one for big pharma! But on the other hand, the major pharmaceutical firms cannot go around warning everyone of the dangers of buying finished drugs outside of the U.S., and then turn around and purchase their feedstocks and perform their manufacturing in a place where there are no guarantees either. This will only encourage those who would shackle the industry or tax and regulate it to death.
There is one other thought which this article brings to mind. The sourcing of manufacturing in China is part and parcel of the corporate fad of offshoring or outsourcing which is a means of using wage arbitrage to pad corporate profits. The defenders of this practice refer to this as free trade, and are only too glad to offer lectures on how the government can only stifle, and that we ought to let the free market dictate everything. In the sourcing of chemicals and ingredients from China, without inspections, without regulations, without anything but the verbal assurance from an anonymous supplier, we have exactly that. Free trade, without interference. Are you really sure you want the government to be hands off in this area? And to the leftists, if you wish to remove all the profit from the greedy drug companies, they are going to have to cut costs somewhere. And usually, the first thing to go is quality (think India-based phone support for your computer). Do you really want your medicines being crafted using supplies from Honest Changs Discount House of Ingredients (formerly Changs Roofing Tar and Cat Butchering Shop)?(+)
Finally, this has applications to the coming election -- if Hillary gets elected, and makes a big push for Hillary care, the push to cut costs will increase dramatically. Could this be the reason she is getting so many suspicious campaign contributions funneled through the Chinatowns in this country?
(*) If you think lead is merely innocuous, a relic from the past dredged up by environmentalists as a catch-all, try reading this from USA Today. Toxic levels of lead can be released by opening and shutting windows whose frames were painted with lead paint more than 40 years ago. (Lead, unlike mercury, is not particularly volatile.)
(+)In economics, Arthur Laffer proposed the Laffer Curve to show how the amount of revenue taken in by the government from taxes drops off at very low tax rates, and again at very high tax rates there is a sweet spot in the middle which maximizes the tax revenue. In regulation, there must be a similar sweet spot which maximizes the amount of goods produced for the consumer at the safest level too little regulation and the industry produces lots of stuff, but everyone gets cheated; too much regulation and people dont cheat, but hardly anyone produces anything, and only the rich can afford it.
The "United States," by way of the FDA, does not "approve" drugs for off-label use; licensed doctors may however, prescribe drugs for other indications, if they believe there is sufficient evidence the drug may be safe and effective.
Regulation is a for profit business. I’ve seen the people you hire to help a manufacturer figure out and comply , at like thousands of dollars per day, where the same people that wrote the regulation when they worked in government. You are then inspected by their buddies, and everything is wink wink, nod nod, ‘fine’.
Did anyone else think it was weird that all children’s decongestants were pulled from the shelves in the middle of the night last week because all of a sudden they are “ineffective?” Not a peep from the manufacturers at the cost they will have to eat. This action taken on recommendation of the American Pediatrics Association PRIOR to any FDA action.
My kids took some Mucinex last summer and both experienced kidney failure (thankfully only temporarily). I wouldn’t doubt that the manufacturers have been getting contaminated ingredients, but don’t want to “panic the public.”
Ping of interest.
It's not a grey area of the law--doctors may prescribe any approved medicine, for any indication. There's no reason to prosecute.
I’m not sure what your point is; I merely wanted to clarify the oft-confused idea that the FDA—through some bureaucratic, backroom process with pharmaceutical companies—does not approve drugs for off-label use. Doctors however, can infer whatever medicinal properties they want, and prescribe drugs for off-label uses.
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