The High Cost of Cheaper Drugs - The heparin scare is a monitory lesson on drug importation.

National Review Online ^ | April 24, 2008 | Roger Bate

[neverdem]

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April 24, 2008, 0:00 a.m.

The High Cost of Cheaper Drugs
The heparin scare is a monitory lesson on drug importation.

By Roger Bate

Tainted heparin in 11 countries has caused the deaths of 81 patients, highlighting the potential danger of cheaply produced — sometimes counterfeit — imported medicines. Congress is holding multiple hearings on the tragedy, but it’s unlikely that they’ll draw the appropriate conclusion. All three presidential candidates support making drug importation easier to combat the “high cost of health care.” But they seldom acknowledge the inherent risk — and associated external costs — in such importation.

According to the FDA, over half of the drugs Americans buy over the Internet don’t work — and at least one North American death has been officially linked to drugs purchased this way. Even in the legitimate supply chain, where businesses have generally done a good job at quality control, risk remains — especially when products are imported from countries with far less stringent manufacturing standards.

Importing finished medicines and the active pharmaceutical ingredients (API) used to make them certainly reduces price. China and India have some of the cheapest drug production around. U.S. companies already import 40 percent of API from India and China, a number that is expected to double within a decade. While a few companies in both countries have the technical capacity to make good products, regulatory structures are weak there, and their markets are plagued by counterfeit and substandard medicines which annually kill tens of thousands — maybe hundreds of thousands — of their citizens.

In the U.S. heparin case, FDA scientists determined that suspicious lots of API used to make the drug were imported from China and appeared to contain 5 to 20 percent of a heparin-like compound which mimicked heparin activity so closely that it was not recognized during routine testing. The FDA was careful to avoid using the word “counterfeit” when discussing the incident – but when pressed by reporters, Center for Drug Evaluation and Research director  Dr. Janet Woodcock, admitted that the agency was “99 percent sure [the contaminant] is not a natural component that got in there as part of the purification process.”

Heparin is a blood thinner, often used on patients undergoing cardiac surgery or kidney dialysis. Raw heparin is normally sourced from the intestines of pigs or the lungs of cows, while the contaminant — oversulfated chondroitin sulfate — comes from animal cartilage. It is more abundant (and so cheaper) than raw heparin, and not registered for medical use because it causes severe allergic reactions.

FDA inspections of the Changzou, China facility of Scientific Protein Labora tories (SPL), the company responsible for producing the suspect API, revealed insufficient standard-setting and poor record keeping. On Monday, the Chinese government suggested that the problem may have been at the U.S. end, and the FDA quickly responded issuing a warning to SPL (and Beijing) citing “significant deviations” from good manufacturing processes and recommending disapproval of future applications to manufacture APIs.

The FDA and the affected companies appear to have managed the incident well, minimizing American exposure to suspect heparin. Baxter International voluntarily recalled nine lots of its multi-dose vials of the drug in January, and the next month expanded the recall. The FDA investigated SPL facilities in China and Wisconsin — as well as a plant in New Jersey, determining whether the heparin could have been contaminated by its packaging.



The diligence appears to have paid off: no new deaths associated with the suspicious allergic reaction have been reported since February.

But the incident exposes the ugly little secret about drug importation as a means to lower the cost of medicine. Substandard and counterfeit drugs proliferate in many countries in Africa, Asia, and elsewhere — even in Finland, as much as 8 percent of pharmaceutical products may be counterfeit. Outside the U.S., businesses not as vigilant as Baxter, Covidien, and B. Braun — all three of whom issued precautionary recalls once the heparin scare began — and regulatory agencies are not as adept as the FDA.

High regulatory standards in the U.S. have limited drug counterfeiting — but have also fostered a complacency over drug safety. The regnant political opinion today is to allow more intermediaries to import more drugs from overseas. While regulators can oversee the output from large manufacturers, widespread importation will put myriad actors into the importation business, some of them criminal operators.

Pharmaceutical companies are better positioned to source and import drugs than patients are: they have experience, expertise, and reputations to maintain. American consumers benefit when U.S. companies import API from Asia (assuming they pass cost savings on to consumers), and they should continue to do so. Interpol and the World Customs Organization should continue to encourage vigilance in exporting countries, and the FDA should send more inspectors to overseas production facilities in China and India.

But the risk remains. An unchecked drive for the cheapest drugs will increase the risk of another heparin-type incident. And there’s nothing cost-effective about such folly.

— Roger Bate is a resident fellow at the American Enterprise Institute. His book Making a Killing: the Deadly Implications of the Counterfeit Drug Trade will be published in May.

[neverdem]

IMHO, doing business with the Chinese capitalists cum communists, also known as Chicapcumcoms, will be like doing business with the Mafia.

[neverdem]

ChiCapcumCom ping!

[ChinaThreat]

Did anyone see that asshole Sen. John Dingel during this hearing? He is atypical of Democrats. A complete and total jerk, that used his bully pulpit to degrade people, when he himself is just as responsible as anyone for this mess.

[Cicero]

The FDA was careful to avoid using the word “counterfeit” when discussing the incident

Of course. The FDA isn't working for us, it's working for the politicians who have been paid off by the companies who find it much more profitable to import ingredients from China.

The authorities did their best to play down the poisoned dog food incident, but that was the one that got away from them.

And can anyone doubt that the Chinese deliberately put ethalene glycol into toothpaste and other products that poisoned people, because it tests like glycerine if you don't check too closely?

There was deliberate counterfeiting in a lot of these cases. The dog food was deliberate, too--a chemical was added to make it seem as if it had more protein in it.

[Dazed_Catt]

Hey it’s just “free market capitalism” like many people here will tell you.

You’re right, the FDA doesn’t work for the people any longer. Neither does the entire federal government actually.

Just remember, China=good........just ask any free market “conservative”.

God help us all.

[Paul Ross]

Just remember, China=good........just ask any free market “conservative”. God help us all.

Yep.

They're going to get us all killed.

[iowamark]

I thought that monitory was misspelled. Learned a new word today.

[JACKRUSSELL]

A ping list dedicated to exposing the quality, safety and security issues of food and other products made in China.


Please FReepmail me if you would like to be on or off of the list.

(This can be a high volume ping list.)

[PGalt]

Thanks for the ping JR. Thanks for posting, neverdem.

What hospitals, clinics, patients, were affected? In what cities, states? Where is the quality control breakdown? Who were at higher risk, given others weren’t affected from the same lot? Where is the traceability? Where is the accountability?

So many questions...so very few answers.

BUMP-TO-THE-TRUTH!

[La Enchiladita]

We are in trouble:

U.S. companies already import 40 percent of API [active pharmaceutical ingredients] from India and China, a number that is expected to double within a decade.

... The regnant political opinion today is to allow more intermediaries to import more drugs from overseas.

... Interpol and the World Customs Organization should continue to encourage vigilance in exporting countries, and the FDA should send more inspectors to overseas production facilities in China and India.

I am not buying any of the "reassurances" offered in this article, either.

[PGalt]

We are in trouble:

I am not buying any of the "reassurances" offered in this article, either.

BUMP!

[TigersEye]

I am not buying any of the "reassurances" offered in this article, either.

I'm not either they were very weak. If you have to use pharmaceuticals it's probably worth the extra cost to get American made. Our standards are still the highest or nearly the highest in the world. There is a reason for that and a cost that goes with it.

[La Enchiladita]

I try not to use pharmaceuticals myself, even minimize OTC usage. I try to keep things simple, don’t go overboard with the “alternative” stuff either. I used to use some herbal sinus pills from China, not anymore.

[TigersEye]

That sounds like my philosophy of medicating. Only when necessary and the lightest possible form when it is. As long as it’s effective or has good potential to be. I have a number of Chinese Patent Formulas on hand that work very well for their intended purpose. But from here on out they will be replaced with American made products based on old TCM formulas. Partly because of quality concerns but largely due to political issues.

[La Enchiladita]

Politics and... this globalism thing has its downside.

In fact, what is the upside of it?

[TigersEye]

I really don’t know of an upside to it. We have lost control of our economy, manufacturing, regulatory oversight, sovereignty, borders... I don’t know where it stops.

[La Enchiladita]

I thought about your post as I was fixing some noodles to eat. It is beyond sad that 81 people died because of the contaminated heparin, and 100+ others suffered severe illness because of it, possibly irreparable harm. This affected several countries. China has been aggressive in promoting widespread trade; I still don’t understand how we got so involved with trade with them, ruthless commies that they are.

Now, fresh garlic in the market is from China... What?! Avocadoes from Chile. Both of these and many more we can and do grow right here in California, only available at the farmers’ markets, however.

So, my answer to “don’t know where it stops” is a whimpering “stay as informed as you can.” We are only along for the ride.

[TigersEye]

I haven’t seen the Chinese grown produce that others have been talking about but I recommend growing your own if at all possible in any case. Fresher, tastier and cheaper.

[nw_arizona_granny]

Bump