Recalled Heparin Contaminant Confirmed, And Congress Grills FDA On Inspections

Researchers have identified the chemical in the contaminated blood thinner Heparin that killed 81 people in the U.S. and made patients here and in Europe sick:

The researchers freeze-dried the heparin and used a combination of nuclear magnetic resonance imaging and liquid chromatography-mass spectrometry to analyze its structure. In addition to a known impurity of heparin called dermatan sulfate, they found that contaminated lots contain a molecule that looks similar to heparin and showed it was almost certainly oversulfated chondroitin sulfate.

China says their tests show that only some of the Heparin that caused the problems contained the contaminants, so it therefore must be something else:

They said other contaminants, problems with the device used to inject the drug or health factors with the patients who used the drug could be to blame.

Yesterday, Congress went after FDA Commissioner Andrew von Eschenbach for the FDA’s lax inspection protocols, particularly with regard to foreign factories. According to ABC News,

Estimates suggest more than 80 percent of all active ingredients used by U.S. drug manufacturers come from abroad. But the FDA only inspects foreign drug plants about once every 13 years, compared to every two to three years for domestic plants, according to the Government Accountability Office. The GAO finds that China’s drug plants are inspected once every 30 to 40 years.
 
The FDA plans to establish permanent overseas offices in numerous countries, including China, to help address the problem. More foreign plant inspections than ever were conducted by the FDA in 2007, dedicating about $10 million to the process. But GAO analysis said it would cost the FDA $67 to $71 million each year to inspect the thousands of foreign plants on the agency’s priority list.
 
Still, von Eschenbach told the House Subcommittee on Oversight and Investigations that in heparin’s case, even if the Chinese plant had been inspected years ago, “we would not have detected that contamination” because the test to detect it was just developed.

The GAO also reported to Congress that “as early as 1998, the FDA needed to improve its foreign drug inspection program,” and that “one database showed 3,000 registered makers and another revealed that 6,800 makers actually shipped their drugs into the country last year.”
 
Fun fact: Heparin is made from pig intestines!
 
“US researchers confirm heparin contaminant” [Reuters]
“FDA Chief Faces Wrath of Congress” [ABC News]
 
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(Photo: beelden zeggen meer)

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  1. Manok says:

    do we know the dates of the bad heparin? My son (before he died) had to have heparin daily to clean out his broviac. He died of organ failure though…but this worries me if his heparin may have been bad. He took heparing from April 07 to Nov 07.

  2. Manok says:

    oh, brain tumor/chemo complications were the cause…no one mentioned heparin poisoning or anything like that to me. Not that doctors would.

  3. bohemian says:

    Wouldn’t setting some sort of standards like all component ingredients must come from either a country that has suitable inspection standards of their own or meet ours help?

    So what they are saying is most of our drugs are largely uninspected. Scary.

    @Manok
    This is the 2008 FDA alerts. You should be able to find out something there.
    [www.fda.gov]

  4. Chris Walters says:

    @Manok: I’m sorry for your loss.

    You can find out more information on the Heparin recall (which happened Jan/Feb) at Baxter’s site. Check the third release, dated 25 Jan, for a list of all the lot numbers.

    [www.baxter.com]

    That page also has a phone number if you’d rather call:

    Customers with questions about Baxter’s U.S. vial-based heparin product recall may call the Center for One Baxter at 1-800-4-BAXTER (1-800-422-9837). Representatives are available Monday through Friday from 8 a.m. – 5 p.m. Central Daylight Time.

  5. AmbroseP says:

    There’s no reasonable expectation for U.S. regulatory bureaus to have access to manufacturing facilities in countries that do not like us to meddle in their affairs.

    Congress unfairly attacks the FDA knowing very well that the FDA is limited in power, both legal and economic. Perhaps Congress shouldn’t have cut so much of the FDA’s funding.

    It’s funny that Baxter in Illinois buys their active ingredient in China from a firm that’s owned by a company in Maryland.

    Why do we allow these companies to outsource to nations with no or substandard safety protocols and good practice guidelines–Chinese FDA has a long way to go and their government will never look out for the working conditions of their citizens the way we do.

    Sure, this translates into cheaper production for Pharms but this has never translates into cheaper prices at the consumer level. These companies are just resorting to another cost-cutting measure to increase profits–especially when many large blockbusters are ready to go off patent.

    In this increasingly globalizing marketplace where we devalue domestic craftsmanship in favor of the value of the foreign bottom-line, we need to hold someone liable for cases like this.

    Sure, the pharmacopoeia wasn’t poised to handle the nature of this error, but the Pharms should be held accountable for these errors

  6. AmbroseP says:

    @bohemian: You know what’s scarier about this case?

    By same severe oversight, that particular plant NEVER had it’s initial inspection. They were operating without being checked at all!

  7. AmbroseP says:

    P.S. It’s late. I’m tired. And my text is riddled with quite a few errors. My apologies.

  8. lictor says:

    The Europeans have a model that seems to work better than bureaucracy: An executive must sign that all products entering the EU meet standards. Later on, when something like this happens, the executive goes to jail. No need to inspect factories – the management keeps their own house clean, because it is their necks! This is called CE Marking, and seems to be much more effective than having inspectors come out every 40 years. Basically it applies to almost all products crossing borders, not just medicines but toys and such too.

  9. Gordon2 says:

    Ambrose, I’ll grant that you’re tired. No apologies needed. I’m a little worn myself.

    Companies don’t manufacture in China just to increase profits. They also do it to stay competitive. Heparin is generic. If Baxter wants to compete with other companies selling it, they have to keep costs as low as they can.

    That competition does lower costs for consumers. I’ve seen my cost for a med I take drop by 90 percent as more companies brought out their generic versions.

    Of course, as other companies have learned, saving money with Chinese manufacture comes with other problems. This will cost Baxter every bit of those savings; probably a lot more.

    Western companies need to take a longer view of the risks. Mattel is still reeling from the lead paint scandal.

  10. Manok says:

    thanks for the condolences. I’ve already been in touch with a lawyer about this. This is scary to me though…I gave him heparin twice a day for 8 months.

  11. Buran says:

    @Manok: Quit blaming yourself for something that you had no way of knowing about. The people who did this deliberately hid it so their crap would make it past all the tests so how could you have known about it unless you did the testing yourself, and even then it still would have got through?

  12. Geez… my dad has taken heparin pretty regularly for about a year because of dialysis, and he recently had a ‘stroke-like’ incident. My mom got some when she was in the hospital a few weeks ago.

  13. bohemian says:

    @lictor: That is a brilliant solution. At least it makes up some of the gaps in the FDA’s ability and might be a better solution if such widespread globalization has to happen.

    I still have to think that between the US & Canada we have enough hogs to supply the materials for heparin.

  14. bohemian says:

    @Gordon2: Or Baxter could take the route that Abbott did with their thyroid drug. They have proven it is more consistent in usable dosage per pill. So some doctors refuse to prescribe the much cheaper generic because it still doesn’t work as well or as consistently.
    If a company like Baxter charged slightly more but had a more reliable product from a safety standpoint they could potentially compete at a higher price against generics.

  15. BigElectricCat says:

    Huh. So Congress and the pharmaceutical industry shriek about senior citizens going on bus trips to Canada to buy medicine because ‘we can’t be sure those medicines are safe,’ but we’ll import most of the constituent reagents and compounds used in MAKING those medicines without ever bothering to inspect the plants that made them.

    I see how this works now.

  16. chemman says:

    The pharmaceutical manufacturer’s that are buying the raw drugs are the ones who are responsible for making sure the drug they are buying is safe for human use. Pharmaceutical manufacturers are supposed to fully test raw drugs to meet USP standards, but nowadays, a lot of them “qualify” their vendor and then only perform identification tests upon receipt of the drug. The problem is, the way the pharmaceutical manufacturers qualify their vendors. They basically full test the first few lots of drug received and audit the vendor by sending them a survey to fill out, without anyone from the company ever visiting the site of manufacture of the drug so these companies can easily be manufacturing in deplorable conditions, without the company knowing. I think we need to be more like the European model and hold these companies and their executives accountable for cutting corners that endanger human life.

  17. bohemian says:

    @BigElectricCat: That is what keeps going through my head. I wish the mainstream media would bring this up and demand an answer out of the FDA how they could get all freaked out about the Canadian drug issue but let this practice slide by.

    I guess they assume all of us have such short memories that we won’t remember something they did five years ago.

  18. Buran says:

    @BigElectricCat: I haven’t seen seniors dropping dead from Canadian medicine, nor do the Canadians drop dead, so … WTF?

  19. BigElectricCat says:

    @Buran:

    Yeah, that’s pretty much where I am with this. If the uninspected heparin compounds are okay, then I’m guessing that the Canadian drugs that don’t appear to be killing Canadians ought to be pretty safe too.

    After all, it’s not like Canada is some sort of Third World hellhole. I’ve never been there, but I hear that the streets are clean, the people are friendly and most folks speak English. The place sounds pretty safe to me. ;)

  20. yagisencho says:

    My wife is currently taking anti-coagulant injections during pregnancy, due to a blood clot complication following a C-section with the first delivery.

    On the one hand, the heparin recall has made it easier to get our insurance company to agree to pay for the more expensive alternative. On the other hand, they plan to transition her to heparin for the final four weeks of pregnancy (since it metabolises in half the time that enoxaparin does).

    Given current events, I suppose our timing is good. But it still has me worried.

    @Manok: I’m sorry for your loss. I hope that you are able to find out one way or the other.

  21. elanne says:

    Congressional investigations. Congressional oversights.

    We all know there are some congress persons who choose to remain oblivious to these things. However, there are also quite a few who are getting frustrated with taking the time to investigate only to be lied to over and over.

    Each new investigation seems to open a new can of worms. Congress (collectively) is being worn down while the executive branch continues to do whatever it wants and big biz calls the shots.

    Ugh!

  22. Gustastic says:

    Ironically, Heparin hasn’t been recalled from human hospitals, but has been pulled from veterinary hospitals. I haven’t even really heard of adverse reactions in animals.