FDA Believes Heparin Contamination Was Intentional

The New York Times reports that the FDA is now working under the assumption that the deadly contamination of heparin was intentional. In her prepared testimony before a congressional subcommittee, Janet Woodcock, director of the FDA’s Center for Drug Evaluation said,

FDA’s working hypothesis is that this was intentional contamination, but this has not been proven.

More details, inside…

The FDA discovered that the drug was contaminated with oversulfated condrotin sulfate, which mimics heparin, thus eluding routine tests. Baxter President Robert L. Parkinson Jr. said in his testimony that his company is “greatly concerned that our heparin product appears to be the target of a deliberate adulteration scheme.” Additionally he said,

“The complexity of the global drug supply chain creates new and emerging risks that call for new ways of thinking about, identifying and addressing vulnerabilities, and that resting on old standards – even ones that have worked for decades – is no longer enough.

It should be interesting in the coming months to see whether this turns out to be another case of Chinese factories trying to save money or actually a case of malicious intent.

Heparin Contamination May Have Been Deliberate, F.D.A. Says [New York Times]
FDA Official: Heparin Contamination May Have Been Intentional [Fox News]
(Photo: Getty)

Comments

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  1. thirdbase says:

    This is turning into a bloody mess.

  2. If your so worried stop outsourcing. From what I heard consumers tend to pay the same price. The company just makes a greater profit. So for decades our drugs were outsourced, Why don’t I belive that. Its a more recent shift

  3. bohemian says:

    I care if it was greed or a deliberate attempt to kill people. Either way this makes the drug supply totally suspect and potentially lethal.

    The FDA has to put a smack down on sourcing raw materials from god knows where. Either make it domestically and have a paper trail to prove it was so or get reciprocating agreements with places like Canada and the EU as long as their oversight and standards match or exceed ours and prevent suspect ingredients from coming in.

    Maybe if Congress took a week and did nothing but hash this out? Kick all the freaking lobbyists out of DC for that week? If there was ever something that needed drastic action this is it.

    BTW, I heard on NPR on the way home tonight that the FDA is doing a huge hiring spree.

  4. Buran says:

    I’m shocked… Shocked.

  5. EllenRose says:

    The government doesn’t have time for the FDA to protect us. They are too busy removing “potentially hazardous” bacon-wrapped hot dogs from the streets of San Francisco.

    Doing symbolism gives a bureaucrat much more joy than doing something which might actually be useful.

  6. How many times do we have to forgive the Chinese and other nations for tainting our products?

    There should be Zero Tolerance. One strike, and you’re OUT. Period.

  7. hellinmyeyes says:

    Seriously, what is SO complex about pharmaceutical production that it has to be outsourced to begin with??

  8. NoNamesLeft says:

    First they tried to poison us through our dogs but the Chineese didnt realize that we don’t eat dogs. Now they are trying the more direct route.

  9. mikelotus says:

    Its the Dali Lama’s fault, clearly. Trying to embarrass this great nation on the eve of the Olympics. Better threaten the parents of any Chinese student here that don’t agree too.

  10. Cliff_Donner says:

    Sorry, but I thought the drug companies were already raping us up the ass with inflated prices based on “research costs” that the government was actaully funding, and through patents prohibiting other companies from producing lower-cost generics for an extended period of time?

    Now they’re trying to cheap out on actually delivering the overpriced drugs we, as consumers, through necessity, have agreed to buy?

  11. forgottenpassword says:

    China needs to start executing the ones who do this disturbing kind of deliberately tainted food/drugs.

    Didnt they recently execute their equivilant of the FDA for being corrupt & taking bribes?

  12. TechnoDestructo says:

    AMERICAN companies, IN THE US intentionally ignore or falsify their testing of pharmaceutical manufacturing.

    Chinese or not, this isn’t surprising.

  13. ageshin says:

    I see….Instead of incompetent gov dept not catching the importation of adulterated med. we have…./////////////Evil and sinister Fu Manchu like attack on the western powers. Poor incompetent gov . department should not be expected to handle such dasturdly deeds. It is not the fault of unregulated capatalist companies in China. It’s the yellow hoard out to get us!!!!!!!

  14. hamsangwich says:

    Ok, so yeah the Chinese manufacturing plant (not to be confused with the nation of China as so many people have generalized) is at fault, but Baxter only inspected the factory once in seven years?? Also, what happened to their quality control? They don’t fully investigate the product they are having produced for them? Ultimately Baxter deserves the lions share of the blame.

  15. LUV2CattleCall says:

    I love how the drug companies scare people into thinking that importing drugs from Canada is what would cause stuff like this to happen…yet they manage to screw it up when everything is in their hands!

  16. Trai_Dep says:

    We need to test all drugs using GOP people that are certain the gov’t is the problem.

  17. Trai_Dep says:

    Why take a chance ordering Canadian drugs for less when our drug companies can poison us certainly for more?

  18. linkura says:

    Of course. The manufacturers were trying to cut corners to save $. Simple as that, horrible as that.

  19. bohemian says:

    @Cliff_Donner: Really. The FDA tells everyone to not buy drugs from outside the US because they are dangerous. There are generic drug factories in India that also make generics on contract for the big US drug makers. Since India doesn’t recognize patents here they make drugs that cost $300 retail here for $20. Sure you might be taking some chances buying something there or online from there. But it is pretty obvious your taking chances here too.

    The sad thing is they also found people in the heparin issue in Germany so this crap is getting through the EU also.

  20. bohemian says:

    @forgottenpassword: Yes they executed an official over the melamine issue. IIRC they also arrested the people running the raw materials factory that did it.

  21. FreeMarketGravy says:

    @hellinmyeyes: It’s not that it’s complex. It’s expensive.

    I hate to draw the parallel, but I hate more that I can: Your cell phone carrier doesn’t hire people in India to answer your customer service calls because it’s “too complex” for American workers.

    The concept of “If we pay Americans 40% of the pie, that only leaves 60% for us, but if we pay foreign workers 10% of the pie, that leaves 90% for us” applies to nearly everything nowadays.

  22. fostina1 says:

    of course it was intentional. as well as all the lead in the kids toys. and everything else china is doing to slowly kill off the united states and take over the world.

  23. BigElectricCat says:

    IMO, the pharmaceutical companies probably knew that the Chinese supplier facilities weren’t following any sort of viable anti-contamination procedures, and I suspect that the pharma companies knew that the Chinese producers couldn’t be doing it based on the prices they were charging. However, now that the stories are coming out, I think we’ll see the pharma corporations throw these nasty little Chinese production shops under the bus and claim that they knew nothing about the hijinks within.

    IOW, a real “Gambling? I’m shocked. SHOCKED!” moment on the part of the big pharma corporations. I bet they knew. But I also bet they don’t want to tell you that.

  24. pzm436 says:

    The root to all these problems we’re having with food, drugs and outsourcing is greed. It isn’t profitable to process pig intestines for heparin here in the U.S In addition any livestock raised for food is prohibited from being used for medical purposes, which add to cost of production.

    Accountability is lacking from the drug companies, suppliers and governments. I highly doubt its the rural farmers of China are the ones adding sulfur to the heparin, in a bid to make a living. Briber, falsifying paperwork and trickery common place in China, allowing a corrupt businessmen to make a exuberant profit.

    The only way to ensure a safe drug supply is to treat it as a national security issue. Bring back resourcing and manufacturing back to this country. Or expand regulation and inspection to include foreign suppliers.

  25. mikey07840 says:

    Well, as someone who uses heparin several times a week, this is all bad news.

    Don’t the manufacturers understand that if I die, I can’t buy my thousands of dollars worth of dialysis supplies each month.

  26. Buran says:

    @bohemian: So if Canadian drugs are so dangerous, why aren’t the Canadians dropping dead in droves?

  27. @pzm436: “The root to all these problems we’re having with food, drugs and outsourcing is greed.”

    You said it.

  28. Dobernala says:

    No new articles today??

  29. BloggyMcBlogBlog says:

    @Dobernala: There are, but they’re only appearing on their RSS feeder for some reason.
    [feeds.gawker.com]

  30. yagisencho says:

    If this was intentional, then the guilty parties will be tried for mass murder. It’s a start.

    Now, what’s being to prevent future contamination?

  31. Whiskey Tango Foxtrot says:

    Our pets get melamine, our kids get lead tainted toys, and we get fake heparin…it it just me, or does this seem a bit too far fetched to simply be mistakes or oversights.

  32. elanne says:

    This is just the tip of the iceburg.
    Anything having to do with Big Pharma just gets curiouser and curioser. Beware.

    We are being led down a very twisted path with lots of misinformation, disinformation, and plenty of finger pointing … all to distract us while the big money does what it wants to do … make more big money.

    Whichever way things go, there’s big bucks to be made from the cycle of cures, outbreaks, epidemics, and, yes, even recalls. Think about it.

  33. Mr. Gunn says:

    HAI GUISE! DON’T BUY CHINEESE BECAUZE THEIR ECOMOMEE IZ KICKIN’ R ASS!!