Contaminants in pig intestines? Who knew! Posted by Daniela at 03/20/08 09:32 AM

Yesterday the FDA announced that it identified the contaminant found in the recalled Bayer product heparin, a China-made blood thinner derived from pig intestines: oversulfated condroitin sulfate, a chemical that does not occur naturally, CNN reported.

Bayer issued a full-scale recall late last month, after 19 people died and over 700 more suffered from the product’s adverse reactions. The FDA says it’s unclear whether the chemical is directly linked to the heparin deaths and side effects.

The NY Times reported that the Chinese heparin market has been in turmoil over the last year. The Chinese heparin plant under investigation may have used crude heparin from unregulated family workshops. Heparin is made from scraped pig intestines.

The FDA wants you to feel safe now: “Doctors and patients now can be confident that the product on the market has been tested and is safe,” said Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research. But the market conditions creating the situation haven't changed and the FDA violated its own policies.

The FDA admitted its violation when it said it failed to inspect the Chinese plant, which sparked a broader discussion of the FDA’s shortcomings in light of foreign drug inspections. Out of 566 Chinese drug plants that export to the U.S., the FDA only inspected 13 last year.

Julie Zawisza, FDA spokeswoman, said the agency was “looking at a number of options in addition to more foreign inspections to increase our presence abroad and our ability to detect problems.” They now say they will open an office in China to conduct audits and inspections.

But for these foreign inspections to occur, some lawmakers like Rep. Bart Stupak (MI) say the agency needs more funding, which may require taking drug company user fees.

Why should the taxpayer pay for these inspections so that you can close a plant here and open it over there to ship it back? It will be sustainable income so that we don’t have to get into these budget battles every year, said Stupak.

While the FDA investigates whether or not the heparin was contaminated intentionally, it’s understandable that heparin users (millions of people) might be nervous about taking the medication.

comments (20)

1 Posted by Vickie at 03/27/08 04:16 PM

Seems to me like idiots run this organiztion as they do our government. They are like blind mice. Cut their pay and make them earn their salaries and maybe they would do a better job.

2 Posted by debbie wheeler at 03/27/08 04:19 PM

why are we relying on the chinese for medicine? Why is the fda not doing there job to keep us safe? Out of 566 medicines,the fda only inspected 13. That is an outrage to put the consumer in that kind of danger.

3 Posted by Pamela Dillon, Ms at 03/27/08 04:46 PM

There is a confilict of interest when the FDA talkes funds from Pharmaceuticals. Drugs that are supposed to be checked, aren't. Is the FDA getting paid off under the table too.

All drugs are not good for everyone. Some persons do not do well with anything Pig related. It is because of a sensitivity in the blood. This goes for pigs, cows, chickens, plants, minerals, etc. By checking the pH of the blood it can better be determined whether or not a product is safe for the individual.

Also, why should the American people pay for the Gov't mistakes. This is an outrage.

4 Posted by Dan Balzer at 03/27/08 04:47 PM

I don't know enough about the particulars of this case, nor do I mean to imply that watchdogs (including CU) are not right to be scrutinizing drug safety.

But I wish CU would stay away from the sensationalism. Pig instestines from China! Horrors! What next? Asperin derived from tree bark?! Calves' stomachs used in making cheese?!

Whether the drugs originate in China or Chicago; whether they are made from pigs or puppy dogs; what is important is that there be rigorous, science-based, product safety standards.

5 Posted by Jane at 03/27/08 05:19 PM

My husband is on dialysis. He mentioned this to me a while back, about a problem with Heparin, and I didn't understand the frightful consequences. I was with him a couple weeks ago, when the nurse at Fresenius/BMA said they make their own. I felt relieved, until my husband remarked ‘Yeah, they just make it in a different area of China.’ And I thought I was the cynic in the family! Thank you for the article and information to help me understand this better. It’s good to know that someone is helping to get the truth out.

6 Posted by Betty at 03/27/08 05:29 PM

My husband has been given heparin on several different occassions due to having strokes.
Its sad to think that the drugs that are meant to save a life can actually take a life instead.
Why aren't the drugs made in the USA. They sure should be. We should be in control of making sure our drugs are safe.

7 Posted by Jane at 03/27/08 05:29 PM

And to think - Congress said it was too dangerous for the elderly to get cheaper drugs from Canada and Mexico.

8 Posted by Pamela Adger at 03/27/08 07:11 PM

Many drugs come from other animals and plants. For example, most antibiotics are derived from mold or bacteria. It is not necessarily the origin of the pharmaceutical that is the problem, but the inability of the regulating body (FDA)to follow its own standards and protocols. The FDA has extremely strict regulations in place that companies must follow in order for a pharmaceutical to be approved. Once approved however, the FDA doesn't follow up on manufacturing practices, side effects, post launch studies and quality control standards. That is where the breakdown in consumer safety happens. Lack of oversight not how the drug is derived.

9 Posted by Ellen Chmiel at 03/27/08 10:03 PM

Every item from China signals caution and we need FDA inspectors there. Or better, get the drugs/ingredients from home where they are verifiable.We don't need more of their contaminated products for the sake of THEIR cash flow!

10 Posted by David Crosbie at 03/27/08 10:31 PM

Why are Canadian drugs manufactured in the USA forbidden and un-inspected drugs OK, can anyone explain the logic. Full inspection without intimidation or any gratuities are clearly a reasonable and necessary requirement. They must be paid for as a value added tax on all drugs exported to the USA from that country. Plants with more than the median number of infractions should pay 60% of the tax. Plants with more than the 95th percentile must close or reduce the number to the median within 15 days including direct payment for all costs of the re-inspection. All processes and safeguards required in the USA must be required of foreign producers at their cost. They will still be cheap drugs, but health everywhere will be better for it.

11 Posted by Diana Little at 03/27/08 11:29 PM

I was given Advair from Mental Health, and my doctors cupboard, a year later, while fighting for disability, and state medical since I was unable to work anymore. I ended up with a Pulminary Ambolism, and almost died, the emergency room doctor said that within 48 hours I would of been dead. I was placed on Coumodine, I took it for a year, and still the State refused to give me medical coverage,or disability, so I had no choice but to go off all of my medications... I live one day at a time, and Thank God for every breath I'm able to take!

12 Posted by B. Benhamid at 03/28/08 05:39 AM

Drugs are released to the public because they are a big money maker and in many cases a life reducer. The FDA is in cahoots with big pharmaceutical companies by letting drugs pass that are in many cases unsafe and have to be pulled from the market later after the damage was already made.

13 Posted by Glenn Whitmore at 03/28/08 08:48 AM

I don't trust any thing that comes from china and I really don't trust the drug companies. All you have to do is listen to their adds on tv, if it don't kill you it might cure you. A few years ago a doctor gave me some samples for a b p med and it had a list of side affects. I had every side effect except for the heart attack it could cause. No I don't trust drug companies.

14 Posted by Mary Whitmore at 03/28/08 11:30 AM

We have to buy everything from China. We have to keep their economy growing so they can lend our government the money it needs to fund our fight for Iraqi (and soon Iranian) oil. "Oh what a tangled web we weave when first we practice to deceive."

15 Posted by Tachia at 03/28/08 12:02 PM

Truth: the FDA is not looking out for anyone's best interest but their own. Many drugs are dangerous, untested, and ineffective and are simply made to make profit and to annoy people whenever they turn on the TV.

16 Posted by CJ at 03/28/08 11:13 PM

Lets see...China...dog toys, children's toys , dog food recalls for contaminants and resulting deaths and injuries....so now..lets let them make our medicine!

PEOPLE are VOTING for candidates who do not care WHAT WE WANT

Now if I recall correctly I believe citizens were reprimanded for ordering medications from Canada and have been treated like are criminals if they crossed the border to buy... but we have the FDA championing /allowing cut rate unregulated drugs and wholesale poisoning of our citizens via China.

The insurance companies are always whining about costs...let them jump on this and stop the poisoning before they have to pay for the results!

I wonder what the costs will be to bankroll the fallout?

17 Posted by Don at 03/29/08 03:52 AM

Many of the drugs we use today are derived from plant and animal sources. For example, the pencillins are produced by a particular mold and estrogen extracted from mares urine.
Chinese products will remain attractive due to cost. Americans have always sought low cost alternatives for everything they consume. Hence the success of Walmart.
It is indeed unfortunate that the regulatory and oversight process has failed on occasion. Fixing this will require that agencies like the FDA be better funded, that industry improve its ethical standards, and, most importantly, that the American public have access to the data and information they need to make informed decisions on everything they consume. Consumers Union has always striven to fill the latter niche.

18 Posted by hodad at 03/29/08 07:04 AM

I don't think any product from china should be allowed to be released to the public without being tested by an inspection agency.. I dont care if its a toy or a medicine, all imports from china need to be inspected, cloths for fire resistance, medicine, toys etc for lead. It appears the chinese govt has no regard for its people so why would they be concerned about others. Bring the manufacturing of these products back to the USA or other countries with inspection systems in place

19 Posted by Jacquie at 03/29/08 10:55 AM

Vicki,
I couldn't agree more!

20 Posted by Kim at 03/30/08 10:00 PM

It's all about money! I liked and agree with all of you. The FDA doesn't do squat other than pretend of looking like they do their jobs, they only want their really big pay checks, and don't want consumers to take it away. Pharmaceutical companies, same thing. They don't won't the consumers to use alternative meds so they start to lead the american people to believing that they are all bad for you. Yet what they don't tell you, is that in order for the human body to handle any of their meds it has to be lined with a natural product. Hmmmm! If you use alternative meds then they would lose all of their money, then they would want to jump on the alternative meds band wagon and try to make their big bucks again. Then they would tell how good it was for you. What's bad about all of their meds is the doctors prescribe it but doesn't ever solve the problem. Why? Because the pharmaceutical companies and doctors alike don't really want to fix you, because they wouldn't have repeated customers. They only treat symptoms and never get to the root of the problem. Just mask it. That's what I call a legalized drug dealer. Let's get them all hooked on a prescriptions that is addicting will help us make some of our big bucks at the consumers expense. It's all about money!