Blood-Thinning Drug Under Suspicion

Dr. Emily Senay Reports On The FDA's Investigation Of The Drug Heparin

(CBS)  Every day thousands of Americans rely on the blood thinner Heparin to survive.

Now that drug is under suspicion for 21 deaths and hundreds of allergic reactions. Baxter International, a major manufacturer of the drug, has stopped selling almost all forms of Heparin.

CBS News medical correspondent Dr. Emily Senay reports that officials say they have not yet identified the cause, but are looking to China where nearly half of Heparin's raw ingredients come from.

Until last week, leading manufacturer Changzhou Scientific Protein Laboratories had no operating license and had been completely unregulated, either by Chinese authorities or the Food and Drug Administration, a violation the FDA's own inspection policy.

The FDA finally inspected the plant two weeks ago.

FDA Commissioner Andrew von Eschenbach says that the investigation of the Heparin issue is "active and underway."

The inspection revealed "use of materials from an unacceptable vendor'" and a failure to "identify impurities and deficiencies'" with manufacturing equipment.

Add that to China's year long struggle with pig disease, with pig intestine a primary ingredient in Heparin, and you have a recipe for a pharmaceutical disaster.

"I don't understand why it takes deaths and serious injuries to a large number of Americans before the FDA wakes up this is clearly a wake up call," Dr. Sidney Wolfe of worstpills.org told Senay.

It's a wake up call for Heparin users like Celeste Lee.

Lee, a dialysis patient, has used Heparin as part of her treatment for thirteen years. Like thousands of other users, she is worried about where the drugs are coming from.

"For me it was more of an indication of 'whoa, how are we going…," Lee told Senay. "It's not like we're processing Intel chips or processing micro-processors, we're talking about products for human beings, for human consumption."

The FDA says itself that it is understaffed and underfunded and needs more regulation authority to deal with the growing international outsourcing for the manufacturing of pharmaceuticals.

Senay added that other manufacturers of Heparin have now stepped up production and health officials say that there is unlikely to be a shortage of the drug.

[cfin5]

I know two people that have had severe strokes. One of them was taking a blood thinner. Haven''t heard about the other person other than he will never be the same again.

[alphaa10-2009]

The disasters from the comatose Bush administration never stop...

But FDA hypocrisy is alive and well. Remember the agency''s "concern" that seniors who wanted to pay less for their drugs by shopping in Canada might be at risk from tainted drugs? That was the explanation for why they should pay more in the US captive market.

Now, it becomes clear the FDA never would have known if the drugs had been adulterated-- it does next to no inspections proactively. The FDA does occasional inspections after scandals break out, and consumers send outraged messages to Bush.

Business as usual between Big Pharma and our FDA. People seem to think that synthetic drugs are their answer when there are so many natural products that can thin blood. Plenty of blame to go around on both sides.

[bflat9]

If the main ingredients of heparin come from China,were do the ingreidents come from for Warfaran?

[jafo21]

The US public has no one else to blame but itself. After a disatrous 4 years in office, Bush was re-elected to continue the same policies that only benfit corporate america and upper economic class. Is it any surprise that national budgets for education, environment, and consumer protection (like the FDA) are shrinking while military budgets are skyrocketing and oil companies still get federal subsidies when they have record profits?

[xlib]

bflat-warafin-rat poison

[xlib]

alphaa10-canada imports many drugs from third world countries and then sells them. There have been many articles written on the subject. Just do a search.

[whatithink-2009]

Less regulations is what the GOP wants, more deaths is what we''ll get. Look at what is happening in the banking industry thanks to lobbyists and their goals to deregulate things. Look what happened to California and their blackouts.

The best society is one that is a combination of both government and market forces!

[Renegade.Rivers]

Could there be more to this story than we are being told? There have been several articles written on the subject of genetically altered crops being blamed for the increase in stomach problems in humans. China has embraced genetically alter foods, and it may be possible there there could be links from the genetically alter foods, and the problems with heparin.

It has been proven that genetically altered food can affect the intestinal track of humans, and that certain parts of the alter remain after processing. It would seem to me that this could also create problems with farm animals as well. Since one of the affected area in humans seems to be the intestine, and since heparin is made from the intestine of hogs, it would not seem to be far fetched that there could be a connection.

For reference see: http://www.seedsofdeception.com/Public/AboutGeneticallyModifiedFoods/index.cfm

On another facet, this once again shows just how ineffective the FDA is, and how we have to wonder just how safe the medicines we get, really are. Over the past several years, we have seen time after time where the FDA has failed to protect the American citizenry, and the blame for this failure falls at the feet of the present administration, and the heavily corporate appointees they have chosen to direct the FDAs operations.

[jn122736]

If the main ingredients of heparin come from China,were do the ingreidents come from for Warfaran?
Posted by bflat9 at 04:09 AM : Mar 02, 2008
~~~~~~~~~~~

Good question;
Warfaran was originally intended for killing rodents (rats), but then found to be effective in blood thinners for humans, and used as the main ingredient in some prescription drugs, such as coumadin.
******************************

%u201CFDA hypocrisy is alive and well. Remember the agency''''s "concern" that seniors who wanted to pay less for their drugs by shopping in Canada might be at risk from tainted drugs? That was the explanation for why they should pay more in the US captive market%u201D.
Posted by alphaa10 at 01:55 AM : Mar 02, 2008
~~~~~~~~~~~~~~~

alphaa10, that restriction by the FDA also included drugs MANUFACTURED in the USA and sold/exported to Canada.

Canadian pharmacies could/can fill American consumer prescriptions at a much lower cost than were/are available at home.
And yes indeed, it is because of the %u201Ccaptive%u201D (monopolized) American drug industry.

[jn122736]

On another facet, this once again shows just how ineffective the FDA is, and how we have to wonder just how safe the medicines we get, really are. Over the past several years, we have seen time after time where the FDA has failed to protect the American citizenry, and the blame for this failure falls at the feet of the present administration, and the heavily corporate appointees they have chosen to direct the FDAs operations.
Posted by renrivers at 09:19 AM : Mar 02, 2008
~~~~~~~~~~~~~~~~~~~~~

It also begs the question:
How many drug approval applications (even drugs of lesser value and more harmful potential) are approved for the companies with operatives working inside the FDA, verses those approved for smaller, possibly more honest companies, that do not have FDA implants?

[barbjc1]

Now I know we are REALLY headed for a bigtime fall. Our prescription medications coming from China. That scares the **** out of me.

[dvldog5]

Another reason to buy hi quality Chinese sh*t!!

Business as usual between Big Pharma and our FDA. People seem to think that synthetic drugs are their answer when there are so many natural products that can thin blood. Plenty of blame to go around on both sides.

Why is it that every government oversight agencies like the FDA only has enough funding to pay their hugh administrative costs. Contaminated food, lead posioning paint, inspection of the flood walls in New Orleans can''t be done or done properly. Drive along the wall for an hour doing nothing then go to a filet mignon lunch. Why have the agencies? There are some emplyees in each agency that are trying to do their job right, but most of them are career, keep the paperwork right, federal ***holes.

[avidreader.corinna]

And this is the same FDA that warns us about using drugs from Canada or Europe (like there is no great agency like the US FDA, because those countries have "other standards"? Yes, higher ones! More reliable agencies and drug manufacture oversight. The arrogance.

[zootallures2]

Like a bunch of false flag Trade Tower Bombers expect people to make sure they live.... LOL!

[chrissmith22]

Hey zoot, F You buddy!

[highhatsize]

Let''s see, the Chinese poisoned pet food because the poison raise the protein content and let them make a higher profit with inferior ingredients. Now, they have supplied infected animal products for the use in making a drug for humans.

Here''s an idea. Don''t import any comestibles or drug precursors from China. We obviously have no idea what they are doing.