Tainted Chinese Heparin Kills 81 in United States

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Tainted Chinese Heparin Kills 81 in United States

_http://www.jonchristianryter.com/2008/081203.html_

(http://www.jonchristianryter.com/2008/081203.html)

 

On April 29, 2008 the widow of a man who died after receiving contaminated

Heparin in a dialysis treatment was among the family members who testified

before the US House Subcommittee on Oversight and Investigations. In the same

hearing, FDA officials also testified that contaminated Heparin was responsible

for 81 deaths in the United States and, in the view of the drug regulator,

Dr. Janet Woodstock, director of the agency's drug center, the contamination

was deliberate. Woodstock said: " The FDA's working hypothesis is that this was

intentional contamination, but this is not yet proven. " Sadly, after several

more deaths, it was. One of the US companies selling Heparin to hospitals,

doctors and medical treatment facilities, Robert Parkinson, head of Baxter

International, also testified. Parkinson agreed with Woodstock's assessment and

said his company was " ...alarmed that one of [their] products was used in

what appears to have been a deliberate scheme to adulterate a lifesaving

medication. "

 

Family members gave the attentive Congressmen heartwrenching stories of the

last moments in the lives of their loved ones. Johanna Marie Staples of

Toledo, Ohio said her husband, Dennis, was looking forward to celebrating his

60th

birthday at a family gathering when he completed his dialysis treatment that

day. What was supposed to be a celebration of life became the mourning of

Dennis' death.

Colleen Hubley, a dialysis nurse reported how her husband, Randy, came home

from his dialysis treatment experiencing diarrhea, abdominal pain and he was

having trouble breathing. He died the following evening after she tried to

save his life with cardiopulmonary resuscitation. Leroy Hunley, also of Toledo,

described to Congress how he lost both his 65-year old wife and his 47-year

old son within weeks of each other. Both suffered from genetic kidney disease

that required regularly scheduled dialysis treatments. During those

treatments, Heparin was routinely used.

The Food & Drug Administration [FDA] is once again in conflict with its own

Congressional mandate to protect the American people from unscrupulous

merchant princes who line the pockets of politicians with gold. China has

proven

over and over again that it will not abide by international food product or

pharmaceutical safety rules. It should be abundantly clear to the American

people by this time that saving a few cents to a few dollars per product to buy

goods made in the 3rd world—particularly in Communist China (which is using

your international trade dollars to upgrade their weapons systems sufficiently

to destroy us)—may put their life at risk.

In July, 2007 over a hundred pet owners in the United States lost both

canine and feline pets who had ingested high levels of a thermoset plastic,

melamine, and also toxic levels of cyanuric acid that had been added to

inferior

grades of both rice and wheat gluten to make the gluten appear that it

contained high levels of healthy protein when it had almost none. Melamine,

when com

bined with formaldehyde, becomes a synthetic polymer resin used to make things

like Melmacâ„¢ dishes and Formicaâ„¢ counter tops. Melamine is not edible.

Why would the Chinese put melamine into the wheat and rice gluten they were

selling to the industrialized nations? Because US, European Union and

Canadian food products buyers do not chemically test the gluten samples they

inspect

to determine the protein levels. They judge the protein levels of the

samples by their appearance only. For the Chinese, who are accustomed to high

profits from using slave labor, using inferior grades of rice and wheat gluten

simply increased their profit margins. (And you never thought that communists

could love the free enterprise system.)

_Over 50% of the trade goods rejected for entry into the United States by

the Consumers Product Safety Commission _

(http://www.jonchristianryter.com/2007/070706.html) [CPSC] are imports that were

made, or processed, in China. In

the first quarter of 2007, FDA and USDA inspectors rejected 298 food product

shipments from China. Among them were baby toys painted with lead-based

paints, children's jewelry made from lead (lead poisoning is one of the causes

of

autism). One victim was a 4-year old boy who swallowed the charm from a

Chinese-made charm bracelet. The charm was 99% lead layered with silver. The

toddler died. Nancy Nord, head of the CPSC said that from 2000 to 2005 over 20

thousand children have been treated at local hospitals for lead poisoning. Most

of them swallowed jewelry elements.

Even though China persists in poking America in the eye with a sharp stick,

this nation's greedy merchant princes ignore the danger that China's products

increasingly pose for US consumers, and to make an extra buck or two on the

products they sell, are buying even more unsafe products from a nation which

remains our enemy. The latest assault on the unsuspecting consumers in the

United States came in the form of a contaminated blood-thinner, Heparinâ„¢,

used

to treat heart attack and stroke patients.

In January, 2008, reports of 350 adverse allergic-reaction events resulting

in 19 deaths from contaminated Heparinâ„¢ reached the FDA. The alert came from

Baxter, International, a major supplier of Heparinâ„¢ in the United States. The

raw Heparinâ„¢ component sold to Baxter International was manufactured by a

large, unregulated Chinese manufacturer, Changzhou SPL Co. Ltd., of Changzhou

City, Jiangsu, China. Changzhou SPL partners with Scientific Protein

Laboratories, LLC of Waunakee, Wisconsin through a Joint Venture. SPL, formerly

Tyco

Heathcare, is a leading global supplier of active pharmaceutical ingredients

[APIs] that are utilized by pharmaceutical companies to produce injectable

solutions to medical problems. Changzhou SPL is not regulated by the Chinese

government because, while it is partially-owned by the Chinese government, it

is also partially-owned by SPL in the United States.

And, because Changzhou SPL is tied to an American company, the FDA did not

feel it was necessary to inspect its plant in Changzhou—a violation of FDA

protocol. Because bureaucrats bowed to political pressure from Congressmen who

bowed to pressure from the lobbyists of the pharmaceutical industry, 19 people

died in the first disbursement of tainted Heparinâ„¢. SPL heparin sodium USP,

an odorless white amorphous hygroscopic powder, is the active ingredient used

to produce serum Heparinâ„¢. It is sold to companies like Baxter

International, Celsus Laboratories Inc. of Cincinnati, Atrium Medical

Corporation and

Medtronic, Inc. who also bought SPL heparin sodium from Changzhou SPL.

On February 12, 2008 as both the death count and number of " allergic

reaction " events increased, the FDA released an advisory to physicians and

hospitals

to stop using Baxter's Multiple-dose Heparinâ„¢ and to use other suppliers

until they discovered what was causing allergic reactions and dangerously low

blood pressure in hundreds of patients. Baxter International stopped

manufacturing Heparinâ„¢, and on Feb. 28 the FDA notified doctors and hospitals

that

Baxter had voluntarily recalled their multi-dose and single-dose vials of

heparin

sodium for injection as well as their heparin lock flush solutions.

By April, over 1,000 people had the symptoms. The death toll reached 81

people. It would not be until May 15, 2008 that Atrium and Medtronic (who do

not

produce injection Heparinâ„¢) would initiate voluntary, and what they called

" precautionary, " recalls of some of the products they do create. Atrium

recalled selected lots of Hydraglideâ„¢ brand heparin-coated thoracic drainage

catheters. Medtronic withdrew selected products used during cardiopulmonary

bypass

heart surgery. In addition, Medtronic advised doctors and hospitals that

selected lots of Trillium-coated products were manufactured with heparin

coatings. (The FDA noted that, based on current data, the benefits of using the

affected products outweigh any potential risk to patients.)

A month earlier—in March— the FDA figured out that the Changzhou SPL

heparin sodium, a highly sulfated glycosaminoglycan, was being adulterated with

a

heparin-like chemical called over-sulfated chondroitin sulfate, a white powder

harvested from shellfish. It appears the over-sulfated chondroitin sulfate

was added as a filler to cut the cost of heparin sodium in powder form.

Apparently the chemists at the Chinese facility, knowing that chondroitin

sulfate

was also a glycosaminoglycan, thought it would be a harmless additive that

would substantially cut the cost of the drug they were selling to American

pharmaceutical companies without causing an adverse affects.

The presence of this synthetic chemical suggested to the FDA that the

heparin sodium manufactured at Changzhou SPL might be tampered with

deliberately,

but at the time the FDA could not determine at what point in the manufacturing

process the chemical was added to the heparin sodium compound. The Bush-43

FDA suspected the contamination occurred at Changzhou SPL but refused to tell

Congress the names of any company in China in may have supplied the

adulterated heparin ingredients to the United States. The office of Dr. Andrew

von

Eschenbach, MD, Commissioner of the FDA through his spokeswoman, Kathleen Quinn

told the media that confidentiality agreements with vaccine and serum

producers bar the FDA from revealing their names.

According to 8th term Congressman Bart Stupak [D-MI] Congress has been at

odds with the FDA from the beginning over the manner they chose to deal with

this problem. " The FDA thinks they have this under control, " Stupak said, " but

they really don't. If I was the FDA Director, I'd shut down every drug coming

in from China until each one had individually proven to be safe. "

The FDA countered that it does not have the legal authority to prevent the

importation of Chinese-manufactured drugs, citing a Memorandum of Agreement

that regulates relations between the FDA and China. The Memorandum was created

to placate the pharmaceutical industry by speeding up the process—and,

conversely, sacrificing the thoroughness—of FDA inspections of Chinese drug

facilities. Stupak countered by criticizing the Memorandum which, he said, is

" useless. " Stupak noted that the agreement does not give the FDA any real

access to

Chinese factories with what amounted to as " walk-throughs. " The FDA admitted

that it had inspected a number of Chinese heparin ingredient factories in

February. Changzhou SPL was one of the plants that was visited. The FDA said it

was not given any access to workers, records or workshops. An FDA compliance

official told Congress that another inspection could be attempted, but " ...I

cannot say whether they will admit us or not, or whether they will allow us

to do a full inspection. " In reality, Stupak said, the FDA teams can go to

China and scrap paint off the walls to inspect all they want. They just can't

inspect the labs where the heparin ingredients are processed.

China has objected to allegations that their country is the source of the

contamination pointing out, in early March, that the drug could just as easily

have been tampered with at Baxter's Cherry Hill, New Jersey plant. The

Chinese Food and Drug Administration accused Baxter International of failing to

cooperate with their investigation into the contamination. Chinese health

officials said Baxter International, and its CEO Robert L. Parkinson, Jr.,

refused

to surrender samples of SPL heparin sodium and the heparin ingredients that

Baxter purchased from other sources to them in April so they could test all

of the samples from all sources for contamination.

Powerless to regulate American partnerships in China, the FDA has had to

rely on US companies voluntarily testing the substandard pharmaceutical

ingredients they purchase from China. Yet that testing failed to detect the

heparin

contamination at Baxter's facility in January and February, 2008. " It was

indistinguishable from the real heparin, " Parkinson told Congress. However, in

the aftermath of the heparin sodium problem, Parkinson said, Baxter

International has developed a new testing method that can distinguish between

pure

heparin and oversulfated chondroitin sulfate. How? They test for oversulfated

chondroitin sulfate and not heparin. What that means is that as soon as the

Chinese chemists find another cheap heparin look-alike (which they assume

should

work the same way for less money), they will try it. Communist China, which is

new to the free enterprise system, thinks that anything that fools the

consumers is doable—even if a few consumers die in the process. After all,

China

is a country with far too many consumers. So a few hundred less can only be

construed as an unexpected caveat. However, where the Chinese may be a little

cavalier about reducing the population with contaminated products, that

practice doesn't bode well in the United States.

And therein lies the problem. American industrialists, eager to escape the

most rigid safety guidelines in the world in the United States used NAFTA to

escape the ever-watchful eye of Big Brother by partnering with companies in

communist China. In the case of Changzhou SPL, Scientific Protein Laboratories,

LLC (formerly Tyco Heathcare), is the majority stakeholder in that

partnership. Yet, the FDA can't honestly inspect that factory since the

minority

shareholder in the Chinese government (or members of that government who are

high

enough in the Party that Changzhou SPL is immune from harassment from the

mosquitoes in the United States government.)

One might think because the FDA was on the problem in February (the first

contaminated heparin ingredients arrived at Baxter's Cherry Hill, New Jersey

plant in November, 2007), and because Baxter, Atrium and Medtronic initiated

voluntary recalls that the problem is over. But that's simply not the case. On

November 6, 2008 the FDA seized contaminated batches of Heparinâ„¢ from

Cincinnati-based Celsus Laboratories. Seized were 11 lots of tainted blood

thinner.

Celsus, like Baxter, learned that the heparin ingredients they received from

China were contaminated. Celsus informed its customers that Heparinâ„¢ shipped

from their facility between January and April, 2008 could be contaminated.

However, according to FDA spokeswoman Karen Riley, Celsus did not tell their

customers to destroy the product or send them back. The tainted Heparinâ„¢, she

said, was sold to universities and research-supply facilities in Australia,

Canada, Europe, Japan, and the United States. " This was a contaminated

product, " she said, " and we don't think that they did enough. We decided to

seize

the remainder and destroy it. "

The FDA noted that there are no reports of anyone taking the Celsus heparin

injectable product dying or suffering from allergic reactions. But then, if

any hospitals and medical treatment facilities who injected a heart attack or

stroke patient, or those on dialysis, or anyone needing Heparin during an

operation with contaminated Heparinâ„¢ without knowing the product was tainted,

they would naturally assume the patients who died—if any—were victims of

their

ailments and not of the medication that should have saved their lives.

It is critical that US consumers look at the country of origin before buying

anything. If that product is made in China, be wary. China is notorious for

taking shortcuts in product creation. Other than the Heparinâ„¢ controversy, its

important to remember the last two scares concern human foods laced with

melamine to make the products appear healthy when the opposite was true.

First, and most recent was the Canadian chocolate-melamine scare. Yes, the

same thing that killed your pets last year targeted Canadian children this

year. Yet another unidentified Chinese factory delivered a shipment of 3,360

kilograms of chocolate coin candy under the brand name Sherwood Brands Pirate's

Gold Milk Chocolate Coins that were sold to Costco (in Canada only) and

several dollar stores across Canada. The affected candy has bar codes of

0-36077,

112407 and lot code 192851. The melamine-laced chocolate was sold to Canadian

retailers between January and April, 2008.

In September the FDA warned US consumers not to feed any baby formulas made

in China to infants. Again, the baby formula was linked to melamine

contamination as well. Infant formula made in the United States is safe, but

you would

be advised to check any containers you purchase to make sure they are not

made in China. Melamine tainted baby formulas is a serious problem in China. To

date over 54 thousand Chinese babies have fallen ill due to malamine-laced

baby formula. Four babies have died.

It's time that US consumers wake up to the problems caused not only by

inferior consumer products that are made in China, but of dangerous consumable

products made there as well. Saving a dollar in hard times is not worth the

risk

of losing the life of a loved one at anytime. If you can't afford to pay a

few dollars more for a product made in this country, do without it. If enough

people leave the Chinese goods on the store shelves, America's merchant

princes will eventually get the message. When they start shopping for the

products

they need to stock their shelves in the United States instead of the third

world, US jobs will increase, the economy will improve and we will have

guaranteed that our children and our children's children will have a chance to

share the great American dream before the movie comes out—in Chinese.