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Families of contaminated heparin victims tell stories of deaths By RANDOLPH E. SCHMID, Associated Press Writer

WASHINGTON - The widow of a man who died after receiving contaminated heparin told a congressional subcommittee Tuesday "we have a false sense of security" in a land where people expect to be protected and safe.

Brushing away tears, Johanna Marie Staples of Toledo, Ohio, said her husband, Dennis, was looking forward to his 60th birthday party on the last day of his life.

Contaminated heparin, a blood thinner used in dialysis and other treatments, has been connected to 81 deaths and 785 severe allergic reactions, said Rep. Bart Stupak, D-Mich., chairman of the House Energy and Commerce subcommittee on oversight and investigations.

The heparin, made from ingredients imported from China, has been recalled by Baxter International and the Food and Drug Administration has blocked imports from the Chinese company.

The FDA found the drug was contaminated with oversulfated chondroitin sulfate, which mimics heparin and thus was not detected in routine testing, Stupak noted.

When — and how — it was introduced into the product has not yet been determined.

"FDA's working hypothesis is that this was intentional contamination, but this is not yet proven," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told the panel in her prepared testimony.

Staples told the subcommittee that her husband was looking forward to an evening birthday party at a steakhouse with friends after receiving his dialysis treatment.

But during the treatment he become unresponsive, stopped breathing and went into cardiac arrest, she said. Paramedics rushed him to a nearby hospital but he never regained consciousness, she said.

Colleen Hubley, a dialysis nurse whose husband, Randy, died after receiving heparin, told of a desperate struggle to save his life with cardiopulmonary resuscitation.

"We were certain that no matter what came our way we could handle it together," she said. "Despite our hope, this man died while I did CPR on him, powerless to save him."

When her husband came home from a dialysis treatment he suffered diarrhea, abdominal pain and had problems breathing, she said.

At 2 a.m., she said, she awoke to him clutching his abdomen and grabbing his chest, unable to breathe. She did CPR and called paramedics who struggled to get a breathing tube in his throat because of swelling.

"I watched my husband and my best friend slip away before my eyes," she said. "I never thought the lifesaving medication we were relying on could be contaminated."

Randy Hubley's death came just a month after that of his mother, Bonnie, under the same circumstances.

Leroy Hubley, dabbing his eyes with a handkerchief, told of losing both wife and son, adding: "I want to know if my daughter, Dawn, and millions of others who continue to receive dialysis are safe."

He told, too, of Bonnie suffering diarrhea, pain and trouble breathing and being rushed to a hospital where doctors recommended removal of her breathing tube to end her suffering.

"Christmas music played in the background as each one of us said our goodbyes," said a shaking Leroy Hubley. "And the nightmare returned only weeks later when my son, Randy, started dialysis at the same clinic."

The Hubleys also reside in the Toledo area.

The FDA's Woodcock told the subcommittee that in recent years major changes have occurred in where drugs are made.

For example, in 2007 the agency received only about 150 applications for approval to make generic drugs in the United States compared to nearly 500 from China and more than 400 from India, she said.

"Great vigilance is required to maintain" drug safety, she said.

Chinese officials have argued that the contaminant could not be the root cause of the allergic reactions and suggested that problem may have occurred in the United States.

Baxter president Robert L. Parkinson Jr., said in testimony prepared for the subcommittee that his company is "greatly concerned that our heparin product appears to be the target of a deliberate adulteration scheme."

"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," Parkinson said.

David Strunce, president of Scientific Protein Laboratories, said in testimony that worldwide problem with contaminated heparin cannot be traced to how heparin was processed at the Changzhou SPL factory in China which supplied the material to Baxter. His company holds a majority interest in Changzhou SPL.

Rather, Strunce said, there appears to be deliberate and widespread contamination of the crude heparin supply in China affecting many manufacturers.

Something really smells here!!! Too much tainting goin on with the foods and medications... I can't help but think that all of it is intentional and somebody is up to no good! Sure makes one suspiscious... How about YOU? What do you think about this? Please, lets discuss this issue. Thank YOU! HL

--- a small glass of red wine a day with good slow cooked food--- thins blood

I am enjoying a glass right now. It doesn't kill us... does it!!???

(Ate the slow cooked food with it)

If in doubt 500mg of asprin.

Sadly, in China some things they do get wrong, but there they put the company directors on trial for it and then execute them.

Perhaps if we did the same in Europe in the States we wouldn't ever get other Corporate crime like the kind of thing Anderson International and Enron got upto.

Robert Maxwell should have been strung up for theft of pension funds as well.

Maybe if we did like the chinese do corporate crime would evaporate?

If its an ethics problem, don't worry, i'll happy take the emotional stress and shoot them.

Ok Robbie, you've got the job!

With Corruption so evident and knowing that China is very harsh with company directors, I would believe that it is highly unlikely that China is responsible in this. Perhaps it is a facade... ment to blame China, when in fact, it is being done by someone else, here in the US perhaps, blaming China so we can do to them what we did to Iraq. It would not surprise me any if this were not propaganda put out to "set up" China for a plan of the Bush regime. Smells like Bullshit to me!

I find this to be an important subject. Perhaps ALL of us on CS are healthy and not using blood thinners or on dialysis, but perhaps you know someone who is?? Maybe their life could be endangered and you could save them by alerting them!

Recently a Chinese man was put on trial when he made toys for export all around the world, where the toys were painted with paint with very high, dangerously high levels of lead.

They have basically laid down the gauntlet at home by making company directors responsible if they damage Chinas reputation by shipping shoddy goods.

There's licenced drugs that are mislabelled and even forged and then exported, expecially over the internet.I would never buy drugs over the net.

These originate from various countries, normally in India, or Africa but there are others that do it.

If you know anyone who needs the medication always make sure they have Asprin 500mg tablets in the house in case of an emergency.

It'd the first thing your given after a heart attack or operation, to prevent a clotting disaster.

I'll let the medical people expand on this.

Yes Robbie, I too have heard this about asprin