Originally published Saturday, March 15, 2008 at 12:00 AM
Heparin probe studies supply chain
The investigation into a blood thinner suspected in 19 U.S. deaths is focusing on the possibility that raw biological ingredients were...
Los Angeles Times
WASHINGTON — The investigation into a blood thinner suspected in 19 U.S. deaths is focusing on the possibility that raw biological ingredients were contaminated even before they reached a factory in China, manufacturer Baxter International said Friday.
That raises the prospect that the problem could have occurred somewhere along a supply chain that includes layers of middlemen and originates in pig farms. The generic medication, heparin, is derived from a substance found in the lining of pig intestines. It is used widely to prevent dangerous blood clots from forming during kidney dialysis and cardiac surgery.
The case has reinforced concerns about quality-control problems with Chinese products. But unlike last year's pet-food recall, it was frail patients who suffered the ill effects of the drug contamination. Some suffered life-threatening allergic reactions.
The Food and Drug Administration (FDA) announced new testing requirements for all imported heparin Friday. Manufacturers who do not agree in advance to sophisticated safety tests will have their shipments held at ports of entry until the government can test them.
FDA officials said they are close to identifying the mysterious look-alike ingredient that contaminated the Baxter heparin and prompted a recall in February. The substance, which acts much like heparin, could not be detected with conventional tests for drug purity and potency.
Once the contaminant is identified, investigators should be able to tell more about whether it was added deliberately or occurred naturally or as a result of a problem with processing, FDA Deputy Commissioner Janet Woodcock said.
"We are very close," she said. "When we complete that, [it] will help our understanding of how it got in."
The source of the contamination might remain murky, however, if it occurred along the chain of farmers and middlemen who handle the material in China, where the FDA's regulatory reach does not currently extend and where local manufacturing standards have been called into question.
The FDA announced Friday that it hopes to place regulators in China, pending approval from the Chinese government.
The State Department approved a plan to establish eight full-time, permanent FDA positions at U.S. diplomatic posts in China. The agency also plans to hire five Chinese employees to work with it at the U.S. Embassy in Beijing and the U.S. consulates in Shanghai and Guangzhou.
"Our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs and medical devices in the global market," said Murray Lumpkin, the FDA's deputy commissioner for international and special programs.
Copyright © 2008 The Seattle Times Company
Landmark health bill passes House on close vote
Fort Hood shooting suspect had shown troubling signs

Mourners gather at KeyArena for slain officer's memorial
Mourners gathered at KeyArena for the memorial service of Seattle police Officer Timothy Brenton on November 6, 2009.
nwjobs

Post a comment

Michelle Goodman blogs about work/life balance.
How to tell your office you're gravely ill
Post a comment
nwautos

Choosing a new sedan? Weigh the impact of your choice on your wallet and on the planet.
Post a comment
- Flags were key link to cop slaying, bombings
- Suspect shot as city mourns slain officer
- Briefs | Soccer: New Mexico suspends hair-pulling player Elizabeth Lambert
- McGinn pulling away as late ballots come in
- Huskies suffer another heartbreaking loss to UCLA
- Using anti-shooter tactics, civilian Army police officer brought down gunman
- Bombs, guns found at home of suspect in Officer Brenton's slaying
- Heavy snow in Cascades shuts down roads
- Consortium on verge of owning Eastside railway land
- Suspect in officer's slaying shot by police
- UCLA game thread
940 - Weapons, bomb-making materials found in suspect's apartment
334 - Troubling portrait emerges of Fort Hood suspect
289 - Decision day for health care in the House
200 - McGinn widens lead over Mallahan in Seattle mayoral race
183 - U.S. House passes health plan
167 - Bombs, guns found at home of suspect in Officer Brenton's slaying
110 - Huskies suffer another heartbreaking loss to UCLA
96 - Referendum 71 show's Washington's strategy for marriage equality is working
84 - Grading the game
52
- Suspect shot as city mourns slain officer
- Flags were key link to cop slaying, bombings
- Consortium on verge of owning Eastside railway land
- Guest columnist | Cut the South Carolina jokes, Seattle. Get ready to compete
- McGinn pulling away as late ballots come in
- Danny Westneat | Lee the Horse Logger found slow wagon shrank tumor
- Movie review | 'An Education' you won't forget
- Do It in a Day | Spend a cozy, homey day in Edmonds
- Practical Mac | With new features, Apple's MobileMe is worth the price
- 10 ways to take control of your health





