(03-20) 04:00 PDT Washington --

U.S. health officials have identified a contaminant in batches of the blood thinner heparin associated with 19 deaths and are trying to determine how the chemical got into the drug.

The lots of heparin, whose key ingredient was imported from China, were recalled Feb. 28, and Food and Drug Administration officials said Wednesday that no new deaths have been reported since then.

Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said the contaminant is oversulfated condroitin sulfate, a chemical that does not occur naturally.

Condroitin sulfate is a natural compound that occurs widely and is used as a dietary supplement, but the oversulfated version has not been widely studied.

"We cannot rule in or out whether this was accidentally or deliberately introduced into the product," Woodcock said, "We are investigating how it got in."

The FDA has also initiated testing of imported heparin entering this country, and Woodcock said the agency feels "doctors and patients now can be confident that the product on the market has been tested and is safe."

Condroitin sulfate is a compound in the same family as heparin, so preliminary testing did not identify it, Woodcock said. She said more exacting tests by the government and university researchers uncovered the contaminant.

Oversulfated condroitin sulfate would be less expensive to make than heparin, but FDA officials said they could not estimate the cost difference.

Congress quickly reacted to the report, with the House Committee on Energy and Commerce's subcommittee on oversight and investigations scheduling an April 15 hearing.

"This latest development underscores our concerns that FDA does not have a robust enough presence overseas in conducting inspections in plants that make drugs for the U.S. market. Ongoing surveillance inspections are critical if FDA is to find shortcomings," said committee chairman John Dingell, D-Mich.

On the other side of Capitol Hill, Sen. Chuck Schumer, D-N.Y., said the FDA "should have identified this contaminant before it hit U.S. shores and caused so many health problems for patients. The agency's ability to perform foreign inspections is woefully inadequate. We will continue to push for greater funding, staff and oversight to better enable the FDA to protect the public's health."

The lots of heparin linked to hundreds of allergic reactions were marketed by Baxter International and produced in China.

Baxter buys its heparin through Scientific Protein Laboratories of Wisconsin, which in turn owns a Chinese factory - Changzhou SPL - and buys additional raw heparin from other Chinese suppliers.

SPL said Wednesday that the contamination occurred earlier in the supply chain.

Robert Rhoades, an independent consultant, was quoted in the statement as saying tests used by the FDA had detected "peaks" in samples of material supplied to the Chinese plant, "indicating that the contaminant was in the material before it reached CZSPL."

"We do know that heparin sourced and produced in North America by SPL has not been shown to have the same peak characteristics seen in certain lots of heparin sourced in China and has not been implicated during the investigation," SPL added.

This article appeared on page C - 3 of the San Francisco Chronicle

More than four in ten maternity units turn away women in labour

Comments (7)

Traumatic: Pregnant women are being turned away from one in four NHS hospitals and forced to give birth miles away

The statistics show the true scale of the crisis facing maternity units across the country, which could be putting the lives of mothers and babies at risk.

Many mothers-to-be have been forced to travel miles away from home after the doors were closed at their local NHS hospital.

The figures, from 103 of the 147 NHS trusts with maternity services, were obtained by the Conservatives under the Freedom of Information Act.

They revealed that 42 per cent have admitted to turning away women in labour on at least one occasion last year.

The figures show that nine per cent of the hospitals have turned women away on more than 10 occasions - the worst unit shut their doors 39 times.

The Conservatives blamed this on the Government's closure of maternity units, which still continues. Ministers are closing smaller units and centralising services in larger hospitals.

There has already been an 18 per cent reduction in the number of beds in maternity wards across England since Labour came to power in 1997.

Overall, the number of maternity beds per 100,000 people across the country has dropped from 22 in 1997 to 18 in 2007.

Speaking last night, shadow health secretary Andrew Lansley, said: "Labour is fixated with cutting smaller, local maternity services and concentrating them on big units.

"But women don't want to have to travel miles to give birth. And they certainly don't want to have to travel even further because they're turned away by the hospital of the their choice."

Katherine Murphy of the Patients Association said: "It is disturbing to see that so many healthcare trusts can turn away mothers at this crucial time.

"The greater the distance to travel, the greater the risk to mother and baby. Being treated near to home is safer."

Mary Newburn, of the National Childbirth Trust, added: "These figures are shocking. The unscheduled closure of maternity units has a major impact on women and their partners.

"Parents lose all sense of control when the unit at which they have planned to give birth has been closed. It's a major cause of anxiety."

A spokesman for the Department of Health said: "It is difficult to precisely predict when a mother will go into labour and sometimes, at times of peak demand, maternity units do temporarily divert women to nearby facilities. "It is often only for a few hours and to ensure mother and baby can receive the best care possible."

A spokeswoman for the Department of Health said: "It is difficult to precisely predict when a mother will go into labour and sometimes, at times of peak demand, maternity units do temporarily divert women to nearby facilities.

"When this does happen it is often only for a few hours and to ensure mother and baby can receive the best care possible."

Louise Silverton, deputy general secretary of the Royal College of Midwives, said: "Size is not everything in maternity care, big does not mean better, and we would question whether bigger maternity units means better care for women and their babies.

"The key issue here is what the women want. Women want to know and develop a relationship with their midwife and not feel as if they are on a production line.

"Midwives want to be able to deliver the best possible individualised care and not feel like they are working in a baby factory."

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