A drug company continued to market its heparin products in Canada even though it knew its supplier was implicated in a growing scandal involving tainted ingredients that have been linked to 19 deaths and hundreds of illnesses in the United States.
B. Braun Medical Inc. announced a recall of its heparin products in Canada, the United States and Australia last Friday, after tests confirmed some products were contaminated with an ingredient also found in heparin products recalled a month ago by Baxter International Inc., which is now the subject of a major U.S. investigation.
Baxter purchased the contaminated ingredients from Scientific Protein Laboratories LLC, a Wisconsin-based company that has a factory in China. B. Braun Medical also buys its heparin ingredients from SPL, but didn't issue a recall until tests confirmed the contamination, weeks after the supplier's ingredients were first called into question.
The incident is raising concerns over the timing of the recall and is prompting some medical experts to question whether drug companies should be required to pull product off the market as soon as it suspects contamination, rather than waiting for test results to confirm problems.
"If they do find out that the shipment has contaminated or potentially contaminated the product they're making, then definitely they need to do something about it," said David U, president and chief executive officer of the Institute for Safe Medication Practices Canada.
The problems involving heparin, a blood thinner made from pig intestines that is commonly used during dialysis and surgery, began in January, when Baxter announced a recall of some heparin products in the United States following reports of severe reactions.
The recall was expanded late last month to include nearly all heparin products sold by Baxter. The U.S. Food and Drug Administration recently said it has received 785 reports of adverse health problems linked to the drug, including 19 deaths. The agency hasn't determined whether the drug caused any of the deaths or other health problems.
But U.S. health officials said last week they have determined the heparin was contaminated with oversulphated chondroitin sulphate, an inexpensive substance altered to mimic the real drug.
Many drugs taken by Canadians are produced in North American factories, but a large portion of the ingredients used to make the drugs come from China and other countries. China supplies a major portion of the world's heparin ingredients, according to Jian Liu, associate professor at the University of North Carolina's school of pharmacy.
B. Braun Medical declined interview requests and only agreed to answer questions by e-mail.
Spokesman Rick Williamson said the company "pro-actively and immediately" contacted its supplier when problems with heparin first emerged earlier this year and was informed that tests were being conducted to determine which products were affected. Tests found evidence of contamination in one product lot on March 18; B. Braun Medical issued a voluntary recall on March 21. The company has not received any reports of health problems or side effects linked to its heparin product.
However, the case highlights what one former Health Canada scientist described as a reluctance by drug companies in some cases to issue recalls.
"It's like all commerce. They [drug companies] keep pushing it as long as the market will bear it," said George Neville, a retired research scientist who worked in the department's defunct drug research branch.
Mr. Neville said Health Canada should be pushing companies to closely monitor every step of their supply chain and immediately take action when there is any suspicion that drugs may be contaminated.
The department has been steadily decreasing its role as a health regulator in recent years, he said, which could increase the likelihood of problematic drugs remaining on the market and posing a consumer health risk.
"That's a good question to put to Health Canada, why they're not pushing this," Mr. Neville said. "They tend to work very closely, hand-in-hand in a protective sense, with the industry [and] not to come down with a hefty stick."
But Health Canada spokesman Stéphane Shank said the federal agency does not currently have regulatory authority over drug ingredients. But, he added in an e-mail, the federal government soon plans to introduce changes that will require drug companies to prove the ingredients they use meet international standards.
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