On March 31st B. Braun Medical announced a recall of its heparin products, after tests concluded that a similar contamination affecting heparin products marketed and sold by Baxter International, had invaded its product as well.
However, the company is being criticized for keeping its heparin products on the market while testing was taking place, and only triggered a recall when tests confirmed a problem.
B. Braun Medical recalled over 20 lots of its heparin product from markets in the United States, Canada and Australia after tests concluded that heparin made with raw ingredients sourced in China was found to be tainted. However, Braun is being criticized by the Canadian Health Authority for waiting, and allowing the product to remain on the market, even though there was ample evidence to suggest that, like the Baxter International product, the Braun product stood an equal chance of contamination given that the Braun product was also sourced from the same plant in China linked to the Baxter recall.
“It’s like all commerce,” said George Neville, a retired research scientist who worked in Health Canada’s now-defunct drug research branch.
“(The drug companies) keep pushing it as long as the market will bear it,” he said, in comments published late March in the Globe and Mail.
For its part, B. Braun Medical indicated to the Globe and Mail through a spokesperson that the company had contacted its supplier when the heparin scare first emerged earlier in the year, and was told that tests were being conducted to determine the presence, or lack thereof, of contamination. The spokesperson went on to say that tests found contamination in one lot of heparin on March 18th. B. Braun issued the voluntary recall of several lots of its heparin product three days later.
However, not lost on those criticizing Braun for waiting, is the fact that earlier in the year, when Baxter International expanded an initial heparin recall and identified virtually all of its heparin product, a similar response would have been prudent on the part of Braun given the latter’s link to Changzhuo SPL, the American-owned plant in China that refines crude heparin that often comes from small, unregulated, family-run sweatshops.
That, and an outbreak of disease last year that affected swine stocks only served to complicate the problem. Crude heparin is made from the intestines of pigs, often in equally-crude conditions, then sold to consolidators which in turn supplies plants such as Changzhuo SPL, which refines the crude heparin for eventual manufacture into the final product.
After hundreds of adverse reaction reports and 19 deaths potentially linked to tainted heparin prompted Baxter International to recall its product, tests concluded that an unknown contaminant that represented as much as 20 per cent of a typical supply of heparin by volume was linked to the Changzhuo SPL plant. The facility is owned by Scientific Protein Laboratories, based in Wisconsin.
Criticism of B. Braun centers on the Changzhuo SPL plant, which it also used to source crude heparin. Critics say that once Baxter triggered its’ recall, and tests verified the presence of an unknown contaminant linked to the Changzhuo SPL facility, it would have been prudent for B. Braun Medical to pull its heparin off the market as a precaution, instead of waiting for weeks until tests verified the suspicion.
US health officials have since determined that the contaminant is oversulphated chondrotin sulphate, a cheap substance used to mimic heparin. It is not known if the contaminant is the actual reason why patients are reacting adversely to the heparin, or if the substance was added to the heparin supply as a response to a supply issue (stemming from diseased livestock), or simply out of greed.
However, rather than exercise prudent caution and pull its own product in the face of screaming headlines alleging contamination linked to the Changzhuo SPL plant, B. Braun waited until tests confirmed that its heparin was tainted in similar fashion, before triggering its recall.
“If they do find out that the shipment has contaminated or potentially contaminated the product they’re making,” said David U, president and chief executive officer of the Institute for Safe Medication Practices Canada, commenting in the Globe and Mail, “then definitely they need to do something about it.”
Some are suggesting that drug companies should be required for the public good to issue a recall at the point that contamination is suspected, rather than when contamination is actually confirmed.
But then, the lawyers wouldn’t be quite so busy, would they?