Wednesday, March 5, 2008

SPL Should Know Its Customer Better

Last week I did a post on Baxter Healthcare's needing to know its heparin supplier better. It detailed the ever changing and disturbing story of their tainted blood thinner. The most recent piece in the New York Times showed Scientific Protein Laboratories needs to know their customer better. Months into investigating the problem of dangerous heparin, a SPL spokesman had this to say about a prior quality inspection of the Chinese supplier by Baxter quality experts.

Baxter undertook last fall its own inspection of the China plant. “A few of our observations touched on the same areas as F.D.A.’s inspectional findings,” said Ray Godlewski, vice president of quality for Baxter’s Medication Delivery Business. Mr. Godlewski refused to be more specific because, he said, of a confidentiality agreement with Scientific Protein.

Mr. Pines of Scientific Protein said that he did not know what problems Baxter uncovered last fall or why those problems were not corrected by the time federal inspectors arrived last month.

Not impressive, Mr. Pines. Neither is the number of reported injuries. They reached 785 with 46 deaths. Reviews dropped the number of deaths attributed to the contaminated drug to 19. But the FDA did find a possible cause. From 5 to 20% of the volume of the bad heparin contained a look alike, a chemical substitute. The story had this to say:

The F.D.A. has yet to prove that the heparin contaminant is the cause of the deaths and illnesses now associated with the use of Baxter’s product. But heparin batches associated with illnesses, all of which were produced with ingredients made in China, were found to contain the contaminant while batches not linked to illnesses proved to be untainted.

Scientific Protein Laboratories said in a statement that “it is premature to conclude that the heparin active pharmaceutical ingredient sourced from China and provided by S.P.L. to Baxter is responsible for these adverse events.”

Recall SPL was acquired by American Capital Strategies in August 2006. Their corporate press release said ACS owned 87% of the company on a fully diluted basis. What management practices did American Capital institute that contributed to the heparin problem. Their history indicates something changed. What was it? Dr. Deming clearly spoke to the relationship between management practices and quality. It seems nobody is listening to his profound teachings today. That includes the FDA, Baxter and SPL.