Lawmaker Seeks GAO Probe of Heparin ScandalNov 20, 2008 | Parker Waichman LLP
The scandal over tainted heparin has prompted one lawmaker to seek a wider investigation into the matter. Rep. Joe Barton, R-Texas, has written to the Governmental Accountability Office (GAO) requesting a thorough investigation into the Food & Drug Administration's (FDA) handling of the heparin issue.
Heparin was the subject of a major product recall after a potentially lethal contaminant was identified and traced to suppliers in China. Last January, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products.
There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, the FDA initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.
In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.
In his letter to the GAO, Barton, the ranking Republican on the House Energy and Commerce Committee, expressed concern about conflicting statements the FDA made to the public and Congress about the number of deaths tied to contaminated batches of heparin. In particular, Barton said he had concern about the FDA’s classification of the deaths of three patients. The letter cites a Chicago Tribune article where it was reported that the FDA “conclusively linked” the deaths of those patients to a foreign substance found in specific lots of Baxter heparin.
However, in his letter, Barton maintains that in a response to his questions about those deaths, the "FDA classified the cause of death from heparin as only ‘possible’ in two of those cases, and ‘unassessable’ in the third case.”
Barton’s letter to the GAO also questions whether the FDA used all of the tools available to conduct comprehensive surveillance of the heparin deaths. “FDA confirmed to the committee’s Republican staff that the agency did not follow up to interview clinical staff or Baxter for further details about each of these cases,” the letter says. “In addition, FDA told staff the agency did not access other databases, even though FDA has testified that such databases enhance FDA’s ability to evaluate drug safety problems.”