Further twists in heparin scandal

By Nick Taylor

- Last updated on GMT

Related tags: Heparin, Government accountability office

A member of the US Congress has called on the GAO to launch an investigation into the FDA’s handling of the heparin crisis, citing “unanswered questions concerning [the] deaths”.

Representative Joe Barton wrote a letter to the acting controller general of the Government Accountability Office (GAO) calling on him to initiate a review of the US Food and Drug Administration’s (FDA) handling of the heparin scandal.

This was prompted by Barton receiving information from his staff “thatcasts a different light on FDA’s public statements about heparin deaths​”. Media reports published at the end of July based on FDA public statements said heparin had been “conclusively linked​” to three deaths.

However, Barton claims to have received a different response from the FDA that stated it was “possible​” heparin was the cause of death in two of the cases and “unassessable​” in the other.

In addition Baxter has independently investigated the three cases that were believed to link heparin to the deaths. During these investigations Barton says that Baxter obtained additional medical information, interviewed pharmacists and nurses and visited one of the hospitals involved.

Based on these investigations Baxter concluded that heparin was unlikely to have caused the deaths in the three cases. However, it did raise five other cases, without lot numbers, where a link between heparin and the deaths could not be ruled out. According to figures obtained from the Center for Responsive Politics ​Barton has received $10,500 from Baxter Healthcare since 2002.

Although Barton’s letter focuses on the three cases that were said to be “conclusively linked​” to heparin, many adverse events were reported to the FDA. In 2006 there were three deaths of patients receiving heparin in which patients had one or more allergic or hypotensive symptom. Over the period from 1 January 2007 to 31 May 2008 this spiked to 149, according to the FDA’s website, although Barton’s letter claims the figure is 167.

Of these 167 reports Barton claims that the FDA only has lot numbers for 16 and that of these only one report deemed that it was “probable​” that heparin was responsible for the death.

The lot number of this heparin can be traced to American Pharmaceutical Partners (APP), according to Barton. APP became the primary supplier of heparin in the wake of the scandal, with the FDA saying it screened the company’s heparin active pharmaceutical ingredient “to ensure that it did not contain the identified contaminant​.”

Barton says that he is not aware of the FDA publicising the information that it is “probable​” APP heparin is linked to a death. Without further information it is not possible to ascertain if the death is the result of uncontaminated heparin, which killed 55 in 2006.

The letters states that additional information on the APP case has been requested by Barton but that the FDA is yet to respond.

The complete letter can be found here​.

Related topics: Markets & Regulations, Globalization, QA/QC

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