Heparin 's Recall--One Year On

Toledo, OHIt has been over a year since the massive Heparin recall was announced in the wake of numerous deaths and reports of serious illness following exposure to Heparin syringes. In that year, patients have learned a lot about Heparin contamination and the factors that can result in their being exposed to contaminated medications.

In April, 2008, a congressional subcommittee heard from the relatives of people who died after they were allegedly exposed to contaminated Heparin. Among the participants in the subcommittee hearing, according to an April 29, 2008, report by Fox News, was Johanna Staples, whose husband became unresponsive and went into cardiac arrest during his dialysis treatment. Dennis Staples was rushed to hospital but never regained consciousness and died later that day.

Another widow to testify was Colleen Hubley, whose husband also died after he was exposed to Heparin. Randy Hubley reportedly came home from his dialysis treatment with diarrhea, abdominal pain and breathing difficulties. According to Hubley, Randy awoke in the middle of the night, unable to breathe. Hubley performed CPR and called the paramedics, who had difficulty giving Randy a breathing tube because his throat was so swollen.

Randy's mother, Bonnie, reportedly died 1 month earlier under similar circumstances. Bonnie's husband spoke before the congressional subcommittee. "I just want to know if my daughter, Dawn, and millions of others who continue to receive dialysis are safe," Leroy Hubley said.

"The complexity of the global drug supply chain creates new and emerging risks that call for new ways of thinking about, identifying and addressing vulnerabilities, and that resting on old standards—even ones that have worked for decades—is no longer enough," said Baxter president Robert L. Parkinson Jr. to the subcommittee.

However, contaminated Heparin did not only come from China. One of the Heparin recalls was related to the product from China, but another involved Heparin produced in the US. The source of this contamination was allegedly an AM2PAT Inc plant in Angier North Carolina, where officials say Heparin syringes were not properly sterilized. According to a February 25, 2009 article in The New York Times, at least 5 people died and hundreds were made sick by the improperly manufactured Heparin.

Now, a nonprofit organization called Project On Government Oversight (POGO) has written a letter to the FDA requesting that the Department of Health and Human Services investigate the FDA's involvement in allowing AM2PAT to continue manufacturing Heparin despite serious concerns about the company's manufacturing facility.

The letter, dated June 6, 2009, and found online at POGO's website, says, "Senior officials of AM2PAT were clearly responsible for this tragedy. However, the FDA bears much of the blame for allowing it to happen. The role of the FDA in this case and others like it is in need of investigation. Accordingly, we ask that you request an investigation by the Inspector General (IG) of the Department of Health and Human Services. Such an investigation is long overdue."

Furthermore, the letter says that the FDA's relationship with drug manufacturers is "collegial and tolerant, rather than arms length, formal, and peremptory." Finally, the letter notes, "FDA officials received repeated, documented warnings of serious problems at AM2PAT." Those warnings, according to the letter, came from FDA personnel, members of the public and a whistleblower at AM2PAT.

In its recommendations to the FDA, POGO says that companies with no preexisting relationship with the FDA, such as AM2PAT, should have to undergo more inspections than companies with existing relationships with the FDA. POGO also recommends that new companies submit test data for products they are making, even if those products are "substantially similar" to products already on the market. The absence of this requirement is one of the reasons that the contaminated Heparin was allowed on the market, according to POGO.