Artificial Blood Risks
The FDA is under fire today, in the wake of a report
released in JAMA
yesterday, detailing the organization approved artificial blood substitute trials even after studies showed the products increased risk of heart attack and death.
"It's hard to understand," said Charles Natanson, MD, an NIH senior investigator who lead the analysis, in a Washington Post article. "They already had data that these products could cause heart attacks and evidence that they could kill."
The meta-analysis examined five blood substitutes:
- HemAssist, Baxter Healthcare Corp., Deerfield, IL;
- Hemopure, Biopure Corp., Cambridge, MA;
- Hemolink, Hemosal BioPharma Inc., Ontario, Canada;
- PolyHeme, Northfield Laboratories Inc., Evanston, IL; and
- Hemospan, Sangart Inc., San Diego.
According to the Washington Post article, the review, released yesterday, combined data from more than 3,711 patients participating in 16 studies testing, and found the products "nearly tripled the risk of heart attacks and boosted the chances of dying by 30 percent."
Not only does the oversight pose a significant risk to patients treated with these substances, but the lack of clear communication can hamper future efforts to produce a viable blood substitute, Dr. Natanson noted. "Keeping data from being public represents real risks to patients. If secret science is allowed, other companies can't build on the successes and failures and [outside reviewers] won't be able to fully assess the risk."