In a report to be released this Monday, May 5, by the Journal of the American Medical Association (JAMA), experimental blood substitute tests allowed by US regulators raised the risk of heart attack and death. The report is written by scientists with the National Institutes of Health Clinical Center and advocates from the watchdog organization Public Citizen.
Biomedical companies and the government have been looking for a way to substitute the need for blood for several years. If a blood substitute is found, it will become a financial boon to companies that market it, as well as save lives in such places as battlefields. Theoretically it could be stored for years without the need for refrigeration, as well as not run the risk of carrying infections such as hepatitis or HIV. According to JAMA, the FDA had completed a dozen studies of blood substitutes by the end of 2000, and the risks were well known at that time. Dr. Charles Natanson of the NIH Clinical Center states that the FDA used their data to look at each product and each use (trauma, surgery, and in stroke patients) separately rather than pooling it to see the whole picture.
Ethical Concerns
After Public Citizen filed a lawsuit in 2006 to protest closed-door hearings, the FDA halted a planned test by the Navy to use the substitute on civilians without their knowledge or consent. While this raises certain ethical questions, American companies are testing products on people in South Africa and in some European countries. Cambridge, Mass.-based Biopure Corp. is using their blood substitute, Hemopure, on anemic surgery patients in South Africa. Study co-author Sidney Wolfe of Public Citizen states it is highly unlikely or even impossible, that these countries are aware of the risks, even though the governments have approved the tests.
Findings
The report shows 16 random control studies of five different blood substitutes with 3,700 patients involved. These patients include trauma, elective surgery, and victims of stroke. The findings show:
- A 30 percent higher risk of death for those who received blood substitute transfusions. 164 patients died compared to 123 who received ordinary blood or saline transfusions.
- Risk of heart attack tripled with blood substitutes. 59 patients suffered heart attacks with the new product compared to 16 who did not. Experts speculate that hemoglobin in the blood substitute removes nitric oxide from the blood, which causes blood vessels to constrict and a buildup of sticky platelets
Perhaps predictably, two of the companies whose products were included in the study call the analysis “flawed.” Biopure vice president, Dr. A.G. Greenburg states, “There are vast differences among these products that make any pooling of data flawed, especially across different clinical experiences.” Evanston, Ill.-based Northfield Laboratories Inc.’s CEO, Dr. Steven Gould explains that though pooled data can be useful to raise questions, it does not “provide answers about specific products or to examine fully the risk-benefit ratio of any particular product.”
Defending the FDA’s decision, Dr. Jay Epstein, the director of the FDA’s office of blood research and review, says there are enough differences among the blood substitute products and their intended uses to allow some of the studies to continue. Dr. Natanson does give the FDA some credit, but says that while the agency may know more than any one individual at any of the companies, “they may not know the whole story” and there may be information being withheld from the FDA by these companies.
Dr. Natanson’s theory seems to be backed up by Dr. William Hoffman, former chief medical officer at Biopure. He left in 2000 because management there wouldn’t let him tell the FDA that he believed one of the studies should be halted. However, he states that management at Biopure has changed since then.
While it would be a huge break though to have a blood substitute, especially in times of crisis, there seems to be little doubt that the products being tested are far from ready. Clinical tests on people are an important step, but the individuals should be able to give their consent, and know the risks.
If you or a loved one has been injured due to a product risk you were not made aware of, please contact an experienced injury lawyer in your area.
