The Journal of the American Medical Association reported last week that it found that artificial blood raised the risk of death by 30 percent and tripled the chances of suffering a heart attack.
The researchers reviewed data collected from sixteen clinical trials and concluded that the dangers were so great that the U.S. Food and Drug Administration should have halted the studies eight years ago.
Because the FDA received the data in 2000, the researchers argued that the agency should have stopped the human trials until a large-scale analysis could be completed. The researchers also blasted a rule that forced the FDA to keep new product information confidential.
In an interview with Bloomberg News, Charles Natanson, one of the study’s authors and a septic shock researcher at the National Institute of Health, said,
“If you have secret science, things like this can happen. Once you’ve randomized patients, your results can’t be a trade secret. It’s a measure of protection to the American public.”
The companies at the center of the blood substitute study include Baxter International Inc., Biopure Corp., Hemosol BioPharma Inc., Northfield Laboratories Inc., and Sangart Inc.
Because actual blood must be refrigerated, has a shelf-life of just over 40 days, carries a disease transmission risk, and may only be used with compatible blood types, pharmaceutical companies have been working on a blood substitute.
Sidney Wolfe, one of the study’s authors and the director of the Washington-based advocacy group Public Citizen, Inc., told Bloomberg News that none of the original trial results were published immediately and the FDA reviewed each study separately.
“When we talk about things that make it more likely people will be harmed or killed, and you keep it a trade secret, it’s inexcusable.”
Once again, the pursuit of profits by drug companies was left unchecked by an impotent FDA. As was the case with Trasylol, Vioxx, and Avandia, the patient is the one who pays the price.
The lawyers of Carey, Danis & Lowe are experienced in helping people injured by dangerous prescriptions drugs and medical devices. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.
We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.