Artificial Blood Products And Artificial Oversight?
4 CommentsBy Ed Silverman // April 28th, 2008 // 5:07 pm
Artificial blood products increased the risk of death by 30 percent and almost tripled the risk of heart attacks in 16 clinical trials, according to a study in the Journal of the American Medical Association. The researchers write that the FDA should have stopped the studies eight years ago, but meanwhile five trials are still under way and another is about to begin.
Eight years ago, the FDA received data on individual studies showing increased risks that should have triggered suspension of testing until a large-scale analysis could be conducted, according to the researchers, who say the FDA should end the trials and Congress should review rules forcing the agency to keep info on new products confidential for competitive reasons.
“One straightforward solution to these problems would be for Congress to reverse the FDA’s policy of treating as confidential all corporate materials submitted during the product development process, including the investigational drug application,” the researchers wrote. The blood products studied were made by Baxter International, Biopure, Hemosol BioPharma, Northfield Laboratories and Sangart.
“If you have secret science, things like this can happen,” Charles Natanson, a septic shock researcher at the National Institutes of Health, tells Bloomberg News. “Once you’ve randomized patients, your results can’t be a trade secret. It’s a measure of protection to the American public.”
But Jay Epstein, director of the FDA’s office of blood research and review, tells Bloomberg that analyzing several studies together as one has its limitations. And he adds that the agency also has unpublished info not available to the study’s authors that shows potential benefits of artificial blood. It’s not clear whether that info will be discussed at an FDA workshop being held tomorrow to review the products.
harpy
“…the agency also has unpublished info not available to the study’s authors that shows potential benefits of artificial blood.”
Odd. Isn’t that usually the first information that comes out? Are we really supposed to think they published all of the bad info and only let FDA see the good stuff?
Nathan
My guess is that this is a tough research area. The problem is that “gold standard” (human blood) can be in short supply in emergencies. (natural disasters, battlefields, etc) Therefore, a blood substitute, even if only 75% as effective and as safe as real blood, is still a major breakthrough. How can you conduct a clinical trial on this? Of course the blood substitute is worse than real blood. That isn’t the issue. The real issue: is the blood substitute better than no blood? (in an emergency)
harpy
I think the real issue is how to devise an ethical clinical trial to test the substitute blood. The real issue is this: “…because some products have been studied under rules allowing researchers to administer them without obtaining consent from individual patients.” link
That particular aspect of the studies was not mentioned in the Bloomberg article. It seems quite important to me. The increased risk of death and heart attacks was borne by people who had no choice in the matter.
david egilman
There is no way any favorable data was held back. If it was the shareholders have a great lawsuit.
You see the companies have a fiduciary duty to spin the results of studies to favor profits. All close calls go to the alternative that leads to increased shareholder value.
As Milton Friedman correctly noted ,”The Social Responsibility of Business is to Increase its Profits” (http://www.colorado.edu/studentgroups/libertarians/issues/friedman-soc-resp-business.html)
“Of course, the corporate executive is also a person in his own right. As a person, he may have many other responsibilities that he recognizes or assumes voluntarily–to his family, his conscience, his feelings of charity, his church, his clubs, his city, his country. He ma}. feel impelled by these responsibilities to devote part of his income to causes he regards as worthy, to refuse to work for particular corporations, even to leave his job, for example, to join his country’s armed forces. Ifwe wish, we may refer to some of these responsibilities as “social responsibilities.” But in these respects he is acting as a principal, not an agent; he is spending his own money or time or energy, not the money of his employers or the time or energy he has contracted to devote to their purposes. If these are “social responsibilities,” they are the social responsibilities of individuals, not of business.”