Ineptitude and shoddy administration by the American Red Cross ( ARC ) may be the principle reason behind continuation of the policy that bans gay men from donating blood. That is one conclusion that can reached from ongoing legal action by the Food and Drug Administration ( FDA ) against the nonprofit behemoth.
Gay men were among the Americans who rushed to donate blood immediately after terrorists attacked the World Trade Center and the Pentagon in September. Many were shocked to learn that their status of being a man who has had sex with a man ( MSM ) at any time since 1977 was enough to ban them for life from donating blood.
The FDA adopted the policy in 1985 as a means of reducing the spread of HIV through blood products. The decision was based upon what was then state-of-the-art knowledge of HIV and existing technology to detect it in blood. The agency periodically has reviewed the policy as technology to detect the virus has improved.
At the latest review, at a public hearing in September 2000, the American Association of Blood Banks, which represents professionals in the field, and America's Blood Centers, the association of nonprofit organizations that collect and process nearly half of the nation's blood supply, went on record as favoring a modification of that policy. They believe that a one-year deferral from donation would offer the same degree of protection from disease while reducing the burden of discrimination.
Only the American Red Cross, which gathers about 45 percent of the nation's blood, opposed changing the policy. "Until data are available to show that changing the MSM deferral criterion will not elevate the risk to the nation's blood supply, we cannot support this change," testified Rebecca Haley, MD. Other experts pointed out that it would be impossible to collect such data until the policy is changed.
Given that testimony, the advisory committee voted 7 to 6 to keep the current policy and the FDA accepted the recommendation.
The American Red Cross projects an image that everything is hunky-dory with its $1.5-billion-a-year blood-processing operation. The medical and regulatory communities have little incentive to loudly challenge that perception, as doing so may shake public confidence in the safety of blood products and upset the precarious balance of supply by volunteer donors.
The facts are a little less reassuring. In May 1993, the FDA and the ARC entered into a judicial consent decree designed to correct deficiencies in quality assurance, training, and systems control in their blood-processing operations.
That by itself is not unusual...the FDA has used a similar mechanism to ensure that many blood agencies bring their operations up to evolving standards and practices.
What is unusual is that eight years later the Red Cross is still operating under that decree. In December 2001 the FDA was back in federal court charging that the ARC was in contempt of court for violating that agreement.
"Unfortunately to date the ARC has exhibited a corporate culture that has been willing to tolerate an unacceptably low level of quality assurance and a lack of concern for the public it is supposed to serve," said acting FDA commissioner Bernard A. Schwetz in a statement released Dec. 13, a day before the parties appeared back in court.
"Despite 16 months of discussion and mediation, the American Red Cross would not agree to meaningful penalties for future violations. In our view, these prospective penalties are necessary to ensure that the ARC is held financially accountable for each unit of blood it fails to manage properly," he said.
Schwetz's language was unusually harsh for a federal agency to use in public. It resonated among the tight-knit blood products community.
The FDA also released a list of deficiencies that include incorrect labeling and release of blood potentially contaminated with cytomegalovirus, and inadequate inventory controls. It is seeking the power to levy a fine of $10,000 a day for each future violation.
Larry Moore, lead attorney for the Red Cross, responded by citing improvements that the organization already has made. But he devoted most of his energy to attacking the FDA for exceeding its statutory authority and trying "to impose new burdensome reporting requirements."
U.S. District Judge John Garrett Penn set Jan. 11 as the hearing date. He had ordered mediation in August but that was unsuccessful in resolving all matters. He urged that mediation continue in the interim. Penn said, "It is in the best interest of everyone and perhaps the confidence of the American public that it be resolved through mediation."
"The Red Cross keeps flouting the law and regulations, and doesn't seem to have taken the consent decree very seriously," said Sidney M. Wolfe, MD, director of the Ralph Nader-affiliated Public Citizen's Health Research Group. Given the long history of this case, "the fines that would accompany a contempt of court citation appears to be the only way the Red Cross will respond."
WHAT ABOUT GAY MEN?
So how does this all tie into the ARC position on gay men donating blood?
Deficiencies in their ability to physically detect the presence of HIV in donated blood and administratively remove those tainted units before they are distributed, led the ARC to rely much more heavily on the "paper" screening of potentially risky donors to keep them from entering the system in the first place. That translates into a complete ban on gay men donating blood.
The ARC had a decision to make when the FDA considered loosening that policy. Maintaining its own policy that was stricter than the federal guidelines would suggest deficiencies in its own ability to detect HIV in blood. Adopting the looser "paper" standard would increase the risk that tainted blood would slip through the system, cause infection in persons who received it, and raise questions of liability for the ARC.
The American Red Cross had a vested interest in maintaining a policy of just say no. Gay men would pay the price in terms of continued stigma and discrimination.