FARMINGTON — Once a week, Dan Gray pays to have a pint of blood taken at Franklin Memorial Hospital. And once a week, that blood is thrown out rather than donated to someone in need.
It frustrates him.
“You could take a pint out of me, a pint out of you and a pint out of somebody else and play three-pint monte with it and they wouldn’t know whose is whose,” Gray said. “As far as the analysis of it, no one would know.”
It’s been a question in America for years: Should people with hereditary hemochromatosis be allowed to donate blood? Their disorder is genetic, after all, which means it can’t be contracted like a virus. And people with the disorder regularly need to lose blood in order to keep their iron stores in check, which means they could be significant donors if their blood was given away.
But many of the country’s blood collectors, including the American Red Cross, don’t accept donations from people with the disorder.
At least two factors have influenced that decision until now.
The Food and Drug Administration has long allowed people with hereditary hemochromatosis to donate blood, though for years it required their blood be labeled, which made some hospitals balk at using it for transfusions. Given the cost of taking the blood, and with nowhere to send it, many blood collectors decided not to take it for donation at all.
A second factor deals with blood supply safety. Some blood collectors have worried that people with hemochromatosis, who require regular, expensive blood draws, would have a financial incentive to lie if they also happened to have a contagious disease — hepatitis, for instance — in order to get the free blood draw that comes with donating blood.
To counter those roadblocks, the FDA changed its rules in 2015. Effective last year, blood collectors no longer had to label blood from eligible donors with hereditary hemochromatosis. The theory: Hospitals and other users of donated blood would take it if it were unlabeled, making the blood useful and valuable.
As it stopped requiring labels, the FDA started requiring that blood collectors who accepted blood from those with hemochromatosis do so for free — including for those with contagious diseases — if the collectors planned on passing any of the blood on for transfusion.
Because it would be free even for hemochromatosis patients with a contagious disease, the theory goes, donors would be willing to alert collectors to those diseases, having no reason to lie about their health; they’d get their blood taken for free and collectors would destroy it rather than pass it on for donation.
While collectors would lose money on patients whose blood they couldn’t use, they’d benefit from the significant amount of blood donated by those with hemochromatosis who had no other health issues.
However, the Red Cross and some other collectors still refuse to take the blood of people with the disorder. A Red Cross representative said the organization is not sure it can meet the FDA’s requirements, but he did not specify which requirements were a problem.
“While the FDA recently removed the specific variance and special labeling requirements for collected whole blood from donors with hemochromatosis, there are additional compliance processes that blood centers must implement to ensure safety of the blood products,” said Jorge Rios, medical director for American Red Cross of Northern New England, Massachusetts and Connecticut Regions.
He added that “these type of changes take time and careful planning and are subject to scrutiny by the FDA. Until the Red Cross is confident that it can meet the stringent regulatory requirements of the FDA, we are unable to utilize hemochromatosis blood for transfusion.”
Although the Red Cross is the largest blood collector in the country, it isn’t the only one. Bloodworks Northwest is based in Seattle but works with Brewer-based Eastern Maine Health Care Systems. It’s gone back and forth on its policy of using blood taken from people with the disorder.
When Bloodworks Northwest took blood from all hemochromatosis patients for free and used it for transfusions, donors didn’t always follow the rules, according to the company. They walked in as regular donors rather than patients, didn’t always get a prescription for their blood draw and weren’t always followed by a doctor as required by FDA rules. Bloodworks leaders worried about donors not being honest.
“The accuracy, the truthfulness of the donor health history is of paramount importance because there are so many other questions that we ask that are very important to make sure that no infectious disease is being transmitted, for example,” said Bloodworks President and CEO James AuBuchon.
Bloodworks then decided to charge hereditary hemochromatosis patients for blood draws and not donate their blood — mirroring Red Cross’ current policy — but then the organization had problems with Medicare billing.
“So currently we are re-thinking,” AuBuchon said. “We will probably go back to the approach of using hemochromatosis donations for transfusions and not charging anybody. But the program is in limbo at the moment.”
Rios said the Red Cross is considering a change, but its policy stands for the moment.
“The Red Cross will continue to evaluate the possibility of being able to provide blood products from individuals with hemochromatosis to patients in the future,” he said.