From the AP comes a report of a clinical study treating stroke subjects with EPO which found a higher death rate in the EPO group. There will be a line in here about the link to sports doping with EPO; however looking at side effects in an elderly population suffering a stroke is far different than looking at side effects in an athletic population.
J&J's Ortho Biotech unit said late Wednesday that it had learned of preliminary data from a study in which participants were being given its drug Procrit within six hours of suffering an ischemic stroke, in which an artery blockage limits the flow of blood and oxygen to the brain.
In the study, which was designed and initiated by a German scientist, more patients treated with Procrit died than in the comparison group receiving a placebo.
Johnson and Johnson released a PR statement, possibly to stem the criticism that pharmaceutic companies cover up deleterious side effects.
"Ortho Biotech chose to publicly communicate the results ... because of what we feel are potential safety implications," said company spokesman Mark Wolfe.
He said it is J&J's understanding that the idea behind the study "was based on data suggesting that patients suffering from stroke might benefit from epoetin therapy."
Epoetin alfa is the chemical name for the Procrit brand. The drug is also sold by another Johnson & Johnson unit under the name Eprex outside the United States, and Amgen Inc. sells it under the name Epogen in this country.
The drugs are all approved for treating anemia in cancer patients, people with kidney disease undergoing dialysis and some patients with HIV. They are not approved in any country for treating ischemic stroke patients.
EPO, although frequently abused by athletes, is dangerous.
Strong warnings have been added to the package information for these drugs in recent years, as they have been linked to growth of existing tumors in some cancer patients and, at high doses, to heart complications and death.
The drugs work by stimulating production of oxygen-carrying red blood cells. Other versions, known as EPO, have been linked to doping by some athletes and banned because they boost endurance...
According to Wolfe, the study had been completed and preliminary data revealed a higher death rate.
Considering the report a few days ago of the ability of EPO to alter neuroanatomic structure, in conjunction with the information given above, this is a very interesting drug which appears to stimulate growth in a number of cell types.