My blog post last Friday was among the top twenty most important ones I have written. I want to be sure that if you have taken Provenge commercially, meaning not during a clinical trial, you need to know that you might have been under-dosed and might need to be retreated.
Dendreon, the company that manufactures Provenge has informed the FDA that less than 0.3% of all men receiving Provenge commercially received a dose that did not meet their standards! Dendreon discovered that in this very small sample of the released product failed to have an adequate uptake of CD54, one of the measures that is used to confirm that the treatment is of adequate potency.
Dendreon has contacted all doctors whose patients received this underpowered dosage and informed them that if the doctor wished they will provide additional Provenge at no coat to the patient. It is up to the individual prescribing doctor to contact their patients who have received this under powered treatment. The FDA has agreed with this plan and has not placed any additional restrictions on Dendreon.
Dendreon has told me that the under dosing does not pose any additional risk to anyone other than the treatment might be less effective.
Some individuals have contacted me and expressed concern that Dendreon has not made a full disclosure about the problem. I understand the concern given the nature of the treatment and its importance to fighting this disease. One individual told me that perhaps this is the reason that her husband has passed. Clearly, there is a lot of significant and justified feelings surrounding this issue.
If you have received Provenge and not heard from your doctor why not be safe. Don’t wait to hear from your doctor, call them now and ask if you were one of the individuals receiving the problematic doses. If you were, have an immediate conversation about the pros and cons of being retreated. If you were and you and your doctor wist for you to be retreated have the doctor make arrangements immediately as we do know that Provenge is more effective in men with lower PSA scores.
Joel T. Nowak, M.A., M.S.W.