Processo que da Rápido-Revisão do FDA os tempos do interesse um NY dizem
por Astrid Fiano, DOTmed News Writer | November 19, 2008
Physicians often prescribe
treatments for off-label uses
treatments for off-label uses
The New York Times has been investigating FDA's review process of medical devices, and whether the Agency has been allowing scores of devices into the market with minimal review or evidence of effect. The Times reports that physicians may prescribe or recommend such products without telling patients that the products are unproved. Some concern has been raised that when the FDA clears a device, the public can mistakenly assume that the government has proof the treatment or device is medically effective. According to the Times report, the Centers for Medicare and Medicaid Services also gives higher payments to physicians using the products in return for "adopting new procedures;" the payments may lead to the devices becoming "widely adopted."
The Times report has comments from critics of the FDA, such as the ECRI Institute, who feels that the reviewing process is "is often too lax" and should be held to the same review as prescription drugs. The Times also quotes FDA officials as saying that full review of devices would be "very, very inappropriate and a waste of resources."
One particular focus of the Times investigation has been a device, Hologic's MammoSite, for treatment of breast cancer. MammoSite uses a catheter and radiation "seeding," for a shorter and more convenient course of treatment, only days compared to weeks of conventional therapy. The Times says that MammoSite is still "highly experimental," but has been used on 45,000 breast cancer patients. The Times also makes note that MammoSite is on the market based on a 25-woman study which did not specify how effective the treatment was against breast cancer. There is debate on the treatment, the Times says, among doctors regarding the effectiveness and whether it should be recommended.
The Times says some critics have expressed concerns that the higher Medicare payment for MammoSite, twice the rate for conventional radiation therapy, may lead to the procedure being recommended more often, as the higher rate encourages "investment in equipment and training involved in a new procedure."
Higher reimbursements may succeed at rewarding leading-edge medicine but the risk is that they also foster the adoption of unapproved approaches as accepted standards of care.
The Times report has comments from critics of the FDA, such as the ECRI Institute, who feels that the reviewing process is "is often too lax" and should be held to the same review as prescription drugs. The Times also quotes FDA officials as saying that full review of devices would be "very, very inappropriate and a waste of resources."
One particular focus of the Times investigation has been a device, Hologic's MammoSite, for treatment of breast cancer. MammoSite uses a catheter and radiation "seeding," for a shorter and more convenient course of treatment, only days compared to weeks of conventional therapy. The Times says that MammoSite is still "highly experimental," but has been used on 45,000 breast cancer patients. The Times also makes note that MammoSite is on the market based on a 25-woman study which did not specify how effective the treatment was against breast cancer. There is debate on the treatment, the Times says, among doctors regarding the effectiveness and whether it should be recommended.
The Times says some critics have expressed concerns that the higher Medicare payment for MammoSite, twice the rate for conventional radiation therapy, may lead to the procedure being recommended more often, as the higher rate encourages "investment in equipment and training involved in a new procedure."
Higher reimbursements may succeed at rewarding leading-edge medicine but the risk is that they also foster the adoption of unapproved approaches as accepted standards of care.
