Two
studies/stories caught my attention this week with respect to breast
cancer. The first
is
a study in the
Annals of Internal Medicine which
found that the risk of an overdiagnosis of breast cancer - meaning the breast
cancer was not likely to cause any symptoms in the remaining years of life
given that some other ailment would likely cause mortality before the breast
cancer progressed to a symptomatic stage- increased significantly with age
(e.g. for women age 70-74 it was a 31% overdiagnosis, for age
f overdiagnosis increased significantly with
age. They report that among women aged 70 to 74, up to an estimated 31 percent
of breast cancer found among screened women was over diagnosed, over age 85 the
rate of overdiagnosis rises to 54%. The other story I came across was
this Nature news piece on the unintended
consequences of the FDAs accelerated-approval process for life saving
drugs. The story focuses on a breast cancer drug that was initially
approved for the accelerated approval in the US but, when subsequent studies
demonstrated it was not effective, that accelerated approval was retracted. However, the drug is still offered as treatment
in India because drug approval is regulated by local health authorities. A sample from the story:
Accelerated approvals in the United States are granted on the basis of
clinical studies that suggest a health benefit without necessarily
demonstrating it fully. The process prioritizes speed over certainty, and it
requires companies to complete follow-up studies to confirm a treatment’s
benefits. This is a “very reasonable compromise”, says bioethicist Holly
Fernandez Lynch at the University of Pennsylvania in Philadelphia, “so long as
we can get the confirmatory evidence quickly and reliably”.
Cheers,
Colin