By Richard Frank, MD, PhD
The medical evidence is well established: Masses in women
with dense breast tissue are more likely to be cancerous, but these cancerous masses are less
likely to be detected with a standard screening mammogram at a stage when they
are most treatable.
The next step is to inform unsuspecting women who have just
received a mammogram that they have dense breasts. Breast-density notification letters refer women to
their physicians for a clear explanation of potential risk factors resulting
from dense breast tissue. And finally, these letters prompt a discussion
regarding the benefit of additional breast screening via ultrasound or magnetic
resonance imaging (MRI). Sounds pretty straightforward, right? Not quite.
Although 12 states have passed breast
density notification legislation since June – with at least 19 additional
states considering such legislation – the content of these inform letters
varies widely from state to state. In some states, for example, inform letters
recommend specific supplemental screening in the form of ultrasound and MRI,
while other notifications merely suggest additional screening without offering
specifics. Some letters do little more than inform patients that they have
dense breasts, while other notifications employ language to the effect of “If you
have dense breasts” or “your mammogram indicates you MAY have dense breasts.”
This variability in notification language from state to
state is troubling. Women in 12 states appear to be receiving the information
they need, when in fact many of them receive incomplete information. A
nationwide notification standard – something long championed by breast density
inform advocates – would ensure that the best notification language is used
across the U.S.
To ensure that all women with dense breast tissue are
adequately informed of their status, risk factors, and screening options, the Food
and Drug Administration (FDA) is proposing to amend regulations issued under
the Mammography Quality Standards Act (MQSA) to address breast density
reporting. This Breast Density Reporting amendment is scheduled to be issued as
a Notice of Proposed Rulemaking in December 2013. These amended regulations
could mean standardized nationwide notification in the letter women receive
following their mammogram.
In my next blog post, I’ll examine the odds and potential
impact of a standardized nationwide notification letter.
Richard Frank, MD,
PhD, is chief medical officer (CMO) at Siemens Healthcare. He has 30 years of
experience in regulatory, labeling, public, and private payment, and clinical
adoption of therapeutic and diagnostic drugs and medical devices. Dr. Frank
trained in internal medicine at Strong Memorial Hospital in Rochester, N.Y.,
earning licensure in the State of New York to practice medicine and surgery. He
holds a PhD in pharmacology from the University of Tennessee-Memphis.
Additionally, he holds two bachelor of arts degrees in chemistry and biology
(honors), with a minor in mathematics, and was elected to Phi Beta Kappa at
Cornell College in Mount Vernon, Iowa.