It seems that as ddn's
focus on oncology research continues its upward trend, so too are
the
incidences of cancer affecting the people around me. While just a few years
ago, I wrote from the floor of the American Association for Cancer Research
(AACR's) 100th Annual
Meeting that I had never personally known
anyone diagnosed with cancer, I can now say—with great sadness—that cancer has
affected many people in my
social circle in various ways.
The most recent case of this is Mihaela, the wife of a high
school
chum. Last month, the 32-year-old wife and mother of two beautiful
little girls was diagnosed with classical Hodgkin's Lymphoma, lymphocytic rich
type, stage 3A. The diagnosis came as a surprise to Mihaela and her family, as
she found an enlarged lymph node on her neck a few months ago, but didn
't think
it was a serious concern, and postponed having it checked out as she focused on
graduating from dental hygiene school.
Bravely documenting her journey with Hodgkin's Lymphoma on a
blog, Michaela has noted that her prognosis is promising, and her
doctors are
committed to treating her disease while maintaining a healthy body during the
process. But her diary has also called attention to a growing
trend in the
pharmaceutical world—not just in oncology, but in medical conditions across the
board—of widespread drug shortages.
Mihaela will need eight to 12 chemotherapy treatments, but
her physicians cannot guarantee that the medications she
needs will be
available.
"There might be a problem with the chemo meds in the long
run," Mihaela
writes on her blog. "There is a national shortage of various
drugs, even simpler ones. We want to make sure they preorder or ensure the meds
will be
available. They cannot guarantee it, but did say they will do all
possible, of course. I guess time will tell."
That's a frightening possibility for someone in Mihaela's
position to face, and she is not alone, as the U.S. Food and Drug Administration
(FDA) reports that the number of reported
drug shortages annually tripled from
61 in 2005 to 178 in 2010. Of the 127 studied shortages in 2010 and 2011, 80
percent involved drugs delivered to
patients by sterile injection, including
oncology drugs, antibiotics and electrolyte/nutrition drugs, the FDA says.
The leading reasons for the reported shortages are problems
at the manufacturing facility (43 percent), delays in
manufacturing or shipping
(15 percent) and active pharmaceutical ingredient shortages (10 percent),
according to the FDA.
A recent Wall Street
Journal report noted that the number of suppliers of generic drugs has also
dwindled due to
industry consolidation. For example, there were 26 U.S. vaccine
makers in 1967; today, there are only six.
These issues have garnered serious concern by the U.S.
government, as President Barack Obama last fall issued an executive order directing
the
FDA and the U.S. Department of Justice "to take action to help
further
reduce and prevent drug shortages, protect consumers and prevent price
gouging." Government intervention has also been cited as part of the
problem,
as the government's tight price controls for generic drugs—especially when
purchased by Medicare and Medicaid—are seen by some as the cause
of many
drugmakers either exiting certain markets or adjusting their manufacturing
capacities toward more profitable pharmaceuticals.
The prognosis for this diagnosis is not promising: "We
expect that reports of potential and actual drug
shortages will continue to
increase in the next months to years," says the FDA, "requiring that the FDA
allocate more resources to mitigate drug
shortages in a timely manner to
protect public health. In doing so, we will continue to focus on assuring a
multifaceted approach, including close
collaboration of all stakeholders within
and outside of the agency, including industry, regulators, payers, Congress and
others."
This is not a uniquely American problem, by the way, as
reports continue to arise that doctors and
patients in Canada and Australia are
also battling this crisis.
While the problem is indeed
multifaceted, and the solutions
thus varied and complex, shouldn't addressing drug shortages a top priority for
an industry that claims—on every press
release that crosses my desk and in most
of the stories we write—that its very reason for existence is "to address a
high unmet medical need?" Is
there any higher unmet need right now for
patients? What must happen in order for pharmas and biotechs to hunker down and
resolve this crisis?
Don't we owe Mihaela—and the millions of other patients in
her situation—more?
