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Falling short of filling unmet medical needs
March 2012
by Amy Swinderman  |  Email the author

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?



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