Falling short of filling unmet medical needs

Shouldn’t addressing drug shortages be 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?"

March9th,2012
Amy Swinderman
It seems that as ddn'sfocus on oncology research continues its upward trend, so too are theincidences of cancer affecting the people around me. While just a few yearsago, I wrote from the floor of the American Association for Cancer Research(AACR's) 100th Annual Meeting that I had never personally knownanyone diagnosed with cancer, I can now say—with great sadness—that cancer hasaffected many people in my social circle in various ways.
 
 
The most recent case of this is Mihaela, the wife of a highschool chum. Last month, the 32-year-old wife and mother of two beautifullittle girls was diagnosed with classical Hodgkin's Lymphoma, lymphocytic richtype, stage 3A. The diagnosis came as a surprise to Mihaela and her family, asshe found an enlarged lymph node on her neck a few months ago, but didn't thinkit was a serious concern, and postponed having it checked out as she focused ongraduating from dental hygiene school.
 
Bravely documenting her journey with Hodgkin's Lymphoma on ablog, Michaela has noted that her prognosis is promising, and her doctors arecommitted to treating her disease while maintaining a healthy body during theprocess. But her diary has also called attention to a growing trend in thepharmaceutical world—not just in oncology, but in medical conditions across theboard—of widespread drug shortages.
 
 
Mihaela will need eight to 12 chemotherapy treatments, buther physicians cannot guarantee that the medications she needs will beavailable.
 
"There might be a problem with the chemo meds in the longrun," Mihaela writes on her blog. "There is a national shortage of variousdrugs, even simpler ones. We want to make sure they preorder or ensure the medswill be available. They cannot guarantee it, but did say they will do allpossible, of course. I guess time will tell."
 
That's a frightening possibility for someone in Mihaela'sposition 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 from61 in 2005 to 178 in 2010. Of the 127 studied shortages in 2010 and 2011, 80percent involved drugs delivered to patients by sterile injection, includingoncology drugs, antibiotics and electrolyte/nutrition drugs, the FDA says. 
 
The leading reasons for the reported shortages are problemsat 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 StreetJournal report noted that the number of suppliers of generic drugs has alsodwindled due to industry consolidation. For example, there were 26 U.S. vaccinemakers 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 directingthe FDA and the U.S. Department of Justice "to take action to help furtherreduce and prevent drug shortages, protect consumers and prevent pricegouging." Government intervention has also been cited as part of the problem,as the government's tight price controls for generic drugs—especially whenpurchased by Medicare and Medicaid—are seen by some as the cause of manydrugmakers either exiting certain markets or adjusting their manufacturingcapacities toward more profitable pharmaceuticals.
 
 
The prognosis for this diagnosis is not promising: "Weexpect that reports of potential and actual drug shortages will continue toincrease in the next months to years," says the FDA, "requiring that the FDAallocate more resources to mitigate drug shortages in a timely manner toprotect public health. In doing so, we will continue to focus on assuring amultifaceted approach, including close collaboration of all stakeholders withinand outside of the agency, including industry, regulators, payers, Congress andothers."
 
This is not a uniquely American problem, by the way, asreports continue to arise that doctors and patients in Canada and Australia arealso battling this crisis.
 
While the problem is indeed multifaceted, and the solutionsthus varied and complex, shouldn't addressing drug shortages a top priority foran industry that claims—on every press release that crosses my desk and in mostof the stories we write—that its very reason for existence is "to address ahigh unmet medical need?" Is there any higher unmet need right now forpatients? What must happen in order for pharmas and biotechs to hunker down andresolve this crisis? 
 
Don't we owe Mihaela—and the millions of other patients inher situation—more?
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