Several of the concerned calls I received were from colleagues in Houston’s Texas Medical Center, the largest medical center in the world with 49 institutions that occupy an area the size of downtown Chicago. If these colleagues cannot get cytarabine, imagine how difficult it is for a solo practitioner in small-town America.
The drug-shortage problem has grown rapidly in this country in the past decade. The FDA reported a record 211 shortages in 2010, up from 58 six years ago, according to the American Society of Health-System Pharmacists. Eighty shortages were reported in the first quarter of 2011 alone. At this rate, the year-end total will be more than double the number last year.
“This problem is not just a blip,” said ASHP spokeswoman Cynthia Reilly. “It is getting worse, not better.”
What is behind these shortages, and what can be done to prevent them?
The FDA has no authority to compel manufacturers to continue producing a drug, nor does it have the power to force companies to inform it about issues that might result in drug shortages. Sen. Amy Klobuchar (D-Minn.) and Sen. Robert Casey (D-Pa.) are attempting to address this issue with legislation that would compel manufacturers to notify the FDA when there are supply problems or when they plan to discontinue a product. This is a start.
Valerie Jensen, associate director of the FDA’s drug shortages program, says it’s not clear why the shortages are getting worse. “We really don’t know the reason, but it is a concerning trend,” she said. Asked whether financial considerations play a role in the shortages, Jensen said, “The older drugs are often not cost-effective for companies to make. Often we see products like [cytarabine] get discontinued. . . . We cannot require a company to manufacture a product.”
Jensen said that the FDA is working with the companies to make cytarabine widely available again. She said the FDA is examining the possibility of allowing temporary importation of the drug from foreign sources.
Why are these shortages almost unique to the United States? We pride ourselves on being the No. 1 nation in medical care, but today a patient with AML in an emerging nation, such as my native Lebanon, may be treated with more-effective therapy than a patient in the United States. No shortages of cytarabine have been reported in other countries. We urgently need to examine and address the reasons behind the increasing occurrence of shortages of generic drugs in the United States.
The most common explanations given for drugs’ presence on the FDA list are “manufacturer delays,” “increased demand” and shutdown of plants for manufacturing issues. Some generic drugs called “sterile injectables,” including cytarabine, are on the list because of their cost and complexity of manufacturing.
There is little financial incentive for any company to produce labor-intensive medications that are heavily regulated but offer a slim profit margin. The fewer companies that manufacture a drug, the more vulnerable the supply, though in the case of cytarabine three companies produce it, which Jensen said “is actually good for one of the older drugs.” The drug is very inexpensive. At my hospital, a two-gram vial costs $16.
Cytarabine is used to treat a leukemia affecting patients numbering in the thousands rather than the millions. Shortages of other drugs affect much larger groups. Why not offer tax incentives to companies willing to fill this need, or perhaps subsidies similar to those offered in the agricultural sector?
In a country as rich as ours, patients should not have the misfortune of contracting a fatal disease for which an unprofitable treatment is withdrawn or not available.
Shortages of sneakers, the latest electronic gizmos and toys around the holidays routinely make headlines with a notable public outcry and demand for more. Surely the shortages of lifesaving medicines demand more attention and more action.
“Sorry, we’re out of stock” is simply not acceptable.
Kantarjian is chairman of the department of leukemia at the University of Texas’s MD Anderson Cancer Center.