A Good Drug is Hard to Find

America has a serious drug problem, but it’s not the problem that you might suspect. The problem isn’t rampant drug abuse among teenagers or the ongoing and bloody war with Mexican drug cartels. Rather, the problem we face is a critical shortage of medicines like antibiotics, anesthetics and cancer-fighting drugs.

I myself was directly affected just last week. Seeking to fill a prescription for a common  antibiotic, I discovered that few pharmacies in the Albany area had it in stock. My pharmacist had to call five different stores in order to locate the drug, and I had to drive 30 miles out of my way to pick up the prescription.

Thankfully, my bout of sinusitis was not life threatening. I was inconvenienced but not placed in any real danger. Others are not so lucky.

Currently, there are almost 300 drugs in short supply. One of these drugs is methotrexate. Methotrexate is used to treat acute lymphoblastic leukemia, the most common type of childhood cancer. Acute lymphoblastic leukemia affects about 3,500 kids a year in the US. With methotrexate treatment, over 90 percent of kids are cured. Without methotrexate treatment, the percentage of children who survive is much lower.

The Food and Drug Administration is hopeful that this shortage can be averted, but others are not so sanguine. The University of Utah’s Drug Information Service, which tracks national drug shortages, estimates that many hospitals will run out of methotrexate by the end of February. There is no substitute for this drug, so when the supply runs out doctors will be unable to provide effective treatment and care for desperately sick kids.

Methotrexate is not the only life-saving drug in short supply. Doxil, a drug widely used to treat breast and ovarian cancer, hasn’t been available for months. Leucovorin and fluorouracil, two drugs used in combination to treat colorectal cancer, haven’t been available for years.

These drug shortages have deadly consequences. According to industry and government reports, dozens of patients have died in recent months because lifesaving drugs or treatments were not available. In a recent survey of American oncologists, 40 percent reported that one or more of their patients had died prematurely or suffered a tumor recurrence because of cancer drug shortages.

In addition, other patients have died as a result of complications with substitute medicines. Nine patients with feeding tubes in Alabama died because a pre-mixed nutritional supplement was unavailable. They were instead fed with a hand-mixed batch that was, unfortunately, contaminated by bacteria during preparation.

Some of these drug shortages are caused by manufacturing problems. The current shortage in methotrexate, for example, occurred when one of the biggest makers of the drug, Ben Venue Laboratories Inc., shut down four of its factories due to quality control problems. There are other companies that make the drug, but their production capacity is limited.

However, manufacturing problems are not the only reason that so many drugs are unavailable. Many shortages are the result of companies voluntarily halting the production of drugs with small profit margins. Over eighty percent of the drugs in short supply are generics. Many US pharmaceutical companies stop producing drugs once they go off patent, as producing low-cost generic versions is simply not as profitable.

That fact, coupled with recent consolidation among generic drug manufacturers, means that only a handful of companies produce a large percentage of the life-saving medications currently on the market. If even a single company has production problems, as is the case with the methotrexate produced by Ben Venue Laboratories, the impact on the overall supply is magnified.

So what can be done about this problem? The FDA cannot require pharmaceutical companies to produce specific drugs. It can, however, provide these companies with incentives to do so, such as offering expedited review and approval of new drugs in exchange for continued or increased production of generic drugs that are currently in short supply.

Similarly, Congress could also act to ease current drug shortages. In addition to pending legislation that would require pharmaceutical companies to report looming shortfalls to the FDA, it could provide additional financial incentives to encourage those companies to manufacture generic drugs. For example, the current cap on Medicare reimbursement rates for generic drugs could be increased, thus improving the profitability of continued production of off-patent drugs.

Even with quick action on the part of the FDA and Congress, unlikely as that is, we will continue to face serious drug shortages for some time to come. As a result, many patients will suffer and some will die. We cannot, however, continue with our business as usual approach to America’s most serious drug problem.

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on February 16, 2012. It is also available on the WAMC website.]

About Sean Philpott

A public health researcher and ethicist by training, Sean holds advanced degrees in microbiology, medical anthropology, and bioethics. He is currently Director of the Center for Bioethics and Clinical Leadership at Union Graduate College and Director of the Bioethics Program of Union Graduate College-Mt. Sinai School of Medicine. Until his term expired in August 2012, he served as Chair of the US Environmental Protection Agency’s Human Studies Review Board, an advisory panel that reviews the scientific and ethical aspects of research involving human participants submitted to the EPA for regulatory purposes.
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