Reducing Drug Shortages: A Good First Step
Has your doctor had to change your treatment plan because of a shortage of your cancer drug? If so, you are not alone. Drug shortages, which used to be rare, have been increasing. According to a White House press release October 31, 2011, "While the Food and Drug Administration has successfully prevented 137 drug shortages since the beginning of 2010, drug shortages have been increasing in frequency and severity in recent years and adversely affecting patient care. A small number of drugs in the U.S. experience a shortage in any given year, but the number of reported prescription drug shortages in the United States nearly tripled between 2005 and 2010, going from 61 to 178."
Now President Obama has signed an executive order designed to reduce the number of shortages in three ways. First, it asks drug companies to voluntarily increase reporting to the Food and Drug Administration of potential drug shortages. Drug shortages can occur for many reasons from problems in the manufacturing process to an actual shortage of the raw material. However, because most of the shortages are of generic drugs while new expensive drugs remain available, many suspect that drug companies could do more to reduce the problem.
In an editorial in The New York Times, oncologist Ezekiel J. Emanuel asserts, "Only the older but curative cancer drugs - drugs that can cost as little as $3 per dose - have become unavailable. Most of these drugs have no substitutes, but, crazy as it seems, in some cases these shortages are forcing doctors to use brand-name drugs at more than 100 times the cost."
He continues, "Only about 10 percent of the shortages can be attributed to a lack of raw materials and essential ingredients to manufacture the drugs. Most shortages appear instead to be the consequence of corporate decisions to cease production, or interruptions in production caused by money or quality problems, which manufacturers do not appear to be in a rush to fix."
Better advance notice of drug shortages can help the second step of the executive order work: asking other manufacturers to make the drug and speeding approval of new production facilities. Part of this phase of the order increases the FDA personnel needed to handle the increased workload resulting from the reporting system. Increased competition may help reduce shortages.
The third phase of the executive order deals with price gouging. It "directs FDA to work with the Department of Justice to examine whether any secondary drug wholesalers or other market participants have responded to potential drug shortages by illegally hoarding medications or raising prices to gouge consumers. For example, the ranking member of the House Committee on Oversight and Government Reforms, when announcing his investigation into so-called gray markets, expressed concerns about a report that a leukemia drug whose typical contract price is about $12 per vial was being sold at $990 per vial - 80 times higher."
The executive order acknowledges that legislation is an important step in solving the problem, but sees these steps as immediate action that can be taken until Congress acts.
The balance of regulation and free enterprise is tricky. The profit motive and the free enterprise system has given us wonderful life-saving drugs. The scientists who develop drugs and the workers who produce them deserve a living wage even after a drug's patent expires. Unfortunately, the profit motive can also lead corporations to forget their responsibility towards the greater good.
Today it is hard for us to imagine a time when anyone could pour some alcohol and colored water in a bottle and claim that it could cure cancer and the common cold. Yet the Food and Drug Administration was started in 1906 just because of that kind of abuse. Dangerous drugs and impure food were harming consumers, who had no way of testing the efficacy or safety of medicine and food.
Breast cancer patients are at the heart of this balance. Because many of the drugs that work well for us are now out of patent and less expensive, cancer treatment need no longer be the financial disaster that has affected so many of us. Yet we also want new drugs to treat more resistant cancers like triple negative tumors. New drugs take research, and research costs money-money that comes from the profits of earlier drugs and money from investors who expect a return on their investment.
In a perfect world, corporations would be good citizens concerned not only with their bottom line, but also with the welfare of their customers. Surely, there is a way they can make a sufficient profit on their generic drugs to stay in business. Aspirin has been generic for years and years, but plenty of manufacturers are still making it profitably.
Unfortunately, I have become rather cynical about big pharma. I hope this executive order reduces shortages. I suspect it will probably require legislation to move reporting from voluntary to mandatory to make effective drugs available for all.
If drug shortages have affected your cancer treatment, we would like to hear about your experience. How has your doctor managed? What steps do you think need to be taken to make sure that every patient has access to the most effective drugs?