Recently the American Society of Health Systems Pharmacists (ASHP) announced that there may be another Doxil shortage coming down the pipeline. Doxorubicin (commonly known as Doxil or the Red Devil) is a chemotherapy drug used to treat adults and children suffering from leukemia, lung cancer, sarcoma, and other types of cancer. It is not a particularly nice drug. Side effects include potential heart damage, swelling of the hands and feet, and peeling skin, not to mention the more conventional side effects associated with chemotherapy such as vomiting and hair loss. But while treatment with Doxil may not be a pleasant experience, the drug saves lives. For patients faced with a decision between the spread of malignant tumors and swelling hands the choice seems obvious.
Currently cancer is the second most common cause of death in the United States, after heart disease. There are more than 10,000 cases of childhood cancer reported annually in the U.S., and more than half a million Americans total die from cancer each year. In view of this, one might expect that chemotherapy drugs would be readily available. Regrettably, this is not always the case. While there is more Viagra, Cialis, and Rogaine than any septuagenarian could possibly want or need, we in the U.S. do not consistently produce enough lifesaving chemotherapy drugs to allow our parents, grandparents, or children their best shot at survival. We have the resources to do so, but we opt not to.
This isn’t a simple issue. No doubt the pharmaceutical companies who manufacture these essential drugs are aware of the number of cancer patients in this country. One obvious factor in the U.S. is that the Food and Drug Administration (FDA) does not strictly control production and pricing. The FDA is primarily concerned with ensuring that products within its purview are safe and effective. Manufacturing details are left in the hands of the for-profit pharmaceutical industry, which spends millions, if not billions, of dollars developing these drugs and shepherding them into production. While there is certainly an upside to producing drugs this way, problems inevitably arise, including issues of patents, pricing, and projected versus actual demand. Such conditions create fragile and sensitive markets where a single problem can send shockwaves through the entire treatment structure.
Unfortunately, a result of this situation is that drug shortages have become a way of life, and hospitals and clinics are constantly preparing for the day when drugs such as Doxil will run out. Eighty-three percent of oncologists in the U.S. report being affected by the lack of chemotherapy drugs. Where can we get more? How quickly can they be delivered? How much is it going to cost? What happens when there is no more to be had? These are the types of questions that haunt clinicians and pharmacists across the country.
These shortages are thrown into even more painful relief when one considers the world of pediatric oncology. In our minds we often relegate cancer to the old or to those who have spent decades smoking cigarettes. But in reality, though a five year old with leukemia may defy logic, according to the American Childhood Cancer Organization (ACCO), cancer is the leading cause of disease-related death in children.
Pediatric oncology is a specialization that requires making very difficult choices on an almost daily basis. Clinicians are constantly making decisions that will affect the health—and in some cases the survival—of their young charges. With the stakes impossibly high and the margin for error impossibly low, the last thing that anyone wants is a shortage of necessary drugs.
Unfortunately pediatric oncology carries perhaps the most burdensome shortage issues of any oncology sub-specialty. As Dr. Yoram Unguru, a faculty member at the Johns Hopkins Berman Institute of Bioethics and a practicing pediatric oncologist, explains, “although some of these are drugs that are short in medical [adult] oncology it doesn’t seem to be to the same degree as it is in pediatrics.”
In pediatrics, many generic drugs that are vital to life saving regimens are in short supply. These are not new, experimental drugs. Some of these drugs have existed in one form or another for the better part of half a century. Acute lymphoblastic leukemia (ALL) is the most common childhood cancer. The past decade has seen shortages of 8 of the 10 most common drugs to treat ALL.
This reality gives rise to specific ethical considerations regarding the distribution of drugs, and the ethical issues are particularly difficult when discussing shortages within the confines of pediatric oncology. The issues boil down to who should be treated, and who should be left out in the cold. How do we go about deciding who gets what? Should children be treated before adults? Should a drug be saved for experimental trials or disseminated for more wide-spread clinical applications? Should children with more serious or advanced cancers be treated before those with less serious cancers?