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?
How clinicians answer these questions depends, of course, on their individual practices and experiences. Some believe that children should be given drugs before their adult counterparts, advancing what is referred to as the ‘fair innings’ argument: Adults have had longer to live, more time to experience life, and the limited supply of drugs should be distributed to those who have yet to have that opportunity. Furthermore, a pediatric oncologist may argue that in light of the societal causes of cancer in adults (poor diet and smoking to name but two), a child who hasn’t ever touched a cigarette should come before the man who has smoked two packs a day for decades. Or so the argument goes.
Perhaps predictably, the resolution of these ethical issues is not so simple. Often adults with cancers are productive members of families. They may have wives, husbands, or children who depend on them to reassume the mantle of breadwinner, partner, and parent. Does one child with leukemia matter more than a family of five who are dependent on Dad to bring home dinner? What about a single mother and her children? Does one child matter more than three? Such questions are—and should be—close to impossible to answer. And who has the authority to make the decisions? Is it the primary clinician? A team of clinicians? Some type of lottery? These hard issues cannot be neatly framed and resolved by some mathematical formula
There are further considerations to take into account. The dosages of many of these drugs depend on the particular vital statistics of the person receiving them. In a strictly utilitarian cost-benefit analysis it would seem prudent in such a situation to sacrifice the adult for the sake of the children. The good of many trumps the good of one. However a strictly utilitarian viewpoint may in some cases lead us to conclusions that we are far from comfortable with. The idea that patients should be treated only as numbers within a larger system clashes with our modern notion of medicine, with its individually-tailored treatment plans and emphasis on personal relationships Even if we wanted to be quantitative in our approach
, there are many different value sets that you can plug into the equation, and each will give you a different result. As with most moral issues there is no clear-cut solution waiting to be discovered like a golden ticket.
The most obvious answer here would be to do whatever we can in order to prevent the need for such decisions in the first place—putting procedures into place and seeking policy solutions that ensure, to the best of our ability, that we are not forced to make these impossible choices when it comes to providing vital treatment. Through rationing, careful monitoring, and communication between the distributors and the producers, we can define protocols to efficiently use our existing supplies, and we may be able to avoid more shortages. However, this does not fix the underlying problem—that when shortages do occur, the impossible decisions fall to doctors.