At first glance, he’s nothing more than some crusty old man with a cane and a Vicodin addiction. He’s bossy, crude, and has a perpetual five o’clock shadow. At the end of every episode, some seemingly incurable patient walks out of his ward with nothing more than an IV scar and a welt from a seizure to remind them of their stay. Dr. Gregory House, the protagonist/antagonist of the FOX medical mystery show “House,” employs an assortment of questionable practices to get results, but he does get results. Does the cure justify the course? This question has guided medicine for years and is currently delaying the implementation of what has come to be called “compassionate drug use”.
Compassionate drug use, formally known as “investigational drug use,” allows the administration of experimental drugs to terminally ill patients while forgoing the necessary clinical trials and the completion of FDA approval. Approved in 1987, the FDA’s Compassionate Drug program offers two options for eligible patients. First, a company that has made it to Phase III of the drug approval process, the stage at which a company must run clinical human trials, is given permission to create an Expanded Access Program (EAP) for patients who are not able to participate in the clinical trial. However, if an EAP isn’t available for a certain patient, the patient’s doctor can work with the drug company to ask the FDA for single patient access. These individual requests are usually processed within 24 hours.
According to Dr. Timothy Moynihan, an oncologist at the Mayo Clinic, there are several essential criteria to be considered for compassionate drug use. The disease in question must be fatal, rare, and have no known cure. Approved treatments for the disease must have failed to yield satisfactory results and the patient is not eligible for the clinical trials currently studying the experimental drug that might prove curative. From an institutional standpoint, the overseeing physician agrees that the patient has no other options and may benefit from an experimental treatment and the company that makes the experimental drug must agree to provide a sufficient dosage to the patient.
Essentially, in the most severe cases, doctors and drug companies have the capacity to remove the red tape and conduct a possibly life saving experiment. However, even this process has its hurdles. In most cases, the FDA requires the submission of an investigational new drug application in order to obtain a drug during its preclinical development. Even after the application process, the drug company has no obligation to comply with the request for their drug. Moreover, if the pharmaceutical company accepts the request, there may be a charge for the drug and it is unlikely that an insurance company will pay for any associated costs of the treatment.
The greatest risk and argument against compassionate drug use lies in the inability to predict the efficacy and side effects of treatment. There is no way to know how an individual patient will react to the experimental drug, much less whether the drug will cure or kill the patient.
In the episode “Detox,” Dr. House is called in for a diagnosis after a patient’s girlfriend wrecks her father’s Porsche because the sight of the patient’s blood in the passenger seat distracts her. At some point before the patient’s belabored diagnosis of Napthalene poisoning, Dr. House responds to one Dr. Lisa Cuddy saying “I take risks, sometimes patients die, but not taking risks causes more patients to die—so I guess my biggest problem is I’ve been cursed with the ability to do the math.” Is it really a curse to pursue whatever means necessary for the wellbeing of a patient?
In a case where compassionate drug use is a possibility, the patient has the right to do with his body as he pleases. The primary doctor and other medical professionals can give their educated recommendations, but ultimately it is up to the patient to choose. If there is even the slightest chance that an experimental medicine could prevent a futilely prolonged hospital stay and eventual death, then it is the patient’s prerogative to choose to pursue a risky treatment in spite of whatever unforeseeable hazards may exist.
Upon graduating from medical school, nearly every prospective medical professional takes the Hippocratic Oath, a promise made unto all future patients to foster proper practices. In the modern translation of the ancient Greek text, those taking the oath swear to “…apply, for the benefit of the sick, all measures [that] are required.” Maybe Dr. House isn’t all that great at sticking to the rules, but at least he got one thing right.
Parker Collins is a sophomore Environmental Engineering major in Trumbull College and a Distribution Director for the YJML.