A major front on the war on cancer has been development of life-extending pharmaceuticals. In the four years since my prostate cancer diagnosis, new drugs such as Zytiga and Xtandi have been released, each extending the life an end stage cancer patient an average of four to six months. And others–such as Alpharadin–are quickly moving toward approval by the FDA.
But these new drugs exact significant costs. There is the obvious financial expense: the retail cost of these life-extending drugs runs from $5,000 to $8,000 per month. The pharmaceutical companies justify these prices by citing their enormous R&D expenses as well as the costs involved with running trials and obtaining FDA approval.
But there are other, less publicized costs: the drugs’ side effects. Every one of these new medications can adversely affect a cancer patient’s quality of life (QOL). Some side effects of chemo, such as nausea and hair loss, are well known. Less known side effects include weight loss, extreme fatigue, insomnia, anxiety, and clinical depression. Often these symptoms are so severe that patients find them intolerable and discontinue the drug.
Traditionally, most doctors and patients have maintained that the life-extending benefits of these potent new drugs invariably outweigh their downsides. But some researchers are beginning to question that assumption.
In an August 2012 article* in the Journal of Clinical Oncology, the authors performed a “meta analysis” (a study of studies) of the side effects of 38 recently-approved anticancer drugs, treating a variety of cancers. Their startling conclusion: “Our analysis shows that most newly approved anticancer drugs are associated with increased odds of toxic death, treatment discontinuation, and severe AEs [adverse events] compared with the standard treatment received by controls.”
In other words, these 38 newer drugs have substantially more worrisome side effects than older cancer drugs.
The article frames the tradeoff in blunt terms: “To conclude, new molecular targeted and chemotherapeutic agents that lead to improvements in efficacy also increase morbidity and mortality owing to the toxicity of treatment.” An editorial in the September 2012 issue of Lancet Oncology, “First Do No Harm: Counting the Cost of Chasing Drug Efficacy,” questions “the headlong rush into increasingly powerful (and expensive) anticancer drugs without a more thorough evaluation of side effects, a number of them life-threatening.”
The researchers suggest that greater weight be given to evaluating the tradeoff between efficacy and side effects during the drug trial and approval process. They state, “although improvements in efficacy are crucial for the approval of a new drug, this should be weighed against its toxicity leading to morbidity and mortality when drugs are reviewed by registration agencies.”
As an engineer, I see this in terms of a basic cost-benefit tradeoff. The cost here is the physical well-being and QOL of the patient. And sometimes the cost is greater than the benefit. In the understandable rush to get the next new anticancer wonder drug on the market (and the income stream flowing to the pharmaceutical company), the FDA would do well to consider the yellow caution flag raised by these researchers.
*Saroj Niraula, Bostjan Seruga, et al., “The Price We Pay for Progress: A Meta-Analysis of Harms of Newly Approved Anticancer Drugs,” Journal Of Clinical Oncology 30 (20 August 2012).