With a recent report from the American Society of Clinical Oncology predicting that cancer cases will increase from 1.6 million to 2.3 million by 2030, the story of 7-year-old Josh Hardy, who is in critical condition due to a virus, highlights an increasingly serious dilemma. Young Hardy was diagnosed with kidney cancer before he reached his first birthday, and now seven years later he’s endured more bodily ailment than others do in their whole life. He has beat out thymus, lung and bone marrow cancer as well.
Unfortunately for his parents, their son, an already four-time cancer survivor, was left with a weakened immune system after receiving a bone marrow transplant. As a result, when Josh contracted an adenovirus his body did not respond in the way a healthy person would.
Adenoviruses are common, affect the respiratory system, and often manifest in the non-serious form of the common cold — even as pink eye. For Josh, an adenovirus meant returning to the intensive care center of a Memphis St. Jude’s Children Research Hospital.
By the time his story had caught national attention, his parents were in the midst of attempts to put pressure on Chimerix Inc., a pharmaceutical company in North Carolina, whose experimental drug, Brincidofovir, could rid Josh of his adenovirus without damaging his kidneys.
A previous antiviral treatment that was being administered to Josh had been damaging his kidneys, subsequently his doctors felt the experimental drug was the preferred, if not only, option.
Brindicofovir is nonetheless an experimental drug. It’s not FDA approved, not available for purchase and still being studied. There was an uphill battle to secure the drug for Josh Hardy.
That’s when the dilemma becomes apparent. How is the medical field going to deal with a 45 percent increase in cancer cases, particularly in regards to the bioethical implications of experimental treatments or drugs?
For the Hardys, the life-threatening status of their sons’ health was at first answered with resounding denials. The U.S. Food and Drug Administration (FDA) allows for individuals who have serious or life threatening conditions to have expanded access to experimental drugs. The process is often referred to as “compassionate use,” and must be determined on a case-by-case basis according to their website fda.gov under the US Department of Health & Human Services.
Generally, to attain permission there must be no other alternative treatment or drugs available to the individual, doctors and the pharmaceutical company making the drug must agree to provide FDA subject arrangements for the individual to take the drug, and an informed consent document must be signed, waiving the legal liabilities of all parties.
This is to prevent unnecessary risks. The problem, however, was that executives of Chimerix were not willing to provide Brindicofovir for Josh.
They later did so after great push back from the public that varied in form from online campaigns to Twitter-bashing of the company for what was deemed a “lack of compassion” to physical threats against company president, Kenneth Moch.
Moch spoke to CNN for a March 11 article and explained that he would feel horrible if Josh’s condition further complicated to the point where the 7-year-old-would die. The next day it was reported that Josh would receive the drug.
“Compassionate use” is not an uncommon practice among pharmaceutical companies. The FDA approved more than 900 such arrangements in the 2013 fiscal year, and even Chimerix participated in this practice some 451 times from 2009 to 2012, reported CNN’s Elizabeth Cohen in the article, “Company denies drug to dying child.”
Nonetheless, before Chimerix Inc. gave Brincifidovir to the Hardy’s, Moch highlighted a serious ethical dilemma being faced: “If this were just one patient wanting this drug, then this would be a very different question … but it’s yes to all or no to all,” as reported by CNN.
For the Hardy’s, “compassionate use” was administered, but what about the next individual in critical condition? Or, better yet, what about the 1,600 people whose organs are so devastated from cancer that they will die before the day is done, as estimated by the American Cancer Society in their Cancer Facts and Figures report from 2013?
It’s a thin line for these pharmaceutical companies, with heavy ethical implications on many levels.
First, if they allow individuals to use their products, then they risk lowering their chances for FDA approval because the unfinished product runs a high risk of not guaranteeing the best results since all of its side effects haven’t been studied. The risk is made greater by the additional fact that those who are in need of expanded access are already in critical health. Any negative results would need to be reported to the FDA, and this would extend the approval process.
Also, manufacturing experimental drugs is costly for the pharmaceutical company. The ways in which corporations get the financial resources to take on difficult projects like creating potent medicine against the varying faces of cancer is through investment. But if a company is spending about $50,000 — the average for a “compassionate use” case — per individual, then investors will lose their incentive particularly because it’s not one but hundreds of individuals who would qualify.
We can’t ask our pharmaceutical companies to become charities of expensive medicine because that risks prolonging the research of effective methods to deal with cancer. But when is it ever ethical to deny “compassionate use” in light of the fact that the individual in need has no other option?
There isn’t an easy answer. Pharmaceutical companies should continue to allow “compassionate use” of their experimental drugs for the very reason that if I were the mother of Hardy, or if I were in the position his parents were in, where one of my loved ones was so ill that last resort options were the only ones, then I could not live with the fact that I had been complicit in allowing the loved ones of others to go without such help.
However, beyond the FDA’s case-by-case process of determination, more needs to be done. If cancer does rise by 45 percent within the next 16 years, then last resort options like “compassionate use” won’t be available for those who need it. Pharmaceutical companies won’t be able to sustain such good Samaritan-type processes.
Instead, long term solutions need to be at the forefront of our agendas. Research and treatment have already come so far, and can hopefully go further.
When questioning whether or not medicine is a field of practice worth sleepless nights of studying for biology exams, I’d urge Seaver College students to take pride in knowing that they are a part of the potential solution, particularly because ASCO’s report predicts that while the demand for individuals to work in oncology will rise to 42 per cent, the estimate is that only 28 per cent of that need will be met.
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