Disclaimer: This piece has been entered in the Patients Have Power Writing Contest, run by Clara Health. It is designed to raise awareness about clinical trials and the importance of breakthrough research. I am passionate about this cause, as it brings hope to millions of individuals, like me, who have chronic illnesses for which there is limited treatment options and no cure. As always, the words and ideas following are my own.
As most patients do, I had a life before chronic illness and advocacy. If I can be honest with you for a moment, I desperately miss it all. It was a life filled with piles of research papers, early mornings, lesson plans, and the dream that I could change the world. I miss public health. I miss analyzing behaviors and finding answers to the most complex health challenges of our times. I miss educating others in a format that feels as familiar to me as breathing. Perhaps because of this, you will find this entire entry a bit different from my more recent posts. I hope that is okay with you, because I want to talk about a topic that is important to me, clinical trials.
As I write this, I am just coming off two weeks of near-constant medication switching. This resulted in three different medication failures, one where I suffered with an allergic reaction. I am tired and am running out of options for effective treatments. There is, currently, no cure for any of the conditions that plague me, so everything focuses on management of symptoms and then further management of side effects. My treatment plan allows me to function on some days, but does little to give me the quality of life I desire. At times I feel guilty for complaining about the seeming slowness of research as it seems to devalue the research conducted and the lives sacrificed long before I gave my first breath.
The history of many of our treatments, medications, and understanding of the workings of the human body trace back to a time where the value of human life was conditional. Rights were eschewed for the pursuit of knowledge and the ‘greater good’. My moral compass often causes me to feel heavily conflicted when weighing the many advances that occurred in circumstances I wouldn’t wish on my worst enemy. Because of decades of ethical failings, our collective historical trauma is stifling clinical advancements. No one wants to “be a guinea pig,” but are clinical trial participants still lacking status above that of animals?
An Overview of Research Ethics, In Brief
In order to understand the current situation, we must take a look back to World War II and Josef Mengele, a Nazi doctor whose experimentation on countless ‘undesirables’ would turn the stomach of most. Such was the depravity of his conduct, The Nuremberg Code was created in 1947, as a direct result of the findings during the Nuremberg Doctor’s Trials. It intended to halt any further atrocities in research. Unfortunately, for several reasons, this did not completely curtail unethical research practices. Continued failures within the borders of the United States, such as “Tuskegee Study of Untreated Syphilis in the Negro Male” (1932-1972), the Willowbrook Hepatitis Study (1955-1970s), the Jewish Chronic Disease Hospital Study (1963), and trials run in United States occupied territories, such as Puerto Rico (1955), effectively chilled clinical trial participation.
With each discovery of ethical failings, increasingly clarifying legislation was enacted to protect all humans involved in any type of research. The World Medical Association (WMA) Declaration of Helsinki created ethical guidelines for research involving humans. It was composed in 1964, and it has been amended and/or clarified an additional nine times, as recently as 2013. In 1974, under President Nixon, the National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 45 CFR 46 was also signed in the same year. This legislation was created in direct response to the numerous ethical failings of the Tuskegee Syphilis Study. The Belmont Report (1979) was written by the previously mentioned National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Nearly four years of research and several days of hearings resulted in a document that “identifies basic ethical principles and guidelines that address ethical issues arising from the conduct of research with human subjects.”
Me, Pop, and Hope Through Trials
In the spring of 2004, my grandfather was diagnosed with Alzheimer’s. It was devastating news to the entire family. At that time, there was little understood about the disease and there was not a lot of hope. I remember crying in my room for what seemed like days. I’d heard horror stories and my mind zeroed in on the worst-case scenarios. I imagined the day where he would no longer recognize me, my siblings, my mother, or my grandmother. What would I do then, when I no longer recognized my Pop? What would I do when the clever and loving man with the sparkling ice blue eyes could no longer make his famous English muffin bread?
Rather than crying or worrying about the future, my grandfather decided “what will be, will be,” but at least he could make a difference while he was still able. By the fall of that year, he enrolled in his first clinical trial, which was for Rasagiline, a medication that was already approved in Canada and New Zealand. It was a double-blind study, as would be all the 5 studies he participated in over the next 10 years. Though we felt he received the medication and not the placebo, when the trial ended, he signed up for another. There was a sense of hope because of the trials and he received the best care imaginable. While I will never know for certain if it was possible trial medication or the care plan that helped, the progression of Alzheimer’s was slow in my grandfather. He lived 10 years past diagnosis and with minimal signs of decline. In the end, what was initially a terminal diagnosis was not the disease that took him from us.
Due to my grandfather’s experience, many in our family have enrolled in their own clinical trials, including my mother. I am currently working with Clara Health to find my own clinical trials for fibromyalgia and migraine. It would be wonderful if something I trial will help me fully return to the life I miss. However, even if I never find a effective treatment or a cure, in a way, I am honoring the incredible sacrifices of those who came before me and helping others both now and in the future. I may have set out to change the world through teaching public health, but through clinical trials I still get to do what I planned, just in a different way.
Through trials and tribulations,