Tuesday marked a first for me. A few months ago my wife told me about a medical research study being conducted for Merck. The purpose of the study was to obtain additional safety data on the study vaccine, Zostavax, in people 60 or older. Zostavax has been approved by the FDA in the United States and by regulatory agencies in Australia for the prevention of shingles in people 60 years of age and older; it has also been approved in the European Union for people who are 50 years and older.
My wife had gotten her information from her boss who told her about the study just after he had been accepted as a participant in the study, which had been brought to his attention by his daughter who is a nurse. With a variation of the six degrees of Kevin Bacon clearly in play, I heeded the tactless bludgeoning of fate and called the study coordinator to offer myself to science as one of the sought after senior volunteers; and, since I had had chicken pox as a kid I am more vulnerable to an outbreak of shingles as I age. I scheduled an appointment for the earliest available time slot remaining in the study, which still left me with nearly a two month waiting period.
After a brief but quite pleasant interview, an LPN popped in to administer an injection: since this is a blind study I don’t know if I received a placebo or the Zostavax; however, when the study is completed I will have the option to be vaccinated with Zostavax at no cost, if I had been given a placebo during the study. The doctor in charge of the study reviewed the legal stipulations contained in the medical release forms as well as any current medical conditions or medications that might disqualify me from participating in the study. Caveats and warnings written in typical legalese were sprinkled copiously throughout the release forms. When I chuckled about the foreboding nature of the disclaimers, I was quickly assured that my signature on the release forms in no way abrogated any of my legal rights to leave the study at any time nor did it limit my rights to pursue any legal action at any time in connection with the study. It was also stressed by my interviewer that I should contact him any time I had a question. I couldn’t resist inquiring about how and where the data obtained in the study was stored. I knew some database somewhere was cataloging the particulars we guinea pigs were contributing. I was assured that only a code number and not my name was related to the data in the database which of course is maintained by Merck. While that may be true at some level, the reality is that I am connected to my data and it would be foolish to assume otherwise–the connecting trail of data is only superficially suppressed. Of course the larger issue is the potential for data to fall into the hands of insurance companies, or others who might base health care or other related decisions on such sensitive information. I was told that the study was monitored by an independent panel of ethicists and only that panel, the FDA, and Merck could possibly have access to the data obtained from the study. As a philosophy major, I know that a panel of ethicists may guarantee vigorous debate if the members of the panel operate from a number of diverse philosophical perspectives; however, the mere presence of that panel doesn’t necessarily underwrite or obviate the decisions Merck might make in what it may consider to be in its best interest, which is most often defined in discrete monetary units.
The evaluation of my medical condition and medications was the least complex aspect of the interview. Aside from the occasional 10 mg tablet of Loratadine ( a generic Claritin substitute) in the late spring and early summer, especially when mowing the lawn, and an 81 mg tablet of aspirin, and the cocktail of vitamins, which have been a part of my daily regime for more than thirty years, I take no prescription drugs. The only medical event I’ve endured in the last five years or so was an episode involving the bane of the south, a kidney stone, noted by a female friend of mine as the nearest approximation of childbirth that a male can experience. If the day long torture of my passing a kidney stone is any indication of what women endure in childbirth, I can only ponder why they are not all celibate!
The timing of my entry into the study was fortuitous as Merck was nearing its target enrollment and would probably reach that goal by the end of the week that I was vaccinated. For my part, I am asked to participate in three follow up telephone interviews over the next six months. Of course, if I were one of the control group that was injected with a placebo, I will have the option to be vaccinated with Zostavax at no charge. Aside from receiving Zostavax, the only other compensation I received was a $25 check presented to me following the interview/vaccination to cover expenses relating to my participation in the study, which is adequate as “gas money”, for 2003!
