According to the investigation, the patient had suffered several small infarctions over the past years. In addition, the autopsy revealed coronary arteriosclerosis and myocardial hypertrophy existing for years.
These findings clearly prove impairment of cardiac function in this patient that had developed for many years. From MediGene's point of view, this is backing the assessment that a causal correlation between the death of the patient, which MediGene deeply regrets, and the administration of the trial medication is unlikely.
Wednesday, July 30, 2008
Another bad clinical trial?
I was reading my backlog of The Scientist and ran across this newsblog entry about the death of a healthy man during a clinical trial for RhuDex, an anti-inflammatory treatment for rheumatoid arthiritis. Although I am usually trigger happy about pointing fingers at the pharmaceutical industry for early testing and gung-ho releases, I am not sure they are to blame on this one. My comments were posted there were as follows: Only 1 person in all the trials exhibited heart problems. Though this may indicate what could occur in a larger treated population, or what could occur if healthy individuals are mistakenly treated with the drug, it is not an indictment of the drug itself. Not yet. Heart problems can go unseen for decades and strike out of the blue in otherwise healthy individuals. I agree with others that caution is needed in proceeding, but cannot condemn the drug, the company, or the testing facility without more information about the man's death (and I'm usually all for holding pharma accountable). Also, this was voluntary. To clear his debts means he signed up for the cash, voluntarily. It was still his choice to pay his bills this way. Though there is some question as to the ethics of offering money to trial volunteers, and it is an ongoing discussion in the medical community, if they're healthy and taking a drug to help determine the side effects they deserve some sort of compensation for that effort. Looking further for more recent information, it turns out that the man had an unknown history of heart disease: