Broken Promise or Ethical Decision - Essay Example

After a series of animal trials and pre-clinical trials, Phase-I trials began in 2001-2002 in the UK and at the University of Kentucky.

These trials showed significant improvement for the participants and researchers at Bristol UK remarked, "Within a couple of months, patients were noticing dramatic improvements in their ability to move". Similar results were reported from the Kentucky trials, which noted, ".there appeared to be bilateral improvements, including improved postural stability [.] evidence of improved effect and fine motor control and speed". GDNF appeared to be a promising breakthrough. Based on the previous favorable results, Amgen initiated Phase-II trials involving 34 patients in 2003.

However, by 2004 GDNF had been shown to cause brain lesions in primate tests and Amgen immediately halted the testing. It was noted by researchers that the primates had been given a dose 10 times that of the human participants and there was overwhelming evidence that the lesions were caused by the sudden withdrawal of GDNF. Amgen also cited inefficacy in the Phase-II trial though the researchers involved have disputed this claim. Amgen claimed any improvements were due to the placebo effect, but neurologists at the University of Kentucky trials claimed the effect was too profound to be attributed to that alone.

Participants in the study had shown marked improvement but were suddenly left with no treatment and facing a future of a return to incurable Parkinson's disease. This story brings into question the ethical issue of a drug's promise for improving a patient's quality of life and the risk that may be involved. Whose decision should it be Should a well-informed patient, given an accurate assessment of the risks, be given the opportunity to continue treatment As one patient noted, he did not consider brain lesions a realistic risk since he already had brain damage from Parkinson's.

Most of the participants involved showed similar improvement and stated a similar sentiment. Yet, in the wake of the Vioxx controversy drug companies may be overcautious when assessing the risks involved. The British Medical Journal The Lancet Neurology stated that "Amgen should be praised for taking a prudent decision, in so far as it is rooted in scientific evidence and ethical reasoning", but recommended continued testing. Other critics agreed and expressed the same opinion as Robin Elliott, Director of the Parkinson's Disease Foundation, who called the decision, "a mistake because it denies the patients and their doctors the opportunity to continue with a potentially useful, albeit yet unproven, treatment".