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-- rayilynlee <[log in to unmask]> wrote: The People vs. Amgen Clinical trial participants rarely sue pharma companies for discontinuing an unsafe drug. Here's what happened when two such cases were brought to court..... Thanks Ray for posting the article “The People vs Amgen” from Pharmaceutical Executive. It appears the second half of the article was cut off. I'll try to repost it. Also the full text is available at: http://www.pharmexec.com/pharmexec/article/articleDetail.jsp? id=333300&pageID=1 My comments on the article: The pharmaceutical industry may consider the judge’s decision against further GDNF treatment to be a victory – but it was a defeat not only for the trial participants, but for all PWP. We have all been robbed of a potential effective and safe treatment, that might have been well into phase III trials by now. The article described the legal aspects of this case, but didn't touch on the medical and ethical issues. The Parkinson’s Pipeline Project and the GrassRoots Connection have been following the GDNF controversy since the trial halt. The following important facts were omitted from the Pharmaceutical Executive article In two Phase I trials of GDNF conducted by the University of Kentucky and Frenchay Hospital in Bristol, UK, 15 out of 15 subjects improved. Two years later improvements continued. An autopsy of one of these subjects who died of unrelated causes revealed resprouting of neurons in the area treated with GDNF, the first time evidence of such regrowth has been reported. The published Phase II results supporting Amgen’s claim of lack of efficacy have been questioned and described as ‘inconclusive “ by a number by independent scientists, as well as trial doctors. The fact that the phase II trial utilized a lower dose of GDNF and a different catheter system made it impossible to meaningfully compare the two trials. Parkinson’s researchers have recommended that another phase II/phase III trial should be conducted. Even Amgen’s own scientists had advised they continue on to a phase III trial. The FDA had approved compassionate use of GDNF for the existing trial patients – but Amgen refused to supply it. Although Amgen made numerous PR statements about safety concerns such as the presence of antibodies in some subjects and cerebellar lesions in a small number of test monkeys, they have still not released their scientific data to prove these claims. However, other researchers have published research articles showing no evidence of serious side effects among human or primate subjects treated with GDNF. The lesions in monkeys were likely due to abrupt withdrawal from extremely high doses of GDNF – much higher than the doses given to any of the human subjects. Other methods of GDNF delivery are being currently investigated, such as gene therapy or stem cells, but they are years away from clinical use. The current GDNF clinical trial participants will probably not be eligible for other trials if any become available. In effect, they have donated their brains to science, while they are still alive. The article claims that FDA regulations “mandate that the study investigators must obtain the informed consent of each human subject to whom the drug will be administered, and that they are responsible for protecting the rights, safety, and welfare of subjects under their care.” How could the trial doctors possibly protect their subjects’ well being when they had no input into the decision to halt the trial or to provide compassionate use for the participants? This decision was made unilaterally by Amgen, over the objections of a number of the trial doctors. If pharmaceutical companies treat clinical trial volunteers with little concern for their welfare, the small percentage of patients who are willing to volunteer for clinical trials will be even smaller in the future. The rights and safety of clinical trial participants need to be better protected. The Parkinson Pipeline Project is working on a Trial Participants Bill of Rights to address this issue. Linda Herman ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn