Must Subjects be Given Access to Experimental Interventions Even if they Do Not Work?
New York Times reports that Amgen has refused to allow subjects in a trial of an experimental drup to resume taking the drug for their Parkinson's disease after the company decided that the drug is ineffective and possibly dangerous.The company said it would not make the drug available to the four dozen patients who had participated in its clinical trials, even though the Food and Drug Administration had left the door open for it to do so. Company executives said that besides exposing the patients to unnecessary risks, to let them continue treatment would only generate false hopes. It might also ultimately hinder development of improved versions of the drug, Amgen said.- Art Caplan
contribute a comment
Comments have been closed for this post.
comments
While I can't help but be saddened that this potential Parkinson's cure turned out to be a dead end, I applaud Amgen's actions. They made their choice in the best interest of a majority of patients and evaluateed options for helping the few before ruling them unfeasible.
Basically, I feel they made the best choice in a "damned if you do, damned if you don't" situation. Withdrawing the drug at this stage of research may draw cries from patient advocates, but it keeps a potentially harmful treatment of questionable efficacy from being tried on more patients.
- by Saint Nate on Feb 15, 2005 at 12:46 PM | link
Amgen has not provided all the facts in its PR campaign to justify its decision. which may be seen as a cover-up of its own mistakes. Lack of efficacy is likely attributable to differences in dose and administration of GDNF from succesful phase 1 studies elsewhere, poor procedure to measure main endpoints, and other flaws. The majority of the investgators for the studies now believe the lesions in 1 monkey are a result of abrupt withdrawal of GDNF. Future recruitment to trials is threatened by researchers who dont heed what the patients are experiencing.
- by the voice of the patient on Feb 15, 2005 at 11:24 PM | link
There is nothing to applaud in Amgen's behavior; they are misleading the public. Data that they refuse to make public indicates that the original statistical analysis was incorrect, however, Amgen has not corrected this misperception. At the same time, the primate data demonstrates that GDNF is a highly safe treatment; the monkeys showed brain lesions because they were abrupdtly taken off GDNF - it was a withdrawl effect from a toxic dose many times higher than anything that would ever be given to a human. This company's actions were completely unethical, as was the way they treated their study participants. This was not a "damned if we do..." situation - the company had a chance to act morally and instead they hired a PR firm to improve it's image while they hide in their offices. Ask them how long their patent is on GDNF and then follow the logical conclusion as to why they will not allow anyone to have GDNF right now.
- by GDNF 4 PARKINSONS on Feb 16, 2005 at 11:54 AM | link
www.gdnf4parkinsons.org/thedocsspeak
See what the study investigators have to say about Amgen's actions.
- by GDNF 4 PARKINSONS on Feb 16, 2005 at 11:56 AM | link
Once again, I've run afoul of a patient advocacy group that values testimonial anecdotes over evidence. Not the first time I've done that.
- by Saint Nate on Feb 17, 2005 at 12:17 AM | link