Compassionate Use and Corporate Profit

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SanDiablo
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Compassionate Use and Corporate Profit

1) Should patients be allowed to waive their rights in order to receive a drug that may have questionable side effects?

2) Do companies have a "moral obligation" to provide a drug that may benefit terminally ill patients, even if development or delivery of that drug is not cost effective, thus conflicting with the companies obligations to its shareholders?

I ask these questions in response to a recent story on 60 Minutes regarding the decision of Amgen to halt clinical trials of GDNF for Parkinson's Disease. Some patients showed remarkable benefit, but the company has animal data that suggests serious side effects.

for the story, see: http://www.cbsnews.com/stories/2005/09/08/60minutes/main828098_page2.shtml

Most interesting, is that the patients in the clinical trial claim they are willing to sign a waiver promising not to hold the company liable if they could just continue receivng treatment. HOWEVER, they are suing Amgen to continue to provide the drug IN SPITE of having signed a waiver during the clinical trial acknowledging that the trial could be halted by the company for any reason.

How can Amgen (or any drug company) trust patients not to sue after signing a waiver, when they are already suing after signing a waiver???

Roshan
Roshan's picture
SanDiablo wrote:1) Should

SanDiablo wrote:

1) Should patients be allowed to waive their rights in order to receive a drug that may have questionable side effects?

2) Do companies have a "moral obligation" to provide a drug that may benefit terminally ill patients, even if development or delivery of that drug is not cost effective, thus conflicting with the companies obligations to its shareholders?

I ask these questions in response to a recent story on 60 Minutes regarding the decision of Amgen to halt clinical trials of GDNF for Parkinson's Disease. Some patients showed remarkable benefit, but the company has animal data that suggests serious side effects.

for the story, see: http://www.cbsnews.com/stories/2005/09/08/60minutes/main828098_page2.shtml

Most interesting, is that the patients in the clinical trial claim they are willing to sign a waiver promising not to hold the company liable if they could just continue receiving treatment. HOWEVER, they are suing Amgen to continue to provide the drug IN SPITE of having signed a waiver during the clinical trial acknowledging that the trial could be halted by the company for any reason.

How can Amgen (or any drug company) trust patients not to sue after signing a waiver, when they are already suing after signing a waiver???

I can put myself in a patients's place with a terminal disease, if I wish to continue living and I have money I might really want to try anything and sign any documents. I think this is done in many cancer centers on patientrs who will accept to try drugs or procedures that are not approved by FDA yet as the last resource. This was the reason for the first heart transplant and many other transplants that were done in the history of medicine. Everybody knows they failed so many times. If a terminally ill patient wants to take a chance, he/she should be given a chance of survival.