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| This picture is not a link because there seems to be uncertainty regarding which DVD by which company is better or best? Here is an article about the making of Pride of the Yankees. |
The FDA is delaying approval for a potentially life-saving treatment. Some activists are quite familiar with this story. Many of us feel that the FDA is simply lined up with Big Pharma. We are not surprised.
Others might ask how or why Big Pharma would benefit from FDA's delay.
ALS is terminal, painful and causes the person with ALS ("PALS") to suffer greatly. The only end to that suffering is a horrible death by asphyxiation.
The FDA would, could and might be able to approve ---- eventually? --- a drug called Genervon GM604, which might turn out to be effective in reversing or slowing ALS.
Two years ago, the FDA held a public hearing regarding ALS. The following excerpt from the petition itself will explain more about this meeting, and why everyone must and should sign the petition asking or insisting on much faster action from the FDA on drug trials, especially for those who are in pain and have a terminal illness.
On 23 February 2013, The FDA held its first public hearing to address the urgency and disparities faced by the ALS Community. The meeting was standing room only and was also attended by the ALS Association (ALSA) and the Muscular Dystrophy Association (MDA). Following the meeting, these two advocacy organizations sent a joint statement detailing action items that were expected to change the design of future clinical trials and make treatments more readily available to people with ALS (PALS). http://mda.org/alsn/mda-and-alsa-urge-fda-take-action-groundbreaking-als-hearing.
It has been over two years since that joint statement was offered to the FDA and still the ALS Community finds there has been absolutely no change with regards to preclinical development or clinical trial design. Neither has the consideration of benefit-risk assessment been implemented in getting new treatments to patients suffering a horrible death.
Additionally, it is hard to ignore that the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) is quite clear in its intent and that FDA is strongly encouraged by Congress to grant Accelerated Approval (AA) to treatments that benefit all serious and life threatening diseases. We see that the FDA has done very little to [move] itself further in this regard. As Congress is crafting the 21st Century Cures Act, you now have an opportunity to show them that you are on board. GM604 is a perfect fit for the AA Program.
Please approve Genervon’s GM604 so all PALS can have access to this promising new treatment and hope for a future.
A few weeks ago, I wrote a little bit about the Works of Mercy on one of my other blogs.
I think that anyone who knows about the suffering of an ALS patient (PALS) is obligated to do whatever possible to alleviate that suffering, no matter what ideology or religion we are.
We are all human beings, and we have an innate desire to alleviate suffering of our fellow humans whenever possible. Please note the words "whenever possible." Sometimes it is not possible, so this is a rare opportunity.
That might be why the story of The Good Samaritan is so popular?
Links to Petitions about ALS and Genervon GM604
Here is a link to the petition.
Here is a petition regarding the same FDA trial, on the White House petition site, We the People.
Here is the Facebook page for Rally in DC, May 11, 2015.
Link to More Information
This article is a blog post for one PALS who has been able to gain "Compassionate Use" status for Genervon GM.
(The article contains other links also. Just keep following links. You will get lots more information.)
