Getting Drugs NOW!


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Getting Drugs NOW!

Postby boxcar9 » Thu Jun 26, 2014 12:07 pm

    Let's Play Connect the Dots: Getting Drugs that Might Work


    I may be opening Pandora's Box, but my ever-thinking brain will not stop thinking about what to do to treat this disease.

    Following is my convoluted way of identifying ways that we can TRY to get access to drugs NOW! (If I had all day, it would be a lot shorter.)


    A: Two Clinical Trials (one yet to come in 2015):

    I am assuming that the 2 clinical trials are most likely using drugs that are already FDA approved for cancer treatments (based on reading various medical and news articles from reliable sources). The trial just starting is sponsored by the Tau Consortium (CurePSP provides funding) and CBD Solutions.

    I contacted the study coordinator and they tell me there is an extensive wait list. I was also told that it involves 19 visits over 7 months (different than the 9wks listed on the clinical trial website).

    I also mentioned that I wasn't sure that mom would qualify due to 1 or 2 of the criteria. I got a response later, asking which criteria I was concerned about. Hmmmm . . . .
    Does that mean they might modify the criteria???? I really don't know anything about clinical trials, but it seems to me that if they can't get the number of participants they want, that they will modify the criteria to better fit the study. There must be SO many variables.


    B. FDA Access to Investigational Drugs


    Getting back to the assumption of the trials using drugs that are already FDA approved: IF this is the case, it seems to be reasonable (to me anyway) that I pursue these drugs as a "compassionate use" treatment option. (it sounds like getting an attorney may be useful in this case)

    here is a link to the FDA about the procedure:

    http://www.fda.gov/forconsumers/byaudie ... efault.htm

    After skimming the info, it seems pretty darn onerous. Getting a doctor who will go thru the process, getting the FDA to approve it AND then getting the manufacturer to agree to supply the drugs. FDA in recent years is probably much WORSE than the VA scandal going on.


    C. Right to Try Laws
    (another Pandora's box?)

    Cut & Pasted from 5/16/2014 Washington Post: http://www.washingtonpost.com/national/ ... story.html

    Colorado, Missouri and Louisiana are poised to become the first states in the nation to give terminally ill patients the right to try experimental drugs without the blessing of the Food and Drug Administration, setting the stage for what could be a lengthy battle over who should decide whether a drug is too risky to try.

    Proponents of the measures argue that patients desperate for treatments must navigate a lengthy, cumbersome process to get the FDA to approve early access to experimental drugs and to persuade companies to provide them. The Right to Try laws are intended to cut through some of that red tape by essentially cutting the federal government out of the picture.


    D. Off Label Use of FDA Approved Drugs


    Getting a reputable dr to go out on a limb to do this seems impossible. How many want to put their career on the line? (or their malpractice insurance premiums)


    E. Observations/Thoughts

    The downside to a clinical trial: it's 50/50 if you get the medication and IF it works, then the trial ends and so does getting the medication.

    The compassionate use/right to try method: a LOT of variables, hoops to jump through, costs, getting a drug that is ONLY "Phase I approved" could . . . . still result in death--even earlier or sudden.

    I'm sure we've all thought an earlier death of this miserable disease is preferable to prolonging the agonizing turtle race.

    EVERY time I am at my limit of frustration with this disease, I turn the tables & think of how much worse it must be for Mom and THAT is what tears my heart into shreds--that I have been selfish to think of how awful it is for me and it MUST be a million times worse for her.


    So, what do we really have to lose?


    Does anybody out there have ANY experience with applying for compassionate use? C'mon PSP Family, lets use our "6 degrees of separation", find some others who have done this, get educated, band together and take some action . . . . because hope matters!
    boxcar9
     
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    Re: Getting Drugs NOW!

    Postby dreamrn » Thu Jul 10, 2014 9:16 am

    If anything I would be looking forward to Acetylon's human clinical trials for their HDAC6 inhibitor that they say crosses the blood brain barrier sometime in 2014 or early 2015!
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    Re: Getting Drugs NOW!

    Postby dreamrn » Thu Jul 10, 2014 9:18 am

    Ps.. I had helped a woman in Florida I cared for apply for compassionate use for a drug for ALS!
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    Re: Getting Drugs NOW!

    Postby boxcar9 » Wed Jul 16, 2014 6:57 pm

    For DreamRN:

    Did the person you helped apply for compassionate use actually get the drugs?

    How long did it take?
    boxcar9
     
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    Re: Getting Drugs NOW!

    Postby TAXED » Thu Jul 24, 2014 2:30 pm

    I tried with requests and letters to get Davunetide a few years ago before it went to trial with no success.

    You point out your suffering, I applaud your bravery as few actually say this, but your honesty helps me in the loneliness of my suffering. It is something I can't or rarely mention to my kids, my in-laws, and others. But the fact is 60% of caregivers die before the care-receiver. It saddens me that there is little compassion from family, and they are more inclined to criticize then contribute. I'm now in a stage where I get up three to four times a night helping my wife go to the bathroom, I feel fatigued and tired all the time from poor sleep; then there is the isolation, emotional loss of your partner, my career put on hold (probably ended), financial drain and uncertainty, helping my family cope with this, and day to day work caring for my wife. It's exhausting! I feel like I deserve a medal, but rarely (or never from some), do I get praise for what I am giving of my life.

    This is the life of caregivers all over America that are taking care of the ones they love. Its probably been going on for thousands of years, but with today's medicine it is harder for the terminally ill and their caregivers because suffering for both is prolonged. I guess for me the only thing that keeps me going is that after this is over.... my efforts will define who I am as a person. After all, what type of care you provided when things got tough is the only thing friends, family, and you will remember going forward. So I believe this will be the reward in the second half of my life. That is enough to keep me focused and going for now!
    TAXED
     
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    Re: Getting Drugs NOW!

    Postby myownwoman » Thu Jul 24, 2014 11:27 pm

    Is there any way you can afford to get help at night? I was like you until I got help thru' the night so I could get a good night's sleep. The days I care for Phil alone is only made possible IF I'm not dead tired. And then there are all the daily tasks of life that are now your burden alone, and you need sleep for that too.

    Is there any way you can afford just a few hours of daytime care too? You can't imagine how nice it is to be able to go to the store, or out to lunch with an old friend and talk about something new. Having friends to talk to is enormously helpful. I think we all know about the 'isolation' aspect of this disease; and it's worse for Phil, no one comes to visit him at all. Chickens say they want to remember him the way he was NOT as he is now. So sad.

    Kate
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    Re: Getting Drugs NOW!

    Postby gulfcoastpsp » Sun Jul 27, 2014 12:29 am

    A simple reply...Keep it simple. NO to your thoughts. Close your mind and explore peaceful thoughts
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    Re: Getting Drugs NOW!

    Postby TAXED » Wed Jul 30, 2014 4:10 pm

    Thanks myownwomen,

    I do have some daytime care, and as we move into hospice I plan to figure out how to get some nighttime care too. I appreciate your thoughts very much, and I'm more positive now. I think I was having a bad day the day I replyed to this.
    TAXED
     
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    Re: Getting Drugs NOW!

    Postby myownwoman » Wed Jul 30, 2014 5:13 pm

    I've had some really bad days - and nights - lately with the wheelbarrow actually tipping over, so I understand the bad days one has that seem to overwhelm us.

    My SIL, who lived for years with a husband who died by inches, told me to get 1000 pieces jigsaw puzzles and work on those. Her theory is that our brain gets so intent on putting together pieces that you can't worry. Son-of-a gun, it works! I just started a new one a few days ago and I'm doing better. You might try it too.... but get ones with more pattern and not too much background.
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