Right To Try Laws

phil · 03-16-2014, 06:30 PM

We have joined up with Abigail Alliance and Goldwater Institute to support State laws for the right of terminally ill pts who have exhausted all approved options , to get access to Phase II, III trial drugs. those who are too sick to jump the rigid trial hurdles. it allows your dr. and you to sign streamlined consent forms and petition co.'s directly. eliminates the extra fda paperwork from comp use . under comp use law they are just a rubber stamp, and unnecessary delay .
we testified in Arizona last week , and colo. check out our testimony on phoenix ch.3 , azfamily.com , search 'Lorraine mccartin ". ( and phoenix ch. 5 - our friend tracy canter , whose mom couldn't handle the 450 mi. each way ride to cali. to get t dm-1). Cut red tape, save Lives , avoid DC gridlock, equalize access for pts too far from trials. it will not undermine the current trial system -which continues to be slow, small as newer , better drugs can't get to pts. our sickest stage iv's can't wait .... Let The Debate Begin ! Bring It On !
they need pt. testimonies ( stage iv denied comp use ?, trials too far, etc. ) at the statehouse in baton rouge , la. this week. if u live fairly near, travel expenses paid. e-mail me at pmccartinjr@comcast.net . Stage IV testimony in Missouri needed soon. fla. and cali by Fall

KDR · 03-17-2014, 05:35 PM

Thank you, Phil and Lorraine, for your tireless work, friendship and game-changing persistence. We need you and thank you.

Yours always,
Karen

phil · 03-17-2014, 06:02 PM

In Colorado the main opposition was from Kaiser permanente. They sent a Dr. and a research analyst who testified that this bill could " undermine " or " circumvent " the FDA drug approval system. even though it addresses compassionate use only. Then they said that Kaiser Permanente of Colorado grants an " average of between 4-8 compassionate use requests per year " ! They say this with a straight face ! They think that's normal ! For all terminal illnesses in all of Colorado ! The comp use system is so broken !

phil · 04-01-2014, 07:00 PM

This Bill - overhauling the almost useless , so - called " compassionate use " law , is gaining momentum . It passed the Missouri House yesterday unanimously ! Colorado Hosue Committee before that . Colordans should thank the Colorado sponsors - Rep. Joshi and Rep. Ginal. and Missourians - call and thank Rep. Jim Neely.
Here is Lorraines' Testimony :
http://youtu.be/AkQOLGpXf98

and here's another resson we terminally ill pts are " mad as hell and not going to take it anymore !!
http://youtu.be/OpjOJmYA16A

Jackie07 · 04-01-2014, 08:26 PM

Thanks for the update, Phil.

The 2nd Youtube link is not working. Do you have the name of the film so we can try a search?

phil · 04-02-2014, 07:15 AM

the second one is from Goldwater also - titled " Darcy on Stossel " , Fox News ,from the Goldwater Institute. if u find it , please post . Stossel was on ABC investigatory shows , now apparently on Fox. It's funny - Goldwater cautioned me that ' we are not trying to bash the FDA " , becuase I can get very irate abut the FDA policies and technocratic / bureuacratic redtape. I don't mean to sound personal _ I personally don't " hate " any FDA official , altho thier policies almost killed my wife . it's a wierd feeling , we repaetdly have said we arre not ant- govt, anti -businesss we are pro -pt. its not pesonal, but oh so, impersonal. but anyway ... Stossel and this Goldwater staff person bash them plenty. when u see the video i, i guess you'll know why, the video tells the story of the mo. of 2 boys w/ Duchennes MD. one got the drug becuase he can still walk - the other was turned down.

phil · 04-02-2014, 07:16 AM

this Bill is getting bi-partisan support . and it should .

KDR · 04-02-2014, 11:36 AM

Phil
60 Minutes worthy? I think so. Let's chat about that this coming week. What can we do locally?
Yours, with deep respect,
Karen

phil · 04-04-2014, 07:11 AM

After the Stossel piece on Fox - a legislator in NJ approached Goldwater . about sponsoring the Bill there . I wil get u the name , hopefully your friends in Jersey wil call him , and join the Pt. Rights cause.

'lizbeth · 04-04-2014, 08:49 AM

Phil,

I have been thinking about the Right to Try efforts. I am in California. Please keep us posted on progress, both in my state and elsewhere.

phil · 04-06-2014, 07:14 PM

absolutely . its spreading fast - lots of pent - up frustration with this so - called compassionate use law. I think calif. will be in the Fall.
but it seems to be getting fdas' attention . reporters asking about it. this past Friday , the commissioner was in boston. talking about speeding up drug approvals , still empty talk , after 5 years ! and she talked about " The patient voice, the patient experience is very important to us " more empty words.
but there was word in the Globe of a " private mtg. " with bio execs to talk about giving " patients with terminal illnesses access to unproven drugs ... ' -sounds like Right To Try to me !
wouldn't it be nice if fda and Pfizer did the right thing with palbociclib this month -approve right way this month. or at least Pfizer could give truly compassionate use to the sickest while fda " analyzes data " for months.

IrvineFriend · 04-07-2014, 03:52 PM

I sent you a PM because I don't really want to get into a debate on a public forum. I do work in the drug/device industry in Quality/Regulatory so I know something of the subject and I can see the other side. I'm considered the "internal FDA" and I consider patient safety in every decision I have to make on a daily basis.

phil · 04-08-2014, 08:25 AM

here is lorraines' arizona news story. have u seen the CNN story from Sunday on " terminally " ill pts fighting for access to life-saving drugs ? this issue is HOT ! just like the aids activists before us we are Speaking Up !

http://www.azfamily.com/news/health/...250000901.html

phil · 04-08-2014, 08:30 AM

and here's our friend Tracys' story. how she couldn't get access to T DM-1 for her mom in Arizona in 2010 , so she tried to drive her mom to Calif. , 450 miles each way , her mom sleeping in the back seat . her mom couldn't handle it after about 3 trips . had to stop- and died.
http://www.abc15.com/news/state/ariz...rimental-drugs

phil · 04-08-2014, 08:32 AM

here is the CNN story :

http://www.wcvb.com/health/Dying-pat...?absolute=true

phil · 04-08-2014, 08:44 AM

That FDA official, richard klein , mentioned in the CNN story is way out of touch with reality . It's true, his agency granted 900 out of 904 comp use requests in 2012 , but that is a patheticaly low no. in a country of 360 million. and it sounds like the rubber stamp, redtape delays that we talk about eliminating with right to try. and his un-predictable, punitive fda since 2009 only makes co.'s more paranoid. and we stage iv pay the price with our lives. not that co's are blameless- $ is always a factor in their decisioon making. $ means co.'s will only make so much of a drug , even as phase I and often phase II data suggest efficacy - 38 % of pts in phase II trials of t dm-1 in early 2010 showed a" complete or significant " clinical response. yet fda rejected early appr. now comes palbociclib , with even better stats - still taking yrs to appr., still not appr. , its coming soon - but is Pfizer making enough ?

'lizbeth · 04-08-2014, 12:13 PM

Julie,

Can you send me a copy of the PM you sent to Phil? I'd like to understand the issue more from your point of view.

I simply can't comprehend that our system just allows people to die. With all the money being raised for research, can't we find a way to support Right to Try. I truly believe everyone has the right to shoot for a miracle instead of being forced to die. Changing legislation is one approach, but creating a non profit support system for both the companies and patients who want the right to try.

We need to do more for those with advanced cancers. Perhaps a little brainstorming?