Re: Re: Barriers to clinical trials ATTENTION CLLers!

[Guest guest]

I would like to add to the conversation. I checked on the

bill through the govtracks.us website:

http://www.govtrack.us/congress/bill.xpd?bill=h111-4732

and the bill has only made it to committee. This is what it

said:

This bill is in the first step in the legislative process.

Introduced bills and resolutions first go to committees that

deliberate, investigate, and revise them before they go to

general debate. The majority of bills and resolutions never

make it out of committee.

[Last Updated: Dec 31, 2010 1:46AM].

There were only 7 sponsors to the bill. Now with the new

Congress in session they have to reintroduce all the bills

again. This was only introduced in the House. Not sure if it

was introduced into the Senate.

I am always writing my Senators and House members about

health issues among other things. I will continue until I

can't write anymore.

I am relapsed CLL after 14 years in remission. I haven't

started chemo yet as my doc is waiting on the new Mayo trial

to start which is for the drug MK 2206. I believe it is to

start sometime this month. Thank you for this list. It is

most helpful.

Jan

On Wed, Jan 5, 2011 at 7:44 PM, Leo wrote:

> RIGHT NOW !!! There is legislation in Congress to Change procedure with

> the FDA. It is called the Compassionate Access Act designated H.R. 4732.

[Guest guest]

Jan said:

I would like to add to the conversation. I checked on the

bill through the govtracks.us website:

http://www.govtrack.us/congress/bill.xpd?bill=h111-4732

and the bill has only made it to committee.

Jan - Were the 7 sponsors Republicans or Democrats or both and how

many of them are still in the House.? Do you know? How much has the

committee changed with the new House? I guess step one is to get it

out of committee. The Senate must have a similar committee - another

place to hit.

Pat

On 1/5/11, Jan Storey <janstorey48@...> wrote:

> I would like to add to the conversation. I checked on the

> bill through the govtracks.us website:

> http://www.govtrack.us/congress/bill.xpd?bill=h111-4732

> and the bill has only made it to committee. This is what it

> said:

>

> This bill is in the first step in the legislative process.

> Introduced bills and resolutions first go to committees that

> deliberate, investigate, and revise them before they go to

> general debate. The majority of bills and resolutions never

> make it out of committee.

> [Last Updated: Dec 31, 2010 1:46AM].

>

> There were only 7 sponsors to the bill. Now with the new

> Congress in session they have to reintroduce all the bills

> again. This was only introduced in the House. Not sure if it

> was introduced into the Senate.

>

> I am always writing my Senators and House members about

> health issues among other things. I will continue until I

> can't write anymore.

>

> I am relapsed CLL after 14 years in remission. I haven't

> started chemo yet as my doc is waiting on the new Mayo trial

> to start which is for the drug MK 2206. I believe it is to

> start sometime this month. Thank you for this list. It is

> most helpful.

>

> Jan

>

> On Wed, Jan 5, 2011 at 7:44 PM, Leo wrote:

>> RIGHT NOW !!! There is legislation in Congress to Change procedure with

>> the FDA. It is called the Compassionate Access Act designated H.R. 4732.

>

[Guest guest]

Sponsor:

Rep. Diane [D-CA33]<http://www.govtrack.us/congress/person.xpd?id=400423>

Cosponsors:

Dan Burton [R-IN5] <http://www.govtrack.us/congress/person.xpd?id=400055>

Gerald Connolly [D-VA11]<http://www.govtrack.us/congress/person.xpd?id=412272>

Sam Farr [D-CA17] <http://www.govtrack.us/congress/person.xpd?id=400129>

Hall [D-NY19] <http://www.govtrack.us/congress/person.xpd?id=412222>

Latham [R-IA4] <http://www.govtrack.us/congress/person.xpd?id=400234>

Meeks [D-NY6] <http://www.govtrack.us/congress/person.xpd?id=400271>

Dana Rohrabacher [R-CA46<http://www.govtrack.us/congress/person.xpd?id=400343>

This is the summary I found on the website

The following summary was written by the Congressional Research Service, a

well-respected nonpartisan arm of the Library of Congress. GovTrack did not

write and has no control over these summaries.

3/2/2010--Introduced.

Compassionate Access Act of 2010 - Amends the Federal Food, Drug, and

Cosmetic Act to require the Secretary of Health and Human Services (HHS) to

permit an investigational drug, biological product, or device to be made

available for expanded access under a treatment investigational new drug

application or treatment investigational device exemption if specified

Compassionate Investigational Access requirements are met. Gives immunity to

the manufacturer, distributor, administrator, sponsor, or physician from

suit or liability relating to products approved under this Act. Establishes

a procedure for accelerated approval of an investigational drug, biological

product, or device that is reasonably likely to predict clinical benefit to

a patient suffering from a serious or life-threatening condition. Requires

the Secretary to establish: (1) the Accelerated Approval Advisory Committee;

(2) a new program to expand access to investigational treatments for

individuals with serious or life threatening conditions and diseases; and

(3) a demonstration project under the Medicare program to pay for drugs,

biological, products, and devices approved under this Act. Requires the

Secretary to consider the clinical judgment and risks to the patient from

the disease or condition in evaluating the safety and effectiveness of

drugs, biological products, and devices that treat serious or

life-threatening diseases or conditions, including the evaluation of

nonstatistical information.

Requires any committee evaluating investigational drugs, devices, or

biological product applications to have at least two patient representatives

as voting members.

So I wonder who the two patient representatives would be. I need to do more

research on this topic.

I think this bill has something to do with any experimental drug therapy

that has not been tested and see if it might work when all other therapies

haven't. Which I stated earlier I need to do more research on this.

Thank you Pat for your questions.

[Guest guest]

Thanks to those who have shown interest in HR 4732. In an e-mail today from

Burroughs cofounder of the Abigail Aliance the bill will be re

introduced again soon. He states that the momentum behind the bill continues to

grow.

This has been a long battle for him to have even arrived this far since his

daughter died of Cancer years ago. I feel that rather than all of us

starting something new, we are better off joining this cause where the ball is

already rolling. We are a large group, we stay around long enough to make a

difference, and we do live in a Country where we honestly can bring about

change. If it happened with the AIDS community, certainly we should be able

to do the same. It will take a determined and constant effort from our

community but I believe we can do it.

Most importantly, we can't control the fact that we have CLL, or that we

don't understand the disease yet. We can't control how much a drug company

charges or their decisions in which drug to develope, but I believe that we

as a society can control the process of how we most intelligently develop

new drugs and bring them into use. I believe that we are pretty much in

agreement that as says, " The system is broken " and I certainly agree with

that.

Leo

[Guest guest]

Thanks Jan for your research. Leo can you bring us up to speed, as

information becomes available, about how the Abigail Alliance is

approaching this. I had only heard of them recently. I agree that the

more united the front, the better our chances of getting somewhere.

Even the many wildlife groups who compete for our dollars to support

their causes have learned to join together when dealing with the

government to co sponsor lawsuits and other activities important to

them.

Pat

On 1/7/11, sacramentodds@... <sacramentodds@...> wrote:

> Thanks to those who have shown interest in HR 4732. In an e-mail today from

> Burroughs cofounder of the Abigail Aliance the bill will be re

> introduced again soon. He states that the momentum behind the bill

> continues to

> grow.

> This has been a long battle for him to have even arrived this far since his

> daughter died of Cancer years ago. I feel that rather than all of us

> starting something new, we are better off joining this cause where the ball

> is

> already rolling. We are a large group, we stay around long enough to make a

> difference, and we do live in a Country where we honestly can bring about

> change. If it happened with the AIDS community, certainly we should be able

> to do the same. It will take a determined and constant effort from our

> community but I believe we can do it.

> Most importantly, we can't control the fact that we have CLL, or that we

> don't understand the disease yet. We can't control how much a drug company

> charges or their decisions in which drug to develope, but I believe that we

> as a society can control the process of how we most intelligently develop

> new drugs and bring them into use. I believe that we are pretty much in

> agreement that as says, " The system is broken " and I certainly agree

> with

> that.

> Leo

>

>

>

[Guest guest]

Thanks so much Pat for your info on the AbigailAlliance. I

haven't heard of the group either so I am going to follow

their efforts and I check every day to see what bills have

been introduced in our Congress. As soon as the Compassion

bill is reintroduced I will let group know. I also agree the

more united we are the better the outcome.

I want to thank everyone for this group. I have learned a lot.

Jan

[Guest guest]

Jan

Actually it was Leo who suggested working through them

(sacramentodds@...). I don't remember how I heard about them or in

what context, but remember looking them up a month or more ago. He is

the one who already has a connection somehow to them.

Pat

On 1/7/11, Jan Storey <janstorey48@...> wrote:

> Thanks so much Pat for your info on the AbigailAlliance. I

> haven't heard of the group either so I am going to follow

> their efforts and I check every day to see what bills have

> been introduced in our Congress. As soon as the Compassion

> bill is reintroduced I will let group know. I also agree the

> more united we are the better the outcome.

>

> I want to thank everyone for this group. I have learned a lot.

>

> Jan

>