clinical trials

[Guest guest]

Hi,

I agree with your comments. Thanks for writing.

Worth noting that the cooperative groups (SWOG, CALGB), funded by NCI, also

design studies - many times testing new uses of the approved agents - with the

goal of improving survival and quality of life.

And then there is the very low participating rate with both patient and

physician determinants. What is the incentive to refer a patient to a clinical

trial, assuming the oncologist knows what trials are appropriate and the patient

is eligible and willing ...

Best wishes,

Karl

>

> I don’t pretend to have any definitive answers as to how best improve the

process of testing new therapies in people with medical issues while

simultaneously insuring that the studies are reasonable, that safety issues are

not overlooked and that patients are not “shut out†from trying potentially

beneficial therapies because of multiple bureaucratic and cost issues. There

are, however, issues that must be carefully understood.

>

> Dr. Furman has correctly pointed out that pharmaceutical companies will always

watch their bottom line. It is axiomatic that under the current ground rules no

studies will be undertaken unless the potential economic gains exceed the

probable developmental costs. This behavior, while logical on the part of the

industry creates several dynamics which do not necessarily serve patients well.

> There is no incentive for pharmaceutical companies to compare new drugs

“head to head†with well established drugs because of the risk of an adverse

economic event. By the same token, pharmaceutical companies and medical device

companies have every incentive to gain approval for their products utilizing the

least costly and most expedient means possible. The potential risks of seeking

approval of therapy with the least amount of data necessary may not be apparent

to most lay people, but I must say that I have already observed several

“breakthrough†therapies that had to be terminated or markedly restricted in

their use because of unanticipated adverse effects which occurred when their use

was expanded to the entire population afflicted with the targeted problem.

>

> Simply put, a therapy which works reasonably well with reasonable safety in a

carefully selected and carefully monitored group of patients may have

unanticipated problems of efficacy or safety in larger, less carefully selected

and monitored groups...even to the point of causing severe and undesirable

problems for people,conceivably creating scenarios that may be worse than the

status prior to the treatment.

>

> For the time being the most reasonable goals to work towards are to utilize

(if possible) whatever government control(s) of health care that will evolve

from the pending legislation to try to “centralize†the process of

conducting reasonable, safe and logical studies of new therapies and

simultaneously to broaden the horizons both of research and availability by

altering the economic dynamics involved. If we are going to pay for things...let

us all benefit!

>

> I am not in a position to speculate as to what the best means of organizing

effective research may be, but I often wonder what we might learn if, in dealing

with diseases such as heretofore incurable malignancies, combinations of drugs

were tried at an earlier stage of disease (in “healthier†subjects). Such

therapies, if potentially helpful, should be more readily available to those

patients whose course is further advanced. Such an approach, of course, would

not necessarily be wise when studying the treatment of other less life

threatening medical conditions where safety concerns and costs may be more

appropriate to consider.Under the current “rules of engagement†these

approaches will never be tried.

>

[Guest guest]

Two quick comments to respond to in that email.

1) The incentive for physicians and patients to be referred to clinical trials

is to enable patients to get access to the best treatment options available. We

have patients here who were receiving lenalidomide more than five years ago.

2) The cooperative groups do not have any great focus on novel agents. They are

really geared more towards changing standards of care through those trials that

are clincally important, but large and cumbersome, and that would otherwise not

get done. CALGB is not looking at CAL-101, but studying FCR vs. FR and

maintenance lenalidomide, etc.

Rick Furman, MD

> >

> > I don’t pretend to have any definitive answers as to how best improve the

process of testing new therapies in people with medical issues while

simultaneously insuring that the studies are reasonable, that safety issues are

not overlooked and that patients are not “shut out†from trying potentially

beneficial therapies because of multiple bureaucratic and cost issues. There

are, however, issues that must be carefully understood.

> >

> > Dr. Furman has correctly pointed out that pharmaceutical companies will

always watch their bottom line. It is axiomatic that under the current ground

rules no studies will be undertaken unless the potential economic gains exceed

the probable developmental costs. This behavior, while logical on the part of

the industry creates several dynamics which do not necessarily serve patients

well.

>

> > There is no incentive for pharmaceutical companies to compare new drugs

“head to head†with well established drugs because of the risk of an adverse

economic event. By the same token, pharmaceutical companies and medical device

companies have every incentive to gain approval for their products utilizing the

least costly and most expedient means possible. The potential risks of seeking

approval of therapy with the least amount of data necessary may not be apparent

to most lay people, but I must say that I have already observed several

“breakthrough†therapies that had to be terminated or markedly restricted in

their use because of unanticipated adverse effects which occurred when their use

was expanded to the entire population afflicted with the targeted problem.

> >

> > Simply put, a therapy which works reasonably well with reasonable safety in

a carefully selected and carefully monitored group of patients may have

unanticipated problems of efficacy or safety in larger, less carefully selected

and monitored groups...even to the point of causing severe and undesirable

problems for people,conceivably creating scenarios that may be worse than the

status prior to the treatment.

> >

> > For the time being the most reasonable goals to work towards are to utilize

(if possible) whatever government control(s) of health care that will evolve

from the pending legislation to try to “centralize†the process of

conducting reasonable, safe and logical studies of new therapies and

simultaneously to broaden the horizons both of research and availability by

altering the economic dynamics involved. If we are going to pay for things...let

us all benefit!

> >

> > I am not in a position to speculate as to what the best means of organizing

effective research may be, but I often wonder what we might learn if, in dealing

with diseases such as heretofore incurable malignancies, combinations of drugs

were tried at an earlier stage of disease (in “healthier†subjects). Such

therapies, if potentially helpful, should be more readily available to those

patients whose course is further advanced. Such an approach, of course, would

not necessarily be wise when studying the treatment of other less life

threatening medical conditions where safety concerns and costs may be more

appropriate to consider.Under the current “rules of engagement†these

approaches will never be tried.

> >

>

[Guest guest]

Thank you for commenting.

re 1) I think this can be true in many of the major centers. Thankfully. Our

survey is beginning to verify a common perception that treating physicians - in

the commmunity setting - do not have the time, resources, or ability to identify

clinical trials appropriate to their patients circumstances. I don't think of

it as a problem with ethics (in most cases), but of systems. The community

doctor doesn't have the tools ... however, I think incentives might be provided

to modify such practices - such as recognition of doctors in the community

setting who do so - and perhaps financial help in the form of tax relief, or

financial awards from Pharma? based on the number of patients referred to

studies. (That said, part of me thinks it just doesn't seem right be complacent

about administering standard practice when it's not yet curative.)

2) re ative groups ... maybe this points to the need for informed patient

advocates to have real input in determining the important clinical questions?

Best regards,

Karl

> > >

> > > I don’t pretend to have any definitive answers as to how best improve

the process of testing new therapies in people with medical issues while

simultaneously insuring that the studies are reasonable, that safety issues are

not overlooked and that patients are not “shut out†from trying potentially

beneficial therapies because of multiple bureaucratic and cost issues. There

are, however, issues that must be carefully understood.

> > >

> > > Dr. Furman has correctly pointed out that pharmaceutical companies will

always watch their bottom line. It is axiomatic that under the current ground

rules no studies will be undertaken unless the potential economic gains exceed

the probable developmental costs. This behavior, while logical on the part of

the industry creates several dynamics which do not necessarily serve patients

well.

> >

> > > There is no incentive for pharmaceutical companies to compare new drugs

“head to head†with well established drugs because of the risk of an adverse

economic event. By the same token, pharmaceutical companies and medical device

companies have every incentive to gain approval for their products utilizing the

least costly and most expedient means possible. The potential risks of seeking

approval of therapy with the least amount of data necessary may not be apparent

to most lay people, but I must say that I have already observed several

“breakthrough†therapies that had to be terminated or markedly restricted in

their use because of unanticipated adverse effects which occurred when their use

was expanded to the entire population afflicted with the targeted problem.

> > >

> > > Simply put, a therapy which works reasonably well with reasonable safety

in a carefully selected and carefully monitored group of patients may have

unanticipated problems of efficacy or safety in larger, less carefully selected

and monitored groups...even to the point of causing severe and undesirable

problems for people,conceivably creating scenarios that may be worse than the

status prior to the treatment.

> > >

> > > For the time being the most reasonable goals to work towards are to

utilize (if possible) whatever government control(s) of health care that will

evolve from the pending legislation to try to “centralize†the process of

conducting reasonable, safe and logical studies of new therapies and

simultaneously to broaden the horizons both of research and availability by

altering the economic dynamics involved. If we are going to pay for things...let

us all benefit!

> > >

> > > I am not in a position to speculate as to what the best means of

organizing effective research may be, but I often wonder what we might learn if,

in dealing with diseases such as heretofore incurable malignancies, combinations

of drugs were tried at an earlier stage of disease (in “healthierâ€

subjects). Such therapies, if potentially helpful, should be more readily

available to those patients whose course is further advanced. Such an approach,

of course, would not necessarily be wise when studying the treatment of other

less life threatening medical conditions where safety concerns and costs may be

more appropriate to consider.Under the current “rules of engagement†these

approaches will never be tried.

> > >

> >

>

[Guest guest]

Hello my cll friends,

I appreciate the conversation concerning clinical trials and there is a better way to do it. In my case I have been diagnosed at 47 with un mutated CLL. Statistically i have accepted that there's a good chance that i will die from my cll. By doing the research and learning all i can, i will fight CLL for a long time.

What bothers me is that eventually, there just won't be much left that anyone can do for me due to FDA policy.

If/ when I get to that point where it is fairly obvious that I'll be passing on, where it my choice, i would try a last ditch effort to save myself with early research. In my case, hypothetically speaking, I would choose to try the ROR1 antibody that UCSD (assuming UCSD had an antibody) even though it hadn't gone through every step.

Even though I would probably die, at least I have the opportunity to donate myself to science and allow for a last ditch try to save my life at the same time. Why does the FDA have control over my health when there is no health to control?

it is plain and simple and there is no doubt other countries will implement similar options thus giving them the edge in getting new technology into patients quicker in coming decades.

If any of you wonder how we can do it............... Check out the web site

Givepatientsafightingchance.com

Go to the proposed legislation page and you will get an idea of how we can appropriately allow patients to truly fight for a cure when no other option exists. sorry for the typos. i'll get those fixed shortly.

Simply put, we can put another type of drug trial system that would be more flexible, controlled somewhat, yet still lead to better informed clinical trials like those we have now.

thanks for the great dialogue.

Leo

[Guest guest]

Karl,I think it's patients whom the drug companies should remunerate. It avoids conflict of interest or any concerns, warranted or otherwise, that a doc might refer for the money. Since many new and experimental drugs are not covered by insurance, this might result in patients like us putting more pressure on the FDR to change their policy. -Ellen On Jan 7, 2010, at 9:48 AM, karlamonyc wrote:

Thank you for commenting.

re 1) I think this can be true in many of the major centers. Thankfully. Our survey is beginning to verify a common perception that treating physicians - in the commmunity setting - do not have the time, resources, or ability to identify clinical trials appropriate to their patients circumstances. I don't think of it as a problem with ethics (in most cases), but of systems. The community doctor doesn't have the tools ... however, I think incentives might be provided to modify such practices - such as recognition of doctors in the community setting who do so - and perhaps financial help in the form of tax relief, or financial awards from Pharma? based on the number of patients referred to studies. (That said, part of me thinks it just doesn't seem right be complacent about administering standard practice when it's not yet curative.)

2) re ative groups ... maybe this points to the need for informed patient advocates to have real input in determining the important clinical questions?

Best regards,

Karl

[Guest guest]

I second your idea, Ellen.

Karni

-------------------------------

I think it's patients whom the drug companies should

remunerate. It avoids conflict of interest or any concerns, warranted or

otherwise, that a doc might refer for the money. Since many new and

experimental drugs are not covered by insurance, this might result in patients

like us putting more pressure on the FDR to change their policy.

-Ellen

[Guest guest]

My comment is that you still need to learn how to best use an approved drug -

alone and in combination or sequence with other therapies. But also in what

clinical circumstance.

.... That it is active is not enough, particularly if it has side effects (as you

correctly note, they all do - but such effects are not all equivalent)

This is one reason that accelerated approvals (reasonable evidence of meeting

unmet needs) are conditional, and that comparative studies are so important ..

because randomized studies eliminate many sources of bias and provides a

reference point for understanding both the activity and the side effects.

I think what was saying, which I agree with, is that there's no incentive

for the company to figure out best use, particularly when good income is already

being generated from the approved drug!

It's an illusion to think that market forces is all that's needed to make

progress against disease. Just one example: companies can " sit " on promising

ideas because of competing interest with already financially successful

products.

Rituxan is a case in point. Used for CLL as a single agent despite lack of

evidence that this is really providing much clinical benefit ... or if it's a

better choice than something else? And certainly the study leading to the

approval of Ofatumumab did not tell us much about how to best use it.

Regarding FDA, its job is to review trials, rigorously and objectively to

protect the public interest. Take that away and anywone could sell anything and

say anything based on theory and opinion. Medicine by sales pitch and opinion.

God help us if it didn't exist.

As you may not know, FDA does not conduct trials, and if a sponsor does not

submit the study data to FDA for marketing review it won't be evaluated by the

agency.

However, FDA will provide guidance about study design and can prevent studies

that it judges to be unethical ... puts patients at undo risk.

Because of user fees, the turnaround for review of study data by FDA is quite

fast - and highly regarded worldwide for its efficiency.

Delays in review of studies (to progress) is mostly a result of the time to

enroll patients but also for the data in some studies to mature ... such as to

adequately measure time to progression, which can take years.

Please read " The Critical Path " document, published on the FDA website for

details about how drugs are developed and reviewed.

Sadly only 1 in 5 clinical studies are ever published, and the majority are not

published because of a failure to accrue patients.

http://theoncologist.alphamedpress.org/cgi/content/full/13/9/923

So it's evident to me that enrolling patients in trials is the key rate limiting

obstacle to progress, not FDA.

Karl

>

> A couple of thoughts on this:

>

> There is an incentive for drug companies to research and market drugs for rare

cancers such as CLL. There is a program for 'orphan' drugs that provides extra

incentives to pharmaceuticals to produce such drugs.

>

> And the market need not be small for a CLL drug. For example, rituximab, a

drug used extensively in CLL and NHL is a $5 billion a year drug. This means

this drug is a big, big success. Other drugs targeting CD20 afflictions are

hoping to tap into this market.

>

> As far as " try[ing] to centralize the process of conducting reasonable, safe

and logical studies of new therapies... " , are you saying this doesn't already

exist? But, it does. That why the FDA exists. It is quite safe. However, all

cancer drug trials pose risks.

>

> And the FDA is about as bureaucratic and 'centralized' as you can get. The

last thing we need is more bureaucracy! The drug approval process is slow

enough as it is.

>

> ***********************************

>

> Clinical trials

>

> Posted by: " Zelnick "

> e.zelnick@...

>  

>

> e.zelnick

>

>

>

> Wed Jan 6, 2010 9:33 am (PST)

>

>

>

>

>

> I don’t pretend to have any definitive answers as to how best

improve the process of testing new therapies in people with medical issues while

simultaneously insuring that the studies are reasonable, that safety issues are

not overlooked and that patients are not  " shut out� from trying

potentially beneficial therapies because of multiple bureaucratic and cost

issues. There are, however, issues that must be carefully understood.

>

> Dr. Furman has correctly pointed out that pharmaceutical companies will always

watch their bottom line. It is axiomatic that under the current ground rules no

studies will be undertaken unless the potential economic gains exceed the

probable developmental costs. This behavior, while logical on the part of the

industry creates several dynamics which do not necessarily serve patients well.

>

> There is no incentive for pharmaceutical companies to compare new drugs head

to head with well established drugs because of the risk of an adverse economic

event. By the same token, pharmaceutical companies and medical device companies

have every incentive to gain approval for their products utilizing the least

costly and most expedient means possible. The potential risks of seeking

approval of therapy with the least amount of data necessary may not be apparent

to most lay people, but I must say that I have already observed several

breakthrough therapies that had to be terminated or markedly restricted in their

use because of unanticipated adverse effects which occurred when their use was

expanded to the entire population afflicted with the targeted problem.

>

> Simply put, a therapy which works reasonably well with reasonable safety in a

carefully selected and carefully monitored group of patients may have

unanticipated problems of efficacy or safety in larger, less carefully selected

and monitored groups...even to the point of causing severe and undesirable

problems for people,conceivably creating scenarios that may be worse than the

status prior to the treatment.

>

> For the time being the most reasonable goals to work towards are to utilize

(if possible) whatever government control(s) of health care that will evolve

from the pending legislation to try to centralize the process of conducting

reasonable, safe and logical studies of new therapies and simultaneously to

broaden the horizons both of research and availability by altering the economic

dynamics involved. If we are going to pay for things...let us all benefit!

>

> I am not in a position to speculate as to what the best means of organizing

effective research may be, but I often wonder what we might learn if, in dealing

with diseases such as heretofore incurable malignancies, combinations of drugs

were tried at an earlier stage of disease (in  " healthier�

subjects). Such therapies, if potentially helpful, should be more readily

available to those patients whose course is further advanced. Such an approach,

of course, would not necessarily be wise when studying the treatment of other

less life threatening medical conditions where safety concerns and costs may be

more appropriate to consider.Under the current rules of engagement these

approaches will never be tried.

>

[Guest guest]

I admit, Karl, I'm not finding these lengthy discussions and diatribes about the motivations, incentives, etc. of large-and-powerful corporations that have us and our doctors by the b---s very productive. The satisfaction those insights provides may last a moment or two but it's not what's going to get them to let go.Nor do these insights result in better-fitting solutions to the problems. What's always produced results in my lifetime is a concerted unified, large, persistent movement stating what we want and what must change. Knowing why they do what they do just doesn't enter into that. We should have an understanding of the major obstacles standing between patients and the drugs and trials we need. Just the facts would be helpful—things like the FDA taking too long to approve drugs vital to our health. Here's a quote expanding on that, focussing on the facts:"New cancer drugs took about seven years to get approved, whether they were part of the accelerated process or not, researchers found. Nineteen new cancer drugs have gotten accelerated approval since 1995, along with 32 given regular approval, the study says."Here's an obstacle Dr. Furman raised recently: The FDA won't approve a cancer drug if another one already exists that successfully addresses that same problem. Ex: If there's already an FDA-approved drug that blocks nourishment from getting to cancer cell XYZ-123, if a new drug claims to do exactly that but without causing nausea or muscle pains in the patient, chances are it won't be allowed to go to a trial that compares its overall performance to the drug already in use—so we won't know if there's a drug that performs just as well or better and with fewer lousy side effects.Some other obstacles: The criteria for entering into trials is often too restrictive. Many of us have misguided fears that clinical trials will offer inferior help.There's a "Mission Day" in Albany on February 1st sponsored by the Leukemia & Lymphoma Society, patients and other advocates to meet with legislators to discuss their experiences with clinical trials and why they feel it's important to grant greater access to them.Every New Yorker concerned with leukemia or lymphoma should at least call LLS to find out more about it. "If you have any questions regarding the posted materials or the Mission Day event itself, please contact Kim at kim.hughes@... or 937.667.1940.

[Guest guest]

Thanks for your input, Ellen. I think it's important to identify the truer

obstacles to progress so that patient advoacacy is not misdirected. So I feel

that such discussion is time well spent. Unfortunately, these are not

discussions that can be covered sufficiently in a few paragraphs.

What takes 7 or 10 years is not the FDA review process, but the entire

development, testing and review. As already noted, the FDA review of the data

is completed in months.

See for details, the Critical Path whitepaper

http://www.c-path.org/pdf/FDAcriticalpathinitiativeinfluenceonnewdrugdevelopment\

WoodcockWoosley.pdf

(There is no controversy about this aspect of the discusion in research

community.)

That patients and investigators are frustrated by the time it takes to test and

develop new drugs is understandable, truly ... but the alternative is medicine

by opinion, which would be very dangerous to patients.

As I said, I am willing to help present new ideas (study designs etc) to FDA

which may make the process faster - assuming I understand it and feel the study

design could provide reliable information about risks and benefits. BTW I have

found the agency particularly receptive to patient input.

You may not know that FDA policy is determined by Congressional laws?

.... The industry has tremendous lobbying power and if the agency's methods and

standards were unfair to the industry or - more importantly - harmful to

patient, they would be able to influence Congress to change current laws.

Regarding rigid eligibility to enter a trial, I agree this can be a problem ...

that it amounts to a kind of selection bias, selecting for patients that are not

equivalent to the general population.

-- I don't think such entry criteria is determined by FDA (although they will

review it), but by the sponsors as advised by investigators ... the objective is

to minimize adverse events (which would put the application at risk) which would

be more common in a population with secondary medical conditions or poor

performance, etc.

Maybe we can use new methods to win faster full (non-conditional) approvals. So

I look forward to reviewing such ideas and would be happy to present them if

asked, or even if not.

I hope this helps.

All the best,

Karl

>

> I admit, Karl, I'm not finding these lengthy discussions and diatribes about

the motivations, incentives, etc. of large-and-powerful corporations that have

us and our doctors by the b---s very productive. The satisfaction those

insights provides may last a moment or two but it's not what's going to get them

to let go.

>

> Nor do these insights result in better-fitting solutions to the problems.

What's always produced results in my lifetime is a concerted unified, large,

persistent movement stating what we want and what must change. Knowing why they

do what they do just doesn't enter into that.

>

> We should have an understanding of the major obstacles standing between

patients and the drugs and trials we need. Just the facts would be

helpful—things like the FDA taking too long to approve drugs vital to our

health. Here's a quote expanding on that, focussing on the facts:

>

> " New cancer drugs took about seven years to get approved, whether they were

part of the accelerated process or not, researchers found. Nineteen new cancer

drugs have gotten accelerated approval since 1995, along with 32 given regular

approval, the study says. "

>

> Here's an obstacle Dr. Furman raised recently: The FDA won't approve a cancer

drug if another one already exists that successfully addresses that same

problem.

> Ex: If there's already an FDA-approved drug that blocks nourishment from

getting to cancer cell XYZ-123, if a new drug claims to do exactly that but

without causing nausea or muscle pains in the patient, chances are it won't be

allowed to go to a trial that compares its overall performance to the drug

already in use—so we won't know if there's a drug that performs just as well or

better and with fewer lousy side effects.

>

> Some other obstacles: The criteria for entering into trials is often too

restrictive.

> Many of us have misguided fears that clinical trials will offer

inferior help.

>

> There's a " Mission Day " in Albany on February 1st sponsored by the Leukemia &

Lymphoma Society, patients and other advocates to meet with legislators to

discuss their experiences with clinical trials and why they feel it's important

to grant greater access to them.

>

> Every New Yorker concerned with leukemia or lymphoma should at least call LLS

to find out more about it. " If you have any questions regarding the posted

materials or the Mission Day event itself, please contact Kim at

kim.hughes@... or 937.667.1940.

>

[Guest guest]

DonI will not, of course, get my blood work results right away. I am going to ask if they can officially tell me that I cleared, when the blood work does come back. Of course, that means that they would have to be doing a PCR. So, hopefully, when I go over again for the CAT, I can get a copy of the results of the blood work then.You know for sure that I will be hitting the sky big time, if it has worked!! I'll be wanting to tell everyone. Oops, I'd better get a little closer to the ground, because if I am an NR again - gawd knows how I'll react.Gloria

Hi Gloria

Please let us all know what your labs say.

We 'really' want to know this trial results for you.

Hi

If I were offered a chance to partake in a trial, I would not hesitate for a second in saying yes.

Trials are so important.

You may get the chance to clear, and everybody else would be that much closer too from the resulting info.

My 2 cents. lol

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Re: Hepatitis C Infection Blocked By Natural Compound (Quercetin) Date: Thursday, January 14, 2010, 8:56 PM

I'm currently just finished a trial!! No, it is not massive dosages, although it's very dependent on the person themselves. Some can do it fairly easily and probably only suffer from the fatigue. Then there's others that simply can not tolerate the treatment at all.I was a Non-Responder the first time around, on the common treatment. Unfortunately, at that time, the only thing to do was hope for something new. Even thought that the Hep C nurses had totally dropped me!! I do vaguely remember the one that asked me if I'd consider a Trial. Well, I said - who knows until it's offered. When I got the call last January, I was actually only given about 4 hours to decide!!When ever I get the results of the blood work I have to do tomorrow - I'll probably want to kiss that nurse for remembering me, even if I only had 4 hours to consider giving up another year to

treatment.Gloria

i've volunteered for trial but don't know if i'll get called( i wonder if it's massive dosage, i.v., etc. )gary

Canada Toolbar : Search from anywhere on the web and bookmark your favourite sites. Download it now!

Canada Toolbar : Search from anywhere on the web and bookmark your favourite sites. Download it now!

[Guest guest]

Hi Gloria

I know your sitting on the edge of your seat, but your not alone there.

We are all sitting there beside you.

Personally, I believe in my heart that you are SVR.....for life.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Re: Hepatitis C Infection Blocked By Natural Compound (Quercetin) Date: Thursday, January 14, 2010, 8:56 PM

I'm currently just finished a trial!! No, it is not massive dosages, although it's very dependent on the person themselves. Some can do it fairly easily and probably only suffer from the fatigue. Then there's others that simply can not tolerate the treatment at all.I was a Non-Responder the first time around, on the common treatment. Unfortunately, at that time, the only thing to do was hope for something new. Even thought that the Hep C nurses had totally dropped me!! I do vaguely remember the one that asked me if I'd consider a Trial. Well, I said - who knows until it's offered. When I got the call last January, I was actually only given about 4 hours to decide!!When ever I get the results of the blood work I have to do tomorrow - I'll probably want to kiss that nurse for remembering me, even if I only had 4 hours to consider giving up another year to

treatment.Gloria

i've volunteered for trial but don't know if i'll get called( i wonder if it's massive dosage, i.v., etc. )gary

Canada Toolbar : Search from anywhere on the web and bookmark your favourite sites. Download it now!

Canada Toolbar : Search from anywhere on the web and bookmark your favourite sites. Download it now!

[Guest guest]

ANY SUGGESTIONS OR INFO >>>>>>>> ABOUT GETTING INTO TRIALS, WILL BE GREATLY

APPRECIATED ! IF I COULD CHOOSE, IT WOULD BE SANTAURUS DRUG SPC 2649 BUT,

WOULD PROBABLY ACCEPT ANY TRIAL OF ANY KIND.... Knowing the Chance of the

Placebo........

tx_jimbo@...

>

>

> From: Gloria <gadamscan (DOT) ca>

> Subject: Re: [ ] Re: Hepatitis C Infection Blocked By Natural

Compound (Quercetin)

>

> Date: Thursday, January 14, 2010, 8:56 PM

>

>

>

>

>

>

>

>

> I'm currently just finished a trial!!  No, it is not massive dosages, although

it's very dependent on the person themselves.  Some can do it fairly easily and

probably only suffer from the fatigue.  Then there's others that simply can not

tolerate the treatment at all.

>

> I was a Non-Responder the first time around, on the common treatment. 

Unfortunately, at that time, the only thing to do was hope for something new. 

Even thought that the Hep C nurses had totally dropped me!!  I do vaguely

remember the one that asked me if I'd consider a Trial.  Well, I said - who

knows until it's offered.  When I got the call last January, I was actually only

given about 4 hours to decide!!

>

> When ever I get the results of the blood work I have to do tomorrow - I'll

probably want to kiss that nurse for remembering me, even if I only had 4 hours

to consider giving up another year to treatment.

>

> Gloria

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> i've volunteered for trial but don't know if i'll get called

>

> ( i wonder if it's massive dosage, i.v., etc. )

>

> gary

>

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>

>

>

>

>

> Canada Toolbar : Search from anywhere on the web and bookmark your

favourite sites. Download it now!

>

>

>

>

>

>

>

>

>

> Canada Toolbar : Search from anywhere on the web and bookmark your

favourite sites. Download it now!

>

[Guest guest]

Hi Tex

I think that if you wanted to get into the vaccine trial [sPC3649], that you would possibly have to go to Europe.

I think thats where the biopharmaceutical firm, Santaris Pharma A/S, a Danish company, is located, and the testing is being done.

I dont know if any USA/NA Pharm company is testing it yet.

http://www.google.com/hostednews/afp/article/ALeqM5iQudLbzUhj3U2BTbrFAo7TwqEMEA

http://www.reuters.com/article/idUS96029+16-Sep-2009+PRN20090916

Your Hdoc should be able to help you with a clinical trial to partake in, if you qualify.

Your Hdoc would also know whats best for you.

There are many all over the place, and they are always looking for people.

Here is some info to help you start.

http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html

http://www.clinicaltrials.gov/ct2/info/new

http://clinicalresearch.nih.gov/

love

don in ks

From: Tex Jimbo <tx_jimbo@...>Subject: [ ] Re: Clinical Trials Date: Saturday, January 16, 2010, 11:37 PM

ANY SUGGESTIONS OR INFO >>>>>>>> ABOUT GETTING INTO TRIALS, WILL BE GREATLY APPRECIATED ! IF I COULD CHOOSE, IT WOULD BE SANTAURUS DRUG SPC 2649 BUT, WOULD PROBABLY ACCEPT ANY TRIAL OF ANY KIND.... Knowing the Chance of the Placebo........ tx_jimbo@... > > > From: Gloria <gadamscan (DOT) ca>> Subject: Re: [ ] Re: Hepatitis C Infection Blocked By Natural Compound (Quercetin)> > Date: Thursday, January 14, 2010, 8:56 PM> > > > > > > > > I'm currently just finished a trial!! No, it is not massive dosages, although it's very dependent on the person themselves. Some can do it fairly easily and probably only suffer from the fatigue. Then there's others that simply can not tolerate the treatment at all.> > I was a Non-Responder the first time around, on the common treatment. Unfortunately, at that time, the only thing to do was hope for something new. Even thought that the Hep C nurses had totally dropped me!! I do vaguely remember the one that asked me if

I'd consider a Trial. Well, I said - who knows until it's offered. When I got the call last January, I was actually only given about 4 hours to decide!!> > When ever I get the results of the blood work I have to do tomorrow - I'll probably want to kiss that nurse for remembering me, even if I only had 4 hours to consider giving up another year to treatment.> > Gloria> > > > > > > > > i've volunteered for trial but don't know if i'll get called> > ( i wonder if it's massive dosage, i.v., etc. )> > gary > > > > > > > > Canada Toolbar : Search from anywhere on the web and bookmark your favourite sites. Download it now! > > > > > > > > > > Canada Toolbar : Search from anywhere on the

web and bookmark your favourite sites. Download it now!>------------------------------------

[Guest guest]

I am currently in the ABT-263 trial. I also felt the resistance of when I was considering it. And, I was at PC's memorial open house when he passed and met her daughter. I live in AZ. She felt that the Bcl-2 protein inhibitor drugs were not that effective. I was seeing Dr. Kipps at the time and he suggested this trial. I never have had high wbc. My spleen was enlarged, platelets down and lymph nodes enlarged as well. Dr. Kipps said it was time to treat. We looked into Revlimid and then realized I couldn't do it because I have been treated before with Chlorambucil. So, Sheila (Kipps nurse) went back and got the paper work on the ABT-263 trial. We couldn't think of a way to make it work living in AZ so came home, researched it on line and found the same trial opening up in Tucson that

week! Now, I am 2 hours north of Tucson but the American Cancer Society paid for our hotel rooms for the first 2 weeks that we had to live down there! It all worked out nicely. The trial is the first one using the ABT drug and Rituxan. I had my 4 rounds of Rituxan in September and the ABT drug is a daily one that I take myself every night. Results? Well, my platelets are back up (and ABT lowers platelets!) spleen down, lymph nodes down and blood work is all normal. I'm unmutated so I do have monthly IVIg. I tend to get frequent bladder and kidney infections. The protein that the CLL puts off is what the drug goes after and that protein is also found in our hearts, skin and GI tracts. They do a lot of heart tests during the study, mine has been fine. The only skin things is that sores do not heal all the way on me, I scar now. And, GI wise I am starting to have some issues with

that. Question is, would I have had these issues regardless of the study drug? Hard to know. I can not have any pain relievers because Tylenol raises liver enzymes and the others lowers platelets. So, that leaves the hard stuff-oxy codene. I don't take more than 4 in any 24 hours but I have disc disease in my lower back and then the kidney infections I get are bad. So, when I started the trial my bone marrow was 90% diffuse CLL. Monday is my next bmb so we'll see what is going on in there. I'll try to remember to inform everyone of what that shows when I find out the results. I am tired right now of the fight but I will press on. I'm only 46 and I have 2 wonderful grandsons and lots of living left to do. I think it is just sinking into me deeper these days even though I have had CLL since 2003. Some how I think in my head, at times, that I don't have cancer even while in the

cancer center! Perhaps because I never lost my hair, had surgery for it or think that doctors take it seriously. We have the 'good' cancer after all. . . ! I just don't know if this stuff is working or if it will keep working or what would happen if I stopped. Would I progress fast and be back in the same boat I was in in August? Should I go for FCR this young and burn my bone marrow? Should I just wait and see? Should I go for a transplant? Anyone have a magic eight ball out there?That's what is going on with me.Feel free to write me on or off the listLori

[Guest guest]

It is not about logic.

Yes, Most drug studies (clinical trials)

theoretically are based scientific guidelines.

But because of politics and agendas often

turn out to be self justifying.

I know I have friends and doctors who

have taken part in them. I have visited a clinic in Miami.

Unfortunately basic pure science and

medicine are not one and the same because politics and money and investors and

agendas are behind most clinical studies.

http://medtruth.blogspot.com/

It’s a throw of the dice.

Here in Miami there was a converted Marriott

that was used as a clinic for clinical trials.

They advertised for subjects in the

Miami New Times. Mostly street people, homeless and destitute and very poor

agreed to be paid trial subjects.

Who in their right mind would want to be

a guinea pig!

Then if in the allotted time period they

dropped out of the study because of adverse effects, they were not paid, and

their original presence in the trial was erased.

How reliable can those results be.

How many studies are conducted in this

manner?

[Guest guest]

Sadly I know this firsthand. I was in a trial for Lialda for my UC, and when I started flaring while on the drug, they immediately dumped me off the trial. Therefore I will not be a part of their 'percentage' since they won't include me because I was unceremoniously dumped off the trial after falling ill. I don't trust all clinical trials having experienced this firsthand. CathleenLDN for UC From: Domin <likethis@...>Subject: [low dose naltrexone] clinical trialslow dose naltrexone Date: Friday, May 21, 2010, 10:11 AM

It is not about logic. Yes, Most drug studies (clinical trials)

theoretically are based scientific guidelines. But because of politics and agendas often

turn out to be self justifying. I know I have friends and doctors who

have taken part in them. I have visited a clinic in Miami. Unfortunately basic pure science and

medicine are not one and the same because politics and money and investors and

agendas are behind most clinical studies. http://medtruth. blogspot. com/

It’s a throw of the dice. Here in Miami there was a converted Marriott

that was used as a clinic for clinical trials. They advertised for subjects in the

Miami New Times. Mostly street people, homeless and destitute and very poor

agreed to be paid trial subjects. Who in their right mind would want to be

a guinea pig! Then if in the allotted time period they

dropped out of the study because of adverse effects, they were not paid, and

their original presence in the trial was erased. How reliable can those results be. How many studies are conducted in this

manner?

[Guest guest]

People volunteer for studies because they want to . . . hopefully . . . help discover healing. My former partner was in a study early on for HIV/AIDS at Duke (Durham) and participated eagerly. His treatment there was nothing short of moral, ethical, and beneficial with great doctors and PA's. It was early in the epidemic and back then it was generally assumed that joining a study was the very best thing one could do at the time, and the wait lists were very long. But the meds for treating HIV were also very few and very toxic and not very effective. His participation was one of many steps people take to find effective treatment and even perhaps (soon) a "cure". Without clinical trials, what would we have? A bunch of people arguing on a listserve? How does that help? I came here looking for positive interaction. NOT arguments and debates. JonOn May 21, 2010, at 1:11 PM, Domin wrote:It is not about logic. Yes, Most drug studies (clinical trials) theoretically are based scientific guidelines. But because of politics and agendas often turn out to be self justifying.I know I have friends and doctors who have taken part in them. I have visited a clinic in Miami. Unfortunately basic pure science and medicine are not one and the same because politics and money and investors and agendas are behind most clinical studies.http://medtruth.blogspot.com/ It’s a throw of the dice. Here in Miami there was a converted Marriott that was used as a clinic for clinical trials.They advertised for subjects in the Miami New Times. Mostly street people, homeless and destitute and very poor agreed to be paid trial subjects.Who in their right mind would want to be a guinea pig!Then if in the allotted time period they dropped out of the study because of adverse effects, they were not paid, and their original presence in the trial was erased.How reliable can those results be.How many studies are conducted in this manner?

[Guest guest]

And let's not forget that a huge percentage of clinical trials are funded (and run) by the companies that manufacture the drugs. And these companies pay the "researchers." But, perhaps even more shocking is the fact that they also pay for the glowing "scholarly" articles that are placed in the medical journals. And here is the kicker: They often pay Big Name Research Doctors to affix their names to the articles as authors.

How fair can this be?

I say that Patient Evidence-Based Medicine, a phrase my friend Shomon and I coined, is the answer. Doctors should believe that LDN works after SEEING actual patients getting better with it. But many of them continue to say they need to see REAL (read billion-dollar) clinical trials run. I don't buy it.

Here are a few links to articles about the DUPLICITY of drug companies when it comes to these studies.

http://www.honestmedicine.com/2009/02/pharmaceutical-news-by-press-release-or-low-dose-naltrexone-study-doesnt-make-the-news.html Pharmaceutical News By Press Release? (OR: Low Dose Naltrexone Study Doesn't Make the News)

http://www.honestmedicine.com/2009/02/drug-companies-doctors-a-story-of-corruption-by-marcia-angell-md.html -- Drug Companies and Doctors: A Story of Corruption (by Marcia Angell, MD, former editor of the New England Journal of Medicine)

http://www.honestmedicine.com/2008/10/dr-john-abramsons-overdosed-america-the-broken-promise-of-american-medicine-or-how-medical-research-lost-its-credibility.html -- my review of Abramson's book about Pharma.

I wish it weren't this way. But it often is.

So, let's just "get on with it," and make sure LDN gets to the people who need it.

Schopick

www.HonestMedicine.com