RE: Trials

March 31, 2005

Tom, very good article. I did not know thay the docs got paid for each patient in a trial. !!! Thanks once again for great info. Kiki

March 31, 2005

To say that doctors/hospitals get paid in the US to do trials, while

implying that this does not happen in China..is distortion of facts.

The only difference is that because salaries are lower in China..the

drug companies have to pay less.

This is just outsourcing of patients.. as opposed to the widely

accepted outsourcing of manufacturing and service jobs.

Secondly, in most cases the doctors do not see the $$..it is the

hospital which gets paid..which then pays the doctors salary, almost

at the same level. The hospital is the major financial benefactor.

Thirdly can you remind me, which professional works for free ?. Do

you know the amount of paper work and compliance related headaches

that go with doing the trial ?. The main reason doctors take on this

extra work is for academic recognition..the extra pay if any is

minor.

Fourthly..you may be interested to know that the Chinese complain

that why are these drugs not being tested first on American

patients !. A case in point is the Tysabri related deaths of

American patients.

So pl. do not bash the medical profession without full knowledge,

afterall even LDN is a product of our imperfect system.

A

> Tom, very good article. I did not know thay the docs got paid for

each

> patient in a trial. !!! Thanks once again for great

info. Kiki

March 31, 2005

I dont have a problem with a neurologist getting paid to be involved

with trials. The ones being done here in Edmonton are very time

consuming and a huge commitment for any physician. They have to do

blood work, check MRIs and monitor how each patient is responding to

either the drug or the placebo. I have about 6 pages of info on the

synthetic peptide they are studying here at the university and it is a

huge amount of commitment for both the patient and the physician to be

involved. Lets be realistic people....can we really expect them to do

it for free? I dont believe every Dr. is just in it for the money

either. It is so easy to get very synacle about any trials but Im sure

most of our neurologists would like nothing better than for each and

every one of us to be cured of this disease. It is the FDA and drug

companies that I dont trust.

Kathy

Begin forwarded message:

> From: aegis_on_ms <aegis_on_ms@...>

> Date: March 31, 2005 4:18:40 PM MST

> low dose naltrexone

> Subject: [low dose naltrexone] Re: trials

> Reply-low dose naltrexone

>

> To say that doctors/hospitals get paid in the US to do trials, while

> implying that this does not happen in China..is distortion of facts.

> The only difference is that because salaries are lower in China..the

> drug companies have to pay less.

>

> This is just outsourcing of patients.. as opposed to the widely

> accepted outsourcing of manufacturing and service jobs.

>

> Secondly, in most cases the doctors do not see the $$..it is the

> hospital which gets paid..which then pays the doctors salary, almost

> at the same level. The hospital is the major financial benefactor.

>

> Thirdly can you remind me, which professional works for free ?. Do

> you know the amount of paper work and compliance related headaches

> that go with doing the trial ?. The main reason doctors take on this

> extra work is for academic recognition..the extra pay if any is

> minor.

>

> Fourthly..you may be interested to know that the Chinese complain

> that why are these drugs not being tested first on American

> patients !. A case in point is the Tysabri related deaths of

> American patients.

>

> So pl. do not bash the medical profession without full knowledge,

> afterall even LDN is a product of our imperfect system.

>

> A

>

> > Tom, very good article. I did not know thay the docs got paid for

> each

> > patient in a trial. !!! Thanks once again for great

> info. Kiki

>

April 6, 2005

It is a 4 billion dollar market..worldwide (split between 3-4

companies).

A

--- In low dose naltrexone , " tom bayuk " <tbayuk@c...>

wrote:

> Look at the dollar volume created by the drug Ribif at the end of

this press release.

>

> Serono Halts 2 Late-Stage Clinical Trials

> Wednesday April 6, 11:43 am ET

> Serono Halts 2 Late-Stage Clinical Trials Under Advice of 2

Separate Monitoring Boards

>

> NEW YORK (AP) -- Swiss biotech company Serono SA said Wednesday

that it discontinued two late-stage clinical trials under the advice

of two separate data and safety monitoring boards.

> One trial involved the use of Canvaxin for the treatment of Stage

IV melanoma, or skin cancer that has spread past the site of origin

to distant areas or lymph nodes. Data showed that the treatment was

unlikely to provide significant evidence of a survival benefit,

Serono said. Serono was developing the drug with CancerVax Corp.

>

> Following the announcement, trading in CancerVax stock was halted

on the Nasdaq. The shares have since resumed and recently fell

$2.74, or 43.6 percent, to $3.54 in late morning trading. Serono

American depositary shares fell 7 cents to $17.97 in late morning

trading on the New York Stock Exchange.

>

> In December, Serono and CancerVax, the maker of Canvaxin, signed a

deal to develop the treatment for melanoma and other indications.

Under the agreement, CancerVax received $25 million upfront and sold

1 million common shares to Serono for $12 million. At the time,

CancerVax said that it could receive up to $253 million in

additional payments from development, regulatory and commercial

milestones.

>

> The other discontinued Phase III trial was studying the use of a

drug called Onercept for the treatment of moderate-to-severe

psoriasis. Investigators in this trial reported that two patients

were diagnosed with a life-threatening blood infection, one of which

later died. The company discontinued the trial based on an

unfavorable risk-benefit profile.

>

> Serono's current best-selling drug is the multiple sclerosis

treatment Rebif, which brought in $1.09 billion, or half the

company's total sales, in 2004.

April 6, 2005

That is not what the press release states.

[low dose naltrexone] Re: trials

>

> It is a 4 billion dollar market..worldwide (split between 3-4

> companies).

>

> A

>

>> Look at the dollar volume created by the drug Ribif at the end of

> this press release.

>>

>> Serono Halts 2 Late-Stage Clinical Trials

>> Wednesday April 6, 11:43 am ET

>> Serono Halts 2 Late-Stage Clinical Trials Under Advice of 2

> Separate Monitoring Boards

>>

>> NEW YORK (AP) -- Swiss biotech company Serono SA said Wednesday

> that it discontinued two late-stage clinical trials under the advice

> of two separate data and safety monitoring boards.

>> One trial involved the use of Canvaxin for the treatment of Stage

> IV melanoma, or skin cancer that has spread past the site of origin

> to distant areas or lymph nodes. Data showed that the treatment was

> unlikely to provide significant evidence of a survival benefit,

> Serono said. Serono was developing the drug with CancerVax Corp.

>>

>> Following the announcement, trading in CancerVax stock was halted

> on the Nasdaq. The shares have since resumed and recently fell

> $2.74, or 43.6 percent, to $3.54 in late morning trading. Serono

> American depositary shares fell 7 cents to $17.97 in late morning

> trading on the New York Stock Exchange.

>>

>> In December, Serono and CancerVax, the maker of Canvaxin, signed a

> deal to develop the treatment for melanoma and other indications.

> Under the agreement, CancerVax received $25 million upfront and sold

> 1 million common shares to Serono for $12 million. At the time,

> CancerVax said that it could receive up to $253 million in

> additional payments from development, regulatory and commercial

> milestones.

>>

>> The other discontinued Phase III trial was studying the use of a

> drug called Onercept for the treatment of moderate-to-severe

> psoriasis. Investigators in this trial reported that two patients

> were diagnosed with a life-threatening blood infection, one of which

> later died. The company discontinued the trial based on an

> unfavorable risk-benefit profile.

>>

>> Serono's current best-selling drug is the multiple sclerosis

> treatment Rebif, which brought in $1.09 billion, or half the

> company's total sales, in 2004.

>

April 6, 2005

It sure don,t take an accountant to figure out what a cure would cost these guys,does it?

Thanks Tom

Reg

-- Re: [low dose naltrexone] Re: trials

That is not what the press release states. [low dose naltrexone] Re: trials> > > It is a 4 billion dollar market..worldwide (split between 3-4 > companies).> > A> > >> Look at the dollar volume created by the drug Ribif at the end of > this press release.>> >> Serono Halts 2 Late-Stage Clinical Trials>> Wednesday April 6, 11:43 am ET >> Serono Halts 2 Late-Stage Clinical Trials Under Advice of 2 > Separate Monitoring Boards >> >> NEW YORK (AP) -- Swiss biotech company Serono SA said Wednesday > that it discontinued two late-stage clinical trials under the advice > of two separate data and safety monitoring boards. >> One trial involved the use of Canvaxin for the treatment of Stage > IV melanoma, or skin cancer that has spread past the site of origin > to distant areas or lymph nodes. Data showed that the treatment was > unlikely to provide significant evidence of a survival benefit, > Serono said. Serono was developing the drug with CancerVax Corp. >> >> >> Following the announcement, trading in CancerVax stock was halted > on the Nasdaq. The shares have since resumed and recently fell > $2.74, or 43.6 percent, to $3.54 in late morning trading. Serono > American depositary shares fell 7 cents to $17.97 in late morning > trading on the New York Stock Exchange. >> >> In December, Serono and CancerVax, the maker of Canvaxin, signed a > deal to develop the treatment for melanoma and other indications. > Under the agreement, CancerVax received $25 million upfront and sold > 1 million common shares to Serono for $12 million. At the time, > CancerVax said that it could receive up to $253 million in > additional payments from development, regulatory and commercial > milestones. >> >> The other discontinued Phase III trial was studying the use of a > drug called Onercept for the treatment of moderate-to-severe > psoriasis. Investigators in this trial reported that two patients > were diagnosed with a life-threatening blood infection, one of which > later died. The company discontinued the trial based on an > unfavorable risk-benefit profile. >> >> Serono's current best-selling drug is the multiple sclerosis > treatment Rebif, which brought in $1.09 billion, or half the > company's total sales, in 2004.> > > > > > > >

April 6, 2005

I don't understand the pharmaceutical poobahs who can only see what

they'll lose. A cure would make someone a LOT of money. Sure it's not

a long-term source of revenue, but I think most of us would pay any

amount to have the MS monkey off our backs.

Besides, there is no shortage in the world today of as-yet-uncured

diseases.

Suz

--- In low dose naltrexone , " Reg Kreil " <regkreil@h...>

wrote:

> It sure don,t take an accountant to figure out what a cure would

cost these

> guys,does it?

> Thanks Tom

> Reg

April 10, 2005

The 3-4 billion market refers to information from other sources I

have read.

A

> >> Look at the dollar volume created by the drug Ribif at the end

of

> > this press release.

> >>

> >> Serono Halts 2 Late-Stage Clinical Trials

> >> Wednesday April 6, 11:43 am ET

> >> Serono Halts 2 Late-Stage Clinical Trials Under Advice of 2

> > Separate Monitoring Boards

> >>

> >> NEW YORK (AP) -- Swiss biotech company Serono SA said Wednesday

> > that it discontinued two late-stage clinical trials under the

advice

> > of two separate data and safety monitoring boards.

> >> One trial involved the use of Canvaxin for the treatment of

Stage

> > IV melanoma, or skin cancer that has spread past the site of

origin

> > to distant areas or lymph nodes. Data showed that the treatment

was

> > unlikely to provide significant evidence of a survival benefit,

> > Serono said. Serono was developing the drug with CancerVax Corp.

> >>

> >> Following the announcement, trading in CancerVax stock was

halted

> > on the Nasdaq. The shares have since resumed and recently fell

> > $2.74, or 43.6 percent, to $3.54 in late morning trading. Serono

> > American depositary shares fell 7 cents to $17.97 in late

morning

> > trading on the New York Stock Exchange.

> >>

> >> In December, Serono and CancerVax, the maker of Canvaxin,

signed a

> > deal to develop the treatment for melanoma and other

indications.

> > Under the agreement, CancerVax received $25 million upfront and

sold

> > 1 million common shares to Serono for $12 million. At the time,

> > CancerVax said that it could receive up to $253 million in

> > additional payments from development, regulatory and commercial

> > milestones.

> >>

> >> The other discontinued Phase III trial was studying the use of

a

> > drug called Onercept for the treatment of moderate-to-severe

> > psoriasis. Investigators in this trial reported that two

patients

> > were diagnosed with a life-threatening blood infection, one of

which

> > later died. The company discontinued the trial based on an

> > unfavorable risk-benefit profile.

> >>

> >> Serono's current best-selling drug is the multiple sclerosis

> > treatment Rebif, which brought in $1.09 billion, or half the

> > company's total sales, in 2004.

> >

May 24, 2005

My husband did the trial for pegatron and ribavirin. Everything was covered by the sponsers of the trial. I guess you have to check and see. Good Luck

Cyndi

July 7, 2007

One of things you don't take into account is that most people, no matter how bad

they might feel, don't say much to their doctor for fear of being told that its

just their age, or just their body type, or whatever the doctor thinks of. Many

of us thought there was nothing better and resigned ourselves until we found the

Internet and discovered that there was something better. I was resigned to a

life that was not really a life. I was only offered synthroid, and many I talk

to are STILL resigned because they believe their doctors that there is nothing

better and they just need to get used to it. Yes, doctors say that. I heard it.

Many, many have heard that. That is what makes me so stinkin' mad. I felt

terrible for so many years, stretching back into my early childhood. Looking

back at all the symptoms I displayed, I should have been diagnosed by the time I

was 6 or 7 if my parents and family doctor had been alert enough. I have had 3

children. It is NOT normal for a child

(myself) to feel too tired to go out and play and prefer to read in her

bedroom. It is NOT normal for a child to lay in bed for hours, unable to sleep.

It is NOT normal for a child to be so fatigued that she falls asleep in class,

has so much brain fog that she barely learns, gains weight no matter what she

eats or doesn't eat, has terrible constipation and is constantly on laxatives,

has bone dry skin that she can write on with her nails, terrific sugar/carb

cravings that are overwhelming, and depression for no apparent reason, among

other things. My childhood was miserable. I started my blog in the hopes that

parents would see it and save their children from a life of misery like mine.

You have no idea how many people think that what is happening to them is

inevitable and don't even bother to ask their doctors because they have been

blown off other times. You precious studies can't and won't show that. I know

what it is like. I have been there. I tried suicide twice in my life time

because the depression was so bad because of my physical symptoms, which I

believed were unfixable. There are many, many more with stories similar to mine;

many have been told by their doctors that they are hypochondriacs, mental cases

(see a psychiatrist, dearie, and here is an AD - don't let the door hit your

fanny on the way out), and more. I have heard from them talked to them, and

those I have heard from and talked to know others in the same boat. They believe

their doctors that they need to resign themselves to the inevitable. Rubbish! I

no longer accept any doctors or other persons opinion without reading a LOT of

research, both allopathic and alternative, before

making a decision. My decision last year to get Armour, iodine to counter all

the other halides in my life, and HC to help out the years of extreme stress

which I won't even go into here; I could write a book. There is an awful lot of

misery out there which doctors are not addressing; it is just too much trouble

anymore. I have seen it and heard it, over and over again, and I am not a unique

case, I am very sorry to say; there are many more like me; unlike me, they are

passively accepting the status quo. I am sick to death of it and sick to death

of our broken medical system.

Rant over.

C.

http://catherineshypohelljourney.blogspot.com/

http://www.youngliving.com - essential oils for healthy living

http://www.stopthethyroidmadness.com

cccquilter53@...

Embroidery from the Heart

http://Embfromtheheart.etsy.com

July 7, 2007

you also describe me and my family. all my sisters are zombies on tons of

psychotropics. my mother has never had a normal day of life and is now

languishing in a nursing home. this is disease maintenance, not health care.

Gracia

One of things you don't take into account is that most people, no matter how

bad they might feel, don't say much to their doctor for fear of being told that

its just their age, or just their body type, or whatever the doctor thinks of.

Many of us thought there was nothing better and resigned ourselves until we

found the Internet and discovered that there was something better. I was

resigned to a life that was not really a life. I was only offered synthroid, and

many I talk to are STILL resigned because they believe their doctors that there

is nothing better and they just need to get used to it. Yes, doctors say that. I

heard it. Many, many have heard that. That is what makes me so stinkin' mad. I

felt terrible for so many years, stretching back into my early childhood.

Looking back at all the symptoms I displayed, I should have been diagnosed by

the time I was 6 or 7 if my parents and family doctor had been alert enough. I

have had 3 children.

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April 24, 2008

OK so this is great as well. I think Zagon is great, but I think there is a difference in animal studies and human studies. I am so happy that Dr. was able to jump to human trials. Also, it is great that Dr. Bihari was able to prescribe and watch what worked best with humans. I really that Dr. Bihari's observations were keen in regards to humans taking LDN for different ailments. I see this through the many experiences that are posted here on this chat site.

Aletha

[low dose naltrexone] trials

You can prescribe medicine for off patent use if you are a doc. They do it all the time. My daughter has rett, and we certainly were prescribed anti eps that were only FDA approved for adults - but her seizures were uncontrollable otherwise - this kind of approach, to use meds for off patent use, as long as the doc prescribes them is something I've often seen in the pediatric community... so I assume it happens for adults all the time as well...To develop a new medicine for something, I know you have to do animal trials and meet other guidelines as well, before it goes to clinical trial for humans, and then that is a 3 tiered kind of trial ... but I thought that was just for a new medicine... when I looked at Dr. Zagon's website, he is doing something with something called opiate growth hormone (I think) - is this the one that he is doing the animal trials with? If that is something new as a medicine, that would make sense he was doing trials with that....I know if you want something to be used more globally, it helps to have any clinical trials for humans - they will measure things in your, in your blood, your brain, your urine, etc,. before and after the med, as well as do checkup, and document everything - the research community likes to show physically that certain things were met in a clinical trial, in part to get better use of the med, or not, depending on their results.My theory in life is if you feel better doing something, that works for you. If you feel worse, that's not your solution.... you know, I take an individual approach.... but researchers often go for more of a population approach....Still, most of the better docs I find will work with you individually... you know, we all read the research, but at the end of the day, we have to do what makes us feel better.... and meds are not always understood well (why they are working, how it happens) - the body is very complex, and is not as well understood as it will be someday....On Apr 24, 2008, at 4:09 AM, low dose naltrexone wrote:Hi Aletha,I really don't know. Have you taken a look at Dr. Zagon's research publications?DestinyAletha Wittmann <Aletharedshift> wrote:Interesting Destiny,I wonder why Dr. Jill did not seem to need to go through the same process with having animal studies first. Or have I missed something?Aletha

April 25, 2008

I wonder why Dr. Jill did not seem to need to go

through the

same process with having animal studies first. Or have

I missed

something?

Aletha

One thing I wonder about, concerning animal vs. human

studies...in one animal study they injected cancer

cells into mice to determine the cancer's response to

LDN. You probably can't, certainly shouldn't, inject

cancer cells into humans. So maybe the distinction is

made, at least partly, on the nature of the study in

question. Does this make sense?

Also, I'd like to apologise for my knee-jerk-stupid

response to the question about oleander extract. Fact

is, I don't know if it is useful, or if it can be used

with LDN. Yes, oleander is a poison, but I realized,

as soon as I hit the " send " button, that all sorts of

useful medicinals are made from poisons. For instance,

the venom of poisonous snakes and spiders is used to

make life-saving anti-venins, pathogenic organisms

produce vaccines, and then, from botulism toxin, we

get botox. So why not oleander?

My bad.

Konnie

Peace

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October 14, 2008

Hi ,

I think that's SOOOOO exciting! I know that Giora's experiment

didn't work but I've heard of others that have.

There's that famous study that was done in France where 8 people who

had been PCRU for some time stopped taking their Gleevec and 4 were

able to remain PCRU. The other 4 relapsed but what was interesting

to note was that the 4 who remained PCRU had all taken INF prior to

Gleevec.

If there was a chance I could be drug free, I think I might be

persuaded to try it, as long as I was monitored VERY closely.

I can't wait to hear about your experience if you choose to do it so

please keep us informed!

Tracey

>

> Tracey,

>

> I think that you had sent the site about all of the trials for

CML. I did write to one in Michigan for the Interferon and Gleevec

one. (Dr. Talpaz is running it.) Well, I'm not eligible for that

one as I have all ready been on INF, but they are interested in

putting me on one to stop my treatment all together! It has not been

approved yet, but should be in a few months. Dr. Talpaz feels that

they do not know of the long term effects of Gleevec, and if you are

PCR negative for a long period of time, maybe you can stop. I know

the Giora tried this at one point and failed, but it is worth

considering as I was on INF for a total of about 3 1/2 years. I

would love to hear what others think of this.

>

> DX. 8/1999

> Hydrea until January 2000

> INF, Ara-C until June 2001

> Gleevec 400mg 6,2001

> Gleevec 600mgOct 2001 with INF , neupogen for 1 1/2 years

> Gleevec 600 mg from 1/2003 until present

>

> _________________________________________________________________

> Stay up to date on your PC, the Web, and your mobile phone with

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October 14, 2008

Tracey,

I just called today about the possiblity of getting into a trial. I fit the

criteria. I called my doc, but she isn't in until tomorrow. I am thinking

the same thing, to be drug free! I am nervous about it, and have a list of

questions started. Ann Arbor isn't that far, and they said that we can learn

to self-infuse possibly.

I'll let you all know what happens with it.

Tammy

_____

From: [mailto: ] On Behalf Of Tracey

Sent: Monday, October 13, 2008 10:12 PM

Subject: [ ] Re: Trials