Leptin Study

[Guest guest]

Thanks to for the information on a Leptin Study at SF General. For those of you who can't make it out to beautiful San Francisco, here is a Leptin Study in Boston...

October 3, 2002

To Whom It May Concern:

I would like to introduce a new clinical research study we are conducting as

a joint effort between the divisions of endocrinology and infectious

diseases.  Our study is interested in HIV patients who have developed

lipoatrophy, or fat depletion, in their faces, arms, legs, and/or buttocks

after starting anti-retroviral therapy.  It is known that significant

lipoatrophy can be associated with high lipid levels, especially high

triglyceride levels, high sugar levels, diabetes, and low levels of a

hormone called leptin.  Leptin is a natural hormone produced by our fat

cells and regulates energy balance and metabolism in our bodies.  The aim of

our study is to examine whether replacing leptin to normal levels will

improve and reverse these metabolic problems.  Recently published studies

suggest that this would be true.

Participation in our study would involve visits to the Beth Israel Deaconess

Medical Center in Boston mainly twice per month over a 7 month period.  Most

of the visits are outpatient appointments with a couple of overnight stays.

In appreciation of your time and effort, you would receive up to $1700 for

participating in the study.

Specifically, we are looking for individuals with:

    1)    Loss of fat from face, arm, legs, & /or buttocks, which

developed after starting protease inhibitors

    2)    Elevated triglyceride levels

    3)    At least 6 months of anti-retroviral therapy in the past

If you are interested in possibly participating and/or would like to receive

more information, please contact Dr. Lee at .  Thank you very

much for your consideration.  We hope to hear from you soon.

Sincerely,

H. Lee, M.D.

Clinical Fellow in Endocrinology

Beth Israel Deaconess Medical Center

[Guest guest]

Racemic means that the molecule comes in left-handed and right-handed

varieties. Now, you might know that the amino acids our body use come in

"left-handed" varieties (like "L" carnitine for levo). The D for ("dextro"

for a right twist) the body isn't able to metabolize.

With the nucleosides/nucleotides, the common form is a D form. With 3TC,

however, the L-form (-) works as well but with considerably less toxicity

than the D (+) form. The effects are particularly acute on polymerase

gamma, the enzyme responsible for aiding the replication of mitochondrial

DNA. The other cytosine nuke in this class, ddC, is considerably more toxic

(and I have not heard about it coming in D or L forms).

If Glaxo's quality control isn't good enough and more of the D form of 3TC

winds up in the mix, it may increase the overall toxicity. I'm not saying

this happens; I should HOPE the mechanisms for assuring product quality for

pharmaceuticals are adequate to catch this.

,

This is interesting. What is your source of information? I would be surprised if GW is providing any of this information. My expectation is that they would claim it's proprietary. Have you been reading patents on 3TC?

Any particular reason you think they could be persuaded to extract the levorotatory isomer from the racemic mixture? I would think they would resist this (I assume) additional expense on product that's been FDA approved for what I guess is somewhere in the neighborhood of a decade. Given past performance, I would not be surprised if the FDA required them to undergo the expense of additional testing if they sought approval. All of which makes it seem increasingly unlikely.

Better try India.

Bob E

[Guest guest]

At 10:06 AM 11/15/2002 -0500, you wrote:

>You don't need to take a protease inhibitor to get lipoatrophy. Just

>3tc and d4t will do nicely. Tex

It does appear to be d4T more than other nukes that is at the root of

lipoatrophy (even as that has often come across as a Glaxo campaign to diss

the BMS competition--all these wacko companies are spending time saying

" gee our drug *doesn't* cause THAT problem " while blithely ignoring the

other problems it may cause. Sigh--ALL the drugs are going to carry risks

and MOST people will probably have to try ALL the drugs at some point;

switching can only go so far as a strategy. We need other

approaches....etc....)

With regard to 3TC I've been reading about it a bit. I am wondering about

how well the stuff is manufactured and whether there is an adequate level

of quality control to assure that it is not produced as a racemic mixture?

Huh? you say?

Racemic means that the molecule comes in left-handed and right-handed

varieties. Now, you might know that the amino acids our body use come in

" left-handed " varieties (like " L " carnitine for levo). The D for ( " dextro "

for a right twist) the body isn't able to metabolize.

With the nucleosides/nucleotides, the common form is a D form. With 3TC,

however, the L-form (-) works as well but with considerably less toxicity

than the D (+) form. The effects are particularly acute on polymerase

gamma, the enzyme responsible for aiding the replication of mitochondrial

DNA. The other cytosine nuke in this class, ddC, is considerably more toxic

(and I have not heard about it coming in D or L forms).

If Glaxo's quality control isn't good enough and more of the D form of 3TC

winds up in the mix, it may increase the overall toxicity. I'm not saying

this happens; I should HOPE the mechanisms for assuring product quality for

pharmaceuticals are adequate to catch this.

But it may be hard to tease out differences in the effects of nukes on

mtDNA when nearly always, 3TC is part of the backbone of therapy.

Again--this doesn't make 3TC evil. Or ddC. Or AZT. It just means they have

different degrees of overall risk as well as specific risks in terms of

toxicities that must be weighed against their antiviral benefit.

Sadly, studies of lower (and less profit-generating) doses are not done.

There is reason to believe that lower doses of some nukes may be as

effective virologically with less dire consequences.

But we have an increasingly corrupt healthcare system with no checks or

balances, an almost complete indifference to conflicts of interest and a

vacuum in terms of simple concepts that should be part of ANY business like

integrity, honesty, the primacy of patient care and safety.

There are still many good people working in pharma, hospitals, etc. But

their efforts are being eclipsed by profoundly evil people whose goal is

money, power and status at the expense of millions of lives globally.

History will recall their eager participation in genocide.

M.

***

[Partial example of another company's outrageous greed that kills]:

Doctors Without Borders/Medecins Sans Frontieres (MSF)

Press Release

AIDS PATIENTS IN POOR COUNTRIES PAY HIGHER PRICES FOR ROCHE'S DRUGS THAN

PEOPLE IN SWITZERLAND

Bern, Switzerland, November 15, 2002 ? Nearly two and a half years after

the Swiss pharmaceutical giant Roche announced dramatic price cuts for its

AIDS drugs in poor countries (*), its most essential AIDS medicine

nelfinavir (Viracept©) actually costs more in Guatemala and the Ukraine

than in Switzerland. Its lowest published price for the same drug is more

than five times more expensive than another drug of the same class by a

competitor. In an open letter addressed to the company and published today,

Doctors Without Borders/Medecins Sans Frontieres (MSF) urges Roche to

significantly lower the price of nelfinavir to do its fair share in the

fight against the AIDS pandemic.

[Guest guest]

At 09:00 AM 11/16/2002 -0500, you wrote:

>This is interesting. What is your source of information? I would be

>surprised if GW is providing any of this information. My expectation is

>that they would claim it's proprietary. Have you been reading patents on 3TC?

Hiya...

Yes--see , KS. Perspectives on the molecular mechanism of

inhibition and toxicity of nucleoside analogs that target HIV-1 reverse

transcriptase. Biochim et Biophysica Acta, 2002;1587:296-299.

>Any particular reason you think they could be persuaded to extract the

>levorotatory isomer from the racemic mixture? I would think they would

>resist this (I assume) additional expense on product that's been FDA

>approved for what I guess is somewhere in the neighborhood of a

>decade. Given past performance, I would not be surprised if the FDA

>required them to undergo the expense of additional testing if they sought

>approval. All of which makes it seem increasingly unlikely.

My presumption is that indeed 3TC is supposed to be ONLY the - enantiomer.

According to the PDR, lamivudine (3TC, Epivir) is referred to as such.

Thus, Epivir should NOT be a racemic mixture and should there be

contamination by +3TC, this would represent a ba product.

>Better try India.

Possibly. The same concern would exist with generic 3TC. However, my guess

is that it is a fairly simple matter to produce only one version.

M.

(PS-My server (Earthlink) was in the midst of a periodic maintenance at the

wee hour of the morning when the other message was sent. I think it screwed

up a few messages...my apologies! )

[Guest guest]

Hi Folks,

I just found out that I have qualified for the Leptin study being conducted at the Beth Israel Deaconess Medical Center here in Boston. Injections of the hormone will not start for at least another month. The first phase may only be placebo but eventually I will get the Leptin. If anyone is interested, I will keep you posted on any changes - - good, bad or indifferent.

(in Boston)

,

That's great that you got into the study! I still haven't heard any firsthand reports from anyone who has actually taken Leptin. By all means, I'm sure everyone here would be extremely interested in hearing how it is working out for you.

Also, please let us know if you've heard anything about them expanding the study to include all types of lipodystrophy.

Glenn

[Guest guest]

That's great that you got into the study! I still haven't heard any firsthand reports from anyone who has actually taken Leptin

I have been taking leptin pills for some time that I got thru i-herb..not sure they are doing anything..they are bottled as a 'slimming' product..made by ImmuneTree.

[Guest guest]

That's great that you got into the study! I still haven't heard any firsthand reports from anyone who has actually taken Leptin

I have been taking leptin pills for some time that I got thru i-herb..not sure they are doing anything..they are bottled as a 'slimming' product..made by ImmuneTree.

Leptin is a recombinant human hormone made by Amgen. Anything else purporting to be leptin is a fraud. I fear you were had Manin. Herbal leptin doesn't exist to my knowledge. God knows what you were taking.

A good rule from Pope's Essay on Criticism that one of my docs was fond of quoting:

Be not the last to set the old aside,

Nor yet the first by whom the new is tried.

Hopefully what you took was not harmfull. Studies have shown that a large percentage of nutrients and herbal products advertised on the web and elsewhere do not contain the ingredients on the label in the quantities stated.

Bob E

[Guest guest]

> In a message dated 12/11/2002 9:47:23 AM Eastern Standard Time,

> ManinSCal@a... writes:

>

> > I have been taking leptin pills for some time that I got thru i-

herb..not

> > sure they are doing anything..they are bottled as a 'slimming'

> > product..made by ImmuneTree.

> >

>

> Leptin is a recombinant human hormone made by Amgen. Anything else

> purporting to be leptin is a fraud. I fear you were had Manin.

Herbal

> leptin doesn't exist to my knowledge. God knows what you were

taking.

>

Also, to my knowledge, there is no pill form. It has to be injected.

Human Growth Hormone is another good example of what you are talking

about, Bob. It seems that hundreds of companies are advertising that

they sell it, but I don't believe that any of it is real.

Glenn

[Guest guest]

Dr. Lee told me Leptin only works through injection.

>>I have been taking leptin pills for some time that I got thru i-herb..not sure they are doing anything..they are bottled as a 'slimming' product..made by ImmuneTree.