Wyeth is trying to make natural hormones illegal

On Mon, 13 Mar 2006 15:57:58 -0600, Ed Friedman <[email protected]> wrote:

>The drug company Wyeth, maker of Prempro, is trying to outlaw
>competition by having the FDA declare bioidentical hormones illegal.
>This is an outrageous money grab that just might succeed in our current
>government environment in which laws are up for sale.

Your header is not true.

For the real story go to:

http://www.fda.gov/ohrms/dockets/dockets/05p0411/05p-0411-cp00001-toc.htm

Click on Citizen Petition to read the entire petition, particularly the first 38
pages.

A word of caution. Usually when we are approached to sign a petition or
protest some kind of action the information we are given is not as accurate as
it should be. I looked up Wyeth's petition (138 pages and read the first 38
pages which included what they are actually requesting. The rest are
copies of ducuments which they included with their petition.

Of course they also mentioned a host of other things which they claim
substantiate their requests.

Ora

[email protected] wrote
> Your header is not true.
>
> For the real story go to:
>
> http://www.fda.gov/ohrms/dockets/dockets/05p0411/05p-0411-cp00001-toc.htm
>
> Click on Citizen Petition to read the entire petition, particularly the first 38
> pages.
>
> A word of caution. Usually when we are approached to sign a petition or
> protest some kind of action the information we are given is not as accurate as
> it should be. I looked up Wyeth's petition (138 pages and read the first 38
> pages which included what they are actually requesting. The rest are
> copies of ducuments which they included with their petition.
>
> Of course they also mentioned a host of other things which they claim
> substantiate their requests.
>
> Ora
>

Ora,

I didn't give more details because I assumed that most of the readers of
this newsgroup understood basic biochemistry. However, in case they
don't, let's start with the basic nomenclature. People used to refer to
difference between natural and synthetic vitamins, based on how they
were made. In some cases the synthetic vitamins were identical to the
natural ones, in other cases they weren't. E.g., natural vitamin C and
synthetic vitamin C are identical (or bioidentical), whereas natural
vitamin D and synthetic vitamin D are not. The real vitamin D (D3) is
different chemically than the fake vitamin D (D2). Applying these same
terms to the Wyeth case, the bioidentical hormones in question are the
real sexual hormones, or real hormones for short, whereas the Wyeth
hormones are the fake sexual hormones, or fake hormones for short.

Now, by law, real hormones (and real vitamins for that matter) cannot be
patented, hence they present no opportunity for giant profits to the
drug companies. However, if a drug company makes any modification to a
real hormone, then this fake hormone can be patented after following the
procedures set forth by the FDA, which requires years of testing to look
for potential health risks. Once they have their patent, they can
charge whatever they want for the fake hormone, and simply have to
convince the doctors to prescribe it. This is essentially a variation
on the current marketing schemes that drug companies use when their own
drugs are about to have their patent run out. They make a minor
modification to the existing drug, apply for a new patent, and then
spend tons of money to convince the doctors to prescribe this new drug,
even if its benefits are less or its dangers are more than the previous
drug that had been prescribed (but was about to lose its patent).

The 138 pages you refer to in the Wyeth complaint is just recitation of
total nonsense. It is the trick used by high school students who know
they have a bad term paper - just make as many pages as possible and
hope that the teacher will give you a good grade based on the number of
pages instead of the quality of the work. The absurdity of the Wyeth
complaint is evident in the beginning of their documentation. They
state: "It is important to know that this petition is not directed in
any way at those pharmacies which satisfy legitimate patient needs by
compounding individual products for individual needs that cannot be made
by an FDA-approved product." This statement is deception at its
highest. Anyone that knows biochemistry knows that hormones work with
hormone receptors in a "lock and key" manner. The real hormones work in
a very specific way with their hormone receptors. No fake hormone can
ever work in the same way. So by basic biochemistry, Wyeth has no case,
since a doctor who insists that his patient receive real hormones will
never have exactly the same results if that patient is given fake
hormones instead. To believe that fake hormones can ever be as safe or
effective as real hormones is to ignore the billions of years of
evolution that resulted in the final real hormones contained in the
human body. The chance that fake hormones would be better than real
hormones, but that somehow that mutation never occured in nature to
produce them, is slim to none.

The Wyeth complaint can be boiled down to a single argument. Basically,
they are saying that it is unfair for drug companies to have to spend
hundreds of millions of dollars to prove the relative safety of fake
hormones, when those people who sell real hormones (at a greatly reduced
price compared to fake hormones) don't have to do any tests to prove
safety. Taking this argument to absurd extremes, this same argument
could be made by makers of synthetic blood to outlaw natural blood
transfusions. What is omitted in the Wyeth complaint, is that the
reason that real hormones (and all of the other real chemicals found in
the human body) don't have to be tested for safety are:
1) If they are in fact dangerous, then we now have to get these
chemicals out of everyone's bodies, which is totally absurd.
2) Since they can't be patented, nobody can ever make enough money from
them in order to be able to afford to do the necessary tests.

The bottom line is that the FDA testing guidelines are seriously flawed.
No drug should be allowed on the market unless it has demonstrated
real benefits over previously patented drugs. No fake hormone should be
allowed on the market unless it has been demonstrated to be at least as
safe as the real hormone, which has not yet been demonstrated for any of
Wyeth's fake hormones.

Finally, I should like to point out that I personally know an enormous
amount about the benefits and risks of real hormones. I have a Ph.D. in
Biophysics and Theoretical Biology, and have published the world's only
biochemical model of prostate cancer which is consistent with all known
experimental results:
http://www.tbiomed.com/content/2/1/10
This paper is already starting to gain some international recognition:
http://www.arabmedmag.com/issue-31-10-2005/urology/bottom.htm
My next paper will detail how to prevent prostate cancer, and how to
wipe out prostate cancer and breast cancer - all with the proper use of
real hormones plus drugs. I personally take real hormones and in the
last two years have succeeded in dropping my PSA by over 67%. With
regards to cancer, no real hormone is good or bad - the key is in
understanding just how it interacts with the various hormone receptors
and understanding exactly what each hormone receptor does.

Ed Friedman

On Tue, 14 Mar 2006 11:22:46 -0600, Ed Friedman <[email protected]> wrote:

>[email protected] wrote
>> Your header is not true.
>>
>> For the real story go to:
>>
>> http://www.fda.gov/ohrms/dockets/dockets/05p0411/05p-0411-cp00001-toc.htm
>>
>> Click on Citizen Petition to read the entire petition, particularly the first 38
>> pages.
>>
>> A word of caution. Usually when we are approached to sign a petition or
>> protest some kind of action the information we are given is not as accurate as
>> it should be. I looked up Wyeth's petition (138 pages and read the first 38
>> pages which included what they are actually requesting. The rest are
>> copies of ducuments which they included with their petition.
>>
>> Of course they also mentioned a host of other things which they claim
>> substantiate their requests.
>>
>> Ora
>>
>
>Ora,
>
>I didn't give more details because I assumed that most of the readers of
>this newsgroup understood basic biochemistry. However, in case they
>don't, let's start with the basic nomenclature. People used to refer to
>difference between natural and synthetic vitamins, based on how they
>were made. In some cases the synthetic vitamins were identical to the
>natural ones, in other cases they weren't. E.g., natural vitamin C and
>synthetic vitamin C are identical (or bioidentical), whereas natural
>vitamin D and synthetic vitamin D are not. The real vitamin D (D3) is
>different chemically than the fake vitamin D (D2). Applying these same
>terms to the Wyeth case, the bioidentical hormones in question are the
>real sexual hormones, or real hormones for short, whereas the Wyeth
>hormones are the fake sexual hormones, or fake hormones for short.
>
>Now, by law, real hormones (and real vitamins for that matter) cannot be
>patented, hence they present no opportunity for giant profits to the
>drug companies. However, if a drug company makes any modification to a
>real hormone, then this fake hormone can be patented after following the
>procedures set forth by the FDA, which requires years of testing to look
>for potential health risks. Once they have their patent, they can
>charge whatever they want for the fake hormone, and simply have to
>convince the doctors to prescribe it. This is essentially a variation
>on the current marketing schemes that drug companies use when their own
>drugs are about to have their patent run out. They make a minor
>modification to the existing drug, apply for a new patent, and then
>spend tons of money to convince the doctors to prescribe this new drug,
>even if its benefits are less or its dangers are more than the previous
>drug that had been prescribed (but was about to lose its patent).
>
>The 138 pages you refer to in the Wyeth complaint is just recitation of
>total nonsense. It is the trick used by high school students who know
>they have a bad term paper - just make as many pages as possible and
>hope that the teacher will give you a good grade based on the number of
>pages instead of the quality of the work. The absurdity of the Wyeth
>complaint is evident in the beginning of their documentation. They
>state: "It is important to know that this petition is not directed in
>any way at those pharmacies which satisfy legitimate patient needs by
>compounding individual products for individual needs that cannot be made
>by an FDA-approved product." This statement is deception at its
>highest. Anyone that knows biochemistry knows that hormones work with
>hormone receptors in a "lock and key" manner. The real hormones work in
>a very specific way with their hormone receptors. No fake hormone can
>ever work in the same way. So by basic biochemistry, Wyeth has no case,
>since a doctor who insists that his patient receive real hormones will
>never have exactly the same results if that patient is given fake
>hormones instead. To believe that fake hormones can ever be as safe or
>effective as real hormones is to ignore the billions of years of
>evolution that resulted in the final real hormones contained in the
>human body. The chance that fake hormones would be better than real
>hormones, but that somehow that mutation never occured in nature to
>produce them, is slim to none.
>
>The Wyeth complaint can be boiled down to a single argument. Basically,
>they are saying that it is unfair for drug companies to have to spend
>hundreds of millions of dollars to prove the relative safety of fake
>hormones, when those people who sell real hormones (at a greatly reduced
>price compared to fake hormones) don't have to do any tests to prove
>safety. Taking this argument to absurd extremes, this same argument
>could be made by makers of synthetic blood to outlaw natural blood
>transfusions. What is omitted in the Wyeth complaint, is that the
>reason that real hormones (and all of the other real chemicals found in
>the human body) don't have to be tested for safety are:
>1) If they are in fact dangerous, then we now have to get these
>chemicals out of everyone's bodies, which is totally absurd.
>2) Since they can't be patented, nobody can ever make enough money from
>them in order to be able to afford to do the necessary tests.
>
>The bottom line is that the FDA testing guidelines are seriously flawed.
> No drug should be allowed on the market unless it has demonstrated
>real benefits over previously patented drugs. No fake hormone should be
>allowed on the market unless it has been demonstrated to be at least as
>safe as the real hormone, which has not yet been demonstrated for any of
>Wyeth's fake hormones.
>
>Finally, I should like to point out that I personally know an enormous
>amount about the benefits and risks of real hormones. I have a Ph.D. in
>Biophysics and Theoretical Biology, and have published the world's only
>biochemical model of prostate cancer which is consistent with all known
>experimental results:
>http://www.tbiomed.com/content/2/1/10
>This paper is already starting to gain some international recognition:
>http://www.arabmedmag.com/issue-31-10-2005/urology/bottom.htm
>My next paper will detail how to prevent prostate cancer, and how to
>wipe out prostate cancer and breast cancer - all with the proper use of
>real hormones plus drugs. I personally take real hormones and in the
>last two years have succeeded in dropping my PSA by over 67%. With
>regards to cancer, no real hormone is good or bad - the key is in
>understanding just how it interacts with the various hormone receptors
>and understanding exactly what each hormone receptor does.
>
>Ed Friedman

Your header is still not true. Wyeth's petition does not have anything to do
with making natural hormones illegal.

Ora

There is a doctor with a local radio talk show here in Houston, Texas
that has been following this very closely. I have not read the
petition (because I'm not all that interested in it) but the doctor is
convinced that Wyeth's ultimate goal is to put their competitors out of
business by abusing the court system and /or trying to change existing
law rather than by making a superior product that is demanded by the
public.

I have to say that such a tactic scares me. If Wyeth is able to do
that, what's next? It's not how a capitalist economy is supposed to
function. If Wyeth can't make a decent product and build a reputable
business in a free market economy, then Wyeth should go out of
business.

Max.

There is a doctor with a local radio talk show here in Houston, Texas
that has been following this very closely. I have not read the
petition (because I'm not all that interested in it) but the doctor is
convinced that Wyeth's ultimate goal is to put their competitors out of
business by abusing the court system and /or trying to change existing
law rather than by making a superior product that is demanded by the
public.

I have to say that such a tactic scares me. If Wyeth is able to do
that, what's next? It's not how a capitalist economy is supposed to
function. If Wyeth can't make a decent product and build a reputable
business in a free market economy, then Wyeth should go out of
business.

Max.

Ed Friedman wrote:

> Now, by law, real hormones (and real vitamins for that matter) cannot be
> patented, hence they present no opportunity for giant profits to the
> drug companies.

The delivery of hormones and vitamins can be patented even if the
substances can't be.

I thought that Premarin was based on horse estrogen and therefore a
natural product.

IIRC, human estrogen wasn't allowed to be used for estrogen
replacenment therapy because it wasn't proven safe compared to horse
estrogen.

> The bottom line is that the FDA testing guidelines are seriously flawed.

> No drug should be allowed on the market unless it has demonstrated
> real benefits over previously patented drugs.

Do you consider price to be a real benefit?

--
Ron

On Tue, 14 Mar 2006 11:22:46 -0600, Ed Friedman <[email protected]>
wrote:

>Finally, I should like to point out that I personally know an enormous
>amount about the benefits and risks of real hormones. I have a Ph.D. in
>Biophysics and Theoretical Biology, and have published the world's only
>biochemical model of prostate cancer which is consistent with all known
>experimental results:
>http://www.tbiomed.com/content/2/1/10
>This paper is already starting to gain some international recognition:
>http://www.arabmedmag.com/issue-31-10-2005/urology/bottom.htm
>My next paper will detail how to prevent prostate cancer, and how to
>wipe out prostate cancer and breast cancer - all with the proper use of
>real hormones plus drugs. I personally take real hormones and in the
>last two years have succeeded in dropping my PSA by over 67%. With
>regards to cancer, no real hormone is good or bad - the key is in
>understanding just how it interacts with the various hormone receptors
>and understanding exactly what each hormone receptor does.

Can PDE5 inhibitors have an influence on prostate cancer?

Max C. wrote:
> There is a doctor with a local radio talk show here in Houston, Texas
> that has been following this very closely. I have not read the
> petition (because I'm not all that interested in it) but the doctor is
> convinced that Wyeth's ultimate goal is to put their competitors out of
> business by abusing the court system and /or trying to change existing
> law rather than by making a superior product that is demanded by the
> public.
>
> I have to say that such a tactic scares me. If Wyeth is able to do
> that, what's next? It's not how a capitalist economy is supposed to
> function. If Wyeth can't make a decent product and build a reputable
> business in a free market economy, then Wyeth should go out of
> business.
>
> Max.
>

Max,

I'm glad to hear that others are also outraged at this. However, I'm
afraid that most people are oblivious to the principle that is at stake
here. Perhaps they will get it when something outrageous happens, such
as when some drug company gets a patent on a chemically modified form of
caffeine that uses the Wyeth precedent to force the FDA to outlaw all
non-modified forms of caffeine.

Ed Friedman

RArmant wrote:
> Can PDE5 inhibitors have an influence on prostate cancer?
>
As far as I am aware, PDE5 inhibitors are just used for ED, which is one
of the side effects of a prostatectomy.

Ed

Ron Peterson wrote:
> Ed Friedman wrote:
>
>
>>Now, by law, real hormones (and real vitamins for that matter) cannot be
>>patented, hence they present no opportunity for giant profits to the
>>drug companies.
>
>
> The delivery of hormones and vitamins can be patented even if the
> substances can't be.
>
> I thought that Premarin was based on horse estrogen and therefore a
> natural product.

You are correct. As was pointed out in an earlier post, I should have
used the phrase "bioidentical hormones" instead of "natural hormones" in
my header. Premarin is in fact natural (for horses), but it contains
25% equiline, a horse hormone never found naturally in humans. Premarin
is not even close to providing the real ratios of estradiol, estrone,
and estriol which are actually found in human women.

> IIRC, human estrogen wasn't allowed to be used for estrogen
> replacenment therapy because it wasn't proven safe compared to horse
> estrogen.

I'm not sure what you mean by "human estrogen", but bioidentical
hormones are chemically identical to what is found naturally inside of
humans. Their safety hasn't been "proven" with FDA regulated tests (nor
has the safety of any natural chemical found within the body for that
matter, nor has water, nor has the food you eat, nor has the air you
breath, etc.), but doctors are currently free to prescribe it for their
patients. If you want make these hormones illegal over the counter, but
legal only with prescription, then that sounds reasonable. If you want
to put a warning label on them, like is done for cigarettes, then that
sounds reasonable too. But outlawing a chemical found naturally within
the body is ludicrous in the extreme (unless you are a drug company
looking to make more money, even if it means killing more people).

To put this into a prespective that might make you more empathetic,
consider what would happen if a horrible accident occurred which caused
you to be castrated. Right now, you have the option of obtaining
bioidentical testosterone (with a doctor's prescription) to replace what
you lost. If Wyeth succeeds, then your choice would be chemically
modified (FDA approved) versions of testosterone. Would you actually
choose to take methyl-testosterone, which has been proven to have side
effects (in some people) of liver damage or uncontrollable rage rather
than take bioidentical testosterone since no tests have ever been done
to show the safety of testosterone? Really? Yet you think it is ok to
force women to only be able to obtain prescriptions for Wyeth fake
hormones and not be allowed to replace the real hormones that their
doctor may think that they require? How sexist is that?

>>The bottom line is that the FDA testing guidelines are seriously flawed.
>
>
>> No drug should be allowed on the market unless it has demonstrated
>>real benefits over previously patented drugs.
>
>
> Do you consider price to be a real benefit?
>

Price can be deceptive. If a drug is coming out that is 10% cheaper
than a previous similar drug, then it might seem reasonable to ok that
drug. However, if the more expensive drug is due to have its patent
expire within a few months, then this is just a blatent move by the drug
company to increase profits at the expense of patients' health. Perhaps
the solution would be to make drugs which are minor chemical
modifications of existing drugs have patents which expire when the
original drug expires.

Ed Friedman