Ok ladies and gentlemen please bare with me because
this post is going to be somewhat longer than I want it to be, but there
is a lot to cover here. Most of you have heard me ranting and raving
about the patent drugs out there taking priority over other non patented
drugs and un-FDA regulated supplements. I have made the arguement that
testosterone therapy is not taken seriously because it is NOT a profit
center for pharmaceutical companies. And without the pharmaceutical
companies generating MAJOR profits on new drugs then 'they' and the
FDA has less fininaces flowing through their hands thus less power.
Don't think for a second that the FDA is not influenced by the BIG money
that these large companies throw around. This is one of my key arguements
in the de-scheduling of anabolics. And that is, that T-therapy amoung
other AAS would treat a broad array of ailments, that now current and
much higher priced patented drugs are now in serving. Have I made some
sense so far? Do you guys and gals see my point? Let me show you another
sample. And this is a good topic to shed new light on with the recent
happening with the attack on Ephedra, Prohormones and DHEA products.
This will tie in well with all the factors. And I'll make my point as
I go. Lets first look at one of the biggest profit generators of all
time in the pharmaceutical field. Lets take a look first at the time,
energy and resources placed in this drug. And it's one you have all
heard of and probably even half of you have used. PROZAC. This below
excerpt was taken from some web site showing a a topic by Staff Research.
Blockbuster drug has had a dramatic history
Prozac has helped Eli Lilly and Co. grow into one of the nation's largest
drug manufacturers during the past 13 years. Some key dates in the drug's
history:
1970 - Lilly begins work in earnest on better anti-depressant.
1972 - Lilly synthesizes fluoxetine hydrochloride, which eventually
will become known as Prozac.
1976 - Begins clinical trials of Prozac.
1983 - Lilly applies to U.S. Food and Drug Administration for approval
to sell Prozac for treatment of depression.
1986 - Prozac approved for sale in Belgium.
1987 - FDA clears Prozac for sale in United States to treat depression.
1988 - Prozac hits the market in United States.
1989 - Prozac sales reach $350 million. Reports of Prozac related suicides
and violence. Joseph Wesbecker, a psychiatric patient on Prozac, storms
Louisville printing plant and shoots 20, killing eight, including himself.
1990 - Prozac story graces the cover of Newsweek. Prozac becomes most
widely prescribed antidepressant in U.S. Sales more than double from
previous year, near $760 million. Team of Harvard Medical School researchers
says Prozac may induce thoughts of suicide.
1991 - Church of Scientology intensifies attack on safety of Prozac.
FDA advisory committee affirms Prozac's safety and effectiveness.
1992 - Prozac sales hit $1 billion.
1993 - Listening to Prozac by Dr. Peter Kramer published for the first
time. The book, which says Prozac makes some people "better than
well," goes on to become a best seller. Prozac cleared by FDA for
treatment of obsessive-compulsive disorder.
1994 - Olympic runner Alberto Salazar makes an amazing come back after
a decade away from the sport. His use of Prozac moves other athletes,
depressed or not, to begin taking the drug. Drug-free runners are outraged.
Prozac cleared by FDA for treatment of bulimia. Kentucky jury absolves
Lilly of blame in first Prozac wrongful death lawsuit to come to trial.
1995 - Talking Back to Prozac by Dr. Peter Breggin, criticizes use of
drugs in psychiatry, refutes Kramer's book.
1995 - Prozac sales top $2 billion. Prozac becomes world's third-largest
selling pharmaceutical.
1996 - Prozac has been prescribed for more than 24 million patients
worldwide. Lilly sues Barr Laboratories for patent infringement to keep
it from selling generic Prozac.
1997 - Prozac shows first decrease in quarterly sales, partly reflecting
competition from newer anti-depressants, like Zoloft and Paxil.
1999 - Federal Judge Sarah Evans Barker denies Barr's clams that Lilly's
Prozac patents are invalid. Barr appeals. Hawaii jury absolves Lilly
of blame in second Prozac wrongful death lawsuit to come to trial.
2000 - FDA approves Prozac for severe PMS in women (under brand name
Sarafem). Federal appeals court overturns lower court's ruling and holds
that Lilly's 2003 patent on Prozac is invalid for double-patenting.
Lilly appeals.
2001 - FDA approves Prozac Weekly. Prozac Users hit the 40 million mark.
Federal appeals court denies Lilly's appeal in patent case against Barr.
GENERIC Prozac hits the market. Staff Research
*************************************************
Superior1 Ok that drug was one that they had a lot of time and energy
invested in. It was paramount that they sold the living caca
out of it. So what is Prozac for those of you that don't know.
The pharmacology of fluoxetine (prozac) is complex and in many ways
resembles that of other antidepressant agents, particularly those agents
(e.g., clomipramine, fluvoxamine, paroxetine, sertraline, trazodone)
that predominantly potentiate the pharmacologic effects of SEROTONIN.
Like other selective serotonin-reuptake inhibitors (SSRIs), fluoxetine
is a potent and highly selective reuptake inhibitor of serotonin and
has little or no effect on other neurotransmitters.
Lets now look briefly (or maybe not so briefly) into pre-87 era, before
Prozac was brought to market through FDA approval. What drugs or supplements
were most effective in this ailment of dismal serotonin levels? I'm
sure by now most of you have guessed it? L-Tryptophan!!!!!!! So what
is it? Again sorry for the post but I want to make this clear and have
the plot flow smoothly. Let's read more.
L-Tryptophan is an amino acid, one of the building blocks of protein,
but unlike some amino acids, L-Tryptophan is considered ESSENTIAL because
the body cannot manufacture its own. L-Tryptophan plays many roles in
animals and humans alike, but perhaps most importantly, it is an essential
precursor to a number of neurotransmitters in the brain. As such, L-Tryptophan
is the ONLY substance that can be converted into serotonin. Since serotonin,
in turn, is converted in the brain into melatonin, L-Tryptophan clearly
plays a role in balancing MOOD and SLEEP patterns.
Superior1( Wow L-tryptophan served 2 purposes!! MOOD and SLEEP. ) Just
a note.
It is a fact, however, that serotonin can also be elevated in the way
nature intended, namely, by elevating serotonin's building blocks in
the diet. L-Tryptophan is the best known and most widely used nutritional
supplement for this purpose. The conversion of L-Tryptophan to serotonin
is a two-step process. First, L-Tryptophan is converted into 5-hydroxy
L-Tryptophan, or 5-HTP, and 5-HTP is then, in turn, converted into serotonin.
This is the process by which serotonin is produced from food. Unfortunately,
L-Tryptophan is also the least abundant amino acid in foods. The good
news, though, is that research conducted at MIT years ago established
that serotonin levels can be increased by supplemental, dietary L-Tryptophan.
Superior1 (this is getting good so you guys and gals again bare with
me, and thanks for reading thus far.)
While animal studies are commonly used to predict the benefits of a
new drug or nutrient to humans, human studies also help to point the
way to improved treatments in animals. In studies done with humans on
two continents by Lehman, Braverman, and Pfeiffer, depressed patients
were found to have very significantly lower plasma levels of L-Tryptophan
than normal controls. By way of contrast, changes in thirty other amino
acids were not significant. To list just a few potential applications,
human studies have also demonstrated L-Tryptophan's benefits in treating
Down's syndrome and aggressive behavior. In parallel to human studies,
a survey of horse owners reported that horses fed soy meal, which has
nearly five times the level of L-Tryptophan as oats, seem less aggressive
than those horses fed oats.
The question remains, how does L-Tryptophan compare with SSRI's in
treating clinical conditions? A study done by a team of Swiss and German
psychiatric researchers comparing the L-Tryptophan metabolite, 5-HTP,
with the SSRI, Fluvoxamine, found that depression was alleviated more
predictably with 5-HTP, and while side effects are commonly reported
for Fluvoxamine, the Physician's Desk Reference does not list any for
5-HTP. The researchers went on to conclude that the L-Tryptophan metabolite
actually treats a broader range of symptoms known as "serotonin
deficiency syndrome," which may manifest as depression, anxiety,
sleeplessness, aggression, nervousness, obsessive-compulsive behavior,
and migraines ... many of the same symptoms that are being treated today
in humans and animals alike with SSRI's.
Superior1(Wow L-tryptophan more effective than Prozac?? Interesting)
While both L-Tryptophan and 5-HTP are building blocks for serotonin,
they are not identical in their action. 5-HTP, for example, is one step
closer in the biochemical pathway to serotonin than is L-Tryptophan,
but 5-HTP is also much more expensive to produce and narrower in its
action. L-Tryptophan, in addition to being a precursor to serotonin,
is also a precursor to niacin and can be used in the treatment of pellagra.
It is really L-Tryptophan rather than niacin that acts as an essential
vitamin. Furthermore, L-Tryptophan is an essential amino acid that plays
a role in structural proteins and enzymes found throughout the body.
Superior1(It still serving purposes beyond mood and sleep, Hell it's
ESSENTIAL!!!)
Whether or not deficiency symptoms exist, L-Tryptophan is clearly an
essential amino acid that supports the nutritional and dietary requirements
of pet and equine health. Furthermore, in the treatment of deficiency
disorders, natural L-Tryptophan has clear advantages over the SSRI's,
Prozac, Zoloft, Praxil, and others, for which severe side effects continue
to be documented.
Grrrr... this makes one very ill at the smoke and mirrors that BIG money
influences.
To save you guys some times no real need to read the below section I
have placed inbeteen the asteriks, It just says how profitable Prozac
was. Scan it and move on.
****START****START*****START*****START******START*
*****START******START*****
The time factor
Time is important because Pomona, N.Y.-based Barr has received six months
of market exclusivity to sell the 20 milligram capsule, the formulation
that accounts for about 80 to 90 percent of Prozac's revenues. Four
other companies have exclusive six-month rights to other strengths or
tablet forms.
Barr stands to benefit tremendously from the generic Prozac launch.
Analysts expect it to earn $1.60 per share for their current fiscal
year, ending June 30; next year, analysts are expecting $3.84 per share.
Meanwhile, revenues are expected to jump nearly 66 percent to $1 billion.
Meanwhile, Lilly will suffer; analysts estimate Prozac sales will fall
by $1 billion over the coming year. Prozac is Lilly's second biggest
selling drug, generating 25 percent of its revenues, and analysts predict
that over the next two years, Lilly will see growth slump to 6 percent,
compared to 14 percent in the industry.
A six-year battle over rights to Prozac ended last week when a U.S.
district judge in Indianapolis issued an order invalidating a patent
that would have protected Lilly's monopoly until December 2003.
"I feel like an expectant father. We've done all the work and now
all we do is wait," Bruce Downey, Barr's chairman and chief executive,
said in an interview earlier this week.
Barr's facility in Forest, Va. has been working 10 hours a day, six
days a week, since February to manufacture the 150 million capsules
for the launch of fluoxetine, the generic name for Prozac. It ordered
about $4 million of new equipment for the facility and has a logistics
strategy set up to fill orders within three days. Typically, it takes
Barr three weeks to fully launch a drug.
The time
NEW YORK - Barr Laboratories Inc. on Thursday began shipping its version
of Prozac, the hugely successful drug that revolutionized the treatment
of depression, in the biggest generic drug launch ever.
Eli Lilly and Co.'s last valid patent for Prozac expired Thursday, paving
the way for the Food and Drug Administration to grant final approval
of Barr's product. The generic should be available for sale today.
Barr won't specify how much the generic Prozac will cost, but said the
price will be between 25 to 40 percent lower than the daily cost of
$2.63, which means the approximately 2 million people taking Prozac
will save up to $383 annually. Both are available by prescription only.
Prozac generated $2.6 billion in sales for Lilly in 2000, and is the
biggest selling drug to ever go off patent. It became a blockbuster
because it lacks the harsh side effects of earlier depression medicines,
an advancement that spurred more doctors to prescribe the medicine and
consequently ended some of the taboo surrounding mental illness.
***END****END****END****END****END*****END********
*****
So what?? What point are you trying to make Supie?? One may ask... Well
as all or most of your know. L-tryptophan was yanked from the market
in 1990 after some mishaps back in 1989. Let's read on. This below article
I do have reference to where it came from and it's actually a very very
insightful article. I suggest you read with clarity.
----------------------------------------------------------------------------------
The FDA Ban of L-Tryptophan:
Politics, Profits and Prozac
by Dean Wolfe Manders, Ph.D.
In the fall of 1989, the FDA recalled L-Tryptophan, an amino acid nutritional
supplement, stating that it caused a rare and deadly flu-like condition
(Eosinophilia-Myalgia Syndrome — EMS). On March 22, 1990, the
FDA banned the public sale dietary of L-Tryptophan completely. This
ban continues today. On March 26, 1990, Newsweek featured a lead article
praising the virtues of the anti-depressant drug Prozac. Its multi-color
cover displayed a floating, gigantic green and white capsule of Prozac
with the caption: “Prozac: A Breakthrough Drug for Depression.”
The fact that the FDA ban of L-Tryptophan and the Newsweek Prozac cover
story occurred within FOUR DAYS of each other went unnoticed by both
the media and the public. Yet, to those who understand the effective
properties of L-Tryptophan and Prozac, the concurrence seems “unbelievably
coincidental.” The link here is the brain neurotransmitter serotonin
— a biochemical nerve signal conductor. The action of Prozac and
L-Tryptophan are both involved with serotonin, but in totally different
ways.
Superior1 (read that again 4 days)
Elevated levels of serotonin in the body often result in the relief
of depression, as well as substantial reduction in pain sensitivity,
anxiety and stress. Prozac, as well as other new anti-depressant drugs
such as Paxil and Zoloft, attempt to enhance levels of serotonin by
working on whatever amounts of it already exist in the body (these drugs
are known as selective serotonin reuptake inhibitors). None of these
drugs, however, produce serotonin. In contrast, ingested L-Tryptophan
acts to produce serotonin, even in individuals who generate little serotonin
of their own. The most effective way to elevate levels of serotonin
would be to use a serotonin producer rather than a serotonin enhancer.
Superior1 (read that again We pulled a natural substance that MAKES
serotonin, and replaced it with a drug that makes the serotonin you
have (either nromal levels or diminished) work better by basically inhibiting
the uptake of it. They virtually built a market for prozac, by pulling
L-tryptophan off the market. This gets good read on!! You'll be glad
you did.)
The continuing FDA public ban of L-Tryptophan prevents popular access
to this most effective serotonin producer. The millions of Americans
who for decades safely had relied upon L-Tryptophan to relieve depression,
anxiety and PMS, as well as to control pain and induce natural sleep,
have been forced elsewhere for solutions. Routinely, such solutions
are pharmaceutical in nature: people are forced to use either often
highly addictive, expensive, and sometimes dangerous drugs like Xanax,
Valium, Halcion, Dalmane, Codeine, Anafranil, Prozac, and others, or,
simply suffer.
Present FDA public policy maintains that L-Tryptophan is an untested,
unapproved and hazardous drug. The analytical work done a few years
ago by the Centers for Disease Control and the Mayo Clinic, research
which traced the fall 1989 outbreak of the serious flu-like condition
to contaminants found in batches of L-Tryptophan made by the Japanese
company Showa Denko, has not convinced the FDA to allow L-Tryptophan
back on the market. This decision is based primarily on the research
of FDA and NIMH scientists who state that L-Tryptophan itself, irrespective
of contaminants, is a dangerous substance. Other university-based research
scientists disagree with these findings.
Superior1 (PLEASEEE Do not call me a conspiracy theorist, but my GOD
how coincidental??)
The public availability of L-Tryptophan is too important an issue only
to be argued and shrouded within a scientific debate that remains, ultimately,
mystifying to the vast majority of Americans. There are many obvious
facts worthy of public attention, and public concern. For example, consider
the following:
On February 9, 1993, a United States government patent (#5185157) was
issued to use L-Tryptophan to treat, and cure EMS, the very same deadly
flu-like condition which prompted the FDA to take L-Tryptophan off the
market in 1989. SUPERIOR1 (Please read read that last bullet statement)
Did you know that ladies and gents??
Notwithstanding its public ban and import alert on L-Tryptophan, the
FDA today allows Ajinomoto U.S.A. the right to import from Japan human-use
L-Tryptophan. Distributed from the Ajinomoto plant in Raleigh, North
Carolina, the L-Tryptophan is then sold to, and through, a network of
compounding pharmacies across the United States. Purchased by individuals
only under a physician's order, L-Tryptophan emerges as a new prescription
drug in the serotonin marketplace; one hundred 500 mg capsules cost
about $75 — approximately five times more than if they were sold
as a dietary supplement. SUPERIOR1 ( I told you this was getting good,
and I bet you didn't know that either)
Since the FDA holds the political mandate and power of a public regulatory
agency established, ostensibly, to protect people from raw corporate
interests in drug production and distribution, the actions of the FDA
in concert with Ajinomoto U.S.A. are illuminating. By publicly banning
L-Tryptophan from its dietary supplement status and price, while allowing
L-Tryptophan to be sold as a high-priced prescription drug, the naked
duplicity of FDA L-Tryptophan policy is revealed.
Superior1 (does this PISS you off too?)
During and after the 1989 EMS outbreak, the FDA did not totally ban
the use of L-Tryptophan in humans — then, as today, the FDA has
granted the pharmaceutical industry the protected right to use L-Tryptophan
in hospital settings. Manufactured by Abbott Laboratories, the amino
acid injectable solutions Aminosyn and Aminosyn II contain as much as
200 mg of L-Tryptophan. (Moreover, L-Tryptophan has never been removed
from baby food produced and sold within the United States.)
SUPERIOR1 (NOW I AM PISSED FOR SURE!!!! Baby food?? If it was truly
dangerous why did the FDA not protect the most innocent creatures on
earth?
While the FDA has banned the public sale and use of safe, non-contaminated,
dietary supplement L-Tryptophan for people, the United States Department
of Agriculture still sanctions the legal sale and use of non-contaminated
L-Tryptophan for animals. Today, as in the past, feed grade L-Tryptophan
continues to be used as a nutritional and bulk feed additive by the
commercial hog and chicken farming industry. Additionally, L-Tryptophan
is now available for use by veterinarians in caring for horses and pets.
Outside of the United States, in countries such as Canada, the Netherlands,
Germany, England, and others, L-Tryptophan is widely used. Nowhere,
have any serious or widespread health problems occurred.
At bottom, the FDA public ban of safe, non-contaminated L-Tryptophan
is uneven, expensive, and biased in favor of the pharmaceutical industry.
The FDA proscription effectively awards billions of dollars in profits
to pharmaceutical companies and their suppliers in the same proportion
as it adds billions of unnecessary dollars to the nation's already bloated
health care expenditures.
SUPERIOR1 (Basically they banned L-tryp solely from the prozac market
base, what a crock)
On June 15, 1993, the FDA Dietary Supplement Task Force published a
report on the work it had been doing in the area of developing FDA policy
around nutritional supplements. On page two, the report admits, “The
Task Force considered various issues in its deliberations, including...
what steps are necessary to ensure that the existence of dietary supplements
on the market does not act as a disincentive for drug development.”
In this case, the FDA has succeeded in carrying out its stated policy
goal. With competition from publicly available L-Tryptophan removed,
the rapidly expanding market in prescription serotonin drugs —
now among them L-Tryptophan itself — contains no major “disincentives”
for the massive accumulation of pharmaceutical industry profits.
It is now time for appropriate congressional committees to review openly
and aggressively the entire matter of L-Tryptophan. This will provide
a needed forum where political, corporate, and scientific issues of
FDA L-Tryptophan regulatory policy may be addressed. There exists ample
precedent for such hearings: in the 1980's and early 1990's, for example,
such investigations uncovered FDA favoritism in the approval of generic
drugs and the bribery of FDA officials.
The story of L-Tryptophan illustrates a sad and perverse picture of
the politics and priorities of public health in America: A safe, dietary-supplement
serotonin producer is publicly unavailable to people, while daily fed
to animals by corporate agribusiness. A drug patent is approved to use
L-Tryptophan to cure the very condition the FDA claims it caused. And,
while publicly exclaiming that L-Tryptophan is a dangerous and untested
drug, the FDA, more quietly, allows human-use L-Tryptophan to be imported,
and then marketed and sold by the pharmaceutical industry.
To allow the FDA ban of L-Tryptophan to continue unreviewed and uninvestigated
condemns millions of Americans to unnecessary financial expenditures
and needless suffering.
Copyright (c) 1995 by Dean W. Manders. All Rights Reserved. Used with
permission.
SUPERIOR1 (There you have it ladies and gents, not much more I can say,
You are free to make your own views at this point, I just hope they
are based on truth and integrity.
To Discuss This Article Further, Please Click
Here:
http://www.professionalmuscle.com/forums/showthread.php?t=3943
