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Long But Interesting Post - 01-13-2013, 08:58 PM

– By Superior1

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 pre***inantly 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****
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****

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.


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