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The New York Times

Heparin Discovery May Point to Chinese Counterfeiting

This is why we recommend that you purchase supplements made in the United States: This article below, and other widely reported safety concerns with the drug Heparin, poison toothpaste, and pet food, underscore the safety challenges consumers face when purchasing products sourced from China. A very large percentage of the Human Growth Hormone (HGH) sprays and patches, sold on the Internet, are manufactured in China. They are rarely, if ever inspected, and while some of them may reflect an acceptable level of quality and effectiveness, we urge the Buyer To Beware! Our company, Phase4 Pharmaceutical-AgeForce® does not and will not import inexpensive HGH supplements from China. Nor will we use any imported ingredients in our formulas. We formulate and manufacture 100% of our AgeForce® HGH Seals and Sprays in our United States Food & Drug (FDA) Certified laboratories in accordance with FDA-Good Manufacturing Practices. (GMP) This assures both our customers and our company, that AgeForce HGH supplements provide the highest levels of safety, quality, and effectiveness. Phase4 Pharmaceutical-AgeForce® Research & Development Division.

The New York Times

By WALT BOGDANICH

Published: March 20, 2008

Federal drug regulators, in announcing Wednesday that the mystery contaminant in heparin was an inexpensive, unapproved ingredient altered to mimic the real thing, moved closer to concluding that Americans might be the latest victims of lethal Chinese drug counterfeiting. Scientists Near Source of Altered Heparin (March 19, 2008)

The finding by the Food and Drug Administration culminated a worldwide race to identify the substance discovered early this month in certain batches of heparin, the blood-thinning drug that had been linked to 19 deaths in the United States and hundreds of allergic reactions.

The contaminant, the regulators said, is a chemically altered form of chondroitin sulfate, a dietary supplement made from animal cartilage that is widely used to treat joint pain. The agency’s announcement followed a report Wednesday in The New York Times that was the first publicly to identify the modified substance as the likely contaminant. That report was based on nearly two dozen interviews with researchers and scientists in China, the United States and Canada.

Federal officials stopped short of saying that the contaminant — constituting as much as 50 percent of the active ingredient in heparin — was counterfeit. “At the moment we don’t know definitely whether the contaminant was introduced intentionally or by accident,” said Dr. Janet Woodcock, director of the Food and Drug Administration’s center for drug evaluation and research.

Even so, the authorities left little doubt that they believed that the contaminant was not an unintended byproduct of some manufacturing process.

In its natural state, chondroitin sulfate does not have anticlotting properties. But it mimics heparin when altered to form what is called oversulfated chondroitin sulfate. That is what made it difficult for Baxter International, the manufacturer of the heparin associated with the allergic reactions, to detect the impurity. “This compound to our knowledge is not naturally occurring,” Dr. Woodcock said. “It should not be in heparin. And it obviously should not be in the form it is in.”

While identifying the contaminant was a significant breakthrough, investigators still do not know if it is responsible for causing the allergic reactions. Nor do they know why the modified ingredient ended up in heparin, though they have raised the possibility that the substance was used as cheap filler.

“The base compound, chondroitin sulfate, is very abundant and an inexpensive compound,” said Moheb Nasr, director of the agency’s office of new drug quality and assessment. Chemically modifying it, Mr. Nasr added, “will not be that expensive either.”

The F.D.A. said it had found the contaminated heparin at Changzhou SPL, the Chinese plant that supplies the active ingredient to Baxter. Changzhou in turn buys its heparin from two companies, called consolidators, that gather crude heparin from workshops that make it from pig intestines.

Many workshops that make crude heparin are unregulated family operations.

Erin Gardiner, a spokeswoman for Baxter, said Wednesday that tests found the supplies were contaminated before they arrived at the Changzhou plant. “The consolidators and workshops handle the crude material, so that is where our focus is turning,” Ms. Gardiner said.

So far, Ms. Gardiner said Baxter’s investigators had been denied access to the consolidators and workshops. “We will continue to seek access.”

Last week, the F.D.A. said it had not yet visited the workshops.

Some heparin producers in China also sell chondroitin sulfate, which can be derived from pig cartilage. Traders and producers say it is far cheaper than heparin, as little as one-twentieth the cost. That could be an enticement for counterfeiters, especially in the wake of a virulent pig virus that swept across China last year, substantially reducing the availability of the starting materials needed to make the active ingredient in heparin.

Contaminated heparin sourced from China has also turned up recently in Germany, where about 80 allergic reactions have been reported. But investigators there have yet to identify the contaminant. F.D.A. officials said their discovery of chemically modified chondroitin sulfate came exactly one year after the discovery that a pet food ingredient shipped from China contained toxic levels of melamine, which was added to make it appear higher in protein. Many pets became ill, and some died.

Around the same time, The Times reported that an unlicensed Chinese chemical plant sold a cheap counterfeit ingredient, diethylene glycol, that was mixed into cold medicine in Panama, killing nearly 120 people and disabling dozens more.

Diethylene glycol mimics its more expensive chemical cousin, glycerine, a safe ingredient used in medicine, food and toothpaste.

The F.D.A. said its search for answers in the heparin case had been made easier because of the cooperation it had received from China’s State Food and Drug Administration. That was not the case when United States officials inquired last year about the melamine and diethylene glycol.

The agency cited an accord signed in December by the governments of China and the United States as one reason for the cooperation they had received recently, which they said allowed American investigators to quickly begin their investigation of the additive.

Baxter has recalled virtually all of its heparin products. The F.D.A. has also asked that all heparin entering the country be stopped and tested for the contaminant. Heparin is commonly used in dialysis and cardiac surgery. “We feel doctors and patients can be confident that the product on the market for the large volume uses of heparin, for dialysis and so forth, has been tested and is safe,” Dr. Woodcock said.

David Barboza contributed reporting from Shanghai, and Jake Hooker from Beijing.

 

January 3, 2008
Staff-Phase4 Pharmaceutical, llc

If you are currently using an HGH supplement, or are considering using one, there are two very important questions that should be asked and answered in light of the recent revelations of performance enhancing substance abuse in professional (and amateur) sports.

Q. What can we learn from the widespread use of human growth hormone (HGH) by famous athletes in baseball, track & field, cycling, boxing, and other sports to improve overall performance and heal injuries faster?
A. To properly answer this question, it is important to first state that the HGH used by athletes is HGH in an injectable format. HGH in an injectable format is a controlled substance must be prescribed and administered by a doctor! Our company is 100% against the use of Human Growth Hormone (HGH) injections without a doctor’s prescription and ongoing supervision throughout the term of the treatment! However wrong it is to use any performance enhancing drugs in sports, the use of HGH by so many athletes begs the question of why HGH? Why are so many athletes risking their reputations and careers by elevating their levels of Human Growth Hormone? (HGH) The answer is self evident. They are taking these great risks because elevating levels of HGH in one’s system really does help to increase strength, energy, and endurance, improve hearing and vision, speed healing, and so much more!

Q. So that begs the question; if HGH supplementation delivers such great benefits, how can anyone get these same benefits safely and legally? Are HGH supplement legal for use without a doctor’s prescription? Are they safe to use? Do they really work?
A. AgeForce® HGH supplements are 100% legal for sale over-the-counter or online without a doctor’s prescription. Our HGH supplement formulas are comply with all FDA and FTC rules and regulations governing the manufacturing, labeling, and sale of supplements with HGH in their formulations. They are very safe to use! All AgeForce® supplements are produced in an FDA certified laboratory, in adherence to strict GMP manufacturing standards. Our Hormonegentic® HGH is constantly tested and shown to be safe from negative toxicity, mutogenicity, and carcinogenic activity. The production laboratory has a state-of-the-art air filtration system and does not have fluorescent lighting, which can compromise formula ingredients. All formulas are hand-succussed (energetically activated) to avoid exposure to any harmful electromagnetic activity. AgeForce® HGH Supplements are perfectly safe for anyone to use, with the exception of pregnant or lactating mothers or anyone under the age of 21 years. AgeForce® HGH supplements contain domestically sourced recombinant human growth hormone that is an exact genetic duplication of human growth hormone. (191 amino acid chain) We do not use animal GH!
Are HGH Supplements As Effective As HGH Injections? You can count on it! AgeForce® HGH supplements will bring you the same benefits of injectable HGH, they just take longer than HGH injections to show results. The process by which AgeForce® HGH supplements work is also quite different than HGH injections. Injections introduce large amounts of HGH directly into one’s system. Our Ageforce® supplements introduce smaller amount of HGH into one’s system and these smaller amounts are specifically designed to increase the production of natural HGH by the pituitary gland. In effect, a one-two punch. Our supplements elevate HGH levels by virtue of the HGH in the formula, and they stimulate the pituitary gland to increase its natural production of HGH.

 

By Jayson Rodriguez

Rap is definitely a competitive sport — just ask 50 Cent. The brash (and buff) G-Unit star has taken aim at his detractors on more than one occasion through some unforgiving rhymes, targeting the likes of Ja Rule, the Game and others. But to gain a one-up on his opponents, it's hard to imagine 50 would turn to steroids, as a New York newspaper article claimed through sources Monday. Why not just grab a dictionary instead?

Why exactly would revered entertainers like 50 — along with Mary J. Blige, Timbaland, Wyclef Jean and playwright/director Tyler Perry, according to the article — decide to use steroids or human growth hormone? The answer may lie in rejuvenation.

According to the Albany Times Union story, Florida doctor Gary Bandwein allegedly shipped the goods to 50, Blige and company. According to the same report, steroids or HGH would be shipped for the artists to Long Island chiropractor Michael Diamond, who holds residency at New York gym Clay. Diamond — who had not been charged under any counts — happens to be an instructor of anti-aging and longevity medicine at the Manhattan fitness center.

Experts believe, according to the article, that more entertainers are turning to "the unproven anti-aging effects of steroids." But why?

According to Dr. Thomas Barnes, a Newport Beach cosmetic surgeon with more than 10 years of experience in the field, HGH, though controversial in some circles, has its benefits. Barnes said when people pass age 30 — especially entertainers — life begins to take its toll.

"With men, particularly, they start literally wasting away and aging," he said.

The thought is that HGH specifically brings levels of testosterone back up. Dr. Barnes said benefits can include thickening of the hair and skin and "a luster again in the eyes and basically helping the body look more vigorous."

The problem, though, Dr. Barnes admitted, is when steroids and HGH begin to be administered by physical trainers and not trained and licensed physicians.

Larger and dangerous doses may be prescribed by those without proper credentials, and if the body has an adverse reaction to the injection, there's no one to properly respond.

"It is a drug, and it really should be administered by someone who is licensed personnel," Dr. Barnes said. "It's easy for a trainer to give it, but when problems start, that's when the finger-pointing starts."

   

By DAN LE BATARD
THE MIAMI HERALD

January 14, 2008

Just one time, above all the noise from media members shaking their torches and pitchfork-wielding politicians following instead of leading, I'd like to hear one thoughtful athlete cut through the crud and say that he/she isn't sorry for anything other than this ridiculous hysteria surrounding our fun and games.

No more lame B-12 excuses. No more homespun "I took human growth hormone just so that I could get back to aid my teammates, city, church and community." No more finger-wagging lies before Congress or 60 Minutes or federal grand juries.

Just once, I'd like to hear an active athlete/entertainer surrounded by a steroid scandal rise up and be honest and unafraid the way retired Charles Barkley can be when he says that, if it meant the difference between being poor and rich, he would have popped illegal pills "like Tic-Tacs" and spent all his time sticking needles in his ample posterior.

Can you picture it?

The scandalous swirl that envelops Marion Jones and Barry Bonds and Roger Clemens (but, inexplicably, not Shawne Merriman) being countered by one brave and defiant athlete standing in front of the cameras and saying the following to America:

"Yes, I used HGH. Used it all the time, illegally, under the supervision of trainers I pay well to keep me at optimum efficiency.

"My body is a business and a source of great profit in the entertainment industry, and I've hired the best mechanics to keep this machine running right.

"I'm sorry that is something you tolerate from the governor of California and Rambo but not me.
"What I do for a living hurts physically, and the hormone helps me heal. Craig Biggio destroys his stomach lining by taking 12 Advil a day. I did this, which is actually safer. I'm not sorry for that. I'm sorry you don't understand the world where I work. I'm sorry I'm surrounded by ignorant judgments and name-calling and sports McCarthyism. But I'm not sorry for being competitive and looking for advantages in medicine the same way I did in film work, scouting reports and training techniques.

"I take cortisone, a steroid, to keep my shoulder and back from screaming. I had Lasik surgery, lasering my eyes, to improve my vision. But with your arbitrary moralities, you are blurring the line for me so much between what is allegedly natural and allegedly unnatural that not even those Lasik lasers help me unblur it.

"There is no sense of proportionality here. The difference between pain-killers such as cortisone and healers such as HGH isn't nearly as large as the difference between how you react to the former and the latter.

"Legal and illegal? Whatever. Growth hormone has been at the core of ethical debates for four decades. Marijuana is arbitrarily illegal, and alcohol is arbitrarily legal. I took ephedra all the time when I could get it legally at any vitamin store early in my career, but then the government banned it. Androstenedione was legal in my sport one year, not the next.
"I'm not sorry for trying to make myself better. It is what I've done all my life, and it's part of why I'm great at what I do. I do what is necessary to stay atop a cruel and competitive ecosystem.

"You cheer my competitive spirit when you aren't busy judging it now. You love how much I care right up until I care too much. You can call it cheating if being judgmental makes you feel good, but I called it the difference between keeping up and falling behind.

"Why are you gasping? Too honest? You wanted a bowed head and contrition and lies like those from all my broken peers who aren't really sorry for what they did as much as they're sorry for how you react to it?

"All I'm sorry about is that you folks have become irrational because of absurd Congressional hearings and the feds trying to wiretap middle reliever Jason Grimsley and a flimsy Mitchell Report that cloaked gossip in credibility and smeared names just to justify 20 months of work and $20 million in wasted dollars.

"Let me put this in human terms:

"I added years to my career. Would you deny yourself a fountain of youth from which everyone else in your workplace was drinking if it meant falling behind? How many of you wouldn't take a magic potion to keep doing something you love for extra years? How many of you wouldn't do it if it provided a better life for your family by getting you from Triple A to the major leagues with all the accompanying benefits?

"So you can say my work is forever stained. That's fine. But y'all can kiss my asterisk."

 

 

Phase4 Pharmaceutical Research Department
April 2007

There are hundred, perhaps thousands of HGH supplements on the market today that have labels indicating that they contain Growth Hormone, or Human Growth Hormone. Buyer Beware!: You should be very careful to insure that the source of growth hormone should not be porcine, (pig) bovine, (cow) or other animal products. Just because a label or brochure may say GH, or Growth Hormone, it does not mean that it is recombinant human growth hormone. AgeForce® supplements contain the highest quality recombinant human growth hormone. We do not use growth hormone from any animal products. AgeForce® supplements use recombinant human growth hormone that is also called somatotrophin, or HGH which has the identical structure of actual human growth hormone.

Answer:

Until 1985, growth hormone was extremely difficult to obtain. It had to be retrieved from human pituitary glands. The process was time-consuming and there were problems of contamination and purification. The limited supply insured that studies and double-blind clinical trials were very limited. Then in 1985, a team of scientists headed by Dr. David Goeddel, patented recombinant, or bio-engineered human growth hormone. This is a natural plasmid purified culture (Which can be non-animal derived) which is inserted where it “infuses” in the culture and over time develops the 191 single chain amino acids pattern that duplicates human growth hormone. The inert powder is removed and the remaining (HGH) is freeze-dried and can be used for injections, homeopathic, or oral molecular use. Since 1985, several other pharmaceutical companies have developed there own versions of genetically engineered HGH.

In summary, we repeat that all Human Growth Hormone is not created equal! So it is always important to check to insure that the supplement you are using, or the supplement you are contemplating using, contains recombinant human growth hormone. (somatotrophin) It is sourced in the United States (not Mexico or the Orient) from the largest pharmaceutical manufacturer in the industry, to insure that AgeForce® supplements maintain the highest quality and pharmaceutical efficacy. And to insure that they work!

   

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Why Choose AgeForce®

If you base your purchase decision on any of these common sense criteria, we believe you'll choose AgeForce® HGH Supplements:

1. Value
2. Pricing
3. Formula Information
4. Safe & Legal
5. Our Company

Benefits Of HGH Supplements