Jan

6

Colorado Springs pharmacy owner Thomas Bader knew he was breaking the law by importing and distributing human growth hormones from China, prosecutors charged Tuesday.

Assistant U.S. Attorney Jaime Peña told a federal jury that Bader and a sales representative had an attitude as they pursued their illicit business.

“They told us we couldn’t do it so we did it anyway,” Peña said, describing that attitude in opening statements of a trial in which Bader, 67, is accused of conspiracy, smuggling and illegal distribution of the hormones. Prosecutors contend the hormones lacked U.S. Food and Drug Administration approval.

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Dec

31

An Orlando pharmacy whose operators were snared nearly three years ago in an Albany County criminal probe has been implicated in an international network that federal authorities say smuggled human growth hormone from China to the United States, court records show.

The controversial drug is strictly regulated by the U.S. Food and Drug Administration. Yet human growth hormone, or HGH, has been used by professional athletes, bodybuilders, celebrities and others who subscribe to its anti-aging and muscle rejuvenating effects.

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Dec

1

Pfizer whistleblower and compulsive blogger Peter Rost has tossed his Panama hat into the ring for the post of FDA commissioner in the new Obama administration.

He’s got the “backing” — or at least the paperwork — of Sen. Sherrod Brown and Rep. Jo Ann Emerson. Rost is best-known as the former Pfizer vp who dragged the company’s name through the mud by opposing its position on reimportation and by going public with the news that Pfizer acquired a company it knew was selling Human Growth Hormone (HGH) illegally.

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Nov

20

When I was a medical reviewer at the FDA in the 1980s, a completely unexpected side effect occurred in the clinical testing of a new formulation of human growth hormone (HGH) synthesized in bacteria.

During the initial clinical studies on healthy volunteers (who happened to be senior executives of the drug company), the drug caused extreme pain at the injection site, fever and abnormalities in blood chemistry that indicated inflammation. The problem resulted not from any anomaly in the growth hormone molecule itself but from a low-level contaminant that, when injected into human subjects, stimulated white blood cells to release a substance that caused the signs and symptoms. Because of the indirect mechanism of its toxicity and its specificity for human cells, the contaminant had been undetectable in both the standard, sophisticated screening tests that are supposed to assure a drug’s purity and quality, and in studies in animals. Thus, the problem only appeared when the drug was injected into humans.

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Nov

13

HGH Use & Cost

November 13, 2009 | Leave a Comment

Another researcher, Dr. Mary Lee Vance of the University of Virginia, has estimated that 30 percent of human growth hormone (HGH) prescriptions in the U.S. are for reasons not approved by the FDA. The price tag for such treatment is hefty: often more than $1,000 per month.

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Oct

8

From the United States Attorney’s Office, District of New Hampshire
On July 27, 2009, Christopher Chase, of Lynn, Massachusetts, was sentenced to three and a half years imprisonment and three years of supervised release for his involvement in an Internet prescription drug scheme that distributed anabolic steroids, human growth hormone (HGH), insulin-like growth factor (IGF-1), and clenbuterol throughout the United States. A two-count indictment charged Chase and two codefendants with conspiracy and money laundering.

According to the indictment, Chase and his team illegally imported the drugs from overseas, primarily China, marketed them as body-building substances, and sold them without a prescription on various websites. Of course, FDA has not approved anabolic steroids, HGH, or IGF-1 for use in body-building activities, and clenbuterol is not approved for use in humans by FDA. Although some countries have approved it as a prescription-only bronchodilator, clenbuterol is known to be abused by bodybuilders for its weight-loss properties, according the the Department of Justice. The money from the sales of these drugs was sent to various merchant bank accounts that Chase had set up, and then laundered through foreign countries such as China and Moldova.

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Jul

1

The FDA issued approval for Antares Pharma’s (Ewing, New Jersey) needle-free injection device for use with Tev-Tropin brand human growth hormone (hGH) from Teva out of Petach Tikva, Israel. The device will be marketed under the name Tev-Tropin Tjet Injector system.

 Reusable Needle-Free Injectors (Medi-Jector VISION®) deliver precise medication doses through high-speed, pressurized liquid penetration of the skin without a needle. These reusable, variable-dose devices are engineered to last for a minimum of two years and are designed for easy use, facilitating self-injection with a disposable plastic needle-free syringe to assure safety and efficacy. The associated disposable plastic needle-free syringe, offers high precision liquid medication delivery through an opening that is approximately half the diameter of a standard, 30-gauge needle and it is designed to last for approximately one week. Antares has sold the Medi-Jector VISION® for use in more than 30 countries to deliver either insulin or human growth hormone (”hGH”).

                  

 

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Apr

15

Today the human growth hormone (HGH) industry approaches $2 billion a year.

 It claims benefits for enhancing athletic performance, anti-aging and stimulating growth. Unfortunately, many of these remain unproven says NAIRO, trade association of independent review organizations (IROs) whose members see daily requests from health plans asking about the medical necessity of growth hormone (HGH) therapies.

Because of its dangers, the Food and Drug Administration (FDA) tightly controls HGH and prohibits doctors from prescribing it for any use the agency has not specifically approved. For example, if doctors prescribe the drug to enhance athletic performance or reverse aging they are breaking the law.

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Mar

11

March 10 (Bloomberg) — Momenta Pharmaceuticals Inc. may become the first drugmaker to win U.S. clearance to sell generic versions of a biotechnology medicine, getting a head start on President Barack Obama’s plan to trim health-care costs by making such copycats commonplace.

Brand-name biotech treatments, which can cost individual consumers or their health plans as much as $200,000 a year, are made from living cells, unlike pharmaceutical medicines that are chemical-based. Generic-drug companies can’t sell copies of brand-name biotechnology drugs because the 1984 U.S. law allowing versions of conventional pills doesn’t provide a system to measure safety and approve so-called biogenerics.

Not all drugs made from living cells are considered by the FDA through the agency’s biologics license application process. For a variety of reasons, some categories of treatments made using living cells, including insulin, human growth hormone (hgh) and heparins, were approved under the process for conventional medications.

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Mar

10

WASHINGTON (Reuters) - U.S. regulators will allow experimental use of Insmed’s drug Iplex for certain patients with Lou Gehrig’s disease, the Food and Drug Administration said on Tuesday.

The drug is approved for treating a growth hormone deficiency but is not currently marketed because of a court order related to patent infringement, an FDA notice said.

The agency said a number of doctors had requested permission to use the drug for patients with Lou Gehrig’s disease, also known as amyotrophic lateral sclerosis or ALS. Similar drugs have been tested for the fatal neurological disease but failed to show benefit. Some trials suggested patients may fare worse with one of the medicines than a placebo, the FDA said.

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Read the entire ALS/HGH article

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