Last updated: December 31, 2012 2:10 p.m. AP IMPACT: Big Pharma cashes in on HGH abuse

DAVID B. CARUSO and JEFF DONN | Associated Press

A federal crackdown on illicit foreign supplies of human growth hormone has failed to stop rampant misuse, and instead has driven record sales of the drug by some of the world's biggest pharmaceutical companies, an Associated Press investigation shows.

The crackdown, which began in 2006, reduced the illegal flow of unregulated supplies from China, India and Mexico.

But since then, Big Pharma has been satisfying the steady desires of U.S. users and abusers, including many who take the drug in the false hope of delaying the effects of aging.

From 2005 to 2011, inflation-adjusted sales of HGH were up 69 percent, according to an AP analysis of pharmaceutical company data collected by the research firm IMS Health. Sales of the average prescription drug rose just 12 percent in that same period.

Source found here

AP IMPACT: Big Pharma cashes in on HGH abuse

Posted: Dec 21, 2012 1:40 AM CSTUpdated: Dec 21, 2012 2:12 AM CST

Associated Press

A federal crackdown on illicit foreign supplies of human growth hormone has failed to stop rampant misuse, and instead has driven record sales of the drug by some of the world's biggest pharmaceutical companies, an Associated Press investigation shows.

The crackdown, which began in 2006, reduced the illegal flow of unregulated supplies from China, India and Mexico.

But since then, Big Pharma has been satisfying the steady desires of U.S. users and abusers, including many who take the drug in the false hope of delaying the effects of aging.

From 2005 to 2011, inflation-adjusted sales of HGH were up 69%, according to an AP analysis of pharmaceutical company data collected by the research firm IMS Health. Sales of the average prescription drug rose just 12% in that same period.

EDITOR'S NOTE - Whether for athletics or age, Americans from teenagers to baby boomers are trying to get an edge by illegally using anabolic steroids and human growth hormone, despite well-documented risks. This is the second of a two-part series.

Continue reading here

Corporate HGH Smuggler Gets Fine

From the Steroids Bodybuilding Peptides and SARMS Blog:


Corporate HGH Smuggler Gets Tiny Fine

A Plattsburgh pharmaceutical company and its president, a Canadian citizen, were fined $15,000 this week for mislabeling more than $1 million worth of human growth hormone that was imported from China and distributed to pharmacies around the country.


The case has ties to a 2007 investigation by the Albany County district attorney's office targeting pharmaceutical companies that illegally sold steroids and other anti-aging drugs.


Antonio Dos Santos, 63, of Montreal and Plattsburgh-based Medisca, Inc., also must forfeit $1.76 million to the U.S. government. Dos Santos and the company pleaded guilty to misdemeanor federal drug charges last October in Albany.


U.S. Magistrate David R. Homer this week ordered Dos Santos to pay a $5,000 fine and the company to pay $10,000.


A former Orlando pharmacy, Signature Compounding Pharmacy, whose owners and operators are under indictment, was among the customers of Medisca, Inc., which also has a corporate office in St. Laurent, Quebec.


John L. Pacht, an attorney from Burlington, Vt., entered a guilty plea on behalf of Medisca last fall.


Plea agreements signed by Dos Santos and Pacht said that between July 2004 and February 2007 Medisca imported 1,737 grams of human growth hormone from China. The criminal accusation is that the company marketed the drug as an "FDA approved drug" which is false, federal prosecutors said.


Dos Santos founded Medisca in 1989. The $1.76 million forfeiture represents the company's gross profits from the unlawful drug sales.


The company ceased importing human growth hormone in February 2007. That month, a multi-agency task force raided Orlando's Signature Compounding Pharmacy. The arrests of Signature's operators were made on warrants filed by Albany County prosecutors who obtained felony indictments against Signature's operators related to the alleged sale of performance-enhancing drugs, including steroids, to customers that included pro athletes and celebrities.


Albany County prosecutors have said Medisca was a primary supplier of Signature pharmacy.


Albany prosecutors allege in their charges that Signature was selling growth hormone to people nationwide who had no legitimate medical reason for the drug.


The plea agreements require Medisca face spot checks by the U.S. Food and Drug Administration for one year. The company must pay the costs of those inspections.


Dos Santos had faced up to a year in prison and a fine of up to $100,000.


Records show Dos Santos, who founded Medisca in 1989, pleaded guilty to a similar charge for illegally importing shipments of minoxidil (Rogaine), a hair-growing product, from Canada into the United States in 1989, when it was prohibited.


The Minnesota conviction was vacated in 2007 after Dos Santos' lawyers filed a motion arguing his plea was flawed and that minoxidil is now approved for distribution in the United States.

Tenth Circuit court of Appeals Affirms Pharmacist's HGH Conviction but Reverses $4.8m Forfeiture

Pharmacist's HGH Conviction Affirmed, $4.8M Forfeiture Reversed

By Robyn Hagan Cain on May 4, 2012 3:02 PM | No TrackBacks

Thomas Bader, a licensed Colorado pharmacist, lost his human growth hormone (HGH) conviction appeal before the Tenth Circuit Court of Appeals this week, but succeeded in getting a $4.8 million forfeiture order overturned.

Bader owned and operated College Pharmacy, a compounding pharmacy located in Colorado Springs. (Though the Tenth Circuit never resolved what a "compounding" pharmacy is, PharmWatch.org described College Pharmacy as "one of several [pharmacies] that supply nonstandard products to offbeat physicians who do chelation therapy, mesotherapy, and other dubious treatments.")

 

Bader was convicted in February 2010 of importation and distribution of anabolic steroids and Chinese-manufactured HGH, reports ABC-7. The charges against Bader even alleged that some of Bader’s HGH went to minors.

In Spring 2004, Bader instructed Kevin Henry, a College Pharmacy sales representative, to locate an economical source of HGH for purchase and distribution. College Pharmacy subsequently began to order and import HGH in bulk quantities from the Genescience facility in China. Employees of College Pharmacy were then directed to repackage the imported HGH into smaller vials for distribution.

Under College Pharmacy’s repackaging protocol, employees copied the relevant HGH drug instruction guides from a Food and Drug Administration (FDA)-approved version of HGH known as Saizen, and included them with College Pharmacy’s own HGH drug, which they labeled and sold as Somatropin. If asked whether Somatropin was FDA-approved, College Pharmacy employees were instructed to explain that the FDA did not have jurisdiction in China, and to reassure customers that the imported HGH was manufactured in an FDA-approved Chinese facility. College Pharmacy also issued several promotional letters and advertisements which implied that Somatropin had been approved by the FDA.

The plan, as Bader’s conviction would suggest, ultimately back-fired.

On Thursday, the Tenth Circuit Court of Appeals affirmed Bader’s convictions for distribution of HGH, but reversed his convictions for possession and distribution of steroids and knowingly facilitating the sale of HGH illegally imported into the United States, and conspiring to do so. (The latter reversal was based on an instructional error.)

In light of the reversals, the Tenth Circuit remanded the forfeiture judgment to the district court for reconsideration.

This summary is found here.

To read the Tenth Circuit Decision, click here.

And yet another example of criminal charges against a compounding pharmacist

Compounding Pharmacist Gains Partial Judicial Relief; Still Guilty on Eight

On April 30, 2010 Judge Marcia S. Krieger, United States District Judge,
District of Colorado dismissed 23 guilty counts against Thomas Bader, a
compounding pharmacist and owner of College Pharmacy in Denver Colorado,
while affirming eight counts and $4.8 million in forfeiture.
The case illustrates many of the nuanced risks involved with compounding
pharmacies, importing and exporting of active pharmaceutical ingredients
(API), compounding and selling high profile drugs such as human growth
hormone (HGH) and anabolic steroids, understanding the subtle distinction
between compounding and manufacturing, and the tenuous interplay between
state compounding laws and the Federal Food, Drug and Cosmetic Act (FDCA).
The case stems back to 2007 when Mr. Bader was charged with illegal
distribution, mail fraud, and conspiracy to facilitate the sale of smuggled
goods. Mr. Bader was importing HGH from China and compounding the API into
finished drug products. As Colorado’s compounding statute is very expansive,
he believed his practice to be protected under state law, and outside the
purview of FDCA.
The federal smuggling charges focused on the fact that imported HGH was from
a non-FDA registered facility and the compounded products thus involved new,
unapproved drugs requiring an NDA under FDCA. Mr. Bader was further charged
with illegal distribution of HGH and testosterone cypionate (a controlled
substance) as both products involved promotion for unapproved uses, illegal
under federal law.
On February 2, 2010 a federal jury found Mr. Bader guilty of 31 counts
including illegal distribution of HGH and controlled substances and unlawful
importation (i.e. smuggling) of HGH. Mr. Bader and counsel then moved to
acquit, or alternatively seek a new trial based on a number of legal
propositions including entrapment by estoppel, violation of due process
rights, erroneous juror instructions, failure to establish a criminal
purpose or intent, and insufficient evidence to support the findings.
Ultimately, on April 29, 2010 Judge Krieger dismissed 23 counts involving
illegal distribution of HGH. The Judge acknowledged a number of Mr. Bader’s
sales were for approved uses of HGH, including some even written for
children. Additionally, Mr. Bader had no way of knowing if the
prescriptions were for permissible uses and thus his actions were protected.
Still, the ruling upheld eight guilty counts. Two smuggling charges were
upheld, as importation of HGH from a non-FDA registered facility was seen as
“contrary to law,” and thus illegal. Simple repackaging or relabeling of a
product may be lawful under state compounding laws; however this
“compounding defense” could not shield Mr. Bader from further provisions of
the FDCA.
Five illegal distribution counts involving HGH were upheld as the use of HGH
as an anti-aging drug is unauthorized and illegal. The lone distribution
charge involving controlled-substances was also upheld, as selling and
promoting testosterone cypionate for muscle building and ant-aging is
illegal. Lastly, the judge affirmed $4.8 million forfeiture in assets based
on the nature of the guilty counts. Sentencing in this matter is scheduled
for June 10, 2010.
To read the remainder of the article click here.

This entry was posted on Monday, May 10th, 2010 at 3:06 pm and is filed under General.