Company fined $10.5m over fountain of youth drug

Boston: A company that distributed human growth hormone to “well known athletes and entertainers” has agreed to pay a $10.5 million penalty and cooperate with ongoing law enforcement investigations, federal prosecutors said on Tuesday.

Under the terms of the agreement, Specialty Distribution Services Inc., a subsidiary of Express Scripts Inc., will not face prosecution for three years if it fully complies with terms of the agreement.

Steve Littlejohn, a spokesman for St. Louis-based Express Scripts, said the company fully cooperated in the federal investigation and has already implemented procedures to prevent the illegal distribution of human growth hormone.

“Express Scripts does not condone the use of human growth hormone for anti-aging, cosmetic or performance enhancement purposes,” the company said in a news release.

Specialty Distribution Services “knowingly distributed human growth hormone to certain well known athletes and entertainers, including a well known athlete in Massachusetts, knowing that their intended use was athletic performance enhancement, cosmetic or anti-aging,” in violation of federal law, the U.S. attorney’s office said in a news release.

Prosecutors did not mention any names of those believed to have bought HGH from the firm.

The drug in question was approved by the Food and Drug Administration only for specific purposes, including treatment of children with growth failure due to inadequate growth hormones, prosecutors said.

“The public should also realize that human growth hormone has not been shown to be safe and effective for athletic, cosmetic or anti-aging uses, and it must not be promoted or distributed for such uses,” U.S. Attorney Michael Sullivan said in a statement.

The company illegally shipped the drugs five times between October 2000 and December 2005, according to court documents prosecutors filed with the agreement.

Human growth hormone was sent to a “well known professional athlete in Massachusetts” in January 2002 and again in October 2003 following a doctor’s request, the documents said.

Drugs were sent to an entertainer in March 2002 at the request of a doctor who said he was filling the prescription at the patient’s request and that the drugs were “not medically necessary,” according to the documents. The doctor identified his practice as an “anti-aging clinic.”

The company shipped the drugs to a 6-foot-5, 276-pound “entertainer/athlete” in January 2003 after a doctor said it was “medically necessary,” even though the dosage was typically used for performance enhancement, the documents said.

Specialty Distribution Services had pharmacists and other employees who should have recognized the prescriptions as illegitimate, prosecutors said. Under the agreement, it will better train employees to recognize fake prescriptions.

Human growth hormone is produced naturally by the body throughout life, but can cause complications when taken in excessive amounts, said Dr. Linn Goldberg, professor of medicine at Oregon Health and Science University in Portland.

“When you are a fully grown adult who takes HGH in excess, it thickens your bones and skin, puts you at risk for diabetes and other conditions, and causes fluid retention, joint pain and nerve damage,” he said.

Goldberg said he is not surprised that entertainers and athletes are using it, because it can cost $100 per day. Prosecutors said HGH treatment can cost up to $20,000 per year.

“Athletes are looking for the fountain of youth, and the fountain of youth is not to be found in a bottle,” he said.

Regulatory Bodies

Human Genetics Commission – The UK Government’s advisory body on new developments in human genetics and how they impact on individual lives. Gives the Government advice on human genetics with a particular focus on the social, ethical and legal issues. One of its key roles is to promote debate and to listen to what the public and our stakeholders have to say.

The Commission is chaired by Baroness Helena Kennedy QC and is made up of twenty-four members including experts in genetics, ethics, law and consumer affairs. It also has a Consultative Panel of people who have direct experience of living with genetic disorders and who act as a sounding board for reports and recommendations. Human Genetics Commission

The Human Fertilisation and Embryology Authority is the UK’s independent regulator overseeing safe and appropriate practice in fertility treatment and embryo research.

It licences and monitors centres carrying out IVF, donor insemination and human embryo research. We provide a range of detailed information for patients, professionals and Government. The Human Fertilisation and Embryology Authority

GeneWatch UK is a not-for-profit group that monitors developments in genetic technologies from a public interest, environmental protection and animal welfare perspective. GeneWatch believes people should have a voice in whether or how these technologies are used and campaigns for safeguards for people, animals and the environment. It works on all aspects of genetic technologies – from GM crops and foods to genetic testing of humans. GeneWatchUK

The BioIndustry Association , the trade association for innovative enterprises in the UK’s bioscience sector. As the voice of UK bioscience, it is active in representing the sector and its needs to audiences, from patient groups to regional, national and pan-European governments. The BioIndustry Association

Scientists experiment with human growth hormone stimulant

Washington: Scientists at the Univesity of Washington are working on an anti-ageing drug using a compound said to stimulate human growth hormone (Hgh) to give people more energy and cut their body fat.

Scientists at the University of Washington said the experimental growth hormone secretagogue forced the body to secrete growth hormone as it did in youth.

Almost 400 men and women aged 65-84 have taken part in a study in which they were given different amounts of the hormone. Their body lean muscle mass and strength were then measured. Lean body mass of about 1.5kg increased and physical function improved over the year.

Head researcher and professor of medicine George Merriam said the hormone was vital in childhood and its production peaked during puberty but declined with age. Hgh is only prescribable for children with a deficiency and adults with an abnormal defiency.

A secretagogue, such as that being reserached by the scientists, stimulates the body
into producing its own Hgh.