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.

Youth hormone – miracle elixir or dangerous drug?

If you type the term “human growth hormone” into the search engine Google you will find more than 5 million entries including paid adverts from web sites around the world touting it as a miracle cure for all the ills of ageing.

This hormone is credited as an elixir of youth with the ability to turn fat into muscle, rejuvenate sagging skin, restoring libido and reversing memory loss.

The majority of these sites are promising eternal youth by selling bottles of water containing vitamins and amino acids and many are labelled “homeopathic” Hgh. But the truth is the real stuff is made synthetically by just a few pharmaceutical companies and the only way to take it is by injection and it is available only on prescription.

The use of Hgh as a rejuvenation treatment is the subject of much controversy amongst the medical profession since it’s only manufactured for the treatment of growth deficiencies in children and severe adult deficiency – not for ageing. There have been no long-term studies of it as a rejuvenation treatment and the possible side effects which might include carpal tunnel syndrome, diabetes, bone loss and even cancer.

But this hasn’t stopped its popularity as a rejuvenation treatment in the expensive clinics of Beverly Hills and New York and London. Doctors prescribe the treatment which costs about $40,000 (£20,000, €30,000) each year to their rich and celebrity clients in the form of a convenient injector pen.

According to the US magazine, the National Enquirer, devotees of Hgh, include Hollywood celebrities such as Nick Nolte, Pam Anderson, Janet Jackson, Madonna, Demi Moore, Brad Pitt, Marla Maples, Britney Spears and Jennifer Aniston.

The popularity of hgH followed an experiment in the US in 1990 in which a group of 12 men aged over 60 years saw dramatic changes in their bodies as signs of ageing melted away. In the Rudman Study, named after Dr Daniel Rudman, fat turned to lean muscle, bone density increased, skin became thicker and the men looked generally dramatically younger. Their sex drive also increased. They were monitored for adverse effects but there were none.

Produced by the pituitary gland, Hgh is responsible for growth in childhood and helps the metabolism of carbohydrate and fat. It peaks in adolescence but by the time a person hits 60 years the bodyÂ’s production will have fallen by 50% or more. It is produced naturally at night and also stimulated by exercise.

In medical rejuvenation programmes the doctor will usually prescribe it alongside other anti-ageing hormones to restore levels to that of a younger person. These hormones include melatonin, testosterone, oestrogen and the so-called “performancing enhancing” steroid used by athletes, DHEA (dehydroepiandrosterone).

The Belgian endocrinologist Dr Thierry Hertoghe who promotes the benefits of Hgh at anti-ageing conferences and takes it himself says that without the hormone’s benefit, “we would all be tiny little dwarfs that are shy, anti-social, weak and tired,”

Hertoghe who is the author of “The Hormone Solution – Stay younger longer with natural hormone and nutrition therapies” believes that current hormone replacement therapy which consists of replacing only one or two hormones is outmoded and that the bodyÂ’s 100 hormones must function in complex harmony.

Problems occur as we age because hormones inevitably diminish, disrupting the balance, which may trigger weight gain, fatigue, wrinkles, and hair loss. Fortunately, a regimen of natural hormones can protect us, according to Hertoghe, and his book offers anecdotal evidence of dramatic transformations. Although he includes self-scoring checklists so you can determine your own hormone profile, he wisely urges you to implement your own “hormone solution” by working closely with your doctor. .

“In less than six months, a woman of 60 can have legs of a 35- to 40-year-old,” he says.

Hertoghe has treated hundreds of elderly patients whom he has given human growth hormone injections. By restoring Hgh levels typical of a twenty-or thirty-year-old, Hertoghe claims to have thickened their thinning hair, erased their deep wrinkles, lifted their sagging eyelids, smoothed their puffy eyes, toned their sagging muscles, and tightened the loose skin on their cheeks and under their chins. “It’s like magic,” he says.

In the UK the debate was reignited recently when one doctor admitted that he and his wife had both rejuvenated themselves with Hgh, But in London’s Harley Street you will find very few doctors who will admit to prescribing this drug even though they are allowed to go what is called “off-label” if they feel it is justified in the interests of a patient.

One doctor who has used the treatment on herself is Dr Cecilia Tregear. She says that when she reached the age of 50, she was overweight with a BMI (Body Mass Index) of 29 to 30 and looked older than her years and tired. So she embarked on multiple hormone replacement therapy after testing her own blood for deficiencies.

After two years of treatment she says she was transformed by her treatment which included a course of bio-identical hormones.

‘My BMI was down to 23 and I was full of energy,’ she says. ‘The wrinkles had vanished from my skin. My brain worked much better and there was no sign of osteoporosis,Â’ says Dr Tregear

But the Hgh debate rumbles on. A review of 31 studies involving 200 patients, led by researchers at Stanford University in the US, recently concluded that the benefits of human growth hormone therapy are insignificant compared to the increased risk of many conditions including joint swelling and pain, carpal tunnel syndrome, diabetes and prediabetes.

They found that the only benefit associated with its use is slightly increased lean body mass. The therapy increased 2 kilograms of muscle mass and reduced 2kg of fat in the study subjects.

But says Dr Ronald Klatz, president of the American Academy of Anti-Aging Medicine (A4M) said “Thousand sof published studies on hundreds of thousands of patients have demonstrated the clear benefits of adult growth hormone replacement therapy, when utilized under proper clinical guidelines and at proper physiological dosages.

“To deny the benefit of HGH and other essential hormonal regulators of metabolism in deficient patients based on age may be considered a heinous act of malpractice which will prove to be erroneous and shortsighted in the years to come.”

ELIXIR’s own fitness expert, Jon Trevor, say: “Most people would be better off exercising more often and taking vitamin supplements. Injecting with Hgh is not only expensive but there appears to be no credible results to back it up. In the same way that the supplement creatine was all the range for body builders, the introduction of yet another stimulant should be treated with caution.

“Hollywood for the here and now is so image driven that I feel that the long term health effects are cast aside, no doubt the doctors that are prescribing Hgh have their clients sign some form of a disclaimer and so the era of the quick fix is upon us. But this may not turn out to be a quick fix years down the line.”

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Avon growth falls – 1 August 2006

Avon Products has announced a significant drop in its profits as restructuring charges hit the bottom line and the companyÂ’s performance in most markets, including the US, came in below expectations.

The company said that during its second quarter, net income dropped 54 per cent to reach $150.9m on the back $2.1bn in sales, up 5 per cent on the same period last year.

The company said that it incurred a $49m charge, as part of its massive restructuring programme, introduced in the last quarter of 2005. These costs included organisational realignments and a reduction in the workforce, particularly in its middle management.

Avon CEO Andrea Jung said that the company has now eliminated more than 25 per cent of its management positions and lowered the number of management tiers from 15 to eight. This means that to date the company has eliminated 10 per cent of its 43,000 workforce worldwide.

Analysts had expected the drop in profits, but the performance was not as good as average forecasts had expected.

Morgan Stanley said that there could be a limited amount of negative reaction on the stock markets in response to weak top line growth in all markets except China.

The North American market remains flat, although that reverses the steady decline in sales experienced last year. The company said that sales volume were down by 5 per cent, in conjunction with a 7 per cent decline in sales representatives that the company said was exacerbated by rising fuel costs.

Although sales were up by 2 per cent in Europe as a whole, many of the established markets have proved to be tough in the face of stiff competition. The exception has been Turkey, which had proved to be a strong performer on the back of good retail conditions.

In the Central and Eastern European region sales were up 4 per cent, representing a decrease in volumes. The company said that this was due to a fall in colour cosmetic sales throughout the Central European market.

This performance was boosted by stronger results in Russia, which helped to offset a poorer performance in Poland.

Outside of Europe, Asia was particularly disappointing, with sales down 10 per cent, mainly caused by a down-turn in the Japanese market.

In Asia the one shining light proved to be the China market, where sales grew by 8 per cent, in line with expectations. The company said that this figure came about from the resumption of direct sales at the beginning of this year.

In Latin America sales were up 17 per cent, boosted by last year’s acquisition in the Colombia market and the continued growth of the Brazilian market. However, the company said that the Mexico market had proved to be ‘soft’ contributing to lower underlying growth.

Avon’s restructuring scheme aims to save the company around $100m a year, but will have to be fed by top line growth that, judging by the last quarter’s result, is not happening.

In the longer-term results will almost certainly be cushioned by significant savings, but top line growth will have to resume if the company is to sustain the estimated $500m total restructuring costs.

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.