FDA Approves Lilly’s Growth Hormone for Healthy Children

FDA Approves Lilly’s Growth Hormone for Healthy Children

Mon, 28 Jul 2003

The FDA has approved Eli Lilly’s injectable human growth hormone (hGH) therapy, Humatrope, for healthy children who are short but have no hormonal deficiency. Lilly claims that its trials in 300 healthy short children resulted in an increase in height of 1.5 to 2.8 inches.

Growth hormone therapy (hGH) has had a tragic history: children suffered the pain of multiple injections and unintended, severe–even fatal–consequences. The National Institute of Child and Human Development (NICHD) conducted a sweeping 22 year experiment from 1963 to 1985 in which world wide, 27,000 healthy children were injected with growth hormone to boost their growth–of these, 7,700 were American children. Growth hormone was obtained from the pituitary glands from cadavers–some of the glands were tainted.

In 1984, Mavis Lay, a 22 year old British woman who had been injected with growth hormone in that experiment developed the deadly Creutzfeldt-Jakob disease (CJD)–which has a long incubation period. She died before she reached her 23 birthday. CJD is rare, in young people it is extremely rare.

Since then a new NIH report (2003) states that the number of CJD casualties among those who were injected with hGH has increased since its 1999 report:

26 Americans died…………. out of 7,700,
89 French died ……………..out of 1,700
38 British died …………….out of 1,848
Another 9 died of CJD in New Zealand (5); Holland (2); Brazil (1) and Australia (1).
Additionally, NIH reports:
“More hGH recipients have died from adrenal crisis than from CJD.”
See NIH report:
http://www.niddk.nih.gov/health/endo/pubs/creutz/update.htm#1

David Davis, a journalist, was one of the subjects of that government approved experiment. His riveting first person accounts are online: Growing Pains. LA Weekly, March 21, 1997, http://www.mad-cow.org/dec_early_news.html and,

Cut Short. Mother Jones, March 23, 2000 http://www.motherjones.com/news_wire/short.html and

When Good Medicine Goes Wrong. Atlanta Magazine, Aug. 2001

An excellent investigative report in the Los Angeles Times (2000) relied on documented evidence unearthed during a 1996 British class action lawsuit. A British court ruled against the government and awarded $7.5 million in damages. None of the surviving American families whose children or parents died of CJD have been compensated. Indeed, the American families can’t even get answers from NIH, which has refused to release the names of participants who want to connect with one another. NIH refuses to disclose the data pertaining to this experiment, claiming “sovereign privilege.” See: EMILY GREEN. A Wonder Drug That Carried the Seeds of Death. The Los Angeles Times, May 21, 2000. pg. 1

In the 1980s and 1990s, a growth hormone experiment was conducted on 20 babies and children with Down syndrome. They were 1 to 4.5 years old. The experiment used synthetic hGH was conducted at the Institute for Basic Research for Developmental Disabilities (IBR), a New York State facility of the Office of Mental Retardation. It is doubtful that children with Down Syndrome could benefit from growth hormone therapy. Without a scientific justification for subjecting the children to pain and discomfort, the experimental treatment is unethical.

Indeed, a letter critical of the IBR experiment following publication of the investigators’ report, is as relevant today as it was in 1992: “Before patients are treated with this or any other therapy, a clearly defined benefit should be seen to outweigh the risks of therapy, including those risks that cannot be foreseen at present.” by Nancy Binder, MD, PhD (Oregon Health Sciences University) Journal of Pediatrics, May 1992, Vol 120, p. 832

Genentech was the supplier of hGH in the IBR experiment. It is estimated that the cost per child, per year was $20,000 to $30,000.

British endocrinologists appear to have learned a lesson: experimental treatments involve risks and unintended consequences. Therefore the precautionary principle–“First, do no harm”–should be followed– especially when children are involved. BBC reports (below) that today, “UK endocrinologists treat growth hormone deficient patients very conservatively, with only the most severely deficient patients receiving ongoing treatment.” FDA officials seem to throw caution to the wind, approving medically unjustifiable treatments whose risks are not fully known.

The New York Times reports (below) that “Lilly pledged tight restrictions on Humatrope’s availability. It will be prescribed only by certain specialists and shipped by special drug stores to patients who undergo tests.”

Who are they kidding? Growth hormone injections are big business. Websites such as, American Pharmacy (a discount drug supplier) offer direct shipments of Humatrope. http://www.mexicohgh.com/chart.html

Humatrope is being marketed much as snake oil was: “…clinical trials demonstrated that somatropin human growth hormone (hGH) replacement therapy resulted in an increase of lean muscle mass, a decrease in body fat, an increase in exercise capacity and an increase in quality of life among adults with somatropin human growth hormone (hgh) deficiency.”

In addition to muscle strength and size, claims are made that GHT improves: energy level; healing powers; sexual function; emotional stability; memory; skin texture and elasticity and makes wrinkles disappear. See; http://www.hgh-humangrowthhormone.com/hgh_growth_hormone_research.htm

The likelihood, therefore, that Lilly will keep its “pledge” and maintain “tight restrictions on Humatrope’s availability” is less than credible.

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http://www.nytimes.com/2003/07/27/science/27HORM.html?pagewanted=print&position=
July 27, 2003
A Hormone to Help Youths Grow Is Approved by F.D.A.
By THE ASSOCIATED PRESS

WASHINGTON, July 26 (AP) – Children who are healthy but abnormally short will be able to have injections of growth hormone in hope of gaining one to three more inches of height, the Food and Drug Administration said Friday, deciding an emotionally charged issue.

The drug, Humatrope, is not for normal children yearning for a few extra inches, the agency cautioned. It is for the shortest 1.2 percent.

The drug’s maker, Eli Lilly & Company, counts about 400,000 such children ages 7 to 15, but predicts that only 10 percent will receive growth hormone because of eligibility restrictions and because six shots a week are required for years.

“This is not cosmetic use,” said Dr. David Orloff, the agency’s chief of endocrinology.

Growth hormone has been used for 16 years to treat children who are extremely short because their bodies do not produce the substance or because of diseases. Some 200,000 children worldwide have taken it.

Lilly sought federal approval to market its brand of growth hormone for children who do not have those medical conditions but are still abnormally short: boys predicted to be shorter than 5-foot-3 as adults, and girls shorter than 4-foot-11.

Lilly’s studies of about 300 children with no known causes of abnormal shortness found injections added an average of 1.5 inches to 2.8 inches of height by adulthood.

Lilly pledged tight restrictions on Humatrope’s availability. It will be prescribed only by certain specialists and shipped by special drug stores to patients who undergo tests.

Copyright 2003 The New York Times Company |

http://news.bbc.co.uk/2/hi/health/2150953.stm
BBC
Friday, 26 July, 2002, 00:43 GMT 01:43 UK
Hormone therapy linked to cancer

Growth hormone has been used for decades

People who take human growth hormone treatment may be at increased risk of developing bowel and colon cancer, research suggests. Scientists say the finding is far from conclusive, and that more work is needed to confirm their suspicions.

Our data do suggest the need for increased awareness of the possibility of cancer risks Professor Anthony Swerdlow

They also stress that no such link has been made with the modern synthetic form of growth hormone that is now used in treatment – although it is possible that it would have the same effect.

Their finding centres on the use of growth hormone taken directly from the pituitary glands of cadavers.

This was widely used until the mid-1980s as a treatment for children and young adults whose growth was impaired.

The researchers from the Institute of Cancer Research and Institute of Child Health, UK, studied data on 1,848 people in the UK who were treated with human growth hormone between 1959 and 1985.

They found that these people were almost three times more likely to die from cancer overall.

But their risk of dying from colorectal cancer was 11 times higher.

Greater vigilance

Writing in The Lancet medical journal, lead researcher Professor Anthony Swerdlow said: “Our data do not show conclusively whether cancer incidence is increased by growth hormone treatment, but they do suggest the need for increased awareness of the possibility of cancer risks, and for surveillance of growth hormone-treated patients.

“At the moment this is a possibility that needs further investigation, rather than a certain relationship that is a cause for immediate concern.”

It is possible that use of human growth hormone increases the risk of cancer by boosting levels of a chemical in the body called IGF-1, which has been shown to stimulate the division of cancer cells.

However, it is also possible that people who are deficient in growth hormone might naturally be more predisposed to colorectal cancer, and that the treatment itself has no effect.

In an accompanying commentary, Dr Edward Giovannucci, of the Harvard School of Public Health, Boston, said it was important to stress that growth hormone treatment had health benefits.

However, he said: “While the data reported by Professor Swerdlow and colleagues should not discourage appropriate treatment of growth hormone deficiency, they should provoke reassessment of the risks and benefits of growth hormone therapy for more controversial indications that are unrelated to growth hormone deficiency, particularly if such treatment is prescribed for long periods.”

Muscle bulk

Growth hormone, as well as helping to promote growth, can be used to build muscle bulk, and improve cardiac performance. It has been used by bodybuilders as an alternative to steroids.

However, it is not officially licensed for such use in the UK.

The Society for Endocrinology and the British Society for Paediatric Endocrinology and Diabetes issued a joint statement welcoming the study.

However, it stressed that artificial growth hormone was of greater purity than the natural version, and that doses were more tightly controlled than they once were.

The statement went on: “We believe replacing the missing growth hormone in severely growth hormone deficient patients can dramatically improve the quality of life of affected adult patients, and allow growth hormone deficient children to grow to a normal adult height.

“UK endocrinologists treat growth hormone deficient patients very conservatively, with only the most severely deficient patients receiving ongoing treatment.”

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