Here we go, another prime example of how the drug lords are medicalizing normal characteristics of children. If they can't hook them with fraudulent mental disorders, they'll go after physical characteristics, such as stature.
FDA Approves Wider Use of Growth Hormone
By Marc Kaufman
Washington Post Staff Writer
Saturday, July 26, 2003; Page A12
The use of human growth hormone to treat children who are healthy but unusually short was approved yesterday by the Food and Drug Administration
-- the first time that the agency has embraced use of the controversial drug to treat UNEXPLAINED shortness.
To advocates of the approval, it offers new possibilities for very small children who suffer from a growth disorder. But critics have attacked the expanded use as a misguided effort to turn a cosmetic or social problem into a medical one.
The FDA based its decision on studies that found the biosynthesized hormone Humatrope added between one and three inches in height to children who took it for four to six years, and that there were no SIGNIFICANT health risks
for the children.
The drug has been available since the late 1980s, but it had been approved by the FDA only for shortness caused by specific diseases and syndromes. The new approval is for shortness -- defined as an adult height of less than 5 feet 3 inches for men and 4 feet 11 inches for women -- without a known cause.
[Must we all fit in the average catagory? Must we have a pasturized, homogenous society? What happens in a few decades when short people are tallere? Those who were once considered normal or average may suddendly fall into the short catagory because the observable standard has changed.]
The approval could significantly increase the number of children who receive the expensive treatment, which doctors say can cost $30,000 to $40,000 a year, because it will put pressure on insurance companies to cover it. The drug's manufacturer says it would cost less.
But the FDA said that the maker of Humatrope, Eli Lilly & Co., has agreed not to advertise it directly to consumers; that can greatly increase demand for a medication. The company estimates that 400,000 children would fit the new category, but that only about 10 percent will get treatment.
[400,000 x $35,000= $14,000,000,000 per year or $1,400,000,000 for 10%. So some short kids can have the "opportunity" to possibly gain an inch or two?]
The medical profession is split on whether expanding the use of human growth hormone is good.
"We really don't have enough information to know how effective it will be and how widely it should be used," said Naomi D. Neufeld, a Los Angeles
pediatric endocrinologist who is a board member of the American Association of Clinical Endocrinologists.
"Some doctors think it can be very helpful, but we also have a small but very loud group that says, 'Don't do it.' " she said. "Clearly, this is a treatment that has to be considered on a case-by-case basis and that involves a major family decision."
She said that doctors are debating whether it makes sense to recommend the medication when it costs so much and has LIMITED effect. [No mention of possible side effects]
But a spokeswoman for Eli Lilly, Judy Kay Moore, :silly: said the new approval will bring relief to thousands of small children. "These kids have a growth disorder, just like the ones who have been getting Humatrope for years," she said. "The difference is simply that the origins of their growth disorders ARE NOT NOW KNOWN. But that shouldn't keep them from getting treatment."
The FDA decision draws on the results of two studies that followed children who were unusually short for unknown reasons, for four years and six years.
The first group received injections three times weekly, and the second group received LARGER DOSES SIX TIMES A WEEK until they reached adult height. The studies found that the final height of the children exceeded what had been PREDICTED without the drug in a majority of patients, and by as much as four inches in some of those in the second study.
[Can one accurately predict the adult height of a child? No. Maybe within an "inch or two"...about what the drug is reported to sometimes acheive.]
The FDA said the drug should be used for only the shortest 1.2 percent of children. The agency said that "short stature" -- shortness without a clear
medical reason to explain it -- is a defined condition, but some do not believe it is a necessarily treatable condition.
University of Pennsylvania ethicist Arthur L. Caplan said he was concerned about the FDA approval, because "we will start to treat the normal as a disease."
"I think it's dangerous when you take people who are normally short and say there is something wrong with them," he said.
"Whenever you take people on the low end of a distribution curve and say they have a disorder, you're starting down a slippery slope."
The FDA decision followed the recommendation of an advisory panel last month that voted 8 to 2 in favor of approving the new usage of the drug. The
chairman of the panel, Glenn Braunstein of Cedars-Sinai Medical Center in Los Angeles, said the panel concluded that the drug produced a usually SMALL BUT DISCERNABLE increase in height in MOST patients, and did not APPEAR TO cause other health problems.
"If a family thinks this will help their child, we concluded they should have the right to use it," Braunstein said. "But it has to be a really
considered and informed consent, because the cost is great and the improvement will probably be limited."
Braunstein also said that he did not think the drug should be covered by government medical programs or insurance companies unless there is a growth disorder with an identifiable cause. "There will always be someone in the
shortest group of a population."
*****************************
Should short children/people scream discrimination? Why don't they make tallness a disorder? Anyone over 6 feet should take anti-growth hormone. :lol:
******************************
http://blueprint.bluecrossmn.com/topic/hghNo one has thoroughly studied the long-term -- or even short-term -- side effects of taking human growth hormone for non-medical reasons. But there's reason to suspect trouble. People who naturally produce too much of the hormone or have received medical treatment for growth failure often develop abnormal hearts, bones, and nerves, and are particularly likely to suffer from osteoporosis, heart failure, and other diseases. Sports medicine researchers at the University of Massachusetts, among other experts, suspect that long-term use of supplemental HGH could have similar consequences.
http://www.niddk.nih.gov/health/endo/pu ... /alert.htmPeople who have been treated with hGH may be at risk of adrenal crisis, a preventable condition that can kill them. These deaths can be prevented if patients and their families recognize the condition and treat it right away. Adrenal crisis is a medical emergency. Know the symptoms and how to adjust your medication when you are ill. Taking these precautions can save your life.
http://www.niddk.nih.gov/health/endo/pu ... date.htm#1Of about 7,700 Americans who received NHPP hGH, 26 people have gotten CJD. The two things that seem to be connected with getting CJD are:
How long a person has been treated with hGH: The average treatment time with hGH was 3 years. People who got CJD typically were treated with hGH for about 9 years.
When a person was treated with hGH: All the people who got CJD had been given hGH before 1977.
Overall, 1 in about 300 people treated with hGH got CJD. All CJD patients received some hGH before 1977. Of those treated before 1977, 1 in 104 got CJD.
In 1977, the NHPP changed the way it made hGH. Scientists added a new purification step that greatly reduced and may have removed the risk of CJD. So far, no patient who started hGH after 1977 has become ill with CJD. Since CJD takes so long to develop, we still don't know for sure that those who started treatment after 1977 are safe.
The longest reported time from the start of hGH treatment to first signs of CJD is 33 years in U.S. patients. One person in Holland got CJD attributed to hGH 38 years after a very brief use of hGH. This is the longest incubation period on record.
http://www.ninds.nih.gov/health_and_med ... htm#whatisCreutzfeldt-Jakob disease (CJD) is a rare, degenerative, invariably fatal brain disorder.
There is no treatment that can cure or control CJD.
****************************
Well, that's about all I need to read on the subject. They certainly are willing to roll the dice with other people's children.
And back to the main point, drug companies are about making humans guinea pigs, profit for themselves and stockholders. The "window of loss" is acceptable, even for "short stature". In my system of judgment, it is criminal to subject children to dangerous drugs when safe alternative exist. And for those who are short because their genes dictated shortness, well they could be best helped by learning to accept their stature.
Deborah