Experiment to Aid Growth of Short Children Resumes : Medicine: But hormone testing faces a court challenge. Foes warn of treating a physical trait as a disease.
The National Institutes of Health has resumed recruiting healthy children for a controversial experiment in which researchers hope to make short children taller by injecting them with genetically engineered human growth hormone.
Some medical experts say they are troubled by the research because it treats a child’s height--so often a matter of emotional bias, peer pressure or parental vanity--as a medical disability, while those who support it say that making someone a few inches taller with hormone injections is no more harmful than breast implants, liposuction or other conventional cosmetic surgery.
Experts in bioethics, however, say the attitudes underlying the experiment offer a disturbing insight into medicine’s willingness to treat physical characteristics that are the target of social prejudices as diseases that can be cured with expensive drugs or surgical procedures.
“If the disease is being short, then half the people in America have a disease,” said George Annas, director of the law, medicine and ethics program at the Boston University School of Public Health. “Once you define something as a disease, you assume a right to treat it.”
And, as researchers become more adept at manipulating the human genetic structure, the day nears when any inherited characteristic deemed socially undesirable, such as height, skin color or gender, may be targeted for medical experiments and treatment.
“The experiment gives us a peek under the curtain of genetic engineering,” said Arthur L. Caplan, director of the Center for Bioethics at the University of Minnesota. “The desirability of the trait is in the eye of the beholder. Are gender or height diseases? Is there no limit to parental choice or consumer demand?”
Dr. Bernadine Healy, outgoing director of the NIH, had suspended the research last year while it was reviewed by an independent safety panel. After the panel endorsed the experiment’s scientific merit, she gave permission last month for the experiment to resume.
A group of 3,000 physicians called the Physicians Committee for Responsible Medicine and the Washington-based Foundation on Economic Trends are seeking an injunction in U.S. District court today to stop the experiment.
“It is the first time the NIH has exposed healthy children to risk in order to make a scientific point,” said foundation director Jeremy Rifkin. “I have no objection to medical uses of growth hormone, but they have reclassified a social issue as a medical problem. The NIH has no mandate to experiment on children simply because they are victims of discrimination.”
NIH officials say the research is needed to judge the safety of a drug that today is being prescribed by pediatricians to as many as 15,000 children, at least half of whom are healthy and who get growth hormone only because they are significantly shorter than their playmates. Of the 4 million children born in the United States every year, 90,000 will be in the bottom 3% in height.
Among other things, the researchers want to determine whether extra growth hormone does indeed make a child grow taller or just faster.
To counter criticism about using the hormone on healthy children, the NIH panel said, “There is substantial evidence that extreme short stature carries distinct disadvantages, including functional impairment and psychological stigmatization. . . .
“Children and adults with extreme short stature may experience difficulty with physical aspects of the culture generally designed for individuals taller than themselves (e.g. driving a car). They may also be harmed by deeply ingrained prejudices resulting in stigmatization and impaired self-esteem,” the panel reported.
Researchers are enrolling 80 volunteers who will be given injections three times a week for up to seven years. Half will be given a placebo. Those recruited are boys ages 10 to 15 and girls 9 to 14 who are no taller than typical children several years younger than themselves.
In a separate study, the NIH team is also assessing the hormone’s effect on girls with a medical condition called Turner’s syndrome, who often do not reach normal height.
“A determination of the efficacy and safety of these drugs was felt to be imperative,” the NIH panel concluded. “At the same time, they pose regulatory and ethical issues on which informed and intelligent people of good will can disagree.”
Dr. David L. Rimoin, a leading authority on short stature and pediatric growth disorders at Cedar-Sinai Medical Center in Los Angeles, said parents often bring him healthy children in the hope that he will prescribe growth hormone to make them taller.
“I have had people request it because they are worried that their kid won’t make a good hockey player,” he said. “I had one man tell me that if he didn’t add three inches to his height, his wife would divorce him.”
Although reluctant to endorse the use of growth hormone, he says he believes that the NIH study is necessary.
“We are in the midst of what I call a growth industry and it is a matter of how much companies can sell,” he said.
If fears about long-range side effects are laid to rest, the commercial market for human growth hormone could be as large as $4 billion a year, NIH officials said. A year’s treatment with human growth hormone can cost $20,000.
“The potential customers are parents who want their kids to have what they consider advantages,” Annas said. “Height is an advantage. You can see the guilt trip: What? You aren’t giving your kid growth hormone? “
