Sunday, July 27, 2008
The New York Times reports on the alarming increase of children experiencing problems such as Type 2 diabetes, high blood pressure, high cholesterol, and acid reflux that were unheard of in children two decades ago. Doctors continue to debate on whether to keep prescribing adult medications to children as a quick fix to lack of exercise and improper diet or because of society and environment. Stephanie Saul writes,
A growing number of American children are taking drugs for a wide range of chronic conditions related to childhood obesity, according to prescription data from three large organizations.The numbers, from pharmacy plans Medco Health Solutions, Express Scripts and the marketing data collection company Verispan, indicate that hundreds of thousands of children are taking medication to treat Type 2 diabetes, high blood pressure, high cholesterol and acid reflux — all problems linked to obesity that were practically unheard-of in children two decades ago.
The data, disclosed publicly in recent months or provided at the request of The New York Times, shows that concerns that children will be taking adult medications — heightened recently by a controversial recommendation by a national pediatricians group — are already a reality.
This month, the American Academy of Pediatrics said that more children, as young as 8, should be given cholesterol-lowering drugs. The recommendation was quickly attacked by some experts as a license to put children on grown-up drugs.
While the drugs do help treat the conditions, some doctors fear they are simply a shortcut fix for a problem better addressed by exercise and diet. Even so, some pharmaceutical companies are developing new versions, including flavored ones, of adult medications for children.
While some of the percentage increases in the three analyses are significant, doctors emphasize that prescriptions of these drugs to children still represent less than 1 percent of their sales.
Express Scripts and Medco developed estimates of how many children might be taking such drugs by extrapolating their data — involving a total of more than four million children — across the broader population.
The companies use different assumptions to reach their estimates, but the data suggests that at least several hundred thousand children are on various obesity-related medications.
The greatest increase occurred in drugs for Type 2 diabetes, with Medco’s data showing a 151 percent jump from 2001 to 2007.
Medco’s data, released in May, showed that use of drugs to treat acid reflux problems in children, often aggravated by obesity, increased 137 percent over seven years. Its analysis also showed an 18 percent increase in drugs to treat high blood pressure and a 12 percent increase in cholesterol-lowering medications during the seven-year period.
Express Scripts found a 15 percent increase over three years in drugs to treat cholesterol and other fats in the blood, a category that is primarily statins.
“We were amazed at how quickly the rates of drugs used have climbed,” said Dr. Donna R. Halloran, an assistant professor at St. Louis University who worked on the Express Scripts analysis, presented at a meeting of the American Public Health Association in November.
Verispan data recorded a 13 percent increase in high blood pressure prescriptions in the under 19 age group from 2005 to 2007. Its numbers show, however, a less than 1 percent increase during the period in cholesterol-lowering drugs in children.
Doctors and some financial analysts have said that less pronounced increases in cholesterol drugs compared with some other medications — seen in all three analyses — reflect a wariness by some doctors about using those drugs in children.
Some experts have expressed concern that the increases in many of these obesity-related drugs reflect a systemic failure, with doctors and parents turning to them because they find lifestyle changes too difficult to implement or enforce.
“I think a lot of people in pediatrics, myself included, are struggling with what is the right management to do for these kids,” said Dr. Russell L. Rothman, an assistant professor at Vanderbilt University, who recently surveyed doctors and found wide variations in how children were being treated.
“You see elevated blood pressure, or elevated sugars, or elevated cholesterol and you try exercise and diet and you don’t see any improvement,” Dr. Rothman said. “I worry that some providers and some families are looking for the quick fix, and are going to want to start medication immediately.” Some pediatricians say they have been treating children with statins for several years.
Dr. David Collier, director of a pediatric weight management center at East Carolina University in Greenville, N.C., an area where 45 percent of the children are overweight, is among doctors who support the recent recommendations that statins may be warranted in some children as young as 8. “We have been using statins for two or three years now,” he said.
One of his statin patients, he said, was a 6-year-old girl.
Dr. Collier, who describes his location as “right smack dab in the middle of the stroke belt,” believes that aggressive therapy is needed to prevent a health crisis. “It’s hard to overstate the size of the problem,” he said.
Dr. Francine R. Kaufman remembers a patient, a 13-year-old girl, whose weight had ballooned to 267 pounds. The teenager appeared destined for the same fate as her grandmother, who lost a leg to Type 2 diabetes.“To control her high blood sugar level, her high blood pressure, and her high cholesterol, this young girl left my office with five medications,” Dr. Kaufman, a pediatric endocrinologist in Los Angeles, told a Senate subcommittee last week during hearings on obesity in children.
The girl stood out as unusual more than 10 years ago, but children with the same array of problems are increasingly seen in the diabetes center where she practices at Children’s Hospital Los Angeles, Dr. Kaufman said.
Diet and exercise are tried first, but “lifestyle is really tough,” Dr. Kaufman said. Some of her patients live in neighborhoods without grocery stores and attend schools that do not offer physical education programs.
“They deserve to be treated,” Dr. Kaufman said. “I think the slant from most of the media is that pediatricians are jumping to put kids on medications. That’s not true at all. Since lifestyle is so difficult, we have no other choice but to go to pharmacotherapy.”
At Camp Pocono Trails, a weight loss camp in Reeders, Pa., that enrolls about 700 children each summer, owner Tony Sparber said that campers are arriving with medications, a pharmacopeia that include statins and diabetes medications.
“You just look at these kids’ medical forms,” Mr. Sparber said. “You see kids with some very high-risk numbers. Cholesterol in the high 200s.”
Experts say that the trend could balloon health care costs. As many as 30 percent of children nationwide are overweight. And children who start such medication often rely on the drugs for a lifetime and are prone to health problems as adults.
Despite a push by the Food and Drug Administration to foster drug studies in children, many experts believe that many clinical studies in children have not been extensive enough. And adult doses are often not correct for children.
The agency publishes a list of drugs for which pediatric versions are needed. So far, the size of the pediatric market is not big enough to make it profitable for companies to make special children’s formulas of drugs for disorders that commonly go along with obesity and high-fat diets. That appears to be changing.
Madeira Therapeutics, based in Leawood, Kan., is formulating a liquid statin for children that will be sold in either grape, cherry or bubblegum flavor, according to the company’s chief executive, Peter R. Joiner.
Madeira became interested in the drug to treat children with a genetic cholesterol condition, familial hypercholesterolemia, which strikes 1 in 500 children regardless of their diet. The recent American Academy of Pediatrics statement adds to the potential market, according to Mr. Joiner.
The company, whose liquid statin may be available by late 2010, is also interested in a liquid oral diabetes medication.
“Because of the obesity epidemic in the United States, we see diabetes as another important area for contribution,” Mr. Joiner said.
A nonprofit group in Cambridge, Mass., the Institute for Pediatric Innovation, is working to encourage the reformulation of medications for children.
Dr. Stephen P. Spielberg, the former dean of Dartmouth Medical School, is leading the effort.
“What we’ve learned over the years is that the way in which the body handles medicines, the half life of a medicine, how it’s metabolized, how it’s excreted by the body, does vary, from babies all the way up to adolescents,” Dr. Spielberg said.
Hypertension medications present a particular challenge in dosing for children. “Even in clinical trials where adult pills were crushed and such, you often can’t even demonstrate that the medication works,” he added.
Medco cautioned that hypertension data can be misleading because some children with attention deficit disorder are treated with hypertension drugs.
The most significant increase in the use of drugs for children has been in oral medication for Type 2 diabetes. And some doctors believe much of those prescriptions were “off-label” use of the drug, metformin, to treat prediabetes, which may affect two million children nationwide.
But some doctors object to the use of metformin for that purpose in children, even though studies have shown it may prevent diabetes in young adults.
“There are no studies like this in children,” said Dr. Tamara S. Hannon, a pediatric endocrinologist at the Children’s Hospital of Pittsburgh.
“The argument may be that we know what happens in adults, so the same should happen in children. It’s been proven untrue in several cases in the history of medicine.”