Wednesday, September 16, 2009

EATING WELL; Children Are Focus Of Diet-Pill Issue.(Living Desk). USA, LLC

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AMERICA'S obsession with dieting is having a severe impact on children, a House subcommittee was told last week in hearings addressing the safety of nonprescription diet pills.

AMERICA'S obsession with dieting is having a severe impact on children, a House subcommittee was told last week in hearings addressing the safety of nonprescription diet pills.

For instance, Dr. Denise Bruner, an obesity specialist in Arlington, Va., said she had seen 8-year-old patients who had used diet pills containing phenylpropanolamine, a drug that can also raise blood pressure and cause dizziness, even strokes and seizures.

A recent survey by the University of California at San Francisco of 500 9-, 10- and 11-year-old girls in California found that almost half of the 9-year-olds were dieting, although few of them were overweight; the study said only 17 percent of all the girls were overweight.

And Dr. David F. Williamson of the Centers for Disease Control in Atlanta told the Subcommittee on Regulation, Business Opportunities and Energy last week that based on a 1987 report, ''nearly seven percent of 8th- and 10th-grade girls in the United States used diet pills or diet candies'' in 1986.

For almost two decades, the Food and Drug Administration has been trying to decide whether the benefits of phenylpropanolamine, usually referred to as PPA, outweigh the risks. It has been widely used in diet pills since the early 1970's, and the F.D.A. has allowed the drug to stay on the market while it decides whether PPA is safe and effective.

Phenylpropanolamine is the active ingredient in such diet aids as Dexatrim, Acutrim, StayTrim and Control. It is also used as a decongestant in cough and cold remedies like Comtrex, Contac and Alka-Selzer Plus.

At an earlier hearing this spring, the F.D.A. told the regulation subcommittee that it would probably officially approve PPA for use in over-the-counter cold remedies and diet pills in the near future.

Most of the criticism of PPA has focused on the weight-loss pills, with critics charging that the ingredient is marginally effective for losing weight and unsafe for many people. The drug industry has financed dozens of studies that it says prove the safety and effectiveness of phenylpropanolamine. But in testimony last week before the subcommittee, whose chairman is Representative Ron Wyden, Democrat of Oregon, the American Society of Bariatric Physicians, doctors who specialize in obesity, called for the removal of PPA as an over-the-counter diet aid.

In a report prepared for the subcommittee, Dr. Paul Raford, a physician for the United States Public Health Service, said young dieters, especially those between 10 and 19 years old, account for the greatest number of adverse reactions to phenylpropanolamine. Citing statistics from agencies that track drug problems, including the Poison Control Center, he said that based on the number of doses sold, ''PPA causes by far more adverse drug reactions'' than any other leading over-the-counter medications, and that ''PPA diet pills register many more adverse effects than PPA cough-cold remedies.''

Research conducted by Dr. Lawrence Krupka, a professor of natural science at Michigan State University who testified at the hearing, indicates that some young people take more than the recommended 75 milligrams of PPA a day, or take it with other prescription or nonprescription drugs.

No clinical studies have been conducted on the effects of phenylpropanolamine on people under 18. Some products carry a warning that diet pills with PPA should not be used by those under 18 without the advice of a doctor or pharmacist, but some packages of diet pills warn only that the product should not be used by children under 12.

Testifying before the subcommittee last week on behalf of the American Society of Bariatric Physicians, Dr. Bruner said PPA should be available by prescription only. ''With the magnitude of eating disorders we see, especially among young women, the first thing they use is diet pills,'' he said. ''With the ease of availability, there is such a potential for misuse it becomes a real problem.''

Vivian Meehan, a registered nurse and president of the National Association of Anorexia Nervosa and Associated Disorders, reiterated that concern in her testimony. ''Over-the-counter drugs play a significant role in adolescent dieting and in the development of adolescent eating disorders,'' she said.

Dr. William Dietz of the Department of Pediatric Nutrition at the New England Medical Center in Boston, said, ''Very restrictive diets may also lead to greater susceptibility to infection, to a weakened heart muscle and to reduced growth.''

When questions about the safety of PPA as a diet aid first arose in 1972, there was little to indicate that young people would routinely misuse it. But Dr. Bruner said that adolescents will do anything to be accepted, and that today being accepted means being ''stick thin.'' ''By today's standards,'' she added, ''Marilyn Monroe would be considered a little pudgy.''

As the obsession with dieting increases, the number of people who contact poison-control centers around the country seeking medical help or reporting side effects from taking PPA diet pills has increased dramatically. In 1983 there were 878 reports; in 1989 there were 2,439. The most serious of these cases are also reported to the Food and Drug Administration, which found that 38 percent of those reports from 1979 to 1990 involved people 10 to 29 years old.

When officials of the F.D.A. division that reviews over-the-counter drugs told the subcommittee in May that it would probably approve PPA for cough and cold remedies and diet pills, they may not have been aware of this evidence.

In an interview after last week's hearing, Dr. William E. Gilbertson, director of the division, said that because of the testimony ''we may have to go back and look at it closely.'' He added, ''We could change our decision if new information was presented.''

Scientists generally agree that phenylpropanolamine, used correctly, appears to be safe for large numbers of people, but Dr. Raford, who was the first to pull together available literature on PPA, said the safety data are not conclusive.

''Even used correctly,'' he said, ''a small but significant percent of the population will experience undesired and potentially dangerous reactions, including heart damage, stroke, seizures and serious problems with other organ systems.''

The industry concludes that whatever the risks, they are outweighed by the benefits. PPA ''is a safe, effective product that really helps the motivated consumer,'' said Dr. Edward L. Steinberg, vice chairman of Thompson Medical Company, which manufactures Dexatrim, in an interview. ''There are no significant untoward effects.''

Whether PPA is safe is only part of the equation. There are many questions about its effectiveness. Several studies for the industry, none conducted over a long period, indicate PPA will increase weight loss by a half-pound a week. The longest of these studies lasted 22 weeks. And what follow-up there has been suggests that the weight is regained quickly and a greater rate than before, Dr. Raford said.

One of the most recent studies was conducted by Dr. David E. Schteingart of the University of Michigan Medical School, who found that a group using PPA and a placebo group, both on a 1,200-calorie diet, both lost weight, but that the loss was greater among the PPA group.

But Dr. Raford said, ''PPA at best has a modest effect on appetite,'' and ''its long-term effects on obesity remain poorly studied.''

After last week's hearing, Mr. Wyden, the subcommittee chairman, wrote to James S. Benson. the Acting Commissioner of the F.D.A., suggesting several alternatives to full approval of phenylpropanolamine. They include an outright ban, restriction of sales to people over 18, and designating it a prescription drug.

Dr. Gilbertson of the F.D.A. said the agency had not considered those alternatives.

''It could be that the agency might decide to allow PPA for cough and cold remedies but not for diet pills,'' he said. In approving over-the-counter drugs, he said, ''the benefits must far outweigh the risks.''

Source Citation:Burros, Marian. "EATING WELL; Children Are Focus Of Diet-Pill Issue.(Living Desk)." The New York Times (Oct 3, 1990): NA. Academic OneFile. Gale. BROWARD COUNTY LIBRARY. 16 Sept. 2009

Gale Document Number:A175591460

Disclaimer:This information is not a tool for self-diagnosis or a substitute for professional care.

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