this raises some interesting questions.
Experts Question Placebo Pill for Children
http://www.nytimes.com/2008/05/27/he...gewanted=print
By CHRISTIE ASCHWANDEN
Jennifer Buettner was taking care of her young niece when the idea struck her. The child had a nagging case of hypochondria, and Ms. Buettner’s mother-in-law, a nurse, instructed her to give the girl a Motrin tablet.
“She told me it was the most benign thing I could give,” Ms. Buettner said. “I thought, why give her any drug? Why not give her a placebo?”
Studies have repeatedly shown that placebos can produce improvements for many problems like depression, pain and high blood pressure, and Ms. Buettner reasoned that she could harness the placebo effect to help her niece. She sent her husband to the drugstore to buy placebo pills. When he came back empty handed, she said, “It was one of those ‘aha!’ moments when everything just clicks.”
Ms. Buettner, 40, who lives in Severna Park, Md., with her husband, 7-month-old son and 22-month-old twins, envisioned a children’s placebo tablet that would empower parents to do something tangible for minor ills and reduce the unnecessary use of antibiotics and other medicines.
With the help of her husband, Dennis, she founded a placebo company, and, without a hint of irony, named it Efficacy Brands. Its chewable, cherry-flavored dextrose tablets, Obecalp, for placebo spelled backward, goes on sale on June 1 at the Efficacy Brands Web site. Bottles of 50 tablets will sell for $5.95. The Buettners have plans for a liquid version, too.
Because they contain no active drug, the pills will not be sold as a drug under Food and Drug Administration rules. They will be marketed as dietary supplements, meaning they can be sold at groceries, drugstores and discount stores without a prescription.
“This is designed to have the texture and taste of actual medicine so it will trick kids into thinking that they’re taking something,” Ms. Buettner said. “Then their brain takes over, and they say, ‘Oh, I feel better.’ ”
But some experts question the premise behind the tablets. “Placebos are unpredictable,” said Dr. Howard Brody, a medical ethicist and family physician at the University of Texas Medical Branch at Galveston. “Each and every time you give a placebo you see a dramatic response among some people and no response in others.”
He added that there was no way to predict who would respond.
“The idea that we can use a placebo as a general treatment method,” Dr. Brody said, “strikes me as inappropriate.”
Ms. Buettner does not spell out the conditions that her pills could treat. As a parent, she said, “you’ll know when Obecalp is necessary.”
Franklin G. Miller, a bioethicist at the National Institutes of Health, is skeptical. “As a parent of three now grown children,” he said, “I can’t think of a single instance where I’d want to give a placebo.”
Much of the power of the placebo effect seems to lie in the belief that it will work, and some experts question whether this expectation can be sustained if the person giving it knows it is a sham.
Most clinical trials that have shown benefits from placebos are double blinded. Neither the recipient nor the giver knows that the pills are fake.
“For this to work really well as placebo, you cannot let the parents know that it’s a sugar pill,” Dr. Brody said. “You have to lie to the parents, too, if you expect them to fool their kids.”
At least one study has shown that placebos can be effective even when the patients know that they are inert. In a study in 2007, 70 children with attention deficit hyperactivity disorder were asked to reduce their medications gradually by replacing some of their drugs with placebo pills. The children and their parents were explicitly told that these “dose extender” pills contained no drug.
After three months, 80 percent of the children reported that the placebo had helped them. Although that study used a placebo in a different context from Obecalp, it did suggest that deception might not be necessary for a placebo to work, said the senior author, Gail Geller, a bioethicist at the Berman Institute of Bioethics at Johns Hopkins.
Even if Obecalp proved helpful, some doctors worry that giving children “medicine” for every ache and pain teaches that every ailment has a cure in a bottle.
“Kids could grow up thinking that the only way to get better is by taking a pill,” Dr. Brody said. If they do that, he added, they will not learn that a minor complaint like a scraped knee or a cold can improve on its own.
Dr. David Spiegel, a psychiatrist who studies placebos at the Stanford School of Medicine, said conditioning children to reach for relief in a pill could also make them easy targets for quacks and pharmaceutical pitches later. “They used to sell candied cigarettes to kids to get them used to the idea of playing with cigarettes,” he said.
Ms. Buettner acknowledged that “we expect controversy with this,” but she added, “We are not promoting drug use.”
Despite his misgivings, Dr. Brody predicted that Obecalp would entice many parents. “Anybody who has ever been up in the middle of the night with a crying child would be tempted to try something like this,” he said. “You’re so desperate for anything that could quiet down your poor, miserable kid.”
Doctors themselves have been known to dole out placebos to overwhelmed parents, said Dr. Brian Olshansky, a physician at the University of Iowa Hospitals. A screaming child with an earache may leave the emergency room with a prescription for antibiotics, even though the drug will not speed recovery and could potentially cause harm.
Ms. Buettner said her pill could satisfy that need while reducing potential harms from unnecessary medications. “The overprescription of drugs is a serious problem, and I think there needs to be an alternative,” she said.
Some experts question whether an alternative should involve deception. “I don’t like the idea of parents lying to their kids,” said Dr. Steven Joffe, a pediatrician and bioethicist at the Dana-Farber Cancer Institute in Boston. “It makes me squeamish.”
Dr. Geller, the bioethicist, agrees that parents should not deceive their children. But she added that a parent who truly believed in the power of the placebo was not really being deceptive. “In principle,” she said, “I don’t have a problem with the thoughtful use of placebo. The starting premise and your own belief about what you’re doing matters a lot.”
Dr. Brody said parents did not need a pill to induce the placebo effect. Mothers have long promised to “kiss it and make it better” and it is that type of placebo children really yearn for, he said.
“Does a sick child really want X-rays or M.R.I.’s or the latest antibiotic?” he asked. “No. All the sick child wants is comforting.”