[e-drug] NY Times: New placebo pill for children

["Libby Levison" <libby@theplateau.com>]

E-DRUG: NY Times: New placebo pill for children
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Dear E-Druggers,

Words fail me on this one.   From the country where Direct To 
Consumer Advertising is taking over the tv, we now bring you Obecalp 
-- a placebo pill for children (get it? It's placebo spelled backwards).

The ethics of this are pretty well discussed in the article.  But I 
think one got left out:  Why do children think a pill will help 
them?  Because they've seen the adults around them take pills. So 
they already have seen people use pills, and now they're being given 
unnecessary pills...  What do we think their pill-taking habits will 
be like when they grow up?

Another reason why the US needs an Essential Medicine List and to 
teach people about the rational use of medicines.

Libby Levison
Boston, USA
libby@theplateau.com

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Experts Question Placebo Pill for Children
By CHRISTIE ASCHWANDEN
Published: May 27, 2008
available at: http://www.nytimes.com/2008/05/27/health/27plac.html?ref=science

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."