Monday, 23 June 2008

Placebo pills for kids.....

Today I have a piece in the Times about placebo pill for kids. You can read it here:

My original piece was rather different - firstly, because it was longer, but also because Dr Ian Paul and the GP mentioned were both people I interviewed at a later date.

So if you want to read my original piece, here it is:

By Sarah Ebner

Your child is crying, unhappy, and says he is ill. You know he isn’t hurt or so unwell he needs medicine, but long for something to help calm him down. Now the makers of Obecalp think they have the solution. Their product, the first standardised, especially made placebo “pill”, has just gone on sale via its American website. But their new product raises a huge number of questions.
The website for Obecalp (placebo spelt backwards) quotes “mommy” Jennifer Buettner, who came up with the idea. “It does nothing,” she writes. “Just like it’s supposed to. The brain does it all (with a kiss on the cheek.)”
It sounds like a brilliant idea, a harmless substance to comfort someone not really in need of medication. But if someone doesn’t really require medicine, should we be giving them a substitute at all? Many medical experts (and parents) think not.
“There’s definitely ethical issues about giving a medication that’s not got any active substance in it,” says Dr Margaret Bamforth from the Royal College of Psychiatrists. “You’d have to think very carefully about it.”
The placebo effect has long been documented. It is usually explained as something which occurs when a patient’s symptoms improve, despite being treated with a product that has no active medical ingredients. It’s thought this happens because patients believe the treatment will work (in other words, they don’t know it’s a placebo). Recent research also suggests that taking a placebo pill stimulates the release of endorphins (which release feelings of euphoria) in the brain.
Of course it would be very rare to find someone who would ask for a placebo rather than medication, and this is one of the ethical issues in which Obecalp is now tangled. By suggesting that parents give their child such a pill, aren’t they suggesting a deception?
Dennis Buettner, co-creator of Obecalp and Jennifer’s husband, thinks not. He’s hoping that Obecalp will help thousands of people, citing children, the elderly and those with special needs.
“This isn’t the deception of a child,” he says firmly. “We like to look at it as the protection of a child. To give them medicine of suspect efficacy is a deception. Children are over-medicated in this country. This is not medicine.”
The Buettners, who have, rather ironically, called their company “Efficacy Brands”, say they are genuinely amazed by the storm their product has created.
“That caught us both,” says Dennis Buettner. “This is a product that is designed to be absolutely nothing, inert. The controversy caught me completely off guard.”
It’s understandable that the Buettners were taken aback. At first glance, their product seems simple. It’s almost like giving a plaster to a child who doesn’t really need one, just to placate them. Except that a child knows that a plaster is just something to cover a scratch. The danger is that they’ll think this cherry flavoured tablet is medication.
“It’s full of contradictions,” exclaims Dr Bamforth, who’s an expert in child and adolescent psychiatry. “It’s saying go to your doctor, but when you find there’s nothing wrong with your child, give them a pill anyway. That doesn’t make any sense, does it?
“You’re also teaching children to rely on a pill. You’re not helping them deal with whatever the problem is, to develop a functional coping strategy.”
When the Buettners initially had the idea for Obecalp, it seemed straightforward.
“My wife and I had our young niece to stay because her parents were on vacation,” says Dennis. “We anticipated that she would be anxious and when she said she had a bad tummy. Jen said that I should go to Wal-Mart and buy a placebo. But they had nothing. That’s when I began to research and found that nowhere in the world had retail placebos.”
The Buettners thought they were on to something big and decided to make a placebo pill themselves. They contacted every drug manufacturer in the country, spoke to numerous scientists (one of whom gave them the idea for making the pill out of dextrose) and eventually came to an agreement with one particular company (with whom they have a non-disclosure agreement.)
“One guy told us that he’d spent his entire career developing products that were designed to do all types of things, but really did nothing. He couldn’t believe that he met us, and we were asking him to specifically design a product that does nothing.”
The sample products (given a cherry taste, because, Buettner says, it’s the most popular over-the-counter flavour), were tested positively on friends and family. Rather surprisingly, Buettner admits that none were tried as a placebo on someone who had a malady, but simply handed out to taste. The couple were obviously happy with the results as the first batch of tablets (5-7000 bottles) went on sale to the public at the beginning of June. The first orders are just being dispatched.
Buettner is passionate about the idea that too many people are given medication when they don’t need it, and argues that Obecalp addresses that issue. That children (and adults) are given too many pills is something others agree with. What they can’t understand is why a product which looks like a pill (even if it isn’t one) is seen as the solution.
“It’s a nonsense,” says Imti Choonara, a professor in medical health at Nottingham University and expert in paediatric clinical pharmacology. “I have no problems with placebos in general, but I’m concerned that this will make children think they always need a medicine to make themselves better.
“I don’t see the logic in having something available that you can buy over the counter as a placebo. It’s a contradiction in terms. You’re not going to buy it for yourself, and it’s inappropriate to give it your partner or other family member because you know it doesn’t work.”
Buettner is exceptionally keen to stress that Obecalp is not medicine, that he doesn’t have medical training, and that he recommends speaking to a doctor before using the product. He won’t even say what he thinks Obecalp might be able to treat, just that it is sold as an over-the-counter dietary supplement.
“We make absolutely no claims which might be construed or misunderstood to be medical advice, so I am unable to give particulars as to its use,” he says when pressed.
However, he is less reticent when talking about the placebo effect in general. He cites a number of medical studies, explaining that recent ones which appear to show that both cough medicines and Prozac work little better than placebos, inspired him to speed up production.
One study he enthusiastically points towards is from the University of Chicago. Earlier this year researchers there found that nearly half the doctors they questioned admitted to giving out a placebo to patients at some point.
“We’re hoping that there’s a potential that if you see your physician and he thinks there’s nothing wrong, we’re providing him with the knowledge that there’s a standardised placebo of high grade quality that exists for use,” says Buettner.
It’s ironic then that Professor John Hickner, who worked on the Chicago study, is not a fan of Obecalp.
“I think it is a terrible idea for parents to give placebos to their kids,” he says. “We are already a society that believes pills are the easy answer to too many problems.”
But Buettner is sticking to his guns. He says that sales are already going well and is keen to move forward. He has plans for a diabetic version of the pill, and a distribution deal to take it into Europe. Could the next big American export really be something that is simply mind over matter?