Did Doc Groups Sneeze At Regulating Kiddie Meds?
7 CommentsBy Ed Silverman // October 26th, 2007 // 8:35 am
The recent campaign to reign in use of cold and cough remedies for children, which resulted in an FDA panel recommending last week that the meds shouldn’t be given to kids younger than 6, is casting a harsh spotlight on professional societies. You know, those organizations that exist to educate docs and protect their collective professional causes. And when it comes to these kiddie meds, some say the groups were missing in action, even though evidence was lacking these products actually worked.
“I think there was a vacuum in leadership on this issue by the professional societies,” Peter Lurie of Public Citizen tells The Washington Post. “You can justify the argument that doctors can make up their own minds, but that’s a much harder argument to make for parents, who have never seen any of these studies.”
Some experts defend the medical groups, saying policy statements from doctors’ groups can do only so much, especially against the aggressive marketing by drugmakers, which spend more than $50 million a year to sell the products, the Post writes.
“For the past 25 or 30 years, we’ve been warning about violence on TV,” says Wayne Snodgrass, a professor of pediatrics at the University of Texas Medical Branch, who signed a petition against use of the drugs in young kids and also chairs the American Academy of Pediatrics committee on drugs. “What has that done? In this case, we’re up against a multibillion-dollar industry. The American Academy of Pediatrics is not a multibillion-dollar industry. We try to do what we can, but there’s only so much we can do. Where are the companies in this? Where was the FDA in this?”
But Josh Sharfstein, the Baltimore health commissioner who spearheaded the campaign (at left in the photo), wonders whether the medical profession could have been more aggressive. “When I was trained as a pediatrician, it was just accepted that these products had no role. This was known in the profession,” he tells the Post. “It’s a fair question why there wasn’t a strong regulatory challenge by the profession. They could have justified one. But what really stunned us was that this was never really looked at from the legal-regulatory side.”
Since drugmakers want to continue selling the products, given the large market that would be taken away from them, it should be interesting to see the lobbying and negotiating that takes place, yes?
Nathan
These stories about kids medicines really upset me. Does anyone understand how much money clinical trials cost? No pharmaceutical company is going to spend $50-$100 million to fund a phase III clinical trial on children to check and see if the $3.50 generic medication sold at Walmart is actually effective. The generic companies certainly aren’t going to fund it either.
This society has become way too concerned about safety. We are concidering yanking kids cold medications that may have killed 6 children (primarily) due to accidental overdose. What do doctors think that parents are going to do when they no longer have access drugs to treat thier children’s colds? Here’s a few choices:
1) Put a bit of whiskey in thier milk (common until 50 years ago)
2) Cut an adult pill in half and give it to thier kid
3) Wait 10 years while big pharma develops new cold medications which will be PRESCRIPTION medications (not OTC) and will not have generic coverage and will therefore cost at least $50 for cold medicine every time your kids gets a cold.
How many kids do you think will die when parents start trying #1 and #2 on the list above? Probably a lot more than 6.
Ed Silverman
Hi Nathan,
I understand your point and that’s why I’ve always advocated whiskey - Rebel Yell, to be specific. Of course, then I get in trouble with Mrs. Pharmalot.
As always, pendulums swing back and forth, and this may swing still more.
Thanks for writing in,
ed at Pharmalot
Nathan
Also, people here should keep in mind that OTC drugs represent only a tiny fraction of revenue for pharma companies. As an example, Robitussin / Dimetapp cold medications (adult and children combined) only account for about 1% of the Wyeth’s revenue this year. Cold medications are NOT big moneymakers for the pharma industry.
Lisa Van S
ED,
In NJ we have a Legislative Bill A4245(Parental Informed Consent for Psychotropic Drugs that carry a Black Box Warning.The American Academy of Pediatrics vigorously opposes this Bill becoming Law,Why,..Listen here
http://www.njleg.state.nj.us/media/archive_audio2asp?key=aco&session=2006
Nancy Pinkin the NJ Lobbyist for this group believes life threatening side effects of these drugs are arbitrary…
Jack
I went to a presentation given by the president of the Amercian Pharmacists Association earlier this week (very charismatic guy). I don’t want to put words in his mouth, but he basically said he didn’t really understand why these drugs were pulled.
Donna
Nathan,
I agree…thinking way back before my kid’s were old enough to take adult medication if i had to run to the dr. everytime there was a cough,chest congestion or runny nose,,between the three of them i would of alway’s been there…and of course knowing what your children can and can’t take, dosage etc. is key…
Donna
Ed,
Were you a Whiskey Baby?….I was…and i wonder if my relative’s ever figured out where the olive’s in their martini’s went???? LOL…Rebel Yell!!!! Billy Idol hmmmmm now we’re going back…..Have a great weekend…:)