If you’ve been following the news lately (and the articles I’ve posted references to in this blog), children’s cold remedies are under fire. Now it turns out that they have been “raised questions for years”, according to the Washington Post. (Here, for now). This article was in the Post on Friday, October 26, 2007.
This situation has raised a number of questions (from the article):
- How could the products remain on the market so ling without proof that they work?
- Why didn’t the FDA act sooner?
- Why didn’t the medical establishment warn parents?
It seems that about two-thirds of drugs prescribed for use in children have not been tested in children! In addition, “there are a huge number of drugs that are regularly given to children that have never been tested in children,” said Michael W. Shannon, a professor of pediatrics at Harvard Medical School. “I’m very concerned that many of these agents may also be inappropriate for children.” One factor in the lack of testing in children is the fact that it was considered unethical and unnecessary to test drugs in children. The dosages were extrapolated from dosages for adults.
In 1972, the FDA did organize a panel to review nonprescription cough and cold medicines; previously, their attention had been focused on prescription medicines. This panel concluded that there was enough evidence to endorce 35 of the 92 ingredients. That recommendation was based on studies in adults. In 1976, the group recommended that doses for children be extrapolated from data for adults.
“As researchers began testing some of the products directly in children, they slowly started to raise disturbing questions. The Journal of the American Medical Association published an analysis in 1993 that concluded there was no good evidence that the medications worked. The Cochrane Collaboration, an independent international project that regularly evaluates medical therapies, reached a similar conclusion in 2004.”
The article goes on to say that although many pediatricians began to counsel their patients not to use these products, some continued to tell them that they could use them. The products remained very popular. In 1997, the American Academy of Pediatrics adopted a policy stating that cough medicines are ineffective. The American College of Chest Physicians produced a similar statement in 2006. However, many other organizations have never issued any formal guidance to doctors on this subject.
I have a two year old (almost two and a half) and my doctor has never mentioned any concern. I have to admit that he is rarely sick, but he has had an occasional cough/cold. I had no idea that these products had not been tested on children, that there were concerns that they were ineffective. Giving a child medicine is enough of a struggle; why would I continue to do so, if it is not going to help?
Some experts are defending the doctors’ groups, saying that they are up against a multibillion-dollar industry, a group that aggressively markets their products (spending more than $50 million a year to sell their stuff). I can understand that to a point – it is like going against the tobacco lobby and all the tobacco firms; they have a lot of money to throw at the situation. Still, as a patient, it would have been nice to have been told this. I don’t understand why more doctors don’t say something to their patients.
On the bright side, the FDA has started demanding that some prescription drugs be tested in children before they are approved. It has also enticed drug companies to conduct pediatric studies of some medications already on the market; unfortunately, the article fails to say how they enticed them. The FDA is reviewing recommendations, but it says that formal action could take years. The industry has voluntarily removed products designed for children younger than two from the market, but “maintains that the remedies are both safe and effective for older children when used properly.”
Well, I’m going to keep watching to see what happens. I want to know if the industry will police itself, if the FDA is going to wake up and take action, … I want to know if doctors are going to pass on information like this to their patients in a more organized fashion. I’m also going to do my part and be a more aware consumer.
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