Don't Give Your Child Cold Medicine

Last week the Food and Drug Administration (FDA) issued a warning to parents: don't give infants and toddlers over-the-counter (OTC) medications for colds. Why not? Because those medications, many of which have been pulled off the shelves by their manufacturers over the past few months, may do more harm than good, overall.

Of course, it's a little more complicated than that.

First of all, we're talking about medications that have been marketed for infants and toddlers - 0 to 2 years of age.

Consider the possibility that an infant or toddler could be given more than the dose prescribed on the label. This might happen when they are given more than one medication (to treat more than one symptom, say a cough and sneezing), each of which contains the same active ingredient. It could also happen when they are unwittingly given multiple doses by multiple caregivers (say a day care staff member, dad, and grandma). Either way, the result is unintentional overdose.

While such overdoses and other adverse reactions may be the exception, they are not rare. Add to that the fact that many of these medications have not been demonstrated to be effective in infants and toddlers, and there is just no reason to expose these children to the risks for no proven benefit.

Let's take a step back and ask a couple of questions.

If the medications in question have not been shown to be effective in children, then why are they being marketed for children in the first place? It's not that they have been proven ineffective. Rather, it's that they have not actually been tested in clinical trials in children. Many have only been tested in adults - that's how they received FDA approval. In those tests, they were shown to be safe and effective at relieving symptoms - in adults. It was just assumed, then, that they would be safe and effective in children - in lower doses. But, in fact, they have never been shown to relieve symptoms in children.

How is it the medications were never tested in children? Probably because of the risk and expense of testing them in children. What if something goes wrong? As I described in a blog posted here two years ago this month, it is not uncommon for a new drug to be tested in adults, but not children (or pregnant women), for fear of harming the research participants.

As a result, we are now at a point where we'll need to await the results of clinical trials of cold medications in infants and toddlers before these products can reappear on the pharmacy shelves. That is, if the manufacturers believe the cost of conducting the clinical trials is worth the potential market.

Something to remember - cold medications do not "cure" a cold, anyway. They only treat the symptoms of a cold, making the person, child or adult, temporarily feel better.

-Joe

Related Topics:

• WebMD Video: Treating Baby's Cold
• Infant Cold Medicine Recall: It's Back to Chicken Soup

Technorati Tags: infants colds, medications, clinical trials

Just Another Lab Rat

Photo: Jean-Etienne Poirrier

www.jalr.org is a web site intended for individuals interested in volunteering as healthy subjects for clinical trials as a way of earning money. The site even suggests it is possible to make a modest living as a "professional" research participant.

While the site's host promotes the idea of volunteering for the money and to "make the world healthier," he also reports having taken over 700 pills and undergoing 1,200 blood draws during the past three years. The host appears to be an experienced participant, but (appropriately) does not provide medical advice.

The site is attempting to maintain a searchable database of clinics for healthy volunteers, but is still struggling a bit with the execution of that database. The site's strength is the candid, practical, often somewhat amusing tips it offers. For example, the site provides a suggestion on how to prepare yourself for being able to provide a urine sample when you arrive at a clinic, as well as where to sit on a bus to be the most comfortable when traveling long distances to a clinic (near the front so as to avoid exhaust fumes and the smell of the rest room). Once at the clinic, it suggests packing plenty of socks and underwear. "Some clinics strip search you down to your underwear. So be sure to wear underwear!"

There are message boards to which registered individuals can post questions, answers or their personal experiences at specific clinics, noting whether the food is good and the study staff are friendly. You don't need to register to view the messages. These boards don't seem to be heavily used yet, but they are available.

Overall, the site attempts to provide some useful information and links. It is obviously run pretty much on the energy, enthusiasm and effort of its host. And while it sometimes falters when navigating from page to page, it probably serves a useful purpose as an information node about clinical trials.

-Joe

Related Topics:

• 12 Answers to Common Questions About Clinical Trials
• Concerns for Women, Children, and Genetic Privacy in Clinical Trials

Technorati Tags: clinical trials, volunteers, health and wellness

The Placebo Effect Strikes Again

Every once in a while a clinical trial produces results that are difficult to accept. Such is the case with a study involving hotel maids published in the journal Psychological Science last year (February 2007, Vol 18, Issue 2). A recent segment of Morning Edition on National Public Radio brought the study to my attention.

The researchers began by measuring the maids’ weight, blood pressure, and body mass index, among other things. And they were all asked about their exercise habits. Interestingly, most reported that they exercised little or not at all on a daily basis. At this point, the maids were divided into two groups. One group was shown how the work they did daily as maids was, in fact, exercise and were told how many calories each of their daily routine cleaning activities burned. The other group (the “control” group) was not given this exercise and calorie information. But they were all observed for 4 weeks, at which time their weights, blood pressures and body mass indexes were measured again and they were again asked about their exercise habits.

What the researchers found was that the group given the exercise and calorie information actually lost weight and registered lowered blood pressure and body mass index, while the control group did not experience these changes. Because they were all observed, the researchers made sure that neither group was actually changing their daily routine.

What could possibly explain this observation?

In January of 2006, I blogged a couple of times on a phenomenon known popularly as "the placebo effect." The experiment with the hotel maids seems to provide evidence of a specific and rather amazing (to most people, at least) placebo effect. The fact that the one group of maids knew they were exercising somehow caused them to lose weight although they apparently did nothing extraordinary to change what they did or ate. The knowledge alone seems to have effected the change.

This study is not without its detractors. Even its authors agree more research is needed to answer lingering questions. But it does provide an example of how some clinical studies can lead to results that capture the imagination - of scientists and the rest of us.

By the way, the American Medical Association's policy on placebo use stipulates that their use by physicians is acceptable only when patients are informed of their use and agree to it.

It wouldn't be surprising to see further developments in this area of research and medicine over the next few years.

-Joe

Related Topics:

• WebMD Video: How Do Placebos Work?
• The Placebo Effect
• Lessons From the Placebo Effect: A New Design for Clinical Trials?

Technorati Tags: clinical trials, medical research, placebo effect

Research While Impaired?

Have you (or a family member or friend) been involved as a research participant while your capacity to make decisions was impaired? If so, you have a unique opportunity to advise the federal government as it considers revising its regulations on research involving human subjects. There are 10 more days remaining for public comment - and yes, you are eligible to comment.

Normally, of course, potential research participants are provided with information about a clinical trial, in writing and usually also orally. If they decide they wish to be enrolled in the study, they are then required to read and sign an Informed Consent form. Some research necessarily involves participants who are decisionally-impaired. That is, due to long-term or temporarily low mental capacity, an individual is unable to adequately understand and weigh the risks and benefits of volunteering for the clinical trial. Examples of such research would include studies of behavior when someone is heavily under the influence of alcohol or drugs, studies of individuals with advanced Alzheimer's disease, and studies of the severely mentally disabled.

The Office for Human Research Protections is soliciting comments from the public through January 14. The original solicitation "Request for Information and Comments on Research That Involves Adult Individuals With Imparied Decision-making Capacity" may be found at http://www.hhs.gov/ohrp/documents/20070905.htm. This deadline represents an extension of the original December 4, 2007 deadline.

Many of the specific questions posted are directed at researchers themselves and at members of Institutional Review Boards (IRBs - the committees that review and approve clinical research at hospitals, universities and other research organizations). However, several of the questions solicit responses which should include those from actual research participants or their family or friends. I've listed some of those questions below, numbered as in the government posting:

1f. For research involving adult individuals with impaired decision-making capacity as subjects, how are subjects' potential or actual objections to enrollment or continued participation in research being addressed by investigators and IRBs?

1h. For studies that have included an assessment of potential subjects' capacity to consent, how has this assessment been used in the informed consent process? Are subjects notified when they have been found to lack capacity to consent? When informed consent is sought from such a subject's legally authorized representative, are potential subjects provided an opportunity to assent or object to their participation in the research?

1i. For research involving subjects who are able to provide informed consent, but are expected to have fluctuating, limited, or diminishing decision-making capacity during the course of the research study, what processes or procedures have investigators implemented, or have IRBs required, in order to ensure that the rights and welfare of such subjects remains adequately protected?

2. What problems or concerns have arisen for investigators, IRBs, or research subjects in the conduct or review of research involving decisionally impaired individuals as subjects?

2b. Please describe the process used when a legally authorized representative is asked to consent on behalf of a prospective research subject for research involving adult individuals with impaired decision-making capacity as subjects. Do the legally authorized representatives use substituted judgment (decisions that reflect the views of the individual expressed while decisionally capable) or the best interest standard? Which seems more ethically justified?

2c. How are advance directives for health care and for research used when a legally authorized representative is available?

2d. Have any problems or concerns arisen in regard to seeking consent from a legally authorized representative on behalf of a prospective research subject for research involving adult individuals with impaired decision-making capacity as subjects? If so, please describe the issues that have arisen.

4. How should the population of adults with impaired decision-making be defined for the purposes of guidance or regulation?

6a. If an adult with impaired decision-making capacity is capable of providing assent to participation in research, should the guidance or regulation indicate that the adult subject's assent should always be a condition for proceeding with the research? If there are circumstances when an adult subject's assent should not be necessary, what are those circumstances?

Your participation in this national dialogue may assist the federal government in hearing all sides of this issue. Your experience is at least as important as what researchers and IRBs will be telling the feds. And please, feel free to share your thoughts here as well.

-Joe

Related Topics:

• 12 Answers to Common Questions About Clinical Trials
• Alzheimer's Disease: Clinical Trials - A Guide for Patients

Technorati Tags: clinical trials, IRBs, research