Today the FDA is holding a hearing on over-the-counter cough medicines marketed for use in children under 6. Our colleagues at the Prescription Project have issued a new report, Risk With No Benefit: The Marketing of Over-the-Counter Cough and Cold Medications for Children. The reports documents that the industry spends more than $50 million a year marketing cough medicines for children under 6, despite the lack of evidence that such drugs are effective for such children, and evidence that the drugs can present serious risks.
See coverage of this issue, and of the industry’s recent preemptive recall of a number of these medications approved for use in children 2 and under, here.

We here at the Prescription Access Litigation blog often lament the explosion of advertising for prescription drugs. But the huge spending on marketing of Over-the-Counter remedies is also troublesome. Over-the-Counter remedies are supposed to be safe enough for patients to take without a physician’s supervision. The disclosures that Over-the-Counter drugs have to make are, thus, much less than for prescription drugs. This lulls people into a false sense of security that if a drug is Over-the-Counter, it must be completely safe. Widespread marketing of these drugs only increases that impression. And marketing such drugs for use in children uses this belief to offer harried parents a quick fix for their children’s symptoms.

At the root of many of the problems caused by drug advertising, whether prescription or over-the-counter, is the shift in recent decades to thinking about medicines not as medical treatment but as a consumer product. But as we here are fond of saying — drugs are not like fabric softener or shampoo, and we treat like as such at our peril.

The FDA recently announced that it will hold a hearing on November 14, to consider whether to make certain drugs available only “behind the counter” — that is, without a prescription but only dispensed by a pharmacist. Presumably, this would introduce the intervention and consultation of a pharmacist, who could ask the patient questions to determine if the drug was really appropriate and advise them of alternatives if it was not. Many other countries have numerous drugs “behind the counter” that are Over-the-Counter in U.S. While we here at PAL don’t have a position on this proposed new status for drugs, it does seem that these cough medicines would be a good candidate if this status were created.

Below is the Prescription Project’s press release on the report, which you can find here.

The Prescription Project Report Shows Industry Spends $50 Million-a-Year Marketing Cough and Cold Medicines for Children Despite Evidence of Risks

Report says lack of results, risks for children under six does not deter drug company marketing of these products as “safe and effective.”

BOSTON–(BUSINESS WIRE)–The Prescription Project today released a report showing that companies producing over-the-counter (OTC) cough and cold medicines spent more than $50 million marketing these widely used products for children under the age of 6 despite evidence of risks and lack of effectiveness in treating children. The report, titled Risk With No Benefit: The Marketing of Over-the-Counter Cough and Cold Medications for Children, was released to coincide with today’s Federal Drug Administration’s Nonprescription Drug Advisory Committee hearing on the potential dangers of these products for children under the age of 6.

The Prescription Project report, which analyzed FDA, industry, and epidemiological documents on OTC remedies, shows a lack of efficacy data but a significant number of reported injuries and deaths associated with overdosing of these products. Manufacturers have heavily marketed this class of OTC preparations for many years based on their FDA classification as “safe and effective,” yet the FDA has not conducted or brought forward a single study or review to prove the safety or effectiveness of these products for use in small children in the last three decades. The full report is available at www.prescriptionproject.org.

“Especially when it comes to over-the-counter drugs, physicians and patients rely on the FDA to ‘calculate’ the benefits versus risks and communicate this to the public,” said John Santa, MD, MPH, a consultant to the Prescription Project and former medical director of the Drug Effectiveness Review Project (DERP). “In this case, it appears the benefits are close to zero while the risks are significant.”

Last week, in response to growing questions and pressure from pediatricians and the FDA, major manufacturers of the popular cold remedies announced that they were voluntarily withdrawing from the shelves OTC infant cold and cough products marketed for children age 2 and under. As of yet, there has been no action on drugs marketed for children 2-6 years old.

About The Prescription Project

The Prescription Project is led by Community Catalyst in partnership with the Institute on Medicine as a Profession. Created with The Pew Charitable Trusts, the Project promotes evidence-based prescribing and seeks to eliminate conflicts of interest in medicine caused by pharmaceutical marketing to physicians by working with academic medical centers, professional medical societies, public and private payers, and state and federal policymakers. For more information, please visit www.prescriptionproject.org.

WebMD reported last week on a new study in the journal Sleep. The study found that doctors are widely prescribing sleeping pills and other drugs to children having sleep problems. An astonishing 81% of the 18.6 million doctor visits studied included a prescription being written. By contrast:

They found that diet and nutritional counseling were advised for 7% of children and that 22% were prescribed behavioral therapy such as psychotherapy and stress management to relieve the sleep problems. For 19% of children, both behavioral therapy and medication were advised.

The data studied only go til 2004. Advertising for sleep drugs has exploded since 2004. Both Lunesta and Rozerem were introduced after that time, and have been extremely heavily advertised. Ambien CR was also widely advertised in that time period, both to compete against these new drugs, and to get patients to switch from Ambien to Ambien CR before generic versions of Ambien came on the market. (In 2006, we gave one of our coveted Bitter Pill Awards to the makers of both Lunesta and Ambien/Ambien CR – the “The While You Were Sleeping Award: For Overmarketing Insomnia Medications to Anyone who’s ever had a Bad Night’s Sleep”) It is likely that the enormous promotion of prescription sleep aids in the past 2 and 1/2 years has increased the number of kids being prescribed drugs for sleep even more.

Several things about these findings are disturbing:

• It suggests that doctors are rushing to medications, and not adequately addressing underlying causes, or emphasizing behavioral changes and “sleep hygiene.”
• Many of the drugs being prescribed have not been tested on children, and are not FDA-approved for use in children — this is so-called “off-label” usage. While off-label prescribing is quite common (one study found that 1 in 7 prescriptions was for an off-label use), it is potentially more troubling when it is done for children. Children are not “little adults” — it cannot be assumed that a drug will work the same, or that side effects and risks will be similar for children as they are for adults. The effects of drugs on children’s growth and development is unclear if the drug has not been studied in children and is not approved for use in children.
• It exposes children to the risk of addiction or dependency. Many drugs used for sleep problems have these risks, even those that are not specifically approved for insomnia.
• It introduces children at an early age to the dangerous idea that there is a pill for all their problems, and that taking prescription drugs is “no big deal,” and just a routine part of everyday life. This cultural attitude has contributed to the extremely troublesome and widespread trend of teenagers and young adults misusing and abusing prescription drugs.

For some children, the use of a prescription drug may be the appropriate route for addressing a sleep problem. Insomnia and other sleep problems can and do interfere with children’s growth, learning and behavior, and need to be addressed. But it is a sad commentary that millions of children are being prescribed prescription drugs, when for many of them, changes in diet, routine and schedule would work just as well and not expose them to the risks, known and unknown, that come with these prescription drugs.

The Sleep study can be found here.

Postscript:
In a bit of irony, the article on WebMd was bordered on two sides by an ad for Rozerem. See screen shot below: