FDA acts to Protect Kids from the Drug Industry

Ten-year old Jack is depressed. Does mom need to head for the medicine cabinet or rush to the pharmacy for antidepressants to help him cope with his emotions? This should be our starting point for a social and bioethical dialogue about the way we deal with both normal emotions and psychiatric symptoms in children, since prescription rates for antidepressant drugs for children has increased substantially over the past 20 years (with prescription rates rising in 2004 to four times what the rates were in 1996). An even more chilling trend is the finding that prescription rates of antipsychotic medications to children with mood problems have increased over three times in a similar period.

We can probably agree that drug company boardroom shareholders should be answering those questions for parents, yet GlaxoSmith Kline’s recent 3 billion dollar fraud suit settlement with the Justice Department gives us a direct example of the way the drug industry’s financial bottom-line influences the way we view our children’s emotions and behavior. Confused about how Glaxo’s case is connected to what you might find in the medicine cabinet in your children’s bathroom? It’s a simple equation based on what we see through the small lens and the big lens.

Here’s the small-lens picture. Glaxo encouraged physicians and pediatricians to prescribe more of its antidepressant drugs Wellbutrin and Paxil to children, even though these medications have not been approved by the FDA for the treatment of mood disorders in children (by the way, Glaxo is said to have made around 17.5 billion dollars from all sales of these products during the period covered by the government case). This influence happened on two fronts, via direct contact with doctors through “drug reps” that visit physician’s offices, and via direct-to-consumer marketing which leads people to approach doctors with requests for specific medications.

Now look through the big lens and a much more disturbing trend comes into view. The pharmacology industry is, remember, an industry, and it is interested in pleasing shareholders with profit. Once a highly profitable sector like the American market for antidepressants is saturated by other competing medications or growth in new patients has slowed, a company can either move on to a more profitable venture or influence the sector in their favor. One tried-and-true way of changing the face of the market is to expand the type of patient who can use the drug or to create a “pseudo-market” by stimulating buzz and talk about new kinds of psychiatric disorders. Unlike other areas of medicine, the psychiatric disorders market is easier to manipulate because most patients are diagnosed based on behavioral symptoms and not physical tests like blood-level measurements or CAT scans. Bring pediatrics into the picture, and the potential for creating a drug-favorable condition in the marketplace becomes an even more lucrative proposition. Creating a “pseudo-market” in children follows when the psychopharmacology industry encourages favorable news articles, TV discussions, or creates a feeling that a diagnosis is on the rise, such as Bipolar disorder in children. Not that bipolar illness can’t exist in children, but it is naïve to think that the recent forty percent increase in diagnosis of bipolar illness in children and correlated increase of bipolar medicine prescription rates of up to 4000 percent since 1996 (no, that isn’t a misprint) to children are the result of a new bipolar plague rather than due to cross-talk among advertisers, doctors, and the drug industry.

At the heart of the matter in the Glaxo case, and other instances of the exponential rise in psychiatric medications prescribed to children, is the expectation that the FDA will be stricter in its regulation of medications prescribed to children. Over the past decade, the FDA has been less than active in censuring drug companies from exploiting ambiguous guidelines regarding “off-label” use of medications by physicians. The Glaxo case is only one of many instances in which shareholders have benefitted from expanded injection of drug therapy into a pediatric population.

But Why Did Parents Fill the Prescription?
In our rush to pass judgment, we might finger-point at parents who accepted the prescription for anti-depressants from their pediatricians, accusing them of suffering from a lack of “plain-old parental common sense.” But blaming parents is just our way of finding an easy answer, ironically, the same thing we are accusing parents of looking for. Instead, take a look at the stress that happens in families when children are having behavioral and psychiatric symptoms. Often, these symptoms go on for weeks or months, with more than enough haphazard advice from others as to how to deal with the problem. “Are you being consistent?” “Are you rewarding the right behaviors?” “Are you keeping him away from food additives?” Most parents have been there, and tried that. By the time a diagnosis of behavioral illness is received, and medication is recommended by the health care provider, it suddenly seems like maybe the most reasonable option. A glance through the magazines in the waiting room with full page ads from the pharmaceutical industry that picture children “on track again…” and “back at school…” because of their medication is enough to seal the deal with many parents. So, instead of asking the question that drug-company advertisers want you to ask, namely “is this medication right for my child,” try asking the following questions before signing on for medication before the research answers are in:

  • What is the status on FDA approval for pediatric use of this medication for this specific diagnosis? Has the drug company applied for FDA approval?
  • Have any controlled research studies shown negative findings for the use of this medication in children?
  • What is the expected duration for a reasonable trial of this medication for this condition?
  • What specific targets or symptoms should I be watching to see if the medication is working?
  • Is this medication expected to relieve my child’s symptoms completely, or is it “symptom management” requiring longer-term use?
  • What is the plan for discontinuing this medication when my child gets better?
  • How do other treatment alternatives such as therapy stack up in research comparisons with medication?

True, parents are the final say, the gatekeepers that determine what medicine a child takes and what he or she doesn’t. But don’t be too quick to judge vulnerable parents who are not given the full story on when the choice to try a medication is premature, and when it is based on solid research and FDA approval.