Miss Diagnosis Uses Drugs to Prove a Point

In a country where practicing medicine has become nearly synonymous with prescribing and dispensing medication, it’s no surprise that the pharmaceutical industry has a prominent place in the health care reform debate. The controversy over whether to allow importation of prescription drugs from abroad has jeopardized the weird alliance between Big Pharma and health care advocates. Obviously, allowing foreign drugs in has serious economic implications for drug-makers and consumers. But a report regarding contaminated drugs published in the Thursday, Dec. 10 edition of the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report highlights safety concerns as well.

According to the report, 54 Nigerian children died from contaminated acetaminophen (the same drug as Tylenol) in a children’s teething medication. The medication was contaminated with diethylene glycol (DEG), a toxic alcohol used illegally as a cheap substitute solvent in drug manufacturing. The contamination resulted from failure to comply with safe manufacturing processes.

I’d like to give us all a moment to imagine the response if 54 American children had died from drug poisoning.

The report may bolster the position of those against the proposed amendment to allow importation of prescription medications from abroad approved by the Food and Drug Administration. The CDC stated “countries that inadequately implement safe manufacturing standards, poorly enforce quality controls, or lack adequate training programs remain at risk for medication-associated poisonings.” The FDA’s ability to ensure safe manufacturing practices abroad remains uncertain.

However, before people jump on the notion that foreign countries represent a unique risk to drug safety, it’s wise to consider the issues surrounding drug safety in our own country. For instance, New Mexico's Attorney General Gary King completed a $10 million settlement against drug-maker Eli Lilly for illegally promoting the use of their anti-psychotic medication Zyprexa in children. Although it is legal to prescribe medications for unapproved or “off-label” uses, it is not legal to market them for off-label uses. Earlier this year, the company plead guilty to promoting the drug's unapproved uses and concealing serious side effects like weight gain and diabetes.

In my humble opinion, drug-makers are as powerful as consumers allow them to be. Though many drugs are absolutely necessary for saving or sustaining life, I’d hazard a guess that most aren’t. Though I’m certainly not anti-medication (hey, I practically live on Ibuprofen for a week out of every month), I don’t believe medications should be the first line of defense against all of our ailments. For example, there’s no harm in medicating your teething child with hugs and kisses and soft things to chew on rather than a bioactive elixir with serious side effects. It’s easy to see why weighing the risks and benefits of medication use is so important. It’s also easy to see why drug companies must be held to extremely strict standards when it comes to marketing and disclosure of risks.

Still, cost should never be a reason to deny someone a needed medication. Rather than importing drugs, which opens a whole new can of regulatory worms and broadens the carbon footprint, perhaps financial regulation of domestic companies would be more prudent.

In any event, we can all hope decent regulatory efforts at ensuring safety and affordability of necessary medications succeed. At the same time, let’s encourage our couch-riding, medicated masses to trade the remote for real friends and the La-Z-Boy for a pair of jogging shoes. This way, we can all jazzercise our way into a future of cardiovascular fitness and mental well-being. That would do more for the health of our nation than any pill.