“[XYZ] can lower your ability to fight infections, including tuberculosis. Serious, sometimes fatal events, such as infections, lymphoma, or other types of cancer, have happened. Blood, liver and nervous system problems, serious allergic reactions, and new or worsening heart failure have occurred … You should not start [XYZ] if you have any kind of infection.” (Television commercial)
With these kinds of side effects, doesn’t XYZ sound like a medication your doctor would offer you only as a last resort–not one you should beg your doctor to prescribe? Advertisements like these walk a fine line between effectively selling a product and literally scaring people away! So how can you, the consumer, feel confident in trying newly-approved medications like those you see on TV or in magazines? The short answer: You can’t.
We generally count on the FDA to know whether a drug’s benefits outweigh its risks before it comes to market, but here are three important considerations:
1. Clinical studies and trials.
A pre-approval study, which is performed by a drug manufacturer, may test a medication on a few thousand people (a small sample, compared to the numbers of folks the drug manufacturer will target in its sales efforts). Once a new drug is approved, the “sample size” of people trying the medicine increases dramatically, and with it a more realistic assessment of side effects and adverse reactions. Half of the drugs withdrawn from the market are withdrawn within the first two years after its approval—and half of the drugs that require the addition of a “black-box” warning require it within the first seven years after approval.
As a Johns Hopkins Health Alert puts it: “When you fill a prescription for a relatively new drug, you are entering, in effect, a vast and unregulated human experiment.”
2. Your personal health profile.
Your own genetics, age, gender, environmental stressors, and possible co-existing health conditions all affect how well a medication may work for you, and what kind of side effects you will experience. The people who were selected for testing by a drug manufacturer easily may have met criteria that could have excluded you. For research purposes, the inclusion of people who fall outside a certain age range, who are taking other medications at the same time, or who have more than one health condition can “muddy the waters” of the trial results. It’s important to remember that study results will not automatically be valid for you individually.
3. The drug regulation process.
The FDA is arguably overburdened, and in 2009 was required to regulate the tobacco industry in addition to its oversight of food, drugs, veterinary medicine, and other industries—without an adequate increase in funding. Here is a sobering reality: 80% of approved applications for drugs contain data from foreign trials—and the FDA inspects less than 1% of those foreign clinical investigators. (Department of Health & Human Services report, 2010)
The CDC estimates that 700,000 emergency room visits and 120,000 hospitalizations each year are due to adverse drug reactions. How can we protect ourselves from these serious events? Whenever possible, use medications that have been on the market longer than seven years. And always know your medications, how they interact, their side effects, your dosage, and why you are taking them. If you need help with a thorough assessment of your medications and supplements, call us at (913) 553-6226.