Direct-to-consumer pharmaceutical ads have come under much scrutiny in recent years as the number of these ads increased while governmental regulations laxed. Perhaps the most common issue brought up regarding pharmaceutical ads is the enhancement of the drug's positive potential effects, while negative side effects are hurried and distorted by background noise.
However, the misrepresentation of research statistics is another big issue common to drug advertisements. Let's look at some examples.
Used to treat some rare blood cell disorders and cancers, drug manufacturer Eisai claimed in a patient brochure that 38% of study patients responded positively to the drug. In a November 2009 letter from the FDA, the study's claims were said to be false. The FDA said the 38% figure was misleading because it was "...taken from a small subgroup of patients who responded well to the drug. Including all the patients in the study, the response rate was a mere 20%."
When reviewing statistical results, it is always important to consider the population from which the sample came from and to compare the statistical results to additional trials or previous related research. This study falsified the generalizability of the statistical results from one subgroup of the sample to say that the results could be expected for many people.
Kaletra is an AIDS drug from Abbott Laboratories. The company came under FDA scrutiny after a testimonial DVD featuring Magic Johnson suggested that the drug could be helpful to most HIV patients in managing their illness. In a July 2009 letter, the FDA warned the company against such claims as in a clinical trial, the drug was shown to be ineffective for 37% of patients.
This example is a reminder of the importance of knowing a research study's methodology. While the drug was ineffective for nearly 40% of participants in one study, the drug company overstated the drug's effectiveness and generalizability with the omission of critical information, such as the overall sample size, population from which the sample was drawn, and subsequent statistical results.