By: Jeff S. Gibson, Attorney
Consumers are bombarded daily by advertisements for pharmaceutical drugs via television commercials, magazine advertisements, banner ads displayed on their computers, and emails. How does this constant stream of information impact a person’s decision to seek medical advice or inquire about a particular drug? What impact, if any, do these advertisements have on drug safety for patients?
In 2004, the Food and Drug Administration (FDA) released survey findings about the impact of direct-to-consumer drug advertisements on patients and physicians. The intent of the survey was to determine if consumers appropriately understood the advertised prescription drug’s risks and benefits or if the FDA’s advertising rules needed to be changed. A lack of patient understanding of risks and benefits could have a negative impact on patient safety. Researchers found 81 percent of consumer respondents in 2002 reported seeing or hearing an ad for a prescription drug and 58 percent agreed strongly that direct-to-consumer advertisements make the drug seem better than they really are. A majority of surveyed physicians said their patients seemed to understand a drug’s benefits very well while only 40 percent of those physicians felt their patients understood the drug’s side effects and risks as well.
Are Consumers Aware of Drug Risks?
Much has changed in the pharmaceutical development and marketing landscape since 2002 when the FDA initially implemented its survey. Drug manufacturers are spreading more and more product messages across a variety of media to sell life-saving drugs as well as lifestyle drugs. One example of the latter is prescription testosterone. While testosterone replacement therapy does help men who suffer from hypogonadism, or low testosterone, some drug manufacturers created advertising campaigns targeting a wider audience. A diagnosis of low testosterone is defined as 300 or less nanograms per deciliter for total testosterone. Symptoms of low testosterone include fatigue, muscle weakness, depression, and low libido. However, aggressive direct-to-consumer marketing campaigns suggested that if a man is overweight, tired, and less interested in sex then he is probably suffering from a condition called “Low T”. These campaigns were so successful in driving prescription sales that industry leaders project revenues for prescription testosterone drugs will reach $5 billion by 2017. This increased interest in testosterone treatment also captured the interest of researchers who discovered approximately 25% of the men who received prescriptions for testosterone drugs had not been tested to determine whether or not they had hypogonadism. These drugs do carry risks. In fact, one study found men on testosterone replacement therapy had double the risk for a heart attack.
FDA Launches New Survey to Measure Patient Impact of DTC Advertising
Testosterone replacement drugs are just one example of the power of DTC advertising. Consumers who buy into the hype of a drug after being bombarded by marketing messages can put their health in danger by not taking the time to learn about the risks associated with these medications. Thousands of lawsuits are filed each year against pharmaceutical and medical device manufacturers who fail to adequately warn patients and doctors of the risks associated with treatment.
The FDA is launching a new survey to measure the impact of DTC advertising on consumers to follow up its last survey conducted twelve years ago. This survey will identify trends in DTC advertising over this timeframe and indicate consumer awareness of drug advertising messages.
Defective Drug Lawsuits
Cohen & Malad, LLP product liability lawyers have been litigating claims for injured people against large pharmaceutical companies and medical device manufacturers for many years. If you have been seriously injured after taking a prescription drug or receiving a medical device, contact us to learn about your legal rights and options.