Sept. 21, 2011 — The results of a study issued last week show that a majority of patients have a preference for new drugs over older drugs, and that the public does not completely understand the FDA new drug approval process. For marketers, this may be good news, but industry also may want to consider participating in efforts to better educate consumers about drug risks and benefits.
The study was conducted by researchers at the Dartmouth Institute for Health Policy and Clinical Practice and the VA Outcomes Group, and appeared in the Sept. 12 issue of the Archives of Internal Medicine. “The public may not realize that even with [FDA] approval, important uncertainties about the benefits and harms of these drugs remain,” the summary states.
Coalition Executive Director John Kamp noted that it is important for the public to be aware of both the risks and benefits that drugs provide. “Let”s not lose sight of the fact that while no drug is absolutely safe, both new and old drugs often help patients live better and longer lives, he said. “Education is key, including the education that comes with every consumer ad.”
During the survey, questions were posed to approximately 3,000 participants randomly selected from 30,000 households. In one scenario, participants received one of three explanations about a pair of heartburn drugs – one that was newly approved and one that was approved eight years ago. Controls received no explanation, the nondirective group was told that it takes time to establish safety for new drugs, and the directive group received explanations plus advice to “ask for [a drug] with a longer track record.”
Close to 40 percent of respondents in the heartburn drug scenario stated they believed that the FDA approves only “extremely effective” drugs, and 25 percent of respondents stated their belief that the FDA approves only drugs without serious side effects. “Brief explanations highlighting uncertainties about the benefit of drugs approved based on surrogate outcomes and the safety of new prescription drugs improved choices,” the survey results state.
The issue here is not the marketing of the new drugs, but better educating the public about the risks and benefits of any drug, explained Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest. “This survey doesn’t speak to industry’s explaining and marketing its own products. It is the FDA’s job to better define its approval process,” Pitts said.
Wayne Pines, consultant to the pharmaceuticals industry, said that the FDA has always had a challenge explaining its approval process and the risks that all products may have. “This study confirms that the public lacks understanding of what FDA approval constitutes,” Pines noted.
According to Pitts, “this is an opportunity for industry to better educate consumers about the benefits and risks of taking new drugs so they can have meaningful discussions with their doctors – who in theory have a better understanding of the FDA product development and
approval processes,” he told the Coalition for Healthcare Communication. “If asked, I would bet that industry would be willing to help better educate the public.”
Pines concurred that it is important for doctors and the pharmaceuticals industry to engage in education programs regarding risk. “The agency has made some investment in this, but clearly it is not enough.”