Steven Woloshin, MD
Unsuccessful efforts have been made to improve the quality of information provided to consumers about advertised drugs, and against that backdrop, the American Medical Association (AMA) has called for an outright ban on direct-to-consumer (DTC) drug advertising.
Physician-researchers and a cancer patient advocate interviewed by Oncology Business Management
said they have deep concerns about the quality of drug and lab test information offered to the public through advertising. The United States and New Zealand are the only two countries that allow DTC drug advertising. Here, many products are marketed with insufficient information about quality and benefit, and there may not be any justification for claims of efficacy, those interviewed said. Furthermore, doctors need better quality information, too, as they often lack the background to discern the value of genomic tests.
“In a study that we published last year in the Journal of Clinical Oncology
, we found that even in a comprehensive cancer center, about a quarter of providers had lower levels of confidence in their ability to understand genomic concepts and to be able to explain genomic concepts to patients,” said Stacy W. Gray, MD, of the Center for Population Sciences at Dana-Farber Cancer Institute.1
“This is a rapidly moving field, so educating physicians and clinicians more generally is a very high priority.”
Steven Woloshin, MD, a professor of medicine at The Dartmouth Institute, has worked with Lisa Schwartz, MD, of the Dartmouth Geisel School of Medicine to develop drug fact boxes for advertisements and prescription information that would provide more comprehensive data for use in interpreting the value of various medications.2
This information would be of value to patients and doctors, Woloshin said. However, efforts to get the FDA to make the fact boxes a standard requirement for drug advertising were unsuccessful. “We first approached the FDA more than 10 years ago, and they said it was a good idea, but they wanted to see that consumers really wanted information about benefits and harm and that they could use it and that it would help them to make better decisions,” Woloshin said.
What followed was a number of studies that found, essentially, that consumers would make better drug decisions when armed with better information, he said. After that, a provision for drug fact boxes was written into the Affordable Care Act and the FDA was granted the option of review before enactment. After several years of review, the FDA announced last year it would not certify the provision. Woloshin and Schwartz then obtained a grant from the Robert Wood Johnson Foundation and established the website Informulary, where their drug fact box information could be obtained by seekers.
The encapsulated material available on Informulary is based on FDA reviews of drugs and contains information that drug companies often leave out of their drug advertisements, Woloshin said. “Doctors don’t generally read the FDA reviews, which is the best way to get as close as possible to the unbiased, transparent information about the drug trials themselves. It’s really crucial that prescribers know how well the drugs work, and it’s hard to find that out; so, one of our hopes is that through Informulary, we can get this information out to the doctors.”
Proponents of DTC advertising have contended that prescription drug ads are a valuable source of information for empowering health care consumers. Whereas the AMA has called for a strict ban on DTC advertising, it’s unclear whether such a ban would make a positive difference in oncology marketing given the esoteric nature of these drugs and patients’ greater dependence on their doctors for guidance.
Woloshin is in the camp of doctors who believe that oncology drug information should be primarily aimed at the prescriber. “Newly advertised drugs are probably the most important. They have the shortest track record and the least is known. It’s hardest to get the information.”
Patients with cancer have a hunger for knowledge about their disease and are almost guaranteed to do a huge amount of research on their own to learn about the nature of their diagnosis and the available treatments, added Gregg Orloff, PhD, founder of CancerQuest, a nonprofit cancer information and outreach site at Emory University. Orloff said that incomplete or biased-nature drug advertising may be a greater threat in other spheres of medicine than in oncology, where patients tend to be much more reliant on their physician’s expertise for treatment planning.
In addition, consumers may have a limited ability to absorb and correctly interpret drug information when it is presented rapid-fire in a television advertisement, Orloff said.