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 has called for an outright ban on direct-to-consumer drug advertising.
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.
Further, Orloff believes that when it comes to oncology, patients are unlikely to initiate treatment conversations with their physicians based on drug advertisements they have seen. While he is not a physician, Orloff has worked with many patients through his advocacy, and he says he cannot recall a patient ever having asked him about a cancer product based upon an advertisement they saw.
“In my mind, I can’t see a patient going to a doctor and saying ‘I need Neulasta,’” he said.
When it comes to the marketing of laboratory developed tests (LDTs) in oncology, the problem of insufficient information provided by marketers should be a concern, said Gray. “We found that with the online marketing of these personalized cancer medicine products and services, the benefit information was reported 85% of the time, whereas the information on the potential limitations was only reported 27% of the time, and that was a statistically significant difference. That’s one thing that both patients and other interested individuals need to think about.”
Furthermore, the standards for marketing of these products are much lower than for drugs, Gray added. “All prescription medicines have to go through the FDA process, and if they’re FDA-approved, there is evidence of clinical benefit; whereas, the vast majority of genetic tests are currently not subject to premarketing review and there are many tests that are marketed that don’t have any evidence of clinical benefit.”
In a November 2015 report, the FDA noted serious quality problems with 20 LDTs that have found their way to market.3 Even though these tests passed muster under Clinical Laboratory Improvement Amendments (CLIA) guidelines, a more rigorous set of standards should have been applied, the FDA wrote in its recommendation for the establishment of stiffer regulation. The report noted huge costs to patients in dollar and health terms as a result of the failure of these products to deliver as promised.
“The regulations that govern genomic testing were written a long time ago, well before we had the ability to do genomic testing at a very large scale for many patients in everyday clinical medicine,” Gray said. “In the short term, what is essential is that people know that a lot of these tests aren’t regulated, that there are things out there that have never been shown to benefit people. Online, claims aren’t routinely regulated either, so the companies can claim that their tests do anything. It makes it quite difficult in some cases for people to really be able to rely on the information that they’re finding on commercial websites.”
Still, much of the information provided by testing companies can be of value for treatment, and Gray recommends that patients bring this information to their doctors for use in determining the best path forward. “What’s important is that people are able to navigate in a way that they get to providers who are able to help them interpret and understand those tests or test results well enough that they can adequately advise them,” she said.
The AMA call for a ban on DTC advertising came out of the group’s Interim Meeting held in Atlanta in November. The AMA said physicians have growing concerns that prescription drug ads are “driving demand for expensive treatments despite the clinical effectiveness of less costly alternatives.” This AMA move was not the first time a ban on DTC has been proposed. In 2006, the National Academy of Sciences’ Institute of Medicine urged Congress to impose a two-year ban on DTC advertising for all new drugs, allowing a chance to determine how well new drugs perform outside of the clinical trial setting.
Source: Steven Woloshin and Lisa Schwartz, professors of medicine at The Dartmouth Institute and co-founders of Informulary.
Kurt C. Stange, MD, in a report published in the Annals of Family Medicine in 2007, argued that pharmaceutical self-monitoring and FDA oversight both had failed to protect the public against misleading DTC advertising.4 Stange said a patient who comes to a doctor with questions based on a product advertisement ends up depriving both patient and doctor of time that could be spent more productively engaged.
“An insidious adverse effect occurs in what is not done during the limited time of a visit,” Stange’s report said. “Discussing why the advertised drug is not the best option for a particular patient may mean that a mammogram is not ordered, an important health behavior is not discussed, a family matter is not brought up, a deeper patient concern is never articulated, and a diagnosis for which there is no drug ad is not made.”
Nevertheless, it’s unlikely that drug ads are going away any time soon, and pharmaceutical companies are unlikely on the whole to upgrade the quality of the information they provide with their advertisements, Woloshin said. “Drug fact boxes would be a great way of making them better, but I don’t have any confidence that the industry is going to do this. They’ve had the opportunity all along to provide that information and they’ve chosen not to. I think it would be great if there were a way to get people unbiased information. I don’t think that drug ads are the best way.”