Buying the Hype

To most medical professionals, the questionable nature of consumer genetic testing seems self-evident. Unfortunately, that isn’t the case for members of the general public, who – without an advanced education in molecular biology or oncology – lack the ability to critically evaluate the marketing of those kinds of tests. It’s a major concern, then, that the Internet marketing of these services is unregulated; commercial testing companies can make whatever claims they choose, which leads to wide variation in how their services are presented to the public. As a result, many physicians are concerned about the challenge this variation poses both to them in lifting the veil of confusion for their patients, and to the patients themselves, who are trying to make the best possible decisions for their own care.

A new study from the Dana-Farber Cancer Institute (Boston, MA, USA) has determined that websites advertising personalized cancer testing offer genetic tests whose value in clinical guidance has not been shown (1). Stacy Gray, lead author on the report, says, “Over 85 percent of the websites that marketed tumor testing marketed at least one or more tests that really have not been proven to improve patients’ outcomes. That means that there are many different types of tests on the Internet – some of them helpful and some of them not yet known to be helpful.” Even the tests that have clinical value aren’t always presented correctly – most Internet copy emphasizes the purported benefits of the tests while downplaying their limitations (1). “Websites marketing personalized cancer medicine tests, services or clinical care were much more likely to endorse the benefits of personalized cancer care than the potential limitations. For example, important issues such as the possibility of test failure or the fact that providers and labs often face a lot of uncertainty as they try to interpret complex genomic data were infrequently mentioned.”

Marketing claims made by the websites include such statements as, “We want you to have the peace of mind that comes from knowing you are doing everything you can to maximize the success of your treatment and limit treatment side effects as much as possible,” or, “Why use your body to investigate a drug’s effectiveness, when we can garner the results safely and in a timely manner? (2)” Even more worryingly, some suggest making or modifying treatment plans developed by the patients’ care providers, saying, “If you want the peace of mind that comes from knowing that you are doing everything possible to beat your cancer with the least amount of side effects and the shortest recovery time possible, let [our company] prepare a [personalized plan] for you.“ Or even claiming, “Our team has helped patients become aware of, and gain rapid access to, innovative treatments that were not initially prescribed by their oncologists. (2)” It’s possible that these often unfounded claims may actually have a detrimental effect on patients’ care if they promote products or treatment pathways not recommended by doctors.

Gray feels that another major risk is patients having unrealistic expectations if they believe many of the online claims. “If patients see interesting information online,” she warns, “they should definitely ask their doctor about it. And given the disproportionate claims of benefit and promotion of tests that may not be beneficial, we would urge clinicians and patients to critically evaluate online personalized cancer products.”

Recently, the US Food and Drug Administration has stated its intention to begin regulating genomic testing more broadly – a promising step forward for a market whose information is as yet unsupervised by any such agency. But even if such regulation does materialize, as consumer genetic testing becomes more popular and more affordable, it will become increasingly important for medical professionals to assist patients in determining the best way forward for their own treatment.