Making the right impression


Is direct-to-consumer advertising appropriate when it comes to health information?

My my, the FDA have been busy recently. Or, perhaps more accurately, they have been publicly busy recently. As the primary agency involved in the regulation and supervision of food and pharmaceutical safety standards, the US Food and Drug Administration may not be the most glamorous of government bodies (FDA, Miami anyone?) but it certainly has its work cut out in an age where technological advances in the generation of health data are outpacing changes in law and policy.

We’re entering a very interesting era of health informatics. We now have the technology to collect, for relatively little cost, terabytes of data on an individual related to their genetics, metabolism, gut flora, immune response, brain activity… the list goes on. The question is – how can we use these data to make meaningful choices about healthcare? And should individuals without medical training, be allowed access to information about their own health status that could be misinterpreted or misused? This is the current subject of debate in the somewhat bizarre altercation between the FDA and 23andme – a company set up to provide (limited) genetic information direct to consumer (DTC). Having been giving out genetic data since 2007, 23andme are facing scrutiny, not because of their technique, but because of their advertising.

As recently as 2007, the cost of sequencing a whole human genome was prohibitive for most individuals. Since you ask, around US$10 million (reference 1). But 23andme don’t sequence the whole genome. Rather, they look at a very small number of genes that have been associated with a particular trait or disease, making the cost of the test low enough for the average Jane or Joe to give it a go. Everyone has the genes 23andme look at, but different people can have slightly different versions, and those versions can work in different ways making people more or less susceptible to a particular disease. By giving information directly to patients on whether they carry a version of a gene that can increase the risk of breast cancer or Alzheimer’s disease, there is concern that people will not have adequate support should they be carrying the “wrong” version. Interpreting the consequences of genetic mutations can be difficult even under the guidance of a genetic counsellor. When faced with a potentially life-threatening change in health status, many people require more support than two pages of disclaimers can provide.

The FDA’s concern about patient reactions is not without precedent. In the early years of the HIV/AIDS pandemic, suicide rates among those diagnosed were shockingly high – the graph below shows suicide rates by year for the general population (blue line) and for those on anti-retroviral therapy following HIV diagnosis (red line). As education about treatment options has improved (along with other changes including a reduction in social stigma), suicide rates among the HIV+ population of British Columbia, at least, have returned to those seen in the general population.


Figure from reference 2

While some consumers will have the nous, the time and the energy to research, understand and interpret their test results, many may see the presence of a gene associated with cancer as a death sentence or may opt to undergo drastic surgery whether or not they fully understand the result. There is also the risk that people will adjust their own medications without consulting a physician. For example, 23andme provide information about a gene associated with the anticoagulant warfarin. If someone finds out they carry a version of this gene that is associated with increased drug activity, they may lower their dose and put themselves at risk of heart disease.

As information becomes more freely available, and consumers become more directly targetable, healthcare professionals need to recognise that this shift in power dynamic will affect decisions about healthcare from all sides. Patients are gaining access to health information along with direct control over which medications they take, perhaps without the adequate knowledge and experience to understand the links between the two or the consequences of either.

In another recent move by the FDA, advertising is, again, under examination; this time for medications targeted toward adolescents. When healthcare choices are a joint decision between children and their parents, as is often the case once children reach adolescence, advertisers are already making sure they target both audiences. Whether the drug being advertised treats acne or anxiety, teenagers are a lucrative market; but the advertisement that appeals most may not necessarily correspond with the most effective drug. With their new online survey, the FDA are setting out to evaluate whether adolescents are more impressionable to these advertisements and, if so, whether DTC drug advertising should be regulated in the same way as alcohol advertising is now. As with 23andme, this sort of advertising has been around in the US for years and is only just coming under the FDA’s radar.

Personally, I’d like to see everyone given access to their own health information. But then again, I’ve never had to give a patient the results of a genetic test. Laura Hercher, a genetic counsellor and faculty at Sarah Lawrence College, provides a balanced first-hand view of this here. Giving sensitive diagnoses online, albeit with several pages of advice and disclaimers (which, of course, everyone reads thoroughly), is risky and is definitely something that should be addressed by the FDA and health professionals. As regards advertisements for drugs directly aimed at patients and specifically at children, I’d like to see them scrapped altogether. No one is better placed than a physician to offer advice on which drugs are most appropriate for a patient and glamour should not be a consideration when it comes to healthcare provision. If you insist on keeping them, there should at least be regulations on the amount of money being spent and the age of the target audience. This is particularly important when the consumer is still developing their decision-making skills and social pressures are at an all-time high.

But where should we draw the line between patient freedom and patient protection? Given that human beings are notoriously bad at evaluating risk, how can we be sure that ambiguous genetic data are used effectively? Maybe we could use the comments section to discuss this further. We need to start the debate now and begin developing legislation to safeguard patient interests before the technology overtakes us.


1)    Wetterstrand KA. DNA Sequencing Costs: Data from the NHGRI Genome Sequencing Program (GSP) Available at: Accessed 2013-12-06.

2)    Gurm et al. (2013) Abstract PS5/3, 14th European AIDS Conference (