Pharma, Social and Human Research Subjects Recruitment

It is not a particularly comfortable time for the pharmaceutical industry. Several extremely profitable drugs, such as Lipitor, Zyprexa, and Levaquin, have lost their patents, whilst other big sellers, like Plavix, Seroquel and Singulair,  lose theirs this year. With an apparent lack of replacement ‘blockbusters’ in the pipeline, the big, ‘brand-name’ pharmaceutical companies’ profits seem likely to take a hit, and market analysts are already talking about potential downgrades in debt ratings. These financial uncertainties merely serve to compound Pharma’s ongoing threats: an increasingly strict regulatory environment, both in the EU and the US, and the industry’s generally unfortunate public image.

On top of all this (as if it were not enough), Pharma still hasn’t quite figured out what it is going to do about social media.

Pharma has a strained relationship with social. Cautious as ever, Pharma was late to the social media party and, having arrived, found that all its fears about DTC advertising, Adverse Event Reporting and regulatory uncertainty were coming true. The Pharma exodus from Facebook represented an increasing assumption within the pharmaceutical sector that social media just is not worth it.

RMM would beg to differ.

Certainly, pharmaceutical companies can forget using social media in the way that, say, the automotive industry does. No-one is going to ‘like’ Acme Pharma on Facebook, even if EU regulations would let them. It is neither ethical nor legal for pharmaceutical companies to push their products on Twitter as though they were the equivalent of a new car. But that is not to say that social media is a completely dead end for Pharma. Indeed, social media presents opportunities to Pharma which may help brighten up the outlook for the future.

Pharma’s social media future lies in the recruitment of human subjects for research. Slow subject recruitment is one of the biggest barriers to advancements in medical science. Social media presents pharmaceutical companies, both large and small, with two extremely promising ways of enhancing the human subjects recruitment process: 1) Direct recruitment through disease-specific online communities, and 2) The dissemination of recruitment materials through online social networks. Both these mechanisms are already being used, with some small-scale success, by pharmaceutical companies and contract research organisations to improve human subjects recruitment. The key challenge will not simply be to expand these efforts, rather it will be for pharmaceutical companies to pre-empt the inevitable ethical and oversight questions that social media recruitment raises.

The State of Play: Numerous pharmaceutical industry articles have sung the praises of social media’s potential for recruitment. Social media has given birth to a huge amount of online communities dedicated to the discussion of specific diseases, ranging from widespread chronic diseases like cancer, HIV-AIDS and diabetes, through to much rarer genetic conditions such as Duchene’s Muscular Dystrophy and specific mutations of Cystic Fibrosis. Broadly, these communities come in three types:

1. Grassroots: These communities are self-organised, either by people with a specific disease or, as is often the case with childhood diseases, by parents or other family members. They exist primarly as a mechanism for the exchange of information and emotional support. Membership of these communities is usually predicated on personal, rather than professional, experience of specific disease.

2. Non-Profits: These communities are organised either by public health authorities or by charities. They exist in order for NP organisations to: a) provide a platform for disease sufferers and their families to exchange information and support, and b) provide professional information about specific diseases as part of the NP mission. They also exist for disease sufferers and their families to exchange information and support.

3. For-Profit: The smallest type of disease community, for-profits are best represented by PatientsLikeMe, who provide well-maintained discussion forums and symptom-recording platforms for various diseases. With the express knowledge and consent of community members, PLM sells member data on to various interested parties, pharmaceutical companies included.

Rather than the slow recruitment process of newspaper advertising and physician referrals, online disease communities present pharmaceutical companies with the opportunity to go directly to the disease population. Approaching these communities and developing appropriate research partnerships with their members is a delicate process. However, the early signs are that far from being unresponsive (or, worse, offended) by approaches to participate in research, members of online disease communities are in fact highly responsive to research participation opportunities and are eager and willing to pass on recruitment information to other members of the community whom they feel may benefit from participating in research. It is clear that the use of social media to enhance research recruitment by pharmaceutical companies and the contract research organisations with whom they partner is only going to expand as more and more organisations realise the opportunities that social media presents in this arena. However, mere expansion of these efforts will not be enough to ensure ongoing success.

How Things Need to Look: To ensure that their efforts to enhance human subject recruitment via social media are not threatened by public criticism or by governmental regulations, pharmaceutical organisations must lead the way in addressing the ethical and oversight issues which will inevitably arise.

Recruitment is not easy. As both pharmaceutical companies and academic researchers have learned to their peril, just barging in to offline communities (student bodies, say, or deprived neighbourhoods) looking for research subjects is almost guaranteed both to cause public anger and to attract the attention of regulatory bodies and research ethics boards. Online disease communities are no different: they have their own standards and their own sets of priorities.  Pharmaceutical companies wishing to recruit from them must respect these standards or face accusations of unethical behavior. This will involve consulting with online disease communities about their priorities and the appropriate mechanisms for recruitment. Pharmaceutical companies who prioritise online community engagement will both ensure that their recruitment efforts are well-received by and are insulated from public criticisms of exploitation and intrusion.

There currently exist no industry-wide guidelines regarding the use of social media to recruit human research subjects. The companies who lead the way in community engagement will, in effect, be setting those standards. They will also be the companies who are able, most convincingly, to tell governmental regulators in the EU and US that they have already addressed the ethical concerns that social media recruitment raises. The pharmaceutical companies who are succesful in using social for human subjects recruitment will be those who best understand the needs and ethical concerns of the online patient communities they engage with.