Archive for the ‘Policy’ category

Why social media matters to FDA, pharma and everyone else

November 14, 2009


November 12 and 13 2009 marked a significant turning point for the US pharmaceutical industry. FDA convened a public hearing on the use of social media by pharmaceutical and medical device companies, officially titled: Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools. The FDA sought input on these five questions:

1. For what online communications are manufacturers, packers, or distributors accountable?

2. How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?

3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties?

4. When is the use of links appropriate?

5. Questions specific to Internet adverse event reporting

Twitterverse and the blogosphere is abuzz with updates from multiple perspectives (see the FDASM site and Shwen Gwee’s compilation) so I will add mine, reflecting on the presentations I listened to on November 12, day 1. Being unacquainted with the the US pharmaceutical advertising and regulatory framework, my observations are mainly informed by my experience as a librarian and interest in helping consumers locate balanced drug information in the Canadian context where direct to consumer advertising of pharmaceutical products is barred.


FDA is to be commended for convening this eagerly awaited forum to deliberate a very important issue. Social media have compounded the minefield that is drug marketing and advertising. A public consultation that brings stakeholders together to articulate the issues, concerns and recommendations is a welcome first step.

The 60 or so speakers represented drug companies; Internet search engines like Google Inc  and Yahoo Inc; the Online Media advertising community; Consulting firms, Research groups and Consumer communities among others. As it was a public hearing, anyone could request to attend or present a response to any of the questions although the speaker selection criteria was not disclosed.

In my humble view, the patient/consumer perspective was underrepresented and while I would like to think that this is reflective of the submitting organizations rather than the selection process, others such as Gilles Frydman share my suspicion.  Commercial interests were well represented and some presenters betrayed a clear preoccupation with self-preservation rather than concern about the issues at hand and the most important stakeholder of all – the patient/consumer.

Common themes

  • With one notable exception, there was consensus that pharmaceutical companies should only be held responsible for content they have originated or sponsored. User generated content should not be treated the same as company generated content. Dr. Diane Zuckerman, National Research Center for Women & Families was the lone dissenting voice which was important because she represented the consumer or patient perspective. To the ire of many pharma representatives, Zuckerman demanded that companies take responsibility for all content relating to their products even when it appears on a third party site.
  • Links that are no more than a click away should be used to provide access to accurate, balanced information on both risks and benefits. A common recommendation to address space limitations was to provide links  to FDA approved information. It was suggested that links to FDA’s adverse reporting site (FDA medwatch) to support voluntary patient reporting would address the thorny issue of adverse reaction reporting.
  • Transparency is paramount. All parties should disclose their affiliations and connections. Consumers should be readily able to distinguish advertising from editorial sources. Accountability should be balanced with content owner’s influence.
  • Companies have the responsibility to make reasonable efforts to monitor product references in social media and respond where appropriate without the regulatory expectation of policing the entire internet.
  • Social media presents new challenges but the existing framework can be reformed to accommodate the new demands of these media although this may require more resources. For example, company policy can handle the corrective action required to correct misinformation on a 3rd party site (Alex Vandevere, Global Prairie Integrated Marketing).
  • Helpful guidance would include standard formatting for product claim ads. Google suggested a format for product claim ads with a header, warning and “more information” link to risk information. The placement and placement of risk information should match that of the benefit information.
  • Consumers value the presence of pharmaceutical companies in social media places. While they recognise that their information may be slightly biased, this risk is outweighed by their obligation to provide accurate drug information and correct misconceptions (WEGO Health). Only 1 in 5 people said that they saw no need for pharmaceutical company participation (Manhattan Research)

Interesting insights, shocking statistics and disturbing discoveries

Some speakers presented data but did not elaborate on their methodology.

  • Medline Plus is a leading provider of consumer health information. It would have been valuable to hear their perspective alongside WebMD.
  • 75% of physicians recommend websites to their patients (Wayne Gattinella, WebMD)
  • 83% of internet users go online for health information (Craig Audet, Sanofi-Aventis)
  • Web display ads are a far better platform for communicating risk information than traditional media because there are no time restrictions
  • The fastest growing segment of health information search is drug information searches: 2/3 in 2009 up from 1/2 in 2004 (Manhattan Research)
  • Pharmaceutical sites make up a small percentage of sites that patients visit. Most patients visit disease sites, only going to pharma sites for more specific information on adverse effects. Patients tend to search for answers before going to the doctor and after getting prescriptions (John Mangano, comScore)
  • Google reported that online health information impacts behaviour with 36% speaking to a doctor and 21% changing their behaviour. Comscore on the other hand stated that 90% of consumers say that the online content they find prompts them to see a doctor. Could some of these searchers have Cyberchondria (” loosely defined as the baseless fueling of fears and anxiety about common health symptoms due to Internet research”) according to recent findings by Microsoft researchers?
  • Pharmaceutical companies post videos on Youtube and disable the comments
  • FDA’s Notice of Violations to 14 companies for using paid search ads had the unintended effect of hiding transparency and interfering with relevance. See eyeonfda’s analysis and Google’s interpretation (slides 9 &10).
  • Zuckerman recommended that FDA create a relationship with wikipedia in order to mitigate the risk of misinformation

Predictably, Zuckerman’s harsh stance was  unpopular with the pharmaceutical industry audience but she made very important and disturbing points. Patient’s access to accurate and credible health information should be of  paramount concern. In wikipedia, apparently, some unscrupulous manufacturers write promotional articles that genuine experts cannot edit (Zuckerman gave the example of breast implants). This is in violation of wikipedia’s policies. Obviously, a company promoting its products without being transparent is outrightly unethical and dishonest and displays flagrant betrayal of public trust. From a search standpoint, it is also disconcerting that the highest ranking results may not lead to complete information on drug safety. When Zuckerman searched for vytorin, the first link was which left out important information.

Zuckerman’s proposal that FDA try to regulate wikipedia is unrealistic but raises the tricky the question of how to address this problem. At the same time, are we overly anxious about the possible harm? In a fascinating post, Susannah Fox reports ” just 3% of e-patients said they or someone they know has been harmed by following medical advice or health information found on the internet, a number that has remained stable since 2006.” If true, this is reassuring. Attempting to regulate social media means stifling the very characteristic and strength of the “social” – participation and user generated content. Commenting on Fox’ post, Kevin Clause suggests that ” it will be easier to improve the quality of health-related information in Wikipedia than to change the search habits of an entire population” – this would be ideal but how can it be done? It is impossible to police wikipedia to ensure that the information is accurate but we can train patients to be more discerning which apparently they can be according to Fard Johnmar (Envision Solutions) who reports that consumers are smarter than we give them credit for: they distrust advertising, avoid sponsored links and prefer content by credible sources such as FDA or WebMD.  Health librarians have a significant role to play in empowering consumers to be active partners in their health care by promoting health literacy and directing users to credible health sources.