1. Exploring the Role of Social Media and New Internet Technologies in the Promotion of Prescription Drugs in Canada Presented by: Shannon Gibson

2. Why is social media important? Increasing prominence of new Internet and social media technologies in modern communication Fiscal pressures pushing pharma towards digital channels Migration away from traditional and more expensive media channels such as print and television, toward more economical Internet and social media platform Consumers increasingly seeking health info online In Canada, 70% of home-internet users consulted the web for health information in 2009.

3. Regulation of DTCA in Canada 1953: Food and Drug Act enacted Places a broad prohibition on advertising prescription-only drugs listed in Schedule F to the public. Section 3(1) and Schedule A of the Act set out a number of diseases and disorders for which treatments, preventatives or cures cannot be advertised to the general public. 1978: Amendment introduces clause C.01.044 Allows advertising of name, price and quantity 1996: Health Canada policy statement Gives implicit approval to help-seeking ads 2000: Second Health Canada policy statement Reminder ads deemed to fit within clause C.01.044

4. Flickr: Can You Feel My Pain?

5. Concerns About DTCA Prescription drug advertising raises important safety concerns because of its effects on medicine use: Rapid uptake of new drugs before their longer-term and/or rare risks are fully known Increased use of lifestyle medicines among the healthy Treatment of increasingly mild forms of common chronic illnesses Increased drug use, leading to higher rates of polypharmacy (use of many medicines per person) Increased rates of physician prescribing in response to patient demands, even when physicians are ambivalent about the treatment decision

6. Case Study: Vioxx From 1999 - 2004, more than 20 million took Vioxx. In the US alone, its estimated that: Between 88,000 and 139,000 people suffered a heart attack or stroke 30-40% of these resulted in death During its five years on the market: Merck spent more than US$500 million advertising Vioxx Generated more than US$2.5 billion in sales

7. Cost Implications These shifts in medicine use also lead to higher costs: Use of expensive new drugs when cheaper alternatives are available Increased overall prescribing volume Increased consultation rates with physicians for conditions not previously considered medical Use of many medicines per person, leading to more adverse drug reactions

8. User-Generated Content Drug companies nervous about consumers potentially posting info on adverse drug events or off-label prescribing. Industry mistrust likely also reflects a broader fear of loss of control over their brand message as consumers may post negative or even scathing reviews of a drug product.

9. Anyone can be a Broadcaster Many pharma advertisers use widgets to encourage consumer to share messages through their social networks. Ultimate goal is to go viral

10. Unprecedented Targeted Marketing Promoters can target ads to based on info in users profiles or search history. Age Gender Occupation Education Location Interests Relationship Status Etc.

11. Social Media Marketing Guidelines? April 2009: PAAB raised the idea of Health Canada creating guidelines DTCA in social media. Health Canada acknowledged the need to be active in this area, but has not yet made any move to clarify the issue. Fall 2011: ASC updated its DTCA and DTCI guidance materials to include tips for social media marketing. December 2011: FDA issues limited social media guidance re: responding to off-label info requests. Previous plans to issue comprehensive social media guidance have been removed from the FDA agenda.

12. Social Media Marketing Guidelines? With the rapid pace of change in digital media, if we had bowed to pressure and produced guidance 12months ago, this would have been out of date as soon as wed written it. - Association of the British Pharmaceutical Industry, January 2012

13. Consumer Health Information Site? Third-party health information sites: maintained by independent organizations that have no direct ties to government or the pharmaceutical industry E.g. WebMD, Yahoo! Health, MayoClinic.com Government-sponsored health information sites: many national and regional governmental organizations maintain websites and portals with reputable health information. E.g. MedlinePlus, HealthLink BC

14. Technological Measures? In Canada, nearly all drug product websites that contain patient information are gated to prevent consumers from accessing the site. Require patient to enter the Drug Identification Number (DIN) assigned by Health Canada. Others, such as the Lipitor website, require patient to register on the website to obtain a user name and password to enter the site. Unfortunately, easily circumvented by simply accessing the US version of the site.

15. Other Recommendations Increase Health Canadas and other regulators presence in social media. Harness the power of social media and consumer reporting to improve monitoring of adverse drug events.