#JusticeForGlitter#1 album on iTunes on November 15, 2018

The album, was originally released 17 years ago as the soundtrack to the critically panned, box-office flop Mariah Carey vehicle

Lead by a social media campaign

Social Media and its unavoidable impact on

Healthcare

Presented by Calvin Hudson Hwang

President + Executive Producer

An education technology company

INSTITUTIONAL

CORPORATE

THEIR PORTAL

BUREAUCRATIC

ARTIFICIAL

INTERRUPTIVE

AUTHENTIC

COMMUNITY

MY DEVICE

REALTIME

AUTHENTIC

ADDICTIVE

Q: Are you on social media?

WHO

WHAT

WHERE

WHEN

WHY

HOW

POP QUIZ: Macro trend towards digital and social

*2013 Pew Research**2011-2012 Pew Research***2015 Adweek Why Influencer Marketing is the New Content King

What percent of Internet users are searching for health-related subjects?

What percent of Internet users are active on social media?

What populations are most engaged and active on social media?

80%*

74%**

Patients with disability or chronic conditions**

What percent of consumers trust recommendations from others, even people they don’t know, over branded content?

92%***

What percent of user-generated social media health content is fact-checked? 0%

The Age of Misinformation

• Of the top 50 viral hoaxes on Facebook*:

* Dec 2017 BuzzFeed News : https://www.buzzfeednews.com/article/craigsilverman/these-are-50-of-the-biggest-fake-news-hits-on-facebook-in#.bkeYzJVKj** 2012 Content Marketing Institute

#1

CRIME

#2

POLITICS

#3

MEDICAL

Healthcare marketers spend significantly less on social and content marketing vs all marketers**

• Anti-vaxxer movement championed by online “influencers” using terms like ”mommy warriors” and stoking anti-pharma, conspiracy, and autism and impurities fear triggers*

• National vaccine sentiment statistic averages obscured localized movement

• Mobilization and anti-vaccine advocacy spread rapidly through social and digital

• Demographics of anti-vaxxers: white, affluent, educated.** / ***

Case Study #1: Vaccines

*Vaccine Rejection and Hesitancy: A Review and Call to Action TC Smith Oxford Press: Open Forum Infect Dis. 2017** Children who have received no vaccines: who are they and where do they live? Pediatrics. 2004 / Pediatrics 2010*** Everything You Need to Know About Anti-Vaxxers Nicki Lisa Cole, Ph.D. 2017 March

Industry Response and Impact

• Vaccine merit discourse largely isolated in academic and medical settings, not direct-to-patient nor social media

• Industry language is technical, jargoned and “balanced”

• Response content “not popular”

• Media coverage gave Anti-Vaxxers exposure, over-representing the movement, driving doubt, encouraging online research

• Distrust in medical and pharmaceutical institutions grew with 19% of parents noting “concerns about vaccines” in a 2000 survey**, skyrocketing to 50% in 2009***

• Measles cases in the United States reached a 20-year high in 2014**Do parents understand immunizations? Gellin BG, Maibach EW, Marcuse EK Pediatrics. 2000 Nov*** Parental vaccine safety concerns in 2009.Freed GL, Clark SJ, Butchart AT, Singer DC, Davis MM Pediatrics. 2010 Apr

Case #2: Influencer Marketing

• Kim Kardashian & Diclegis

• Undeclared paid brand endorsement of a prescription anti-morning sickness drug

• FDA response: “The social media post is misleading.”

• The post was removed, but had already amassed 464K likes amongst her 40.8 million followers

• Kim’s company reportedly paid $500,000 USD, with the Diclegis sales jumping 21% to $41.7M*

* https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM457961.pdf**https://www.statnews.com/pharmalot/2018/07/10/kim-kardashian-morning-sickness-instagram/

• “Social Influencers” don’t know the regulation, the onus falls on the advertiser

• Paid social posts on a specific drug or product are advertising, as such all prescription drug regulation applies, including advertising preclearance• HCP to PAAB, DTC to ASC or PAAB

• Implications and Penalties (Jennifer to cover)• Reputational damage (brand, company + industry)• PAAB publishes all stage II or III complaint• Penalties are levied by Health Canada, and/or self regulatory associations

(Innovations Medicines Canada, BioTech Canada, etc)

Canada Impact & Implications

* IQVIA Market Research https://www.statnews.com/pharmalot/2018/07/10/kim-kardashian-morning-sickness-instagram/

Case Study #3: Biologic Therapy

Youtube.com

This man is not a doctor. This video has been viewed over 18K times

A Response and Impact

Excerpt Only, NOT FOR PUBLIC RELEASE

*Exiting Hell Bar full film ASC reviewed

Pharma Barriers to Social Media

• Pharmacovigilence: monitoring and adverse event reporting is costly and burdensome

• Urgency: Social media is real-time. Few pharma companies have the agility to move at that pace

• Regulated Content: online communities expect safe environments, candid, and vulnerable conversations. Immediate removal of off-label/inaccurate therapeutic claims, brands and promotional language from pharmaceutical oversight may impact perceived value to community engagement

• Prioritization: Lack of expertise, lack of focus, lack or resources, “it’s not my problem”, reactive mentality, short term sales/prescriber focused, market implication harder to quantify

Key Insights and Take-aways

• Social Media is not a messaging channel, it is an engagement channel• Participants expect real-time interaction, trusting users over brands, and expecting authenticity

and seeking community.

• Social media is an ecosystem of unregulated user generated content• People tend to vent on social media – negative experiences tend to overwhelm, endure and create

doubt, triggering fear, avoidance and delayed intervention.• How to responsibly support positive dialogue on what success could look like to motivate patients

to appropriate action.• It is happening. Ignore it at your own risk.

• Big companies tend to have control issues• Pharma owned sites are held responsible for regulatory compliance for all content on that site,

including user generated content. Pharmaceutical oversight may hinder perceived user value.• Do pharma companies have capable third-parties that can facilitate DTC content and social media

conversation responsibly and effectively?

Thank you

“delivering educational solutions while navigating the inefficiencies related to healthcare regulation”

Presented by Calvin Hudson Hwang

President + Executive Producer

Social media for timely and effective communications

Speaker: Jennifer Carroll, PAAB Reviewer

Agenda

• Learn how to approach social media in a compliant manner

• Learn how to work with social media platforms to create timely and relevant communications and posts.

Generally:

User Generated Content (UGC)

• Canadian regulations apply to online activities which are:

– Within the sponsor’s control or influence

– And where the intended audience is Canadians

• Subsequently:

– Sponsor loses some control over message

• BUT

– Retains much of the regulatory risk

Public Social Platforms

• Paid and unpaid content: who’s responsible?

• If you create a handle or hashtag, etc. you are creating the space for discussions around that topic to take place

The SPONSOR is responsible

Know your audience

Consumer Regulations

Patient Regulations

Healthcare professional Regulations

Start by asking yourself some questions to align the site with your risk tolerance:

• Will I have site rules? What will they be? How will I communicate them?

• To what extent will I be monitoring? What will I be looking for?

• How much control am I giving to the audience?

• To what extent will the site be moderated

Terms and conditions:

- Clear and accessible

• Statement outlining how the site will be monitored and moderated

• What type of comments will be removed or modified – May minimize frequency of misuse

Monitor the conversation:

Correcting misinformation:e.g. misinformation about company or disease

– Corrections must be made promptly. PAAB preclearance not required if limited precisely to the minimum needed to correct misinformation.

Off-label discussions:– Remove outright!!

Adverse event monitoring:– Not enough to only provide a statement referring

reporters to the pharmacovigilance / medical department.

Monitor the conversation:

- Example

• Semantic

• Automatic filtering mechanism– (brand key words, side effects etc.)

Microblog

• Consumer

• Rx product

– Cannot go beyond name price quantity

– Cannot create a link between product and therapeutic use

• Vaccines

– Can create link between therapeutic use if for the prevention –must include risk benefit content

Microblog

• Patients

• Can make a direct link between product and therapeutic use

• Must not be promotional in nature

Microblog

– HCP

• Direct or implied claims must include risk/benefit fair balance and be page-linked to the product monograph

Responding to individual users questions

– One-on-one correspondence exempt from PAAB review

– PAAB review required for sponsor/agent generated answers openly visible to entire community

Time sensitive

• PAAB can provide pre-approved standard responses

Penalties

PAAB DOES NOT ENFORCE FINES

REFERRAL TO HEALTH CANADA

REFERRAL TO TRADE ASSOCIATIONS

Questions?