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3. Times change
2004 Now
Spend on detail reps rising 25%/yr Aggressively cutting sales forces
DTC reached $4.3 B in just 8 years DTC peaked, now declining
CME spend increasing CME market sinking
Small spending on Web Growing amounts for Web 1.0 and 2.0
31 NMEs approved, many primary care 26 NMEs/BLAs, but few primary care
JAD spending growing slowly JAD spending down sharply
4. Agenda
Overview of eight trends that matter
– P
Personal i t
l interpretation f
t ti from medical communications perspective
di l i ti ti
– Sources of challenge
– Sources of opportunity
One trend that represents underappreciated threat
– Why you should care
– Why you should get involved
5. 1: Practicing medicine in a 24/7 world
Physicians’ place in society, and economy, has changed
– L
Less exalted, l
lt d less i d
independent, perhaps l
d t h less affluent
ffl t
Pressure on physician time
– Impact of managed care, need to see more patients
– Reimbursed for procedures > History and physical
– Every 5-minute block is scheduled
– And they expect family/personal time, too!
Competition among information sources
Physicians want quicker information—in smaller, specific units
Younger physicians l
Y h i i learn diff
differently th older
tl than ld
More emphasis on case-based learning
Trend to evidence-based medicine
How to put the evidence into practice?
How to quickly access the practical information needed
6. 2: Recession: Not just a cycle, but a true reset
Global recession appears to be ending, but unevenly
– P bl
Problems i E
in Europe and emerging markets matter t global pharma
d i k t tt to l b l h
At best, economic recovery will be slow
All businesses changed: pace, globalization, productivity
Pharma is no longer immune to economic issues
– Lower sales: Unemployed without prescription coverage
– Higher borrowing costs to fuel operations and research
– Biotechs threatened—and vulnerable to acquisition
Bi h h d d l bl i ii
– Heightened political pressure for generics, importation, price limits
Procurement presses ever harder on pricing
Continuing delays in budgets and decisions
Rationalization of pipelines can eliminate communications programs
A double-dip downturn in Europe could be a drag on pharma here
Innovation the key: offer a better mousetrap for less
7. 3: Pharma restructuring
Began before the recession, but is accelerating
– Business i
B i issues: P t t expirations, gaps i pipeline, slowing sales growth
Patent i ti in i li l i l th
– Scientific issues: R&D processes less productive than expected
– Regulatory issues: Subpoenas, compliance agreements, slower approvals
– Political issues: Anti-pharma sentiment strong and widespread
Anti pharma
Prioritizing R&D spending on fewer categories
Changes in marketing mix
– Reducing sales forces, less DTC more Web
forces DTC,
– More focus on other clinicians, payors, and patients
– More decisions pushed to regional
Responding to compliance issues
– Changes in relationships with clinicians, eg KOLs, ad boards
– Separation of activities, eg medical affairs vs marketing vs CME
Mergers and acquisitions
g q
– To cut costs
– To buy a pipeline
8. Pharma restructuring…continued
Threats
– P
Pressing vendors t h ld d
i d to hold down or d
decrease prices
i
– Consider many services to be commodities
Opportunities
– Pharma needs/wants to outsource more activities
– Need to make smaller sales forces more effective
– Need to educate new audiences (NP, PA, allied health, pharmacy, payors, patients)
– Custo
Customize p og a s for regional aud e ces
e programs o eg o a audiences
Value proposition
– Pharma won’t pay premium prices unless see clear value add
– Look for “sticky business”
y
9. 4: Focus on specialty markets and emerging nations
Rate of growth in pharma sales slowing overall, but large variations
In 2009, global sales about $820B up 5%
2009 $820B,
– U.S., $300B, up 2 to 3%
– Europe, $167B, up 5%; Japan, $86B, up 4.5%
– Emerging $100B up 14% (Brazil Russia, India, China, S Korea Mexico Turkey)
Emerging, $100B, (Brazil, Russia India China Korea, Mexico,
Greatest growth in specialties
– Oncology, up 15% globally
– Specialty p
p y products, up 7.5%
p
– Biotech, up 2.5% (absent EPO, up 10%)
Many of specialty-focused drugs more complex, require more education
y p y g p q
Specialists work in different environment, have different information needs
Reaching audiences in emerging nations
– Local companies will take market share
10. 5: A reinvigorated FDA
Adrift during much of past 6-7 years
– After McClellan long period without any or strong commisisoner
McClellan,
– Funding declined for 2 decades (adjusted for inflation) until 2009
Current administration more decisive and activist
– Product approval process policy on social media etc
process, media, etc.
– Increased funding (but also more tasks)
– Increased use of Risk Evaluation and Management Strategies (REMS) programs
• Mandates more educational programs
• Reaffirms FDA sees value in medical communications strategies
More targeted education and communication programs
Educational programs addressing safety issues
More effective use of Internet and social media for education
11. 6: Reforming health care—by regulation….
Rapid evolution since about 2003
– Traditional Federal regulation intensified (eg FDA warning letters)
(eg,
– Newer Federal regulation (eg, OIG, DOJ, Corporate Integrity Agreements)
– Subpoenas and lawsuits
– State and local regulation ( g, SafeRx Act; limits on use of prescribing data)
g (eg, ; p g )
– Quasi-official regulation (eg, ACCME, AMA CEJA)
– Internal rules at academic centers
– Internal rules at pharma companies
– Think tanks
CME and “regulation by implication”
“First, do no harm”
Diversify revenue streams
Look for compliance solutions
12. 7: …or by legislation
PhRMA actively supported Obama approach, weighing trade-offs:
– $80+ billion cost contribution
– Pilot programs on comparative effectiveness, other metrics
– Increased market of 25 to 30 million patients
– After reform passes, assumed no further major changes for y
p , j g years
Fate of legislation in doubt
– At best, watered down compromise
– Strong possibility overall reform will die
Potential issues for pharma
– If no bill—could see negatives without positives
– “Adjustments” could drag on for years
Potential issues for med comms
– Tax on pharma marketing expenditures
– Physician Payment Sunshine Act variants
– Restrictions on use of prescription data
– Pharma not going to fight on these issues
13. Strategies in this evolving market
Embrace the changes
Understand your customers and your end users
U d d d d
Differentiate your products and services
Develop innovative products
Embrace the Web
Diversify revenue streams
Quality really does count
Compliance really does count
Speed to market is a differentiator in a 24/7 world
14. 8: Pharmaskepticism
Intense suspicion of the motives and actions of pharma—and of those
who partner with pharma
Examples of recent issues that relate to MECCs and publishers
– Access to prescribing data
– Content and design of CME activities
– Involvement of expert physicians as speakers or trial investigators, both in
general and if they participate in certified CME activities
– U of advisory b d of k opinion l d
Use f d i boards f key i i leaders
– Alleged “ghostwriting” of articles in the literature
All concern the proper relationships of medical communications
companies and pharma with h lth
i d h ith healthcare professionals
f i l
16. Sound familiar?
Similarities to the discussion surrounding CME:
– Allegations promoted by poorly informed sources
poorly-informed
– Fanned by selective or misleading news reporting and blog commentary
– Citing an example of poor practice from years ago without acknowledging that it
doesn’t reflect current practice
– Tarring everyone with the same brush
– Failing to seek alternative information from persons who actually participate in and
know about the topic
– Ignoring all that the industry has done to self police and establish best practices
self-police
– Highlighting calls from a few that full disclosure not enough, that ban on physicians
working with industry-supported writers needed
17. Evolution of publication guidelines*
p g
*Dates represent most recent revision of guidelines AAMC Task
GPP2
Force
• Publication guidelines have changed 2009
substantially in recent years Report,
WAME
20087
• Each set of guidelines complements, and
rather than replaces, the others
replaces ICMJE,
ICMJE
20075,6
GPP CSE,
and 20064
AMWA,
AMWA
CONSORT, 20032,3
20011
1Moher D et al. Lancet. 2001;357:1191-1194. 2Wager E et al. Curr Med Res Opin. 2003;19:149-154. 3Hamilton CW et al. AMWA Journal. 2003;18-13-15. 4CSE
Editorial Policy Committee’s white paper. Available at: http://www.councilscienceeditors.org/editorial_policies/white_paper.cfm. Accessed October 23, 2008.
5WAME recommendations. Available at: http://wame.org/resources/policies. Accessed October 23, 2008. 6ICMJE requirements. Available at:
http://www.icmje.org. Accessed October 23, 2008. 7Available at: https://services.aamc.org/Publications/. Accessed October 23, 2008.
18. There’s another side to this story
It’s important to get the data into the literature clearly and promptly
But it won’t happen unless researchers have editorial support
Industry has joined in an educational organization to establish best practices
Good Publication Practices have been published for all to review
– GPP2 , the latest, developed with extensive input and published in BMJ 12/09
latest
Publication planning under today’s guidelines is not “ghostwriting”!
GPP are fully in spirit of transparency, of identifying conflicts, of accurately
representing data of fairly identifying who involved in work and funding
data,
ISMPP has established a credentials exam and program
There are additional protections in the evolving system
– Journal peer review
– Clinical trials registry
– Physician payment registries, etc.
19. A call to action
Clear danger that the discussion around publication support tracks
down the same path as that for CME, with loss for health care system
CME
This is not just about “ghostwriting”
– It is more broadly about relationships with leading clinical experts to
help i f
h l inform and educate h lth care providers i a variety of ways
d d t health id in i t f
Too often, medical communicators—and journal publishers—have
been slow to realize the need to present their side of the story
It’s time to proactively present the full picture
20. Underlying fundamentals
Still huge unmet clinical needs
– R d i th b d of common and serious di
Reducing the burden f d i diseases f which th
for hi h there are
still no cures
– Providing effective care in less invasive settings
– Greater attention to prevention and early care
High R&D spending to develop drugs that save lives, enhance quality
of life, and reduce societal costs
Must d
M t educate physicians, other clinicians, payors, and patients about
t h i i th li i i d ti t b t
new diagnostic and therapeutic developments
Health care system depends on healthy pharma industry and
educated clinicians
d t d li i i
21. Health care system also depends on…
Journals: Critical to peer review and to early and broad access to new
clinical information
Med comms providers: Critical to disseminating information in ways
that improve patient care delivery
• Support efforts to make key clinical d t available i th lit t
S t ff t t k k li i l data il bl in the literature
• Inform clinicians of new diagnostic and therapeutic alternatives
• On label, within supportable claims, put in perspective
• More creative and effective use of adult learning principles and technology
• Filling real need, especially as other sources of education wither
• Neither the Federal government nor individual clinicians shows any willingness to
pay for these educational services
Opinion leaders: The persons with the most experience in clinical
trials, clinical practice, and clinical teaching
Prescriber data: To help identify information gaps and audiences most
needing information
22. It’s up to us
Proactively state the value of our own roles in the healthcare system
– D not assume it is understood
Do t i d t d
– Do not assume this makes no difference
Address multiple stakeholders
– Pharma
• Business model in transition
– Physicians and other clinicians
• Cl if what i at risk
Clarify h is i k
• Clarify how past errors addressed and best practices developed
• Consider communicating with your own readers
– The public and government
• Medical communications aren’t driving healthcare costs, but they are the key to
effective and cost-effective patient care
• Best practices are in spirit of transparency and accuracy
Support Coalition for Healthcare Communication, AMM, other groups
