Evolving challenges in medical communications:Eight trends that matter

Association of Medical Media2/24/10 General Session

Jon BigelowPresident and CEO, KnowledgePoint360 Group

Copyright © 2010 KnowledgePoint360 Group, LLC

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Times change

2004

Spend on detail reps rising 25%/yr

Now

Aggressively cutting sales forces

DTC reached $4.3 B in just 8 years

CME spend increasing

DTC peaked, now declining

CME market sinking

Small spending on Web

31 NMEs approved, many primary care

Growing amounts for Web 1.0 and 2.0

26 NMEs/BLAs, but few primary care31 NMEs approved, many primary care

JAD spending growing slowly

26 NMEs/BLAs, but few primary care

JAD spending down sharply

Agenda

Overview of eight trends that matterP l i t t ti f di l i ti ti– Personal interpretation from medical communications perspective

– Sources of challenge– Sources of opportunityOne trend that represents underappreciated threat– Why you should care– Why you should get involved

1: Practicing medicine in a 24/7 world

Physicians’ place in society, and economy, has changedL lt d l i d d t h l ffl t– Less exalted, less independent, perhaps less affluent

Pressure on physician time– Impact of managed care, need to see more patients

Reimbursed for procedures > History and physical– Reimbursed for procedures > History and physical– Every 5-minute block is scheduled– And they expect family/personal time, too!

Competition among information sourcesCompetition among information sources

Physicians want quicker information—in smaller, specific unitsY h i i l diff tl th ldYounger physicians learn differently than olderMore emphasis on case-based learningTrend to evidence-based medicineHow to put the evidence into practice?How to quickly access the practical information needed

2: Recession: Not just a cycle, but a true reset

Global recession appears to be ending, but unevenlyP bl i E d i k t tt t l b l h– Problems in Europe and emerging markets matter to global pharma

At best, economic recovery will be slowAll businesses changed: pace, globalization, productivityPharma is no longer immune to economic issues– Lower sales: Unemployed without prescription coverage– Higher borrowing costs to fuel operations and research

Bi h h d d l bl i i i– Biotechs threatened—and vulnerable to acquisition– Heightened political pressure for generics, importation, price limits

Procurement presses ever harder on pricingProcurement presses ever harder on pricingContinuing delays in budgets and decisionsRationalization of pipelines can eliminate communications programsA double-dip downturn in Europe could be a drag on pharma hereInnovation the key: offer a better mousetrap for less

3: Pharma restructuring

Began before the recession, but is acceleratingB i i P t t i ti i i li l i l th– Business issues: Patent expirations, gaps in pipeline, slowing sales growth

– Scientific issues: R&D processes less productive than expected– Regulatory issues: Subpoenas, compliance agreements, slower approvals– Political issues: Anti-pharma sentiment strong and widespreadPolitical issues: Anti pharma sentiment strong and widespread

Prioritizing R&D spending on fewer categoriesChanges in marketing mix

Reducing sales forces less DTC more Web– Reducing sales forces, less DTC, more Web– More focus on other clinicians, payors, and patients– More decisions pushed to regional

Responding to compliance issuesResponding to compliance issues– Changes in relationships with clinicians, eg KOLs, ad boards– Separation of activities, eg medical affairs vs marketing vs CME

Mergers and acquisitionsg q– To cut costs– To buy a pipeline

Pharma restructuring…continued

ThreatsP i d t h ld d d i– Pressing vendors to hold down or decrease prices

– Consider many services to be commodities

OpportunitiesPharma needs/wants to outsource more activities– 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)– Customize programs for regional audiencesCusto e p og a s o eg o a aud e ces

Value proposition– Pharma won’t pay premium prices unless see clear value add– Look for “sticky business”y

4: Focus on specialty markets and emerging nationsRate of growth in pharma sales slowing overall, but large variationsIn 2009 global sales about $820B up 5%In 2009, global sales about $820B, up 5%– 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, up 14% (Brazil, Russia, India, China, S Korea, Mexico, Turkey)

Greatest growth in specialties– Oncology, up 15% globally– Specialty products, up 7.5%p y p p– Biotech, up 2.5% (absent EPO, up 10%)

Many of specialty-focused drugs more complex, require more educationy p y g p qSpecialists work in different environment, have different information needsReaching audiences in emerging nations– Local companies will take market share

5: A reinvigorated FDAAdrift during much of past 6-7 years

After McClellan long period without any or strong commisisoner– After McClellan, long period without any or strong commisisoner– Funding declined for 2 decades (adjusted for inflation) until 2009Current administration more decisive and activist– Product approval process policy on social media etcProduct approval process, policy on social 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 programsEducational programs addressing safety issuesMore effective use of Internet and social media for education

6: Reforming health care—by regulation….Rapid evolution since about 2003

Traditional Federal regulation intensified (eg FDA warning letters)– Traditional Federal regulation intensified (eg, FDA warning letters)– Newer Federal regulation (eg, OIG, DOJ, Corporate Integrity Agreements)– Subpoenas and lawsuits– State and local regulation (eg, SafeRx Act; limits on use of prescribing data)g ( g, ; p g )– Quasi-official regulation (eg, ACCME, AMA CEJA)– Internal rules at academic centers– Internal rules at pharma companies– Think tanksCME and “regulation by implication”

“First, do no harm”Diversify revenue streamsLook for compliance solutions

7: …or by legislationPhRMA actively supported Obama approach, weighing trade-offs:

$80+ billion cost contribution– $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 yearsp , j g yFate 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– Physician Payment Sunshine Act variants– Restrictions on use of prescription data– Pharma not going to fight on these issues

Strategies in this evolving market

Embrace the changesU d d d dUnderstand your customers and your end usersDifferentiate your products and servicesDevelop innovative productsEmbrace the WebDiversify revenue streamsQuality really does countQuality really does countCompliance really does countSpeed to market is a differentiator in a 24/7 world

8: Pharmaskepticism

Intense suspicion of the motives and actions of pharma—and of those who partner with pharmawho partner with pharmaExamples 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 activitiesU f d i b d f k i i l d– Use of advisory boards of key opinion leaders

– Alleged “ghostwriting” of articles in the literatureAll concern the proper relationships of medical communications

i d h ith h lth f i lcompanies and pharma with healthcare professionals

A case to illustrate the pointA case to illustrate the point

Sound familiar?Similarities to the discussion surrounding CME:

Allegations promoted by poorly informed sources– Allegations promoted by poorly-informed sources– 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 topicIgnoring all that the industry has done to self police and establish best practices– Ignoring all that the industry has done to self-police and establish best practices

– Highlighting calls from a few that full disclosure not enough, that ban on physicians working with industry-supported writers needed

Evolution of publication guidelines*p g

AAMC Task Force

*Dates represent most recent revision of guidelinesGPP2

WAME and

ICMJE

Force Report, 20087

• Publication guidelines have changed substantially in recent years

• Each set of guidelines complements, rather than replaces the others

2009

CSE, 20064

ICMJE, 20075,6

rather than replaces, the others

GPP and

AMWACONSORT,

20011

AMWA, 20032,3

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.

There’s another side to this storyIt’s important to get the data into the literature clearly and promptlyBut it won’t happen unless researchers have editorial supportBut it won’t happen unless researchers have editorial supportIndustry has joined in an educational organization to establish best practicesGood Publication Practices have been published for all to review

GPP2 the latest developed with extensive input and published in BMJ 12/09– GPP2 , the latest, developed with extensive input and published in BMJ 12/09Publication 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 fundingrepresenting data, of fairly identifying who involved in work and fundingISMPP has established a credentials exam and programThere are additional protections in the evolving system– Journal peer reviewJournal peer review– Clinical trials registry– Physician payment registries, etc.

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 systemdown the same path as that for CME, with loss for health care systemThis is not just about “ghostwriting”– It is more broadly about relationships with leading clinical experts to

h l i f d d t h lth id i i t fhelp inform and educate health care providers in a variety of waysToo often, medical communicators—and journal publishers—have been slow to realize the need to present their side of the storyIt’s time to proactively present the full picture

Underlying fundamentals

Still huge unmet clinical needsR d i th b d f d i di f hi h th– Reducing the burden of common and serious diseases for which there are still no cures

– Providing effective care in less invasive settingsGreater attention to prevention and early care– Greater attention to prevention and early care

High R&D spending to develop drugs that save lives, enhance quality of life, and reduce societal costsM t d t h i i th li i i d ti t b tMust educate physicians, other clinicians, payors, and patients about new diagnostic and therapeutic developmentsHealth care system depends on healthy pharma industry and d t d li i ieducated clinicians

Health care system also depends on…

Journals: Critical to peer review and to early and broad access to new clinical informationclinical informationMed comms providers: Critical to disseminating information in ways that improve patient care delivery

S t ff t t k k li i l d t il bl i th lit t• Support efforts to make key clinical data available 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 technologyMore 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 teachingPrescriber data: To help identify information gaps and audiences most needing information

It’s up to us

Proactively state the value of our own roles in the healthcare systemD t it i d t d– Do not assume it is understood

– Do not assume this makes no differenceAddress multiple stakeholders– Pharma

• Business model in transition– Physicians and other clinicians

Cl if h i i k• Clarify what is at risk• Clarify how past errors addressed and best practices developed• Consider communicating with your own readersThe public and government– 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

Contact info: jon.bigelow @ kp360group.com

Visit: www.knowledgepoint360.com