Bigelow feb2010


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Bigelow feb2010

  1. 1. Evolving challenges in medical communications: Eight trends that matter Association of Medical Media 2/24/10 General Session Jon Bigelow President and CEO, KnowledgePoint360 Group Copyright © 2010 KnowledgePoint360 Group, LLC
  2. 2. KnowledgePoint360 Group Clinical Bridges g Physicians World Disease state Speakers Bureau Shared services education Service/technology solutions • Facilities • Finance • Human Resources • Information Technology • Medical Information • Meetings Management • Registration Services • Visual Services Healthcare • ACUMED Communications • BlueMomentum Network • CodonMedical Medical communications • eMedFusion • FireKite • Gardiner-Caldwell Communications • GeoMed • Glasgow HIV Therapy Congress • Interphase • Medex-Media M d M di • Physicians World • Physicians World Europe • Scientific Connexions • StemScientific
  3. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
  15. 15. A case to illustrate the point
  16. 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. 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: Accessed October 23, 2008. 5WAME recommendations. Available at: Accessed October 23, 2008. 6ICMJE requirements. Available at: Accessed October 23, 2008. 7Available at: Accessed October 23, 2008.
  18. 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. 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. 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. 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. 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
  23. 23. Contact info: jon.bigelow @ Visit: