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Show Me the Evidence!. Identifying the Truth about Rx Drugs Enter event/location May 19, 2008. Faculty Disclosure. Your Name Here, MD Dr. Your Name Here reports that he has No Conflict of Interest with this presentation.

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show me the evidence

Show Me the Evidence!

Identifying the Truth about Rx Drugs

Enter event/location

May 19, 2008

faculty disclosure
Faculty Disclosure

Your Name Here, MD

Dr. Your Name Here reports that he has No Conflict of Interest with this presentation.

In accordance with the requirements of the Standards for Commercial Support of the Accreditation Council for continuing Medical Education adopted by the AMA and the Oregon Medical Association, each instructor is asked to disclose any affiliations with, or financial interests in, companies whose products are discussed in his/her presentation.

Event/Location of Lecture CME Presentation

May 19, 2008

learning objectives
Learning Objectives
  • Recognize cost and health impact of inappropriate or excessive utilization of prescription drugs
  • Increase awareness of biased information and pharmaceutical industry marketing practices.
  • Describe strategies that can reduce the influence of biased information.
learning objectives con t
Learning Objectives, con’t.
  • Describe how evidence-based approaches can be used to guide prescribing decisions.
  • Provide reliable sources of unbiased prescribing information and practice guidance.
  • Provide educational resources for more in-depth information regarding pharmaceutical industry marketing and use of evidence-based methods to make prescribing decisions.
us health spending in 2006
US Health Spending in 2006

$2.1 trillion or $7,026 per person

Health care inflation generally outpaces increase in GDP.

When health care costs rise faster than the overall economy, affordability and range/quality of benefits decrease.

Health Affairs 2008;27(1):14-29

slide6

Healthy Life Expectancy & Per Person

Medical Expenses: 22 Developed Countries

HealthLifeExpectancy

Per Person Annual Medical Expenses

rx costs are a large part of overall health care spending
Rx Costs Are a Large Part of Overall Health Care Spending

Source:

2007 DMAP class 07/11 expenditures (total fund, excludes rebates)

http://www.oregon.gov/DHS/aboutdhs/budget/07-09budget/index.shtml (accessed 6/10/08)

http://www.oregon.gov/DAS/BAM/GRB0709.shtml (accessed 6/10/08)

prescription drug expenditures
Prescription Drug Expenditures

Increased at a faster rate than any other area of health care over the last 15 years

Major contributor to rising health care costs

Responsible for a large portion of insurance cost increases

Costs increased because of

Increased utilization (prescribing rate)

Increased price per prescription

factors driving utilization
Factors Driving Utilization

Increase in prescription drug coverage

Marketing

Aging population

More chronic conditions

Impact of Medicare Coverage

increased price per rx
Increased Price Per RX

Price increases for existing drugs exceed inflation

Largest driver of increased Rx spending

Newer drugs replace older less expensive agents

Shorter approval time

Marketing of newer agents drives market share

slide13

Premiums, Earnings & Inflation

Source: Kaiser/HRET Survey of Employer-Sponsored Health Benefits

implications of current trends
Implications of Current Trends

Health care affordability continues to deteriorate

Health costs, including Rxs, expected to rise faster than economy

Increased consumer out-of-pocket costs  increased premium share, deductibles, co-insurance, and co-payments

State & Federal budget deficits

Increased rate of uninsured/underinsured

conclusions about costs
Conclusions About Costs

Currently, the US spends more per capita on health care than any other developed country, yet is ranked near the bottom in terms of quality.

Continuing on the current path has huge societal implications. How much more can we spend?

The alternative is to spend more wisely.

Payers are looking at all options to contain health care and pharmaceutical costs, and to get better value.

This creates a great opportunity for prescribing physicians.

quality of care issues with prescription drugs
Quality of care issues with prescription drugs
  • Over-medicalization (disease mongering)
    • Treatment of non-disease or trivial entities
    • Premature intervention in less severe conditions
  • Poly-pharmacy
    • Increasing med side effects leading to more medications
    • Unpredictable interactions and greater potential for errors
  • Off-label use
disease mongering
Disease Mongering

US has 5% of the worlds population but 50% of drug consumption

Strategies to expand markets

Promotional campaigns change the way people think about common ailments

Menopause becomes hormone deficiency

Shyness becomes social anxiety disorder

Acid indigestion becomes gastroesophageal reflux disease

Lowering thresholds for treating common conditions

Selling Sickness by Moynihan and Cassels

what the fda does
What the FDA does
  • Approves new drugs and devices based on:
    • The medicine or device is “effective”
      • Endpoint may be a surrogate such as lowering cholesterol as opposed to longer life
      • Usually 2 RCTs required to prove clinical efficacy for drugs
    • The medicine or device is “safe”
  • Charged with oversight of DTC materials
    • Small number of DTC materials are actually reviewed
    • Regulatory letters are often delayed and marginally effective.
what the fda doesn t do
What the FDA doesn’t do!

Does not assess cost vs benefit for a drug or device.

Does not determine whether one drug is better than another.

Does not approve every use to which a product may be put.

Does not require large trials that will identify all potentially rare complications.

important contributions by the pharmaceutical industry
Important Contributions by the Pharmaceutical Industry
  • Development of new treatments that improve health and well-being
  • Substantial contributions to educational, health care and professional organizations
  • Provide samples and free meds to many patients
  • …but, their main goal is to make profits for their shareholders and they spend enormous amounts to influence all involved, including legislators, providers, patients, and the general public, to help them maintain or increase those profits.
pharmaceutical industry methods for increasing market share
Pharmaceutical Industry Methods for Increasing Market Share
  • Marketing expenditures
  • Drug reps
  • DTC advertising
  • Journal ads
  • Prescriber data
  • What can be done?
slide24

Promotional Spending

and Advertising, 2005

Total spending: $29 billion

(Source: IMS Health, in Donohue, NEJM 2007)

slide25

Socolar D, Sager A. Pharmaceutical marketing and research spending: the evidence does not support PhRMA’s Claims.

http://dcc2.bumc.bu.edu/hs/sager/pdfs/120601/DrugIndustryMarketingStaffSoarswhileReserchStaffingStagnates5Dec01.pdf; Accessed 3/6/08

pharmaceutical representatives
Pharmaceutical Representatives
  • Remains the major marketing focus
  • ~ 100,000 reps in 2005 vs 38,000 in 1995
  • 1 rep/6 MDs in US and 1 rep/2.5 targeted MDs
  • 6 million detail visits annually
  • Cost estimate $12-$13K/MD for detailing
  • Industry spends $150K annually/primary care rep and $330K/specialty rep*

*Med Ad News 2004;23(3):1

docs perception vs brutal reality
Docs’ Perception vs. Brutal Reality
  • Studies consistently show physicians do not believe that promotion affects their prescribing habits*, but…
  • Studies consistently show drug promotion increases prescribing of targeted drugs**

*Sigworth SK et al. JAMA. 2001;286(9):1024-5.McKinney WP et al. JAMA 1990;264(13):1693-7

**Chren MM et al. JAMA 1994 Mar 2;271(9):684-9; Lurie N et al. J Gen Int Med 1990;5:240-243; Wazana A. JAMA 2000 Jan 19;283(3):373-80.

.

details of detailing impact on prescribing costs
Details of Detailing: Impact on Prescribing & Costs
  • Increased likelihood of formulary requests for targeted drugs
  • Increased awareness, preference and rapid prescribing of new drugs
  • Higher prescribing costs
  • Less use of lower cost, but equally effective, generics
  • Less rational prescribing

(Wazana A, JAMA 2000)

direct to consumer dtc ads
Direct to Consumer (DTC) Ads
  • Directly target consumers & general public
  • 1997: FDA relaxed regulations
    • Eliminated requirement to list all side-effects by simply referring to additional sources of information, e.g., 1-800 number or website
  • As of 2005, the US and New Zealand only developed nations with DTC Rx advertising
dtc expenditures are huge
DTC Expenditures Are Huge…
  • $4.5 billion spent on DTC in 2005*
  • 296.4% increase from 1997-2005*
  • 14% of total industry marketing for DTC**
  • Hoechst spent $580K on 60-second Allegra ad***
  • Merck spent $161M advertising on 1 drug, Vioxx, whereas total annual ad budgets: Dell ($160M), Budweiser ($146M), Pepsi ($125M) or Nike ($78M)****

*Shuchman, NEJM, 2007

**Donohue et al. NEJM, 2007

***Eaton, Stanford University Press, 2004

****Gellad et al. Amer J Med, 2007

but dtc ads pay off
But, DTC Ads Pay Off
  • 1998-1999: 25 most advertised drugs account for 43% growth in Rx sales compared to 13.3% for all other drugs*
  • 1998: Claritin, Allegra, and Zyrtec increase sales by 32%, 50% and 56%*
  • 2002: >53M patients discuss DTC-advertised meds with their doctors**

*Eaton, Stanford University Press, 2004

**Rosenthal, NEJM, 2002

the quantity and quality of scientific info in journal ads
The Quantity and Quality ofScientific Info in Journal Ads

1999 review of pharm ads from 10 US journals:

  • 498 unique ads (3,185 total)
  • 74 unique graphs
  • 36% of graphs: “numeric distortion”
  • 66% of graphs: “chart junk”
  • 54% list intermediate outcomes

JGIM 2003;18:294-297

big brother pharma knows what you are doing
Big Brother (Pharma) Knows What You Are Doing
  • Industry has access to AMA managed databases that track prescribing patterns of most practicing providers
  • Such data is used to more precisely target specific providers with specific types of products or messages
  • AMA has an “opt out” option
but you can opt out
But You Can “Opt-out”
  • Physicians can enroll at:

www.ama-assn.org/go/prescribingdata

  • Purchasers of the data must agree to restrict prescriber profiling by reps for those who have opted out.
  • Must be renewed every three years and manufacturers have 90 days to comply after opt-out is exercised.

Ann Intern Med 2007;146:742-48

what clinicians can do to reduce marketing impact
What Clinicians Can Do To Reduce Marketing Impact?
  • Reduce or eliminate contact with industry representatives
    • “Just say no”
  • Identify/use unbiased and independent sources of prescribing information
  • Opt out of use of your data in the AMA master profile
cme incentives and gifts
CME: Incentives and Gifts
  • Free Meals
  • Payment for attendance at lectures and conferences
    • Stipend
    • Time
    • Travel
    • Registration fees
industry support of continuing medical education
Industry Support of Continuing Medical Education
  • In 2006, half of the $2 billion dollars spent on CME came from industry sponsorship
  • Medical Education and Communication Companies (MECCs)
    • Organize meetings, find speakers for grand rounds and symposia, develop written materials
    • About 76% income from industry
  • Medical Schools
    • Industry provides almost two thirds (62%) of CME income to medical schools (ACCME)

Source: ACCME, Annual Report Data 2006

does this affect prescribing
Does this Affect Prescribing?
  • Attending drug company–sponsored CME
    • 5-19% increase in rate of prescription of sponsor’s drug vs. competitor’s drug (P<.05)
  • Funding for travel or lodging to attend educational symposia
    • Increased formulary requests for the sponsor's drug
    • Increased rate of prescribing of sponsor’s drug
    • Impacted hospital prescribing practices 2 years later

(Wazana A, JAMA 2000)

does the source of funding affect the content of cme
Does the Source of Funding Affect the Content of CME?
  • Content analysis of two different CME courses sponsored by two different drug companies, each discussed 3 calcium channel blockers
  • Drug company–sponsored CME preferentially highlighted the sponsor's drug(s) compared with other CME programs
    • 2.5-3 times more likely to mention positive effects of sponsor’s drug and negative or equivocal effects of competitor’s (P<.05)

(Bowman MA, Mobius1986)

deal with conflicts of interest
Deal With Conflicts of Interest
  • Eliminate the conflicts whenever possible
    • Can be difficult and painful, especially with friendly reps
    • Even the perception of conflicts create credibility problems
  • Recognize tendency to rationalize
    • “It’s an educational dinner”
    • “patients need samples”
  • Denial
    • “It doesn’t affect my prescribing decisions”
    • “I take it with a grain of salt”

J Gen Int Med 2007;22:184-90

sage advice
Sage Advice

“The best defense the physician can muster against (misleading) advertising is a healthy skepticism... cultivate a flair for spotting the logical loophole, the invalid clinical trial . . . and the unlikely claim. Above all, develop greater resistance to the lure of the fashionable and the new.”

P.R. Garai, 1964

conclusions about marketing
Conclusions About Marketing
  • Industry marketing is very influential and definitely impacts decision making
  • Marketing can lead to ineffective prescribing
  • Current marketing practices are controversial and opinions vary
  • Health professionals can make choices to avoid undue influence
need for evidence
Need for evidence

“First of all, do no harm” (Hippocratic Oath)

2008 version: Never offer treatment to a patient without convincing evidence that it will provide more help than harm.

Shouldn’t we also consider help/harm to the patient’s family & overall community in this equation?

principles of evidence based medicine ebm
Principles of Evidence-based Medicine (EBM)

Decision making in clinical practice

What is EBM?

What EBM is not

decision making in clinical practice
Decision Making in Clinical Practice

Unfortunately, many decisions are made based on unreliable “evidence”

Expert opinion plays a heavy role in medical decision making

Personal observation or anecdotal experience can frequently overcome clear evidence to the contrary

clinical decision making
Clinical Decision Making

Guidelines

Knowledge

Ethics

Mulrow: Ann Intern Med, Vol 126(5) 3/1/97, pp 389-91

what is ebm
What is EBM?

EBM is "the conscientious, explicit and judicious use of best current evidence in making decisions about the care of individual patients.”

-David Sackett

what is ebm1
What is EBM?

Evidence based medicine requires the integration of the best research evidence with our clinical expertise and our patient’s unique values and circumstances.

Sharon E. Straus: Evidence Based Medicine 3rd Edition

what is evidence based practice
What is Evidence-Based Practice?

A process in which we:

Ask – to precisely define a patient problem

Acquire – figure out what’s needed to answer the question, conduct an efficient search of the literature.

Appraise – Select the best of the relevant studies and apply rules of evidence to determine their validity

Apply – Extract the clinical message and apply it to the patient problem

Assess – Determine if the action was helpful

Adjust – Use the outcomes of intervention to modify the treatment

what ebm is not
What EBM is not:

The same old thing we’ve always done

Something that can only be done from ivory towers

A “cookbook” method of practice

A method for administrators to save costs

Restricted to randomized trials

study types evidence hierarchy
Study Types – Evidence Hierarchy

Systematic

Reviews

RCTs

Cohort Studies

Case Control Studies

Case Series

Case Reports

Editorials and Opinions

Lab studies and Animal Research

53

advantages of an ebm approach
Advantages of an EBM Approach
  • Sorts through the marketing, opinions, and theory to get an accurate assessment of the proven and comparative benefits and risks of various treatments.
  • Supports policies that reduce variations in practice, especially expensive or inappropriate prescribing.
  • Provides incentive to conduct research on more meaningful questions, especially comparative studies
practical application of evidence based methods
Practical Application of Evidence-Based Methods
  • Understand terms used in research and comparative reviews, such as:
    • Generalizability/Applicability/Relevance
    • Number needed to treat
    • Target outcomes
    • Publication bias
practical application of evidence based methods1
Practical Application of Evidence-Based Methods
  • Rely on systematic or comparative reviews, rather than single studies whenever possible
  • Recognize factors that truly impact findings, e.g. strength of evidence and quality of research methods
  • Find reliable and unbiased sources of information for summary and comparative reviews
web site examples of cers
Web Site Examples of CERs
  • http://effectivehealthcare.ahrq.gov
  • www.ohsu.edu/drugeffectiveness
  • www.OregonRx.gov
unbiased sources on drugs
Unbiased Sources on Drugs
  • Agency for Health Care Research and Quality’s Effective Healthcare Program: http://effectivehealthcare.ahrq.gov
  • National Institute for Clinical Excellence: www.nice.org.uk
  • Cochrane Collaboration: www.cochrane.org
  • Canadian Common Drug Review: www.cadth.ca/index.php/en/cdr
unbiased sources on drugs1
Unbiased Sources on Drugs
  • Pub Med:http://www.ncbi.nlm.nih.gov/pubmed/
  • Clinical Trials Database:http://clinicaltrials.gov/
  • Carlat Report (Psychiatric Drugs):

http://www.thecarlatreport.com/

  • Oregon Health Policy & Research

www.OregonRx.gov

  • Drug Effectiveness Review Program: www.ohsu.edu/drugeffectiveness
other information sources
Other Information Sources
  • Consumer Union: www.prescriptionforchange.org
  • No Free Lunch:www.nofreelunch.org/
  • Pharmed Out: http://www.pharmedout.org/
  • DUR Newsletter:

www.pharmacy.oregonstate.edu/drug_policy/pages/dur_board/newsletter

  • DHS Pocket Drug Guide:

www.pharmacy.oregonstate.edu/drug_policy/prescriber_tools.html

thank you
Thank you

This work was made possible by a grant from the state Attorney General Consumer and Prescriber Education Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin.