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Drug Advertising, Detailing, Sampling, Etc'

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PMAD 385: Critical Analysis of Pharmaceutical Marketing ... Explain the role of sampling in pharmaceutical company promotion to physicians. ... – PowerPoint PPT presentation

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Title: Drug Advertising, Detailing, Sampling, Etc'


1
Drug Advertising, Detailing, Sampling, Etc.
  • Bruce Lambert, Ph.D.
  • and Jay Duhig, M.S.
  • Pharmacy Administration, UIC
  • For the FLIP Team

2
Lecture Objectives
  • Summarize main points in current debate about
    public health effects of DTC advertising
  • Explain the role of sampling in pharmaceutical
    company promotion to physicians.
  • List at least three resources pharmaceutical
    sales representatives use to influence physician
    prescribing
  • Critically evaluate the PhRMA Code on
    Interactions with Health Professionals and apply
    it to example scenarios

3
Direct to Consumer Ads Debate about Public
Health Risks and Benefits
  • Overview
  • Based on Almasi EA, Stafford RS, Kravitz
    RL, Mansfield PR (2006). What Are the Public
    Health Effects of Direct-to-Consumer Drug
    Advertising? PLoS Med 3(3) e145
  • DTCA legal only in USA and New Zealand (where it
    may be banned)
  • Even where its legal, govts try to regulate it
    to maximize benefit/risk ratio
  • Proponents say is informs public about treatments
    and stimulates use of appropriate drugs for
    important diseases (e.g., statins)
  • Opponents say its biased and misleading and
    increases costs of care by encouraging
    unnecessary prescribing with no evidence of
    benefit

4
Direct to Consumer Ads Debate about Public
Health Risks and Benefits
  • Claim 1 DTCA may produce valuable placebo effect
  • Placebo effect refers to phenomenon where
    patients experience real relief after taking fake
    medicine or having fake procedures
  • Two models of placebo effect
  • Classical (Pavlovian) conditioning
  • Expectancy theory

5
DTCAs and Placebo Effect
  • Ads may create placebo effect which enhances drug
    effectiveness
  • May reduce amount of treatment needed
  • May improve adherence and outcomes
  • May enhance provider/patient collaboration
  • Goal of regulation should be to facilitate
    favorable responses while decreasing
    inappropriate use

6
Claim 2 DTCAs Should be Regulated Not Banned
  • Background
  • Rx costs are rising due to increased prices and
    increased use of old and new drugs
  • Some drugs over prescribed (antibiotics for URI,
    antihistamines, benzos and sedatives in elderly,
    inhaled beta-agonists in kids without controllers
    for asthma, neuromodulators for pain, sildenafil
    and fluoxetine for enhanced sexual function).
    DTCA role in overprescribing at least lowers
    threshold for prescribing
  • Some drugs are underprescribed (e.g., beta
    blockers for MI, ACE inhibitors for CHF, adjuvant
    hormone or chemo after breast surgery,
    antibiotics prior to hip surgery, warfarin in
    atrial fibrillation)

7
DTCAs Should be Regulated Not Banned
  • By increasing prescribing, DTCAs could be
    beneficial, harmful or both
  • In general, DTCA is most likely to deliver
    public health benefits when the condition to be
    treated is serious and when the treatment is
    safe, effective, and underused. DTCA will tend to
    deliver net harms when the condition is mild or
    trivial and when the treatment is potentially
    dangerous, marginally effective, or overused.
    Almasi EA, Stafford RS, Kravitz RL, Mansfield PR
    (2006). What Are the Public Health Effects of
    Direct-to-Consumer Drug Advertising? PLoS Med
    3(3) e145

8
DTCAs Should be Regulated Not Banned
  • Implement 2-year DTCA ban for new drugs and
    require post-marketing surveillance
  • Tax drug sales and use proceeds to do DTCAs to
    promote underutilized, safe, effective therapies
    for high impact conditions

9
Claim 3 Harms Outweigh Benefits
  • Health promotion should be publicly funded
  • DTCAs focus on expensive new drugs for common
    uses
  • Can lead to overprescribing of new drugs and
    underprescribing of safer, cheaper older drugs
  • De-emphasizes non-drug therapies and other health
    hazards

10
Claim 3 Harms Outweigh Benefits
  • DTCAs are more persuasive than informative, often
    flawed, biased and unbalanced
  • Creates illusion of being well informed
  • Manufactures distress by increasing current
    unhappiness and expectations of future relief
  • DTCAs are ambiguous and cause indication creep
  • DTCAs increase many social costs (drugs, biased
    media, distorted health perceptions,
    medicalization, distraction from social problems
    etc.)

11
Claim 3 Harms Outweigh Benefits
  • Root causes
  • Financial incentives in reimbursement systems to
    sell expensive drugs
  • Peoples basic gullibility or vulnerability to be
    misled or persuaded
  • Many independent studies find net harm from DTCAs
  • Solution
  • Ban DTCAs and regulate drug web sites
  • Publicly fund health information campaigns based
    on consensus, high priority messages

12
PhRMA Code on Interactions with Health
Professionals
  • Stated Goals
  • inform healthcare professionals about the
    benefits and risks of our products,
  • provide scientific and educational information,
  • support medical research and education, and
  • obtain feedback and advice about our products
    through consultation with medical experts.
  • http//www.phrma.org/files/PhRMA20Code.pdf

13
PhRMA Code
  • In interacting with the medical community, we
    are committed to following the highest ethical
    standards as well as all legal requirements. We
    are also concerned that our interactions with
    healthcare professionals not be perceived as
    inappropriate by patients or the public at large.
    This Code is to reinforce our intention that our
    interactions with healthcare professionals are to
    benefit patients and to enhance the practice of
    medicine. The Code is based on the principle that
    a h e a l t h c a re pro fe s s i o na l s care
    of pati e n ts should be based, and should be
    perceived as being based, solely on each
    patients medical needs and the health-care
    professionals medical knowledge and experience.

14
Basis of Interactions
  • Our relationships with healthcare professionals
    are intended to benefit patients and to enhance
    the practice of medicine. Interactions should be
    focused on informing healthcare professionals
    about products, providing scientific and
    educational information, and supporting medical
    research and education

15
Informational Presentations by or on behalf of
Pharma Company
  • Informational presentations and discussions by
    industry representatives and others speaking on
    behalf of a company provide valuable scientific
    and educational benefits. In connection with such
    presentations or discussions, occasional meals
    (but no entertainment/recreational events) may be
    offered so long as they (a) are modest as judged
    by local standards and (b) occur in a venue and
    manner conducive to informational communication
    and provide scientific or educational value.
    Inclusion of a healthcare professionals spouse
    or other guests is not appropriate. Offering
    take-out meals or meals to be eaten without a
    company representative being present (such as
    dine dash programs) is not appropriate.

16
Third-Party Educational or Professional Meetings
  • Supporting CMS is OK if goes to meeting
    sponsor. Content of meeting controlled by meeting
    sponsor.
  • Travel, lodging and personal expenses of
    non-faculty attendees should not be paid.
  • Meals and receptions can be funded but should be
    modest and conducive to discussion among faculty
    and attendees

17
Third-Party Educational or Professional Meetings
  • A conference or meeting shall mean any activity,
    held at an appropriate location, where (a) the
    gathering is primarily dedicated, in both time
    and effort, to promoting objective scientific and
    educational activities and discourse (one or more
    educational presentations(s) should be the
    highlight of the gathering), and (b) the main
    incentive for bringing attendees together is to
    further their knowledge on the topic(s) being
    presented.

18
Consultants
  • Reasonable fees can be paid for appropriate
    services and expenses. No token consultants or
    advisors.
  • Written contract, legitimate need, specific
    selection criteria drawn up by relevant experts,
    reasonable number, maintain records, venue and
    circumstances of consultation not primarily
    social or educational

19
Speaker Training Meetings
  • It is appropriate for healthcare professionals
    who participate in programs intended to recruit
    and train speakers for company sponsored speaker
    bureaus to be offered reasonable compensation for
    their time, considering the value of the type of
    services provided, and to be offered
    reimbursement for reasonable travel, lodging, and
    meal expenses, when (1) the participants receive
    extensive training on the companys drug products
    and on compliance with FDA regulatory
    requirements for communications about such
    products, (2) this training will result in the
    participants providing a valuable service to the
    company, and (3) the participants meet the
    criteria for consultants (as discussed in part
    4.a. above).

20
Scholarships and Educational Funds
  • Financial assistance for scholarships or other
    educational funds to permit medical stud e n ts,
    re s i d e n ts, fe l l ow s, and other
    healthcare pro fe s s i o nals in training to
    attend carefully selected educational conferences
    may be offered so long as the selection of
    individuals who will receive the funds is made by
    the academic or training institution. Carefully
    selected educational conferences are generally
    defined as the major educational, scientific, or
    policy-making meetings of national, regional, or
    specialty medical associations.
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