Drug Advertising, Detailing, Sampling, Etc.

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Drug Advertising, Detailing, Sampling, Etc.

• Bruce Lambert, Ph.D.
• and Jay Duhig, M.S.
• Pharmacy Administration, UIC
• For the FLIP Team

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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

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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

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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)

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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

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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

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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.)

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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

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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

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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.

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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

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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.

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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

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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.

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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

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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.