drug advertising tactics by @pharmed_out
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Drug Adver*sing Tac*cs ©PharmedOut 2013
Georgetown University Medical Center Part of the Drug Ads Exercise Presenta5on Series
Disclaimer: Intellectual Property
In this presentaCon, you will noCce that we use images of many registered trademarks, many branded drug trade names, and many copyrighted adverCsements -‐-‐ from many different business concerns -‐-‐ including drug companies, markeCng consultants and medical journals. All of the intellectual property contained therein is, and remains, the exclusive intellectual property of the respecCve owners. Each images is used for the purpose of educaConal, and criCcal, analysis. No endorsement of any posiCon arCculated in this presentaCon should be inferred from the appearance of any brand, trademark, trade name or ad copy herein. This presentaCon has been designed with the intent to qualify for the doctrine of "fair use" -‐-‐ as to these pieces of intellectual property -‐-‐ under the law of the United States.
We Think That We Don’t Look at Ads, But…
We do.
• In 2011, pharmaceuCcal companies spent $322 million on journal adverCsing.†
• Ads return $2.43 to $4.00 in prescripCons for every dollar spent.
†IMS Health StaCsCcs 2011
Ads Affect Us
• “Medical journals are the leading source of medical informaCon for 76% of physicians.”
• “As many as 65% [of physicians] will correctly associate the ad’s messages with its product.”
• “Message retenCon correlates with increased sales.”†
†Marshall, MMM 2006
Medical Journals
AdverCsements in medical journals reinforce markeCng messages.
AdverCsing in Medical Journals
• Most medical journals’policies limit adverCsing to drugs.
• AdverCsing, sponsored subscripCons, and reprint sales are major sources of revenue for medical journals.
• Therefore, journals shy away from publishing arCcles criCcal of industry.†
†Fugh-‐Berman, PLoS Med 2006; 3:e130
Physicians Receive Different Ads
• AdverCsing is targeted to physicians by: • Specialty • Geographic locaCon • Prescribing behavior
• Different subscribers to the same journal will receive different ads.
The Importance of Ads in Medical Journals
Ads in medical journals are important because they • Are an important part of promoConal campaigns.
• Reinforce markeCng messages conveyed by drug reps, direct mail, and speaker programs.
• Provide reminders that retain drug names in our subconscious.
• Reinforce direct-‐to-‐consumer-‐adverCsing (DTCA) via coordinaCon of product logos, colors, and symbols. See example on next slide.
Consumer AdverCsement
Medical Journal AdverCsement
InformaCon in Ads is Not Accurate
Studies have found that: • One-‐third of pharmaceuCcal ads are scienCfically inaccurate.1
• Graphs can be misleading.2
• 36% of graphs had numeric distorCon. • One-‐third contained design features that distorted the
data depicted. • Only 58% presented an outcome relevant to the drug’s
indicaCon. • Only 4% contained confidence intervals.
1 Wilkes, Ann Intern Med 1992; 116:912 2 Cooper, JGIM 2003; 18:294
Example: Numeric DistorCon
*Note the range of the y-‐axis {0-‐2}
Time (months)
Percen
t (%) o
f Pa*
ents
Compare with the same results on a 100-‐point scale
When evaluaCng medical literature, there are two important concepts Absolute Risk vs. RelaCve Risk
Absolute Risk and RelaCve Risk
PresenCng
benefits in rela5ve terms and
risks in absolute terms
is a classic way to exaggerate benefits and minimize risks.
Absolute Risk and RelaCve Risk
Absolute Risk (AR)
describes the incidence of a condiCon in a populaCon.
Rela0ve Risk (RR) compares the probability of an event occurring in the exposed group vs. the non-‐exposed group.
RR= Exposed
Non-Exposed
Let’s Look At An Example…
A placebo-‐controlled trial of a lipid-‐lowering drug is performed in 200 people (100 treated with the drug and 100 treated with placebo). Three people on the drug and six people on placebo have heart asacks.
Drug Placebo
Heart asacks 3/100 6/100
• We might say that Drug A reduces heart asack risk by 50% or cuts heart asack rate in half.
• We could also say that the heart asack risk is reduced by 3%.
RelaCve Risk and Absolute Risk
RR for MI= 36
=0.50
AR for MI= 6%-3%= 3%
Unfortunately, several people in the study develop lung cancer.
Drug Placebo
Lung Cancer 3/100 1/100
• We could also say that lung cancer risk increases by 2%.
• We could say that the lung cancer risk increases by 200%.
RelaCve Risk and Absolute Risk
RR for Lung Cancer
= 31 = 3
AR for Lung Cancer= 3%-1% = 2%
RelaCve Risk and Absolute Risk
RelaCve risk makes risks or benefits look BIGGER.
Absolute risk makes risks or benefits look smaller.
To be fair, both harms and benefits should be presented in either RR or AR
• RelaCve Risk: This drug reduces heart asacks 50% while increasing lung cancer 200%.
• Absolute Risk: This drug reduces heart asacks 3% while increasing lung cancer 2%.
Drug Placebo Heart Asacks 3 6 Lung Cancer 3 1
The Wrong Way To Present The Data:
• Using RR for benefit and AR for risk: This drug reduces heart asacks 50% while increasing lung cancer 2%.
• A may use AR for benefit and RR for risk: This drug reduces heart asacks 3% while increasing lung cancer 200%.
Drug Placebo Heart Asacks 3 6 Lung Cancer 3 1
Surrogate Markers vs. Clinical Endpoints
Clinical Endpoints
are events such as death, hospitalizaCon, heart asack, or cancer diagnosis.
Surrogate Markers
are stand-‐ins or subsCtutes, such as cholesterol, CRP (C-‐reacCve protein), and PSA (prostate-‐specific anCgen), for clinical endpoints.
CitaCons Used in Ads May Not Be Reliable
Unreliable cita0ons include: • Conference abstracts or posters • Unpublished, non-‐peer-‐reviewed, usually incomplete
data
• Supplements to journals
• Non-‐peer-‐reviewed, paid special issues, usually industry-‐sponsored
• Studies that do NOT support claims in ad
• Poorly designed or poorly implemented studies
• Data on file
“Data on File” CitaCons
“Data on File” CitaCons
Data on file are unpublished internal company documents
• Companies are not obligated to share these documents.
“Data on File” CitaCons
Researchers have found it difficult to obtain data on file. Examples of study results: • Only 40% of “data on file” references requested were returned.1
• Among 125 referenced promoConal claims, 23 could not be retrieved. Eleven of these were irretrievable “data on file”.2
• Only 20% of “data on file” references requested were returned.3
1Lexchin, CMAJ 1994; 151:47 2Villanueva, Lancet 2003; 361:27 3Cooper, CMAJ 2005; 172:487
Misleading Ads
Natrecor is ONLY indicated for the symptomaCc relief of dyspnea in paCents with acutely decompensated CHF.
PaCent Mortality
This figure appears to demonstrate a decreased 30-‐day mortality for Natrecor (nesiriCde).
Using the complete data set of seven clinical trials, 30-‐day mortality was actually higher for paCents on Natrecor.
References
†BMJ 1994; 308:1692.
• Journal Supplements are non-‐peer reviewed collecCons of papers that are published as separate issues of the journal. Supplements are typically funded by pharmaceuCcal companies.†
• MeeCng abstracts are not peer reviewed.
Summary
• Natrecor is indicated for symptomaCc relief, NOT reducCon of mortality.
• Moreover, the evidence indicates increased mortality.
Geodon Ad
This ad campaign for Geodon touts comparable efficacy to other an5psycho5cs, “without compromising metabolic parameters.”
• This claim is misleading. Geodon increases weight and cholesterol levels, although less so than other anCpsychoCcs.
• Therefore, Geodon DOES compromise metabolic parameters.
Lipitor Ad
• The ad notes a 45% reduc5on in non-‐fatal MI in the ASCOT-‐LLA study.
• However, the published ASCOT-‐LLA study does not assess non-‐fatal MI alone (there was a 36% reducCon in nonfatal MI and fatal CHD).†
• The reference in the ad is NOT to the ASCOT-‐LLA study published in the Lancet. The reference is to data on file.
• Furthermore, the study found that there was no significant difference between groups in all-‐cause mortality or cardiovascular mortality.
Indirect MarkeCng
Indirect MarkeCng: PromoCon Without MenConing the Product
Indirect marke0ng includes: • “Disease Awareness” (also called “Disease Mongering”) • PromoCng a condiCon that a targeted therapy treats
• MiCgaCng negaCve percepCons of a product
• Disparaging compeCng products
Pre-‐launch PromoCon
• PromoCon of a drug starts years before regulatory approval is expected.
• Companies cannot legally promote a drug “pre-‐launch” before approval.
• Indirect markeCng is allowed.
• More money is spent on promoCng a drug in the three years prior to launch than in the first year awer the drug arrives on the market.
EducaConal IniCaCves Awer a Drug is Available
Educa0onal ini0a0ves may posiCon a drug as advantageous in terms of
• FormulaCon
• Mechanism of acCon
• Adverse effects
Pain Balance is an educaConal iniCaCve that emphasizes gastrointesCnal complicaCons caused by oral NSAIDs.
PainBalance.org is Sponsored by ALPHARMA
Pain Balance serves to market Flector Patch, a transdermal NSAID purported to have a more favorable side effect profile due to limited systemic absorpCon.
Indirect MarkeCng of Gardasil (an HPV vaccine)
Why Does Merck emphasize genital warts, a cosmeCc problem?
The answer lies in the compeCCon: • Merck’s Gardasil protects against two strains of HPV that
cause cervical cancer AND protects against strains that cause genital warts.
• GlaxoSmithKline's Cervarix protects against four types of HPV that cause cervical cancer but does not protect against any strains that cause genital warts.
Therefore, it is logical for Merck to market using this dis5nc5on by promoCng protecCon against genital warts.
Disease Mongering/ Disease Awareness
Disease Mongering: “The selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments.” †
-‐ Ray Moynihan
Disease Awareness: Industry term for disease mongering
†Moynihan, PLoS Med 2006; 3:e191
Disease Mongering During Pre-‐launch
• Example: Modafinil (Provigil) was originally approved for narcolepsy.
• “Disease awareness” campaigns created new condiCons: • Hypersomnolence, • excessive sleepiness (ES) • shiw-‐work syndrome (SWS)
• See examples on next slides.
Mechanism Mongering
Increased Screening can Cause Increased Sales
Why wait for paCents to complain when you can elicit symptoms that call for drug treatment?
See example on next slide.
This ad urges physicians to probe for BPH symptoms, rather than relying on paCents to express complaints.
Conclusion
• PharmaceuCcal adverCsements owen include misleading graphics, figures, and references.
• Beware of benefits being presented as relaCve risks and harms being presented as absolute risks.
• Disease awareness and other indirect markeCng techniques can affect our percepCons of disease prevalence and appropriate treatments.
• Promotes raConal prescribing.
• Provides Grand Rounds, seminars, and free, web-‐based CME.
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