FEATURE
Direct-to-Consumer Advertising
content for people living with bleeding disorders , to host a three-day workshop in which performers will work with professional composers , facilitators , and therapists to create an original , six-song musical . The material will eventually be turned into “ educational and inspirational videos and shorts to be distributed more broadly ,” according to a press release announcing the program .
While consumers may benefit from an increased awareness of relatively common diseases thanks to these efforts , what happens when entertainment is sponsored by a company that manufactures drugs for a rarer disease ?
In a 2017 episode of the soap opera “ General Hospital ,” doctors diagnosed a patient with polycythemia vera , but the writers did not make this decision on their own . Incyte , a pharmaceutical company whose only FDA-approved drug ( ruxolitinib ) is indicated to treat the disease , asked the show ’ s writers to introduce the disease into a plotline to raise awareness . 17 The producers complied , and , without naming the drug , the fictional doctor suggested that leaving disease symptoms untreated would put the patient in danger .
“ DTCA promotes use of higher-cost medications when cheaper , generic alternatives that work equally well are available .”
— JOSEPH ROSS , MD , MHS
When the character asks , “ But this protocol sounds like you are treating the symptoms of this cancer ; how do we beat it ?” he suggests initiating the standard treatments for the disease ( anticoagulation and phlebotomy ). According to clinicians and researchers , this dialogue “ may constitute subtle promotion of ruxolitinib .” 18
Successful campaigns increase viewers ’ awareness of a disease and , after watching the show , viewers may get tested for the publicized condition . If the disease ’ s diagnosis is not always definitive , as is the case with polycythemia vera , an awareness campaign could lead to overdiagnosis and overtreatment .
The Ups and Downs of DTCA
Many doctors and researchers fear that the costs of DTCA outweigh any benefits . When the AMA voted to recommend a full ban on DTCA , it argued that this move could help curb the rising costs of drugs . 1
“ Today ’ s vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially driven promotions and the role that marketing costs play in fueling escalating drug prices ,” said AMA Board of Trustees Chair-elect Patrice A . Harris , MD . 1 “ DTCA also inflates demand for new and more expensive drugs , even when these drugs may not be appropriate .”
Joseph Ross , MD , MHS , a professor of medicine and health policy at the Yale School of Medicine , agreed . “ Because we rarely , if ever , see advertising for drugs available as generics , DTCA promotes use of higher-cost medications when cheaper , generic alternatives that work equally well are available ,” he told ASH Clinical News .
Dr . Ross also claimed there is little evidence that advertising helps properly inform patients . On the contrary , the evidence suggests that the practice is associated with overdiagnosis and inappropriate treatment . 19 Along with minimal information about risks , the ads rarely provide sufficient evidence to inform patients about how likely they are to experience a benefit from the medication . “ My opinion is that all of these issues together contribute to lower-quality , more expensive care for patients ,” Dr . Ross added .
However , other researchers believe that DTCA plays an important role in public health and patient empowerment .
In an FDA survey conducted in 2004 ( a decade before the AMA called for the ban ), many doctors ( 73 %) agreed that because a patient saw DTCA , he or she “ asked thoughtful questions during the visit .” Also , 72 percent agreed that DTCA increased awareness of possible treatments . 20 Still , 60 percent of respondents thought that the ads did not convey information about risks and benefits equally . Most believed that patients understood the possible benefits of the drug “ very well or somewhat ,” compared with 40 percent who believed patients understood the possible risks .
In addition , about 75 percent of physicians surveyed believed that DTCA caused patients to think that the drug works better than it does , and 22 percent of physicians felt some pressure to prescribe when patients mentioned seeing DTCA . Overall , though , the report authors stated “ doctors believe that patients understand that they need to consult a health-care professional about appropriate treatment .”
Dr . Shapiro , whose research focuses on antidepressant advertisements , contended that the public health benefits of DTCA balance out the costs . He offered the following example : Pharmaceutical companies spend up to $ 32 million annually on DTCA for medications to treat depression – a condition that has massive economic consequences in the form of missed workdays and decreased productivity . More DTCA “ leads to $ 770 million in wage benefits from increased labor supply ,” he explained . If the FDA were to ban all DTCA , “ you would lose much more in benefits than you would save in costs .” 21
The jury is still out about whether pharmaceutical DTCA is satisfying the “ fair-and-balanced ” requirements originally outlined in FDA guidance for promotional materials , but it is clear that the system needs to evolve with the advertising . Some researchers who spoke with ASH Clinical News suggested that increasing funding for the FDA would allow the regulatory agency and its OPDP to keep a more watchful eye on – and respond more quickly to – misleading advertisements .
Or perhaps the U . S . could adopt the European Medicines Agency ’ s model of bringing in third-party companies ( separate from drug companies and regulatory agencies ) to develop unbiased educational materials about treatment options . Others , like Dr . Ross , had a more straightforward solution : “ DTCA should be illegal in the U . S .” — By Emma Yasinski ●
REFERENCES
1 . American Medical Association . “ AMA calls for ban on DTC ads of prescription drugs and medical devices .” Accessed July 5 , 2018 , from https :// www . ama-assn . org / content / ama-calls-ban-direct-consumer-advertising-prescription-drugs-andmedical-devices .
2 . U . S . Food and Drug Administration . “ FDA in brief : FDA unveils research plan to inform policy , enforcement work related to prescription drug promotion .” Accessed July 5 , 2018 , from https :// www . fda . gov / NewsEvents / Newsroom / FDAInBrief / ucm600586 . htm .
3 . Donohue J . A history of drug advertising : the evolving roles of consumers and consumer protection . Milbank Q . 2006 ; 84:659-99 .
4 . U . S . Food and Drug Administration . “ Kefauver-Harris Amendments revolutionized drug development .” Accessed July 5 , 2018 , from https :// www . fda . gov / ForConsumers / ConsumerUpdates / ucm322856 . htm .
5 . Ventola CL . Direct-to-consumer pharmaceutical advertising : therapeutic or toxic ? PT . 2011 ; 36:669-84 .
6 . DTC Perspectives . “ DTC in perspective : spending tops $ 5 billion in 2015 , up 14 % vs . 2014 .” Accessed July 5 , 2018 , from http :// www . dtcperspectives . com / dtc-inperspective-spending-tops-5-billion-in-2015-up-14-vs-2014 /.
7 . U . S . Food and Drug Administration . “ Basics of drug ads .” Accessed July 5 , 2018 , from https :// www . fda . gov / Drugs / ResourcesForYou / Consumers / PrescriptionDrugAdvertising / ucm072077 . htm .
8 . U . S . Food and Drug Administration . “ From the manufacturers ’ mouth to your ears : direct to consumer advertising .” Accessed July 5 , 2018 , from https :// www . fda . gov / Drugs / ResourcesForYou / SpecialFeatures / ucm319379 . htm .
9 . Parekh N , Shrank WH . Dangers and opportunities of direct-to-consumer advertising . J Gen Intern Med . 2018 ; 33:586-7 .
10 . STAT News . “ Hemophiliacs can more easily play soccer thanks to this drug ? FDA says not so fast .” Accessed July 5 , 2018 , from https :// www . statnews . com / pharmalot / 2018 / 03 / 07 / hemophilia-fda-soccer-promotions /.
11 . Klara K , Kim J , Ross JS . Direct-to-consumer broadcast advertisements for pharmaceuticals : off-label promotion and adherence to FDA guidelines . J Gen Intern Med . 2018 ; 33:651-8 .
12 . Mintzes B . The tip of the iceberg of misleading online advertising . Int J Health Policy Manag . 2016 ; 5 ( 5 ): 329-31 .
13 . Pew Research Center . “ Majority of adults look online for health information .” Accessed July 5 , 2018 , from http :// www . pewresearch . org / fact-tank / 2013 / 02 / 01 / majority-of-adults-look-online-for-health-information /.
14 . Egilman D , Druar NM . Spin your science into gold : direct to consumer marketing within social media platforms . Work . 2012 ; 41 suppl 1 ; 4494-502 .
15 . Novo Nordisk . “ Anthony Anderson , star of ABC ’ s “ black-ish ,” partners with Novo Nordisk to launch “ Get Real About Diabetes™ .” Accessed July 6 , 2018 , from http :// press . novonordisk-us . com / 2017-11-14-Anthony-Anderson-Star-of-ABCs-black-ish- Partners-with-Novo-Nordisk-to-Launch-Get-Real-About-Diabetes-TM .
16 . BioMarin press release , “ BioMarin Partners with Believe Limited for ‘ Breaking Through !’ Musical Theater Intensive .” Accessed July 16 , 2018 , from https :// www . prnewswire . com / news-releases / biomarin-partners-with-believe-limited-forbreaking-through-musical-theater-intensive-300677452 . html .
17 . Vox . “ Big pharma ’ s newest marketing tactic : infiltrating soap operas like General Hospital .” Accessed July 6 , 2018 , from https :// www . vox . com / 2017 / 5 / 18 / 15655520 / pharma-marketing-disease-awareness-soap-operasgeneral-hospital .
18 . Mailankody S , Prasad V . Pharmaceutical marketing for rare diseases : regulating drug company promotion in an era of unprecedented advertisement . JAMA . 2017 ; 317:2479-80 .
19 . Layton JB , Kim Y , Alexander GC , et al . Association between direct-to-consumer advertising and testosterone testing and initiation in the United States , 2009- 2013 . JAMA . 2017 ; 317:1159-66 .
20 . U . S . Food and Drug Administration . “ The impact of direct-to-consumer advertising .” Accessed July 6 , 2018 , from https :// www . fda . gov / Drugs / ResourcesForYou / Consumers / ucm143562 . htm .
21 . Shapiro B . “ Promoting wellness or waste ? Evidence from antidepressant advertising .” Becker Friedman Institute for Research in Economics Working Paper No . 2018-14 . Accessed July 6 , 2018 , from https :// ssrn . com / abstract = 3130327 .
46 ASH Clinical News August 2018