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Since 1997, market trends have clearly demonstrated that DTCA campaigns are highly successful in increasing prescription rates of advertised drugs.

AAOS Now

Published 12/1/2007
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Sharat K. Kusuma, MD; Ryan M. Nunley, MD; Samir Mehta, MD; James W. Genuario, MD; Jeanie Kennedy; the Washington Health Policy Fellows

DTCA: Improving patient education or simply increasing pharmaceutical profits?

Direct-to-consumer advertising (DTCA) in the healthcare arena generally refers to marketing activity conducted by a producer or provider of a drug, medical device, or medical service that bypasses physicians and other healthcare professionals and focuses on the actual recipient (the patient or “consumer”). Until recently, pharmaceutical companies directed marketing efforts to the prescribers of their products, such as physicians and other healthcare professionals. For many years, patients had limited autonomy with regard to prescribed drugs and treatments. Such an environment naturally favored the use of physician-directed marketing campaigns by pharmaceutical companies.

New guidelines released by the U.S. Food and Drug Administration (FDA) in 1997 significantly broadened the ability of pharmaceutical companies to use electronic and broadcast media to advertise medications directly to potential patients. The guidelines allowed companies to advertise the names of drugs or devices and the condition that they treated, while only requiring a brief mention of a few “important” risks of these treatments. They were a significant departure from the requirements under the Food, Drug, and Cosmetic Act of 1938, which had prohibited the use of print and television media for advertising prescription drugs.

Since 1997, market trends have clearly demonstrated that DTCA campaigns are highly successful in increasing prescription rates of advertised drugs.1,2 Accordingly, pharmaceutical companies have increased spending on DTCA at exponential rates. The total amount spent on DTCA has increased from roughly $55 million in 1991 to more than $4 billion in 2004.3

Pros and cons of DTCA
The benefits and downsides of DTCA are currently being debated within the policymaking arena. Given the success of DTCA in increasing sales, huge profits are at stake for pharmaceutical companies if they can successfully block future anti-DTCA legislation.

Proponents of DTCA claim that it affords patients a myriad of benefits. They say that direct, targeted ads provide an important source of educational material for patients regarding diseases and available treatments. Theoretically, this patient education will increase the likelihood that patients will seek treatments for previously untreated ailments, thereby increasing overall public health.

Supporters also contend that DTCA fosters a new sense of patient empowerment and personal responsibility for individual health by bridging the information gap that previously existed between patients and their doctors. Better educated patients, the argument goes, will be able to make smarter, patient-centered decisions regarding their own health care.

Published data regarding the accuracy and validity of many DTCA campaigns indicates the contrary. Studies show that DTCA information provides patients with an incomplete and biased “education.” Nearly 87 percent of television advertisements present the potential benefits of medications in vague, qualitative terms that are not backed by scientific data.4

Research has also shown that most television advertisements present the benefits of drugs at a sixth-grade reading level that most people can understand. The risks, however, are presented at a more difficult to understand ninth-grade level.5 Such misrepresentations of information suggest that pharmaceutical companies may not be purely interested in “educating” patients through the use of DTCA.

Opponents of DTCA argue that most advertisements are filled with inaccuracies and misrepresentations. Fundamentally, critics of DTCA contend that it is impossible for pharmaceutical companies to create advertisements that both fully educate patients about medicines and treatments and maximize pharmaceutical sales.6,7

Opponents also contend that misinformed patients often make unreasonable demands for inappropriate tests and treatments. Physicians must spend a larger proportion of precious office visit time explaining why heavily marketed drugs and treatments are not appropriate rather than focusing on the patient’s disease process. Such counseling sessions can significantly and unnecessarily lengthen the office visit and put undue strain on the doctor-patient relationship.2,8,9 Ultimately, critics argue, DTCA encourages often inappropriate patient demands for the latest, most costly, and most heavily marketed drugs or devices. The growing use of such treatments can lead to a misallocation of resources and increase overall healthcare costs.

DTCA and orthopaedic surgery
Most recent research has focused on prescription drugs and the effects of DTCA on the use of such drugs. Orthopaedic device and implant manufacturers have lagged slightly behind their pharmaceutical counterparts in using DTCA, but this is changing.

Since 2000, orthopaedic implant manufacturers have significantly expanded their use of DTCA. Given the proportion of the Medicare budget consumed by total joint replacement procedures, device manufacturers have substantial incentives to use DTCA to increase their share of these expenditures.

Unlike DTCA for pharmaceuticals, however, DTCA in orthopaedic surgery is not limited to just manufacturers. Physician practices and hospitals also produce DTCA. A recently published study found that 70 percent of Internet Web sites addressing minimally invasive total hip arthroplasty are authored and administered by physician practices and hospitals; only 6 percent of these Web sites are administered solely by orthopaedic implant manufacturers.10 Many of these hospital- and physician-sponsored sites have significant backing from implant companies.

Orthopaedic surgeons and hospitals also seem to be suffering negative consequences of the increasing prevalence of DTCA for orthopaedic products. A recent award-winning study by Bozic et al showed that 74 percent of orthopaedic surgeons believe that DTCA negatively affected their patient interactions and their overall practices. Additionally, 77 percent of surgeons believe that patients came to office visits with inaccurate information and were confused about procedures and implants for their particular orthopaedic ailments.11

In part, this may be because DTCA by orthopaedic implant manufacturers is dealing with the same issues that face pharmaceutical companies. At least one study has shown that only 7 out of 50 claims made by implant manufacturers in print media ads were well supported by scientific data.12

In summary, although DTCA in orthopaedic surgery lags behind DTCA in the more mainstream pharmaceutical industry, both evidence many similar trends.

The future of DTCA
For the foreseeable future, it appears that DTCA will continue, and pharmaceutical and orthopaedic implant manufacturers will increase spending on such advertising tactics.

Additionally, it appears that regulatory agencies such as the FDA will be hampered in their ability to control and monitor the content of such advertising. Currently, the FDA has only 40 employees to review more than 30,000 advertisements per year.13

Widespread evidence demonstrates that DTCA fosters the utilization of advertised drugs and treatments, thereby increasing pharmaceutical and implant manufacturer profits. Additionally, the recent media focus on relationships among physicians, surgeons, and the pharmaceutical industry will limit the ability of pharmaceutical companies to market directly to physicians, thereby encouraging them to market directly to patients. If left to their own devices, implant manufacturers, which are ultimately profit-driven enterprises with responsibilities to shareholders, cannot be expected to self-police their use of DTCA.

With such strong forces encouraging the use of DTCA and with very few obstacles to its use, the effects of DTCA on the healthcare industry can only be expected to multiply. Overburdened regulatory agencies responsible for controlling content and use of DTCA may need to partner with professional societies to evaluate the content and accuracy of DTCA campaigns. Only through such collaborative efforts to improve the accuracy and true educational content of direct-to-consumer marketing can the healthcare system truly realize the benefits that DTCA may offer to patients.

The Washington Health Policy Fellows include Sharat K. Kusuma, MD; Ryan M. Nunley, MD; Samir Mehta, MD; James W. Genuario, MD; Anil Ranawat, MD; Alok D. Sharan, MD; Aaron Covey, MD; John Flint, MD; and Amir A. Jahangir, MD. Jeanie Kennedy is AAOS manager of regulatory and government affairs.

References

  1. Kravitz RL, Epstein RM, Feldman MD, et al: Influence of patients’ requests for direct-to-consumer advertised antidepressants: A randomized controlled trial. JAMA. 2005;293:1995-2002.
  2. Aikin KJ, Swasy JL, Braman AC: Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA Survey Research Results. Rockville, MD, Center for Drug Evaluation and Research, Food and Drug Administration, US Dept of Health and Human Services; 2004.
  3. Querna B: The big pill pitch. U.S. News and World Report 2005;52-53.
  4. Woloshin S, Schwartz LM, Tremmel J, et al: Direct-to-consumer advertisements for prescription drugs: What are Americans being sold? Lancet 2001;358(9288):1141-1146.
  5. Kaphingst KA, Rudd RE, Dejong W, et al: Comprehension of information in three direct-to-consumer television prescription drug advertisements among adults with limited literacy. J Health Commun 2005;10(7):609-619.
  6. Bell RA, Kravitz RL, Wilkes MS: Direct-to-consumer prescription drug advertising and the public. J Gen Intern Med 1999;14(11):651-657.
  7. Jeffords JM: Direct-to-consumer drug advertising: You get what you pay for. Health Aff (Millwood). 2004;Suppl Web Exclusives:W4-253-255.
  8. Robinson AR, Hohmann KB, Rifkin JI, et al: Direct-to-consumer pharmaceutical advertising: Physician and public opinion and potential effects on the physician-patient relationship. Arch Intern Med 2004;164(4):427-432.
  9. Murray E, Lo B, Pollack L, Donelan K, et al: Direct-to-consumer advertising: Physicians' views of its effects on quality of care and the doctor-patient relationship. J Am Board Fam Pract 2003;16(6):513-524.
  10. Labovitch RS, Bozic KJ, Hansen E. An evaluation of information available on the internet regarding minimally invasive hip arthroplasty. J Arthroplasty 2006;21(1):1-5.
  11. Bozic KJ, Smith AR, Hariri S, et al: The 2007 ABJS Marshall Urist Award: The impact of direct-to-consumer advertising in orthopaedics. Clin Orthop Relat Res 2007;458:202-219.
  12. Bhattacharyya T, Tornetta P 3rd, Healy WL, et al: The validity of claims made in orthopaedic print advertisements. J Bone Joint Surg Am 2003;85(7):1224-1228.
  13. Direct-to-Consumer Prescription Drug Advertising. Philadelphia, PA, American College of Physicians: Position Paper; 2006.

DID YOU KNOW?

  • The European Union banned direct-to-consumer advertising (DTCA) many years ago and continues to restrict such marketing activity.
  • The United States and New Zealand are the only two countries in the world that allow DTCA.
  • In 2000, Merck & Co. spent $161 million marketing the drug Vioxx; in that same year, Dell Inc. spent a total of $160 million on marketing, and Anheuser-Busch spent $146 million on marketing.1
  • Spending on DTCA by pharmaceutical companies for prescription drugs has grown from $55 million in 1991 to $4 billion in 2004.2,3
  • Based on average television viewing in the United States, the average adult is exposed to 100 minutes of DTCA each year for every ONE minute spent with a doctor.4

References:

  1. Rosenthal M, Berndt ER, Donohue JM, et al: Promotion of prescription drugs to consumers. N Engl J Med 2002:346:498-505.
  2. Kravitz RL, Epstein RM, Feldman MD, et al: Influence of patients’ requests for direct-to-consumer advertised antidepressants: A randomized controlled trial. JAMA 2005;293:1995-2002.
  3. Robinson AR, Hohmann KB, Rifkin JI, et. al. Direct-to-consumer pharmaceutical advertising: Physician and public opinion and potential effects on the physician-patient relationship. Arch Intern Med 2004;164(4):427-432.
  4. Brownfield ED, Bernhardt JM, Phan JL, et al: Direct-to-consumer drug advertisements on network television: An exploration of quantity, frequency, and placement. J Health Commun 2004;9(6):491-497.