Is it hazardous to public health?

Executive Summary

Pharmaceutical makers spend hundreds of millions of dollars each year on marketing activities that include catchy direct-to-consumer (DTC) television ads for prescription drugs, physician-targeted promotions and other strategies. Critics contend that this aggressive marketing is a threat to public health because companies overemphasize a drug’s benefits and downplay potentially dangerous side effects. The industry responds that its marketing promotes awareness of treatments for chronic conditions and helps generate revenue for research. Federal regulators have collected more than $20 billion in settlements from drug companies accused of trying to inflate sales by marketing their products “off-label,” or for purposes not approved by the U.S. Food and Drug Administration.

The key takeaways in the debate over drug marketing include:

  • The United States is one of only two countries – New Zealand is the other – where DTC drug advertising is legal.

  • Federal law requires drug companies to disclose payments made to physicians, payments that consumer advocates argue may create a conflict of interest when doctors prescribe treatments.

  • Defenders of drug marketing cite studies showing that the ads promote better understanding of treatment options among racial minorities and other groups that often lack access to health information.

Resources for Further Study

Bibliography

Books

Goldacre, Ben, “Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients,” Faber and Faber, 2012. British physician Goldacre explains how new drugs are developed and argues that pharma companies’ marketing drives bias everything from clinical trials to scientific publications.

Moynihan, Ray, and Alan Cassels, “Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All into Patients,” Nation Books, 2005. Health writer Moynihan and policy researcher Cassels go inside drug companies, ad agencies and other corners of the pharmaceutical industry to show how they make up illnesses and attract millions of patients in search of “cures.”

Articles

Donahue, Julie, “A History of Drug Advertising: The Evolving Roles of Consumers and Consumer Protection,” The Millbank Quarterly, December 2006, http://tinyurl.com/gl2gxoo. A University of Pittsburgh scholar provides historical perspective on drug regulations in the United States and how changes since the early 20th century have allowed pharmaceutical companies to join the medical dialogue that previously only existed between physicians and patients.

Greene, Jeremy, and Elizabeth Watkins, “The Vernacular of Risk – Rethinking Direct-to-Consumer Advertising of Pharmaceuticals,” New England Journal of Medicine, Aug. 19, 2015, http://tinyurl.com/jef3hq9. This article examines the ongoing efforts by the Food and Drug Administration (FDA) to regulate how the risks of prescription drugs are communicated to patients in direct-to-consumer (DTC) advertisements.

Krause, Joan, “Off-label Drug Promotion and the Ephemeral Line Between Marketing and Education,” Journal of Law and the Biosciences, Nov. 18, 2015, http://tinyurl.com/ztha7ca. A lawyer provides perspective on a proposed model of drug regulation that would give the FDA limited authority to restrict how companies communicate information about their products.

Mackey, Tim, and Brian Liang, “After Amarin v FDA: What Will the Future Hold for Off-label Promotion Regulation?” Mayo Clinic Proceedings, June 2016, http://tinyurl.com/j3dupnm. The authors examine the likely future impact of a case in which a U.S. District Court ruled that the FDA does not have the authority to prohibit off-label marketing of drugs provided such communication is “non-misleading.”

Reports and Studies

The Henry J. Kaiser Family Foundation, “Impact of Direct-to-Consumer Advertising on Prescription Drug Spending,” June 2003, http://tinyurl.com/jvbpw8p. Researchers from Harvard University and the Massachusetts Institute of Technology investigated the financial impact of direct-to-consumer advertising in five therapeutic classes and found that every dollar spent by a company on DTC marketing brought in an additional $4.20 in sales and drove up overall drug spending.

Perlis, Roy, and Clifford Perlis, “Physician Payments from Industry Are Associated with Greater Medicare Part D Prescribing Costs,” PLoS One, May 16, 2016, http://tinyurl.com/jhcnner. The authors linked Medicare prescribing data with information about physicians who accept promotional payments from pharmaceutical companies and discovered that the higher those payments were, the greater the prescribing costs per patient.

The Pew Charitable Trusts, “Persuading the Prescribers: Pharmaceutical Industry Marketing and its Influence on Physicians and Patients,” Nov. 11, 2013, http://tinyurl.com/mac4o5d. A fact sheet that looks at a half dozen key marketing activities undertaken by drug companies and reviews key literature showing the effects of those practices on consumers and medical professionals.

Sullivan, Helen W., et al., “Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration,” Plos One, May 5, 2016, http://tinyurl.com/zsq9ka8. By reviewing the amount of promotional pieces submitted to the FDA for review from 2001 to 2014, the authors tracked several trends over time, including a continued increase in internet-based DTC advertising.

The Next Step

Advertising Controversy

Frakt, Austin, “Ban Drug Ads on TV? Some Positive Outcomes Would Be Lost,” The New York Times, March 14, 2016, http://tinyurl.com/zvo5pmq. Some experts say that drug advertising can decrease the stigma of illness, encourage patients to continue taking prescribed medication and lead people to visit doctors more often.

Picchi, Aimee, “The rise of the ‘unbranded’ pharmaceutical ad,” CBS News, Aug. 29, 2016, http://tinyurl.com/jgmosge. Spending jumped 31 percent in 2015 on so-called unbranded advertisements, which mention a drug maker and a condition but not a specific medicine.

Weltman, Brad, “Why Pharmaceutical Advertising Is Virtually Absent From the Web,” AdWeek, Nov. 2, 2016, http://tinyurl.com/jmjp3al. The Food and Drug Administration’s failure to provide clear guidance about its rules for advertising drugs on the internet has left Web marketing in limbo.

Regulating the Industry

Avery, Greg, “McKesson paying $150 million in prescription drug probe, halting sales from Colorado center,” Denver Business Journal, Jan. 19, 2017, http://tinyurl.com/zhkfwwh. Drug distributor McKesson Corp. agreed to pay $150 million to settle allegations that it failed to report suspicious pharmacy orders, as required by federal law.

Grant, Charley, “Why Merck’s Pricing Candor Is Good for Big Pharma,” The Wall Street Journal, Jan. 27, 2017, http://tinyurl.com/j8oflez. Pharmacy giant Merck & Co. published a report on its average price increases, and other drug makers plan a similar move in an effort to increase transparency.

Weintraub, Arlene, “Why Big Pharma Gets A Failing Grade On Clinical Trial Transparency,” Forbes.com, Aug. 17, 2016, http://tinyurl.com/hnjnwkh. A New York University assistant professor’s scorecard measuring how open pharmaceutical companies are about communicating clinical-trial results found a lack of transparency.

Organizations

Biotechnology Innovation Association
1201 Maryland Ave., S.W., Suite 900, Washington, DC 20024
202-962-9200
https://www.bio.org/
info@bio.org
@IamBiotech
Trade organization representing biotechnology companies in the United States.

Coalition for Healthcare Communications
405 Lexington Ave., New York, NY 10174-1801
212-850-0708
http://www.cohealthcom.org/
jkamp@cohealthcom.org
Advocacy group representing members of the advertising industry; it lobbies in favor of the free flow of medical information to consumers.

Food and Drug Administration – Office of Prescription Drug Promotion
10903 New Hampshire Ave., Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
http://tinyurl.com/zcwoyjd
Federal agency responsible for approving prescription drugs and for enforcing rules related to the marketing of those products.

National Conference of State Legislatures
444 N. Capitol St., N.W., Suite 515, Washington, DC 20001
202-624-5400
http://tinyurl.com/hzwpsmp
This organization maintains a website that lays out all state-level efforts to legislate on drug advertising, marketing and activities by pharmaceutical sales representatives.

Pharmaceutical Research and Manufacturers of America (PhRMA)
950 F St., N.W., Suite 300, Washington, DC 20004
202-835-3400
http://www.phrma.org/
@phrma
Trade organization representing pharmaceutical companies that operate in the United States.

Public Citizen – Health Research Group
1600 20th St., N.W., Washington, D.C. 20009
202-588-1000
http://www.citizen.org/Page.aspx?pid=524
@Public_Citizen
Consumer advocacy group founded by Ralph Nader that conducts research and lobbying activities aimed at protecting public health.

DOI: 10.1177/237455680304.n1