August 2004

Grant Results

National Program

Strengthening the Patient-Provider Relationship in a Changing Health Care Environment

SUMMARY

From 2000 to 2001, researchers at Boston University School of Public Health examined how the growth of direct-to-consumer advertising of prescription drugs affects the patient-provider relationship.

The research team interviewed 42 leaders in the field about how direct-to-consumer advertising of prescription drugs has affected patients and providers.

The project was part of the Robert Wood Johnson Foundation (RWJF) Strengthening the Patient-Provider Relationship in a Changing Health Care Environment national program.

Key Findings

  • Spending on direct-to-consumer prescription drug advertising increased from $1.9 billion in 1999 to $2.5 billion in 2000, a rise of 32 percent.
  • Most of the respondents expressed concern that direct-to-consumer advertising for prescription drugs has strained patient-provider relationships, and most feel that it has helped raise health care costs.
  • Based on interviewees' ratings of 19 public and 12 private sector options designed to address problems related to direct-to-consumer advertising, it appears "impossible to find measures that would be both effective and feasible to adopt" in the present political climate.
  • Focusing on direct-to-consumer advertising alone is a "diversion from the main challenge of reining in prescription drug costs and making needed drugs affordable to all."

Funding
RWJF supported this project through a grant of $89,539.

 See Grant Detail & Contact Information
 Back to the Table of Contents


THE PROBLEM

Prior to the 1960s, drug manufacturers had virtually free rein in their advertising. They could say what they wanted, when they wanted, to whomever they wanted. Then Congress and the Food and Drug Administration (FDA) took steps that substantially limited direct-to-consumer advertising of prescription drugs, particularly on radio and television. However, in August 1997, the FDA reversed its stance and liberalized guidelines on this advertising. Total direct-to-consumer advertising for drugs rose from roughly $500 million in 1996 to $1.9 billion in 1999. Much of the rise was attributable to the FDA's loosening of its direct-to-consumer advertising policies for drugs.

The increase in direct-to-consumer advertising of prescription drugs raised several concerns, Among them:

  • U.S. spending on prescription drugs — already the highest in the world per person — might accelerate and put further upward pressure on health insurance premiums.
  • Direct-to-consumer advertising of prescription drugs might provide incomplete or inaccurate information to consumers who may then demand inappropriate drugs from their physicians.
  • The patient-physician relationship might be damaged if physicians are unwilling to prescribe inappropriate drugs that patients nonetheless want because of direct-to-consumer advertising messages.

 Back to the Table of Contents


THE PROJECT

Using survey findings and existing research, the research explored the following topics:

  • The influence of direct-to-consumer advertising of prescription drugs on the patient-provider relationship.
  • Possible private and public actions (as well as their strengths and weaknesses) that might be taken to modulate the effects of direct-to-consumer advertising on the patient-provider relationship.

Using a survey that included 16 open-ended questions, the research team interviewed 42 leaders in the field. Respondents included physicians, representatives from public interest advocacy groups, drug manufacturers, health care advertising agency executives, government agency representatives, academicians and pharmacists. Respondents completed a scoring sheet rating an array of public and private sector actions that might be used to mediate the effects of direct-to-consumer advertising. The options include the following (see the Appendix for a complete list):

  • Strictly specify the requirements of advertising.
  • Closely enforce the accuracy and completeness of ads.
  • Require preapproval of new ads by the FDA.
  • Encourage pharmacists to spend more time counseling patients filling prescriptions for new drugs that have been intensely advertised.
  • Provide educational brochures on new drugs at physician offices.

The investigators also conducted an extensive literature search to document what is known about direct-to-consumer advertising and its effects on the patient-provider relationship.

The investigators noted that executives from the pharmaceutical industry were particularly reluctant to participate in the survey and those who did so were unwilling to rate the interventions.

 Back to the Table of Contents


FINDINGS

In his final grant report to RWJF, the principal investigator reported the following findings:

  • Spending on direct-to-consumer prescription drug advertising increased from $1.9 billion in 1999 to $2.5 billion in 2000, a rise of 32 percent. Overall, direct-to-consumer advertising represents about 16 percent of drug makers' total spending on marketing.
  • Drug industry data show that from 1995 to 2000, the number of U.S. workers in marketing rose 59 percent. Fully 39.1 percent of drug industry employees were in marketing in 2000 — or 87,810 individuals, up from 55,348 in 1995 (then 27.8 percent of total employees). Meanwhile, all other employee categories (including research and development) were stable or shrank.
  • Most of the respondents expressed concern that direct-to-consumer advertising for prescription drugs has strained patient-provider relationships. In addition, most feel that it has helped raise health care costs.
  • Based on interviewees' ratings of 19 public and 12 private sector interventions to address problems related to direct-to-consumer advertising, it appears "impossible to find measures that would be both effective and feasible to adopt," the investigators say.
  • Based on their findings, the investigators contend that focusing on direct-to-consumer advertising alone is a "diversion from the main challenge of reining in prescription drug costs and making needed drugs affordable to all."

Communications

The principal investigator presented the study findings at the American Public Health Association's annual meeting in 2001. Sager also testified before the U.S. Senate Commerce Committee in December 2001 and the U.S. House of Representatives Subcommittee on Government Reform in July 2002.

 Back to the Table of Contents


LESSONS LEARNED

The project director offered one lesson for the field:

  1. Identifying and recruiting knowledgeable and highly regarded survey participants for a study on a controversial and provocative topic can be difficult and time-consuming. However, once the investigators found individuals who were willing to be interviewed, the interviewees provided a large volume of high-quality information. In fact, most interviews took twice as long to conduct as expected. Pharmaceutical company executives were the only exception. They were unwilling to rate the interventions, which the project director suggests was because of their general discomfort with initiatives that might constrain their freedom of action. (Project Director)

 Back to the Table of Contents


GRANT DETAILS & CONTACT INFORMATION

Project

Research on the Effects of Direct-to-Consumer Advertising on Patient-Provider Relationships

Grantee

Boston University School of Public Health (Boston,  MA)

  • Amount: $ 89,539
    Dates: January 2000 to June 2001
    ID#:  038186

Contact

Alan Sager, Ph.D.
(617) 638-4664
asager@bu.edu

 Back to the Table of Contents


APPENDICES


Appendix 1

(Current as of the time of the grant; provided by the grantee organization; not verified by RWJF.)

Options Considered for Public and Private Interventions against Direct-to-Consumer Advertising

Public Interventions

  • Develop a center for drug advertising that identifies large advertising campaigns and provides educational information about these drugs.
  • Ban direct-to-consumer advertising using various media.
  • Ban direct-to-consumer advertising for certain kinds of drugs.
  • Closer enforcement of accuracy and completeness of ads.
  • Require preapproval of new ads by FDA; give FDA resources to do this.
  • Require drug makers to prove public utility of ad to FDA.
  • Strictly specify content/format requirements for ads.
  • Require each ad to give equal attention to risks and benefits.
  • Require each ad to describe reasonable alternative treatments, e.g., exercise and diet.
  • Allow information ads, not image ads.
  • Require that each medication be on the market for a set period of time before direct-to-consumer advertising is allowed.
  • Require that each medication be used by a certain number of people before direct-to-consumer advertising is allowed.
  • Require rotating cautionary language in the body of each ad.
  • Require physicians to prescribe only after counseling patients and require them to report adverse reactions.
  • Improve patient-physician relationships to counteract effects of direct-to-consumer advertising.
  • Eliminate tax-deductibility of direct-to-consumer advertising of prescription drugs.
  • Limit the share of their revenue drug makers can spend on direct-to-consumer advertising.
  • Facilitate lawsuits against drug makers for patients hurt by misleading claims in direct-to-consumer advertising; hold drug makers liable for these harms.

Private Interventions

  • Develop a center for drug advertising that identifies large advertising campaigns and provides educational information about these drugs.
  • Provide better education on drug advertising for patients and physicians.
  • Encourage physicians to spend more time counseling patients about proper drug use and adverse reactions.
  • Encourage pharmacists to spend more time counseling patients who are filling prescriptions for widely advertised drugs; urge patients to look for side effects.
  • Prepare educational brochures on direct-to-consumer advertising for physician offices to help them manage inappropriate requests for medications.
  • Prepare educational brochures on specific drugs for physician offices to help them manage inappropriate requests for medications.
  • Implement higher cost-sharing for highly advertised drugs when prescribed against a physician's better judgment.
  • Implement higher cost-sharing for prescription drugs generally.
  • Establish guidelines for which medications should be included in formularies and which in co-payment classes.
  • Improve patient-physician relationships to counteract effects of direct-to-consumer advertising.
  • Facilitate lawsuits against drug makers for patients hurt by misleading claims in direct-to-consumer advertising; hold drug makers liable for these harms.
  • Encourage news media to report more responsibly about new medications, including side effects, lack of long-term data, etc.

 Back to the Table of Contents


BIBLIOGRAPHY

(Current as of date of this report; as provided by grantee organization; not verified by RWJF; items not available from RWJF.)

Presentations and Testimony

Deborah Socolar and Alan Sager, "Throwing Money, Cutting Prices, and Negotiating Peace Treaties: The Three Phases of State and Federal Prescription Drug Reform," at the American Public Health Association Annual Meeting, October 21, 2001, Atlanta.

Alan Sager, "Importing Medications from Canada: Americans Would Save $38 Billion if They Could Pay Canadian Prices for Brand Name Prescription Drugs," to the U.S. Senate Commerce Committee, Washington, September 5, 2001. In: Committee on Commerce, Science, and Transportation, United States Senate, Comparative Pricing of Prescription Drugs Sold in the United States and Canada and the Effects on U.S. Customers, Hearing before the Subcommittee of Consumer Affairs, Foreign Commerce, and Tourism, September 5, 2001, pp. 68–90.

Alan Sager, "Creating an Affordable Medicare Prescription Drug Benefit," to the U.S. House Government Reform Committee, Subcommittee on National Security and Veterans Affairs, July 22, 2002, Washington.

 Back to the Table of Contents


Report prepared by: Karin Gillespie
Reviewed by: Richard Camer
Reviewed by: Molly McKaughan
Program Officer: Judith Whang

Most Requested