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Workshop Summary

Direct to Consumer (DTC) Advertising of Genetic Tests

March 23, 2004

Welcome and Introductions:

Francis S. Collins, M.D., Ph.D., Director, NHGRI

Dr. Collins began the meeting by highlighting that direct-to-consumer (DTC) marketing of genetic tests and services is a very timely topic and merits significant consideration. His presentation included several slides demonstrating the high visibility of DNA, genetics, and the potential of genomic medicine in the mainstream public media, and commented on the optimism and hope for cures that such media reports stimulate within the general population.

It was pointed out that among the "Grand Challenges" for genomic research put forth by the National Human Genome Research Institute (NHGRI) at the completion of the Human Genome Project in April 2003, two specifically pertained to the scientific development of improved genetic tests and the development of policy options for the use of genetic/genomic tools.

Dr. Collins then proceeded to give the group several specific charges for the day:
  1. Articulate opportunities presented through direct-to-consumer advertising and marketing.
  2. Articulate areas of concern regarding direct-to-consumer advertising and marketing.
  3. What specific issues need further development or data collection?
  4. What, if any, is the appropriate role for:
    1. consumers?
    2. health professionals?
    3. industry?
    4. the federal government?
  5. What timelines could be set for achieving the desired outcomes?

At this point, all participants in the room introduced themselves and provided a brief comment on their interests in the DTC advertising issue.

Session One: Alan Guttmacher, Moderator

A Tour of Genetic DTC Advertising: Alan Guttmacher

Dr. Guttmacher gave a slide presentation with various examples (current and past) of DTC advertisements in the realm of genetic tests and services. He noted that among the advertisements identified were some in which only information was provided, some that sold products directly to consumers, others that marketed to consumers through health professionals (e.g., physicians), and those providing access directly to genetic/genomic tests and linking test outcomes to other product sales. Examples include advertising of medical and non-medical uses of genetic tests, found in print, and on television, billboards and the Internet. Some advertisements do target specific populations, others specific diseases.

DTC Marketing of Genetic Tests in Print, Television and on the Internet

Sara Hull

Dr. Hull began by presenting a framework to consider what is potentially of concern regarding DTC advertising for genetic testing and discussing the complexities surrounding the promise of genetics and the potential for health care professionals to play a role in mitigating some issues. Dr. Hull then provided an overview of her research group's work, using the described framework to analyze DTC ads on the Internet. Several implications of direct sales of genetic tests, including potential harms, were reviewed. She concluded by emphasizing that oversight is needed with regard to DTC genetic offerings and noted that more research is needed to understand more fully the consumer response to ads and use of services, as well as their views of the benefits and/or harms of genetic testing.

FDA Study of the Impact of DTC Advertising on the Physician-Patient Relationship

Kathryn Aikin

Dr. Aikin briefly reviewed results from two telephone surveys completed by the FDA in 1999 and 2002 of both the general public and physicians. Among the key findings from the general public pool were that over the three years there was a 20% jump in the number of individuals turning to the Internet for information regarding pharmaceutical advertising, and that people were largely looking for information regarding potential side effects. Forty-one percent of physicians found beneficial effects from DTC pharmaceutical advertising, while 18% thought that it created problems in the physician-patient relationship. Dr. Aikin highlighted that the FDA data pointed to an increase in awareness among patients due to DTC advertising, but that the information provided in the advertisements did not effectively communicate relevant risks.

CDC Investigation of the Myriad Direct-to-Consumer Marketing Campaign

Melanie Myers

In an effort to assess the near-term public health impact of the first multi-media DTC advertising campaign in the area of genetic tests, the CDC, in conjunction with the relevant state health departments, launched an inquiry into the response to the advertisements among both consumers and physicians in the months following the Myriad campaign. Among the preliminary findings were that consumers in pilot cities (Denver, CO and Atlanta, GA) were more likely than those in control cities (Raleigh, NC and Seattle, WA) to have heard of the BRACAnalysis®® test, but reported being no more interested in pursuing it for themselves, or speaking to their doctors about it, and no increase in cancer worries compared to their counterparts. Of the providers responding to the survey, more physicians within the pilot cities reported an increase in patient requests for referrals for the test, but not in the actual number of referrals provided. Providers also reported an increase in requests for testing and the number of tests ordered. It was also pointed out that while physicians' awareness of the test was heightened in the areas in which the campaign was implemented, their basic knowledge of the underlying genetics and implications of the analysis for their patients was not. Conclusions for the study to date point to needs for education at both the consumer and the physician level, increased data on the utilization of the test, and the development of models for integrating genomics into health care and disease prevention.

General Discussion

The group speculated that it may not be very surprising that consumers were not pursuing BRACAnalysis® in greater numbers following the advertising campaign, since people are generally reluctant to get bad news, particularly when it is not accompanied by a course of action to mediate any symptoms or outcomes. However, at this time, the data available do not provide any insight into why people did not pursue, or were not interested, in the test.

Myriad shared that although there was an incremental jump in consumer interest in BRACAnalysis® following the campaign, it was not sustained. Also, it was pointed out that additional contracts between local insurance providers and Myriad to perform breast and ovarian cancer testing were secured in the test markets prior to launching the ad campaign. CDC representatives pointed out during this discussion that the CDC had developed a fact sheet for dissemination to the public at the time of the ad campaign, but that there was no concerted education effort initiated to coincide with the marketing activities.

Session Two: Moderator Steve Gutman

Consumer Perspective

Frances Visco

Ms. Visco began by providing background information on the structure of the National Breast Cancer Coalition (NBCC), its organizational goals, and its mission - to eradicate breast cancer. The NBCC position on genetic testing for breast cancer is that it is a research tool, and as such should only be used in the context of rigorous clinical trials. NBCC believes that consumers, when provided with adequate time and information, are capable of understanding complex medical and genetic information; however, neither the general public nor the clinical community is currently ready for broad implementation of genetic testing. NBCC concerns include: the current lack of a clearly defined intervention based upon test results, the unclear confidentiality of testing services, involvement of insurance companies without protection from genetic discrimination, and insufficient understanding of complex genetic information on the part of some genetic counselors and clinicians. Ms. Visco stressed the need for oversight and regulation of genetic/genomic tests and clinical services as soon as possible, as well as the need for unbiased genetic education for health professionals and consumers.

Consumer Perspective

Diane Dorman

Ms. Dorman spoke on behalf of the National Organization for Rare Disorders (NORD). NORD's position on genetic testing is that no test should be performed without the involvement of a qualified provider before and after the test, to ensure that reliable, safe, and predictable information is provided more consistently. NORD also believes that patients' families should be included in counseling activities when possible and appropriate. Among the NORD concerns regarding increased genetic testing are the risks stemming from inappropriate tests and the potential for genetic discrimination. Ms. Dorman stressed that the risks and benefits of any genetic test must be fully considered in every situation and that false positive results can be harmful. Ms. Dorman reemphasized the NBCC position that further education for genetic counselors and other health professionals is needed.

Industry Viewpoint and Goals for the DTC Advertising of Genetic Tests

Sandra Blum

Ms. Blum discussed the Myriad BRACAnalysis® Integrated Awareness Campaign, which took place in Denver and Atlanta in 2002. BRACAnalysis® is a genetic test for hereditary breast and ovarian company that is the foundation upon which the company was built. The pilot campaign was a learning experience for Myriad. The goal of the campaign was to increase awareness on the part of both consumers and providers about hereditary breast and ovarian cancer, with the intent of encouraging at-risk individuals to self-identify, as well as to motivate providers to identify these patients and refer or test them as appropriate. Television and print advertisements were only one element within the overall campaign, which also included five months of health professional education and outreach. The television commercial was developed following extensive market research that included focus groups of women with a family history of cancer and interviews with health care professionals. The final ad was chosen in part because it led to appropriate questions among focus group participants and motivated the appropriate women to seek more information, yet did not heighten motivation among low-risk women. The campaign yielded a 400% increase in AMA case study requests and a 200% increase in health professional workshop participation in the test markets. Within the comprehensive campaign, the television ad generated the greatest response from consumers. Myriad experienced a 38-fold increase in phone calls compared to established control cities during the timeframe that the media ads ran. Kaiser Colorado (Denver) showed a 240% increase in referrals for BRACA1/2 testing, without an increase in the testing of low probability women. However, because the health care infrastructure was not prepared for this influx of patients, Kaiser patients experienced up to an eight-month wait for risk assessment with a genetic counselor and greater than 50% of approved patients dropped out of the process. Ms. Blum noted that one key lesson from the pilot was the need for expanded infrastructure for genetic services.

Regulatory Overview

Matthew Daynard

Mr. Daynard reviewed the Federal Trade Commission's (FTC) jurisdiction regarding the advertising of genetic tests, and explored the criteria for the investigation of a "case" by the FTC. FTC jurisdiction is fairly general, covering unfair or deceptive practices, and false ads for foods, drugs, devices, and services, including claims for genetic tests. For substantiation of claims made in an advertisement, the standard is rigorous ("competent and reliable scientific information"), but flexible. Consumer testimonials are not adequate substantiation for a health-related efficacy or safety claim, but are allowed if they describe representative experiences and if the underlying claims in the testimonial can be substantiated. Mr. Daynard outlined the criteria for initiating a new case by the FTC, namely: products or services that represent significant safety concerns, unfounded treatment claims for serious diseases, and a national ad campaign where supporting scientific evidence is nonexistent or clearly inadequate. It was noted that potential "harms" of an advertisement do not have to be physical, and that potential economic harm is also a concern for the agency. The FTC is also interested in online privacy information, e.g., an ad that states that information provided to the website is "secure" when it is not a secure site, is a clear violation. Mr. Daynard encouraged visiting the FTC website for further information on this point: During follow-up questions, it was clarified that the FTC welcomes the assistance of other federal agencies in the analysis of the validity and truthfulness of suspect claims.

General Discussion

The ability of the FTC to "go after" problem DTC advertisers was discussed. Mr. Daynard stressed that the FTC is an agency of only 1000 people, and hence actions must be prioritized to large-scale transgressors. He noted internet advertising is particularly difficult to regulate, as the volume of material is enormous. Genetic testing is also challenging to regulate because FTC does not have the in-house expertise able to properly understand the nuances of technical claims, which further challenges their ability to prioritize possible transgressors and pursue them. One suggestion from Mr. Daynard was for concerned parties to forward appropriate information regarding potential problem issues and advertisements to the FTC. In general, it is the goal of the FTC to partner with the appropriate federal and state officials to achieve the most efficient enforcement approach possible.

The issue of "home brew" tests was raised, and it was clarified that the FDA regulates only test kits. FDA's regulation of "home brew" or "in house" tests is indirect and applied to the building blocks of these tests (so-called analyte specific reagents or ASRs) which must conform to general controls, such as registration and listing and production using good manufacturing practices.

The potential role for states' Attorney Generals was raised, and it was pointed out that while they do often have some authority in this area. Oversight by the states may be limited by state legislative language and the personal and political agendas of the offices involved.

Session Three: Kathy Hudson, Moderator

Discussion Topic: Is there a Problem with DTC Advertising of Genetic Tests Today?

This portion of the discussion was structured to identify policy issues and needs regarding DTC advertising of genetic tests. To accomplish this, four primary topics were identified (Problems, Possible Harms, Data Needs, and Possible Solutions and Goals) and specific issues were categorized accordingly.

Problems Associated with DTC Advertising
  • Genetic infrastructure (number of professionals and their understanding of genetics and genetic testing)
  • Provider education (or lack thereof) with regard to genetics, non-health implications within families AND how to communicate genetic information
  • Lack of validated tests
  • Lack of consensus on methods for validating genetic tests
  • Patients'/providers' inability to deal with complexity of the information
  • Lack of regulatory oversight for tests
  • Little data regarding harms or benefits of tests
  • Broad range of intended use for genetic tests
  • Ad content (e.g., scientific accuracy and validity)
  • Limited access to technologies
  • Misinformation in public sector about genetics
  • Existing oversight is technology driven - not public health oriented
  • Fear of regulation, includes:
    • patient choice vs. "controlled" access
    • need to stratify risks by intended use of genetic tests
Possible Harms of DTC Advertising:
  • Resource allocation (in terms of the implications of misdirected testing on consumer and provider time and counseling requirements)
  • Lack of utility of available interventions
  • Consumer confusion
  • False hope
  • False anxiety
  • Economic harm to consumer
  • Missed opportunities to pursue other health interventions
Data Needs:
  • Evidence of any harms done (through advertisements, and testing)
  • Evidence of any benefits provided (through advertisements, and testing)
  • Other facts to consider:
    • percentage of CLIA certification among laboratories
    • percentage of tests which do rely on ASRs
  • impact of resource allocation on healthcare resources due to DTC advertising
Possible Solutions and Goals:
  • Standards for DTC advertising of genetic tests/services (e.g., best practices or professional guidelines)
    • crafted by whom? Consumers? Industry? Both?
  • Creating a "seal of approval" for ads and/or Web sites that meet particular standards
  • Provide better consumer information
  • Prevent fraud
  • Ensure accurate content of advertisements, including appropriate expectations for the process and regarding potential benefits and harms.

Session Four: Francis S. Collins, Moderator

Discussion Topic: What are the Most Effective Strategies for Moving Forward?

Major recommendations stemming from the group discussion:

  • Facilitate the development of a stakeholder consensus document or white paper outlining "best practices" for DTC advertising in the realm of genetic tests (and, ideally, services).
    • Pertinent stakeholders to include in any activities: consumers, industry (biotech, pharma and clinical laboratories), health care professionals, policy makers (as observers?), health care payers (insurance representatives and federal authorities - CMS).
    • Possible points to address: How to better convey accurate information to the public, including expected benefits and potential harms of learning genetic information; what to expect from the process itself; criteria or points to address through advertisements.
    • Possible group through which to explore potential new models for providing some type of regulatory oversight to the field (e.g., the "Voluntary Genomic Data Submision" model for genomic data)?
    • May be useful for the development of criteria upon which "seals of approval" might be granted and displayed on quality ads.
  • Coordinate/facilitate the development of a formal petition to the FTC outlining the concerns with current DTC advertising practices for genetic tests.
    • Petition could originate with one group, or better, a coalition of interested groups.
    • Petition should explicitly cover the following areas: what is known about current DTC practices; what is the prevalence of such ads; what harms are occurring as a consequence of the advertising practices (e.g., deception, fraud, etc.); are doctor's orders required to obtain tests featured in questionable advertisements (the FTC would not have authority over issues of "medical practice"); what are the regulatory gaps in this area; why is the FTC the most appropriate agency to respond?
  • Research collaborations should be encouraged with members of the private sector. Develop a research agenda able to inform future advertising practices and any policy development, including the questions below.
    • Generate a comprehensive inventory of DTC uses in genetics.
    • What is the impact of existing advertisements on the utilization of their target genetic test?
    • What messages within the advertisements are remembered/understood by consumers? By providers?
    • What messages influence behavior or decision-making in target audiences (consumers and providers)?
    • Are appropriate candidates for the genetic test responding to these messages?
    • What are the basic elements of DTC ads for genetic tests and services?
    • How do those elements relate to potential positive or negative outcomes within the consumer audience (e.g., provide education or promote unfounded hope for cure)?
    • What information are consumers looking for from DTC ads in general?
    • Is this different in the realm of genetics?
    • Are there significant distinctions between the advertising practices and the impact of ads for genetic vs. non-genetic diagnostic tests?
    • Are there unique considerations relative to issues involving families that merit different standards or practices?

Concluding Remarks

Francis Collins

Dr. Collins closed the meeting by thanking participants for their active participation in the day's discussions and for the many useful suggestions provided to NHGRI. He noted that many of the ideas put forward by the group call for substantial collaboration among the stakeholders identified through the discussion, and thus will require the time and energy of the organizations represented in the room. Dr. Collins concluded his remarks by reiterating that NHGRI is eager to pursue the research and policy issues identified during the workshop, and looks forward to working with consumers, researchers, health professionals and other policy makers to ensure that the public benefits from the opportunities provided through genetic technologies, and that it is protected from advertising claims that offer unrealistic hope based on inaccurate scientific information.

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Last Reviewed: November 23, 2011