eHealth Marketing

1. eHealth Marketing Benefits, Risks, Challenges Richard Cleland Senior Attorney Federal Trade Commission

2. Introduction • What a difference a year makes! • 17,000 Internet health sites • 52 million Internet health seekers* • Progress will not be linear; at times there will be plateaus and even a reversal or two

3. Benefits • Enables a large number of people to quickly access medical and other information that was never available to the general public before. • Empowers consumers to take a more active role in their health care management.* • New information can be disseminated quickly to the public and medical community.

4. Benefits • Easier for researchers and others to share information, avoid duplication, and pool resources. • Potential for delivery of services and products more efficiently and cost effectively. • Facilitates b/b and b/c commercial transactions.*

5. Potential Harm • Dangerous products* • hydrazine sulfate • oil of wormwood • Inaccurate information** • Health Fraud • Violation of professional practice standards • Privacy violations

6. Consumer Attitudes • Consumer attitudes toward technology are important. • Internet users may be one of the most studied populations in history.

7. Pew Internet and American Life Project Study • 52 million American adults have used the Internet to look for health information. • 23% used the Internet within the last week • 35% used within the last month. • Looking for information about specific diseases and conditions • Convenience, quantity of information, and anonymity

8. Internet Use • Primary use of the internet is to supplement conventional medicine, not to replace it. • 2% of Internet health users reported that they used the Internet instead of seeing a physician • 61% said they looked for health information for themselves either before or after visiting a doctor or clinic • Only 10% said they bought medicine or vitamins on the Internet.*

9. Consumer Satisfaction • 90% report that the information they found was useful • 80% said they learned something new • 55% say it improved the way they get medical information • 48% say it improved the way they care for themselves • 47% of persons who sought information for themselves say that the information affected their decisions

10. Concerns: Privacy • 86% say they are concerned that health-related web site will sell or give away information about what they did online • 60% say that maintaining medical records online would be a bad thing, because they would worry about other people seeing their health records

11. Concerns: Accuracy • 86% say they are concerned about accuracy • 44% said that they believe some of what they see on the Internet • 35% said they believe most • 16% said they believe almost all • 70% report trouble distinguishing credible information from untrustworthy information*

12. FTC’s eHealth Mission • Help consumers find truthful and accurate health information • Provide consumers with the tools and information needed to distinguish legitimate health products from health scams • Protect vulnerable consumers from injury • Foster the growth of internet commerce

13. FTC eHealth Initiatives • Consumer protection • Privacy • Industry self-regulation

14. FTC or FDA? • Federal Trade Commission • Advertising of OTC drugs, foods, dietary supplements, cosmetics, devices and services • FDA • Advertising of prescription drugs and restricted medical devices • Labeling of prescription drugs, medical devices, OTC drugs, foods, dietary supplements, and cosmetics

15. Prohibited Acts & Practices • Unfair and deceptive acts or practices • False advertisements for foods, drugs, devices, cosmetics and services • In or affecting commerce

16. Examples • False statements • Deceptive omissions of material fact • Lack of a reasonable basis • Unfair practices*

17. Reasonable Basis Reguirement • FTC Act requires that an advertiser making an objective performance or efficacy claim for a product or service have a reasonable basis to make that claim.* • Most common advertising violation (on and off the Net)

18. Determining Reasonable Basis • Reasonable basis varies • Level advertiser claims • Type of product • Type of claim • Benefits of a truthful claim • Costs and feasibility of developing substantiation for a claim • Consequences of a false claim • Amount of substantiation that experts in the field believe is reasonable

19. Health Claims • Health claims generally require competent and reliable scientific evidence* to support the claim. • Totality of the evidence • Well-controlled clinical studies • See Dietary Supplements: An Advertising Guide for Industry. This document is available at http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm.

20. Health Fraud on the Net • Operation Cure.All (June 1999) • target deceptive and misleading online marketing of products and services being promoted as cures or treatments for serious diseases • consumer and business education • law enforcement • FDA & several state attorneys general.

21. Health Claim Surf Days • What is a surf? • Over 1,000 sites identified – tip of the iceberg • Therapies and devices, but the vast majority of products are supplements • Compliance advisory letters** • Random sampling

22. Consumer Education • www.ftc.gov, www.consumer.gov • Links to reliable sources of health information, including healthfinder.gov • Consumer education tips such as those found in “Virtual Treatments” and “Fraudulent Health Claims.” • Teaser sites like “Arthriticure” and “Virility Plus.” • Goal: Real time consumer education

25. Law Enforcement • The FTC has filed seven Operation Cure.All cases since June of 1999. • Cat’s Claw • Shark cartilage • Glycoalkaloid cream • Cetylmyristoleate (CMO) • Essiac tea • Magnetic therapies

29. Metatags CONTENT="cancer, cancer treatments, Essiac ESSIAC Essiac essiac essiac TEA tea tea tea CANCER CANCER Cancer cancer CURES Cures cures cures information, brain tumors, lymphoma help, essiac, ESSIAC teas, natural colon treatments, natural remedies remedies REMEDIES remedies remedies REMEDY Remedy remedy remedy

32. Androgen Supplements • FTC v. AST Nutritional Concepts Research, Inc. (Colorado) (99-WI-2197) (May 4, 2000) (Stipulated Order) • FTC v. Met-Rx (SAC V-99-1407) (C. Dist. Cal.) (Nov. 24, 1999) (Stipulated Order).

33. HIV Rapid Tests • FTC v. Cyberlinx, Inc. and Jeffrey S. Stein • FTC v. Medimax, Inc. and David Rothbart • FTC v. Alfa Scientific Designs, Inc. • FTC v. Sovo Tec Diagnostics, Inc. • FTC v. Chembio Diagnostic Systems, Inc. • Joint FTC/FDA consumer warnings

34. Privacy • Privacy is critical – 89% of health seekers are concerned! • Significant deterrent to Internet development • Gaps in self-regulation – 40% of health products sites have no policy • Gaps in HIPPA

35. Privacy • Privacy is an Internet wide public relations problem • Notice of privacy policy is critical to building consumer confidence • Compliance with privacy policies is critical to maintaining consumer confidence

36. Privacy – Common Mistakes • Privacy practices inconsistent with privacy policy • Inconsistent statements • Unintelligible policy • Third party access or collection not disclosed • Information leakage

37. Privacy – Deceptive Practices • Consumer told that information is not individually identifiable when it is • Information used for a purpose other than the one disclosed • Consumer told that information is encrypted when its not • FTC v. Rennert

38. Self-Regulation • Self-regulation is the predominant form of regulation on the Internet • FTC fully supports self-regulation efforts • Compliment to effective law enforcement. • Standards • Employ high standards • Vigorously enforced • Meaningful independent oversight • A question of harm

39. Online Ethical Codes/Seals • Health on the Net • AMA • Hi-Ethics/Trustee • eHealth Code/URAC • Address issues transparency, blurring, privacy, professional standards, and accuracy

40. Death of the Gatekeeper? • Historic role of physicians and government regulators as gatekeepers • Primary care provider • Governments play a predominant role in determining what health products could be sold and under what conditions (e.g., prescription drugs) • Little need to educate consumers of the rationale behind the system

41. Gatekeeper • Online pharmacies, contact lenses, medical information, alternative and complimentary medicine • Consumer demand • Education • Limits to consumer protection model

42. Online Pharmacies • Buying prescription drugs on line • Congressional hearings • State actions • Federal Actions • Criminal charges • FTC v. Rennert • The Global Net

43. Health Literacy • 90 million U.S. adults are functionally illiterate or marginally literate. • Difficulty understanding the health care information they need and receive. • How is the Internet serving these people? • Internet depends primarily on search engines and health portals to deliver users to text-based content. • Written at a level that may be beyond many current and future Internet users.

44. Health Literacy • Reliable health content (not just advertising) available at all levels • Develop alternatives to text based communications (technology) • Navigational aids that go beyond text-based queries • Improvements in health, medical & scientific literacy

45. eFuture Shock • Future will not look like the past • Telemedicine • At home health monitoring • Product sales • Online medical records • Education • Advances in evidence based medicine • Reducing medical errors

46. eFuture Shock • Is this a technology we need? • Will it improve health? • Will consumers accept it? • What are the ethical implications?

47. Summary • Help consumers find truthful and accurate health information • Provide consumers with the tools and information needed to distinguish legitimate health products from health scams • Protect vulnerable consumers from injury • Foster the growth of internet commerce