eHealth Marketing

Benefits, Risks, Challenges

Richard Cleland

Senior AttorneyFederal Trade Commission

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

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.

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.*

Potential Harm

Dangerous products*hydrazine sulfateoil of wormwood

Inaccurate information** Health FraudViolation of professional practice standardsPrivacy violations

Consumer Attitudes

Consumer attitudes toward technology are important.

Internet users may be one of the most studied populations in history.

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 week35% used within the last month. Looking for information about specific diseases and conditionsConvenience, quantity of information, and anonymity

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 physician61% 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.*

Consumer Satisfaction

90% report that the information they found was useful 80% said they learned something new55% say it improved the way they get medical information48% say it improved the way they care for themselves47% of persons who sought information for themselves say that the information affected their decisions

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

Concerns: Accuracy

86% say they are concerned about accuracy

44% said that they believe some of what they see on the Internet35% said they believe most16% said they believe almost all

70% report trouble distinguishing credible information from untrustworthy information*

FTC’s eHealth Mission

Help consumers find truthful and accurate health informationProvide consumers with the tools and information needed to distinguish legitimate health products from health scamsProtect vulnerable consumers from injuryFoster the growth of internet commerce

FTC eHealth Initiatives

Consumer protection

Privacy

Industry self-regulation

FTC or FDA?

Federal Trade CommissionAdvertising of OTC drugs, foods, dietary supplements, cosmetics, devices and services

FDAAdvertising of prescription drugs and restricted medical devices Labeling of prescription drugs, medical devices, OTC drugs, foods, dietary supplements, and cosmetics

Prohibited Acts & Practices

Unfair and deceptive acts or practices False advertisements for foods, drugs, devices, cosmetics and servicesIn or affecting commerce

Examples

False statements

Deceptive omissions of material fact

Lack of a reasonable basis

Unfair practices*

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)

Determining Reasonable Basis

Reasonable basis varies Level advertiser claims Type of productType of claimBenefits of a truthful claimCosts and feasibility of developing substantiation for a claimConsequences of a false claimAmount of substantiation that experts in the field believe is reasonable

Health Claims

Health claims generally require competent and reliable scientific evidence* to support the claim.

Totality of the evidenceWell-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.

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 diseasesconsumer and business educationlaw enforcement FDA & several state attorneys general.

Health Claim Surf Days

What is a surf? Over 1,000 sites identified – tip of the icebergTherapies and devices, but the vast majority of products are supplementsCompliance advisory letters**Random sampling

Consumer Education

www.ftc.gov, www.consumer.govLinks to reliable sources of health information, including healthfinder.govConsumer 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

Law Enforcement

The FTC has filed seven Operation Cure.All cases since June of 1999. Cat’s ClawShark cartilageGlycoalkaloid creamCetylmyristoleate (CMO)Essiac teaMagnetic therapies

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

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).

HIV Rapid Tests

FTC v. Cyberlinx, Inc. and Jeffrey S. SteinFTC 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

Privacy

Privacy is critical – 89% of health seekers are concerned!Significant deterrent to Internet developmentGaps in self-regulation – 40% of health products sites have no policyGaps in HIPPA

Privacy

Privacy is an Internet wide public relations problemNotice of privacy policy is critical to building consumer confidenceCompliance with privacy policies is critical to maintaining consumer confidence

Privacy – Common Mistakes

Privacy practices inconsistent with privacy policyInconsistent statementsUnintelligible policyThird party access or collection not disclosedInformation leakage

Privacy – Deceptive Practices

Consumer told that information is not individually identifiable when it isInformation used for a purpose other than the one disclosedConsumer told that information is encrypted when its notFTC v. Rennert

Self-Regulation

Self-regulation is the predominant form of regulation on the InternetFTC fully supports self-regulation efforts

Compliment to effective law enforcement.

StandardsEmploy high standardsVigorously enforcedMeaningful independent oversight

A question of harm

Online Ethical Codes/Seals

Health on the NetAMAHi-Ethics/TrusteeeHealth Code/URACAddress issues transparency, blurring, privacy, professional standards, and accuracy

Death of the Gatekeeper?

Historic role of physicians and government regulators as gatekeepers Primary care providerGovernments 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

Gatekeeper

Online pharmacies, contact lenses, medical information, alternative and complimentary medicineConsumer demandEducationLimits to consumer protection model

Online Pharmacies

Buying prescription drugs on line Congressional hearingsState actionsFederal Actions

Criminal chargesFTC v. Rennert

The Global Net

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.

Health Literacy

Reliable health content (not just advertising) available at all levelsDevelop alternatives to text based communications (technology)Navigational aids that go beyond text-based queriesImprovements in health, medical & scientific literacy

eFuture Shock

Future will not look like the pastTelemedicineAt home health monitoringProduct salesOnline medical recordsEducationAdvances in evidence based medicineReducing medical errors

eFuture Shock

Is this a technology we need?Will it improve health?Will consumers accept it?What are the ethical implications?

Summary

Help consumers find truthful and accurate health informationProvide consumers with the tools and information needed to distinguish legitimate health products from health scamsProtect vulnerable consumers from injuryFoster the growth of internet commerce