CANCER PREVENTION,

ETHICS, AND MANAGED CARE

Gilbert S. Omenn, MD, PhDExecutive Vice President for Medical Affairs

University of Michigan

ACS Schilling Cancer ConferenceSanta Cruz, California

29 October, 2000

ADVANCES IN CANCER CARE AND CANCER PREVENTION

WILL ARISE FROM:

• Genetics, genomics, proteomics

• Cell biology and immunology

• Molecular epidemiology/biomarkers

• Bioinformatics

• Behavioral sciences

CLINICAL APPLICATIONS ARE MANY

• Recognize predispositions to cancers of many types• Delineate heterogeneity of etiology and

pathogenesis of various cancers• Detect precursor lesions/molecular tissue changes • Intervene selectively in new, more effective ways• Treat more specifically/increase therapeutic margin• Protect patients from adverse effects of

treatments/from systemic complications• Design/demonstrate effective preventive strategies

• Better to avoid cancers than need them

treated

• Limited benefit of many treatments

• Mandate from Congress for National Cancer Program to reduce the incidence, as well as the burden, of cancers

THE COMPELLING CASE FOR PREVENTION

MODALITIES FOR PREVENTION

• Behavior Change: smoking, alcohol, diet,

physical inactivity

• Reduce occupational, environmental,

medical exposures to carcinogenic agents

• Hormonal

• Nutritional

• Immunological (vaccines)

• Pharmacological

EARLY DETECTION: NINE SCREENABLE CANCERS

• Breast

• Colon

• Rectum

• Prostate

• Cervix

• Testis

• Tongue

• Mouth

• Skin

NCI EARLY DETECTION RESEARCH NETWORK

• Development of Biomarkers

• Validation of Biomarkers

• Clinical/Epidemiological Studies

• Specimen and data resources

• Informatics developments

• Organ-based collaborative groups:

breast/gyn; prostate; lung/aero; GI.

THE CRUCIAL INFLUENCE OF HETEROGENEITY

• The illusion and confusion of “The War on the Cancer”

• The need to speak of “cancers” in the plural• The importance to research strategies for diagnosis, mechanisms, treatments, and preventive interventions• The ramifications of subpopulation analysis/pharmacogenomics

GENETIC SCREENING FOR CANCER RISK: TECHNICAL AND ETHICAL ISSUES

• Genetics complex, heterogeneous• No standards for test characteristics• Limited capacity for genetic counseling• Generally unreimbursed • Lack of effective prevention (or treatment)• No guarantee against discrimination• ADA Act does not provide protection• Business aspects: patents on genes/tissues?• Databases: who has right to know? To sell?•

MICHIGAN GOVERNOR’S COMMISSION ON GENETIC PRIVACY AND PROGRESS

• Balanced approach

• Put issues in broad medical context rather

than supporting concept of “genetic

exceptionalism”

• Need for public & professional education

• Led to several specific statutes

MICHIGAN’S GENETIC STATUTES

Signed March 14, 2000

• Newborn Screening

• Employment - non-discrimination

• Health insurance - non-discrimination

• Informed Consent

• Disposal of DNA of excluded suspect

• Paternity testing

ETHICS AT VARIOUS LEVELS

• Public Policy: Statutes, Allocation of Resources, Access to Care, Prevention, Research • Institutional Responsibilities: Community Outreach, Patients First, Financial Viability, Commercial Ties• Professional: Relations with Patients/Colleagues, Efforts to Stimulate/Assist Behavior Change• Personal: Values,Volunteer Roles, Sense of Responsibility for Others vs “Freedom”

Examples of Ethical Issues in Cancer Prevention

• How much should physicians insist on telling persons at “high-risk”, if the person doesn’t

ask or requests to be spared such information?• How strong should evidence be before authorities recommend certain actions: tamoxifene, Cox-2 inhibitors, beta-carotene, lycopene, folic acid, physical activity, antibiotics against Helicobacter pylori?

• How does one best explain the limitations of present tests?• How can a genetic counseling team anticipate the psychosocial dilemmas within a family, as in testing for BRCA 1,2 among sisters? for colon cancer risk?

• How will we explain the complex patterns of genomic and proteomic expression? Heterogeneity of cause and of response?

• Who will pay? Who knows the cost?• Who will know the results?

ETHICAL PRINCIPLES

• FROM BIOMEDICAL RESEARCH AND CLINICAL CARE:

• Autonomy • Justice

• Beneficence • Lack of maleficence

• Reliance on informed consent procedures

• FOR POPULATION-BASED STUDIES AND PROGRAMS: need community- based principles and procedures

PRINCIPLES OF COMMUNITY-BASED RESEARCH

University of Washington

• Community partners should be involved from the earliest stages• Community partners should have real influence on project• Research processes and outcomes should benefit the community• Community members should be part of the analysis/interpretation• Productive partnerships should last beyond the project• Community members should be empowered to initiate projectsOmenn, in Academic Medicine (1998)

CONFUSION ABOUT MANAGED CARE

“Managed care” covers a broad array of

very different payment practices, from

annual capitated rates to fee-for-service

with discounts, disallowances, disputes,

and other forms of harassment.

“Managed care” is mostly “managed cost”.

Is “ethics & managed care” an oxymoron?

THE POSITIVE POTENTIAL OF MANAGED CARE HEALTH PLANS

• Welcome innovations that improve patient

outcomes and patient satisfaction• Gain market share and high-end referrals through

competitive advantages in the marketplace,

including prevention services• Choose more effective and/or less expensive

services, on a comprehensive basis• Seek evidence for low-cost interventions--behavior

change, supplements, generics

NATIONAL CANCER CARE NETWORK (NCCN)

• Collaboration of 18 leading cancer centers• Periodically updated clinical care guidelines

for most cancers by site• Base for better care and appropriate

referrals regionally• Potential for carve-outs with payors• Base for policy advocacy and political

activism

POLITICAL ACTION• Some objectives require concerted political

action by providers aligned with patients

• Coverage for clinical care for patients on

protocols/trials: kudos to President Clinton

• Evidence to justify risk-based adjustments

• Assurance of compliance with clinical research

regulations/avoidance of harsh penalties

• Graduate medical education: new APCs

• Broad-based support for increasing biomedical

research/institutional life sciences investments

DOES CARE COST MORE WHEN PATIENTS ARE ON TRIALS PROTOCOLS?

• 3 Pilot Studies reported at NCI Conference and at U of Michigan AACI Conf., 1999

• Mayo Clinic, 1988-94: average cumulative cost over 5 yrs/case = $46.4K vs $44.1K

• Group Health Cooperative, Puget Sound, SWOG trials 1990-1996: no difference on computer match; after medical records review and further adjustments, $30K vs $25K (at 2 yrs)

• Kaiser Permanente Northern Calif, 1994-96; 135 pts in trials/135 matched not in trials

- At 1 yr, trials pts 10% higher cost

- After excluding bone marrow transplant

trials, trial patients’ mean cost slightly lower

than patients receiving standard care

Conclusion from pilot studies:

NEGLIGIBLE DIFFERENCE IN COST

Note: marked variation in cost within diagnosis/tumor site/stage.

MANAGED HEALTH CARE PLANS

• December 1998 Agreement between NIH and American Association of Health Plans (AAHP); 1000 managed care plans of various types, covering 100 million people

• AAHP committed to encourage plans to pay for costs of “routine patient care for individuals enrolled in trials, up to same amount as they would pay for standard treatment outside a trial”; need to monitor impact of new coverages

• Each plan is independent. Only anecdotes so far on plans that participate.

• Champus and TriCare managed care companies cover all military personnel and civilian dependents for DOD- supported trials.

PRESENT PARTICIPATION

• Estimated 250,000 Americans participate

in clinical trials each year. About

160,000 on Medicare--half of one

percent of the 38 million Medicare

beneficiaries

• Estimated that Medicare pays 50-90% of

routine costs currently for those

individuals

• Deficiencies of minorities in enrollment

VALUE OF CLINICAL RESEARCH

In clinical research volunteers choose to participate to test the effectiveness of certain treatment in improving the care of patients. How do you perceive

the value of this kind of research?

Great Deal54%

Some Value39%

Not Much Value4%

Don't Know3%

A majority (59%) of Michigan residents say they would be likely to participate as a volunteer in a clinical research study. The most important factor in deciding to participate is the opportunity to improve personal health or that of others. Sixty-seven percent of all respondents feel this was a major reason in the decision to participate. The next most important factor is the reputation of the institution conducting the research, followed by privacy and confidentiality issues.

WILLINGNESS TO PARTICIPATE

CHALLENGES FOR ALL OF US AND OUR PANEL

• Move more expeditiously from lab to animal model to clinic to approvals: “My risk is advancing more rapidly than your

research”!• Use knowledge of mechanisms and animal models of human cancers both for testing carcinogenicity and for developing chemo-prevention and chemotherapy agents

CHALLENGES (cont’d)

• Be crystal clear about differences between

epidemiological “associations” and

“effects” demonstrated in randomized trials

• Engage ACS chapters and many other

stakeholders in the campaign to reduce the

incidence of human cancers and the goal of

“eliminating cancers as major health problem”

Details on March 14, 2000 laws• Newborn screening. No need for prior consent. MDCH can retain or dispose of

samples.• Employment and Health insurance benefits-non discrimination. Can not require a genetic test for employment or health insurance. Can not refuse to hire for disability or genetic information unrelated to ability to perform the duties of the job.

March 14, 2000 Laws- Cont.• Health insurance/employment: Individuals can voluntarily supply information if they wish.• DNA of Excluded suspects: Must be destroyed in presence of witness.• Paternity testing: Destroy DNA of excluded

person. Do not disclose DNA in public court file.

• Informed consent: Written consent before testing.

March 14, 2000 Consent law

• Written consent prior to pre-symptomatic

or predictive genetic testing including:

• Nature/purpose of test.

• Implications (medical/social) of the test.

• Future uses of test samples.

• Meaning of results.

• Who will have access to results.