Roth Stein
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ETHICAL ISSUES IN PERSONALIZED MEDICINE Mark A. Rothstein, J.D. Herbert F. Boehl Chair of Law and Medicine Director, Institute for Bioethics, Health Policy and Law University of Louisville School of Medicine
A. B. C. D.
Research Ethics Access Issues Race and Ethnicity Personalized Medicine and Privacy
A. Research Ethics 1. Biobanks • • • •
Consent / authorization Confidentiality Intellectual property Benefit sharing
2. Selecting drug targets • Demographic profiles R & D for new pharmaceuticals costs millions (sometimes tens or even hundreds of millions of dollars).
Before committing these resources, any biotech or pharma company would want to know whether they could expect to recoup those costs – and to do that they would need to know the demographic profile of people with the genotype of interest.
• Orphan genotypes
A related issue is simply the number of individuals with a certain genotype. If it’s sufficiently rare, then it would not be cost-effective to develop meds specifically targeted for this group.
The Orphan Drug Act of 1983 defines an “orphan drug” as one affecting fewer than 200,000 persons in the U.S., and it gives incentives (e.g., tax incentives) to companies to develop drugs for these diseases. Should there be comparable legislation for “orphan genotypes”?
B.
Access Issues 1. Health disparities Pharmacogenomics, by definition, means spending (at least at the R & D stage, and perhaps much longer) more health care resources on one or more segments of the population.
• Is it ethical to do so when much of the world lacks basic sanitation, immunization, and “common” medications? • Is it ethical to do so when nearly 50 million Americans are uninsured? • Could pharmacogenmics increase overall spending on drugs to the point where more people will actually become uninsured?
2. Payment systems How will payers decide whether to cover pharmacogenomic-based medications? • Diagnosis and prognosis • Relative safety, efficacy, and cost
Will pharmacogenomics lead to increased stratification or “tiering” of health care in the U.S. between private and public payers and based on the nature of an individual’s health insurance?
C. Clinical Issues 1. Burdens on the health care system • Education and continuing education for physicians, nurses, pharmacists, et al. • More genetic testing, more genetic counseling, more patient education • Who has the time? Who will pay?
2. Pressures for adoption of pharmacogenomics • Liability avoidance • Patient demand (including DTC advertising)
D. Race and Ethnicity 1. BiDil
Ethical Issues Raised by BiDil BiDil is a combination of 2 drugs that have been available in genetic form for decades: hydralazine and isosorbide (nitroglycerin). It was postulated that this combination of drugs would benefit individuals with endstage cardiovascular disease.
In 1997, the FDA rejected the drug after a trial in a mixed race group, although a subgroup of African American subjects appeared to show benefit. Medco then sold its rights to BiDil to Nitromed, Inc.
African Americans are more likely than White Americans to have decreased levels of nitric oxide, and BiDil is a nitric oxide enhancer. This was the biological hypothesis for an improved outcome in this subpopulation.
Nitromed joined with the Association of Black Cardiologists to sponsor the African American Heart Failure Trial, which involved 1,000 patients at 170 sites. On July 19, 2004, the trial was halted because of the significant success of patients enrolled in the treatment arm of the trial.
Results: 43% improvement in survival and 33% reduction in first hospitalization. A patent was issued for BiDil on August 31, 2004.
On December 23, 2004, a new drug application was submitted to the FDA in which approval was sought only for African American patients. Approval was granted on June 23, 2005 only for self-identified African Americans.
Why has BiDil been a commercial failure? • Substitution by physicians? • Rejection by patients?
2.
The importance of public education and public trust
E. Personalized Medicine and Privacy 1. Generating genetic information 2. Commercial personal health records (PHRs) • Not covered by HIPAA • Bankruptcy Issues
A. B. C. D.
Research Ethics Access Issues Race and Ethnicity Personalized Medicine and Privacy
A. Research Ethics 1. Biobanks • • • •
Consent / authorization Confidentiality Intellectual property Benefit sharing
2. Selecting drug targets • Demographic profiles R & D for new pharmaceuticals costs millions (sometimes tens or even hundreds of millions of dollars).
Before committing these resources, any biotech or pharma company would want to know whether they could expect to recoup those costs – and to do that they would need to know the demographic profile of people with the genotype of interest.
• Orphan genotypes
A related issue is simply the number of individuals with a certain genotype. If it’s sufficiently rare, then it would not be cost-effective to develop meds specifically targeted for this group.
The Orphan Drug Act of 1983 defines an “orphan drug” as one affecting fewer than 200,000 persons in the U.S., and it gives incentives (e.g., tax incentives) to companies to develop drugs for these diseases. Should there be comparable legislation for “orphan genotypes”?
B.
Access Issues 1. Health disparities Pharmacogenomics, by definition, means spending (at least at the R & D stage, and perhaps much longer) more health care resources on one or more segments of the population.
• Is it ethical to do so when much of the world lacks basic sanitation, immunization, and “common” medications? • Is it ethical to do so when nearly 50 million Americans are uninsured? • Could pharmacogenmics increase overall spending on drugs to the point where more people will actually become uninsured?
2. Payment systems How will payers decide whether to cover pharmacogenomic-based medications? • Diagnosis and prognosis • Relative safety, efficacy, and cost
Will pharmacogenomics lead to increased stratification or “tiering” of health care in the U.S. between private and public payers and based on the nature of an individual’s health insurance?
C. Clinical Issues 1. Burdens on the health care system • Education and continuing education for physicians, nurses, pharmacists, et al. • More genetic testing, more genetic counseling, more patient education • Who has the time? Who will pay?
2. Pressures for adoption of pharmacogenomics • Liability avoidance • Patient demand (including DTC advertising)
D. Race and Ethnicity 1. BiDil
Ethical Issues Raised by BiDil BiDil is a combination of 2 drugs that have been available in genetic form for decades: hydralazine and isosorbide (nitroglycerin). It was postulated that this combination of drugs would benefit individuals with endstage cardiovascular disease.
In 1997, the FDA rejected the drug after a trial in a mixed race group, although a subgroup of African American subjects appeared to show benefit. Medco then sold its rights to BiDil to Nitromed, Inc.
African Americans are more likely than White Americans to have decreased levels of nitric oxide, and BiDil is a nitric oxide enhancer. This was the biological hypothesis for an improved outcome in this subpopulation.
Nitromed joined with the Association of Black Cardiologists to sponsor the African American Heart Failure Trial, which involved 1,000 patients at 170 sites. On July 19, 2004, the trial was halted because of the significant success of patients enrolled in the treatment arm of the trial.
Results: 43% improvement in survival and 33% reduction in first hospitalization. A patent was issued for BiDil on August 31, 2004.
On December 23, 2004, a new drug application was submitted to the FDA in which approval was sought only for African American patients. Approval was granted on June 23, 2005 only for self-identified African Americans.
Why has BiDil been a commercial failure? • Substitution by physicians? • Rejection by patients?
2.
The importance of public education and public trust
E. Personalized Medicine and Privacy 1. Generating genetic information 2. Commercial personal health records (PHRs) • Not covered by HIPAA • Bankruptcy Issues
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