Ethics and Values in Biotech

Transcription

1 Ethics and Values in Biotech Thane Kreiner, Ph.D. Senior Vice President, Corporate Affairs Affymetrix The Promise of Genetics Public Perceptions

2 The Genome is Complex 3 B base pairs Only ~1.5% of genome encodes ~30,000 genes Millions of differences between any two people Much unknown about dark matter of genome All Disease is a Result of Genes Interacting with the Environment Exercise Diet Drugs Genetics Tay-Sachs Cystic Fibrosis Environment Diabetes HIV / AIDS Lead Toxicity Cancer Heart Disease Infectious Disease Lifestyle Choices Exposures

3 Packaging Genetic Information 5 * * * * * * 5µm 5µm Millions of identical probes / feature 5 chips / wafer 1.28cm Up to ~6,500,000 features / chip 1.28cm Information Capacity is Exploding Information Capacity Cost 3

4 Clinical Applications of Microarrays Pharmacogenetic testing: CYP450 Example: Roche AmpliChipTM Companion diagnostics: determine safety and efficacy Example: Herceptin Future? Combined use array: symptom & treatment decisions Diagnosis Disease Therapeutic Classification Choice Prognosis Applications of Genetics Technology Livestock diagnostics or grading Environmental testing Identity testing Food testing Human diagnostics Agricultural biotech Basic Research Personalized medicine 4

5 Why Care About Ethics in Biomedical Science? Research and clinical applications are often: High visibility High expectation High potential revenue Lacking policy and precedent Tied to moral values of society Why does business care about ethics? Want to do the right thing Public perceptions and acceptance ultimately affect bottom line Companies, Healthcare & Society healthcare providers have a direct effect upon the lives of people in the societies they operate in, and consequently their activities are subject to understandable scrutiny The pharmaceutical industry is founded on trust, and we must preserve and encourage trust at all times - Liz MacGillivray, Novartis Pharma

6 Corporate Social Responsibility CSR Issues Stakeholder involvement Supply chain management Issues of access Expanded Responsibilities? Actively encouraging broad discussion about social issues Pursuing self-regulation when appropriate Examination of product use issues Ethical Questions Gene Patenting: Should one firm own the rights to research and development on this gene? Ability to control access Ability to control price Marketing: should genetic tests be marketed directly to the public?

7 Example: The BRCA Case BRCA1 Gene, implicated in some hereditary breast cancers, discovered by Mary Claire King in 1990 Research done by Francis Collins to understand mutations related to breast cancer Patents granted to a single firm Test available using common laboratory equipment through a single source for ~$2400 Example: Gene Patenting The SARS Genome: Who Owns It?

8 No One Should Own the Genome Some things should not be patentable: Periodic table of elements Anatomy maps Cell structure No one should own the genome Can t invent around a gene Many diseases are caused by interactions of multiple genes and the environment Gene patents slow access to tests & treatments Active Ethics: Currently exploring concept of gene patent pooling allows all researchers access to genetic information for reasonable access fee DTC Marketing of Health Products Pharmaceutical Marketing $2.8B in 2001 Appears to influence consumer opinions and physician prescribing 33% have asked their doctor (Weissman et al, Health Affairs, 2003) Genetic Test Marketing Range of sources, largely web-based Ads attempt to simplify complex issues and diseases Focus on themes: Powerful hope for better health Desire for control over health care options Motivation to relieve fear

9 Is it Appropriate to Market Hereditary Breast Cancer Testing to the Public? American women estimate there is a 40% chance they will get breast cancer, when in fact their overall risk is less than 10% The CDC recommends hereditary breast cancer testing for <1% of population No special treatment currently exists for women who pre-symptomatically test positive for BRCA1 and BRCA2 Harris Poll #7, Jan 27, ~1000 adults > age 18 Complicated Social Context Makes Marketing Ethically Challenging Challenges: Fears about genetics Heightened expectations about genetics Risk information is difficult to understand Tempting to oversimplify issues Does the healthcare industry have a greater obligation to consider these issues from an ethics perspective?

10 The Promise of Genetics Hype vs. Hope? 2001 Harris Poll Survey (US): 84% Americans believe genomics research will have a positive impact improvements in detection and treatment of disease Improvements in the quality and length of life 45% concerned that genetic information will be misused Harris Poll Public Awareness in the Age of Genomics. ~1000 adults > age 18 Words Matter Genetics evokes feelings of permanence, accuracy and destiny Often tied to the moral values of society Public perceptions are critical to understanding moral and ethical issues for businesses

11 Genetic Discrimination Example: Burlington Northern 2000: Burlington Northern began secret genetic testing of its workforce The railroad hoped to prove a pre-existing condition, thus reducing their workers compensation costs. The EEOC sued for discrimination based upon predictive genetic testing 2002: Case settled with Burlington Northern paying $2.2 million to the workers Genetic Privacy & Non-discrimination 2002 Harris Poll Survey (US): Who should have access to your genetic information? 17% employers 25% life insurance 39% health insurance Affymetrix advocates for privacy & nondiscrimination protection Insurance Employment Important for public to be comfortable with genetics and genetics research Harris Poll #26, June 5, ~1000 adults > age 18

12 Status of Federal Nondiscrimination Bill Genetic Non-Discrimination legislation Non-discrimination in health insurance Non-discrimination in employment Senate: has passed Senate twice Current bill, S306 Passed 98-0 House: has not been brought to a vote HR 1227 Ethics at Affymetrix Social Initiatives Genetic Age Symposium series is designed to reach the general public, focused primarily on policy issues ( Internal Initiatives Ongoing Ethics Speaker Series designed to encourage employees to think about ethical ramifications of their work, to de-mystify ethics and make it accessible Policy Initiatives In favor of Federal genetic non-discrimination legislation Against the patenting of naturally occurring gene sequences Ethics Advisory Committee

13 Affymetrix Ethics Advisory Committee Formed in March, 1997 to understand how technology can best be used Genetic Counselor Biochemist (Nobel Laureate) No approval or veto advisory role Diversity of experience and opinion Sociology Professor Ethics Advisory Committee Former Ethics Center Director No conflicts of interest Advisor names kept confidential no PR Physician Formerly on NBAC Law School Professor EAC: Logistical Issues Minimize conflicts of interest Payment Discussed at formation of EAC Paid going rate for consultants to cover their time 2 accept payment, 3 do not, 1 donates funds to charity Personnel Changes 2 members stepped down, 1 addition handled case-by-case Confidentiality Advisors are asked to sign a non-disclosure agreement Do not want to inhibit ongoing research or publications; handled case-by-case

14 Discussion Topics Any department can bring topics (research, EH&S, legal, collaborations, commercial team) Two main categories: Broad topics including ethics positions, company responsibility and informed consent Specific topics including contract language, product development and collaborations Common Topics: Corporate vs. social responsibility how responsible should we be for our customers use of our products? Moving genomics to the clinic what issues matter in the healthcare realm? What type of PR is appropriate? EAC Output: Ethical Framework Custom Generic Product Use Employment or Insurance Discrimination Non Human Research Participant Market Position Monopolist Based on the analysis of ethical responsibility, the corporation has a number of possible actions: Put limitations on use of chips Make recommendations Encourage state or federal legislation Avoid market entirely Do nothing

15 Example Use Employment or Insurance Discrimination Non Human Research Generic Participant Market Position Monopolist Hypothetical Example: Universally applicable product for research on chickens Product Custom Low need for ethical concern Examples Potential for misuse increases ethical burden Use Employment or Insurance Discrimination Non Human Research Market Position Generic Participant Monopolist Product Hypothetical Example: Test for predisposition to late-onset disease, similar to other tests on market Custom Presence of competition lessens ethical burden

16 Example? Public good { Generic Product Use Employment or Insurance Discrimination Non Human Research Participant Market Position Hypothetical Example Low cost smallpox test, only offered by Affymetrix Monopolist Custom Custom product increases ethical burden No competition increases ethical burden Real Life Example Potential Diagnostic company wants to offer ethnically targeted genetic testing for couples and potentially children Single diagnostic product to allow comprehensive diagnosis of ~70 disorders (Carrier frequency above 1:200) Will include regions of that gene that are known or may contain potential mutation hot spots, functional or structural domains

17 High Ethical Concern Use Employment or Insurance Discrimination Generic Product Non Human Research Participant Market Position Monopolist Custom Example Discussion: Questions Content Do we have a responsibility to examine which disorders are included? What if IQ gene was included in list? Quality Do we have a responsibility to curate content (i.e. which polymorphisms are included)? Legal What if we suspect content is in violation of existing IP?

18 Ethical Analysis: Actions Based on the analysis of ethical responsibility, the corporation has a number of possible actions: Put limitations on use of chips Make recommendations Encourage state or federal legislation Avoid market entirely Do nothing Ethics Informs Policy Affymetrix strives to be: Informed Involved Influential In front Logical outgrowth of company s commitment to examining ethical issues Policy important to company s future business objectives Divergence of interests with industry associations

19 Conclusions Social contract and public perceptions matter and may obligate extra work on the part of the corporation Compliance framework alone will not work There are often no regulations or precedents Ethics may compel you to lobby for regulation of your own industry Questions