1. Protecting Human Subjects in Clinical Trials
This issue has generated considerable debate since 1999, when 18-year-old Jesse Gelsinger died while participating in a gene therapy trial at the University of Pennsylvania.The episode prompted a great deal of soul-searching among researchers and many universities began implementing new standards as a result of the harsh spotlight that was cast on the clinical trial world.
In a 2002 article in Epidemiology Review, Jeremy Sugarman, MD, MPH, a professor of bioethics and medicine wrote, “It is critical to ensure that research is conducted responsibly throughout the entire study cycle, from the way participants are selected to the way data are entered, analyzed, and reported. Attention to each aspect of research conduct is necessary to the success of the scientific enterprise and to the protection of study participants and others from unnecessary harm.”
The issue, of course, is complicated, because patients — especially suffering patients — are willing to try something new.
Arthur L. Caplan, PhD,2 who heads the Center for Bioethics at the University of Pennsylvania, stressed in a recent interview with Biotechnology Healthcare that researchers must ensure that clinical trials are not distorted by incongruous arrangements.
2. Affordability
The rising cost of healthcare — and the cost of medications in particular — is a political hot potato and will remain so.
Governors do not seem to believe the pharmaceutical industry argument that reasearch and development are funded by today's prices. The ethical concerns are likely to get still more heated when the value of expensive biotech treatments for chronic illnesses is debated.
This may place payers and purchasers, who are already struggling with the question of how much cost sharing is appropriate, on the defensive. Insurers and employers juggle actuarial concerns with the risks of patient nonadherence and its potential for poor clinical outcomes when coverage decisions are made.
What happens when some patients can’t afford the out-of-pocket share of a given treatment?
“It’s certainly an economic issue if biologics are priced so high that some patients are priced out of the market,” says Sean Nicholson, PhD, assistant professor of policy analysis and management at Cornell University.
3. Stem Cell Research
This one shouldn’t be a surprise.It is somewhat ironic that a scientific area of research based on trials and data could be reconfigured into an emotional issue. The debate, of course, pits people who believe the research may one day find cures for diseases against others who say it violates human life.
On one side, the American Society of Clinical Oncology issued this policy statement in 1999: “Whether privately or publicly funded, researchers should be mindful of the ethical issues that may be raised when research involves embryos, fetal tissue, cloning, or other controversial questions." On the other hand, the founding statement of Do No Harm – The Coalition of Americans for Research Ethics argues: “Stem cell research promises great good and is a worthy scientific priority as long as we pursue it ethically"
4. Defending the United States Against Bioterrorism
Security is hugely important, and public fears over terrorism are unlikely to diminish. Project Bioshield also raises ethical problems, experts say. For starters, the investment will be large and probably will grow over time. “If we fund this, what are we not funding? And how do you divide the pie?” asks David Krause, MD, senior vice president of clinical research and medical affairs at Vicuron Pharmaceuticals, in King of Prussia, Pa. “And that’s just part of the problem. We don’t know if anybody will ever die from bioterrorism. We don’t know what the threat is. Can we ever predict all the possible terror threats and provide protection against them?"
On the positive side, bioterrorism research may yield the same sort of consumer-product payoff NASA research did. A subsidiary ethical issue to bioterrorism research, says Krause, is clinical testing. Human subjects couldn’t be used in smallpox trials, for instance, so surrogate markers are required. This can make it difficult to determine the effectiveness of an antiterrorism agent.
This issue has generated considerable debate since 1999, when 18-year-old Jesse Gelsinger died while participating in a gene therapy trial at the University of Pennsylvania.The episode prompted a great deal of soul-searching among researchers and many universities began implementing new standards as a result of the harsh spotlight that was cast on the clinical trial world.
In a 2002 article in Epidemiology Review, Jeremy Sugarman, MD, MPH, a professor of bioethics and medicine wrote, “It is critical to ensure that research is conducted responsibly throughout the entire study cycle, from the way participants are selected to the way data are entered, analyzed, and reported. Attention to each aspect of research conduct is necessary to the success of the scientific enterprise and to the protection of study participants and others from unnecessary harm.”
The issue, of course, is complicated, because patients — especially suffering patients — are willing to try something new.
Arthur L. Caplan, PhD,2 who heads the Center for Bioethics at the University of Pennsylvania, stressed in a recent interview with Biotechnology Healthcare that researchers must ensure that clinical trials are not distorted by incongruous arrangements.
2. Affordability
The rising cost of healthcare — and the cost of medications in particular — is a political hot potato and will remain so.
Governors do not seem to believe the pharmaceutical industry argument that reasearch and development are funded by today's prices. The ethical concerns are likely to get still more heated when the value of expensive biotech treatments for chronic illnesses is debated.
This may place payers and purchasers, who are already struggling with the question of how much cost sharing is appropriate, on the defensive. Insurers and employers juggle actuarial concerns with the risks of patient nonadherence and its potential for poor clinical outcomes when coverage decisions are made.
What happens when some patients can’t afford the out-of-pocket share of a given treatment?
“It’s certainly an economic issue if biologics are priced so high that some patients are priced out of the market,” says Sean Nicholson, PhD, assistant professor of policy analysis and management at Cornell University.
3. Stem Cell Research
This one shouldn’t be a surprise.It is somewhat ironic that a scientific area of research based on trials and data could be reconfigured into an emotional issue. The debate, of course, pits people who believe the research may one day find cures for diseases against others who say it violates human life.
On one side, the American Society of Clinical Oncology issued this policy statement in 1999: “Whether privately or publicly funded, researchers should be mindful of the ethical issues that may be raised when research involves embryos, fetal tissue, cloning, or other controversial questions." On the other hand, the founding statement of Do No Harm – The Coalition of Americans for Research Ethics argues: “Stem cell research promises great good and is a worthy scientific priority as long as we pursue it ethically"
4. Defending the United States Against Bioterrorism
Security is hugely important, and public fears over terrorism are unlikely to diminish. Project Bioshield also raises ethical problems, experts say. For starters, the investment will be large and probably will grow over time. “If we fund this, what are we not funding? And how do you divide the pie?” asks David Krause, MD, senior vice president of clinical research and medical affairs at Vicuron Pharmaceuticals, in King of Prussia, Pa. “And that’s just part of the problem. We don’t know if anybody will ever die from bioterrorism. We don’t know what the threat is. Can we ever predict all the possible terror threats and provide protection against them?"
On the positive side, bioterrorism research may yield the same sort of consumer-product payoff NASA research did. A subsidiary ethical issue to bioterrorism research, says Krause, is clinical testing. Human subjects couldn’t be used in smallpox trials, for instance, so surrogate markers are required. This can make it difficult to determine the effectiveness of an antiterrorism agent.