Candice Player
From Cyberlaw
Outsourcing Clinical Trials to India
Late Sunday into early March 06 2006
Last week I heard a great segment on NPR about outsourcing clinical trials to India. http://www.npr.org/templates/story/story.php?storyId=3850929 Among the many issues presented, one of the toughest seems to be that while the influx of money might be good for India as a country, experiments testing the efficacy of stroke treatments are of little use in a place where most people suffer from malaria and snake bites. Further patients are much more deferential to their doctors than internet and med. research savvy Americans. As the reporter noted, most patients recruited for trials are poor and uneducated and therefore at a disadvantage when it comes to asking tough questions. This question strikes me as a fascinating topic and one I’d like to write up in a final paper. I also wonder whether we might be able to workshop papers on the wiki.
Does anyone know anything about FDA regulations re: foreign clinical trials??
Interactive Biotech Conference: Ames Courtroom
Tuesday, March 07, 2006
Opening remarks from Larry Summers in NYC • since coming to Harvard, Summers has been guided by the conviction that what is happening in the life sciences will be in the history books 500 years from now • at the same time science is too important to leave to scientists. the transformational effects of these discoveries require scrutiny by all us. • science needs to be part of the curriculum review.
Miller: let’s make believe that we are in a hypothetical world. Miller directs David Altshuler to imagine that he is the CEO of Gizmo Inc. which has established a policy in connection with its insurer that people who do not smoke get a break on their premium. Miler plays the employee of Gizmo. He (Miller) is a chain smoker who runs into David in the hallway. Miller knows that he is disliked by society, but there are certain genes that promote smoking in certain individuals, perhaps even five times the likelihood of becoming a chain smoker. Miller notes that David would not charge him more if he had a weak heart.
Altshuler: the key issue is whether the gene makes you less responsible for your behavior and Altshuler proposes that they do not.
Steven Hyman jumps in: there are genetic vulnerabilities involved in smorking or drinking but genes are not fate. by creating strong incentives to smoke, people can stop smoking. which is a benefit to the employee.
Miller: Hyman sounds like a high school football coach.
Altshuler: Is there a line that Hyman would propose between that which is controlled by
genes and behavior?
Hyman: we have to make certain social decisions. as a public health matter, and despite our admittedly paternalistic stance toward the employee, we want to create disincentives.
Dan Brock: (prof. department of social medicine, division of medical ethics) wonders whether employee is being treated fairly given that he has a gene. it is unfair to penalize him for something that it is hard for him to do.
Hyman: uterine lottery is generally not fair. but the company has made decisions
Altshuler: questions why we are introducing fairness at this point when all along success has
to do with merit….why not poke around in other aspects of DNA?? to minimize
other aspects of cost. why stop at observable behavior.
Miller: let’s move this along. suppose that research has been done. turns out that the core research has been done in a south American country called Gadamia where there is a high incidence of smoking and the people of this country have the genes to a much higher degree than others. There are those that don’t like Gadmians.
Miller directs Brock to think as a Gadamian
Brock: feels that he has suffered a disadvantage and wonders why this research is being done? Does it help to ameliorate health problems? or does it reinforce stigmas that will be harmful?
George ??: would expect that proceeds of the research should go back to Gadamia
Deborah. Spar: proposes a corporation that would market the genetic information of Gadamians. who will be protected through encryption and consent; drug discoveries will be delivered at cost to the Gadamians. we don’t do stereotyping
Miller: good news. research has produced a medication that reduces smoking. turns out
though that the medication has another effect. medication is called prevail. it has
the ability to make the people more effective in dealing with other people.
George is to imagine that he is going on his first date with the woman of his dreams. George knows that he is sort of awkward with people (laughter from the crowd).
George: sure he would take the prevail, but he wonders about the side effects. Will it make his skin fall off?
Debroah is to imagine that she is the girl of our dreams. Does she want to know whether he is taking the Prevail?
Debroah: she might want to know overtime, but not sure whether she would toss him out if it worked.
Sandel: asks whether we always want to prevail in our arguments with children and colleagues. something might be lost
What if you have to take prevail to work at a law firm? Sandel would not hire a lawyer from that firm.
What if prevail is a powerful anti-psychotic? Do we feel differently if the person at the law firm was schizophrenic and now able to practice law? Sandel says of course, but the line is between a medical and non medical use.
Miller: suppose you (Altshuler) have a 7 year old child who is
not doing well in the classroom. in part because the other kids think that he is weirdo. prevail can go a long way toward making that child acceptable to his or her peers.
Althsuler would not want to use Prevail because he would want to determine whether the child can outgrow it. but what if the child had a risk factor caused by a genetic defect. In that case Altshuler would feel differently.
A problem might arise if a kid decided that he just wanted to be himself, but everyone one else is “improved” on drugs.
Consider Huck Finn. What would happen if we put him on Retilin to treat his ADHD.
Miller: let’s go to the future in our hypothetical world. I stand before you as someone
who is convinced about this genetic stuff. my wife and I want to have children,
but we might want to do IVF and preimplantation genetic diagnosis (PGD)
Spar: PGD allows parents to determine whether an embryo is at risk for diseases; as well as gender, and perhaps in the future height hair color. Is there a problem with wanting to determine gender?
private decisions have potential to become public issues. When parents are given options to choose, we come into trouble when people try to give their children more desirable characteristics than they have -- to make their children prettier, or smarter than they are.
we should watch the genders people choose and then decide. presently in the U.S. people tend to choose girls over boys.
Brock: there is nothing wrong with wanting to balance a family with one boy and one girl; but if we are playing into a discriminatory practice, then there is a problem.
Hyman: there is nothing wrong with preventing suffering, but gender is not a disease. picking and choosing is like shopping for cars. But suppose you don’t get the hair color you ordered. Is there a money back guarantee?
Would it be acceptable to have surgery to change the sex of a newborn to get the sex you have ordered? (Brock claims that a newborn has moral claims.) change then to a 9month fetus just about to be born.
Spar: Parents should be able to choose not to have a deaf child. what if a deaf parent wanted a child who was deaf ? Spar proposes that this needs to be subject to a messy political process.
Miller: As parents we believe that homosexuality would make life difficult for the child though we have nothing against homosexuals
Brock: proposes that we need a distinction between truly serious disadvantages, and lesser disadvantages i.e things that people have to learn to live with.
Hyman: the more power we have to manipulate genes to fit each other and us and them, the less time we spend trying to fix the world.
Questions from the audience
• what if our hypothetical Gadamians do not have an understanding of what a gene is? How do we connect the pace of science and the understanding of science by society?
o Brock: some will not be able to provide informed consent. However, one does not have to have a PhD to understand how participation or failure to participate effects the things that are important to me in my life
• What about diseases that confer benefits? Sickle cell is thought to be protective against malaria? Are we playing God? Aren’t there things that we can learn from people who have disabling diseases?
o Altshuler: many genetic variations will persist in the population because they have other benefits.
• Aren’t we degrading human life by choosing some parts over the other? What is human at that point once we have pieced these parts together?
o Hyman: cutting open a body to repair an organ was seen as trespassing upon God’s role. For that matter agriculture, pricking the earth, to make it produce what it would not produce on its own is also taking on God’s role. but we might think of ourselves as being partners with God to understand how nature works for the benefit of health but not for other enhancements
• What if we cure diseases by eliminating their genetic causes? The transition period would be a rough time. in that the rich will have and eventually the poor will as well. but what about the one in a million case where a person still has the disease? pharamaceutical companies will not invest in treating the diease.
o NIH has an orphan drug program to create research where the economic incentives will not move the pharmaceutical companies • if genetic treatments have reduced 99% of disease, perhaps that is the best way to go rather than investment through the pharama companies
The committee seemed to suggest that society should come together and create a set of rules. Is that really going to happen?
• Spar proposes that we don’t actually have a better choice • Brock notes that we still have to figure out what should be left to parents. • Sandel notes that legislative solutions tend to be sledge hammers
What about the evolutionary problems presented by genetic conformity (the consequence of narrowing the gene pool)?
