Please read this article very carefully and substitute the "word vaccine in the place of chemical now". I guess Thimersol in vaccines? qualifies as a chemical?!
>>Genes, chemicals and the law make a heady brew
3 December 2001 17:00 EST
by Tabitha M. Powledge,
Rapidly accumulating information on how individuals respond to chemicals - "natural" and otherwise - appears likely to have a big impact on both tort law and regulatory policy. As a meeting on gene expression and proteomics in environmental health research opened today at the US National Institutes of Health, law and ethics were high on the agenda.
At most scientific meetings, they are relegated to the end when everyone is rushing for the airport, observed Gary Marchant, who is an associate professor at Arizona State University College of Law in Tempe. He said he appreciated being in the middle of the agenda for a change, as he informed scientists about the impact they can expect from the emerging field of toxicogenomics.
It could make life much easier for plaintiffs, Marchant noted. Courts have generally ruled that they must show not just that a chemical causes bodily damage, but that it causes the specific sort of damage a plaintiff exhibits and that the damage results from that specific chemical, not a related one.
Courts may be more willing to accept a link between a chemical and a particular tumor, he predicts, if microarray studies show that gene expression patterns in that tumor tissue are similar to a different cancer known to be caused by the chemical, or by a related cancer-causing chemical. Another potential hurdle is demonstrating and quantifying exposure; gene expression data could help with that too, he said.
But gene chips could be an equally powerful legal tool for defendants, he speculated, if they show that gene expression patterns differ between two cancers or between two supposedly similar chemicals.
Gene expression data might also spare employers from liability if they are used as an early warning system, identifying potentially harmful physiological changes in time to prevent harm. However, susceptibility genes will also find their way into the courtroom eventually, Marchant forecast, raising questions about whether a manufacturer has a duty to warn potential users that a product could be toxic to some of them, or even to test for susceptibility before sending a product to market. On the other hand, based on recent case law such a defendant could argue successfully that susceptible individuals are atypical, and that a manufacturer is under no legal obligation to protect users against abnormal reactions.
In the courts, there will be pressure to use new tests as soon as they are available but before they are validated, Marchant observed. Regulators may be more careful about embracing new tests, but microarrays and other tools of toxicogenomics may help bring back assessment of individual risks as a way to regulate toxic substances, he speculated. The effects could be dramatic - incredibly expensive, but perhaps carrying real health benefits.
"As lawyers," Marchant concluded cheerfully, "we're looking forward to the science you develop."
Most moral and legal issues emerging from toxicogenomics are the same as those that have arisen from other kinds of genetic testing over the last two decades, observed bioethicist Mark Rothstein, who is chairman of law and medicine at the University of Louisville School of Medicine. What is new is that science finally is beginning to generate the tests that will bring issues of privacy and non-discrimination into the real world, and force people to decide them.
The Americans with Disabilities Act (ADA) makes no mention of genetics, and Rothstein says he doubts *****susceptibility genes will have a big impact on its anti-discrimination provisions. Is someone currently asymptomatic covered under the ADA? No court has yet grappled with that issue, but Rothstein suspects the eventual answer would be "no."
When is it lawful for an employer to refuse to assign someone to a job - for example, someone susceptible to a chemical that is a normal part of the work environment?
Congress says an employer can refuse to hire someone who is a threat to others, but it's not yet clear whether employment can also be denied to someone who might be a threat to his own health. The issue is presently being litigated, Rothstein said, and the Supreme Court will eventually issue a ruling>>.
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