One potential weakness, however, is patient and physician education. Companies developing personalized medicine tools must therefore play a more active role to address the public perception issues that intersect with pharmacogenomics technologies lest they risk hampering their market, according to industry insiders.
"None of this is going to be successful if the public is afraid to use it," Francis Collins, director of the National Human Genome Research Institute, said at Scientific American's Targeted Medicine conference, held here last week. He emphasized this point several times during the conference. After indicating that the Human Cancer Genome project could drive new sequencing technologies, and vice versa, he pointed out that the success of the project largely hinges on public affairs.
It's been widely said that the ability to sequence an individual genome cost-effectively could enable health care professionals to tailor diagnoses, treatments, and preventative steps to each person's unique genetic profile. But people who are worried about the release of their genetic information coming back to haunt them are likely to shun this emerging market.
To avoid this, Collins said, those involved in the personalized medicine research market must keep their eye on relevant legislation and regulation issues.
"In 2005, we have not yet passed effective federal legislation to prevent genetic discrimination in health insurance and the workplace, despite numerous studies indicating that this is really the only effective solution ... [and] despite numerous surveys indicating that the public is deeply concerned about this," said Collins. He pointed out that fears about genetic privacy "is a major deterrent for participation in research."
In addition, a 2003 study on hereditary colon cancer showed that 39 percent of participants identified the potential effect on their health insurance as the most important reason behind their decision not to undergo genetic testing. Many at the Targeted Medicine conference said there is a need to help the public understand these technologies.
"What does this mean from an end user approach?" said Brian Meltzer, director of strategy integration at Johnson and Johnson Development Coordination. "How are we going to use these tests? The responsibility falls on us to bring that evidence out -- the value for the future."
There is some evidence that the tide may be turning in the United States.
Last February, a bill (S. 306) that would prohibit discrimination on the basis of genetic information with respect to health insurance and employment passed in the Senate. Its companion bill, H.R. 1227, which was introduced last February by the House of Representatives, is still working its way through committee. The future of this bill, however, is uncertain. Currently, the Chamber of Commerce and the National Association of Manufacturers are actively lobbying against H.R. 1227, and Collins pointed out that a similar bill died in the 108th Congress, which ended in January.
"If we are worried about roadblocks and this certainly could be one, this is something we ought to try to fix," Collins said.
Fears about genetic testing are fueled by several factors, including publicized cases such as the one involving the Burlington Northern and Santa Fe Railway Company. This company allegedly performed genetic tests on its employees without their knowledge or consent, according to the US Equal Employment Opportunity Commission. The group, which sued the company in 2001 for allegedly violating the Americans with Disabilities Act, claimed that the railroad tried to use genetic tests to prove that certain employee injuries were caused by genetic conditions. The company settled for $2.2 million a year later.
According to Harriet Pearson, vice president of corporate affairs and chief privacy officer for IBM, if you look globally, few laws address genetic privacy issues. In
Thirty seven states, she said, have laws that address some aspect of genetic discrimination and privacy issues. The reach and power of these, however, is varied. For this reason, in October, IBM changed its employment policy to include a promise not to discriminate based on genetics. The policy is believed to be the first of its kind for a major corporation. "One company doesn't do much, but raising the profile of an issue," said Pearson.
Collins says IBM's move is a step in the right direction. "If all of the companies here would follow the lead of IBM, that would make a very strong statement," Collins said. "None of [the medical advances heralded by pharmacogenomics and new sequencing technologies] is going to happen unless we keep our eyes carefully on important policy issues that are still not resolved," Collins said.
Kate O'Rourke covers the next-generation genome-sequencing market for GenomeWeb News. E-mail her at [email protected].