Advances in Genetics Outpace Public Policy

Advances in Genetics Outpace Public Policy

NewsMax.com Wires
Friday, March 30, 2001

WASHINGTON (UPI) – Researchers are on the verge of a technological revolution in interpreting the genetics of human disease, but public policy lags far behind the progress, two leading geneticists said Thursday.

"Within this century I believe we will understand the molecular mechanism of most diseases. But we need to be systematic in our application of this information, and that will require rules. policies and guidelines that have yet to be developed," said Dr. Eric Lander, director of Whitehead Center for Genome Sciences in Boston.

Addressing a gathering of 200 public and private sector policy analysts, Lander, one of the leaders of the Human Genome Project, said basic societal questions had yet to be addressed by lawmakers.

For example, "Does the public have the right to know your genotype?" he asked, noting that anyone born after 1960 is already part of a DNA database, genetic information from infant blood tests.

"Our DNA material is available whenever we touch a napkin to our lips and leave it in public. Like it or not."

With the human genome in hand, scientists are poised to discover new disease genes, identify new drugs, and develop therapies custom-tailored to fit patients' genetic profiles, said Lander.

However, first they must build new tools – the next generation of DNA chips, cell and protein arrays and bioinformatic programs – to help fulfill the promise of the human genome. None of this will be possible without policy direction, he told a briefing sponsored by the Center for Strategic and International Studies.

By way of illustrating the scale at which the genetic revolution is taking place, Dr. Phillip Reilly, CEO of Boston-based Interleukin Genetics, held up a glass of water.

"All of the sperm cells that helped create every person that ever lived, 10 billion or so human beings, would fit in this glass," he said. Holding up a water pitcher next, Reilly continued, "In this pitcher would fit all of the tiny, glorious eggs that have created all people – from the beginning."

Although researchers are setting out toward the frontiers of genetic discovery, they are working with a small world with huge potential, the researchers said.

"The boundaries of DNA research are being pushed all the time, but privacy protections don't exist yet for the individual," Reilly said. "Yet in just a few years, it will be impossible to differentiate genetic information from medical information on a patient's chart."

For genetic research to proceed in a positive direction, there need to be strict policies in place, especially with regard to medical privacy issues, Reilly and Lander agreed.

But there are also commercial questions that need legal answers, especially with regard to patents based on new genetic findings, he said.

"Some lawyers have already filed for patents on entire sequences of molecules," Lander noted. If they succeed – and there few laws to stop them – it will block all "me too" drugs based on that information, effectively blocking any new competition, he explained.

Perhaps even more disturbing is the example in Europe of the public's growing opposition to any genomic science, based on general opposition to genetically modified foods, he continued.

"We've seen what happens when you lose the public's trust. That's why this genetics revolution needs clear policy guidance."

The need to protect an individual's genetic privacy and doctor-patient confidentiality on genetic information goes "far beyond" the individual, added Reilly.

"I think we're moving towards a world where physicians have the right, but not the obligation, to share genetic information with a third party," he said.

"If I slipped and fell and hurt myself, for instance, that information would not pose much of a risk for my brother. But if I develop a type of colon cancer we know is prevalent with a certain dominant gene, and there's a one-in-two chance my brother also has this gene, should my doctor share this information?

"Right now there are few rules or guidelines about sharing sensitive genetic medical information. And there needs to be."

Insurance companies are not waiting for guidelines or regulations, he noted, but are already testing the use of genetic profiling to deny coverage. For instance, he said, some insurers would deny coverage to elderly people with a gene associated with an increased risk of Alzheimer's disease.

"I've already been called by two insurance companies who are considering this," Reilly said.

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