Scientists worry about promises

by Carolyn Y. Johnson

Whether it is a new skin care product that promises to "reactivate" the youth in your genes or tests that offer nutrition advice tailored to your DNA, the age of consumer genetics is here.

Lancome is selling "Genifique," a skin serum developed by identifying genes more active in young skin. Procter & Gamble, the world's largest consumer products company, has been investigating the genetics of everything from dandruff to the common cold. Startups are offering consumers full-genome scans and more targeted genetic tests to customize advice on weight loss or heart health.

But as genetics spreads beyond the lab, scientists worry that companies are making overblown promises before the science is mature enough to meet public expectations - and that this could spark a backlash. It is one thing, they say, for scientists to study the role of genes in illness or aging. But it is another to give directly to consumers information about genes that might raise risk for a disease in poorly-understood ways, or to offer an effective product that makes genetic claims.

"What has happened is some of these companies have cribbed from our sheets about where we hope to be going, and they've turned that into their business plans for where we are now," said Dr. Isaac Kohane, a Harvard Medical School professor. "It does hurt us. . . . All you need is sufficient disappointing, if not dangerous, outcomes or horrible outcomes for enthusiasm for funding . . . to decrease."

The companies, on the other hand, contend that even if much of the complexity of genetics continues to be worked out in labs, enough is already known that they are providing valuable information to customers.

"It's an early science; it's in flux, it's changing . . . and I think that's the context by which people have to understand consumer genetics - this is something that's in the process of evolution, but that doesn't mean there isn't utility," said Lew Bender, chief executive of Interleukin Genetics, a Waltham company developing genetic tests for consumers.

The disconnect stems partly from ordinary people's expectations of genetics, which have been set by the powerful - but often oversimplified - idea they learned in high school that inherited genes determine traits such as blood type or eye color and that a single errant gene could be the culprit for a disease, such as cystic fibrosis or Huntington's disease. Such clear-cut examples of the power of genetics do not exist in most diseases, or complex phenomena like aging, where a confusing stew of genetic, lifestyle, and environmental factors seems to play a role.

Most of the genes or snippets of DNA that have so far been linked to diseases confer a small, or hard-to-interpret amount of risk for a disease. Dr. W. Gregory Feero, chief of the genomic healthcare branch at the National Human Genome Research Institute, said he is concerned that consumers' initial introduction to genetics could come in tests that find genes associated with a disease, but might worry them unnecessarily or give them a sense of false security.

"There's likely to be this sort of let-down about how useful this information is in the near term."

As a sign of genetics' arrival in the marketplace, the first Consumer Genetics Show will land in Boston in June. With panels of doctors and scientists as well as presentations on emerging technologies, it is a forum for establishing and questioning the field's legitimacy. Sessions include not only intellectual property and investment in such companies, but also, "Is the science ready yet?" and "Personal Genetics - is it Really Here?"

That time is here for Gayle Averyt, a 75-year-old from South Carolina who got a slate of genetic tests a few years ago during a visit to the upscale Berkshires resort Canyon Ranch. Averyt was determined to peer into his genome, but felt ill-equipped to interpret the results himself, so he was pleased that his longtime doctor at the resort went through the data with him.

"My intent was to find a doctor who could interpret the gene," said Averyt, who was told he has 15 times more risk for Alzheimer's disease because of his genes. Under the advice of the doctor, Averyt has changed his lifestyle to try and decrease his risk for the disease.

One of the companies betting that consumers will pay to figure out genetics themselves is Interleukin Genetics, which plans to next month launch a slate of tests that it says will give consumers a sense of their health through their genes. A nutritional test examines genes involved in metabolism of vitamin B or antioxidants, for example.

They are moving forward despite a 2006 report from the US Government Accountability Office, which sent patient data to four unnamed websites offering genetic tests with nutrition advice, to see whether the advice given seemed valid.

"The results we received from all the tests we purchased mislead the consumer by making health-related predictions that are medically unproven and so ambiguous that they do not provide meaningful information to consumers," the report stated.

The Food and Drug Administration licenses labs that administer the tests, but the tests are generally not closely regulated.

The Federal Trade Commission has issued a warning to consumers about genetics tests on its website, urging skepticism.

Interleukin Genetics tests for genes shown to elevate risk for different health conditions. Though he was not familiar with the company's products, Kohane pointed out that finding genes is generally less valuable than talking to your parents.

"Family history is probably the biggest predictor we have right now of your risk," Kohane said. "No single gene or group of gene gets anywhere as close."

Procter & Gamble scientists sequenced the genome of the fungus that causes dandruff and compared gene activity in old and young skin, work that helped the development of a skincare product line called Olay Pro-X.

George Rivera, senior scientific liaison for L'Oreal, Lancome's parent, said his company has been measuring gene activity and proteins in skin for years to find ingredients that could influence genes. Genifique openly flaunts the genetic research that went into the product in its very title.

But Kohane pointed out that just because a gene seems to be less active in skin aging, that does not mean acting on that gene will prevent wrinkling.

Dr. Robert Green, a genetics fellow at Harvard Medical School, said the potential is great, but if genetics are used purely as a marketing tool on products that can't live up to their promise, it could be dangerous. "Many of us in genetics think this is one of the greatest dangers to the field - that the legitimate field of genetics will be overwhelmed by a kind of popular pseudoscience that will delegitimize and confuse the actual scientific potential," he said.