[Ip-health] Gene Testing Questioned by Regulators

[Joana Ramos]

http://www.nytimes.com/2008/06/26/business/26gene.html?_r=3D1&oref=3Dslogin

June 26, 2008
Gene Testing Questioned by Regulators
By ANDREW POLLACK

Regulators are cracking down on companies that sell genetic tests
directly to consumers, threatening to crimp the growth of one of the
hottest sectors of the biotechnology industry.

The California Department of Public Health sent =93cease and desist=94
letters to 13 genetic testing companies two weeks ago, telling them they
could not solicit business from state residents. The companies include
the early leaders in the field =97 23andMe, Navigenics and deCode Genetics
=97 which are trying to carve out a new business of offering personal
genetic information for use in health and lifestyle planning.

The California action follows efforts by New York State, which has sent
letters to 31 genetic testing companies since November, saying they need
licenses to solicit DNA specimens from the state=92s residents.

Pressure is also mounting for the federal government to take more
action. A report in April by a federal advisory committee said there
were significant gaps in the oversight of genetic tests that could lead
to patient harm. The Department of Health and Human Services will hold a
two-day public meeting July 7 and 8 to discuss regulation of personal
genetic information services.

The Federal Trade Commission, meanwhile, has started investigations into
possibly deceptive advertising or marketing of genetic tests, according
to an agency official who spoke at a June 12 meeting convened by Senator
Gordon Smith. The senator, an Oregon Republican, has been prodding
federal agencies to take a stronger stance in overseeing genetic tests
sold to consumers.

Yet the move to regulate the tests is raising many issues. What are the
standards for proving a genetic test is valid? Must a doctor always be
involved in ordering such tests to protect patients, or is that an
attempt by doctors to protect their turf?

Some of the companies say people have a right to know the information in
their genes and to guide their own health care.

=93We think your genetic information is a fundamental part of you,=94 said
Anne Wojcicki, a co-founder of 23andMe. The company, based in Mountain
View, Calif., has attracted attention not only because of its $1,000
genome testing service but because it is partly financed by Google and
because Ms. Wojcicki is married to the Google co-founder Sergey Brin.

Navigenics and 23andMe say they are not offering medical testing, but
rather personal genetic information services. Using a saliva sample,
they scan a person=92s genome at multiple points looking for variations
that might indicate a person is at a higher than normal risk for certain
diseases.

=93This doesn=92t say you have a disease,=94 said Mari Baker, the chief
executive of Navigenics, which is based in Redwood Shores, Calif., and
whose service costs $2,500. =93It says you carry a genetic predisposition
for the disease and should talk with a health care professional.=94

But not everyone agrees with that rationale.

=93We think if you=92re telling people you have increased risk of adverse
health effects, that=92s medical advice,=94 said Ann Willey, director of th=
e
office of laboratory policy and planning at the New York State
Department of Health.

Genetic tests that are developed by clinical laboratories generally do
not require approval by the Food and Drug Administration before they can
be marketed.

The laboratories themselves are regulated by the Centers for Medicare
and Medicaid Services. Such regulation is meant to ensure that
laboratories are proficient and that the tests are =93analytically valid.=
=94
That means that if a test purports to detect a particular genetic
variation, it does so reliably.

But critics say such regulation does not assure that tests are
=93clinically valid=94 =97 that having a particular genetic variation actua=
lly
means a person has a disease or is at risk for one. Critics also say
many tests now being sold to consumers are not backed by adequate
scientific studies.

The California letters, sent on June 9 and 10, said the companies needed
to have state licenses as clinical laboratories. In addition, they said,
genetic tests could be ordered only by a doctor, not by consumers.

=93We started this week by no longer tolerating direct-to-consumer genetic
testing in California,=94 Karen L. Nickel, chief of laboratory field
services for the state health department, said during a June 13 meeting
of a state advisory committee on clinical laboratories.

Lea Brooks, a spokeswoman for the health department, said the letters
were sent in response to consumer complaints about the cost and accuracy
of the tests.

Most of the attention so far has focused on Navigenics and 23andMe
because of their high profiles and the fact that they acknowledged
getting the state=92s letters. The identities of most of the other
recipients were unknown until Tuesday, when the state health department
posted all 13 letters on its Web site.

The other recipients include Knome, which is offering to do a complete
sequence of a person=92s genome for $350,000.

Also on the list were a few companies that give diet advice based on a
person=92s genes (and in some cases also sell dietary supplements). There
were also some companies that offer genetic tests for single conditions,
like the risk of baldness or Alzheimer=92s disease.

The companies had until this Monday or Tuesday to respond to the agency,
which will now review the responses.

At least one company that received a letter, Sciona, has stopped
offering its gene testing and related diet advice to residents of
California and New York. DeCode=92s Web site indicates that certain
calculations of disease risk will not be available to residents of New
York, California and several other states.

But Navigenics and 23andMe say they believe they comply with the
regulations and are continuing to accept samples from Californians.
Navigenics has stopped accepting orders from New York while its
laboratory seeks a state license. But 23andMe said it continues to
accept orders from New York.

Both companies say they do not need a license from California because
the genome scans are actually performed by outside laboratories that do
have state licenses.

Navigenics said its tests are ordered by a physician because a doctor on
contract to the company reviews customer orders before the specimens are
passed to the testing laboratory.

But Kathy Hudson, director of the Genetics and Public Policy Center at
Johns Hopkins University, said that =93some doc on the payroll at Genes R
Us=94 is not the same as a personal physician.

Dr. Hudson said it was =93not surprising that the states are stepping in,
in an effort to protect consumers, because there has been a total
absence of federal leadership.=94 She said that if the federal government
assured tests were valid, =93paternalistic=94 state laws could be relaxed
=93to account for smart, savvy consumers=94 intent on playing a greater rol=
e
in their own health care.


-----------------
Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
+1-206-229-2420
http://ramoslink.info/
www.bmtbasics.org