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Science Fuels DNA Testing Controversy with Prejudicial Misquote
Date:4/3/2008

SEATTLE, April 3, 2008 /PRNewswire/ -- A policy comment in Science today quotes Genelex out of context:

"Some Web sites make explicit claims about the utility of CYP450 testing for particular drugs, such as the claim by Genelex that pharmacogenetic testing is "required to effectively prescribe Paxil" (http://www.healthanddna.com/professional/paxil.html).

The actual statement is:

Paxil (paroxetine) is metabolized through CYP2D6. Pharmacogenetic testing of this pathway serves as an anchor for the intense personalization required to effectively prescribe Paxil and other antidepressant medicines.

Facts and quotes:

-- "The cytochrome P-450 test represents a major advance in the ability

to provide the best care possible for depression."

http://www.mayoclinic.org/depression/cytochrome.html.

-- Hospitalized psychiatric patients who are poor metabolizers cost

$4,000 - $6,000 more in medical care compared to patients with an

average metabolizer genotype. Virtually, all antidepressants and

antipsychotic medicines are processed by enzymes with a high

incidence of poor metabolizers. Journal of Clinical

Psycopharmacology 20:246 2000.

-- Fifty-nine percent of drugs most commonly cited in ADR studies are

processed by enzymes with genes known to have poor metabolizer

variants. This is compared to 7% of a random selection of the top

selling drugs. (JAMA 286:2270 2001).

-- Multiple studies have found that people with CYP variants require

lower doses of the affected medications. Molecular Psychiatry

9:442-473, 2004.

-- "Putting what we know into practice would prevent more disease than

worshiping at the altar of randomized trials." John Concato, MD,

Yale University.

Genelex's Position:

-- Individuals have a right to learn their genotype and control who

accesses this confidential information.

-- Excessive regulation will impede the already slow adoption of DNA

testing in medication management.

-- There needs to be symmetry between the level of proof required for

technology adoption and the potential risk and cost benefit ratios.

-- A peer-developed rating system needs to be developed that describes

where a given test lies on the continuum of scientific knowledge

about the utility, acceptance and proof of that test as a tool for

informed decision-making.

Randomized trials are in progress that will add to our knowledge. In the meantime clinicians and patients who find this information useful should have access to it. Physicians don't prescribe without knowing the patient's age, sex, and medical history, and often CYP genetics are more important than all these factors combined.


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SOURCE Genelex Corporation
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