FDA-Approved Test for Plavix May Be Pointless and a Waste of Money

Is the FDA recommending genetic tests that waste money? A new study published in the Dec. 28 issue of the Journal of the American Medical Association reveals that an FDA approved test may actually be pointless. CYP2C19 genotype testing may not be an effective method for determining a prescription. Although this genetic test has been recommended for patients who may not benefit from the blood thinner clopidogrel or Plavix, the paper published in JAMA points out that the CYP2C19 genotype should not be used for cardiovascular diseases. I am not surprised by the findings of the recent study because the FDA has issued premature warnings and supported wrong data in the past.

It appears that the FDA may be encouraging patients to waste money on unnecessary tests. CYP2C19 genotype testing is recommended to patients, so their ability to metabolize Plavix can be determined. The researchers included an analysis of 42,016 patients and a meta-analysis of 32 different studies. Focusing on the connection between the CYP2C19 genotype and cardiovascular problems, the effect of genetic testing was evaluated. Although some connections were found, the results indicated that CYP2C19 genotype testing is not the best method for determining the potential benefits of clopidogrel or Plavix. The CYP2C19 genotype is not a good indicator for cardiovascular diseases.

Despite several studies now pointing out the fallacy of the FDA's recommendations, the FDA has not made an official comment on the situation. I am not sure if the organization is embarrassed or simply waiting for more data. The new study published in the Journal of the American Medical Association adds to previous findings in the British Medical Journal. The BMJ article published in August shows similar conclusions about the CYP2C19 genotype. Both groups of researchers believe that this type of genetic testing does not offer any real benefit to patients.

CYP2C19 genotype testing has spawned a small industry of labs and researchers who offer this service to patients suffering from cardiovascular diseases. The promise of customized treatments based on a person's DNA is fueling this industry and making individualized genetic testing grow in popularity. Since 2010, CYP2C19 genotype testing has been encouraged by the FDA. The discovery that some patients do not metabolize Plavix well, named poor metabolizers by the FDA, stimulated the growth of more tests. Although I support genetic testing, I hate to see ineffective tests that waste patients' money and provide no real benefit.

The real problem with CYP2C19 genotype testing goes beyond the usefulness of the procedure. CYP2C19 genotype testing is expensive, and some insurance companies may not cover the entire cost. The test can cost $200 to $500 with some patients being forced to pay the entire amount without help from insurance. Since several studies have now shown that CYP2C19 genotype testing is not an effective method of determining a person's metabolism of Plavix, it will be interesting to see if the FDA changes its recommendations.

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