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Unproven genetic tests called public health threat

April 9, 2008
Courtesy Johns Hopkins University
and World Science staff

No mech­an­ism ex­ists to en­sure ge­net­ic tests are sci­en­tif­ic­ally val­id and hon­estly ad­ver­tised be­fore they’re mar­keted in the Un­ited States, a new re­port warns. That, the au­thors add, could pave the way for doc­tors and pa­tients to make wrong de­ci­sions about which tests to take and how to use them.

No mech­an­ism ex­ists to en­sure ge­net­ic tests are sci­en­tif­ic­ally val­id and hon­estly ad­ver­tised be­fore they’re mar­keted in the Un­ited States, a new re­port warns.


“Ge­netic tests of­fer doc­tors and pa­tients an un­prec­e­dent­ed op­por­tun­ity for im­prov­ing health care,” said Kathy Hud­son, di­rec­tor of Johns Hop­kins Uni­ver­s­ity’s Ge­net­ics and Pub­lic Pol­i­cy Cen­ter in Mar­y­land. 

But “mar­ket­ing un­prov­en tests to an un­sus­pect­ing pub­lic could un­der­mine the very fu­ture of per­son­al­ized med­i­cine.”

Per­son­al­ized med­i­cine is just what ge­net­ic tests are sup­posed to achieve—a new era in which treat­ments are tai­lored in­di­vid­ually to each per­son’s ge­net­ic make­up.

The re­port’s au­thors, all mem­bers of the cen­ter, rec­om­mended bol­ster­ing U.S. Food and Drug Ad­min­istra­t­ion over­sight of cer­tain ge­net­ic tests. They al­so sug­gested cre­at­ing a man­da­to­ry, pub­lic in­forma­t­ion reg­is­try on each avail­a­ble test, in­clud­ing da­ta sup­port­ing its in­tend­ed uses, and en­hanced U.S. Fede­ral Trade Com­mis­sion en­force­ment against false or mis­lead­ing ad­ver­tis­ing.

De­scribed as a pol­i­cy anal­y­sis, the re­port ap­peared in the April 4 is­sue of the re­search jour­nal Sci­ence

Tests for more than 1,500 dis­eases and con­di­tions are avail­a­ble, yet the ef­fi­ca­cy of many has not been eval­u­at­ed, the au­thors wrote. While most ge­net­ic tests must be or­dered through a doc­tor, a grow­ing num­ber al­so are avail­a­ble di­rectly to users over the In­ter­net; these are es­pe­cially trou­bling, the pa­per ar­gues.

In particular, the au­thors re­viewed claims made by com­pa­nies about the val­ue of test­ing for vari­abil­ity in en­zymes called cy­to­chrome P-450 in pre­dict­ing how in­di­vid­uals will me­tab­o­lize an­ti­de­pres­sants known as se­lec­tive ser­o­to­nin re­up­take in­hibitors. At least 15 busi­nesses cur­rently of­fer the test­ing, four of which spe­cif­ic­ally claim it can serve as a ba­sis to de­cide treat­ments, the au­thors not­ed. Yet an in­de­pend­ent pan­el com­mis­sioned by the U.S. Cen­ters for Dis­ease Con­trol and Pre­ven­tion re­ported last year that the tests should be dis­cour­aged pend­ing fur­ther clin­i­cal tri­al re­sults.

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No mechanism exists to ensure genetic tests are scientifically valid and honestly advertised before they’re marketed in the United States, a new report warns. That, the authors add, could pave the way for doctors and patients to make wrong decisions about which tests to take and how to use them. “Genetic tests offer doctors and patients an unprecedented opportunity for improving health care,” said Kathy Hudson, director of Johns Hopkins University’s Genetics and Public Policy Center in Maryland. But “marketing unproven tests to an unsuspecting public could undermine the very future of personalized medicine.” Personalized medicine is just what genetic tests are supposed to achieve—a new era in which treatments are tailored individually to each person’s genetic makeup. The report’s authors, all members of the center, recommended bolstering the U.S. Food and Drug Administration’s role in overseeing certain genetic tests. They also suggested creating a mandatory, public information registry on each available test, including data supporting its intended uses, and enhanced U.S. Federal Trade Commission enforcement against false or misleading advertising. Described as a policy analysis, the report appeared in the April 4 issue of the research journal Science. Personalized medicine’s success depends on public confidence in genetic tests, the authors wrote. Tests for more than 1,500 diseases and conditions are available, yet the efficacy of many has not been evaluated, they added. While most genetic tests must be ordered through a doctor, a growing number also are available directly to users over the Internet; these are especially troubling, the paper argues. The authors reviewed claims made by companies about the value of genetic testing for variability in enzymes called cytochrome P-450 in predicting how individuals will metabolize antidepressants known as selective serotonin reuptake inhibitors. At least 15 businesses currently offer the testing, four of which specifically claim the test can be used as a basis to decide treatments, the authors noted. Yet an independent panel commissioned by the U.S. Centers for Disease Control and Prevention reported last year that the tests should be discouraged “until further clinical trials are completed.”