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Direct-to-consumer (DTC) advertising is driving up use of BRCA and testosterone diagnostics. The rub is these marketing efforts don’t always target or attract the highest risk patients or lead to quantifiable health gains. 

A study that identified a recent shift in BRCA testing from women with a family history of breast or ovarian cancer to unaffected or low-risk populations, underscores this trend. 

In 2004, just over 24% of low-risk women were getting screened for the BRCA mutation, which increases risk for breast and ovarian cancer. A decade later in 2014, that percentage had gone up to 61.5%, researchers at the University of Texas Medical Branch in Galveston discovered in their analysis of BRCA claims from more than 53,000 women. Findings appeared in the American Journal of Preventive Medicine

Lead investigator Fangjian Guo, MD, PhD and his colleagues suggest that aggressive DTC advertising has led to the rise in physician and self-referrals to BRCA tests, even in unaffected women. 

Oversaturation can explain the diminished effect marketing has had on women at high risk for mutations. “The testing rate reached a threshold after which more campaigns have limited incremental effect,” Guo told CLN Stat

“On the other hand, clinicians would probably not suggest this test to low-risk women if there were no direct-to-consumer marketing for genetic tests. As a result, more low-risk women started to receive the test, whereas the number of high-risk women receiving BRCA testing may have increased only slightly,” he said. 

The study listed other factors in the rising use of these tests: The Affordable Care Act’s mandated coverage for preventive services such as BRCA testing; and the Supreme Court’s ruling against Myriad Genetics’ patent claim over the BRCA gene, which has since made it easier and less expensive for other clinical laboratories to do BRCA testing. 

The U.S. Preventive Services Task Force in 2005 recommended that women with a family history of ovarian and breast cancers get BRCA screening. Yet, in comparison to low-risk women, the proportion of women between the ages of 20 and 40 with previous diagnoses of breast or ovarian cancer who are getting BRCA tests is significantly lower, the investigators determined. “The majority of at-risk women do not get referral for genetic counseling and testing. Among 220,000 BRCA mutation carriers in the U.S., it is estimated that more than 90% have not been identified,” the researchers stated. 

In Canada, where 1 in 200 women have the BRCA gene but have low referral rates for genetic tests, researchers are looking at DTC, population-based strategies to close healthcare gaps. Participants in The Screen Project study at Women’s College Hospital in Toronto will be able to register online, where they’ll receive information about familial cancer and genetic testing and then undergo BRCA1 and BRCA2 gene mutation tests at a reduced cost from Veritas Genetics, a U.S.-based genetic sequencing and interpretation company. Through such a program, investigators are hoping to estimate the number of cancers that could be prevented. 

Another study published in the Journal of the American Medical Association (JAMA) on the effects of televised androgen replacement therapy ads in 75 designated market areas (DMAs) in the United States, provides an even stronger example of the association between DTC marketing and diagnostic testing. 

In a related JAMA editorial, Richard L. Kravitz, MD, MSPH, explains how the loosening of U.S. Food and Drug Administration DTC advertising regulations in the late 1990s “unleashed a torrent of television ads” on therapies for a number of different health conditions, including testosterone deficiency or male hypogonadism. 

“Ads promoting androgen replacement therapy for testosterone deficiency emphasized the high prevalence of subnormal testosterone values in men older than 45 years and implicitly promised better quality of life and improved performance ‘in the boardroom and the bedroom,’” wrote Kravitz. 

The JAMA study’s investigators correlated DMA-level testosterone use data taken from commercial insurance claims from 2009-2013 to monthly testosterone advertising ratings.  Among more than 17 million insured men studied, just over 1 million had undergone new serum testosterone tests, and more than 280,000 had opted for testosterone treatment. 

“Although the average increase in testosterone rates associated with a single ad exposure was less than 1%, advertisements were widespread and frequent during the study period; with cumulative ad exposures of close to 200 in some DMAs, DTC [advertising] was associated with substantial overall increases in testosterone testing and initiation,” according to the study’s authors. 

Ad exposures varied from no exposures to more than 13 exposures per household, with the southeastern part of the United States yielding the highest advertising intensity. Branded advertisements have become more common over the last 4 years, compared with nonbranded advertisements. 

“Each exposure to a testosterone advertisement was associated with monthly relative increases in rates of new testosterone testing of 0.6%, new initiation of 0.7%, and initiation without a recent baseline test of 0.8%,” the investigators reported. 

Considering that 3 to 9% of patients make DTC advertising-related inquiries to their doctors, it’s indisputable that these ads influence consumers and drive up prescription requests, Kravitz noted in his editorial. 

The question is whether the treatments these ads promote ultimately result in better health outcomes, he continued. In the case of testosterone testing for male hypogonadism, “the opportunities for overdiagnosis are substantial, with many men receiving androgen replacement therapy without appropriate diagnostic testing. Although symptomatic androgen deficiency by definition impairs quality of life, the effects on mortality are unclear,” wrote Kravitz. 

Androgen replacement therapy has also broached ongoing safety concerns over its potential to raise risk for cardiovascular disease, he noted. An outright ban on DTC advertising probably isn’t realistic, yet, other proposals have suggested either an FDA review of these ads before they go live, or possibly a 3-year moratorium on ads once a new therapy is introduced, he indicated.