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Researchers Suggest Payors and Clinicians Should Choose BRCA Labs that Behave Ethically, Make Data Available

NEW YORK (GenomeWeb) – Patients who receive genetic tests for cancer risks should be able to trust that the labs conducting their tests behave ethically, and that the genetic data these labs generate will be made publicly available, three genetics researchers said in a commentary published this month in Evidence-Based Oncology.

The authors believe payors and clinicians have a responsibility to ensure that the labs they contract with will follow open data-sharing policies and select tests based on performance and price, rather than based on pressure or incentives from testing firms.

Competition has increased in the BRCA testing market since the US Supreme Court ruled that a number of Myriad Genetics' claims on isolated BRCA1/2 gene sequences are patent ineligible, stating that such claims describe naturally occurring products.

Since that ruling, several firms and labs have either started offering or said that they plan to begin offering BRCA testing. And according to the authors of the commentary, some genetic testing firms have been engaging in unethical "aggressive and manipulative" practices to strengthen their market position.

Some genetic counseling centers have reported that referring clinicians have requested or demanded that their patients' BRCA tests be sent to a particular lab, and some of these clinicians were either paid consultants for genetic labs or had received speaking fees or research funding from those labs, the authors stated. Such behavior is a clear violation of a physician's ethical obligations to patients, argued authors Ellen Matloff and Rachel Barnett of Yale University's Yale Cancer Center and Robert Nussbaum of the University of California, San Francisco School of Medicine.

"We have had people who said that they would not refer patients to us for genetic counseling anymore unless we use the lab they specifically pointed out, and these were people who we later found out had a relationship with the lab," Matloff told GenomeWeb Daily News in an interview Tuesday. "I hope that payors and clinicians will see that this is simply not acceptable."

Because many clinicians may not be very knowledgeable about the tests, the methods they use, or about the many variants that may be involved, it is easier for labs to pressure them and steer them to use their services, said Matloff, who was a plaintiff in the case challenging Myriad's BRCA patents. There also is very little regulation regarding such practices when it comes to genetic testing, while the pharmaceutical field has regulations in place covering these kinds of relationships, she said.

"We are having these clinicians say: 'Why aren't you using Myriad Genetics? Their data is vastly superior. Their techniques are better.' And they learn it from Myriad sales reps," Matloff said.

For instance, if a physician were trying to decide whether or not to put a patient on tamoxifen or AstraZeneca's Arimidex, "you wouldn't call AstraZeneca and ask sales reps there for their opinion about which drug you should put your patient on, and [clinicians] don't realize that [genetic testing] is exactly the same scenario," she added.

Yale performs its own BRCA tests and sends out tests to outside labs, when necessary. Earlier this year, Yale Cancer Genetic Counseling issued a position statement laying out the criteria counselors should consider when deciding which lab to send patients' samples to for genetic testing, including quality of testing, its turnaround time, its cost, and whether the lab shares patients' de-identified variant data in open-access databases.

Matloff and the other authors reiterated this criteria in their paper. They pointed out that Myriad Genetics stopped contributing its data to a public database in 2004, and "now appears to be relying on trade secrets to maintain its share of the BRCA market."

Myriad has claimed the public database to which it contributed was intended for research use but was being used in clinical settings, and that two-years worth of the data it provided was not entered into the database. For regulatory, quality, and legal concerns, Myriad stopped contributing its data to the database, the company said.

Nussbaum has tackled the issue of data openness by creating the Sharing Clinical Reports Project, which aims to collect information on BRCA1 and BRCA2 variants and make it available through the National Center for Biotechnology Information's ClinVar database.

Some BRCA testing labs have joined with "clinicians, scientists, and patients to expand the pool of publicly available genetic information as part of the Free the Data movement," the authors wrote, noting that some patients are now requesting that their tests be sent to labs that share data, and many labs are now advertising that they share their data.

A growing number of labs are offering BRCA testing and insurers are beginning to contract with particular labs and designating them as their in-network providers, the authors said, which could create an opportunity to expand data sharing.

"Before negotiating such partnerships, payors and regulators have the opportunity to choose to partner only with high-quality laboratories that pledge to share all past, present, and future data in public databases," the authors stated.

"We are at a very critical period in the marketplace, where insurance companies are making decisions about which labs they're going to pair with. This is a very critical window of time," Matloff told GWDN. "Particularly because many of these patients will have government-subsidized insurance companies, we certainly should not be using a genetic testing lab that hoards data, and that doesn't put data back into the public domain."

The decisions payors and clinicians make now could set the stage for how future genetic tests are handled, and could impact many tests far beyond BRCA testing, Matloff said.

"For example, let's say that Medicare and Medicaid make the decision right now that all government-funded or government-subsidized insurance companies will only pay for genetic testing through laboratories that share data. If that policy is set now, then that is going to influence testing for other genes, for other diseases, by other laboratories moving forward," she told GWDN.

"If [testing labs] can see that it will hurt their bottom line for payors and clinicians to team only with laboratories that share data … then this may actually get them to change their policies. And it will change the policies of other labs going forward."