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State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?

Oct 13, 2017 | Uncategorized

Media coverage of a recent Orig3n promotion-and intervention from state and federal officials-reveals the level of discomfort public and policymakers have for handling the publics’ protected health information, including genetic test data

Is it appropriate to offer free genetic tests to 70,000 fans attending a professional football game? Apparently not, say federal and state healthcare regulators who took steps to block a planned free genetic test giveaway that the Baltimore Ravens and clinical laboratory company Orig3n planned to conduct on Sunday, September 17.

Genetic testing has become a mainstay of clinical laboratories and pathology groups. And it can’t be denied that the growing popularity of self-administered genetic tests could have an impact on medical laboratories’ revenue. Additionally, there’s the issue of state and federal privacy laws in the handling of protected health information (PHI) as outlined by the Health Insurance Portability and Accountability Act (HIPAA) to consider. Thus, the news that a developer of genetic self-test kits planned to distribute hundreds of free tests at an NFL football game in Baltimore quickly garnered the attention of federal and state officials, as well as the national media.

Instead of handing out t-shirts, Orig3n, a developer of genetic self-tests kits based in Boston, planned to offer free DNA tests at the September home opening game of the Baltimore Ravens. However, the giveaway was not to be. The promotion attracted the attention of the Centers for Medicare and Medicaid Services (CMS), the Maryland Department of Health (MDH), and a range of media outlets. This led to postponing the event just days before it was scheduled to happen.

According to Forbes, the test promotion claimed to provide information on genetic markers related to vitamin D deficiency, skin aging, language ability, and muscle force.

However, news coverage in The Baltimore Sun of the cancellation of the free genetic test giveaway cited concerns from CMS officials about Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements.

Orig3n told Vice in 2016 that Food and Drug Administration (FDA) approval, and other typical genetic test requirements that apply to medical laboratories, weren’t needed because their tests are non-diagnostic. However, genetic testing often does require physician orders and lab approval in the state of Maryland.

Speaking with The Baltimore Sun, Kevin Byrne, Senior VP of Public and Community Relations for the Baltimore Ravens, stated, “[We are] working with the Maryland Department of Health. Orig3n is confident it can receive the proper approvals and plans to have a fan giveaway later this season at one of our games.”

Criticism of Direct-to-Consumer (DTC) Genetic Testing

In Forbes, journalist Rita Rubin noted, “I paid $99 for the 23andMe direct-to-consumer genetic testing service several years ago. Turns out 23andMe included at least one of the four genes covered by the test Orig3n plans to give out to Ravens fans.”

23andMe is also familiar with the regulatory hurdles of DTC genetic testing. As we reported in 2013, the company received letters from the FDA demanding they cease sale of their genetic tests. These letters were followed by a $5-million class-action law suit in California claiming the test results were “meaningless.” (See Dark Daily, “23andMe Socked with FDA Warning Letter and Class Action Lawsuit over Company’s Genetic Testing Services,” December 11, 2013.)

These concerns were echoed by Toni I. Pollin, PhD, Associate Professor at the University of Maryland School of Medicine. “There’s nothing in this that I think is a good idea,” she told The Baltimore Sun. “The tests they’re talking about doing are not going to be useful for a particular individual.”

The graph above, which is drawn from a Kalorama report on the current and future market for US Direct-to-Consumer (DTC) genetic testing, illustrates the meteoric increase in value of the DTC tests market. (Image copyright: MedCityNews/Kalorama.)

Modern Healthcare followed up on the 23andme story in 2016. Although the class-action suit eventually failed in the 9th US Circuit Court of Appeals, it took nearly two years for 23andMe to bring a portion of their tests to the market.

However, the coverage surrounding both events illustrate how wary government regulators might be to allow direct-to-consumer genetic testing to become a commonplace service. And how wary the public is to trust these new technologies and services with their protected health information.

Privacy Concerns and Media Backlash Still Common

In a September press release promoting the event, Orig3n states, “Orig3n is on a mission to advance the future of health. We believe that everyone should have direct, affordable access to their genetic information and reaching people with DNA tests on such a large scale is a natural and exciting way for us to demonstrate that.”

While Orig3n claims security is in place to protect sensitive genetic information, Bethesda, Maryland, attorney Bradley Shear and Peter Pitts, President of the Center for Medicine in the Public Interest (CMPI), both cited security concerns in the Baltimore Sun article.

The privacy and security concerns surrounding the collection and pooling of genomic and healthcare big data are not limited to the US. This trend continues to shape how innovative technologies grow and how systems and companies communicate data around the world.

A June ebriefing highlighted how even blinded data can be collated and compared to learn far more about a person or patient than a single dataset might suggest. (See Dark Daily, “Coverage of Alexion Investigation Highlights the Risk to Clinical Laboratories That Sell Blinded Medical Data,” June 21, 2017.)

Alexion (NASDAQ:ALXN), a pharmaceutical company specializing in orphan drugs, was shoved into the spotlight by Bloomberg Businessweek for aggressive marketing tactics in several countries around the world using blinded data to target patients and clinicians. The story also brought with it mentions of high-profile clinical laboratories and diagnostics providers—a potential PR nightmare for all involved.

Direct-to-consumer genetic tests offer opportunities for consumers to discover facets of their health and genetic backgrounds. However, the potential risks, security/privacy concerns, and the true value of test results continue to create hurdles for commercial service providers, as well as for pathologists and clinical laboratories.

Until public and regulatory scrutiny decreases, the value of the data gathered by these tests is determined, and standards are in place regarding security of customers’ protected health information, laboratories should remain vigilant and tread carefully when considering DTC testing as a viable opportunity to expand revenues.

—Jon Stone

Related Information:

‘DNA Day’ Planned for Ravens’ Game Undergoes Federal and State Scrutiny

Ravens Decide That Perhaps ‘DNA Day’ at M and T Bank Stadium Should Be Postponed

Orig3n Holds Inaugural Ravens DNA Day on September 17 at M and T Bank Stadium to Kick Off the Season

Beyond Bobbleheads: One NFL Team Wants to Offer Fans Free Genetic Testing

Biotech Company Offers Fitness and Beauty-focused Genetic Tests

Baltimore Ravens to Hand Out Free DNA Test Kits

Ravens Fans to Be Offered DNA Test Kits Sunday in Unusual NFL Promotion

Promotion Offering DNA Test Kits to Ravens Fans to Be Rescheduled

Football Team’s DNA Day Postponed

23andMe Socked with FDA Warning Letter and Class Action Lawsuit over Company’s Genetic Testing Services

23andme Escapes California Class Action for Arbitration

Coverage of Alexion Investigation Highlights the Risk to Clinical Laboratories That Sell Blinded Medical Data

Jun 21, 2017 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

Despite blinding data and following protocols, a recent investigation in Bloomberg Businessweek shows that clinical laboratories can be at risk in deals with pharmaceutical and big data companies

While big data is transforming how healthcare is both researched and applied, it also offers opportunities for clinical laboratories to create additional revenue from the endless streams of data generated by diagnostic tests and genetic assays. However, these opportunities come at a cost.

Data mining and pharmaceutical companies are turning to medical laboratories for blinded data (patients’ names are removed) to aid in their research and marketing efforts. Although the data is blinded to adhere to consumer privacy protocols, a story on the biopharmaceutical company Alexion (NASDAQ:ALXN) in Bloomberg Businessweek shows how clinical laboratories may be at risk for civil and legal ramifications, as well as public relation concerns.

When Blinded Patient Data Is Not Blind

Despite requirements to anonymize medical data, the increased computing and data collection abilities of data mining companies make it possible to bridge gaps in information by collating multiple data sources. Companies then can make assumptions about the data with relative accuracy.

With Alexion’s drug Soliris, the blinded data was enough to locate healthcare professionals treating patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare disease of the blood, and atypical hemolytic uremic syndrome (aHUS) a rare disease of the immune system.

Cover of the Bloomberg Businessweek issue containing the article on Pharmaceutical companies’ use of blinded patient data for marketing high-cost “orphan drugs” that were developed to treat just one specific rare disease. (Photo copyright: Bloomberg Businessweek.)

On the surface, this seems like an ideal example of how making clinical laboratory and pathology data available to companies can be beneficial to patients and a victory for healthcare.

However, the Bloomberg Businessweek article highlights a darker side of the issue, noting, “Alexion set out to persuade doctors to test more frequently for PNH and aHUS—and to find a way to glimpse these test results, which traditionally have been shared only among the patient, the doctor ordering the test, and the lab.”

Liability and Risk in Age of Big Data

By reaching out to doctors and encouraging them to route lab tests to preferred medical laboratories with which they allegedly had partnered, Alexion could collect information and compare it to their database to pinpoint opportunities to sell their orphan drug Soliris. An orphan drug contains a unique pharmaceutical agent that was developed to treat a specific rare disease.

Five clinical laboratory companies are named in the story. While these laboratories might have followed regulations and the partnerships might be legal, news stories such as these could result in public relations crises and damaged reputations.

According to the Bloomberg Businessweek article, Alexion is resolving legal or regulatory concerns in at least seven countries. Though there is no precedent for medical laboratories assuming liability or being implicated in the crimes of a company to which they sold blinded data, the possibility exists.

Increased Scrutiny as Privacy Becomes a Public Concern

Healthcare big data continues to unlock new opportunities and create new approaches in treating disease and improving health around the world. However, as the public gains awareness of how healthcare big data is collected, shared, and used, greater scrutiny of how the data is handled, and the parties involved, will likely follow.

Dark Daily reported on the balancing act faced by laboratories in a 2016 e-briefing titled, “Trading in Medical Data: Is this a Headache or an Opportunity for Pathologists and Clinical Laboratories?”

That e-briefing cites a Scientific American article in which author Adam Tanner, a fellow at Harvard University’s Institute for Quantitative Social Science, states, “At present, the system is so opaque that many doctors, nurses, and patients are unaware that the information they record or divulge in an electronic health record, or the results from lab tests they request or consent to, may be anonymized and sold.”

In a similar story, Ancestry recently experienced how fast opinions can shift when certain online publications questioned the terms and conditions of the company’s AncestryDNA service. In a matter of days, the service went from an interesting example of consumer genomics to a trending topic on social media.

In the Slate article “Who Owns Your Genetic Data After a Home DNA Test?,” author Jacob Brogan notes, “Even if Ancestry maintains its current commitment to protecting its customers’ data, its willingness to profit from that information may raise red flags for the future of consumer genetic testing.”

While Ancestry might resolve its immediate troubles with an update to its terms of service governing how and when it sells the genetic information of its customers, the hit to the company’s reputation could continue to impact its business. This is something the five clinical lab companies affiliated with Alexion and named in the Bloomberg Businessweek story may be experiencing as well.

As competition increases and clinical laboratories work to cultivate and improve revenue streams and reduce costs, it remains important to stay ahead of trends—and public opinion—by choosing partnerships carefully and remaining transparent about how patient data is collected, shared or sold, and used.

—Jon Stone

Related Information:

When the Patient Is a Gold Mine: The Trouble With Rare-disease Drugs

Your Medical Data Is for Sale, and There’s Nothing You Can Do About It

How Data Brokers Make Money Off Your Medical Records

Who Owns Your Genetic Data After a Home DNA Test?

State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?

Coverage of Alexion Investigation Highlights the Risk to Clinical Laboratories That Sell Blinded Medical Data

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