Myriad Genetics is among a handful of companies that make a genetic test to help doctors choose psychiatric medicines for patients. Evidence that the tests are effective has been called "inconclusive." Myriad Genetics hide caption
Myriad Genetics is among a handful of companies that make a genetic test to help doctors choose psychiatric medicines for patients. Evidence that the tests are effective has been called "inconclusive."
As a teenager, Katie Gruman was prescribed one mental health drug after another. None seemed to help her manage symptoms of anxiety and bipolar disorder, so she self-medicated with alcohol and illicit drugs.
It would take five years, and trying more than 15 different medications, before she found meds that actually helped.
Now 28 and in recovery, Gruman has been on the same drugs for years. But when a clinician recommended a genetic test to see which drugs work best for her, she took it.
Reading the test results "was definitely vindicating," she says. Medications that hadn't worked for her as a teenager were the same ones the results marked as bad fits.
She says she wishes she had taken the test as a teenager. "I could have avoided a lot of disaster in my life," she says.
Psychiatric medications are known to be hard to match to symptoms, and many patients like Gruman live through years of trial and error with their doctors.
Companies that make genetic tests like the one Gruman used say they can save patients and doctors from prolonged searching for the right medication and save insurance companies from paying for ineffective drugs. But many researchers say the tests don't have enough evidence backing them up. The Food and Drug Administration has warned that the tests could potentially steer patients towards the wrong medications. Nonetheless, UnitedHealthcare, the nation's largest insurer, began covering them October 1 for its 27 million individual and group plans.
Test makers hailed the announcement of United's coverage, the first from an insurance company to apply to all of its commercial plans across the country.
"We expect this to be a tipping point," says Shawn Patrick O'Brien, CEO of Genomind, a company that makes one of the tests. Other insurers will cover the tests "because they don't want to be uncompetitive in the marketplace," he predicts.
If the prediction is correct, it would likely fuel a market that has seen its largest test maker, Myriad Genetics, sell about 375,000 of its psychiatric medicine tests in the 2019 fiscal year, according to Jack Meehan, an industry analyst for Barclays. Myriad reported that it sold $113 million worth of the tests.
In addition to UnitedHealthcare's coverage, Myriad Genetics' test is covered by Medicare, a regional Blue Cross Blue Shield affiliate, and the insurance network for the grocery chain Kroger, a spokesperson says.
Genomind has discussed coverage with insurers including Anthem and Blue Cross Blue Shield, O'Brien says.
Debates over efficacy
As the field of genetic testing to help diagnose and treat disease grows, medicine has embraced certain tests, such as that for the BRCA gene linked to breast cancer. But many researchers say there is not enough evidence tying genetic variants to better outcomes for most psychiatric medications.
James Potash, the head of psychiatry at Johns Hopkins Medicine and an expert on psychiatric genetics, says of all the tests claiming to improve depression treatment, GeneSight's has the most proof. That isn't saying much, though.
"I wouldn't say there's no evidence that it works," he says. "It's just the evidence at this point is still weak."
The idea behind the tests is that in some cases, people can have different reactions to the same drug, even at the same dose, because they have different gene variants. Which variant a person has can affect how quickly or slowly a medicine moves through their body.
This link between genes and drug metabolism has been known for decades, says Francis McMahon, who leads genetic research into mood and anxiety disorders at the National Institutes for Mental Health.
Usually, the longer it takes your body to process a drug, the easier it is for that medication to have an effect. But in psychiatry, McMahon says, how fast someone processes a drug, or metabolizes it, and how well they respond to the drug "are sometimes not strongly related."
This skepticism is shared by some insurance companies. "Anthem considers these tests investigational and not medically necessary," says a spokesman for the carrier, which covers 41 million people. The Blue Cross Blue Shield Federal Employee Program, which covers about two-thirds of government workers and their families, said "there is not enough evidence at this time to determine the effect of genetic testing on health outcomes," according to a spokeswoman.
Test makers are also facing FDA objections that they haven't proven some of the claims underpinning genetic tests for medications, including that antidepressants work better with some gene variants.
"Changing drug treatment based on the results from such a genetic test could lead to inappropriate treatment decisions and potentially serious health consequences for the patient," the agency warned in late 2018. It told companies to stop naming specific drugs, in marketing materials or test results, for which its tests "claim to predict a patient's response" without "scientific or clinical evidence to support this use."
Most test makers complied. One, Inova Genomics Laboratory, stopped selling a range of tests, including its test for mental health disorders, after the FDA followed up with a warning letter in April.
Several mental health advocacy groups, including the National Alliance on Mental Illness, have sided with test makers in their dispute with the FDA. Keeping the names and types of medication off of genetic test reports, as the FDA has required, will "impede the ability of psychiatrists and other front-line health care professionals to personalize medication decisions" for patients with depression, the groups wrote the FDA in September.
Some have argued that genetic tests like these shouldn't be regulated by the FDA at all. Tests conducted in a lab are a medical service, not a medical device that's shipped like a product, says Vicky Pratt, president of the Association for Molecular Pathology. As a medical service, she says, clinical laboratories are already regulated by the Centers for Medicare and Medicaid Services.
"It would be redundant to have dual regulation by both the FDA and CMS," says Pratt.
Research into the tests' efficacy is ongoing and continues to be debated.
Myriad hoped to bolster evidence for its test, GeneSight, in a study it funded that was published this year in the Journal of Psychiatric Research, but the results were mixed.
In the study, doctors used genetic tests to help prescribe medications for one group of patients with depression, while another group of patients received usual care. There was overall no difference between the groups in the study's primary measure of symptom improvement, though some patients showed improved response and remission rates.
Responding to criticisms of its clinical trial results, Myriad Genetics spokesman Ron Rogers says the trial population whose average participant had tried more than three unsuccessful medications for depression was uniquely difficult to treat. He says he expects to see stronger outcomes in a forthcoming review of the trial data.
In a statement on the use of genetic testing in psychiatry, the International Society of Psychiatric Genetics, calls the existing evidence "inconclusive," and notes that if 12 patients take such a test for antidepressants, just one will benefit from it.
A low rate of success means insurers will have to pay for a lot of tests for one useful result, says Barclays analyst Meehan. Meehan pointed to a letter about the recent GeneSight study that was published in the same journal, which found that 20 patients would need to take the test for one to recover as a result. At $2,000 for a GeneSight test, the authors wrote, that means patients and insurers would have to cover $40,000 worth of tests. (While competitor Genomind does not share pricing information, a spokeswoman confirmed that it has an active contract with the Department of Veterans to supply tests for $1,886.)
Still some clinicians value the tests. Skeptics often misunderstand how the tests should be used, argues Daniel Mueller, a professor at the University of Toronto who researches how genes and drugs interact. (Mueller is involved in research comparing Myriad's GeneSight to another test developed by a University of Toronto-affiliated hospital.) Most of the time, he says, doctors who order the test already plan to prescribe medication. The test is just another tool to help them decide which one to prescribe.
"It's not an alternative intervention," Mueller says. "It's additional information." He orders the test for most patients who do not respond to at least one antidepressant.
"If you think about the cost of depression and weeks of suffering that you can potentially avoid for some patients," Mueller says, he thinks anyone who can afford a test should take it. (Myriad says 95% of patients pay less than $330 for their test, the cost remaining after insurance and possible financial assistance; Genomind says most privately insured customers pay no more than $325.)
A lack of watertight evidence for the tests should not stop doctors from using it to inform their choice of medication, says Reyna Taylor, who leads public policy for the National Council for Behavioral Health, one of the advocacy groups that defended the tests in a letter to the FDA. "You use the science that you currently have," she says.
"Whether our providers choose to use [a genetic test] or not, we want them to have that choice," she adds.
Disagreement among experts hasn't dissuaded UnitedHealthcare from paying for the tests.
In a statement, UnitedHealthcare spokeswoman Tracey Lempner says they "frequently review our coverage policies to ensure they reflect the most current published evidence-based medicine and specialty society recommendations."
Graison Dangor is a journalist in Brooklyn.
View original post here:
- Medical genetics - Wikipedia - January 10th, 2020
- Genetic Medicine | Department of Medicine - January 10th, 2020
- Distribution of Genes Encoding Virulence Factors and the Genetic Diver | IDR - Dove Medical Press - January 10th, 2020
- In defence of imprecise medicine: the benefits of routine treatments for common diseases - The Conversation UK - January 10th, 2020
- IDEAYA Biosciences and Boston Children's Hospital Collaborate on Preclinical Evaluation of IDE196 for Sturge Weber Syndrome - a Rare Disease... - January 10th, 2020
- Study ties gene active in developing brain to autism - Spectrum - January 10th, 2020
- Faculty and alumni appointed to state medical boards - The South End - January 10th, 2020
- Why This Thematic Healthcare Could be a January Winner - ETF Trends - January 10th, 2020
- New year health kicks are great but your environment is also vital - The Guardian - January 10th, 2020
- Biofidelity and Agilent complete successful molecular assay study for rapid and accurate detection of key lung cancer mutations - BioSpace - January 10th, 2020
- New MD Treatments the Main Goal of Astellas, Audentes Merger - Muscular Dystrophy News - January 10th, 2020
- Physicians' Education Resource Presents the 2nd Annual Precision Medicine Symposium in New York City - BioSpace - January 10th, 2020
- A Genetic Mutation Is Responsible for Mysterious Deaths in the Amish Community, Researchers Say - Gizmodo - January 10th, 2020
- Kyoto Univ.-distributed iPS cells found with abnormalities after differentiation - The Mainichi - January 10th, 2020
- The Importance of Understanding TargetProtein Interactions in Drug Discovery - Technology Networks - January 10th, 2020
- Webinar: How Providers are Harnessing the Power of Genomics to Improve Community Health - ModernHealthcare.com - January 5th, 2020
- Genomics and Medicine | NHGRI - January 5th, 2020
- These 2 Stocks Will Fall After the New Year - Motley Fool - January 5th, 2020
- Free Gene Therapy Available for Patients with Alzheimer's - HealthITAnalytics.com - January 5th, 2020
- Chinese Researcher Who Created Gene-Edited Babies Sentenced To 3 Years In Prison - NPR - January 5th, 2020
- Duke Researchers Garner Over $6 Million in NIH Funding to Fight Genetic Diseases - Duke Today - January 5th, 2020
- Stanford Team Proposes Automated Clinical Trial Accrual Strategy, Increased Trial Annotation - Precision Oncology News - January 5th, 2020
- Dr. Timothy Eberlein and Alvin Siteman named Citizens of the Year 2019 - STLtoday.com - January 5th, 2020
- Did Cellectis Just Provide a Glimpse of the Future of Cellular Medicine? - The Motley Fool - December 27th, 2019
- Sickle Cell Therapy With CRISPR Gene Editing Shows Promise : Shots - Health News - NPR - December 27th, 2019
- Sarepta Therapeutics Announces Partnership with Roche in Territories Outside the United States for its Investigational Micro-dystrophin Gene Therapy... - December 27th, 2019
- What is multifocal pneumonia, the illness ESPN reporter Edward Aschoff tweeted about before his death? - USA TODAY - December 27th, 2019
- The travellers within us - Myanmar Times - December 27th, 2019
- This Start-up Might Be the Next Gene Editing IPO - The Motley Fool - December 19th, 2019
- How to bring precision medicine into the doctor's office - World Economic Forum - December 19th, 2019
- Form of severe malnutrition linked to DNA modification - Baylor College of Medicine News - December 19th, 2019
- 'Polygenic' profile could better predict disease risk for those with cancer mutations - Science Magazine - December 19th, 2019
- Here's Why You Should Avoid Betting on RPC (RES) Stock Now - Nasdaq - December 19th, 2019
- UNC Police Investigating Series of Credit Card Thefts on South Campus - Chapelboro.com - December 19th, 2019
- Personalized CF Medicine to be Tested for Rare Genetic Defects in Europe - Cystic Fibrosis News Today - December 19th, 2019
- Has Innovative Industrial Properties (IIPR) Outpaced Other Finance Stocks This Year? - Nasdaq - December 19th, 2019
- BioReference Laboratories Showcases 2019 Growth through the Addition of Cutting Edge Tests, Greater Access to Services, and Optimized Patient... - December 19th, 2019
- Gene Therapy Arrives - Scientific American - December 18th, 2019
- Detection of Secondary Metabolites as Biomarkers for the Early Diagnos | DMSO - Dove Medical Press - December 18th, 2019
- Roche concludes acquisition of Spark Therapeutics, Inc. to strengthen presence in gene therapy - GlobeNewswire - December 18th, 2019
- 10 Years Ago, DNA Tests Were The Future Of Medicine. Now Theyre A Social Network And A Data Privacy Mess. - BuzzFeed News - December 18th, 2019
- Mosaic Angelman Should Be in Differential Diagnosis of AS, Study Says - Angelman Syndrome News - December 18th, 2019
- Sarepta Therapeutics Announces $250 Million of Non-Dilutive Senior Secured Loan Financing - Yahoo Finance - December 18th, 2019
- Triplet Therapeutics Launches with $59 Million in Financing to Further its Development of Transformative Treatments for Triplet Repeat Disorders -... - December 18th, 2019
- Genetic clues of TB spread between cows and badgers revealed - Irish Times - December 18th, 2019
- The first U.S. trials in people put CRISPR to the test in 2019 - Science News - December 18th, 2019
- Care Coordination and Precision Medicine Improve Early Diagnoses - HealthPayerIntelligence.com - December 13th, 2019
- Penn Team Finds Genetic Variant Largely Found in Patients of African Descent that Increases Heart Failure Risk - Clinical OMICs News - December 13th, 2019
- For Nobel laureates, a whirlwind welcome - The Hub at Johns Hopkins - December 13th, 2019
- A Nobel journey a lifetime in the making - The Hub at Johns Hopkins - December 13th, 2019
- Teams of Microbes Are at Work in Our Bodies. Drexel Researchers Have Figured Out What They're up to. - DrexelNow - Drexel Now - December 13th, 2019
- 5 things a Nobel Prize winner wants you to know about science - Futurity: Research News - December 13th, 2019
- Aspen Neuroscience Launches With $6.5 Million Seed Funding to Advance First-of-its-Kind Personalized Cell Therapy for Parkinson's Disease - P&T... - December 13th, 2019
- Researchers unfold genetic code that controls cell function and disease - BSA bureau - December 13th, 2019
- Cannadabis: tissue culture and the future of cannabis cultivation - Health Europa - December 13th, 2019
- The genetic mutation behind a new autoinflammatory disease - Pursuit - December 13th, 2019
- 21st century medicine helps Amish deal with rare, inherited illnesses - University of Wisconsin-Madison - October 19th, 2019
- Research presented by Invitae at the American Society of Human Genetics Meeting Pushes Science and Practice of Genetics Forward - P&T Community - October 19th, 2019
- How Artifical Intelligence Is Advancing Precision Medicine - Forbes - October 19th, 2019
- Ochsner Health System teaming up with Color on population health pilot - FierceHealthcare - October 19th, 2019
- Scientists at Wake Forest School of Medicine Identify Genetic Variation Linked to Severity of ALS - Newswise - October 19th, 2019
- 100 Health Summit: How to Make Research Better | Time.com - TIME - October 19th, 2019
- Genetic counselors save health care dollars when involved in the testing process | TheHill - The Hill - October 19th, 2019
- New Gene Therapy Approach Reduces Cost and Improves Efficiency - DocWire News - October 19th, 2019
- NIH funds new All of Us Research Program genome center to test advanced sequencing tools - National Institutes of Health - October 19th, 2019
- Gait and Aging; Statin Use in Kids: It's PodMed Double T! - MedPage Today - October 19th, 2019
- SIDS May Be Linked To A Genetic Inability To Digest Milk, Study Finds - Moms - October 19th, 2019
- Are Pricey Fertility Treatments Helping Women Have Babies...Or Preying On Them? - Women's Health - October 19th, 2019
- My Daughter and I Were Diagnosed With Autism on the Same Day - NYT Parenting - October 19th, 2019
- Embodied: The Elusive Science Of Sleep - WUNC - October 19th, 2019
- Cryptocurrency News: This Week on Bitfinex, Tether, Coinbase, & More - May 25th, 2019
- Ripple Price Forecast: XRP vs SWIFT, SEC Updates, and More - May 25th, 2019
- Cryptocurrency News: Bitcoin ETFs, Andreessen Horowitz, and Contradictions in Crypto - May 25th, 2019
- Cryptocurrency News: Looking Past the Bithumb Crypto Hack - May 25th, 2019
- Cryptocurrency News: XRP Validators, Malta, and Practical Tokens - May 25th, 2019
- Cryptocurrency News: Bitcoin ETF Rejection, AMD Microchip Sales, and Hedge Funds - May 25th, 2019
- Cryptocurrency News: What You Need to Know This Week - May 25th, 2019
- Cryptocurrency News: New Exchanges Could Boost Crypto Liquidity - May 25th, 2019
- Cryptocurrency News: Vitalik Buterin Doesn’t Care About Bitcoin ETFs - May 25th, 2019
- Bitcoin Rise: Is the Recent Bitcoin Price Surge a Sign of Things to Come or Another Misdirection? - May 25th, 2019