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From suicide prevention to genetic testing, there’s a widening disconnect between Silicon Valley health tech and outside experts who see red flags

From suicide prevention to genetic testing, there’s a widening disconnect between Silicon Valley health tech and outside experts who see red flags

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Samantha Lee/Business insider
  • As Silicon Valley tech companies increasingly push into the realm of healthcare, outside experts and clinicians are raising red flags.
  • In the cases of suicide prevention, genetic testing, and e-cigarettes, lives may hang in the balance.
  • In the tech universe, much of the motivation for a new technology is wrapped up in its potential to disrupt existing markets.
  • In healthcare, clinicians have to think about what could happen to someone after they use the tool they are given. The risk of harm is high.
  • Visit Business Insider’s homepage for more stories.

When the Harvard psychiatrist and tech consultant John Torous learned that Facebook monitors its users’ posts for warning signs that they might be at risk of suicide, he was shocked.

Having grown accustomed to working with tech giants like Microsoft on scientific research, he wondered why he’d never heard about Facebook’s program. He was even more surprised to find out that as part of its efforts, Facebook was sending emergency responders to people’s homes.

Facebook’s monitoring tool has been running since 2017 and was involved in sending emergency responders to people more than 3,500 times as of last fall, the company said. But the reason Torous hadn’t heard of it is because the company hasn’t shared information about the tool with researchers such as him, or with the broader medical and scientific community.

Without that information, Torous said, big questions about Facebook’s suicide-monitoring tool are impossible to answer. Torous is worried the tool might home in on the wrong users, discourage frank discussions about mental health on the platform, or escalate, or even create, a mental-health crisis where there wasn’t one. In sum, Torous said Facebook’s use of the tool could be harming more people than it’s helping.

“We as the public are partaking in this grand experiment, but we don’t know if it’s useful or not,” Torous told Business Insider.

Facebook says the tool isn’t a health product or research initiative but more akin to calling for help if you see someone in trouble in a public space.

It is the latest example of a trend in Silicon Valley, where the barriers that separate tech from healthcare are crumbling. A growing array of products and services – think Apple Watch, Amazon’s Alexa, and even the latest meditation app – straddle the gap between health innovation and tech disruption. Clinicians see red flags. Tech leaders see revolution.

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Silicon Valley’s critics like to point to Theranos as a dramatic example of what can go wrong as a result of the breakdown. Bolstered by big investors, the secretive blood-testing startup reached a valuation of $9 billion, despite publishing little research showing its tech worked. When it was gradually revealed that the advanced technology required for its devices did not exist, the company and its founder, Elizabeth Holmes, toppled.

Clinicians and researchers interviewed for this article said that tech products and services could often be overhyped or even harmful, even if they couldn’t reach Theranos-level deception. They said the health claims that companies make frequently run ahead of the evidence – a problem when people’s health is on the line.

“There’s almost this implicit assumption that they play by a different set of rules,” Torous said.

Take Juul, which is now the top seller of e-cigarettes in the US. When the San Francisco company launched its high-nicotine vaping devices, it styled them as compatible with a healthy lifestyle. When Juul was then tied to a teen-vaping epidemic, experts called attention to Juul’s lack of published health research and its youthful launch campaign. Had Juul been required to rigorously study its e-cigarettes before flooding the market with them, the company might have avoided putting youth at risk, experts say.

Founded in 2006, 23andMe is one of the oldest Silicon Valley healthcare startups. The company has long portrayed its genetic tests as helping people take better control of their health by providing a snapshot of their risk of diseases like late-onset Alzheimer’s and cancer. In 2013, however, regulators forced the company to stop selling the tests on the grounds that they hadn’t proven their results to be accurate with published research.

Now, with limited regulatory sign-off and dozens of published studies, 23andMe is selling its health tests once again. Yet clinicians still call the reports subpar. These experts say the reports can mislead. They point out that although regulators have approved of them as medical tools, the bar for that threshold was significantly lowered recently. 23andMe, on the other hand, says its reports are empowering and touts regulators’ blessing.

‘The walls are breaking down fast’

Some experts find 23andMe's health reports concerning.

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Some experts find 23andMe’s health reports concerning.
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Hollis Johnson/Business Insider

In the view of Laura Hercher, the director of research in human genetics at Sarah Lawrence College, tech companies and clinicians approach health problems from fundamentally different perspectives. Where tech tends to prioritize disruption and convenience, healthcare puts an emphasis on safety.

But the invisible barriers that once separated tech from health are deteriorating, she said. In the meantime, patients and consumers may suffer the consequences, other experts say.

“The walls are breaking down fast,” Hercher told Business Insider. “There’s going to be a lot to figure out as we go along.”

At Facebook, a health problem came to the company. Staff had known there was an issue since 2009, when a cluster of suicides occurred at two high schools near the company’s headquarters in Palo Alto. Then, things became personal. After the company rolled out a livestreaming tool called “Facebook Live” several people used it to livestream their suicides. First it was a 14-year-old girl and then a 33-year-old man, both in the US. Later, in the fall, a young man in Turkey broadcast himself taking his own life.

Facebook tasked its safety-and-security team with doing something about it.

The team spoke with experts at several suicide-prevention nonprofits, including Daniel Reidenberg, the founder of Save.org. Reidenberg told Business Insider that he helped Facebook create a solution by sharing his experiences, bringing in people who’d struggled personally with suicide, and having them share what helped them.

The result was Facebook’s suicide-monitoring algorithm, or, as the company calls it, its suicide-prevention algorithm. Using pattern-recognition technology, the tool identifies posts and livestreams that appear to express intents of suicide. It scans the text in a post, along with the comments on it, such as “Are you OK?” When a post is ranked as potentially suicidal, it is sent first to a content moderator and then to a trained staff member tasked with notifying emergency responders.

Clinicians and companies disagree on the definition of health research

Antigone Davis, Facebook’s global head of safety, told Business Insider that she likens the tool to crisis response and does not consider it health research. She said Facebook doesn’t store data on individuals related to what the algorithm detects about their suicide risk.

“The AI is working on the content, not on the individual,” Davis said.

It is unclear how well the tool works. Because of privacy issues, emergency responders can’t tell Facebook what happened at the scene of a potential suicide, Davis said. In other words, emergency responders can’t tell Facebook if they reached the scene too late to stop a death, showed up to the wrong place, or arrived only to learn there was no real problem.

Torous, a psychiatrist who’s familiar with the thorny issues in predicting suicide, is skeptical. He points to a review of 17 studies in which researchers analyzed 64 different suicide-prediction models and concluded that the models had almost no ability to successfully predict a suicide attempt.

“It’s one thing for an academic or a company to say this will or won’t work. But you’re not seeing any on-the-ground peer-reviewed evidence,” Torous said. “It’s concerning. It kind of has that Theranos feel.”

Reidenberg told Business Insider that he believes Facebook is doing good work in suicide, but because its efforts are in uncharted waters, he thinks everyday issues will arise with the tool. He disagrees with Torous’ view that the efforts are health research. “There isn’t any company that’s more forward-thinking in this area,” Reidenberg said.

Something that’s easier or prettier may not be good enough in healthcare

When Pax Labs launched the Juul e-cigarette in 2015, the company had published no health research on the device.

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When Pax Labs launched the Juul e-cigarette in 2015, the company had published no health research on the device.
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Melia Robinson/Business Insider

Juul has long presented itself as a health-tech company and is eager to show that its devices can improve the health of adult smokers. When it launched its e-cigarettes in 2015 with a party in New York City, Juul’s then-parent company, the tech startup Pax Labs, called the Juul “smoking evolved.”

Before the launch party, though – and for several years afterwards – neither Pax nor Juul published any real health research. Then, reports of a vaping epidemic among teens began to surface.

Meanwhile, clinicians and academics looked at Juul’s devices and saw a big problem: They had a handful of qualities that made them uniquely appealing to young people.

Even compared with other e-cigarettes, Juul devices contain very high levels of addictive nicotine, which may help adult smokers but which also appear to interfere with learning and memory in the still-developing teen brain, according to Suchitra Krishnan-Sarin, a professor of psychiatry at Yale’s center for nicotine and tobacco research. Juuls are also easier to hide and to use discretely, another quality that could be helpful for adults but especially harmful for teens, Krishan-Sarin said.

Other experts point to Juul’s 2015 ads – which depicted young models on flashy backgrounds – and Juul’s sweet flavors, such as crème brûlée and cool cucumber. They say both appealed uniquely to youth. Had the startup studied its devices before selling them, those problems may have been foreseeable, they say.

“The problem is Juul products just came onto the market without any regulation and without any controlled studies,” Krishnan-Sarin told Business Insider.

In a statement emailed to Business Insider, a Juul spokesperson said the company “exists to help adult smokers switch from combustible cigarettes, which remain the leading cause of preventable death around the world,” and added that Juul is now publishing research. The representative also said the company is committed to preventing youth access to its products and supports raising the national tobacco and vapor purchasing age to 21.

“We invite those who criticize us for launching in 2015 to talk to former smokers about the impact switching to Juul has had on their lives,” the spokesperson said.

Who are 23andMe’s genetic tests for?

Then there’s 23andMe, which rolled out the health and disease component of its genetic tests in 2013, before publishing research that showed the tests to be accurate, according to regulators at the US Food and Drug Administration. Today, the agency has approved of 23andMe’s products as medical tools, thanks in part to a less-stringent process introduced last year. In addition, the company has now published dozens of basic research papers. But clinicians say those things don’t mean the tests are safe.

Jeffrey Pollard, 23andMe’s director of medical affairs, told Business Insider that its tests are designed for healthy people who want to learn more about their genes and are not intended to meet the level of care designed for the clinic. He said the company is clear in how it communicates that to customers. Pollard also said 23andMe regularly engages with experts outside the company to ensure their products are up-to-date.

“I think it’s obvious that genetics and the tests we provide are quite impactful, and in that way, we deserve to be paid attention to and embraced,” he said.

But to Hercher, 23andMe’s reports are concerning for several reasons. One is that the tests don’t include counseling, a service that she and other experts see as critical to ensuring that people understand their results and their real risk of disease. Another is that they are not comprehensive because they only look at a select few genes involved in one’s risk of disease.

“Producing something that kind of works and is faster, cheaper, or easier isn’t always an adequate answer if it turns out to put some people at risk,” she said.

‘Move fast and break things’ versus ‘first, do no harm’

Facebook CEO Mark Zuckerberg answered questions about privacy at a Senate committee last year.

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Facebook CEO Mark Zuckerberg answered questions about privacy at a Senate committee last year.
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Chip Somodevilla/Getty Images

A decade ago, Facebook cofounder and CEO Mark Zuckerberg told Business Insider founder Henry Blodget that his prime directive to his team was to “move fast and break things.”

“Unless you are breaking stuff,” he said, “you are not moving fast enough.”

It has become the unofficial motto of Silicon Valley.

But experts including Torous say that mantra is at odds with medicine’s Hippocratic oath, in which doctors swear to “first, do no harm.”

In the cases of suicide prevention, genetic testing, and e-cigarettes, lives may hang in the balance. In the tech universe, much of the motivation for a new technology is wrapped up in its potential to disrupt existing markets. But in healthcare, clinicians have to think about what could happen to someone after they use the tool they are given.

Healthcare is an industry that requires particular caution because patients are often in a vulnerable position. They might be sick or facing an elevated risk of disease or death. The chance of causing harm is high.

Hercher and Torous said that academics and clinicians play by rules different from Silicon Valley’s.

“It’s not that we’re dealing with different fact sets – we have different obligations,” Hercher said. “We live in different universes.”

Academics are worried about vulnerable populations

DNA Testing 23andMe

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Hollis Johnson/Business Insider

Torous is worried that Facebook’s suicide-monitoring tool doesn’t work very well, especially based on what he’s seen published about other similar algorithms. He’s also concerned that it could cause problems by either identifying the wrong people, which would add stress to an already strained healthcare system and waste money, or by discouraging Facebook users from speaking frankly about their mental state with their peers.

“We know Facebook built it and they’re using it, but we don’t really know if it’s accurate, if it’s flagging the right or wrong people, or if it’s flagging things too early or too late,” Torous said.

Krishnan-Sarin and University of Southern California preventive-medicine professor Jessica Barrington-Trimis are concerned that even if Juul helps adult smokes, the products could hurt thousands of young people who wouldn’t have otherwise smoked by making them more likely to pick up a cigarette.

“We want smokers to quit. If you can provide them with a cleaner form of nicotine, that’s great. But many kids say they go through a whole pod in 24 hours. That’s very concerning. Nicotine is a neurotoxin to the adolescent brain,” Krishnan-Sarin said.

In a similar vein, Hercher and Ross are worried that people at a high risk of disease who take a 23andMe test could be harmed. Both of them said the tests are set up in a way that customers could believe that they’ve been screened for a serious disease such as cancer, for example, when in reality, they have not.

One case of this occurred in 2010 when an oncologist named Pamela Munster took a 23andMe breast cancer test and was relieved to learn she was negative, as the New York Times reported.

Two years later, Munster learned she had breast cancer. A more thorough clinical test revealed that indeed, she had a genetic mutation that had raised her risk of the disease. It was a mutation that 23andMe didn’t test for.

“It’s like you bring your car in for service and they say, ‘OK, we checked your rear right brake and it’s working,’” Hercher said. “If you think you’ve just had your car serviced, you’ve not been well informed.”

A developing playbook for health-tech startups: Publish more research

To John Ioannidis, an early Theranos skeptic and a professor of medicine at Stanford University, the time is ripe for another Theranos-like debacle in health tech. In January, he and a team of researchers published a study that suggests that of all the well-funded health-tech startups out there, very few are publishing scientific literature.

The answer to avoiding that problem is simple, he and his coauthors suggest: The startups need to start publishing results. “Startups are key purveyors of innovation: holding them to a minimum standard of evaluation is essential,” they wrote.

Peer-review research involves subjecting your work to a group of outside experts in the same field. Whether it’s a biotech company claiming its new therapy can cure cancer or a tech company that is trying to prevent suicide, those assertions can and should be measured and quantified, Ioannidis and his coauthors say.

Juul appears to have heeded Ioannidis’ call.

Starting this year, the company began to publish health research and told Business Insider last month that it was beefing up its research efforts with a team focused on doing more of that kind of work. Business Insider also exclusively reported that Juul is also exploring a digital-health offering that could complement its devices with an app or other smartphone-based tool designed to help smokers quit.

In addition, Juul has made over its image and done away with ads that outside experts said appealed to teens. Advertisements that featured young models on bright backgrounds have been swapped for images of adults with pops of gray in their hair. A neon online color scheme has shifted to muted hues of navy and gray. Flavors such as cool cucumber and crème brûlée have been shortened to cucumber and crème.

Juul pod flavors

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Hollis Johnson/Business Insider

“We are committed to continuing to research the potential public health impact of our products and have over 100,000 participants enrolled in behavioral studies across the world,” the Juul spokesperson said.

Prioritize safety

In addition to publishing research, experts say startups need to place a clearer emphasis on safety and transparency. To do that, companies like 23andMe, Juul, and Facebook all need to think more about how their tools might impact potentially vulnerable people.

“There have to be quality controls, there has to be truthfulness,” Hercher said. “Is simply having good information enough? There has to be a line somewhere.”

Facebook maintains that its work in suicide does not fall under the domain of health, but instead is restricted to emergency response. It has not published any data on the algorithm.

As far as the world of genetic-testing is concerned, experts say it’s still something of a Wild West for customers, but a handful of companies are trying to address that. They hope to combine the convenience and simplicity of 23andMe with the thorough nature of a clinical experience.

Invitae, one startup, recently announced plans to roll out a test that, like 23andMe’s, could be ordered by consumers, only it would incorporate genetic counseling and require a doctor’s sign-off. Last month, another startup called Helix launched a comparable test that includes optional genetic counseling. And Color Genomics has long had a test that works similarly and links customers to genetic counselors over the phone.

“There’s some great science out there,” Ross said. “I want to see more of it.”

Google’s life-extension spinoff teamed up with Ancestry to study 54 million family trees — and learned that a surprising factor helps determine how long we live

Google’s life-extension spinoff teamed up with Ancestry to study 54 million family trees — and learned that a surprising factor helps determine how long we live

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Yulia Mayorova/Shutterstock
  • Genealogy and DNA site Ancestry once partnered with Google’s stealthy life-extension spinoff, a company called Calico, to study the genetics of longevity.
  • The new study suggests that our genes play less of a role in how long we live than previously believed.
  • Instead, traits and behaviors that include everything from diet and exercise to friendliness appear to play a strong role in longevity.
  • But surprisingly, we still pass these traits on through generations – mostly by picking partners who look and act like us, the researchers suggest.

The road to achieving a long life is littered with hype. The usual life-extension suspects include pricey pills and supplements; the peculiar involve infusions of young blood and chambers pumped with sub-zero temperatures.

Then there’s science. And one scientific factor that has long been presumed to dictate much of how long we live is our DNA. For decades, it was assumed that the genes we inherit from our parents explain anywhere from 15% to 30% of the variations in longevity that are observed between people.

But a new study that came from quiet collaboration between genetics company Ancestry and a Google life-extension spinoff called Calico suggests that our genes play less of a role in our lifespan than we thought.

Instead, traits and behaviors that include everything from diet and exercise to friendliness appears to play a strong role in longevity. Surprisingly, we still pass these traits on through generations – mostly by picking partners who look and act like us, the researchers report.

In essence, the findings suggest that people effectively transfer longevity from one generation to the next much in the same way that wealth and socioeconomic status are passed from parents to children: by choosing partners with attitudes and attributes that mirror our own, regardless of how different their DNA may be.

Picking partners who act and think like us

older people

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seyfettin dincturk / Unsplash

For decades, researchers studying longevity and genetics had estimated that the genes we inherit from our parents play a significant role in determining how long we live. Previous studies suggested that genes account for as much as 30% of the total variability in lifespan between individuals.

But the new study from Ancestry and Calico indicates that our DNA may be much less important in determining longevity than traits and behaviors like diet, exercise, and personality. After looking at data from more than 54 million family trees and the birth and death information for over 400 million individuals, the researchers concluded that our DNA accounts for less than 10% of lifespan variability.

Instead, we pass on longevity through generations by choosing partners whose attitudes and attributes look much like our own. In research parlance, that’s known as “assortative mating.”

“The true heritability of human longevity for birth cohorts across the 1800s and early 1900s was well below 10%, and … has been generally overestimated due to the effect of assortative mating,” the scientists wrote.

Put another way, we tend to pick partners with attitudes and attributes – from eating and exercising to friendliness – that mirror our own. And as a result, we tend to live similar amounts of time, and have children who do as well.

How friendly we are and how often we work out may play a stronger role in our longevity than our DNA

woman running jogging exercise

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Shutterstock

Previous studies shed light on how important lifestyle factors are when it comes to how long we live. In a recent study published in the journal Circulation, for example, scientists pinpointed five lifestyle factors that appear to be linked with a significantly longer lifespan, judging by the outcomes of two long-term studies that involved about 123,000 adults.

People in the study who lived long lives tended to:

  • Do at least 30 minutes of cardio exercise every day.
  • Eat a Mediterranean diet.
  • Never smoke.
  • Stick to a healthy body weight.
  • Drink no more than 1-2 alcoholic beverages a day.

As part of several other recent studies, scientists have uncovered a handful of personality traits that also appear to be strongly linked to longer-than-average lives. They include:

Taken together, the findings suggest that how long we live may be less a matter of what we’re born with than the circumstances in which we live and the choices that we make. Those choices, as the Ancestry and Google researchers acknowledge in their new paper, tend to be based on everything from social status to wealth and then, just like genetics, passed on from one generation to the next.

6 medical questions you should ask your family to better predict your own health

6 medical questions you should ask your family to better predict your own health

Knowing the answers to certain medical questions can help you to calculate your potential future health risks.

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Knowing the answers to certain medical questions can help you to calculate your potential future health risks.
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ABC

Some medical conditions are hereditary or influenced by your genes, so it can be proactive to learn more about your family’s medical history. In some cases, it can help you start taking the appropriate steps if certain diseases or conditions do run in your family.

To spark that conversation, INSIDER spoke with several doctors to find out which questions you should ask your family to better understand your health.


Do you, or any of our blood relatives, have any chronic health conditions like diabetes, high blood pressure, heart disease, kidney disease, Alzheimer’s disease, etc.?

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Knowing this information can help you to better gauge your risk for developing certain conditions.
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Rawpixel/iStock

It’s important to know the answer to this question because your chances of developing a chronic health condition are much higher if your parents or immediate family members have such a condition, according to Kumar Dharmarajan, MD, MBA, Chief Scientific Officer at Clover Health.

Genetics play a key role in high blood pressure, heart disease, and other related conditions, meaning some people are more susceptible to developing these conditions than others.

Dr. Dharmarajan explained that when you know your family’s medical history you can work with your doctor to identify potential risk factors and develop a plan to delay or even prevent the onset of some of these conditions.


Did you or anyone in your family ever have problems with anesthesia?

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The answer can help you figure out if you have a rare genetic mutation.
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Getty Images/Carsten Koall

There is an extremely rare hereditary genetic mutation that can actually cause a deadly reaction when put under anesthesia, Celine Thum, MD of ParaDocs Worldwide, Inc told INSIDER. The condition is called Malignant Hyperthermia Syndrome (MHS).

Knowing if your family has a history of MHS can help you plan for the use of different drugs to control pain and sedation during any future surgeries.


Have you, or any of your blood relatives, had a major medical event such as a heart attack, stroke, or cancer diagnosis?

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Knowing your risk factor can be helpful.
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AFP

In many instances, if your parents or immediate family members have experienced major disease complications or health events, there’s a higher risk you may have similar issues, Dr. Dharmarajan told INSIDER.

The good news is that the risk factors are modifiable and early detection and treatment can potentially prevent serious illness such as stroke and heart attacks, adds Dr. Thum.

Plus, depending on your history, your doctor may encourage early screenings for cancers or other diseases that run in the family, depending on the age that your family members were diagnosed.


Is there any history of mental health issues in our family, including alcoholism or other kinds of substance abuse?

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In some cases, you could be more at risk. for developing certain issues.
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Shutterstock

Your chances of having a mental illness are sometimes higher if a family member also has a mental illness such as ADHD, bipolar disorder, and schizophrenia, said Dr. Dharmarajan.

You may also want to ask if your family has a history of alcoholism or substance abuse because some risk factors for mental illness are passed on behaviorally. A New Zealand study found that the more relatives a person had with major depression, anxiety, or alcohol or drug dependence, the more likely they were to have that condition, too.


Have you been tested for genetic diseases?

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This is especially good to know if you plan to have children.
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Syda Productions/Shutterstock

If your parents carry any disease genes, there is a chance you have inherited those gene mutations that could cause problems for your future biological children, should you choose to have any.

Even though you may not have the disease, you could be a carrier with only one disease gene. If you have a biological child with someone who also is a carrier of the same disease gene, then your child could develop the disease. There is an increased chance you and your partner carry the same disease-causing gene if you’re of the same ethnic background.


Has anyone in your family died at a young age and if so, was the cause known?

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There could be a hereditary condition in your family.
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John Moore/Getty Images

There are some hereditary heart conditions that may go undetected unless early testing is done, said Dr. Thum.

One of these conditions is Hypertrophic Cardiomyopathy (HCM), a disease in which the heart muscles become abnormally thick, making it harder for the heart to pump blood. Oftentimes HCM goes undiagnosed in people who have the disease because so few symptoms exist.

But if you know that someone in your family has HCM or another hereditary heart condition, you can be proactive by letting your doctor know so you can receive early testing and treatment.

Visit INSIDER’s homepage for more.

The CEO of Silicon Valley DNA testing startup 23andMe shares the health product she hopes to sell next

The CEO of Silicon Valley DNA testing startup 23andMe shares the health product she hopes to sell next

23andMe Co-Founder and CEO Anne Wojcicki

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23andMe Co-Founder and CEO Anne Wojcicki
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Steve Jennings/Getty Images for TechCrunch
  • Anne Wojcicki, the CEO and founder of Silicon Valley’s most popular genetics testing startup, 23andMe, said this week that she hopes the company expands its current health offering lineup.
  • 23andMe, which made headlines recently on the heels of a new $300-million partnership with drug giant GlaxoSmithKline, currently offers health screenings for some of the genes involved in breast cancer, Alzheimer’s, and Parkinson’s.
  • On Tuesday, Wojcicki said she hopes to add a new health offering that looks at how you process medications including those for depression.
  • Albertsons pharmacies and gene testing startup Color Genomics currently offer that kind of test for $250-$750, but many scientists say it’s not worth the money.

Anne Wojcicki, the CEO and founder of popular Silicon Valley gene testing company 23andMe, doesn’t feel like the company is currently offering what she called a “complete product.”

That’s because the current gene testing kit – which includes health screenings for some of the genes involved in Alzheimer’s, Parkinson’s, and breast cancer – does not include a test that looks at how you process medications including those for depression.

Those DNA tests, which assess genes involved in the break down of antidepressants in the body, are currently being offered by psychiatrists and Albertsons pharmacists in three major cities at a hefty price tag of $750. Just last month, another Silicon Valley genetics testing startup called Color Genomics began offering the test as part of its $250 kits.

And on Tuesday at a conference organized by Rock Health, one of Silicon Valley’s premier health-tech funding groups, Wojcicki said she hoped her company could include that kind of test in its product lineup soon.

But many scientists feel the tests don’t offer a clear benefit to people and in some cases are not worth the money. Among other issues, the tests may give conflicting results to the same patient for the same medication and don’t tell providers which specific medication is best, according to experts.

‘When we can bring pharmacogenomics back, then we have a complete product back’

23andMe kit

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Lydia Ramsey/Business Insider

In the early days of 23andMe, the company included a test for depression medications in its lineup of health offerings, Wojcicki said. But in 2013, the Food and Drug Administration forced the company to stop selling those products and get federal approval on the grounds that the tests could be misinterpreted as health advice. The company was allowed to continue selling the genealogy component of its kit, which looks at ancestry.

Last year, the FDA gave the company the green light to again sell some of its health screenings. On the heels of that decision, 23andMe rolled out a limited selection of some of its original products. The most recent addition, unveiled in March, is a test for some of the genes involved in the risk of developing breast cancer, also known as BRCA genes.

Now, the company is only missing one of those original health products, Wojcicki said: a test for depression medications, also called pharmacogenomics.

“The only one we don’t have back yet is pharmacogenomics. We used to have that and we’d like to have that one come back,” Wojcicki said on Tuesday at a panel discussion at the Rock Health Summit in San Francisco.

“When we can bring pharmacogenomics back, then we have a complete product back,” she said.

It remains to be seen how the company would roll out such a test. Because 23andMe sells its tests directly to people (they can be purchased online and at a selection of drug stores), it would need to get FDA approval before selling an additional health product. The test could be incorporated into the existing health lineup, which currently includes tests for Alzheimer’s, Parkinson’s, and breast cancer for $199, or it could be sold as a stand-alone test.

Color Genomics chose to incorporate its new pharmacogenomics product into its existing $250 test. Unlike 23andMe, which sells its services directly to consumers, Color requires people to order their tests through a medical provider. In addition, the company mandates talking with a professional genetics counselor and a clinical pharmacist to avoid potentially dangerous misinterpretations of the results.

Genomind and Assurex, the two companies who offer a standalone pharmacogenomics product, sell the test through psychiatrists and some pharmacists for $750.

Wojcicki did not provide further details on how much the test – should the company ultimately choose to offer it – would cost or when it would be available. A company representative also declined to offer Business Insider more information about the test. But Wojcicki said she saw the pharmacogenomics service as part of the company’s overall mission to help empower customers with more data about themselves and prevent negative health outcomes when possible.

“I think one thing genetics can do is help prevent a lot of early deaths,” Wojcicki said.

A DNA test offered by Albertsons claims to tell you which antidepressant is best for you, but scientists say it’s not worth the money

A DNA test offered by Albertsons claims to tell you which antidepressant is best for you, but scientists say it’s not worth the money

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Flickr/Jane Rahman
  • Several companies make DNA tests that claim to tell you how well you’ll respond to certain antidepressants based on your genetic profile.
  • Two personalized medicine companies – Assurex and Genomind – offer some of the most popular tests and work with physicians and pharmacists to provide them to patients.
  • A chain of Albertsons pharmacies in Chicago, Philadelphia, and Boise is running a pilot program in which pharmacists can offer the Genomind test.
  • Silicon Valley genetics testing startup Color Genomics recently began offering a similar test as part of its services.
  • The costs of the tests range from $250 to $750, but some scientists say it’s not worth the money.

Around the time that 26-year-old Courtney Luk got in line at the pharmacy to pick up her 25th depression medication, she decided she’d had enough.

Over the previous two years, Luk had been prescribed everything from Klonopin to Xanax to treat the anxiety and depression she’d experienced since adolescence. Nothing seemed to do the trick. One medication would make her feel numb; others seemed to make her symptoms worse.

Then a psychiatrist suggested she try a genetic test that could provide guidance about which drug Luk should try next. They swabbed the inside of Luk’s cheek for a spit sample and sent it off to get tested.

Using DNA testing to determine how well a given depression medication will work with a patient’s genetic makeup is becoming a popular approach. More than 750,000 people have taken one such test, called GeneSight, which is made by personalized medicine company Assurex, according to its website. A network of 28 Albertsons pharmacies offers a similar test made by a company called Genomind as part of a pilot program. And just last month, Silicon Valley genetics testing startup Color Genomics began offering a test as part of its $250 kits.

But some scientists say the tests have limited utility.

That’s because they doesn’t tell providers which specific medication is best to prescribe patients, according to Alan Schatzberg, a Stanford University psychiatrist and the director of the Stanford Mood Disorders Center. And Cristina Cusin, a Harvard psychiatrist, said the test won’t give helpful results to patients who take more than one medication.

Plus, the tests may give conflicting results to the same patient for the same medication, according to a peer-reviewed analysis of four different gene tests published this summer.

A pricey test with a lofty goal

DNA Swab

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Since adolescence, Luk had experienced debilitating anxiety that sometimes turned into panic attacks, along with mood swings and depression that sometimes led her to contemplate taking her own life. Despite trying more than two dozen different medications, Luk and her psychiatrists had yet to come up with a combination of drugs that significantly lifted her mood without contributing to her anxiety.

Luk had heard of genetics tests for antidepressants before, but previously declined to take one since she couldn’t afford the $750 price tag.

But when a psychiatrist suggested a test she could get for free through insurance, a kit from Genomind called the Genecept Assay, Luk said yes. The test appealed to her as a potential way to eliminate the trial-and-error process of starting a new drug and waiting – sometimes up to six weeks, the standard for most antidepressants – to see if it worked.

“I don’t feel like my medications right now are working optimally, and I was hoping to learn if there’s a cocktail of medications that would do that,” Luk said.

Her psychiatrist told her the test might show them what to do next. Perhaps they’d learn that one medication wasn’t right for her body and could be replaced with a different drug. But when the results came in, they were murkier than Luk anticipated.

Her report listed all the antidepressants she’d taken along with several she’d yet to try. Each got a colored check mark: red checks suggested Luk would likely have negative reactions to a drug, green checks suggested no negative reactions, and orange checks indicated something in between.

Next to a popular antidepressant called Celexa, for example, Luk’s test showed an orange check mark and said, “increased risk for adverse events or poor response.” That meant that because of the way her body processed the drug, Luk was more likely than the average person to experience negative side effects or see no positive results.

Sure enough, Luk recalled that when she’d taken Celexa several years earlier, she had experienced painful bruising across her arms and legs.

But another drug Luk had recently begun taking, called Topamax, carried a green check and said “use as directed – no known gene-drug interactions.” Despite taking that medication for several weeks, however, Luk said she hadn’t experienced any change in her symptoms.

So she went back to trial and error.

Daniel Dowd, Genomind’s vice president of medical affairs, acknowledged that some patients may read too much into the test.

“I think patients do tend to think, ‘OK, this is going say exactly what this specific drug is going to do for me,’ and that’s not what this test is,” Dowd told Business Insider. “Like any other branch of medicine, [the test] provides an estimation of risk.”

Genomind funded a 2018 study of its test that analyzed patient spending in the six-month period following use of the test. The authors – one of whom sits on Genomind’s scientific advisory board – compared roughly 800 people with mood and anxiety disorders who took the test with nearly 3,000 people who didn’t take it. They found that people who took the test spent nearly $2,000 less on healthcare on average, mostly because they visited ERs and hospitals less frequently in the months following the test than people who didn’t take it.

The researchers wrote that it could represent “a promising strategy to reduce costs” in people with depression and anxiety.

To Dowd, the finding was a big endorsement of the test.

“If we can get this test embedded in the healthcare record, that could mean a big cost savings,” he said.

Who the test may – and may not – help

Once you swallow a pill, various genes control how your body will break it down. One gene in particular, called CYP2D6, is one of the most closely studied. Some people have faulty or abnormal copies of that gene, meaning they don’t process drugs like antidepressants as they should. That increases the chances that someone could have an adverse reaction like bruising or not respond to a medication at all.

The gene tests are designed to assess whether a patient is likely to have a negative outcome on any common antidepressants. In theory, that would help patients and their providers narrow down the list of potential medications to try.

“In these cases, I think there is clear evidence” for using a gene test, Michelle Whirl-Carrillo, a senior research scientist at the Stanford University School of Medicine, told the author of an article published by the Journal of the American Medical Association (JAMA).

But Schatzberg, the Stanford psychiatrist, said a narrower list is not what his patients need.

“What’s really needed is a test that says, ‘You have this profile, these are the two drugs you need to use.’ That’s what’s missing,” he said.

Instead, the tests merely tell him if someone’s body doesn’t process a drug properly – a conclusion they’d reach anyway after trial and error.

“I don’t necessarily need to know up front if a person is a poor drug metabolizer. I need to know which specific drug to use where I will get the positive effect with less side effect burden,” Schatzberg said. “These tests don’t do that.”

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Cusin, the Harvard psychiatrist, specializes in treating people with severe depression. She agreed with Schatzberg.

“I don’t think psychiatrists get much information about the costs and benefits or much predictive value for this type of test,” she said.

Cusin added that she doesn’t think the test helps in cases where people are taking multiple medications or when patients have a history of failing to respond to medications. Plus, she said, a recent study made her hesitant to use the tests in her own practice.

That study found major inconsistencies among four different gene tests (including Genomind’s). In roughly one out of five cases, the authors said, different tests gave conflicting advice to the same patient.

“The level of disagreement in medication recommendations … indicates that these tests cannot be assumed to be equivalent or interchangeable,” the researchers wrote.

‘I jumped on it because I was tired of trial and error’

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Unlike Luk, Allyson Byers, a 27-year-old in Los Angeles, said taking a genetic test saved her time in the quest to find the right medication.

Byers took Assurex’s GeneSight test after trying several drugs for her depression.

“I jumped on it because I was tired of trial and error,” she told Business Insider.

Byers said she paid $60 for the test after talking with her therapist and an Assurex representative (though she initially received a bill for several hundred dollars).

Her results weren’t perfect. Byers had been taking the antidepressant Zoloft for nine months, but she experienced several negative side effects, including weight gain. On the Assurex test, however, Zoloft was green-lit.

“When the results came back, I was questioning myself and thinking, ‘Did I make that all up? Did I really gain weight?’”

But the test also suggested another medication called Pristiq that Byers had not previously taken, she said. So Byers’ therapist suggested they try that instead of Zoloft. Several weeks later, Byers said she felt better – and thanked the test for helping her find a different medication.

“I’ve had to go up in dose a couple times, but I feel like I’ve finally found the right dose,” she said. For her, the test was “just another tool to help narrow things down.”

Coming to a pharmacy near you?

Increasingly, some patients are learning about genetics tests for antidepressants from their pharmacist instead of a psychiatrist.

In Chicago, Boise, and Philadelphia, 28 Albertsons drug stores are offering the Genomind test, according to Kimberly Hecht, a patient care services coordinator with Albertsons who leads the project.

She told Business Insider that mental health became a focus at the pharmacies she oversees when they began offering medications for drug addiction. Plus, because Albertsons’ pharmacies are open longer and on more days of the week than others nearby, they sometimes function as a default mental health provider, Hecht said.

“It just made sense with what we were offering and also because of our position in the community,” Jennifer Rapley, a marketing manager with Albertsons who works closely with Hecht, told Business Insider.

The project is currently in a pilot phase, but Genomind hopes to eventually offer its gene test in all 1,760 Albertsons-owned pharmacies throughout the country, JAMA reported this month.

But some components of the Albertsons program – such as how pharmacists determine whether a patient is a good candidate for the test and how it evaluates whether the results are effective – remain hazy.

For example, a patient does not have to have a history of using antidepressants to be offered the test, Hecht said.

“Typically it’s going to be patients who’ve tried a couple different things and it’s not working, but we kind of leave it up to our pharmacists’ professional judgment,” she said.

That makes Schatzberg wary.

“I think it presents real problems,” he said. “It’s practicing a level of medicine and offering a test where it’s not clear whether and how it should be used. It’s hard for me to believe that’s a good idea.”

The future of genetic testing for depression

Last month, Silicon Valley genetics testing startup Color Genomics began offering a test for antidepressants as a component of its DNA tests, which screen for gene variations linked to cancer and heart disease. Color’s service includes a professional genetics counselor as well as a clinical pharmacist who walk a patient through their results.

Othman Laraki, the company’s founder and CEO, told Business Insider that he sees the new test in a similar light to Color’s cancer test, which the company began offering in 2013.

“Like we saw with cancer, it’s definitely a moving target, it’s definitely still early, and there’s still a lot of uncertainty,” Laraki said. “But there’s enough support and enough scientific validity where it makes us feel comfortable enough to offer it.”

Hecht, the Albertsons coordinator, agreed.

“These types of tests really are the future and have the potential to really help people,” she said.

But for some patients, that future may not have arrived yet.

“After 25 different drugs, I may just be one of those people whose bodies doesn’t respond to medication,” Luk said. “In the end, it’s still trial and error, but it’s a little bit more of a targeted trial and error – a little bit more of an educated guess.”

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