ELIZABETH Holmes started with a simple idea.
Afraid of needles, the 19-year-old university student wondered if there was a better, less painful way of extracting blood and testing for diseases.
Afraid of needles, the 19-year-old university student wondered if there was a better, less painful way of extracting blood and testing for diseases.
Twelve years on — and after dropping out of school — her idea to patent a simple pinprick blood test has transformed her into one of America’s youngest self-made female billionaires. She has drawn flattering comparisons with Apple founder Steve Jobs and amassing her a net worth of roughly $5 billion, thanks in part to the $400 million investors have poured into her tests, which have been performed on millions of people.
But her astonishing rise has suddenly hit a troubling bump in the road.
On the fringes of her success story are suggestions the technology she patented is inaccurate and unsafe.
One of her business partners, biochemist Dr Ian Gibbons, took his own life in 2013, telling his wife “nothing was working” in the lab, the Wall Street Journal reported. But lawyers for Theranos deny the scientist’s work or technology failures at the company had anything to do with his suicide.
Last month news reports began to surface suggesting Ms Holmes’ test results were alarmingly off the mark, prompting Silicon Valley’s ‘it girl’ to come out swinging against critics, who she says view her company as “a target to be taken down”
‘NEEDLES ARE LIKE TORTURE’
“I really believe that if we were from another planet and we sat down to put our heads together on torture experiments, the concept of sticking a needle into someone and sucking their blood out would probably qualify as a pretty good one,” Ms Holmes once said.
Her idea as a teenager led to what has been hailed one of the biggest scientific breakthroughs in years.
Studying at Stanford University, one of America’s most elite schools, Ms Holmes envisaged a world with no more tourniquets and no more painful needles through the basilic vein.
She dropped out of school, teamed with Dr Gibbons in 2005 and launched Real-Time Cures in Palo Alto, California. She would later change the name to Theranos — an amalgam of “therapy” and “diagnosis”.
Ms Holmes and her team claimed patients could avoid painful — and costly — blood tests by drawing a tiny amount of blood from a patient’s finger. No big needles and no long wait for results.
She opened 42 “wellness centres” in 2013 in Phoenix, California and Pennsylvania by convincing politicians to allow patients to get tests without a doctor’s order.
“Theranos is working to reinvent the lab experience by providing high quality tests faster, cheaper, and more conveniently, requiring less blood, and causing less patient discomfort than ever before,” Ms Holmes said in a blog post on the company’s website last week.
A number of doctors have publicly supported her ambitious project. Scott Wood, a primary-care doctor in California told the Wall Street Journal he would continue to happily recommend Theranos to his patients.
“That’s exciting and could be very useful in emergency situations,” he said of the pinprick tests. When his patients ask about trying Theranos, he tells them: “Sure, go ahead.”
But others are sceptical. The company has been described as “highly secretive” and its refusal to publish its medical data in peer-reviewed journals has raised eyebrows.
Despite doubts about her company’s methods, Ms Holmes has said she still has no plans to make public its results, The New York Times reports.
THE CRITICS
Dr Gary Betz is one of the sceptics. The Phoenix-based GP told the WSJ a patient of his underwent a routine potassium test using the Theranos method and received a disturbing result, suggested he was close to the threshold considered critical. When the same patient was sent for traditional tests three days later, the results came back normal.
“I don’t want my patients going there until more information and a better protocol are in place,” he told the newspaper.
Former employees of Theranos have also spoken out about the program. One told regulators the company had failed to report results that raised questions about the accuracy of the pinprick system. Another said the company might have manipulated the proficiency-testing when reporting results.
Theranos responded in no uncertain terms, slamming the article as “factually and scientifically erroneous and grounded in baseless assertions” in a blog post on its website.
“Theranos’ products and services have proven accurate and reliable for tens of thousands of satisfied customers through millions of tests and experiences and in ongoing review by our various regulators.
“Our focus remains on ensuring high quality, real-time, actionable information to improve diagnosis and treatment decisions. When you create innovative technology, scrutiny is to be expected. We have always welcomed that scrutiny.”
It is certain to continue, but Ms Holmes says it’s all part of shaking up an industry which hasn’t changed since the 1960s.
AHEAD OF HER TIME?
The 31-year-old said last year she knew she was on to something special in her sophomore year at Stanford, and she saw no point waiting before taking it to market.
“I think a lot of young people have incredible ideas and incredible insights,” she told CNN.
“Sometimes they wait before they go give their life to something. What I did was just to start a little earlier.”
She said she was doing something important for “40 to 60 per cent of Americans” who fail to test for basic diseases because they either can’t afford the treatment or are “scared of needles”.
“It’s bringing the testing closer to where people live and also changing the hours of operation, so that on a weekend or late at night you can get access to these tests. You don’t have to leave work, leave your job during the day.”
It sounds convenient, but accuracy will determine her success.
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