Theranos founder Elizabeth Holmes will soon come face-to-face with a few of the patients that were misdiagnosed by her faulty blood tests.
Federal prosecutors will be calling approximately 11 men and women to the stand in their cases against Holmes. One of the individuals prosecutors are expected to call is Mehrl Ellsworth, a retired dentist who was told he was at high risk of prostate cancer after the test inaccurately determined the amount of prostate-specific antigens (PSA) in his body.Read More
Instead of halting, Theranos kept running tests on Dr. Ellsworth, now 73, after his doctor advised him to get retested. The second one was normal for his age, and the third showed another big spike, again over 20.
After that, Dr. Ellsworth recalled, Theranos sent a phlebotomist to his office who drew a full-size vial of blood.
That result was normal again. Dr. Ellsworth, who has a background in microbiology, and his doctor concluded the high results were false positives. Dr. Ellsworth, now retired, said he had always suspected the Theranos test results were wrong.
Holmes and her lawyers are now busy getting to work, and have filed a subpoena seeking Ellsworth’s medical records.
Major errors in the test devised by Theranos to determine the presence or propensity or prostate cancer first came to light back in 2016, courtesy of a letter sent to the company from the Centers for Medicare and Medicaid Services.
The CMS also released the 147-page report of a 2015 visit to the company’s California laboratory which had formed the basis for the letter.
Those reports revealed that that 29% of the quality-control checks on Edison, the name for Holmes’ proprietary blood testing device, failed to meet the standards which had been set by Theranos.
This included the test devised by Theranos to determine if an individual had prostate cancer or a propensity for the disease, which officials found failed to accurately determine the amount of PSA present 22% of the time.
What’s more, the CMS found that Holmes and the company often failed to notify people of false results in a timely manner.
Holmes, 37, had attempted to suppress this report at her upcoming trial but a judge denied that motion on Wednesday.
The subsequent fallout from the release of that report marked the beginning of the end, and soon more stories about problems with Theranos’ testing practices came to light.
In one instance, talks to put the biotech’s botched systems in Safeway were abruptly ended when testing determined one executive had prostate cancer. A visit to his own doctor for further testing revealed, however, that the executive did not in fact have the disease.
Theranos eventually disbanded in 2018, after much resistance from Holmes. The Stanford dropout, whose company’s valuation reached as high as $10 billion, was then charged by federal prosecutors that same year with two counts of conspiracy to commit wire fraud and nine counts of wire fraud.
Holmes is facing 20 years in prison, a $250,000 fine, and possible restitution to victims in convicted in the case.
Federal prosecutors in the Northern District of California say that Holmes defrauded medical professionals “by making false claims concerning Theranos’s ability to provide accurate, fast, reliable, and cheap blood tests and test results, and (2) by omitting information concerning the limits of and problems with Theranos’s technologies.”
Holmes then marketed these tests to individuals in other states knowing that they did not work, argue prosecutors.
Jury selection is set for August 31 in the case.
Do Blood Tests to Detect Cancer Work?
Theranos may have proved to be a bust, but in recent years a number of companies have made some major strides when it comes to detecting cancer with a simple blood draw.
Early detection is still the most powerful tool in fighting cancer, but the Centers for Disease Control have only recommended screening tests for five forms of the disease in the US – breast, cervical, colorectal, lung and prostate. These new blood tests offer hope for those whose cancers are hidden inside the body.
Cancer detection company Grail made headlines earlier this month with the release of Galleri, a multi-cancer early detection blood test that the company says has the ability to detect over 50 different forms of the disease. A recent study in the Annals of Oncology found that Galleri had the ability to detect 45 types of cancer that lack recommended screening tests while still in the early stages of the disease.
The Galleri test is similar to a number of others on the market, such as Guardant 360 which uses cfDNA technology to locate tumors in patients with advanced-stage cancer. The drug company Natera has also used cfDNA for everything from inherited condition testing in pregnant women to allograft rejection in transplant patients. That company also has a cancer detection test, but it utilizes circulating-tumor DNA (ctDNA) rather than cfDNA.
Galleri also comes a year after CancerSEEK, a test developed at Johns Hopkins University and acquired by Thrive Early Detection. A study published in Science last year revealed that the test had discovered 26 malignancies that were not detected during mammograms or colonoscopies in the 10,000 participants, all of whom were healthy females over the age of 50.
“What I’m most excited about in the field of cancer care, generally speaking, is that I think we’re really on the cusp of a paradigm shift to understanding and identifying earlier stage cancer,” said Steve Kafka, a chairman at Thrive previously told Survivor Net. “That’s important because we know that the earlier the better in terms of finding cancer, and being able to have treatment options available to patients that lead to vastly improved outcomes and cures in many cases.”
The success of these tests have all helped to turn the narrative around when it comes to blood testing, and undo some of the damage caused by the collapse of Theranos.