Medivation: Senate and House members send letter to the Department of Health and Human Services and the NIH to step in to lower the cost of a prostate cancer drug Xtandi
Theranos Results Could Throw Off Medical Decisions, Study Finds
Researchers find that lab-testing company’s results on cholesterol tests were lower by an average of 9.3% than Quest and LabCorp
A study by researchers at the Icahn School of Medicine at Mount Sinai showed that results for cholesterol tests done by Theranos Inc. differed enough from the two largest laboratory companies in the U.S. that they could throw off doctors’ medical decisions.
The Mount Sinai study was published online Monday in the peer-reviewed Journal of Clinical Investigation. The authors recruited 60 healthy adults in the Phoenix area and sent them for 22 commonly prescribed blood tests over a five-day period in July 2015.
The tests were performed by Theranos, which operates blood-drawing sites in Walgreens drugstores, Quest Diagnostics Inc. and Laboratory Corp. of America Holdings, according to the study. The researchers at Mount Sinai in New York said they did the blood-testing comparison without the companies’ knowledge or participation.
The study concluded that Theranos’s results for total cholesterol were lower by an average of 9.3% than those produced by Quest and LabCorp. Doctors often use cholesterol-test results to determine whether to prescribe statins, a class of drugs that can help ward off heart disease.
The Mount Sinai researchers wrote that the average gap on the cholesterol test between Theranos and the other labs was large enough that it could lead doctors to “either inappropriately initiate or fail to appropriately initiate statin therapy” in some patients.
A Theranos spokeswoman didn’t respond to requests for comment.
LabCorp said the study shows that its tests “are well within established guidelines and meet performance expectations,” according to a spokeswoman for the Burlington, N.C., company.
A spokesman for Quest, of Madison, N.J., said the Mount Sinai researchers found “a concerning lack of agreement between the reference labs and the ‘low-volume-specimen’ lab, especially for heart health.”
Eric Schadt, chairman of the department of genetics and genomics at Mount Sinai and one of the study’s lead authors, said in an interview that executives at Theranos, based in Palo Alto, Calif., didn’t responded to his attempts last fall to discuss the findings.
The Mount Sinai study is the first peer-reviewed comparison of Theranos test results with those of other labs.
Some scientists have called on Theranos to publish data in a peer-reviewed medical journal to support the accuracy of its fingerprick blood-testing technology. Theranos founder and Chief Executive Elizabeth Holmes said in October that the company would publish peer-reviewed data but it hasn’t done so yet.
One key question that wasn’t addressed in the Mount Sinai study is whether Theranos used its proprietary devices to run those tests.
Test reports provided to patients show that the tests were run at the company’s lab in Newark, Calif. That lab has Theranos’s proprietary Edison devices and traditional lab machines bought from diagnostic-equipment makers such as Siemens AG, according to former Theranos employees.
One former Theranos employee said the company wasn’t performing the 22 tests in question on Edison devices as recently as June 2015, or the month before the Mount Sinai tests.
Instead, Theranos was diluting small blood samples collected from fingers to increase the volume of those samples and then running them through traditional lab machines, according to the former employee.
Dr. Schadt said the Theranos tests assessed in the study were run on small blood samples drawn from patients’ fingers. Quest and LabCorp ran their tests on larger blood samples drawn with needles from patients’ arms.
If Theranos diluted blood samples from patients in the Mount Sinai study, that might help explain the average difference in cholesterol-test results, because dilution introduces more potential for error, said Stephen Master, associate professor of pathology at Weill Cornell Medical College in New York.
Timothy Hamill, professor emeritus at the University of California, San Francisco’s department of laboratory medicine, said Theranos’s results also might have been affected “by the differences between capillary and venous samples.” He said capillary blood pricked from a fingertip often mixes with fluids from tissue and cells, making it less pure than blood drawn from an arm vein.
Drs. Hamill and Master weren’t involved in the Mount Sinai study.
Ms. Holmes denied in October that Theranos diluted blood samples before running them on traditional machines. Since then, the company has declined to comment on the matter. Theranos has stood by the accuracy of tests run from finger-pricked blood.
The Mount Sinai study also concluded that Theranos was more likely than Quest and LabCorp to reject samples as inadequate for testing.
In addition, the researchers found that Theranos flagged test results as being outside the normal range 60% more often than the two other lab companies.
“This increase in abnormal test results can have negative consequences for medicine in the form of extra testing, additional patient visits to clinics/hospitals, and added doctor services, all of which result in additional costs and burdens to patients or to the healthcare system and are potentially harmful, if the abnormal tests were misdiagnoses,” the Mount Sinai researchers wrote.
A federal inspection of the same Theranos lab in Newark, Calif., last fall found “deficient practices” in five categories. The lab is at risk of losing its federal certification if the problems aren’t resolved.
Theranos has said the inspection report “does not reflect the current state of the lab.” Theranos has said it has fixed many of the problems and has submitted a correction plan to regulators to remedy the remaining problems.
Closing Market Summary: Mixed Results as Energy Tumbles and Consumer Discretionary LeadsThe stock market began the week on a flat note as the S&P 500 added 0.1% while the Nasdaq Composite (-0.1%) underperformed. Today's action featured a slide in crude oil, a noteworthy revision to economic data from January, and relative strength from the consumer discretionary space (+0.5%).
Overall, the Monday affair was very quiet as post-holiday trade failed to garner much interest ahead of a data-heavy week. To that point, fewer than 688 million shares changed hands at the NYSE floor, versus last week's average of 833.8 million shares.
A cautious tone was set this morning as a tumble in oil helped drag the major averages to opening lows. Meanwhile, some mixed data readings clouded sentiment as investors weighed a cooler-than-expected reading of Core PCE Prices for February (0.1%; consensus +0.2%) and an above-consensus reading of February Personal Income (+0.2%; consensus +0.1%). The former is the Fed's preferred measure of inflation, and investors will be on the lookout for any implications this may hold for future fed funds rate hikes.
The major indices hit their highs around 14:00 ET as WTI crude ended its rally off its low. The energy component would end its pit session near those levels, ticking down 0.3% to $39.38/bbl.
Four sectors ended beneath their flat lines with energy (-0.5%), utilities (-0.4%), technology (-0.3%), and health care (-0.3%) leading to the downside. Meanwhile, consumer discretionary (+0.5%), consumer staples (+0.5%), materials (+0.4%), and financials (+0.3%) outperformed.
Lodging names outperformed in the consumer discretionary space following reports that Starwood Hotels (HOT 83.75, +1.62) received a revised non-binding offer from the Chinese consortium headed by Anbang Insurance Group. Elsewhere, Time Warner (TWX 72.54, +2.53) rallied 3.6% following the release of ‘Batman v Superman: Dawn of Justice', which resulted in the third largest global opening for a March release in IMAX (IMAX 30.38, +0.20) theaters.
The top-weighted technology space (-0.3%) spent most of its day behind the benchmark index as Microsoft (MSFT 53.54, -0.67) weighed on the sector. The tech giant underperformed following headlines that it may be interested in acquiring Yahoo! (YHOO 35.23, +0.37). Meanwhile, Oracle (ORCL 40.62, -0.35) underperformed among software names while Qualcomm (QCOM 50.19, -0.67) displayed relative weakness in the PHLX Semiconductor Index (-0.1%).
The industrial sector (UNCH) finished above its flat line, as a rally in large cap General Electric (GE 31.49, +0.38) outweighed the underperformance of rail names in the Dow Jones Transportation Average (-0.9%). Elsewhere in the Transportation Average, JetBlue (JBLU 20.79, +0.55) spiked after reports indicated that the company put in a bid for Virgin American (VA 37.70, +3.53).
Biotechnology endured a choppy session as the iShare Nasdaq Biotechnology ETF (IBB 252.08) swung from a 1.5% loss to a 0.9% gain. The ETF ended its day down 1.3% despite strength from constituent Gilead Science (GILD 92.46, +1.14). The biotech name ended higher by 1.6% after a ruling in a patent dispute case was deemed better than feared.
The U.S. Dollar Index (95.97, -0.20) finished lower as the greenback lost ground to the euro. The euro/dollar pair ended higher by 0.3% at 1.1200. For its part, the dollar gained 0.2% against the yen to end at 113.38.
Treasuries ended in the green, but off their best levels. The yield on the 10-yr note settled lower by three basis points at 1.88% (-1 bps) after dipping into the 1.86% area.
Today's economic data included PCE Prices for February, Personal Income for February, Personal Spending for February, and Pending Home Sales for February:
- The Personal Income and Spending report for February was released to little fanfare as the report came in right around expectations. Income increased 0.2% month-over-month (consensus +0.1%), spending increased 0.1% (consensus +0.1%), and the core PCE Price Index, which excludes food and energy, increased 0.1% (consensus +0.2%).
- Overall, this set of figures is not expected to do much in terms of strengthening or weakening a rate-hike argument, but it is worth noting that a 0.5% increase in January Personal Spending was revised down to an increase of just 0.1% in today's report.
- The Federal Reserve is looking for 2.0% year-over-year inflation as expressed by the core PCE Index. Following today's report, the index remains unchanged at 1.7% year-over-year.
- The personal savings rate edged up to 5.4% from 5.3%.
- Pending home sales for February climbed 3.5% while the consensus expected an increase of 1.1%. Meanwhile, the January reading was revised to -3.0% from -2.5%.
Tomorrow's economic data will include the Case-Shiller 20-city Index for March (consensus +5.7%) and Consumer Confidence for March (consensus 94.5), which will be released at 9:00 ET and 10:00 ET, respectively.
Separately, Fed Chair Janet Yellen will speak at the Economic Club of New York at 12:20 ET.
USGS revises seismic risk map to include quakes caused by humans
The seismic risk maps are used by emergency management officials as well as the country's major engineering and design associations to guide how strong to construct buildings.
"By including human-induced events, our assessment of earthquake hazards has significantly increased in parts of the U.S.," Mark Petersen, Chief of the USGS National Seismic Hazard Mapping Project, said in a statement.
Some 7 million people in the Central and Eastern United States live or work in areas threatened by so-called induced seismicity, and in parts of these regions, the damage caused by earthquakes could be at parity with that seen in high-hazard regions of California, the USGS said.
Oklahoma is at the greatest risk for hazards associated with induced seismicity, the USGS said, followed by Kansas, Texas, Colorado, New Mexico and Arkansas.
Oklahoma in 2015 experienced 907 magnitude-3.0 or greater earthquakes, compared with just two of similar size in 2009. In February, a 5.1-magnitude temblor shook the area around Fairview, Oklahoma - the third strongest recorded in the state.
The uptick in quakes has prompted serious concern among locals, particularly those in close proximity to the oil storage hub at Cushing, Oklahoma, which is home to some 66 million barrels of oil and the delivery point for the widely-traded West Texas Intermediate futures contract.
"We have had some earthquakes that were way to close to those tanks," said Michael Teague, Oklahoma's Secretary of Energy and Environment.
The disposal of saltwater - a natural byproduct of oil and gas drilling - into wells has been tied to earthquakes. Oklahoma regulators have already ordered many wastewater well companies to curb operations.
The USGS said building code committees are still determining whether to include induced earthquakes in their revisions, in part because they could be temporary.
The American Society of Civil Engineers is already in the process of publishing 2016 guidelines that do not take into account man-made earthquakes.
But the group does not anticipate updating those standards again until 2022.
"There is always a delay in design codes adapting the USGS Seismic Hazard Maps," said Muralee Muraleetharan, a civil engineering professor at the University of Oklahoma.