Little Kate Summersgill absolutely didn’t attending like a adolescent with Bottomward syndrome—no advancement askance eyes or admonition collapsed facial features.
Devon and Mike Summersgill had believed babyish Kate was all but assertive to be built-in with the intellect-stunting ataxia because of a claret analysis Devon’s doctor recommended during her 2014 pregnancy. Even afterwards the birth, back their babyish looked fine, their abiogenetic counselor, Laura Limone, insisted that the aftereffect of the analysis was not a mistake, Devon says.
Only afterwards the Summersgills aching over Kate’s approaching and spent about $2,000 added on addition analysis were they annoyed that Limone was wrong—their babyish was fine. And back they abstruse that Limone had a banking accord with the aggregation that makes the test, alleged MaterniT21 PLUS, they wondered whether money had afflicted the counselor’s advice.
“My aboriginal acknowledgment was aloof absolute abashing followed by anger,” said Devon Summersgill, 33, a appropriate apprenticeship teacher.
Parents are starting to catechism the ability of the fast-growing acreage of abiogenetic counseling as added and added attorneys are paid by the companies that accomplish the tests. About 14 percent of the nation’s 4,000 abiogenetic attorneys formed anon for testing labs in 2014, up from 9 percent aloof two years earlier, according to the latest calculation by their able society. The antithesis tend to assignment for hospitals or doctors’ practices.
“It’s a accumulation departure to labs” area pay tends to be college and the allowances are better, said Cori Feist, a abiogenetic advisor with Oregon Bloom & Science University.
Eighteen states, Massachusetts amid them, authorization abiogenetic counselors, but none of them crave acknowledgment to patients if a advisor is paid by a lab.
Limone, the advisor in the Summersgill case, does not assignment anon for a lab. She arise in a medical account aftermost year that she is a affiliate of the “speaker’s bureau” for Sequenom Inc., maker of MaterniT21, and has been paid to allege about its test. Sequenom accepted it has paid her.
Limone said that she does not adjustment tests for any banking gain, and offers patients tests fabricated by assorted companies. She said that she did not adjustment the Sequenom analysis for Summersgill, but contrarily beneath to animadversion on the case.
“I accept no adversity authoritative decisions based on complete science,” Limone said by email.
But the allowance industry and some accompaniment regulators are alpha to able bottomward on the ties amid abiogenetic attorneys and the testing companies. As of this year, some bloom affairs offered by insurer UnitedHealthcare no best awning assertive abiogenetic tests ordered by attorneys that assignment for labs. Cigna Corp. already has a agnate policy.
Concerns are additionally growing that attorneys alive in abutting adjacency to patients in doctors’ offices may be over-promoting tests. Pennsylvania and Florida accept banned lab personnel, including abiogenetic counselors, from alive at health-care providers’ sites.
George J. Annas, a bioethicist at Boston University’s School of Public Health, said attorneys accept an allurement to favor companies that pay them, and that may blush what they acquaint patients, including what to say about a test’s limitations. Whenever a “highly aggressive bartering business” gets complex in medical choices, “you’ve got problems,” he said.
Officials at Laboratory Corp. of America Holdings, which sells a ample arrangement of tests, says the 140 abiogenetic attorneys they apply consistently put the accommodating first. F. Samuel Eberts III, the company’s arch acknowledged officer, said accepting attorneys based in doctors’ practices—fewer than bisected of the company’s total—is acceptable for patients. “There is no abeyant or absolute battle of interest,” he said in an email. The attorneys aren’t salespeople and can action tests from added companies, he wrote.
There’s little catechism that abiogenetic attorneys are operating in a added able ambiance than added bloom affliction professionals. The Food and Drug Administering doesn’t adapt the majority of the estimated 13,000 abiogenetic tests offered by U.S. labs, according to a federal database. Companies don’t accept to prove to regulators that their tests are authentic to be able to acquaint them.
Most medical companies charge address how abundant they pay doctors for research, royalties, biking and speaking fees, but the federal law doesn’t awning payments to abiogenetic counselors. As a result, patients generally accept no accessible way to apperceive whether their advisor has a accessible battle of interest.
Devon Summersgill, right, believed her babyish Kate, left, would be built-in with Bottomward affection based on a prenatal analysis that angry out to be wrong.Photo: Jeff Zelevansky for NECIR
All prenatal screening tests accept limitations, but attorneys don’t consistently explain them clearly, commodity Jessica Daviso of Andover, Massachusetts, abstruse in an alarming way. Daviso said her lab-employed advisor never told her “that my analysis aftereffect was apparently wrong.”
Daviso, 33, accustomed a prenatal analysis aftereffect from California-based Counsyl Inc., a lab company, in October that adumbrated a aerial likelihood her fetus had Turner syndrome, a action apparent by abbreviate ability and infertility in girls, according to emails amid her and a Counsyl abiogenetic counselor, Kristen Rauch.
Rauch told Daviso that a contempo abstraction showed the “false positive” amount for Turner and agnate syndromes was about 1 percent, the emails show, and recommended a additional analysis that would affirm the condition.
Daviso and her bedmate Eugenio again approved out experts at Tufts Medical Center, area a abiogenetic advisor looked at the analysis and added factors, including her age and added claimed data, and estimated there was abandoned about a 14 percent adventitious that her fetus had Turner’s—not the abreast authoritativeness that Daviso said she was led to believe.
That’s because the apocryphal absolute amount is abandoned one agency in barometer a test’s accuracy. In pregnancy, it represents the allotment of times that women accustomed advantageous fetuses are accustomed apocryphal alarms.
But a abundant woman who receives a absolute aftereffect needs to apperceive commodity more: amid the abundant abate accumulation of women who analysis positive, how generally is the analysis right? Many prenatal genetic-test companies do not acutely acquaint this rate, accepted as the absolute predictive value, the New England Center for Investigative Reporting has found.
After the Tufts ascribe and ultrasounds that accept not adumbrated a problem, Daviso beneath to accept the more-definitive test, which carries a accident of miscarriage. She is due in April and says she and her bedmate accept there’s little adventitious the babyish will accept Turner.
“The accurateness of these tests comes anon from the labs that assay the after-effects and seek to accumulation best from [their] administration,” said Daviso. “The companies are announcement an inaccurate test.”
Rauch beneath to comment, but the company’s arch science officer, Eric Evans, said Counsyl helps patients accept that the analysis Daviso had abandoned letters the adventitious of a problem. If addition tests positive, he said, a analytic analysis is bare for confirmation. The aggregation has arise numbers on the likelihood that a absolute analysis aftereffect is actual for several abiogenetic conditions, but not for Turner syndrome, Evans wrote. He said the aggregation was alive against “incorporating these into approaching reports.”
The abiogenetic counseling acreage is exploding—with 29 percent job advance anticipation over the abutting decade—in ample admeasurement because labs action non-invasive prenatal tests, or NIPTs, which crave abandoned a simple claret sample.
Other prenatal tests, such as amniocentesis, crave aqueous abstraction from areas abutting to the fetus, bringing a accident of miscarriage.
The tests usually retail amid $700 and $3,000 and are accretion rapidly. One bazaar analysis close estimated the all-around bazaar at $563 actor in 2014, and predicted 18 percent anniversary advance through 2020.
Several studies accept begin that non-invasive analysis after-effects advertence a fetus is at aerial accident for some abiogenetic problems can be amiss added than 50 percent of the time.
Some women arise to accept concluded pregnancies based on the screening analysis alone, according to scientists and an industry-funded study. Officials at Stanford University in California said in 2014 that there accept been at atomic three cases of women aborticide advantageous fetuses relying on after-effects of a abiogenetic screening test.
“Women are not accepting complete information,” said Dr. John Williams III, administrator of Reproductive Genetics at Cedars-Sinai hospital in Los Angeles. “We accept apparent several cases in which the NIPT analysis after-effects were apocryphal positives.”
But bartering labs say abiogenetic attorneys accept the science abaft the tests and that they comedy a basic role presenting authentic advice to both doctors and patients.
Physicians who can’t accumulate up with the fast-changing science “value the testing but don’t consistently feel able to absolutely use it,” said Rachel Klein, a genetic-counseling administrator for New Jersey-based BioReference Laboratories, which offers a ample ambit of abiogenetic tests including prenatal diagnostics. The aggregation employs 130 abiogenetic counselors, whose roles accommodate post-test counseling and accompanying sales teams to physicians’ offices.
Still, some bartering labs such as BioReference and Quest Affection Inc. that abode a bound cardinal of attorneys in doctors’ offices, say they are phasing out the practice.
Jessica Daviso, whose babyish is due in April, says a abiogenetic advisor active by a lab did not acquaint her a prenatal analysis aftereffect she accustomed was apparently wrong.Photo:Shawn Musgrave for NECIR
Devon Summersgill said it was her obstetrician, Dr. Neil Russo, who appropriate she accord a claret sample for Sequenom’s MaterniT21.
After the absolute analysis result, Summersgill said Russo told her the screening analysis was 99 percent authentic and referred the brace to New Jersey Perinatal Associates, a high-risk abundance convenance area Limone works. Limone said she is not paid by Sequenom for New Jersey Perinatal analysis orders.
Summersgill said Limone told her the analysis was about absolutely accurate. Limone said that the apocryphal absolute amount for the analysis was tiny—0.2 percent, according to medical annal the Summersgills aggregate with NECIR. The Summersgills say Limone told them an amniocentesis would accept to be done to affirm the finding.
Dr. Leon G. Smith, Jr., of New Jersey Perinatal, wrote to Summersgill’s obstetrician, adage she was “counseled” about “the absolute attributes of NIPT studies” and said that there was a “very aerial likelihood that this babyish has fetal Bottomward syndrome.”
As a teacher, Summersgill had dealt with accouchement with Bottomward syndrome, and she and her bedmate had already absitively aborticide wasn’t an advantage because “we acquainted she could alive a blessed and accomplishing life.” They chose not to accident a acknowledging amniocentesis. The analysis result, and Limone’s comments acquainted “pretty definitive,” Summersgill said.
They began cogent ancestors and friends, that their babe was about absolutely activity to accept the condition.
After Kate’s 2014 birth, addition abiogenetic analysis the brace approved from a hospital seemed to aphorism out Down, and they began to breathe easier. Again came a aftereffect alarm from the obstetrician, Russo, who ordered the aboriginal test. The doctor insisted that he had never heard of a MaterniT21 analysis actuality wrong, according to Summersgill, and appropriate addition alarm to Limone.Russo beneath to comment.
Dr. Wayne LaMorte, who teaches medical-test estimation in a advance at Boston University, affected that a absolute Bottomward awning from Sequenom was actual for addition of Summersgill’s age abandoned about bisected the time.
The Summersgills said Limone never told them the analysis could be amiss so generally for addition of her age accumulation and did not acknowledge her affiliation with Sequenom back she counseled them on the analysis results. They say the acquaintance has larboard them anxious that women may abolish pregnancies based on analysis after-effects that are shakier than portrayed.
“We awkward a activity time of anguish into six months of pregnancy,” Mike Summersgill said.
This commodity originally appeared at New England Center for Investigative Reporting. It is reprinted with permission.
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