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    Did Theranos Use Arizonans as Guinea Pigs for Faulty Blood Tests?


    Jefferson Adams
    • Theranos will pay Arizona consumers $4.65 million under a consumer-fraud settlement Arizona Attorney General Mark Brnovich negotiated with the embattled blood-testing company.

    Did Theranos Use Arizonans as Guinea Pigs for Faulty Blood Tests?
    Image Caption: Image: CC--Wheeler Cowperthwaite

    Celiac.com 07/16/2018 - Did weak public oversight leave Arizonans ripe for Theranos’ faulty blood tests scam? Scandal-plagued blood-testing company Theranos deceived Arizona officials and patients by selling unproven, unreliable products that produced faulty medical results, according to a new book by Wall Street Journal reporter, whose in-depth, comprehensive investigation of the company uncovered deceit, abuse, and potential fraud.

    Moreover, Arizona government officials facilitated the deception by providing weak regulatory oversight that essentially left patients as guinea pigs, said the book’s author, investigative reporter John Carreyrou. 

    In the newly released "Bad Blood: Secrets and Lies in a Silicon Valley Startup," Carreyrou documents how Theranos and its upstart founder, Elizabeth Holmes, used overblown marketing claims and questionable sales tactics to push faulty products that resulted in consistently faulty blood tests results. Flawed results included tests for celiac disease and numerous other serious, and potentially life-threatening, conditions.

    According to Carreyrou, Theranos’ lies and deceit made Arizonans into guinea pigs in what amounted to a "big, unauthorized medical experiment.” Even though founder Elizabeth Holmes and Theranos duped numerous people, including seemingly savvy investors, Carreyrou points out that there were public facts available to elected officials back then, like a complete lack of clinical data on the company's testing and no approvals from the Food and Drug Administration for any of its tests.

    SEC recently charged the now disgraced Holmes with what it called a 'years-long fraud.’ The company’s value has plummeted, and it is now nearly worthless, and facing dozens, and possibly hundreds of lawsuits from angry investors. Meantime, Theranos will pay Arizona consumers $4.65 million under a consumer-fraud settlement Arizona Attorney General Mark Brnovich negotiated with the embattled blood-testing company.

    Both investors and Arizona officials, “could have picked up on those things or asked more questions or kicked the tires more," Carreyrou said. Unlike other states, such as New York, Arizona lacks robust laboratory oversight that would likely have prevented Theranos from operating in those places, he added.

    Stay tuned for more new on how the Theranos fraud story plays out.

    Read more at azcentral.com.

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  • About Me

    Jefferson Adams earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in biology, anatomy, medicine, and science. He previously served as Health News Examiner for Examiner.com, and provided health and medical content for Sharecare.com.

    Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book Dangerous Grains by James Braly, MD and Ron Hoggan, MA.

  • Related Articles

    Tina Turbin
    This article originally appeared in the Autumn 2010 edition of Journal of Gluten Sensitivity.
    Celiac.com 01/10/2011 - As an author, researcher, and gluten-free advocate, I work hard to raise awareness for celiac disease and gluten issues, particularly when it comes to increasing the diagnosis rate. Part and parcel of improving diagnosis is proper testing. Evidence is mounting that indicates that blood testing may not be the most effective way to test for celiac disease, and I would recommend that people who suspect they have celiac disease to check with their doctors about other testing options.
    Celiac disease, which is essentially an autoimmune reaction to gluten, a protein found in wheat, barley, and rye, affects approximately three million Americans, but according to estimates, only three percent of them have been properly diagnosed with the disease. Once celiac disease is diagnosed, treatment is simple—following a gluten-free diet. With so many American celiacs going without a diagnosis,  this painful and potentially fatal autoimmune disorder, with its easy method of treatment, attention needs to be focused on effective, efficient testing.
    Although awareness of celiac disease and gluten-free living is increasing in the various medical fields, accurate and reliable testing has not been definitively tackled or uniformly implemented by medical practitioners. Currently a popular method of testing is a blood test, but some people with celiac disease can get blood testing many times and the results will nevertheless be negative.
    Although blood testing has been successful in diagnosing some people with celiac disease, this method is inaccurate at least 80 percent of the time, according to Dr. Datis Kharrazian, Blood Chemistry Seminar instructor and the formulator for Apex Energetics, Inc. supplements. To understand how blood testing works, a basic grasp of the workings of the immune system is essential. Antibodies are part of the immune system and designed to attack specific antigens, or invaders, of the body. Tests can be conducted that find an increase of antibodies in the system, which are on the prowl for certain foreign invaders. Specifically, anti-gliadin, or anti-gluten antibodies, can be tested for; when these exist in the system in large amounts, it is a sign of the autoimmune disorder, celiac disease. Although this may sound workable in theory, in practice blood testing is insufficient and inaccurate due to the fact that the autoimmune response doesn’t occur in the blood stream, but in the small intestine, as the immune system attacks this organ’s absorptive finger-like structures called villi which line the inside. Thus, for the sake of reliability, this suggests that testing should be focused on the gut.
    So what method can we turn to? Fortunately, there is another method apart from an intestinal biopsy, which is an invasive as well as expensive procedure. It turns out that the immune cells which surround the gut also can be located in large numbers in the stool, making a stool anti-gliadin antibody test a reliable alternative to blood testing.
    Stool testing may be more accurate than blood testing and is more convenient. One doesn’t need a doctor’s prescription for the test, which can be conducted in the privacy of one’s own home with an online-ordered kit from EnteroLab, which according to its website, is “a registered and fully accredited clinical laboratory specializing in the analysis of intestinal specimens for food sensitivities.”
    Enterolab offers the Anti-Gliadin Antibodies Stool Test as well as additional tests which can be ordered may be important diagnostic tools for people who have celiac disease or gluten-sensitivity. These additional tests include the Tissue Transglutaminase Stool Test, which tests whether gluten is actively attacking the intestine and other tissues, the Malabsorption Test, used to determine whether the intestine is malabsorbing nutrients due to the autoimmune reaction to gluten, or the Celiac and Gluten-Sensitivity Gene Test. The lab also offers a Milk Sensitivity Test, which tests for reactions to casein, a milk protein
    With millions of celiac Americans living with their disease undiagnosed, we can’t afford to waste time with inaccurate and inefficient testing. The anti-gliadin antibodies stool test, so easily available to the public, is a great stride forward for the celiac community.
    Talk with your health care provider today about this alternative to celiac blood testing.


    Jefferson Adams
    Celiac.com 12/16/2013 - Numerous popular herbal products may be contaminated or may contain unlabeled substitute ingredients and fillers, meaning that they are not what their labels claim. According to the World Health Organization, adulterated herbal products are a potential threat to consumer safety.
    These revelations came to light after a group of Canadian researchers conducted an investigation into herbal product integrity and authenticity, with hopes of protecting consumers from health risks associated with product substitution and contamination.
    Using a test called DNA barcoding, a kind of genetic fingerprinting that been effective in uncovering labeling fraud in other commercial industries, the researchers found that nearly 60% of herbal products tested were not what their label claimed them to be, and that pills labeled as popular herbs were often diluted or replaced entirely, sometimes with cheap fillers that could be dangerous to consumers.
    In all, the researchers tested 44 herbal products from 12 companies, along with 30 different species of herbs, and 50 leaf samples collected from 42 herbal species.
    The researchers were Steven G. Newmaster, Meghan Grguric, Dhivya Shanmughanandhan, Sathishkumar Ramalingam and Subramanyam Ragupathy. They are variously affiliated with the Centre for Biodiversity Genomics, Biodiversity Institute of Ontario (BIO) at the University of Guelph, the Bachelor of Arts and Science Program at the University of Guelph in Guelph, Ontario, Canada, and with the Plant Genetic Engineering Laboratory, Department of Biotechnology, Bharathiar University in Tamil Nadu, India.
    Their laboratory also assembled the first standard reference material (SRM) herbal barcode library from 100 herbal species of known provenance that were used to identify the unknown herbal products and leaf samples.
    The team recovered DNA barcodes from most herbal products (91%) and all leaf samples (100%), with 95% species resolution using a tiered approach (rbcL + ITS2).
    Nearly 60% of the products tested contained DNA barcodes from plant species not listed on the labels. That means they were not what the label said they were.
    Furthermore, even though 48% of the products contained authentic ingredients, one-third of those also contained contaminants and/or fillers not listed on the label.
    The air data showed clearly that most herbal products tested were not what their labels claim, while most of the rest were poor quality, and often contained unlabeled, possibly dangerous, product substitute, contamination and fillers.
    They note that selling weak, ineffective, or mislabeled herbal supplements reduces the perceived value of otherwise helpful products by eroding consumer confidence.
    The study team recommends that the herbal industry embrace DNA barcoding to ensure authentic herbal products by effectively documenting raw manufacturing materials.
    They suggest that the use of an SRM DNA herbal barcode library for testing bulk materials could provide a method for 'best practices' in the manufacturing of herbal products, and note that this would provide consumers with safe, high quality herbal products.
    What do you think? Should herbal products and supplements be tested, authenticated and verified? Share your thoughts below.
    Source:
    BMC Medicine 2013, 11:222. doi:10.1186/1741-7015-11-222

    Jefferson Adams
    Celiac.com 12/24/2015 - Laboratory tests for hemoglobin, ferritin, calcium, folate, vitamin B12, vitamin D, and thyroid function are regularly ordered in children with celiac disease, despite sufficient evidence for their necessity. To determine the frequency of nutritional deficiencies and levels of thyroid dysfunction in children with celiac disease, researches conducted a study that examined children before and after the initiation of a gluten-free diet.
    The research team included Margaretha Maria Susanna Wessels, MD, Iris I. van Veen, MD, Sabine Lisa Vriezinga, MD, Hein Putter, PhD, Edmond Henri Herman Maria Rings, MD, PhD, and Maria Luisa Mearin, MD, PhD. They are affiliated with the Department of Pediatrics, Department of Statistics, and the Department of Pediatrics, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands.
    For their study, the team evaluated test results for hemoglobin, ferritin, folate, vitamin B12, calcium, vitamin D (25[OH]D), free thyroxin, and thyroid stimulating hormone of children with celiac disease regularly seen at the Leiden University Medical Center between 2009 and 2014. The team used laboratory reference ranges to define abnormal results. For statistical analysis, they used Pearson χ2 test for trend, unpaired t test, and 1-way ANOVA. 
    Their results for 182 children evaluated, showed 119 were newly diagnosed. About 17% of results were missing for any given year, due to incomplete blood results.
    The most common deficiencies at the time of celiac diagnosis were iron deficiency, found in 28% of celiac patients, vitamin D deficiencies in 27%, and folate deficiency, in 14%. They also saw iron deficiency anemia in 9%, and vitamin B12 deficiency in 1% of celiac patients. They saw no hypocalcemia or thyroid dysfunction.
    At follow-up, they observed iron deficiency, iron deficiency anemia, and folate and vitamin D deficiency 8%, 2%, 3%, and 25% of patients, respectively. They found no vitamin B12 deficiency, hypocalcemia, and thyroid disease.
    From these results, the team concluded that complementary blood investigations are relevant at the time of celiac diagnosis, but have little follow-up use, once the patients adopt a gluten-free diet. They recommend that such tests be conducted only if there is a clear physical issue, such as fatigue or abnormal growth.
    Source:
    Journal of Pediatrics. DOI: http://dx.doi.org/10.1016/j.jpeds.2015.09.078

    Jefferson Adams
    New Blood Test May Change the Way We Diagnose Celiac Disease
    Celiac.com 08/28/2017 - After 14-day gluten challenge, an HLA-DQ-gluten tetramer blood test provides better detection of celiac disease than biopsy. Can that lead to new disease detection methods in patients who are already on a gluten-free diet?
    Doctors attempting to diagnose celiac disease are often confronted by patients who have already given up gluten. For such patients, diagnostic guidelines currently call for a gluten challenge of at least 14 days, followed by duodenal biopsy. There isn't much good data on how many false-positive results are generated by this method. To get a better picture, a team of researchers recently studied responses to 14-day gluten challenge in subjects with treated celiac disease.
    The research team included Vikas K Sarna, Gry I Skodje, Henrik M Reims, Louise F Risnes, Shiva Dahal-Koirala, Ludvig M Sollid, and Knut E A Lundin. They are variously affiliated with the Department of Immunology and Transfusion Medicine, Oslo University Hospital, Norway; K. G. Jebsen Coeliac Disease Research Centre, University of Oslo, Norway; Department of Clinical Service, Oslo University Hospital, Norway; Department of Pathology, Oslo University Hospital, Norway; Centre for Immune Regulation, University of Oslo and Oslo University Hospital, Norway; and the Department of Gastroenterology, Oslo University Hospital, Norway.
    The research team took a group of 20 patients with biopsy-verified celiac disease, all in confirmed mucosal remission, and presented them with a dietary gluten challenge of 5.7 grams per oral gluten per day for 14 days, then conducted duodenal biopsies. They analyzed blood by multiplex assay for cytokine detection, and by flow cytometry using HLA-DQ:gluten tetramers.
    Nineteen of the twenty participants completed the challenge. Biopsy results showed villous blunting in 5 of those 19 patients. Villous height to crypt depth ratio reduced with at least 0.4 concomitantly with an increase in intraepithelial lymphocyte count of at least 50% in 9 of the 19 patients. Interleukin-8 plasma concentration increased by more than 100% after 4 hours in 7 of 19 subjects. Frequency of blood CD4+effector-memory gut-homing HLA-DQ:gluten tetramer-binding T cells increased by more than 100% on day 6 in 12 of 15 evaluated participants.
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    The team is calling for further study. Being able to diagnose celiac disease without biopsy could really help to improve the entire diagnostic process, and could easily lead to an increase in diagnosis.
    Source:
    Gut

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