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Jefferson Adams posted an article in Additional Celiac Disease ConcernsCeliac.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.
Jefferson Adams posted an article in Additional Celiac Disease ConcernsCeliac.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 posted an article in Additional Celiac Disease ConcernsCeliac.com 04/09/2011 - A Durham, North Carolina man is currently on trial for fraud after being accused of deliberately selling bread labeled gluten-free that contained gluten, and which sickened more than two dozen people with food allergies. According to a Wake County prosecutor, the man, Paul Seelig, owner of Great Specialty Products, repeatedly lied to customers about the ingredients in his bread. Seelig faces more than two dozen fraud charges for taking customers' money under false pretenses. Prosecutors plan to call almost 50 witnesses. Prosecutor Evans told jurors that witnesses would include two dozen customers who suffer from celiac disease and gluten intolerance, and who became ill after eating Seelig's products, along with the University of Nebraska experts who tested the bread. Evans said a former employee would testify that Seelig told her to lie to investigators about their operation, and that, during the State Fair, Seelig sent her and other workers to buy standard bagels at Costco and B.J.'s that Seelig's operation sold as gluten-free. "What this case is about is misrepresentations built on top of misrepresentations that this defendant made to people with medical conditions," Assistant District Attorney Shawn Evans said Tuesday during opening arguments in the trial. "The consequence was that many people got sick." According to prosecutors, Seelig knowingly misrepresented his bread as handmade, prepared in a dedicated gluten-free facility, and tested weekly for gluten contamination. Defense lawyer Blake Norman of Durham says Seelig, who reportedly suffers from Crohn's disease and cannot eat gluten, is merely a businessman who was looking to offer "reasonably priced gluten-free products" for consumers who suffer from food allergies. Norman also told jurors that Seelig would take the stand to tell his side of the story. However, Seelig might face an uphill battle for credibility if his criminal past comes under scrutiny. He has spent time in prison for two separate criminal convictions, the first for grand theft in 1991, which sent him to prison for more than two years, and a second in 2002, when Seelig was convicted in federal court of wire fraud and sentenced to four months in prison followed by three years of federal probation. If convicted of all the charges in the Wake County cases, Seelig, 48, faces at least eight years in prison if sentenced to consecutive terms. Source: Newsobserver