Category: Daily News

John Carlisle, a consultant anesthetist at Torbay Hospital in the UK, used statistical tools to conduct a review of thousands of papers published in leading medical journals. While a vast majority of the clinical trials he reviewed were accurate, 90 of the 5,067 published trials had underlying patterns that were unlikely to appear by chance in a credible dataset.

While some of these errors may be the result of “misinterpretation, statistical error, or plain simple mistakes,” Carlisle says in a press release emailed to The Scientist, it’s likely that some of the research in question “may have been deliberately falsified.” He published his results on June 5 in the medical journal Anaesthesia.

The tool works by comparing the baseline data, such as the height, sex, weight and blood pressure of trial participants, to known distributions of these variables in a random sample of the populations.

If the baseline data differs significantly from expectation, this could be a sign of errors or data tampering on the part of the researcher, since if datasets have been fabricated they are unlikely to have the right pattern of random variation.

“This study is about working to correct the scientific record,” Andrew Klein, the editor-in-chief of the journal, said in a press release. “The new Carlisle screening tool has been developed here in the U.K. and it is now clear that it should be used by medical publications around the world. The integrity of medical science demands that we do everything we can to ensure complete accuracy in the publication of research.”

In the case of Japanese scientist, Yoshitaka Fuji, the detection of such anomalies triggered an investigation that concluded more than 100 of his papers had been entirely fabricated.

The latest study identified 90 trials that had skewed baseline statistics, 43 of which with measurements that had about a one in a quadrillion probability of occurring by chance.

The published review includes a full list of the trials in question, allowing Carlisle’s methods to be checked but also potentially exposing the authors to criticism. Previous large scale studies of erroneous results have avoided singling out authors.

Relevant journal editors were informed last month, and the editors of the six anesthesiology journals named in the study said they plan to approach the authors of the trials in question, and raised the prospect of triggering in-depth investigations in cases that could not be explained.

The flagged studies came from eight journals, including the New England Journal of Medicine, Anaesthesia, and JAMA. As Klein tells Retraction Watch, all the journals responded “swiftly and positively” to Carlisle, who reached out with the findings of his study. Six of the journals in the new analysis are in anesthesiology, where Carlisle has focused his efforts for several years, refining the method since 2012.

That earlier work led to the revelations that much of Yoshitaka Fujii’s research was fraudulent, and Fujii now has made 183 retractions of his voluminous “research”. The method has also been used by others to identify issues in more than 30 papers by bone researcher Yoshihiro Sato.

A Murrieta woman is accused in an insurance fraud case that allegedly netted her more than $230,000. Brooke Elizabeth Best-Freeman, 34, operated a licensed alcohol and drug treatment program in the Murrieta and Temecula areas, according to the Riverside County District Attorney’s Office.

The charges against Best-Freeman, who had run Best New Life Recovery since 2015, include four felony counts of insurance fraud and one felony count of solicitation or referral for purposes of insurance fraud – which is sometimes known as “capping.” She’s also facing a sentence-enhancing white collar crime allegation.

Her co-defendant, 49-year-old Robert Cramer of Lake Elsinore, is charged with one count of referral of a client for purposes of insurance fraud, and is the alleged “capper” in the case. He remains at large.

According to prosecutors, Best-Freeman came under investigation last September after the D.A.’s office was contacted by fraud investigators from Health Net Inc. who had flagged multiple billings from the defendant’s business, Best New Life Recovery.

The treatment facility, originally located in Murrieta, then Temecula, was licensed by the California Department of Health Care Services in 2015.

Prosecutors allege that, over a nine-month period, Best-Freeman submitted claims to Health Net and Cigna for treatments that were never provided to patients. The defendant also allegedly misclassified other services, forging or otherwise altering documents to commit acts of fraud, according to the D.A.’s office.

Cramer, the alleged “capper,” was tasked with finding prospects willing to go along with the conspiracy. He was promised $2,000 for his part, according to the prosecution.

Health Net lost just over $195,000 paying the alleged bogus claims, while Cigna suffered a $36,000 loss, according to court papers.

Over the past decade, the US has undergone an opioid epidemic. Prescriptions for opioid painkillers like oxycodone, hydrocodone, fentanyl, and morphine have skyrocketed.

The trend has been decades in the making. On careful reflection, one might ask “have we backed ourselves into this corner?”

An article in Business Insider claims that Increases in painkiller prescriptions are linked to a “big push” in the early 1990s from medical groups encouraging doctors to treat pain more aggressively, according to Dr. Ted Cicero, a professor of psychiatry at Washington University in St. Louis and an opiate-use researcher.

Though the increased focus on pain treatment resulted in increases in opioid prescriptions in most doctors initially, for years now, pain specialists have advocated using alternative treatments to alleviate their patients’ chronic pain.

There’s one problem: Health-insurance companies and worker’s compensation treatment guidelines are increasingly cutting reimbursements for these alternative treatments or not covering them at all.

Steroid injections, joint injections, fluid injections, physical therapy, nerve blocks, and radio-frequency ablation are just a few of the treatments advocated by pain specialists in place of opioids. Such treatments are frequently called interventional pain treatments.

“Every year, pain interventions go to the chopping block, and doctors have to figure out how to provide that treatment and make ends meet,” Dr. Janet Pearl, the medical director of Massachusetts-based pain-management center Complete Pain Care and the secretary of the Massachusetts Society of Interventional Pain Physicians, told Business Insider.

The policies of insurance companies have forced doctors to increasingly offer pain patients a difficult choice. Pay for expensive alternative treatments out-of-pocket, use opioids and possibly suffer a myriad of side effects and risk opioid addiction, or choose to do nothing and live with debilitating pain.

“Even if we want to climb a population out of the well of the opioid epidemic and give alternatives, we can’t,” Shah told Business Insider. “Patients can’t afford the alternatives and insurance companies won’t cover them.”

The coverage issue hasn’t gone unnoticed at a national level. In the January 2014 issue of Pain Physician, the official publication of the American Society of Interventional Pain Physicians (ASIPP), a cadre of pain specialists lamented the “draconian cuts” to numerous interventional pain treatments by commercial insurers and Medicare in a piece titled “Declining Value of Work of Interventional Pain Physicians.”

The article referred to reimbursement cuts ranging from 19% to 56% for various epidural injections by the Centers for Medicare and Medicaid Services (CMS). While some evidence suggests that the shots can ease lower-back pain caused by nerve problems in the short-term, they’re not going to provide long-term benefits. Thus, treatment guidelines such as the ACOEM Guideline concluded that treatment had no impact on functional impairment, the need for surgery, or pain relief beyond three months.

Applying the same logic to prescribing opiates for pain would rule them out also. They do not provide pain relief for more than a few hours. Yet, somehow opiates are authorized as a treatment option for decades, and epidural injections that last three months are not. This approach seems to have backed the industry into the corner of epidemic addiction problems, and increasing annual death rates.

Maybe it is time to rethink the cost versus benefits of pain treatment alternatives. A recent study published by the Pain Physician Journal found the cost utility analysis of caudal epidural injections in the treatment of disc herniation, axial or discogenic low back pain, central spinal stenosis, and post surgery syndrome in the lumbar spine shows the clinical effectiveness and cost utility of these injections at less than $2,200 per quality-adjusted life year.

Sara Charis Snow worked part-time at Trader Joe’s as a “crew member,” a position that required her to stock shelves, gather shopping carts from the store parking lot, provide customer service and perform other miscellaneous tasks.

In January 2011, Snow claimed that her right wrist hurt and that she believed the pain was caused by repetitive movements associated with her job. Trader Joe’s approved Snow’s claim and provided benefits for a three-month period.

Snow reported back to work on May 24, 2011. On her first day back she initiated a second claim alleging that she had injured her back while collecting three shopping carts from the parking lot that day. The adjuster delayed approval to allow for further investigation, and ultimately denied the claim.

At her November 2011deposition, when questioned about how she spent her time, Snow described participating in church activities, walking her dog on the beach, lying on the beach, going to the library and attending concerts and films.

But, a December 2011 subrosa video showed Snow standing on the running board of a Toyota 4Runner and removing a 12-foot paddleboard from the roof of the vehicle, carrying it approximately 150 feet down the sandy beach into the water, bending over to place the board in the water, climbing on the board and then paddling in a standing position until the investigator could no longer see her.

Snow is later seen paddling back to the beach, removing the board from the water, carrying it back up the hill to the vehicle with her right hand, lifting the board over her head and securing it to a rack on the roof of the vehicle. Snow was on the paddleboard for approximately 45 minutes. The investigator did not observe any signs of restrictions or limitations in Snow’s movements.

In her August 2012 second deposition she claimed she needed help carrying and loading her surfboard.

Snow was charged with insurance fraud and perjury based on false statements she made during her August 2012 deposition. A jury convicted her of three counts of workers’ compensation fraud and two counts of attempted perjury under oath for lying at her deposition about her ability to carry her paddleboard, and another count of attempted perjury for lying at her deposition about her ability to lift her paddleboard onto her vehicle.

Snow contends on appeal that her two convictions for attempted perjury should be consolidated into a single conviction because they are based upon the same “material matter.” Alternatively, she contends that her convictions on the two counts represent multiple convictions for the same offense in violation of the double jeopardy clause of the Fifth Amendment. The Court of Appeal rejected these arguments in the unpublished case of People v Snow.

Separate false statements given under a single oath may give rise to separate perjury charges under Penal Code section 118(a). (People v Jimenez, 11 Cal.App.4th at pp. 1623-1624.)

Last week Teva Pharmaceuticals, agreed to settle a civil action filed jointly by the Santa Clara County Counsel’s Office and the Orange County District Attorney’s Office for $1.6 million. Teva and four other companies were accused of engaging in deceptive marketing that helped spawn an addiction epidemic in those counties.

The opioid drugmakers who are alleged to have caused an opioid epidemic may now also be responsible for the litigation epidemic which seems to be headed headed their way.

The state of Ohio on Wednesday has now sued five major drug manufacturers, accusing them of misrepresenting the risks of prescription opioid painkillers that have fueled a sky-rocketing drug addiction epidemic. Reuters reports that the suit, filed by Attorney General Mike DeWine, comes as a growing number of state and local governments are suing drugmakers and distributors, seeking to hold them accountable for a deadly and costly opioid crisis.

The five companies Ohio sued were Purdue Pharma LP, Johnson & Johnson’s Janssen Pharmaceuticals Inc unit, a unit of Endo International Plc, Teva Pharmaceutical Industries Ltd’s Cephalon unit and Allergan Plc.

DeWine said the companies helped unleash the crisis by spending millions of dollars marketing and promoting such drugs as OxyContin and Percocet, overstating their benefits and trivializing their potential addictive qualities. “These companies continue to mislead the public,” DeWine said at a press conference in Columbus.

Janssen spokesman Jessica Castles Smith said in an emailed statement: “The allegations in this lawsuit are both legally and factually unfounded.” She said Janssen has acted responsibly regarding its opioid pain medications, which are approved by the U.S. Food and Drug Administration and carry FDA-mandated warnings on their labels about the drugs’ known risks.

Purdue said in an emailed statement: “We share the attorney general’s concerns about the opioid crisis and we are committed to working collaboratively to find solutions.”

Allergan and Teva declined to comment. Endo could not immediately be reached.

The suit, filed in Ross County, in Southern Ohio, where addiction has hit hard, alleges the drug companies violated the Ohio Consumer Sales Practices Act, committed Medicaid fraud, and created a public nuisance by disseminating false and misleading statements.

It seeks to halt deceptive practices, a declaration the companies acted illegally and unspecified damages to the state and consumers.

In Ohio, which has one of the nation’s highest overdose rates, 4,169 people died from overdoses last year, according to figures compiled by the Columbus Dispatch. Last year, 2.3 million Ohio residents were prescribed opioids, nearly a fifth of the state’s population, in turn helping fuel heroin abuse, DeWine said.

Drug companies including Purdue and Johnson & Johnson have been fighting lawsuits by two California counties, the city of Chicago, four counties in New York and the state of Mississippi over their opioid marketing practices.

Several West Virginia counties have filed lawsuits in recent months against drug wholesalers McKesson Corp, Cardinal Health and AmerisourceBergen for failing to report suspicious orders of opioids in the state.

West Virginia’s attorney general earlier reached settlements with Cardinal Health and AmerisourceBergen for a combined $36 million to resolve similar claims.

Some might be thinking about the potential for workers’ compensation subrogation against these drug companies.  Most assuredly, the opioid addiction epidemic has had a financial impact on the national cost of industrial claims exacerbated by the effects of these drugs.