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Officials Claim Purdue Misled World Health Organization

Vice Chair of the Democratic Caucus Congresswoman Katherine Clark  and Congressman Hal Rogers, co-founder and co-chairman of the Congressional Caucus on Prescription Drug Abuse, released a report exposing that Purdue Pharma L.P. funded organizations, people, and research to influence the World Health Organization (WHO)’s opioid prescribing recommendations.

The report reveals that two WHO guidelines released in 2011 and 2012 contain dangerously misleading and, in some instances, outright false claims about the safety and efficacy of prescription opioids. Alarmingly, these guidelines mirror Purdue’s marketing strategies to increase prescriptions and expand sales.

The report uncovers that in 2011, the WHO published a guidance document called Ensuring Balance in National Policies on Controlled Substances, Guidance for Availability and Accessibility of Controlled Medicines that, in addition to other falsehoods, repeats Purdue’s disproven claim that dependence occurs in less than one percent of patients.

Then, in 2012, the WHO published a second guidance document called Pharmacological Treatment of Persisting Pain in Children with Medical Illnesses claiming that there is no maximum dosage of strong opioids, like OxyContin, for children. The WHO published this claim despite the fact that U.S. public health agencies had already found that fatal overdoses skyrocket in adult patients who are prescribed above 90 morphine milligram equivalents (MME) per day.

“The web of influence we uncovered paints a picture of a public health organization that has been manipulated by the opioid industry,” said Congresswoman Clark. “The WHO appears to be lending the opioid industry its voice and credibility, and as a result, a trusted public health organization is trafficking dangerous misinformation that could lead to a global opioid epidemic.”

In addition, it appears Purdue was able to insert their marketing strategies into the WHO by creating and funding front organizations, who participated in research that acted as the foundation for the WHO’s guideline documents. The guidelines are widely available and are currently being distributed as public health best practices and reference material for other publications.

In response to their findings, Clark and Rogers published a letter along with the report directed to the WHO. It calls on the WHO to rescind the two guidelines, provide a comprehensive explanation of why the WHO’s internal controls failed to prevent this scheme, and issue a warning to the world that their 2011 and 2012 guidelines should not be followed.

Clark and Rogers were inspired to look into the connections between the opioid industry and the WHO after the WHO failed to respond to a letter sent by the lawmakers in 2017. The letter warned the WHO that Purdue was attempting to expand their drug sales to international markets using the same fraudulent marketing tactics that instigated the opioid crisis in the United States and that if not stopped, Purdue could create a global opioid crisis.

May 20, 2019 News Podcast


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: En Banc WCAB Defines “Catastrophic Injury”, California Jury Stunning $2B Cancer Verdict, 44 States Claim 20 Drugmakers Fixed Prices, Jurisdiction Over Home Health Care Limited to UR/IMR, Findings in WCAB Psyche Case Binding in FEHA Claim, LAPD Officer Charged with Comp Fraud, Insurance Agent Allegedly Steals Premiums, USDOL Opposes ABC Employment Test, Comp 83% Combined Ratio Lowest Since 1930s, Opioid Crisis Spreads to Canada and Europe.

States Pursue Strategies Against Purdue Bankruptcy

Last March, Business Insurance reported that OxyContin maker Purdue Pharma LP was exploring filing for bankruptcy to address potentially significant liabilities from thousands of lawsuits alleging the drug manufacturer contributed to the deadly opioid crisis sweeping the United States.

Purdue and its wealthy owners, the Sackler family, are under pressure to respond to mounting litigation accusing the pharmaceutical company of misleading doctors and patients about risks associated with prolonged use of its prescription opioids.

Perhaps in response to the suspected Purdue strategy, recently a number of states, and now this week the Minnesota Attorney General Keith Ellison is naming members of the Sackler family behind opioid manufacturer Purdue Pharma in the state’s ongoing lawsuit over marketing tactics that have been linked to a wave of addictions and overdose deaths across the country.

“Their misconduct led directly to damage and death in every community in Minnesota,” Ellison said. “They knew what they were doing, and they did it anyway. Today, we’re holding them personally accountable for the harm they and their greed have done to the people of our state.”

In a statement, the Sackler family described the lawsuit as “baseless” and a “misguided attempt to place blame where it does not belong for a complex public health crisis.”

Purdue Pharma notched a legal win this week when a North Dakota judge dismissed that state’s claim that the company minimized risks and inflated the benefits of long-term use of its narcotic painkillers. The judge found “holding Purdue solely responsible for the entire opioid epidemic in North Dakota is difficult especially given Purdue’s small share of the overall market for lawful opioids.” Minnesota Attorney General Keith Ellison

North Dakota Attorney General Wayne Stenehjem said Friday he will appeal the ruling.

Minnesota originally filed suit last year against Purdue Pharma, the Sackler-founded company in Connecticut that created OxyContin. The litigation was modeled after successful efforts to sue tobacco companies, with the aim of using a judgment to fund addiction treatment.

Ellison said that he is seeking to add eight members of the Sackler family as individual defendants after finding that each played a role in allegedly deceptive marketing tactics “at a granular level.”

According to Ellison, Sackler family members attended sales meetings and directed compensation of Purdue’s sales force in ways that encouraged inappropriate opioid prescriptions. He added that the family knew of the addictive power of opioids as early as 1999 but dismissed and withheld such information for years.

Nearly every state is involved in litigation against companies tied to opioid production or distribution, with both state and federal officials increasingly trying to force Big Pharma to foot the bill for addiction treatment and prevention. In addition to the states’ suits, a massive federal lawsuit involving 1,600 cities, counties, American Indian tribes and labor unions was consolidated last year in Ohio. Purdue Pharma is one of more than a dozen defendants named in that case.

Now, state attorneys general are increasingly trying to bring members of the Sackler family to account for their roles with Purdue Pharma. This week, Iowa, Kansas, Maryland, West Virginia and Wisconsin each announced new legal actions against Purdue Pharma, and all but Kansas targeted at least one member of the Sackler family. Minnesota’s lawsuit would be one of the more extensive pieces of litigation against the family, with eight members named.

Purdue agreed with Oklahoma in March to a $270 million settlement out of court, staving off what would have been its first trial over the opioid epidemic. Sackler family members will personally pay $75 million of that total.

CompWest Announces California Expansion

CompWest Insurance is continuing its expansion in California and the West, adding more than 50 new classifications that broaden its workers’ compensation appetite in construction, manufacturing and other areas.

CompWest specializes in workers’ compensation insurance, servicing accounts up to $1.5 million of annual premium in California and select Western states with consistent risk evaluation and pricing.

“This is our largest class code expansion and the sixth consecutive year our appetite has been expanded,” said Gene Simpson, vice president of Underwriting and Marketing at CompWest.. “We continue to see a strong demand for our comprehensive array of workers’ compensation solutions and we believe this expansion will be a springboard toward continued growth in the months and years ahead.”

CompWest’s current class expansion broadens the company’s ability to write new business and introduces new opportunities for agents to expand their book of business with new and existing clients. The rollout will take place in three phases through August.

CompWest’s appetite focuses on mid-size businesses in healthcare, hospitality, manufacturing, professional services, construction, retail and wholesale services. CompWest Insurance Company is a member of AF Group.

CompWest Insurance is part of the Accident Fund Holdings, which is a workers’ compensation insurance holding company conducting business through four operating units in the US – Accident Fund Cos., located in Lansing, Mich.; United Heartland, located in New Berlin, Wisc.; CompWest, located in San Francisco; and Third Coast Underwriters, located in Chicago.

Accident Fund Holdings, Inc. is one of the largest privately held monoline workers’ compensation carriers in the country. The company was founded in 1912 as a Michigan accident fund.

Accident Fund Insurance Company of America operates as a subsidiary of Blue Cross Blue Shield of Michigan, Inc.

Welding Fumes Linked to Lung Cancer

Workers exposed to welding fumes are more likely to develop lung cancer than those not exposed to the fumes, and the new study published in the BMJ Occupational and Environmental Medicine suggests this holds true regardless of other risk factors like smoking or exposure to asbestos. This research will likely result in an increase of workers’ compensation claims for lung cancer by employees in this industry.

“Welding fumes have previously been classified as ‘possibly carcinogenic’ to people,” said Dr. Denitza Blagev, a researcher at the University of Utah and Intermountain Medical Center in Murray, Utah.

“Although welders have been observed to experience higher lung cancer rates, there are many other factors – including smoking, asbestos and other carcinogen exposures – that were likely contributing to that increased risk,’ Blagev, who wasn’t involved in the study, said by email according to the summary reported in Reuters Health.

For the current analysis, researchers examined data from 45 previously published studies with a total of roughly 17 million participants. Overall, people who worked as welders or had exposure to welding fumes were 43 percent more likely to develop lung cancer.

When researchers looked only at data from studies that accounted for both smoking and asbestos exposure, welding was still associated with a 17 percent higher risk of lung cancer.

“It is now clear that the increased lung cancer risk in welders is not fully explained by these other factors,” Blagev said by email. “And with this review, welding fumes can be classified as ‘carcinogenic’ to humans.”

Worldwide, an estimated 110 million workers are exposed to welding fumes either as welders or as bystanders, Dr. Neela Guha of the California Environmental Protection Agency and colleagues note in Occupational & Environmental Medicine.

Welding fumes are generated when metals are heated above their melting point and then vaporize and condense into very fine solid particles in the air. The exact blend of chemicals in these vapors can depend on the type of metals involved, the welding process, and the occupational setting where the work is performed.

For example, nickel compounds and chromium are both known to cause lung cancer and are typically present in fumes when workers weld stainless steel, the study team writes. These metals are in much lower concentrations in other types of steel, which tend to produce fumes with more fine particulate matter – tiny solid and liquid bits of soot, dust and chemicals that can damage the lungs.

The process can take decades of exposure,” said Paul Cullinan, an occupational and environmental health researcher at Royal Brompton Hospital and Imperial College London in the UK.

Chiropractor Convicted of Insurance Fraud

SF Gate reports that a licensed chiropractor who worked out of an office in Daly City pleaded no contest to felony insurance fraud and other charges related to a food allergy test that he offered even though it was not covered by insurance companies and has not been proven effective, prosecutors said.

Benjamin Zimberoff Darrow, 48, had been charged with insurance fraud, the unlicensed practice of medicine, illegal laboratory markup and the theft of over $100,000, and faces up to two years in prison, according to the San Mateo County District Attorney’s Office.

Darrow operated three businesses out of the same office — Darrow Chiropractic, Pacific Spine and Joint, and Coastside Medical — and often offered patients a food allergy test called ALCAT that involved drawing a blood sample in the office, prosecutors said.

Darrow performed the test on more than 250 patients and claimed to have been performing the blood work on site, but instead was paying about $600 to send them to an outside lab, prosecutors said.

The test was not covered by insurance because of its ineffectiveness at testing for food allergies, but Darrow manipulated the way he billed for it to disguise the fact that he was performing the ALCAT test.

He billed insurance companies about $3,000 per test, receiving more than $790,000 in improper insurance payouts as a result, according to the district attorney’s office.

Darrow remains out of custody on $350,000 bond and will return to court on July 2 for sentencing. His attorney was not immediately available to comment on the case.

Startup Disrupts Pharmacy Business Model

A team of Internet entrepreneurs in downtown Manhattan wants to revolutionize how Americans get prescription drugs. Their company, Blink Health, has a crazy idea: let customers shop for the best deal. The founders of Blink Health seek to eliminate the middlemen and comparison-shop at their website to see if you can get a better deal than what’s being offered by and insurance plan or the drugstore.

Blink Health claims that the pharmacy business remains largely untouched because customers haven’t easily been able to shop online for a better price. They’re buying drugs the way they bought them in the predigital age – at the drugstore. The middlemen still flourish, at the expense of everyone else..

The dominant middlemen are the pharmacy benefit managers, or PBMs, which are hired by private and government health-insurance plans to administer drug benefits. Dozens of small PBMs once competed for business, but today three large firms – Express Scripts, CVS Caremark, and OptumRx – together control more than 75 percent of the market.

While other twentysomethings were launching Internet startups, Geoffrey Chaiken was wondering why there was no Uber or Airbnb in the pharmacy industry. After dropping out of Yale to start a company developing epilepsy drugs, he began studying the industry’s supply chain.

Together with his younger brother, Matthew, he started Blink Health in his downtown apartment four years ago. Today, it has 600,000 customers and an office in SoHo with 220 employees. To help them run the company, the Chaikens brought in veterans of online companies like Kayak as well as the drug industry, including Bill Doyle, who’d spent decades working for Johnson & Johnson.

Blink negotiates with drug manufacturers, using its purchasing power to extract discounts off the list price. Then, instead of collecting secret rebates or steering patients to a preferred drug, it posts all the discounted prices on its website (and makes money by charging the patient slightly more than it reimburses the pharmacy). Instead of forcing patients to turn over their prescription to a pharmacist to find out what it will cost, Blink lets doctors and patients shop on the web before making a commitment.

For example, a month’s supply for the generic version of Lipitor (atorvastatin) would typically cost more than $100 at CVS and more than $200 at Walgreens. The generic version of Crestor (rosuvastatin) would cost more than $175 at either chain. If your plan covered the Lipitor but not the Crestor generic, you might spend between $5 and $40 for the Lipitor, but you’d have to pay the full $175 for the Crestor – so you might not buy it, even though it would be the better option for you.

At Blink’s website, you can typically find the Lipitor generic priced under $9 and the Crestor under $12. If you buy it from Blink, you can get it delivered to your home or pick it up at a local drugstore. Independent pharmacies have been eager to work with Blink because it’s simpler and more profitable than dealing with insurance plans.

Blink makes straightforward payments for the drugs and doesn’t impose complicated contracts (or gag clauses). The PBMs often pay less, and they impose various fees, like charging pharmacists $5 if they call their help desk to deal with a prescription. The PBMs can decide months after a transaction that the pharmacy must give back part of the reimbursement—a retroactive penalty called a “clawback”—which can cause the pharmacy to lose money on the prescription.

Blink Health has shown that the same market forces that liberated airlines and their passengers can liberate drugmakers and patients. These forces could transform the rest of the health-care industry. The prices of most medical procedures and hospital stays are as complex and opaque as they are for prescription drugs. The prices are known, again, only to the middlemen, so it’s not surprising that costs keep rising.

WC Drug Costs and Utilization Improved in 2018

Overall drug cost and utilization were both down for workers’ comp payers in 2018. Combined with tighter regulatory control, this trend helped to reduce drug spend by nearly 4% over 2017.

That’s the key takeaway from myMatrixx’s 2018 Workers’ Compensation Drug Trend Report, which highlighted the industry’s progress toward decreasing reliance on opioids and better managing prescription authorization.

But though the overall outlook is positive for payers, some troubling trends are taking shape. Brand-name versions of the most common drugs prescribed to injured workers are 65% more expensive today than they were in 2014. Generics, on the other hand, have dropped 35% in price over the same time period. Across all myMatrixx payers, 86% of prescriptions filled were generic versions.

Together, lower prices and higher utilization of generics have driven an overall 0.9% reduction in unit costs.

Between 2019 and 2022, a number of brand name drugs will also lose patent protection, opening the door for manufacturers to bring more generic versions to market. Nine of these are indicted for pain and inflammation, and thus represent potential new alternatives to opioids as payers shift away from addictive painkillers.

Average opioid spending among myMatrixx payers has dropped by 15%, thanks to broad efforts at prescriber education and more aggressive prescription management. In 2017, 21% of injured workers used an opioid for at least 30 days. In 2018, that rate dropped to 17.6%.

Utilization among both NSAIDS and gabapentin – another non-opioid alternative – increased slightly, suggesting that prescribers are beginning to favor these non-addictive pain management drugs over opioids.

The use of compounds has been significantly curtailed to the point where they are nearly extinct in the world of workers’ comp. Utilization has decreased 24% since 2017, driving a 43% reduction in spending. In 2018, only 0.2% of medications were compound creams.

“We’ve pretty much eliminated compound creams from the picture,” said Rochelle Henderson, PhD & VP of Clinical Research at Express Scripts. “That being said, dermatologicals are growing as a category, and they will be an area to watch going forward.”

Diabetic Drug Greatly Reduces Fibromyalgia Pain

Researchers led by a team from The University of Texas Medical Branch at Galveston were able to dramatically reduce the pain of fibromyalgia patients with medication that targeted insulin resistance.

This discovery could dramatically alter the way that some forms of chronic pain can be identified and managed. Dr. Miguel Pappolla, UTMB professor of neurology, said that although the discovery is very preliminary, it may lead to a revolutionary shift on how fibromyalgia and related forms of chronic pain are treated. The new approach has the potential to save billions of dollars to the health care system and decrease many peoples’ dependence on opiates for pain management.

The UTMB team of researchers, along with collaborators from across the U.S., including the National Institutes of Health, were able for the first time, to separate patients with fibromyalgia from normal individuals using a common blood test for insulin resistance, or pre-diabetes. They then treated the fibromyalgia patients with a medication targeting insulin resistance, which dramatically reduced their pain levels. The study was recently published in PlosOne.

Fibromyalgia is one of the most common conditions causing chronic pain and disability. The global economic impact of fibromyalgia is enormous – in the U.S. alone and related health care costs are about $100 billion each year. Despite extensive research the cause of fibromyalgia is unknown, so there’s no specific diagnostics or therapies for this condition other than pain-reducing drugs.

“Earlier studies discovered that insulin resistance causes dysfunction within the brain’s small blood vessels. Since this issue is also present in fibromyalgia, we investigated whether insulin resistance is the missing link in this disorder,” Pappolla said. “We showed that most – if not all – patients with fibromyalgia can be identified by their A1c levels, which reflects average blood sugar levels over the past two to three months.”

Pre-diabetics with slightly elevated A1c values carry a higher risk of developing central (brain) pain, a hallmark of fibromyalgia and other chronic pain disorders.

The researchers identified patients who were referred to a subspecialty pain medicine clinic to be treated for widespread muscular/connective tissue pain. All patients who met the criteria for fibromyalgia were separated into smaller groups by age. When compared with age-matched controls, the A1c levels of the fibromyalgia patients were significantly higher.

“Considering the extensive research on fibromyalgia, we were puzzled that prior studies had overlooked this simple connection,” said Pappolla. “The main reason for this oversight is that about half of fibromyalgia patients have A1c values currently considered within the normal range. However, this is the first study to analyze these levels normalized for the person’s age, as optimal A1c levels do vary throughout life. Adjustment for the patients’ age was critical in highlighting the differences between patients and control subjects.”

For the fibromyalgia patients, metformin, a drug developed to combat insulin resistance was added to their current medications. They showed dramatic reductions in their pain levels.

Other authors include UTMB’s Clark Andersen and Xiang Fang as well as Laxmaiah Manchikanti from Louisiana State University School of Medicine Health Sciences Center; Nigel Greig from the National Institutes of Health; Fawad Ahmed from St. Michael’s Pain & Spine Clinics; Michael Seffinger from the College of Osteopathic Medicine of the Pacific and Andrea Trescot from the Pain and Headache Center in Eagle River, Alaska.  

LAPD Officer Charged with Comp Fraud

The Los Angeles County District Attorney’s Office announced that a Los Angeles Police Department officer has been charged with workers’ compensation fraud.

Mario Jacinto (dob 8/6/78) of Diamond Bar faces four counts of workers’ compensation insurance fraud and one count of attempted perjury under oath, all felonies, in case BA477808. Jacinto, described as an “Officer III,” is a 16-year veteran of the force and is assigned to Newton Area, Los Angeles Police Department officials said.

The case was filed for arrest warrant on May 15 and the defendant was arrested. Jacinto was released after posting $50,000 bail.

Jacinto is accused of misrepresenting the extent of his job-related injuries for which he was receiving disability benefits.From October 2018 through January,he allegedly engaged in activities that were inconsistent with his work-related claims, said Deputy District Attorney Arunas Sodonis of the Healthcare Fraud Division.

While under oath during a deposition, Jacinto claimed he had not participate in martial arts classes after being injured, but according to the complaint, those claims were false.

A complaint against officer Mario Jacinto, 40, said he “falsely claimed he had not participated in martial arts classes since the date of his injury,” said Paul Eakins, a spokesman for the Los Angeles County District Attorney’s Office, in an email to McClatchy.

Jacinto faces a possible maximum sentenceof eight years and eight months in state prison if convicted as charged. The prosecutor is requesting that bail be set at $40,000.The case remains under investigation by the LAPD, Special Operations Division.