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Experts Say Drugmakers Influence Clinicians One Meal at a Time

An expert in pharmaceutical policy has said that the frequent interactions between pharmaceutical companies and health professionals can pose a conflict of interest for clinicians.

Prof. Barbara Mintzes told The Epoch Times that research has demonstrated that there was a corollary between health professionals receiving a low price meal while being promoted a drug and the rate of the professional then prescribing that medication compared to generic alternatives of similar quality.

Mintzes said a common example is pharmaceutical companies sponsoring events to provide food and drinks for health professionals.

“If you survey doctors, they will say, I can’t be bought for the price of a pizza or I can’t be bought for the price of a sandwich,” Mintzes said but she noted that research in the US found physicians that receive a meal promoting the drug of interest, averaging less than $20, had a significantly higher rate of prescribing that medication compared to generic alternatives of similar quality.

The study also found a dose-response where “the more meals provided; the more likely doctors are to prescribe the product.

Mintzes noted that while the decision may not be conscious, “we’re all human and there is a tendency to reciprocity whether we’re conscious of it or not.”

“You would also expect that the companies are also looking at the returns on investment on their marketing activities and would not continue with marketing activities that were ineffective in terms of stimulating sales.”

Prior to 2015, Medicines Australia required its member companies to publicize each event they had sponsored, including information of the event such as the number of health professionals and who had attended, how much money was spent and what was spent on with spending on food and drinks by far the most common.

Additionally, from Medicines Australia’s data from 2011 to 2015, Mintzes’s team found that on average, corporate sponsored events for pharmaceuticals were being held at hospitals and universities over 600 times every week, averaging 30 attendees per event.

However, since October 2015, Medicines Australia changed its codes of conduct from requiring food and drink payments being reported to have companies only listing clinicians they provided funding for.

Whilst this enhanced transparency around the identification of individual health professionals, subsequent studies led by the University of Sydney also observed a 34.1 percent reduction in disclosed spending in 2016 and decreased expenditure reports in the year following.

Despite Medicines Australians change in 2015, Mintzes’s recent co-authored study on underreporting of conflicts of interests by health professionals has raised further questions about the limitations of a self-reported system.

The team examined Medicines Australia’s public data and found that nearly half of pharmaceutical trials with Australian authors had omitted or incomplete conflicts of interest declarations when the research team received commercial funding.

“It certainly seems that it’s not a situation where there are just like one or two bad apples, who are hiding their conflicts of interest, it seems more of a situation where it’s quite widespread,” she said.

March 21, 2022 – News Podcast


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: WCAB Panel Clarifies Requirements for Reopening an Award. WCAB Panel Reviews Case Law Allowing Minor Pleading Errors. 9th Circuit to Rule on Federal Preemption of California Sick Pay Law. After Ten Years of Litigation – Jury Clears Sutter Health of Antitrust Claim. Pain Clinic Chain with 20K Patients Abruptly Closes Under Investigation. Judicial Council Votes to Rescind Covid-19 Superior Court Rules. Newsom Proposes New Office of Health Care Affordability. Scientists Report on the Pandemic Related Research Sliver Lining. Researchers Study Use of Plastic Barriers On COVID-19 Transmission. Google Announces New Technology For Electronic Health Records.

Modesto Wastewater Surveillance Key to Early COVID Detection

William Wong, director of utilities for Modesto, oversees water and sewage operations. Since early in the pandemic, he’s wanted to monitor the city’s sewage for SARS-CoV-2. It’s a natural extension of his work.

Kaiser Health News reports that across the country, academics, private companies, public health departments, and sewage plant operators have been working to hone a new public health tool, one with uses that could reach well beyond covid.

Wastewater surveillance is not a new concept, but the scale and scope of the current pandemic have vaulted the technique over the narrow walls of academic research to broader public use as a crucial tool for community-level tracking of covid surges and variants.

Sewage surveillance is proving so useful that many researchers and public health officials say it should become standard practice in tracking infectious diseases, as is already the case in many other countries. But whether that happens – and which communities get access – depends on the nation’s ability to vastly scale up the approach and make it viable in communities rich and poor.

Like many other public health tools, wastewater testing initially took off in big cities and university towns with access to research expertise, equipment, and money. The Modesto California project offers a glimpse of the challenges and opportunities involved in making this technology available in communities with more limited resources.

In Modesto, wastewater also revealed that the delta variant remained the dominant strain well into January, weeks after omicron had taken over elsewhere. That was important, said Dr. Julie Vaishampayan, the health officer for Stanislaus County, where Modesto is located. because some of the available treatments that don’t work for omicron are effective against delta. Her department told local doctors to keep using the full range of medicines, even after other areas had narrowed their treatment arsenal.

“You should be injecting more resources in places that are underserved since they have the disproportionate burden of disease,” said Colleen Naughton, an engineering professor at the University of California-Merced who is helping set up testing in Merced, Modesto, and surrounding Central Valley farm towns.

For covid surveillance, wastewater isn’t subject to the tricky inconsistencies that come with testing for the coronavirus in humans. Covid testing shortages have been a persistent problem throughout the pandemic, stemming both from supply-chain shortfalls and wide variation in local governments’ response. Long delays in test results can leave health officials weeks behind in detecting and monitoring infection trends.

More recently, at-home tests, whose results rarely find their way to public health departments, have proliferated. And for people living in lower-resource communities, there are incentives not to test at all, said Dr. Vaishampayan. A positive test can be a huge problem for people who can’t take time off work or keep their kids out of school.

By contrast, sewage surveillance is an effective and relatively low-budget enterprise, less reliant on human whim.

Dozens of research projects around the country have shown that the method can be used to accurately track covid trends over time. Upticks and drop-offs in neighborhood- and community-level infections can appear in sludge several days before they show up in tests.

Recent research has found that wastewater surveillance is a reliable method for monitoring flu and the common respiratory illness RSV. The Centers for Disease Control and Prevention told KHN it will soon launch pilot studies to see whether sewage can reveal trends in antibiotic-resistant infections, foodborne illnesses, and candida auris, a fungal infection.

There are places where sewage may not be a great way to keep tabs on covid. That includes communities without sewers; areas with industrial sewage, where treatment techniques can mask the virus; and communities with huge fluctuations in population, such as ski towns.

But where available, the data has already proven powerful. During the winter surge caused by omicron, California, Colorado, New York, and Texas first detected the variant via sewage. Central Valley health officials have said that sewage monitoring has assured them that declines in covid cases are real, and not a distorted reflection of declines in reported testing.

IMR Reviews Hit All Time Low in 2021

A new California Workers’ Compensation Institute study on the Independent Medical Review process, used to resolve workers’ comp medical disputes, shows that the number of IMR decision letters hit an all-time low in 2021 as pharmaceutical disputes – especially those involving opioids – have continued to decline since the state adopted evidence-based chronic pain and opioid guidelines and a prescription drug formulary.

Data for CWCI’s study was derived from more than 1.1 million IMR decision letters issued from 2015 through 2021 in response to applications submitted to the state after a Utilization Review (UR) physician modified or denied a workers’ comp medical service request.

In addition to measuring changes in IMR volume, the authors used the data to measure shifts in the mix of medical services reviewed and uphold rates by major medical service category; IMR response times; regional variations; the distribution of prescription drug IMRs and uphold rates for various drug categories; the proportion of IMRs involving medical service request modifications among six service categories; and the concentration of IMRs involving high-volume medical providers.

The IMR letter count showed that since peaking at 184,735 letters in 2018, IMR letter volume has declined for three years in a row, falling to 163,899 letters in 2019, 136,738 letters in 2020, and 133,494 letters in 2021.

While some of that decline reflects decreasing claim volume in 2020 – the first year of the pandemic – the study found that much of the decline came after the Division of Workers’ Compensation (DWC) incorporated Chronic Pain and Opioid Guidelines into the Workers’ Compensation Medical Treatment Schedule in late 2017 and implemented a Prescription Drug Formulary.

Overall, there were more than 51,000 fewer IMR letters in 2021 than in 2018, with more than half of that decline occurring in 2020, when IMR letter volume fell by more than 27,000 letters.

Since 2018, IMR letter counts have been down across all medical service categories, though the huge reduction in IMR disputes involving prescription drug requests has led to a redistribution of IMRs among the major medical service categories.

The biggest percentage increases have been in physical therapy; injections; and durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), each of which saw their share of the IMR letters increase by 2.4 to 3.1 percentage points since 2018. Last year’s overall IMR uphold rate of 92.0 percent was up from 89.4 percent in 2020 and was the highest uphold rate since IMR took effect in 2014, though here too the results varied by medical service category, with uphold rates ranging from 84.9% to 95% among the different categories.

The study’s regional analysis identified areas of the state where 2021 IMR letter volume was high or low relative to each region’s workers’ compensation claim volume.

Los Angeles County, widely known as a hotbed for workers’ compensation litigation, accounted for 24.7% of California’s 2021 workers’ comp claims and 27.6% of the IMR letters, while in contrast, IMR letter volume was disproportionately low in the Inland Empire/Orange County region, which had 20.7% of the state’s claims but 13.9% of the IMR letters.

Surprisingly, the greatest disparity between claim volume and IMR letters was in the San Francisco Bay Area, which had 17.8% of the claims but 25.7% of the IMR letters. The study notes that one factor that likely contributed to that disparity is the prevalence of pain management specialists in the Bay Area.

A review of the doctors with the highest number of IMR disputes last year showed that five of the top six in the state were pain management specialists, and four of the top six were located in the Bay Area, which would at least partially explain the disproportionate share of IMR letters – especially those involving prescription drug disputes – sent to the region.

Scientists Unsure if BA.2 Variant Will Cause Another U.S.Surge

A new omicron subvariant of the virus that causes COVID-19, BA.2, is quickly becoming the predominant source of infections amid rising cases around the world. A new article in the Ventura County Star provided a closer look at what makes it different from previous variants, whether there will be another surge in the U.S. and how best to prepare.

BA.2 is the latest subvariant of omicron, the dominant strain of the SARS-CoV-2 virus that causes COVID-19. While the origin of BA.2 is still unclear, it has quickly become the dominant strain in many countries, including India, Denmark and South Africa. It is continuing to spread in Europe, Asia and many parts of the world.

The omicron variant has three main subvariants in its lineage: BA.1, BA.2 and BA.3. The earliest omicron subvariant to be detected, BA.1, was first reported in November 2021 in South Africa. While scientists believe that all the subvariants may have emerged around the same time, BA.1 was predominantly responsible for the winter surge of infections in the Northern Hemisphere in 2021.

Some scientists have called BA.2 a “stealth” variant because, unlike the BA.1 variant, it lacks a particular genetic signature that distinguishes it from the delta variant. While standard PCR tests are still able to detect the BA.2 variant, they might not be able to tell it apart from the delta variant.

BA.2 is considered to be more transmissible but not more virulant than BA.1. This means that while BA.2 can spread faster than BA.1, it might not make people sicker.

A recent preliminary study that has not yet been peer reviewed of over 1 million individuals in Qatar suggests that two doses of either the Pfizer-BioNTech or Moderna COVID-19 vaccines protect against symptomatic infection from BA.1 and BA.2 for several months before waning to around 10%. A booster shot, however, was able to elevate protection again close to original levels.

Importantly, both vaccines were 70% to 80% effective at preventing hospitalization or death, and this effectiveness increased to over 90% after a booster dose.

CDC data suggests that BA.2 cases are rising steadily, making up 23% of all cases in the U.S. as of early March. Scientists are still debating whether BA.2 will cause another surge in the U.S.

Though there may be an uptick of BA.2 infections in the coming months, protective immunity from vaccination or previous infection provides defense against severe disease. This may make it less likely that BA.2 will cause a significant increase in hospitalization and deaths.

The U.S., however, lags behind other countries when it comes to vaccination, and falls even further behind on boosters.

Whether there will be another devastating surge depends on how many people are vaccinated or have been previously infected with BA.1. It’s safer to generate immunity from a vaccine, however, than from getting an infection.

Insurance Survey Says Fraud Accounts for 10% of Claims Cost

In a recent study by FRISS, a risk and compliance solution provider for P&C insurance companies worldwide, the challenges and opportunities facing insurers in their efforts to combat fraud throughout the entire policy lifecycle are highlighted. The study gathered input from over 400 insurance professionals worldwide and provides insight into topics such as fraud schemes, data challenges, process automation and more.

Survey respondents have differing views on the challenges and benefits of fraud detection software solutions. The common theme however is the data challenge; from underwriting to claims to special investigations. The difficulty is harnessing timely data to respond quickly when fraud is detected. FRISS’ past biennial surveys indicate that insurance professionals have struggled with inadequate data – either poor-quality internal data or limited access to external data sources.

COVID-19 will have a lasting impact on insurance, in large part because the pandemic has accelerated digital processes. Insurers must continue to address their technology debt by digitizing core processes, migrating to the cloud and embracing flexible sourcing models. Insurers are using a multilayered approach to minimize their risk of fraud, and improving protection at the front door at underwriting is definitely an area of focus. While these trends are continuing, insurers also are better positioned to take advantage of digital tools to combat fraud end-to-end.

Exactly how much fraud impacts the industry is always hard to pinpoint, however according to the Coalition Against Insurance Fraud, in the US alone, fraud steals at least $80 billion every year from American consumers. Creativity and persistence in claims fraud is therefore a serious threat for insurers. Fraudsters continue to perpetrate schemes against insurers and inevitably work to exploit emerging system gaps, continuing to drive up the cost of insurance for honest consumers. For 41% of survey respondents, keeping up with modern fraudster modus operandi was their greatest challenge in effective responding to fraud. The top fraud schemes that saw an increase in popularity the past year are claiming false injuries, nondisclosure of relevant information and staged accidents.

The industry generally agrees fraud accounts for about 10% of all claims cost. However, one change since the prior survey is an increase in the percentage of claims suspected as fraudulent. In 2021 the suspicion of claims containing a potential element of misrepresentation or fraud rose to 20% – a rise predicted by FRISS in the previous report.

Having the right data in the right place, and in real time, is essential to improving fraud detection. With many insurers utilizing digital processes for almost all of their operations, the ability to see real-time data identifying potential fraud is hugely beneficial across the policy lifecycle – from first-party policy requests, to underwriting, and of course as claims are reported. The difficulty is harnessing timely data to respond quickly when fraud is detected. FRISS’s past biennial surveys indicate insurance professionals have struggled with inadequate data – either poor-quality internal data or limited access to external data sources. This year, amongst the top challenges in fighting fraud again where data protection and privacy, internal data quality and inadequate access to external data.

The future of fraud detection lies in the use of advanced technologies to support real-time, large-volume, and highly precise modelling for claims and underwriting fraud. Fortunately, respondents do see significant benefits in fraud detection software. These include:

– –    Improve loss ratio, cited by 59%
– –    Stay ahead of developing fraud schemes, cited by 53%
– –    Increase investigator efficiency, cited by 52%

A hybrid approach of human expertise and predictive models will be essential in preventing losses. This will reduce the costs of underwriting and claims handling by removing unnecessary and error prone steps, and enables discovery of suspicious behavioural trends in data. This not only can augment the results of the existing data, it would give insurers an advantage when identifying the ever-changing schemes of fraudsters. Because FRISS believes that when insurance is more transparent and everyone can pay fair premiums that aren’t inflated by the real costs of fraud, businesses and individuals can thrive and achieve their dreams.

Carriers Exempt From Insurance Frauds Prevention Act Liability

In January 2016, Gilbert Ellinger injured his back while working, and he immediately informed his supervisor.

The following month, Ellinger reported to his employer’s human resources manager that he had sustained a work-related injury and had told his supervisor about it. The human resources manager created a “time line memorandum” summarizing the conversations she had with Ellinger about the injury. She placed the memorandum in Ellinger’s personnel file.

Ellinger filed a workers’ compensation claim based on the injury. Zurich was the workers’ compensation insurance carrier for Ellinger’s employer, and ESIS was Zurich’s claims administrator. Stephanie Ann Magill worked as a senior claims examiner for ESIS and was the adjuster assigned to investigate Ellinger’s claim.

ESIS denied Ellinger’s claim. Magill later testified that she denied the claim because of an April 2016 written statement from Ellinger’s supervisor in which the supervisor claimed that Ellinger had not reported the injury to him.

When the human resources manager was deposed in November 2016, she produced the time line memorandum, which Ellinger’s counsel in the workers’ compensation action did not know about until then. Nearly eight months after that disclosure, in July 2017, ESIS reversed its denial of the claim and stipulated that Ellinger was injured while working, as he had alleged.

When Magill was deposed in September 2018 she testified that she was unaware of the time line memorandum. Contrary to Magill’s testimony, her email messages show that the human resources manager had emailed Magill the time line memorandum in March and April 2016, and Magill thanked the manager for sending it.

Ellinger brought suit on behalf of the People of the State of California against Zurich American Insurance Company, ESIS, Inc., and Magill under Insurance Code section 1871.7, a provision of the Insurance Frauds Prevention Act (IFPA). Ellinger alleged that Magill’s concealment of or failure to disclose the time line memorandum violated Penal Code section 550, subdivision (b)(1) to (3).

Defendants filed demurrers. They argued that insurers and their agents, such as a claims administration company and a claims adjuster, could not be held liable in a qui tam action under section 1871.7. The trial court sustained defendants’ demurrers without leave to amend. The Court of Appeal affirmed in the unpublished case of People ex. rel. Ellinger v Magill (March 2022) E076378.

The trial court found persuasive State of California ex rel. Nee v. Unumprovident Corp. (2006) 140 Cal.App.4th 442 and State of California ex rel. Metz v. Farmers Group, Inc. (2007) 156 Cal.App.4th 1063, and concluded that insurance carriers are not subject to liability under the IFPA for claims handling practices.

In this case the opinion rejected arguments against these prior decisions and concluded that “excluding insurers and their agents from liability under section 1871.7 does not “tacitly approve of insurance company fraud” or otherwise entail that insurers and their agents can commit fraud with impunity. It means only that insurers and their agents cannot be sued under the IFPA. That holding is not surprising, because the IFPA expressly targets only deceptive conduct directed at insurers, not improper conduct by insurers.”

State Fund Announces $55M Dividend to 2021 Policyholders

State Compensation Insurance Fund announced plans to distribute an approximate $55 million dividend to its qualifying policyholders with policies that took effect between January 1 and December 31, 2021.

This dividend equals approximately 5% of the estimated annual premium reported during that period.

In 2021, State Fund reported approximately $1.1 billion in estimated annual premium (EAP) and approximately $159 million in realized capital gains.

“Due to the significant capital gains we realized in our equity portfolio, and our strong financial position, we are able to return money to our policyholders for the third consecutive year,” said State Fund President & CEO Vern Steiner.

“We are always looking for ways to help our policyholders improve their bottom lines and invest in California’s economy and we’re pleased to be able to provide this support.”

Since its creation in 1914, State Fund has paid out more than $5 billion in dividends to policyholders.

State Fund policyholders eligible for the 2021 dividend will begin to receive their payments after the expiration date of their individual policies.

Last year, it announced plans to distribute an approximate $39 million dividend to its qualifying policyholders with policies that took effect between Aug. 27 and Dec. 31, 2020.

This 2020 dividend equaled approximately 10% of the estimated annual premium reported during that time period.

That announcement followed up State Fund’s August declaration of an approximate 10% mid-year dividend that applied to all policies incepted between Jan. 1 and Aug. 26, 2020. The dividend distribution for the entire year equals approximately $114 million.

March 14, 2022 – News Podcast


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: Judge Allows Insurers San Francisco Antitrust Suit Against Drugmakers. Santa Paula Doctor and Patient Recruiter Arrested in $30M Fraud Case. White House Announces Help for EDD Fraud Prosecution. Sports Medicine Director Charged With Sexually Assaulting Athletes. RAND COVID-19 Presumptions Study Shows Challenges & Confusion. WCAB to Reopen for Trials on Monday March 21. OSHA Fines Pauma Valley Zip-Line Attraction $25K for Worker Fatality. Luxury Resort Fined $3.3M for Pandemic Re-Hire Rule Violations. CWCI Study Shows Consistent Acceptable Access to Medical Care. CorVel Critical Incident Stress Debriefing Program in City of Beverly Hills.

California “Test to Treat” Facilities May be COVID Game Changers

The president launched a nationwide “Test to Treat” Initiative on March 8 that seeks to make treating COVID-19 simple: You get tested at a pharmacy-based clinic. If you’re positive and at high risk, you can get antiviral pills on the spot, which can cut the chance of developing severe disease by some 85%.

“It’s a very exciting time,” said Dr. Annie Luetkemeyer, professor of medicine at UC San Francisco, in a recent USC webinar.

According to the story in DailyNews, all told, more than 2,300 pharmacies, hospitals and medical providers are distributing the drugs in California. CVS, Walgreens and Rite Aid stores represent more than half of the stocked sites, with Kaiser Permanente, medical groups, hospitals, grocery chains and smaller pharmacies comprising much of the rest.

“The therapeutics are very different now than they were a year ago,” said Dr. George Rutherford, professor of epidemiology and biostatistics at UC San Francisco. They can be game-changers for people who can’t get vaccinated or who haven’t had a robust immune response after vaccination.

Test and treat can be helpful if it can be implemented well, said Dr. Elizabeth Hudson, regional chief of infectious diseases at Kaiser Permanente Southern California, which has 4.8 million members in Southern California.

What are these drugs?

Antivirals prevent viruses from making copies of themselves, while monoclonal antibodies bind to virus and help the body get rid of it. Here’s a few of the treatment options:

  • Pfizer’s Paxlovid is the new star in the antiviral treatment arsenal. It’s a series of pills, taken orally. They contain nirmatrelvir, which stops the virus from replicating, and ritonavir, which helps the main drug stay in the body longer, at higher concentrations. It’s three tablets taken together, twice daily, for five days, for a total of 30 tablets. Paxlovid significantly reduced the proportion of people with COVID-19-related hospitalization or death from any cause by 88% compared to placebo, the U.S. Food and Drug Administration said when it issued an emergency use authorization in December.
  • Also new is Merck’s molnupiravir, an antiviral that received emergency use authorization in December as well. It works by introducing errors into the virus’ genetic code, which prevents the virus from replicating. It’s only for patients 18 and older, as molnupiravir can affect bone and cartilage growth, the FDA said. It’s a course of four capsules taken orally every 12 hours for five days, for a total of 40 capsules.
  • Veklury, the antiviral remdesivir, has been available since 2020 and isn’t part of the federal/state effort; clinics can order it directly. The drug must be delivered intravenously.
  • Monoclonal antibodies must be given intravenously or through injection as well, within about 10 days after symptoms. Sotrovimab is effective against omicron and part of the federal effort; Evusheld is for those who can’t get COVID-19 vaccines for medical reasons, or who didn’t have robust immune responses to vaccination.

Candidates for these treatments are those at high risk for developing serious disease, including folks who are older, overweight, pregnant, diabetic or have heart issues and other underlying health problems.

People should act as quickly as possible, contacting their doctors or finding a Test to Treat site at a local CVS or Walgreens, officials said.

“Although supplies remain limited, more residents are receiving these treatments through pharmacies, partners, and providers,” L.A. County’s COVID-19 update said. “To date, Public Health has distributed 20,960 doses of Paxlovid, 39,764 doses of Molnupiravir, and 13,584 doses of Evusheld, with 73% of Paxlovid doses, 82% of Molnupiravir doses and 66% of Evusheld allocated to residents in the most under-resourced communities.”