Oregon Drug Treatment Hotline Cost $7,000 Per Call

 In 2020, Oregon voted to decriminalize the possession and use of almost all drugs. Now, addicts do hard drugs in the open, and a treatment hotline has so far cost taxpayers $7,000 per call, according to The Economist, putting the spending at $1.4 million.

The Associated Press reported Oregon was “awash in treatment funds after decriminalizing drugs,” adding the state has allocated $265 million to recovery centers. The funding came from taxes levied on the sale of marijuana. Sadly, the rollout of these funds has been slow, with only $184 million distributed as of May 26.

Despite this massive funding, The Economist reported that “…help seems hard to come by.” The overdose death rate in Oregon almost doubled since 2019, twice the national average.

The New York Times has reported on the horrid conditions on the streets of Portland, including needles and humans feces littering the streets, drug addicts using drugs at all times of the day, and violent addicts in tents beating other homeless people with baseball bats.

One program that has been particularly costly and unsuccessful is the treatment hotline. Meant to be a resource for addicts to call for help after receiving a citation for using drugs, The Economist found that in its first two years of existence, fewer than 200 people called the hotline, and fewer than 40 callers were interested in treatment. That put its cost to taxpayers at $7,000 per call.

The #WasteOfTheDay is brought to you by the forensic auditors at OpenTheBooks.com

https://www.realclearinvestigations.com/articles/2023/08/30/oregon_drug_treatment_hotline_cost_7000_per_call_975339.html

JPMorgan processed more than $1 bln for Epstein, US Virgin Islands says

 A lawyer for the U.S. Virgin Islands said on Thursday that JPMorgan Chase told U.S. authorities it processed more than $1 billion for Jeffrey Epstein over 16 years.

JPMorgan reported the transactions as suspicious to the U.S. Treasury Department following Epstein's suicide in 2019, Mimi Liu, a lawyer for the territory, said at a hearing concerning its lawsuit against the largest U.S. bank.

Reuters did not view the bank's disclosures to the Treasury, which are not public. A JPMorgan spokesperson declined to comment.

Epstein had been a JPMorgan client from 1998 to 2013, when the bank fired him. The disgraced financier had been awaiting trial on sex trafficking charges at the time of his death.

The U.S. Virgin Islands, where Epstein owned two private islands, is suing JPMorgan for at least $190 million and likely much more, saying it ignored red flags that Epstein was running a sex trafficking operation because he was a lucrative client.

JPMorgan has denied knowing that Epstein was running a sex trafficking operation, and has faulted the territory for having a cozy relationship with him.

Liu mentioned the $1 billion amount, which had not been previously disclosed, in arguing that U.S. District Judge Jed Rakoff in Manhattan should find before the case goes to trial that the bank participated in Epstein's sex trafficking.

She said no reasonable juror could find that JPMorgan was in the dark about its jet-setting client.

"JPMorgan was a full service bank for Jeffrey Epstein's sex trafficking," Liu said.

Felicia Ellsworth, a lawyer for JPMorgan, said it was not appropriate for the judge to determine the question of the bank's knowledge before trial, because current and former employees have testified that they were unaware of Epstein's sex trafficking.

She said JPMorgan notified the Treasury Department at least six times about Epstein's transactions, including as early as 2002.

https://finance.yahoo.com/news/jpmorgan-processed-more-1-bln-001948071.html

ADC Therapeutics calls it quits on solid tumor collaboration with Adagene

 ADC Therapeutics is stepping away from a solid tumor pact with Adagene rather than take the collaboration to the next stage.

Details were sparse in Adagene’s Thursday update, which said only that the deal had expired after ADC elected not to sign into a licensing option. Adagene says the two companies remain open to working together in the future. 

The two linked up in April 2019 to combine Adagene’s antibody production platform with ADC’s payload attachment to produce a new antibody-drug conjugate aimed at a solid tumor target. ADC also had the option to tack on one additional target.

Adagene received research funding plus an undisclosed upfront payment, with the potential for additional development and commercial milestone payments. A spokesperson for ADC did not immediately respond when asked whether any milestone payments were triggered.

ADC, like many of its biopharma colleagues, has been in cash preservation mode as it tries to maximize value for approved med Zynlonta. The company announced in May that it would focus on the lowest-risk R&D projects, culling two preclinical assets as a result. Corresponding layoffs left 17% of the company without a job, with the cuts mainly impacting preclinical researchers and employees working in “back office efficiencies.” 

More than two months later, the company scrapped a trial testing Zynlonta combined with Roche’s Rituxan to treat unfit or frail patients with diffuse large B-cell lymphoma. The FDA had placed a partial hold on the study after 12 respiratory-related events arose, seven of which led to death. The company concluded that 11 out of the 12 events were not related to the study drug. 

https://www.fiercebiotech.com/biotech/adc-therapeutics-calls-it-quits-2019-adagene-research-and-licensing-pact

AI may influence whether you can get pain medication

 Elizabeth Amirault had never heard of a Narx Score. But she said she learned last year the tool had been used to track her medication use.

During an August 2022 visit to a hospital in Fort Wayne, Indiana, Amirault told a nurse practitioner she was in severe pain, she said. She received a puzzling response.

“Your Narx Score is so high, I can’t give you any narcotics,” she recalled the man saying, as she waited for an MRI before a hip replacement.

Tools like Narx Scores are used to help medical providers review controlled substance prescriptions. They influence, and can limit, the prescribing of painkillers, similar to a credit score influencing the terms of a loan. Narx Scores and an algorithm-generated overdose risk rating are produced by healthcare technology company Bamboo Health (formerly Appriss Health) in its NarxCare platform.

Such systems are designed to fight the nation’s opioid epidemic, which has led to an alarming number of overdose deaths. The platforms draw on data about prescriptions for controlled substances that states collect to identify patterns of potential problems involving patients and physicians. State and federal health agencies, law enforcement officials and healthcare providers have enlisted these tools, but the mechanics behind the formulas used are generally not shared with the public.

Artificial intelligence is working its way into more parts of American life. As AI spreads within the healthcare landscape, it brings familiar concerns of bias and accuracy and whether government regulation can keep up with rapidly advancing technology.

The use of systems to analyze opioid-prescribing data has sparked questions over whether they have undergone enough independent testing outside of the companies that developed them, making it hard to know how they work.

Lacking the ability to see inside these systems leaves only clues to their potential impact. Some patients say they have been cut off from needed care. Some doctors say their ability to practice medicine has been unfairly threatened. Researchers warn that such technology—despite its benefits—can have unforeseen consequences if it improperly flags patients or doctors.

“We need to see what’s going on to make sure we’re not doing more harm than good,” said Jason Gibbons, Ph.D., a health economist at the Colorado School of Public Health at the University of Colorado’s Anschutz Medical Campus. “We’re concerned that it’s not working as intended, and it’s harming patients.”

Amirault, 34, said she has dealt for years with chronic pain from health conditions such as sciatica, degenerative disc disease and avascular necrosis, which results from restricted blood supply to the bones.

The opioid Percocet offers her some relief. She’d been denied the medication before but never had been told anything about a Narx Score, she said.

In a chronic pain support group on Facebook, she found others posting about NarxCare, which scores patients based on their supposed risk of prescription drug misuse. She’s convinced her ratings negatively influenced her care.

“Apparently being sick and having a bunch of surgeries and different doctors, all of that goes against me,” Amirault said.

Database-driven tracking has been linked to a decline in opioid prescriptions, but evidence is mixed on its impact on curbing the epidemic. Overdose deaths continue to plague the country, and patients like Amirault have said the monitoring systems leave them feeling stigmatized as well as cut off from pain relief.

The Centers for Disease Control and Prevention (CDC) estimated that in 2021, about 52 million American adults suffered from chronic pain, and about 17 million people lived with pain so severe it limited their daily activities. To manage the pain, many use prescription opioids, which are tracked in nearly every state through electronic databases known as prescription drug monitoring programs (PDMPs).

The last state to adopt a program, Missouri, is still getting it up and running.

More than 40 states and territories use the technology from Bamboo Health to run PDMPs. Those data can be fed into NarxCare, a separate suite of tools to help medical professionals make decisions. Hundreds of healthcare facilities and five of the top six major pharmacy retailers also use NarxCare, the company said.

The platform generates three Narx Scores based on a patient’s prescription activity involving narcotics, sedatives and stimulants. A peer-reviewed study showed the “Narx Score metric could serve as a useful initial universal prescription opioid-risk screener.”

NarxCare’s algorithm-generated “Overdose Risk Score” draws on a patient’s medication information from PDMPs—such as the number of doctors writing prescriptions, the number of pharmacies used and drug dosage—to help medical providers assess a patient’s risk of opioid overdose.

Bamboo Health did not share the specific formula behind the algorithm nor address questions about the accuracy of its Overdose Risk Score but said it continues to review and validate the algorithm behind it based on current overdose trends.

Guidance from the CDC advised clinicians to consult PDMP data before prescribing pain medications. But the agency warned that “special attention should be paid to ensure that PDMP information is not used in a way that is harmful to patients.”

These prescription-drug data have led patients to be dismissed from clinician practices, the CDC said, which could leave patients at risk of being untreated or undertreated for pain. The agency further warned that risk scores may be generated by “proprietary algorithms that are not publicly available” and could lead to biased results.

Bamboo Health said that NarxCare can show providers all of a patient’s scores on one screen but that these tools should never replace decisions made by physicians.

Some patients say the tools have had an outsize impact on their treatment.

Bev Schechtman, 47, who lives in North Carolina, said she has occasionally used opioids to manage pain flare-ups from Crohn’s disease. As vice president of the Doctor Patient Forum, a chronic pain patient advocacy group, she said she has heard from others reporting medication access problems, many of which she worries are caused by red flags from databases.

“There’s a lot of patients cut off without medication,” according to Schechtman, who said some have turned to illicit sources when they can’t get their prescriptions. “Some patients say to us, ‘It’s either suicide or the streets.’”

The stakes are high for pain patients. Research shows rapid dose changes can increase the risk of withdrawal, depression, anxiety and even suicide.

Some doctors who treat chronic pain patients say they, too, have been flagged by data systems and then lost their license to practice and were prosecuted.

Lesly Pompy, M.D., a pain medicine and addiction specialist in Monroe, Michigan, believes such systems were involved in a legal case against him.

His medical office was raided by a mix of local and federal law enforcement agencies in 2016 because of his patterns in prescribing pain medicine. A year after the raid, Pompy’s medical license was suspended. In 2018, he was indicted on charges of illegally distributing opioid pain medication and healthcare fraud.

“I knew I was taking care of patients in good faith,” he said. A federal jury in January acquitted him of all charges. He said he’s working to have his license restored.

One firm, Qlarant, a Maryland-based technology company, said it has developed algorithms “to identify questionable behavior patterns and interactions for controlled substances, and for opioids in particular,” involving medical providers.

The company, in an online brochure (PDF), said its “extensive government work” includes partnerships with state and federal enforcement entities such as the Department of Health and Human Services’ Office of Inspector General, the FBI and the Drug Enforcement Administration.

In a promotional video, the company said its algorithms can “analyze a wide variety of data sources” including court records, insurance claims, drug monitoring data, property records and incarceration data to flag providers.

William Mapp, the company’s chief technology officer, stressed the final decision about what to do with that information is left up to people—not the algorithms.

Mapp said “Qlarant’s algorithms are considered proprietary and our intellectual property” and that they have not been independently peer-reviewed.

“We do know that there’s going to be some percentage of error, and we try to let our customers know,” Mapp said. “It sucks when we get it wrong. But we’re constantly trying to get to that point where there are fewer things that are wrong.”

Prosecutions against doctors through the use of prescribing data have attracted the attention of the American Medical Association (AMA).

“These unknown and unreviewed algorithms have resulted in physicians having their prescribing privileges immediately suspended without due process or review by a state licensing board—often harming patients in pain because of delays and denials of care,” said Bobby Mukkamala, M.D., chair of the AMA’s Substance Use and Pain Care Task Force.

Even critics of drug-tracking systems and algorithms say there is a place for data and artificial intelligence systems in reducing the harms of the opioid crisis.

“It’s just a matter of making sure that the technology is working as intended,” said health economist Gibbons.

https://www.fiercebiotech.com/medtech/artificial-intelligence-may-influence-whether-you-can-get-pain-medication

Bristol: 'modest' multiple myeloma survival data on heir to Revlimid, Pomalyst

 Bristol Myers Squibb has reported full phase 1 data on one of its successors to Revlimid and Pomalyst. An outside expert called the multiple myeloma survival data “modest,” but the potential for the therapy, mezigdomide, to find a place in combination therapies is spurring hopes heading into phase 3 readouts. 

BMS shared an earlier cut of the data, which tracked patients through to May, late last year. The figures shifted a little, both for and against mezigdomide, in the New England Journal of Medicine paper posted Wednesday. The paper covers outcomes in recipients of mezigdomide, a cereblon E3 ligase modulator created in light of insights into the mechanism of thalidomide analogues, up to mid-September. Subjects had received at least three prior lines of treatment, including Revlimid and Pomalyst. 

The final median duration of response (DoR) and progression-free survival (PFS) are shorter than the preliminary data released last year. DoR fell from 8.3 months to 7.6 months. PFS slipped slightly, falling from 4.6 months to 4.4 months. Overall survival data remained immature as of the September cutoff. In an accompanying editorial, Jake Shortt, a professor at Monash University, called the PFS “modest.”

Response rates ticked up between the two looks at the data. The overall response rate rose from 40% to 41%, while the proportion of participants experiencing a very good partial response climbed from 18% to 20%. The data leave unanswered questions about whether mezigdomide can find a place in the changing multiple myeloma landscape.

Late-line treatment of multiple myeloma has changed since Celgene began the mezigdomide clinical trial in 2018. Over the past two years, Johnson & Johnson has won approval for a pair of bispecific T-cell engagers, Tecvayli and Talvey, and a CAR-T cell therapy, Carvykti, in people who have received four or more lines of therapy, by linking the treatments to response rates upward of 65% and “game changing” PFS.

The authors of the mezigdomide paper note the efficacy of cell therapies and bispecifics but caution that the “therapies may not be available or appropriate for all patients, and the risk of severe toxic effects such as cytokine release syndrome” may outweigh the potential benefits in some patient populations.

“Oral regimens such as mezigdomide and dexamethasone can readily translate a potential clinical benefit into real-world practice, especially among patients with limited access to specialized hospitals, since patients do not have to be hospitalized to receive these treatments,” the authors wrote.

BMS has identified mezigdomide as a potential replacement for its own Pomalyst in combinations aimed at patients who have received one to three lines of therapy, including Revlimid. A phase 3 trial in that setting got underway 11 months ago. BMS is also studying the effect of adding mezigdomide to Amgen’s Kyprolis and dexamethasone in a second phase 3 trial that began enrolling patients earlier this year.

https://www.fiercebiotech.com/biotech/bms-posts-modest-multiple-myeloma-survival-data-heir-revlimid-pomalyst

GOP governors call on Congress to take more action on US drug shortages

 After FDA Commissioner Robert Califf, M.D., recently made comments about the untenable nature of generic drug production in the U.S., a clutch of governors has raised its own set of concerns about shortages.

This week, 11 Republican governors sent a letter (PDF) to Congress demanding action on the spate of drug shortages plaguing the U.S.

Citing shortfalls of critical meds like albuterol, amoxicillin and certain chemotherapies, the governors noted that shortages have sometimes lasted for years, often with “no good explanation for why.”

One possible reason for the shortages, they added, is tied to the fact that more than 80% of active ingredients in prescription drugs sold in the U.S. come from overseas.

“This limited supply chain creates a national security risk and leaves America competing with other nations for essential resources,” the joint letter states.

The governors called on Congress to adopt a clutch of new policy solutions to ensure adequate supplies of medicines.

Their letter calls for added transparency in the pharmaceutical manufacturing chain, ranging from the sourcing of raw materials to the finished product, including country of origin labeling. Additionally, Congress should help foster increased diversity in generic drug manufacturing with regards to both raw materials and final manufacturing, the governors said.

The group is also pressing for more transparency from the FDA about ongoing shortages and events that can cause supply chain disruptions. They further want the agency to reconsider its expiration date guidance on certain medications.

“The FDA and medical companies are currently restricted by federal law regarding their transparency policies,” the governors wrote. “Congress must grant additional authorities that allow more transparency throughout the drug manufacturing process.”

The governors also appear to favor drug importation. The group requests that Congress enable waivers to allow the purchase of medications from Canada to quickly expand the U.S. supply chain.

Lastly, the governors want the U.S. to foster a regulatory environment that is “more favorable” to domestic production.

The governors’ concerns echo those raised by Califf last week.

Discussing drug shortages during a presentation of the Alliance for a Stronger FDA, Califf said the “fundamental problem” is that “we essentially have two drug industries in the U.S.”

There’s the “innovator industry,” where Califf said he thinks "the prices are too high,” and then there’s the generics industry, where “a lot of the prices are too low.” 

“What I mean by that is that the price has been driven down below the cost of manufacturing and distributing the drug,” he said. “And we have an industry which is continuing to leave the U.S. because it’s not viable to run the business.”

The FDA currently lists around 137 unresolved drug shortages on its online database. 

https://www.fiercepharma.com/pharma/republican-governors-call-congress-resolve-spate-us-drug-shortages

Ukraine's Defense Chief Expected To Be Sacked Next Week Amid Corruption Probe

 Significant rumors are once again swirling over the possible imminent sacking of Ukraine's defense minister, with Bloomberg also reporting.

Defense chief Oleksiy Reznikov has overseen a series of embarrassing military corruption scandals at a time Kiev is trying to tout its democratic and corruption reform credentials. He could be dismissed from the top post as early as next week, and given a new role as ambassador to the United Kingdom.

But the decision is "not finalized" according to sources speaking to Kyiv Post, which names Rustem Umerov – currently head of the State Property Fund – as a likely candidate to replace Reznikov.

DM Reznikov has overseen Ukraine's military and defense strategy since the start of the Feb. 2022 invasion, but the much-hyped counteroffensive launched at the start of the summer has been widely seen as a failure, despite tens of billions of dollars of Western aid and weaponry.

Reznikov is now front and center in an anti-graft probe, Bloomberg writes, citing local Ukrainian media:

President Volodymyr Zelenskiy’s anti-graft crackdown is fueling speculation that he may dismiss Ukraine’s defense minister following accusations of corruption linked to procuring military supplies.

The Ukrayinska Pravda newspaper, citing sources it didn’t name, said on Thursday Minister Oleksii Reznikov may be replaced as early as next week. The report followed accusations from anti-corruption activists and media that under his leadership the ministry has purchased food and uniforms at inflated prices. It also coincides with comments from a lawmaker that Reznikov may be shifted to the post of Kyiv’s ambassador to the UK.

Additionally, parliament's People's Deputy Yaroslav Zheleznyak, wrote in a Thursday Telegram post that "…Rustem Umerov will be nominated for the position of Minister of Defense." 

Kyiv Post has detailed the latest scandal as follows:

The latest scandal was exposed by Ukrainian journalist Yuriy Nikolov who, citing sources at the State Customs Service of Ukraine, reported that the Ministry of Defense had acquired 233,000 winter jackets for $20 million from a Turkish firm.

Documentation from customs regarding one shipment unveiled a startling increase in cost for a batch of 4,900 jackets en route from Turkey to Ukraine.

The price had tripled, soaring from $142,000 to $421,000 (a per-unit rise from $29 to $86). Furthermore, it was revealed that the jackets, despite being marketed as winter wear, turned out to be lightweight.

High-ranking military officers and Kiev officials have for months come under scrutiny for driving expensive luxury cars and acquiring expensive villas. 

The Ministry of Agriculture has also recently been under fore for inflated pasta purchases, which caused a reported loss for state coffers of at least $1.7 million, and triggering suspicions that corrupt officials lined their pockets.

https://www.zerohedge.com/geopolitical/ukraines-defense-chief-expected-be-sacked-next-week-amid-corruption-probe