Pfizer Pauses Distribution of Stop-Smoking Pill Chantix – cure worse than the addiction ?

Pfizer Pauses Distribution of Stop-Smoking Pill Chantix

https://www.medscape.com/viewarticle/953780

Pfizer is suspending distribution of the anti-smoking treatment Chantix after heightened levels of the carcinogen N-nitrosodimethylamine (NDMA) were found in some lots of the pills.

The pharmaceutical company is also recalling some lots of Chantix that may have high levels of NDMA, Reuters reported.

Pfizer told Reuters the distribution pause was ordered out of abundance of caution while further testing is conducted. The FDA approved varenicline, which is marketed as Chantix, in 2006.

“The benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime,” Pfizer spokesperson Steven Danehy said in an email, according to Reuters. 

The FDA has not issued a recall on Chantix. In Canada, health authorities instituted a recall June 8 for Champix, the name under which the drug is sold in that nation.

The Chantix website says it’s a three-to-six-month treatment that helps people overcome the need to smoke tobacco. The website says more than 13 million people have been prescribed Chantix.

Other health concerns have been raised about Chantix, such as mental health side effects. 

In 2016, researchers concluded Chantix did not appear to raise the risk of serious health disorders such as depression, anxiety, and suicidal thoughts.

Other health concerns have been raised about Chantix, such as mental health side effects.

back in the day

Device Makers Have Funneled Billions to Orthopedic Surgeons Who Use Their Products

Device Makers Have Funneled Billions to Orthopedic Surgeons Who Use Their Products

https://khn.org/news/article/spine-surgery-implants-device-makers-orthopedic-surgeons-kickbacks/

Dr. Kingsley R. Chin was little more than a decade out of Harvard Medical School when sales of his spine surgical implants took off.

Chin has patented more than 40 pieces of such hardware, including doughnut-shaped plastic cages, titanium screws and other products used to repair spines — generating $100 million for his company SpineFrontier, according to government officials.

Yet SpineFrontier’s success arose not from the quality of its goods, these officials say, but because it paid kickbacks to surgeons who agreed to implant the highly profitable devices in hundreds of patients.

In March 2020, the Department of Justice accused Chin and SpineFrontier of illegally funneling more than $8 million to nearly three dozen spine surgeons through “sham consulting fees” that paid them handsomely for doing little or no work. Chin had no comment on the civil suit, one of more than a dozen he has faced as a spine surgeon and businessman. Chin and SpineFrontier have yet to file a response in court.

Medical industry payments to orthopedists and neurosurgeons who operate on the spine have risen sharply, despite government accusations that some of these transactions may violate federal anti-kickback laws, drive up health care spending and put patients at risk of serious harm, a KHN investigation has found. These payments come in various forms, from royalties for helping to design implants to speakers’ fees for promoting devices at medical meetings to stock holdings in exchange for consulting work, according to government data.

Health policy experts and regulators have focused for decades on pharmaceutical companies’ payments to doctors — which research has shown can influence which drugs they prescribe. But far less is known about the impact of similar payments from device companies to surgeons. A drug can readily be stopped if deemed harmful, while surgical devices are permanently implanted in the body and often replace native bone that has been removed.

Every year, a torrent of cash and other compensation flows to these surgeons from manufacturers of hardware for spinal implants, artificial knees and hip joints — totaling more than $3.1 billion from August 2013 through the end of 2019, a KHN analysis of government data found. These bone specialists make up a quarter of U.S. doctors who have accepted at least $100,000 or more, and two-thirds of those who raked in $1 million or more, from the medical device and drug industries last year, the data shows.

“It is simply so much money that it is staggering,” said Dr. Eugene Carragee, a professor of orthopedic surgery at the Stanford University Medical Center and critic of the medical device industry’s influence. Much of the money is deemed to be compensation for consulting duties or medical research, or royalties for inventing, or fine-tuning, new surgical tools and techniques. In some cases, it pays for trips or splashy junkets or rewards surgeons for promoting products to their peers.

Device makers say the long-established practice leads to higher-quality, safer products. “Doctors help develop and refine medical devices, and they even create new devices themselves, sharing their intellectual property with companies to help save and improve patients’ lives,” said Scott Whitaker, president and CEO of AdvaMed, the medical technology industry’s trade group.

But industry whistleblowers and government investigators say all that money changing hands can corrupt medical judgment and tempt surgeons to perform unnecessary and wasteful operations. In ongoing lawsuits, patients say they have suffered life-altering injuries from screws or other spinal hardware that snapped apart or live with disabilities they blame on defective knee or hip implants. Patients alleging injuries range from seniors on Medicare to celebrities such as Olympic gold medalist Mary Lou Retton, who had surgery to replace both her hips. The gymnast sued device maker Biomet in January 2018, alleging the hip implants were defective. The suit has since been settled under confidential terms.

The case of Chin’s company, SpineFrontier, is among more than 100 federal fraud and whistleblower actions, filed or settled mostly in the past decade, that accuse implant surgeons of taking illegal compensation from device makers — from surgeon entrepreneurs like Chin to marquee names like Medtronic and Johnson & Johnson. In some cases, device makers have paid hundreds of millions of dollars in fines to wrangle out of trouble for their involvement, often without admitting any wrongdoing.

Court pleadings examined by KHN identified more than 700 surgeons who have taken money, including dozens who pocketed millions in royalties, fees or other compensation from 2013 through 2019.

The names of hundreds more surgeons were redacted in court filings or sealed by judges.

Court filings named 35 spine surgeons who used SpineFrontier’s surgical gear, some for years. At least six of those surgeons have admitted wrongdoing and paid a total of $3.3 million in penalties. Another has pleaded guilty to criminal charges. It’s illegal under federal law to accept anything of value from a device maker for using its wares, though most offenders don’t face criminal prosecution.

Chin, 57, who lives in Fort Lauderdale, Florida, and owns SpineFrontier through his investment company, declined comment about the DOJ lawsuit or the consulting agreements.

 

Suicide crisis call line stretched thin in Kentucky

https://www.whas11.com/article/news/local/suicide-crisis-call-line-stretched-thin-kentucky-indiana/417-22301a3b-e284-4085-aa60-3372817635ea

LOUISVILLE, Ky. — We want to warn you: The information presented in this report may be difficult for some to watch.

Suicide has been the 10th leading cause of death in the United States among adults, and among young adults, it’s been the second, according to the CDC. It’s why experts say crisis call centers are critically important, helping people connect with potentially life-saving resources.

But during the pandemic, those resources have been especially strained. Many crisis call line counselors say calls about suicide and depression have increased in frequency. 

“I really can truly understand how people could get there, and that’s sad,” said Louisville resident Kevin Burch. “I can sit here and cry just thinking about that.”

Desperate for help, he said he called the National Suicide Prevention Lifeline last month. He said he was put on hold for around 20 minutes. 

“That really makes you start to think, holy smokes this is not my day,” he said. 

Meanwhile, he said he planned his death.

“I had my mind made up, yeah, yeah I did,” said Burch.

Burch made it through the night. But his anxiety attacks have persisted. More than a year of the pandemic left him without a job. He used to sell cable and Internet. COVID-19 has prevented that.

“Your business dwindles down and down and down. To where it’s literally nothing at this point,” he said.

And finding a job has its own challenges.

“I can’t go driving around because the tags are expired, I don’t have car insurance, my license is passed due, and it takes money to get those things and I have no source of income,” he said. 

Credit: WHAS

He said unemployment payments just stopped coming in September. And hundreds of calls to state agencies have been unsuccessful.

“And it just rings and rings and rings,” said Burch.

But among the worst punishments, he said, has been isolation.

“The socialization, that’s been the awfulest thing. Not being able to go to a restaurant with your buddies and just talk and have fun,” he said. 

“We definitely have seen an increase in calls related to the unprecedented pandemic situation that we’ve all been through,” said Geneva Robinson, the director of the Louisville area’s crisis and information center at Seven Counties Services.

She’s also a survivor.

“In my younger life, I dealt with my own severe depression. And I did make several attempts on my own life,” said Robinson. 

To relieve her pain, she takes medication every day and devotes her life to showing others that in their darkest moments, help is within reach.

“Our services are available 24/7, 365 days a year. So we are available to provide services around the clock to folks at any time if the need comes in,” said Robinson. 

But she said that need has never been greater.

“We, at the height of the pandemic, saw a 40 percent increase in calls to all the lines that we answer,” she said. 

It’s why she said it’s disheartening but not surprising Burch was forced to wait when he called the National Suicide Prevention Lifeline. Each call gets routed through more than 180 crisis centers around the country.

“It goes through a national call switchboard if you will that tries to find the next available open phone line for a trained counselor in their network of centers,” said Robinson. 

But on the night Burch called, it took much longer than usual to find one. So far this year, the average pickup time for Louisville’s crisis call center was around 2 minutes. A typical call lasts about 15 minutes. Calls have not only increased in frequency and length during the pandemic, but they’re also more intense.

“There have been just so many new problems that people have experienced,” said Robinson. “We have a number of folks who have called us who actually have loaded guns in their hand and they want us to give them some reason not to have to go and pull that trigger… We have people that call that have already taken an overdose of medication and they just want someone caring to listen to them and to be with them while they die.”

“Do you think that COVID has opened our eyes in some ways about the need for mental health services?” asked FOCUS investigative reporter Paula Vasan.

“There is no question about that,” said Lisa Willner, Kentucky State Representative.

Willner, a licensed psychologist, supported legislation this year to make mental health a higher priority. Among the bills she advocated for that have been signed into law, House Bill 140 expands access to telehealth.

“I think it really is going to revolutionize the way people access mental health treatment,” said Willner. 

House Bill 50 mandates insurance companies cover mental health and drug addiction the same way they’d cover physical illness, like cancer and heart disease.

“We need to make investing in people, investing in emergency services a very high priority,” she said. 

For now, Burch just tries to make it through the day.

“I hope it’s a moment I never have to go back to,” he said. 

He hopes someone returns his calls about unemployment benefits. He hopes he’ll find a job again.

“I haven’t had any significant income in forever,” he said. 

And he hopes that if he revisits that dark and painful moment, someone will pick up.

If you are struggling with depression and thoughts of suicide, know that you’re not alone. We as a community care about your life. Here are some local and national resources to help you. 

To contact our local crisis line, call 502-589-4313. To reach the national suicide hotline, call 800-273-8255.

These resources are free, and you can access them 24/7. Counselors said if no one picks up within around three minutes, hang up and keep trying. 

Additional Resources

The Louisville area’s crisis call lines at Seven Counties Services:

  • 24/7 Addiction Help: 502-583-3951
  • 24/7 Adult Crisis Line: 502-589-4313
  • 24/7 Child Crisis Line: 502-589-8070

The National Suicide Prevention Lifeline’s toll-free number, 800-273-TALK(8255) connects the caller to a certified crisis center.

The National Suicide Prevention Lifeline is composed of a network of over 180 local and state-funded crisis centers located across the United States. 

Trained counselors at these local crisis centers respond and provide support to people in distress every day. When people call the Lifeline, they hear a greeting, and then music as they are routed to their local crisis center. If a local center is unable to answer the call, the call is then rerouted to one of their national backup centers. The average speed of answer for Lifeline calls is approximately 45 seconds.

“That said, we recognize that wait times may increase when calls are routed to states with limited crisis center resources, or during times of high call volume, and that this can be difficult for people in crisis,” said a spokesperson at the National Suicide Prevention Lifeline.

“We encourage those who have had a negative experience with the Lifeline to share them with us via our Contact Us form,” the spokesperson said. “It is a priority of the Lifeline to continue to strengthen our growing infrastructure, help support local crisis centers, and provide support for the counselors answering Lifeline calls and chats across the United States.” 

Contact reporter Paula Vasan at pvasan@whas11.com, on Twitter, Facebook or Instagram.

Have a story tip? Contact the FOCUS Investigative Team at focus@whas11.com.

 

 

 

Pharmacist: just the middleman/robber for the PBM industry.

Democrats in Congress introduce decriminalization bill for all drugs, not just weed

I find this very interesting…. it was a <D> controlled Congress that passed the Harrison Narcotic Act 1914 which basically created the “black drug market” and some prohibition of opiates being prescribed… and it was a <D> controlled Congress that passed the Controlled Substance Act 1969 and it was the <D> party that was OPPOSED to granting Medicare folks medication coverage via Medicare Part D and it was <D> party that declined/refused to reup the  Decade of pain law when it expired in 2009… that was passed by a <R> controlled Congress 10 yrs before.  But here is the “hook” under the “bait” Under the act, people could still face fines for drug possession, but a court could waive the fine if the person is unable to pay.  They have decided to put a “sin tax” on potentially additive drugs – just like they did two other such drugs – ALCOHOL & NICOTINE. The way that this Congress is spending money… it was just a matter of time that they had to find a new source of revenue… I have been saying for some time that legalization of all drugs and a taxing revenue was just a matter of time… BUT… they don’t forgive the “sin tax” on Alcohol & Nicotine for people that cannot afford paying it…  How long before the FEDS will make anyone that has a income will have to pay the fine for having any of these medications ?

Democrats in Congress introduce decriminalization bill for all drugs, not just weed

https://www.theverge.com/platform/amp/2021/6/15/22533396/democrats-congress-decriminalization-marijuana-drug-policy-reform-act

US Reps. Cori Bush (D-MO) and Bonnie Watson Coleman (D-NJ) are introducing a bill today that would decriminalize not just cannabis but all drug possession, in favor of what they’re calling a “health-centered approach.”

The Drug Policy Reform Act (DRPA) would end criminal penalties for “personal use” drug possession at the federal level, expunge criminal records, and shift the regulatory authority from the attorney general to the secretary of Health and Human Services, “to emphasize that substance use is a health issue and not a criminal issue.”

Under the act, people could still face fines for drug possession, but a court could waive the fine if the person is unable to pay.

The act would require HHS to establish a commission on substance abuse, health, and safety to determine the “benchmark” amount for personal use drug possession.

It would also limit state and local governments from being able to receive funds under the Byrne and Community Oriented Policing Services (COPS) grant programs — both of which help fund state and local police departments — if they don’t adopt decriminalization policies.

“Growing up in St. Louis, I saw the crack-cocaine epidemic rob my community of so many lives,” Bush said in a statement. “It’s time to put wellness and compassion ahead of trauma and punishment.”

Under the DPRA, a criminal drug possession charge would not be grounds to deny someone employment or to terminate an employee. It also would prevent drug charges and convictions from being used as grounds to deny someone federal assistance benefits such as the Supplemental Nutrition Assistance Program (SNAP), Temporary Assistance for Needy Families (TANF), and housing assistance. The act would restore voting rights to those previously convicted of drug possession.

The treatment piece of the bill requires the HHS to establish grant programs to support the expansion of treatment programs and connect people to services, including medication-assisted treatment, peer support and recovery services, and emergency response and crisis intervention programs that don’t involve police.

The bill is being introduced just days before the anniversary of the war on drugs that President Richard Nixon launched in the 1970s.

“The United States has not simply failed in how we carried out the War on Drugs — the War on Drugs stands as a stain on our national conscience since its very inception,” Coleman said. “As we work to solve this issue, it is essential that we change tactics in how we address drug use away from the failed punitive approach and towards a health-based and evidence-based approach.”

To this point, most of the conversation about decriminalization of drugs has focused on marijuana, which is legal for recreational or medical use in dozens of states. But people convicted of prior marijuana-related crimes continue to languish in jails across the country, and half a million people are arrested for marijuana possession annually in the US.

Sen. Chuck Schumer (D-NY) has said that he and Sens. Ron Wyden (D-OR) and Cory Booker (D-NJ) are working on cannabis reform legislation, saying in a February joint statement that lawmakers “must enact measures that will lift up people who were unfairly targeted in the War on Drugs.”

And late last month, Democrats reintroduced the Marijuana Opportunity Reinvestment and Expungement Act (MORE), which would eliminate criminal penalties and expunge prior cannabis possession charges, as well as create social equity programs. The MORE Act was introduced in the last Congress, but ended in the Senate which was Republican-controlled at the time.

But even though the Democrats included marijuana decriminalization in their 2020 platform, President Joe Biden was once a leading voice in the War on Drugs. He’s shifted his stance on the issue since, and said on the campaign trail that he would “reschedule cannabis as a Schedule II drug so researchers can study its positive and negative impacts.”

It’s been a tough uphill climb for federal marijuana reform legislation, even as the public largely supports legalizing it. How an even broader piece of legislation like DRPA may fare in the divided Congress (the bill doesn’t have a Senate sponsor yet) remains to be seen.

But Matt Sutton of the Drug Policy Alliance, which worked with Bush and Coleman on the bill, said DRPA marked a first step toward federal decriminalization and would not interfere with the cannabis-specific legislation Schumer has planned. “We will be building support for all drug decriminalization, which will end the more far-reaching harms of the drug war,” he said. “Specifically for people who use other drugs or have other drug convictions, and lead to a health-centered alternative approach to drugs in this country.”

‘Nobody is catching it’: Algorithms used in health care nationwide are rife with bias

back in the late 90’s – I think – I heard a report on the radio where England  – where they have a national health insurance – they were testing a software algorithms when a pt was admitted to the hospital as the probability that the pt would live to be discharged.  The goal was that anyone that the computer tagged as not living to be discharged would only be provided palliative care.  At the time – and computer capability was no where near their capacity today – the algorithms – back then – was ONLY 95% accurate.  But to this article have some health entities continued on getting the accuracy of such algorithms to be MORE ACCURATE ?

‘Nobody is catching it’: Algorithms used in health care nationwide are rife with bias

https://www.statnews.com/2021/06/21/algorithm-bias-playbook-hospitals/

The algorithms carry out an array of crucial tasks: helping emergency rooms nationwide triage patients,  predicting who will develop diabetes, and flagging patients who need more help to manage their medical conditions.

But instead of making health care delivery more objective and precise, a new report finds, these algorithms — some of which have been in use for many years — are often making it more biased along racial and economic lines.

Researchers at the University of Chicago found that pervasive algorithmic bias is infecting countless daily decisions about how patients are treated by hospitals, insurers, and other businesses. Their report points to a gaping hole in oversight that is allowing deeply flawed products to seep into care with little or no vetting, in some cases perpetuating inequitable treatment for more than a decade before being discovered.

“I don’t know how bad this is yet, but I think we’re going to keep uncovering a bunch of cases where algorithms are biased and possibly doing harm,” said Heather Mattie, a professor of biostatistics and data science at Harvard University who was not involved in the research. She said the report points out a clear double standard in medicine: While health care institutions carefully scrutinize clinical trials, no such process is in place to test algorithms commonly used to guide care for millions of people.

“Unless you do it yourself, there is no checking for bias from experts in the field,” Mattie said. “For algorithms that are going to be deployed in a wider population, there should be some checks and balances before they are implemented.”

The report, the culmination of more than two years of research, sets forth a playbook for addressing these biases, calling on health care organizations to take an inventory of their algorithms, screen them for bias, and either adjust or abandon them altogether if flaws cannot be fixed.

“There is a clear market failure,” said Ziad Obermeyer, an emergency medicine physician and co-author of the report. “These algorithms are in very widespread use and affecting decisions for millions and millions of people, and nobody is catching it.”

The researchers found that bias is common in both traditional clinical calculators and checklists as well as more complex algorithms that use statistics and artificial intelligence to make predictions or automate certain tasks. Some of the flawed products guide millions of transactions a day, such as the Emergency Severity Index, which is used to assess patients in most of the nation’s emergency departments. The researchers’ review was not exhaustive. It was limited by the willingness of health care organizations to expose their algorithms to an audit. But the variety and magnitude of problems they discovered is indicative of a systemic problem.

The report flags bias in algorithms to determine the severity of knee osteoarthritis; measure mobility; predict the onset of illnesses such as diabetes, kidney disease and heart failure; and identify which patients will fail to show up for appointments or may benefit from additional outreach to manage their conditions.

The researchers found that the Emergency Severity Index, which groups patients based on the urgency of their medical needs, performs poorly in assessing Black patients, a conclusion that mirrors findings in prior research.

Obermeyer said the index suffers from a flaw found in many of the algorithms: It relies on certain proxies that are by degrees different from the thing clinicians are trying to measure, introducing imperceptible gaps where biases often hide. The tool uses a variety of factors to make triage decisions, such as vital signs and the resources patients may require when receiving care. But Obermeyer and his colleagues found its use fails Black patients in multiple ways, underestimating the severity of their problems in some instances and in others suggesting they are sicker than they are.

“It’s very natural to make shortcuts, and to use heuristics, like, ‘This person’s blood pressure is fine so they don’t have sepsis,’” Obermeyer said, referring to a life-threatening complication of infection. “But it’s very easy for those shortcuts to go wrong.”

He and other researchers who examined the use of the index at Brigham and Women’s Hospital in Boston said it was unclear what factors introduced bias, but they sought to build a machine learning model aimed at improving its accuracy across all patients. The findings will be described in more detail in a forthcoming paper.

“Our general approach was being curious about what was going on, and not to label a group of providers or a process as bad,” said Michael Wilson, an emergency medicine physician at Brigham and Women’s who helped conduct the study. “This is an endemic problem whenever you have subjectivity. We wanted to measure for bias and correct it.”

The Emergency Severity Index was developed by physicians in the late 1990s, including one who worked at Brigham and Women’s. It’s now owned and managed by the Emergency Nurses Association (ENA), a trade group that purchased the rights to the algorithm a couple years ago. The association’s website said the tool is used to triage patients in about 80% of hospitals in the United States.

“Although ENA takes seriously the report’s focus on bias in algorithms, it is important to note that potential bias is user dependent based on a person’s interpretation of what an algorithm presents,” the association’s president, Ron Kraus, said in a statement to STAT. “Since acquiring ESI in 2019, ENA has continually looked at avenues to evolve the way triage is performed — including through the use of technology, such as AI — to identify the right course of treatment for each patient based solely on their acuity — not their race or the cost of care.”

The research to identify bias — based in the Center for Applied Artificial Intelligence at the University of Chicago’s Booth School of Business — was established after an initial study uncovered racial bias in a widely used algorithm developed by the health services giant Optum to identify patients most in need of extra help with their health problems. They found that the algorithm, which used cost predictions to measure health need, was routinely giving preference to white patients over people of color who had more severe problems. Of the patients it targeted for stepped-up care, only 18% were Black, compared to 82% who were white.  When revised to predict the risk of illnesses instead of cost, the percent of Black patients flagged by the algorithm more than doubled.

The study struck insurers — and the broader health care industry — like a lightning bolt, momentarily illuminating the extent of racial bias in a methodology used to allocate scarce health care resources across the United States. The researchers announced plans to broaden their inquiry, and invited organizations across health care to submit algorithms for review.

Health insurers became the primary patron of the research team’s services, which were also used to assess bias by dozens of organizations, including larger providers and health technology startups.

Among the insurers to reach out to the researchers was Harvard Pilgrim Health Care, a nonprofit health plan in Massachusetts that wanted to assess the potential for bias in its efforts to identify members who might benefit from additional outreach and care. A preliminary review suggested that one algorithm, a model developed by a third party to predict cost, places people with chronic conditions such as diabetes at a lower priority level than patients with higher-cost conditions such as cancer. Since diabetes is experienced at a high rate among Black patients, that could lead to a biased output.

Alyssa Scott, vice president of medical informatics at Harvard Pilgrim, said algorithmic flaws arise from the use of financial forecasts in decisions about who should qualify for additional outreach. Those forecasts, while accurate, often reflect historic imbalances in access to care and use of medical services, causing bias to bubble up in ways that are difficult to detect. “If you are not aware of that, implicit bias arises that is not intended at all,” Scott said.

Harvard Pilgrim is continuing to analyze its algorithms, including those that focus on chronic condition identification, to assess bias and develop a framework for eliminating it in existing and future algorithms. “Right now we’re in the phase of trying to brainstorm and get extra input to determine whether our methodology is valid,” Scott said. “If we do find there’s bias in our algorithms, we’ll make adjustments to accommodate for the imbalance.”

Another business that worked with the researchers, a Palo Alto, Calif.-based startup called SymphonyRM, found that an algorithm it was developing to identify patients in need of a heart consultation was not performing accurately for Black and Asian patients. The company, which advises providers on patients who need additional outreach and care, adjusted the thresholds of its model to increase outreach to those groups and is planning to conduct a follow-up study to examine outcomes.

Chris Hemphill, vice president of applied AI for SymphonyRM, said bias can be the product of what seem to be tiny technical choices. For example, by adjusting a model to prevent false alarms, one might fail to identify all the people in need of additional care. An adjustment in the opposite direction — to ensure that everyone at risk of a negative outcome is identified — can produce more false alarms and unnecessary care.

Along that pendulum are biases that are difficult to detect without careful auditing by an independent party. “If you’re not doing this audit — if you’re not looking for bias — then you can pretty much guarantee that you’re releasing biased algorithms,” Hemphill said. “You can have a model that’s performing really well overall, but then when you start breaking it down by gender and ethnicity, you start seeing different levels of performance.”

But as it stands now, oversight of algorithms is heavily reliant on self-enforcement by companies that are free to decide whether to expose their products to outside review. The Food and Drug Administration reviews some algorithmic products prior to their release, but the agency tends to focus scrutiny on products that rely on artificial intelligence algorithms in image-based disciplines such as radiology, cardiology, and neurologic care. That leaves unexamined a wide swath of checklists, calculators, and other tools used by providers and insurers.

Obermeyer said there is a clear need for additional regulation, but innovation in the use of health care data is outpacing the ability of regulators to develop performance benchmarks akin to those used to evaluate drugs and traditional devices.

“These algorithms don’t affect someone’s health. They reveal it,” he said. “I don’t think we’ve come to terms with how to regulate the production of information, making sure that the information is good and accurate and what we want.”

substantial proportion of 2016 Medicare Part D spending was for drugs with absent or low-quality cost-effectiveness analyses ?

Is this a LAST PUSH for the generic industry to cement their place on formularies of PBM and “nose out” brand name meds ? About 10%-12% of all meds provide the funding for new med Research and Development.  Who is going to pay for any/all R&D going forward and/or how expensive are new meds going to be ?  Here is a recently approved new med for Alzheimer that reportedly has questionably efficiency and the cost is > $1000 PER WEEK ! the approval of Biogen Inc.’s controversial Alzheimer’s drug aducanumab — science took a back seat    With Pharmacogenomics (PGx) becoming a “go to test” to help determine what med is best for a pt…  This JAMA study was about “cost effectiveness”… Just what is “cost effectiveness”… is a 5%-10% improvement in QOL sufficient improvement … when the more appropriate – higher cost med – would produce a much higher improvement in a pt’s QOL.

Bang for the buck in Part D

https://ncpa.org/newsroom/qam/2021/06/21/qam-ad-bang-buck-part-d

A recent JAMA study showed that a substantial proportion of 2016 Medicare Part D spending was for drugs with absent or low-quality cost-effectiveness analyses. This could present a challenge in efforts to develop policies addressing drug spending in terms of value. The study looked at 250 drugs with the greatest Medicare Part D spending in 2016. No cost-effectiveness analyses were available for 46 percent of those drugs, which represented 33 percent of Medicare Part D spending. For the remaining 54 percent, many did not meet minimum quality standards. In short, more cost-effectiveness research is needed to be sure that expensive drugs, where cheaper alternatives exist, are worth their price

Alabama mom faces felony for filling doctor’s prescription while pregnant

Kim BlalockAlabama mom faces felony for filling doctor’s prescription while pregnant

https://www.al.com/news/2021/06/alabama-mom-faces-jail-for-filling-doctors-prescription-while-pregnant.html

An Alabama mom battling chronic back pain faces felony charges for refilling her prescription while pregnant – in a case her attorneys from sweetesq.com say tests the limits of legal protections for women receiving medical care.

Kim Blalock had back problems before she became pregnant. She suffered from arthritis and degenerative disc disease. Surgical complications and a car accident the year before her pregnancy made her pain even worse.

Blalock, a married stay-at-home mother of six, managed her condition under the care of a local orthopedist. He prescribed hydrocodone, one of the most common medications for patients with chronic pain. It enabled the 36-year-old to keep up with her young children and two older teens.

“There are days that I can’t get up,” said Blalock, who lives in Florence in north Alabama. “There are days where I’m OK, and there are days that are just horrible. It is debilitating. I have a lot of pain and limited mobility, and I’ve got two little kids (and older ones) who need me all day.”

Four years after she started taking hydrocodone, Blalock became pregnant with her youngest son and stopped her medication in early 2020. “It was a very rough, painful, long pregnancy,” Blalock said.

The pain became unbearable in the last six weeks before her due date, so she refilled her prescription. When Blalock delivered, she told her obstetrician about the hydrocodone, according to a letter from her lawyers to Lauderdale County authorities. Staff at North Alabama Medical Center tested her newborn for opiates, and it came back positive.

That triggered a brief investigation by the Department of Human Resources, which closed the case after Blalock showed them the prescription bottle and allowed a case worker to count the pills.

But that didn’t satisfy the Florence Police Department or Lauderdale County District Attorney’s Office, which investigated and charged Blalock with prescription fraud for not telling her orthopedist she was pregnant.

Most of the time when newborns test positive for drugs in Alabama, authorities prosecute mothers for chemical endangerment – a law that was written to protect children from exposure to fumes from home-based meth labs. The Alabama Supreme Court later upheld felony chemical endangerment convictions against two mothers who used drugs during pregnancy, a broad interpretation of the statute that opened the door for hundreds of cases that followed.

In 2016, after an investigation by ProPublica and AL.com, Alabama lawmakers amended the law to protect mothers who took drugs prescribed by doctors. Dana Sussman, an attorney at National Advocates for Pregnant Women, said that bill made it clear state leaders did not want prosecutions against mothers with legal prescriptions.

Alabama authorities have prosecuted hundreds of women for drug use during pregnancy in the last decade, but this may be the first case charging fraud because a woman allegedly didn’t tell her doctor about a pregnancy, Sussman said.

Prescription fraud cases usually happen when a person uses a false identity or forgery to get controlled substances. Emma Roth, an attorney for National Advocates for Pregnant Women representing Blalock, said Lauderdale County officials are using charges of prescription fraud to get around the exemption in the chemical endangerment law.

“It seems to us that this is a way that the state and the prosecution wants to circumvent the acts of the legislature,” Roth said. “Legislators excluded women from lawful prescriptions from the chemical endangerment law. This is a way for the prosecution to work around that.”

Roth and Blalock’s other attorneys have asked for the charges to be dropped. Attorneys at National Advocates for Pregnant Women regularly handle criminal cases from around the country involving pregnant women. If Blalock is convicted, Sussman said it means any woman in Alabama could be arrested if she doesn’t inform her doctor she is pregnant before refilling or receiving a prescription – whether or not she is asked.

Lauderdale County District Attorney Chris Connolly said his office is not trying to get around the state’s ban on bringing chemical endangerment charges against women with lawful prescriptions. Although most of his previous prosecutions for prescription fraud concern doctor shopping – where patients visit several providers to obtain multiple prescriptions – he said this case fits the bill.

“It is alleged that the defendant obtained hydrocodone from a medical doctor while she was pregnant without disclosing to the doctor that she was pregnant,” Connolly said. “Had the defendant disclosed her pregnancy, she would have been weaned off of the hydrocodone by the medical doctor.”

The doctor did not respond to requests for comment. Blalock said her doctor and nurses never asked about pregnancy. She didn’t have an appointment in the office due to the pandemic, but did have some through the window of her car.

Connolly said Blalock had a responsibility to inform her doctors. Although Blalock said she told her obstetrician about the pain pills, Connolly said she did not. Newborns exposed to hydrocodone during pregnancy can experience withdrawal symptoms after birth, which can be treated with medication in neonatal intensive care units. While not life-threatening, the condition can cause irritability, excess crying, poor feeding and tremors.

In recent years, the number of babies treated for neonatal abstinence syndrome has increased in Alabama and across the country. Authorities in the Yellowhammer State have reacted by imposing harsher penalties on mothers who use illegal drugs during pregnancy. Connolly said Blalock’s doctors would have altered her treatment if they had known she was pregnant.

“It is further alleged that had she disclosed to her ob-gyn doctor that she was taking hydrocodone, she would have been instructed to stop taking the medication while pregnant,” Connolly said.

Her newborn showed no signs of drug withdrawal after birth and was discharged after four days of treatment for jaundice – a common condition that usually subsides after treatment with ultraviolet lights. Her son has been healthy, but Blalock has struggled.

Less than two months after the birth, police officers swarmed Blalock’s house while she and her husband were out of town. Her two teenagers were at home and said at least seven armed officers entered asking questions about her whereabouts. The teenagers were so rattled they went to stay with their grandparents.

“The incident with the police left Ms. Blalock and her sons feeling terrified, confused, and unsafe,” Roth said.

A public information officer with the Florence Police Department declined to answer questions about the raid because the investigation remains open.

As the investigation dragged on, Blalock said her neighbors saw the police coming and going from her home and read about her arrest in the paper.

“Something that I found really tragic about this story was that she was afraid to spend the money she had saved up for Christmas presents in case she needed it for bail,” Roth said.

Roth has represented Blalock for months, and said her client has a close bond with her children.

“I’ve been so impressed with her and how she interacts with her baby,” Roth said. “But she is also experiencing incredible levels of stress and fear. It’s been really devastating for her and she just wants closure.”

Blalock’s child is a healthy eight-month-old. Blalock said he has never been sick and is almost crawling. But while she should have spent the last several months enjoying and bonding with her new baby, she has instead wrestled with fear and pain. She went off her medication until her case is resolved, and her back problems have become excruciating.

Blalock said she had no idea filling her pain prescription could have gotten her into so much trouble.

“If I had known what I know now, I would rather lay in bed my entire pregnancy in pain than take a pill,” Blalock said. “I thought it was ok. I didn’t think it was a big deal. My son is perfectly fine.”

Blalock wants to warn other women this could happen to them.

“I thought if a doctor wrote you a prescription, you can take it,” Blalock said. “If not, there needs to be posters everywhere in the doctor’s office that says, if you’re pregnant, and the doctor prescribes you something, you still may not be able to take it.”

 

University of Florida Lab Finds Dangerous Pathogens on Children’s Face Masks

A student wears a mask as he does his work at Freedom Preparatory Academy in Provo, Utah, on Feb. 10, 2021. (George Frey/Getty Images)

University of Florida Lab Finds Dangerous Pathogens on Children’s Face Masks

 

https://www.theepochtimes.com/university-of-florida-lab-finds-dangerous-pathogens-on-childrens-face-masks_3865300.html

A laboratory at the University of Florida that recently analyzed a small sample of face masks, detected the presence of 11 dangerous pathogens that included bacterias that cause diphtheria, pneumonia, and meningitis.

Gainesville parents in Florida concerned about the harm caused to their children wearing face masks all day at school in 90 °F weather sent out six masks—five that were worn by children ages 6 to 11 for five to eight hours at school, and one worn by an adult—to be analyzed for contaminants at the University of Florida’s Mass Spectrometry Research and Education Center.

Of the six masks, three were surgical, two cotton, and a poly gaiter. Masks that have not been worn and a t-shirt worn at school acted as the control samples.

Five of the masks were found to be contaminated with parasites, fungi, and bacteria, according to Rational Ground. Only one mask was found to contain a virus that can cause a fatal systemic disease in cattle and deer. Other less harmful pathogens that can cause ulcers, acne, and strep throat were also detected.

None of the controls were contaminated with pathogens, while “samples from the front top and bottom of the t-shirt found proteins that are commonly found in skin and hair, along with some commonly found in soil.”

Amanda Donoho, a mother of three elementary school children, teamed up with other parents to send the masks to the lab because her sons broke out in rashes from prolonged mask-wearing.

“Our kids have been in masks all day, seven hours a day in school,” Donoho told Fox & Friends on June 17. “The only break that they get is to eat or drink.”

Donoho said that while students do not have to wear a mask outside at school since April 2021, masks were still required when they were within six to eight feet of each other. Masks must also be worn on school buses.

Further research is needed to better understand what is being put on children’s faces, says Donoho.

Superintendent Carlee Simon at the Alachua County Public Schools (ACPS) in Gainesville, Fla. did not respond to a request for comment.

The director of the Centers for Disease Control and Prevention (CDC) says that kids should continue to wear masks and social distance until they are able to get vaccinated, despite data showing that children are minimally affected by COVID-19 and are not super-spreaders of the virus.

Gov. Ron DeSantis, a Republican, signed an executive order on May 3, suspending all COVID-19 emergency restrictions, including mask-wearing. However, certain school districts like ACPS kept their mask policy in place for the remainder of the school year, while masks were optional within the community.

ACPS says masks will be optional for the 2021–22 school year but would continue to be required on school buses until mid-September unless the federal transportation regulation changes.

The CDC says masks are still required on planes, trains, buses, and at airports.

In an updated June 17 guidance, masks are no longer required in “outdoor areas of a conveyance (like a ferry or the top deck of a bus)” and fully vaccinated individuals may resume everyday activities that were done prior to the pandemic without mask-wearing or physically distancing unless required by federal or state law.

People are considered fully vaccinated two weeks after their second shot of a messenger RNA vaccine or after a single-dose Johnson & Johnson vaccine.

The CDC did not give guidance for people who’ve recovered from COVID-19 and have natural immunity.