‘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.

Should Dying Cancer Patients Suffer From Undertreated Pain Because of ‘Concerns Regarding Addiction’?

Should Dying Cancer Patients Suffer From Undertreated Pain Because of ‘Concerns Regarding Addiction’?

https://reason.com/2021/04/27/should-dying-cancer-patients-suffer-from-undertreated-pain-because-of-concerns-regarding-addiction/

Two recent studies show how the attempt to curtail drug abuse by discouraging and restricting opioid prescriptions has hurt bona fide patients by depriving them of the medication they need to ease their pain. The harm inflicted on these innocent bystanders, which would not be morally justified even if the opioid crackdown did what it was supposed to do, is all the more appalling because limiting legal access to these drugs seems to have accelerated the upward trend in opioid-related deaths by driving nonmedical users toward black-market substitutes.

Jon Furuno, an associate professor of pharmacy practice at the Oregon State University College of Pharmacy, looked at prescribing patterns among 2,648 terminal patients who were transferred from an academic medical center to hospice care from January 2010 through December 2018. During that period, regulators and legislators responded to the “opioid crisis” by directly and indirectly limiting analgesic prescriptions, often in ham-handed ways. While that was happening, the study found, the share of hospice-bound patients who had opioid prescriptions when they were discharged fell from 91.2 percent to 79.3 percent—a 13 percent drop.

Furuno and his co-authors, who reported their results this month in the Journal of Pain and Symptom Management, controlled for age, sex, diagnosis, and the location of hospice care, so changes in those factors do not account for the decline in opioid prescriptions. Furthermore, “prescribing of non-opioid analgesic  medications increased over the same time period,” meaning that pain was more likely to be treated with less effective but still potentially dangerous drugs.

The average age of these patients was 66. Nearly three-fifths had cancer diagnoses, and all of them were expected to die soon, meaning that treatment should have been focused on making them as comfortable as possible in their remaining time.

“Even among patients prescribed opioids during the last 24 hours of their inpatient hospital stay, opioid prescribing upon discharge decreased,” Furuno noted in a press release. “It seems unlikely that patients would merit an opioid prescription on their last day in the hospital but not on their first day in hospice care, and it’s well documented that interruptions in the continuity of pain treatment on transition to hospice are associated with poor patient outcomes.”

Furuno noted that “pain is a common end-of-life symptom, and it’s often debilitating.” He added that more than 60 percent of terminal cancer patients report “very distressing pain.”

In this context, it is especially striking that Furuno and his colleagues cite “patient and caregiver concerns regarding addiction” as one obstacle to adequate pain treatment. The risk of addiction is exaggerated and overemphasized even when physicians are treating chronic pain in patients who may have years or decades to live. When patients on the verge of death are suffering severe pain that could be relieved by opioids, “concerns regarding addiction” seem like a cruel joke.

Furuno et al. also mention “policies and practices aimed at limiting opioid use in response to the opioid epidemic,” which are based on similar fears and reinforce them. In particular, Furuno cites the opioid prescribing guidelines that the Centers for Disease Control and Prevention (CDC) issued in 2016.

Those recommendations, which were widely interpreted as setting firm and binding limits, led to large, sudden, and indiscriminate dose reductions, along with outright cessation of treatment and patient abandonment. The suffering caused by that response has been highlighted by the American Medical Association, the Food and Drug Administration (FDA), and the CDC itself. The authors of the guidelines blamed clinicians who “misimplemented” their advice.

“There are some concerns…that indiscriminate adoption or misapplication of these initiatives may be having unintended consequences,” Furuno said. “The CDC Prescribing Guideline and the other initiatives weren’t meant to negatively affect patients at the end of their lives, but few studies have really looked at whether that’s happening. Our results quantify a decrease in opioids among patients who are often in pain and for whom the main goal is comfort and quality of life.”

A Journal of General Internal Medicine study published in February further illustrates how indiscriminate efforts to drive down medical use of opioids have undermined patient care. Researchers at Harvard and the University of Minnesota examined prescribing records for a 20 percent sample of Medicare patients treated from 2012 to 2017. They identified nearly 260,000 patients who were on long-term opioid therapy (LTOT) during that period and found that LTOT was discontinued in 17,617 of those cases.

“Adjusted rates of LTOT discontinuation increased from 5.7% of users in 2012 to 8.5% in 2017, a 49% relative increase,” the researchers reported. In a large majority of cases, LTOT “stopped abruptly,” and sudden cessation became more common during the study period, accounting for 81.2 percent of discontinuations by the end, up from 70.1 percent at the beginning. Two years ago, the FDA warned that such abrupt tapering may lead to “serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.”

Study co-author Michael Barnett, a physician and an assistant professor of health policy and management at Harvard’s T.H. Chan School of Public Health, was dismayed by the frequency of such “off the cliff” dose reductions. “The vast majority of long-term opioid users whose therapy was discontinued had an extremely rapid, abrupt taper that was far outside of guideline recommendations,” he told MedPage Today. “It would have been concerning to find that, say, one in four long-term opioid users had abrupt cessation of their therapy, but we found that it was most, even among those with very high daily doses of opioids.”

Barnett concluded that “we need more education and support for patients on long-term opioid therapy to taper in a clinically rational way.” But the speed of tapering is not the only concern raised by these findings.

Drug warriors may assume that all of these LTOT discontinuations would have been medically appropriate if only they had been carried out more gradually—in other words, that all of these patients were better off without the opioids they had long used to relieve their pain. But it seems unrealistic to suppose that doctors, operating under extraordinary government pressure, never sacrificed the interests of their patients to avoid unwelcome scrutiny. The increased risk of suicide among patients suddenly deprived of pain medication suggests otherwise.

Another PAIN WARRIOR SUICIDE: Heidi Ferrer, ‘Dawson’s Creek’ and ‘Wasteland’ Writer, Dies at 50

Heidi Ferrer

Another PAIN WARRIOR SUICIDE: Heidi Ferrer, ‘Dawson’s Creek’ and ‘Wasteland’ Writer, Dies at 50

https://variety.com/2021/tv/news/heidi-ferrer-dead-dawsons-creek-writer-1234999438/

Heidi Ferrer, a television and film writer known for her work on “Dawson’s Creek” and “Wasteland,” died on May 26, her husband Nick Guthe confirmed to Variety. She was 50.

Ferrer died by suicide after an ongoing battle with long-haul COVID-19. She first contracted the virus in April 2020 and saw her health worsen. By May 2021, she was bedridden due to constant physical pain and suffered from severe neurological tremors, in addition to other symptoms.

Born in Salinas, Kans., Ferrer made her way to Los Angeles by the late ’80s to pursue an acting career at the American Academy of Dramatic Arts. A few years later, she pursued screenwriting and sold her first spec, “The C Word,” to producer Arnold Kopelson, setting her down on a path that would lead to her 24 years as a member of the WGA.

In 1999, Ferrer served as a writer for several episodes of the hit teen drama “Dawson’s Creek” and “Wasteland,” on which she worked with producers Kevin Williamson and Julie Plec. Over her career, she sold screenplays and pitches and did re-writes for major studios. Her 2008 movie, “Princess,” for ABC Family did well for the network and played for many years.

That same year, Ferrer pivoted her writing skills to the web where she started her blog, GirlToMom.com, to document her then-infant son’s battle with progressive infantile scoliosis. As her online following grew, so did the incorporation of writing into the blog. In 2014, she was invited to speak at the BlogHer Conference.

For her passionate advocacy, the Infantile Scoliosis Project honored Ferrer in 2010 with the National Hero Award. In her memory, the organization has named the annual Parent Initiative Award after her.

Ferrer is survived by her mother, Nancy Gilmore; sisters Laura Frerer-Schmidt and Sierra Summerville; her husband Nick Guthe, a screenwriter, director and producer; and her 13-year-old son, Bexon.

If you or anyone you know is having thoughts of suicide, please call the National Suicide Prevention Lifeline at 1-800-273-8255 or go to SpeakingOfSuicide.com/resources.

Untreated chronic pain can lead to suicide

The FDA Is Failing the American People

The FDA Is Failing the American People

https://www.medpagetoday.com/opinion/vinay-prasad/93136

FDA’s recent approval of a controversial drug — aducanumab (Aduhelm) — to treat people living with Alzheimer’s disease shows just how broken the agency is, and reminds us that we all have to pay for it.

A series of events that has unfolded since January tells the story.

In late April, the FDA’s Oncologic Drugs Advisory Committee reviewed six accelerated approvals — a provisional pathway — involving a group of cancer immunotherapies where clinical trials had failed to confirm that the drugs extended survival or improved quality of life. Yet, in four of the six cases, the advisory committee voted to keep the accelerated approvals intact. The lesson was painfully clear: once the toothpaste is out of the tube it is hard to get it back in. Once doctors get used to using a therapy, pulling a drug from the market or in this case, revoking indications, is hard — even after the drugs fail to confirm benefit.

On June 7, the FDA approved aducanumab for the treatment of Alzheimer’s disease. The drug received accelerated approval because it showed it could reduce the rate of amyloid plaque on scans. What remains uncertain is whether this reduction in plaque means Alzheimer’s patients live longer or better lives — and notably, the totality of the clinical trial data do not show that. Moreover, the drug has various side effects and a whopping price tag: $56,000 a year.

In response to the FDA’s approval, three members of the Peripheral and Central Nervous System Drugs Advisory Committee who opposed approval of the drug, quit the panel in protest. Aaron Kesselheim, MD, JD, MPH, a Harvard professor called the drug “problematic,” and argued that there was little evidence it would help patients. Writing in The Atlantic, Nicholas Bagley, JD, and Rachel Sacks, JD, MPH, estimate that if the drug is prescribed to just one-third of eligible patients, it would cost Medicare $112 billion a year — a massive figure that dwarfs any other medication.

What Is FDA Thinking?

In the last 3 months we have seen that the FDA does not have the ability to revoke accelerated approvals, even when the drugs and their sponsors fail to meet the promises made. And to wash that down, the FDA has now approved another uncertain drug for people suffering from Alzheimer’s, against the wishes of a different advisory panel. With Alzheimer’s disease affecting 6 million Americans, the financial and human implications of the approval are staggering.

FDA Has Pitched Their Tent on the Side of the Mountain

Many observers don’t fully appreciate how the FDA has taken a position that is indefensible. The agency does not guarantee that drugs that come to the U.S. market actually help Americans live longer or better lives (beyond what could be achieved without these drugs). At the same time, the FDA insists on interfering in the market and sets arbitrary standards for approval. The combined effect is the worst of all possible worlds: we don’t know if drugs work, and the companies can charge massive prices for them!

Let’s consider, two views of what the FDA could be.

One vision of the FDA — held by progressive reformers — is that the purpose of the agency is to shield desperate, sick, and vulnerable patients from making choices that may not be in their best interest. That is why we demand drugs be safe and effective, and not let any charlatan sell you any snake oil. The FDA exists to protect the American public from taking toxic drugs that don’t work. By that metric, our system has failed. The FDA often makes products available with no robust proof they are effective — such as in the case of aducanumab — and remains reluctant to withdraw the products or specific indications even when trials fail to confirm the benefit of living longer or better lives.

The other vision for the FDA is to abolish it entirely. Some libertarian policymakers argue that without the FDA, the market would work itself out. Without the agency, the barrier to sell a drug would be dramatically lowered. Small companies that cannot afford to jump through the FDA’s regulatory hoops might be able to bring small-batch products to market. Prices would tumble as drugs would flood the market and compete based on price and patient experience. In this vision, word of mouth would help clarify which drugs were effective, and some payers might conduct good randomized controlled trials to decide whether to fund products. I am not in this camp — I see dangers with this approach — but even I must concede, prices would likely fall.

Yet, instead of either of these visions, we have an agency that lives in between the two. The FDA poses a series of hurdles to get a drug to market, but none of those hurdles are an assurance a drug works or has net benefit to people. Then the agency stamps drugs with their imprimatur. Ironically, this system is ideal for medium and large pharmaceutical firms. Small firms are kept off the market, and larger firms specialize in jumping through the hoops. Once approved, costs can be astronomical, and the FDA seal of approval justifies the high price. Along the way, no one seems to ask whether patients are better off.

From this vantage, the FDA looks like an agency whose goal is to preserve pharmaceutical profits. Coincidentally, among medical reviewers at the agency, the prime destination after working at the FDA is either as a consultant for or employee of a biopharmaceutical company.

Just this week, yet another former FDA Commissioner, Stephen Hahn, MD, joined a venture capital firm in healthcare.

What is the American public to think? We have an agency that is happy to approve $100-billion-a-year drugs to a desperate and vulnerable population without knowing that patients are better off. Society pays for those costs — often through Medicare — but that same society won’t pay for a caregiver who might actually ease the burden on families who have a loved one with Alzheimer’s. If drugs approved by accelerated approval later don’t work, experts are happy to continue to keep them on the market, citing anecdotal impressions of their utility. The bar for approval is ridiculously low, but not absent altogether — a fact that facilitates high drug prices. Finally, the people who work at the FDA later go to work predominately for the companies that profit from the FDA’s lax standards. The revolving door spins so fast it might hit you in the rear.

Our system is grievously and horribly broken. I have been following it closely and my worry is that I see no signal it is getting better any time soon.

Is our healthcare system and pt care attempting to go into a different direction ?

We may be seeing a “quantum leap” in the bureaucrats’ view of what has been declared as “dangerous drugs” when the Controlled Substance Act was passed in 1970 .. the bureaucratic agency that was created was the Bureau of Narcotic and Dangerous Drugs… https://en.wikipedia.org/wiki/Bureau_of_Narcotics_and_Dangerous_Drugs  which evolved into the DEA in 1973.

Over the years the number of substances that ended up as been classified as controlled substances has continued to grow over the five decades since. There has been some reports that we are spending upwards of 100 billion/yr in fighting the war on drugs and we have spent nearly TWO TRILLION since 1970.

There is so many moving parts that seems to suggest that we are headed toward some weakening of the DEA…  Some states – RI & NH comes to mind that have attempted to pass state laws that is trying to assure chronic pain pts get better/more appropriate pain management..  How successful they are has yet to be determined in the long run.

VT has decriminalized and placed a “sin tax” on the possession of small quantities of Buprenorphine

Is this most recent ruling by the Supreme Court has it opened the door for  Obamacare – Here to stay !!! Supreme Court Upholds Affordable Care Act

There is some rumors of Congress considering the legalization/decriminalization of MJ.   Just imagine the impact on chronic pain pts if this happens, and it becomes a OTC med/supplement and Congress/DEA cuts the production limits of opiates by the Pharmas.  The dollars that could be shifted to pts and the billions of dollars that would not be paid out by Insurance/Medicare/Medicaid.  This could be viewed as necessary to cut the costs that turning Obamacare into a national healthcare insurance.  This could be a option instead of putting a “sin tax” on the sale/use of MJ ?

Democrats Unveil Bill to Decriminalize Drug Possession at Federal Level, Expunge Records

https://www.newsbreak.com/news/2281498829307/democrats-unveil-bill-to-decriminalize-drug-possession-at-federal-level-expunge-records

A bill to end criminal penalties for drug possession at the federal level was unveiled by Democrats on Tuesday, ahead of the 50th anniversary when President Richard Nixon declared the “war on drugs.” The Drug Policy Reform Act (DPRA) would decriminalize personal use possession of all scheduled drugs—including marijuana, heroin…

DATA BREACH: over one billion healthcare records of CVS Health (Pharmacy and Aetna)

Over a billion records belonging to CVS Health exposed online

https://www.zdnet.com/article/billions-of-records-belonging-to-cvs-health-exposed-online/

In another example of misconfigured cloud services impacting security, over a billion records belonging to CVS Health have been exposed online. 

On Thursday, WebsitePlanet, together with researcher Jeremiah Fowler, revealed the discovery of an online database belonging to CVS Health. The database was not password-protected and had no form of authentication in place to prevent unauthorized entry.

Upon examination of the database, the team found over one billion records that were connected to the US healthcare and pharmaceutical giant, which owns brands including CVS Pharmacy and Aetna. What people should be asking is “is meritain health the same as aetna?”

The database, 204GB in size, contained event and configuration data including production records of visitor IDs, session IDs, device access information — such as whether visitors to the firm’s domains used an iPhone or Android handset — as well as what the team calls a “blueprint” of how the logging system operated from the backend. 

Search records exposed also included queries for medications, COVID-19 vaccines, and a variety of CVS products, referencing both CVS Health and CVS.com and many other additional resources to claim the orders and data of the patients. Everyone was taken aback by this incident. Contact the Canadian Pharmacy for more info.

“Hypothetically, it could have been possible to match the Session ID with what they searched for or added to the shopping cart during that session and then try to identify the customer using the exposed emails,” the report states. 

The researchers say the unsecured database could be used in targeted phishing by cross-referencing some of the emails also logged in the system — likely through accidental search bar submission — or for cross-referencing other actions. Competitors, too, may have been interested in the search query data generated and stored in the system. 

WebsitePlanet sent a private disclosure notice to CVS Health and quickly received a response confirming the dataset belonged to the company. 

CVS Health said the database was managed by an unnamed vendor on behalf of the firm and public access was restricted following disclosure. 

“In March of this year, a security researcher notified us of a publicly-accessible database that contained non-identifiable CVS Health metadata,” CVS Health told ZDNet. “We immediately investigated and determined that the database, which was hosted by a third party vendor, did not contain any personal information of our customers, members, or patients. We worked with the vendor to quickly take the database down. We’ve addressed the issue with the vendor to prevent a recurrence and we thank the researcher who notified us about this matter.”