Our Freedom is NOT FREE

Shirley Nelson

I put my carry-on in the luggage compartment and sat down in my assigned seat. It was going to be a long flight. ‘I’m glad I have a good book to read. Perhaps I will get a short nap,’ I thought.
Just before take-off, a line of soldiers came down the aisle and filled all the vacant seats, totally surrounding me. I decided to start a conversation.
‘Where are you headed?’ I asked the soldier seated nearest to me. “Petawawa”. We’ll be there for two weeks for special training, and then we’re being deployed to Afghanistan
After flying for about an hour, an announcement was made that sack lunches were available for five dollars. It would be several hours before we reached the east, and I quickly decided a lunch would help pass the time…
As I reached for my wallet, I overheard a soldier ask his buddy if he planned to buy lunch. ‘No, that seems like a lot of money for just a sack lunch. Probably wouldn’t be worth five bucks. I’ll wait till we get to base.’
His friend agreed.
I looked around at the other soldiers. None were buying lunch. I walked to the back of the plane and handed the flight attendant a fifty dollar bill. ‘Take a lunch to all those soldiers.’ She grabbed my arms and squeezed tightly. Her eyes wet with tears, she thanked me. ‘My son was a soldier in Iraq ; it’s almost like you are doing it for him.’
Picking up ten sacks, she headed up the aisle to where the soldiers were seated. She stopped at my seat and asked, ‘Which do you like best – beef or chicken?’
‘Chicken,’ I replied, wondering why she asked. She turned and went to the front of plane, returning a minute later with a dinner plate from first class.
‘This is your thanks..’
After we finished eating, I went again to the back of the plane, heading for the rest room. A man stopped me. ‘I saw what you did. I want to be part of it. Here, take this.’ He handed me twenty-five dollars.
Soon after I returned to my seat, I saw the Flight Captain coming down the aisle, looking at the aisle numbers as he walked, I hoped he was not looking for me, but noticed he was looking at the numbers only on my side of the plane. When he got to my row he stopped, smiled, held out his hand and said, ‘I want to shake your hand.’ Quickly unfastening my seatbelt I stood and took the Captain’s hand.
With a booming voice he said, ‘I was a soldier and I was a military pilot. Once, someone bought me a lunch. It was an act of kindness I never forgot.’ I was embarrassed when applause was heard from all of the passengers.
Later I walked to the front of the plane so I could stretch my legs. A man who was seated about six rows in front of me reached out his hand, wanting to shake mine. He left another twenty-five dollars in my palm.
When we landed I gathered my belongings and started to deplane. Waiting just inside the airplane door was a man who stopped me, put something in my shirt pocket, turned, and walked away without saying a word. Another twenty-five dollars!
Upon entering the terminal, I saw the soldiers gathering for their trip to the base. I walked over to them and handed them seventy-five dollars. ‘It will take you some time to reach the base.. It will be about time for a sandwich. God Bless You.’
Ten young men left that flight feeling the love and respect of their fellow travelers.
As I walked briskly to my car, I whispered a prayer for their safe return. These soldiers were giving their all for our country. I could only give them a couple of meals. It seemed so little…
A veteran is someone who, at one point in his life, wrote a blank check made payable to ‘The United States of America ‘ for an amount of ‘up to and including my life.’
That is Honor, and there are way too many people in this country who no longer understand it.’
May God give you the strength and courage to pass this along to everyone on your email buddy list….
I JUST DID
Let us pray…
Prayer chain for our Military… Don’t break it!
Please send this on after a short prayer.. Prayer for our soldiers Don’t break it!
Prayer:
‘Lord, hold our troops in your loving hands. Protect them as they protect us. Bless them and their families for the selfless acts they perform for us in our time of need. Amen.’
Prayer Request:
When you receive this, please stop for a moment and say a prayer for our troops around the world.
There is nothing attached. Just send this to people in your address book. Do not let it stop with you. Of all the gifts you could give a Marine, Soldier, Sailor, Airman, & others deployed in harm’s way, prayer is the very best one.
GOD BLESS YOU FOR PASSING IT ON!

Your Pain is ALL IN YOUR HEAD

https://i.redd.it/ifk2iyldx6i71.png

Doctor Wins Restraining Order Against CVS After Prescription Ban – whose on first and what’s on second

This story is so strange… you almost need a road map to follow all the twists and turns ….  Michael DeAngelis is the regular spokesperson for CVS with the media… and his statement seem to be pretty clear that CVS is using GROSS DISPENSING DATA – and not clinical data to make “clinical decisions” that a prescriber is writing too many controlled substances…   “It is alleged in many lawsuits that pharmacies fill too many opioid prescriptions and should operate programs that use data to block prescriptions written by some doctors ”  There is a phrase in the controlled substance act “corresponding responsibility”… which basically means that both the prescriber and the pharmacist are responsible to make sure that prescribed opiates are for valid medical necessity..  The intent of this law is that both prescriber and pharmacist are both responsible to make sure that a pt with a medical need for opiates get the controlled substance that they have a valid medical necessity for.  It would appear to me, that according to Mr DeAngelis statement… the decision to stop filling this pain clinic’s controlled meds prescription was made by CVS Health  THE CORPORATION…. which has neither a pharmacist degree, nor pharmacist license and since one the basics of the practice of medicine is the starting, changing, stopping a pt’s therapy…  so it would also appear that CVS Health THE CORPORATION made a decision to stop the therapy of all of the pts of this clinic…. so apparently they could also be guilty of practicing medicine without a license and intentionally throwing hundreds of pts into cold turkey withdrawal.

According to this quote in this article  …  Kahra Lutkiewicz, director of CVS’ retail pharmacy professional practice, wrote in the letter. “Thus, we are writing to inform you that effective August 5, 2021, CVS/pharmacy stores will no longer be able to fill prescriptions that you write for controlled substances. We take our compliance obligations very seriously, and after careful consideration, find it necessary to take this action.”    According to information on FB and LinkedIN indicates that Ms Lutkiewicz  has been a licensed pharmacist, for about 20 yrs and she is the one who seem to indicate that she is the primary CVS Health employee who made this decision to cut this pain clinic and all its pts off…  Could she also be responsible for practicing medicine without a license ?

It also appears that Dr Hansen was sued 2 yrs ago In 2019, a patient sued him for negligence and fraud for allegedly performing medically unnecessary and excessive injection therapy. The suit claims the patient was required to undergo injection therapy on a continuing basis in order to receive her narcotic pain medication, according to the lawsuit filed in Kenton Circuit Court. The complaint alleges that Hansen made false representations to the patient and to her i nsurers that the injections were necessary for the treatment of the patient’s chronic pain.

I am no attorney but this seems to be a straight forward case of a violation of parts of the Sherman Antitrust act referred to as “Tying Commerce ”  https://en.wikipedia.org/wiki/Tying_(commerce)

that law is basically that a vendor will require a customer to purchase something that they don’t want to be able to purchase something that they do want. According to that lawsuit,  Dr Hansen was requiring pts to get ESI’s in order for Dr Hansen to provide the pt with a Rx for oral opiates and/or other controlled substances.

It is buried somewhere in the Federal Anti -Kickback Statute and/or Stark act, but it is something should be explored.

Everyone seems to be a “HOT MESS” to some degree… except the poor intractable chronic pain pts that were pts of Dr Hansen’s pain clinic.

Doctor Wins Restraining Order Against CVS After Prescription Ban

https://www.medscape.com/viewarticle/956705 

A Kentucky pain specialist has won a temporary restraining order against CVS Pharmacy after the retail chain forbade its pharmacies to fill his prescriptions.

In an August 11 decision, District Court Judge William Bertelsman ordered CVS to stop refusing prescriptions written by Kendall E. Hansen, MD. Judge Bertelsman ruled that Hansen is likely to succeed in his claim that CVS barred his prescriptions without evidence that he violated any law or professional protocol. The restraining order will remain in place while Hansen’s lawsuit against CVS Pharmacy proceeds.

Ronald W. Chapman II, an attorney representing Hansen, said the order is groundbreaking and that to his knowledge, it’s the first time a federal court has overturned a pharmacy’s decision to block a prescriber.

“We believe that CVS’ decision was based solely on algorithms they use to analyze prescriber practices and not an any individual review of patient records,” Chapman said. “In fact, we invited CVS to come out to Dr Hansen’s practice and look at how he was treating patients and ensure things were compliant, but they refused. Instead, they had a phone call with him then cut his patients off.”

Michael DeAngelis, a spokesman for CVS, said the court’s order illustrates the proverbial rock and hard place that pharmacies are placed between in the country’s fight against the misuse of prescription opioids.

“It is alleged in many lawsuits that pharmacies fill too many opioid prescriptions and should operate programs that use data to block prescriptions written by some doctors,” DeAngelis wrote in an email to Medscape Medscape News. “And yet other lawsuits, including this one, argue that we should not operate programs that may block prescriptions. Such contradictions are grossly unfair to the pharmacy profession.”

DeAngelis declined to comment about Hansen’s claims or specify what led CVS to refuse his prescriptions.

Hansen declined to comment for this story through his attorney.

Hansen is no stranger to the spotlight. The Northern Kentucky pain doctor made headlines in 2012 when two of his horses, Fast and Accurate, and Hansen, ran in the Kentucky Derby. In February 2019, he drew media attention when his practice, Interventional Pain Specialists PLC, in Crestview Hills, Kentucky, was raided by federal agents. Hansen owns and operates the facility, which serves patients in Kentucky, Ohio, and Indiana.

The search yielded no findings, and no charges were filed, according to Chapman. Scott Hardcorn, director of the Northern Kentucky Drug Strike Force, confirmed that his agency assisted in the operation but said he was unaware of the outcome and that his officers generated no reports from the investigation. A spokesperson for the Drug Enforcement Administration (DEA) would not comment about the investigation and directed a Medscape reporter to the DEA website where enforcement actions are listed. No records or actions against Hansen can be found.

The CVS complaint stems from actions taken by the pharmacy against Hansen earlier this year. In June, a pharmacy representative allegedly contacted Hansen by phone and asked him questions about his practice and his prescribing practices, according to his lawsuit filed in US District Court for the Eastern District of Kentucky. During the call, the representative did not inform Hansen that any of his prescriptions were in question or were suspected of being medically unnecessary, the complaint alleges.

On July 28, 2021, CVS sent Hansen a letter announcing that its pharmacies would no longer be honoring his prescriptions. The letter, entered as an exhibit in the lawsuit, states that CVS contacted Hansen twice in 2021 about his prescribing practices ― once in May and again in June.

“Despite our attempts to resolve the concerns with your controlled substance prescribing patterns, these concerns persist,” Kahra Lutkiewicz, director of CVS’ retail pharmacy professional practice, wrote in the letter. “Thus, we are writing to inform you that effective August 5, 2021, CVS/pharmacy stores will no longer be able to fill prescriptions that you write for controlled substances. We take our compliance obligations very seriously, and after careful consideration, find it necessary to take this action.”

The letter does not explain the details behind CVS’ concerns.

Hansen sued CVS on August 4 for torturous interference with a business relationship and defamation, among other claims. His complaint alleges that Hansen and his patients will suffer irreparable injury if the prescription decision stands. More than 250 of Hansen’s patients use CVS pharmacies for their prescriptions, and some are locked into using the pharmacy because of insurance contracts, Chapman said.

“There really is nowhere else for these patients to go,” Chapman said. “They would have to go to a new doctor and establish a new relationship, and obviously that has devastating consequences when we’re talking about people who need their medication.”

CVS has not yet issued a written response to the lawsuit. In his order, Judge Bertelsman stated that a preliminary conference was held in which all parties were represented and stated their positions to the judge.

“Plaintiffs are likely to succeed on the merits of their claims that defendant has interfered with plaintiffs’ relationships with their patients by refusing to fill prescriptions written by plaintiffs, and defendant has done so without evidence that plaintiffs have violated any law or professional protocol related to such prescriptions,” Bertelsman wrote. “The balance of the hardships between the parties weighs in favor of issuing a temporary restraining order inasmuch as defendant’s actions pose a threat to plaintiffs’ professional reputation and livelihood and…because plaintiffs’ patients’ medical care is implicated by defendant’s actions, the public interest weighs in favor of issuance of the temporary restraining order.”

Hansen is currently embroiled in several other legal battles as both a plaintiff and a defendant.

In 2019, a patient sued him for negligence and fraud for allegedly performing medically unnecessary and excessive injection therapy. The suit claims the patient was required to undergo injection therapy on a continuing basis in order to receive her narcotic pain medication, according to the lawsuit filed in Kenton Circuit Court. The complaint alleges that Hansen made false representations to the patient and to her insurers that the injections were necessary for the treatment of the patient’s chronic pain.

The federal government is not involved in the case.

The negligence lawsuit is in the discovery stage, and attorneys plan to collect Hansen’s deposition soon, said Eric Deters, a spokesman for Deters Law, a law firm based in Independence, Kentucky, that is representing the patient.

“The crux is that he performs unnecessary pain procedures and forces you to get an unnecessary procedure before giving you your medication,” Deters said.

However, Hansen’s and Deters’ history together includes a recent riff, according to an August 2021 lawsuit filed by Hansen against the law firm. Hansen was a former medical expert in cases for Deters and Associates PSC, but the relationship turned sour when attorneys believed Hansen was retained as an expert in a case against their clients, according to Hansen’s suit. Hansen claims that as retribution, Deters and Associates issued a medical malpractice lawsuit against him in 2020, even though attorneys allegedly knew the statute of limitations had run out. A trial court dismissed the 2020 lawsuit against Hansen as being untimely filed. Hansen’s lawsuit alleges wrongful use of civil proceedings and requests compensatory, punitive damages and court costs from the law firm.

The law firm has faced trouble in the past. In August 2021, the Ohio Supreme Court ordered that Eric Deters pay a $6500 fine for engaging in the unauthorized practice of law. Deters’ Kentucky law license has been suspended since 2013 for ethics infractions, according to court records. He retired from law in 2014 and now acts as a spokesperson and office manager for the law firm. The fine resulted from legal advice given by Deters to two clients at the law firm, according to the Ohio Supreme Court decision.

As for the CVS lawsuit, an upcoming hearing will determine whether the federal court issues a permanent injunction against CVS’s actions. CVS officials have not said whether they will fight the temporary restraining order or the withdrawal of their prescription ban against Hansen.

 

Flu Season is coming

I rode by one the chain pharmacies stores yesterday… you know the one some refer to as the THREE LETTER CHAIN.  On their “road sign” they were advertising “GET YOUR FLU SHOT”…. there is four main influenza viruses exist: A, B, C, and D.  A&B is the most common types that affect humans, but there is A total of 131 sub-types  (mutations) of influenza A have been identified to date.

Our healthcare system pharma system looks for which varieties are circulating south of the equator during our summer period which is there winter period and make flu shots for USA based on what is prevalent “down south”. 

Each year, it is unusual for the same mutation to be prevalent the following winter.  That is why the flu shot has become a annual happening…

Also the flu vaccines and the antibody titters that they create tend to wane over time.  The “peak” of a flu season can vary from Dec thru March on any given year.

People are at risk by getting their flu shot in July or Aug, because their antibody titters will be reduced by the time peak flu season rolls around, but apparently some chain pharmacies are more interested in generating revenue… maybe even be able to get to give a SECOND FLU SHOT if the flu season peaks in March… because those pts who got a shot in July/Aug.. their antibody titters could be TOO LOW and justify them getting a second flu shot…  what the hell … just more revenue for the chain that convinced them to get their ANNUAL FLU VACCINATION way too early.

The CDC estimates that upwards of 60,000 people die every year from the flu and of course, if a person dies from getting their flu shot too early and ends up catching the flu and dying… unlikely that whoever encouraged the pts to get a very early flu shot, will not experiences and financial consequences… Getting the flu shot – even on a timely manner….does not mean that they won’t catch the flu.

Personally, we try to get our annual flu vaccinations the last week of Sept or the first week of Oct.  It takes abt two weeks for antibodies to develop, so even if the flu season is very early – like starting in Nov… we should be covered for the entire flu season.

 

AARP has also fought the elimination of the legalized kickback system enjoyed by pharmacy benefit managers, notorious middlemen in the American system of health care

Guest Opinion: AARP and the triumph of image over skeezy reality

By Marion Mass

President Biden has decided to enforce an executive order issued by former President Trump that requires hospitals to post their prices publicly — to be “transparent.”

Not only is the administration insisting on compliance, but it’s doubling down by increasing the penalties for the 80% of large hospitals that have dragged their feet so far.

Dr. Marion Mass

The administration should be congratulated not only for the policy, but for not suggesting to the media that the previous administration had nothing to do with the original order. After all, politicians often say they will promote a good idea, no matter where it comes from. For once, they appear to be doing it.

As we often discover when contemplating Washington’s healthcare policymaking swamp, there’s many a profiteer who stands to make a killing from the final decision. If voters only knew of the countless ways that healthcare law and regulation have been turned to the service of picking their pockets… c’mon man, time to get woke about the skeeziness in which this sector of the American economy is drenched! 

Anyway, we shine today’s spotlight on AARP. (What?! You mean those nice people who arrange discounts and put out a magazine that makes oldsters look better than the overwhelming majority of youngsters?!)

Yes, AARP. 

In April, the Biden administration proposed exceptions to the order on price transparency. Specifically, the exception means that rates negotiated by hospitals for Medicare Advantage plans could be excluded from Medicare’s reporting of hospital prices.

Hmm. Rules for thee, but not for me.

Let’s follow the money.

Surprise! It leads to AARP.

In reality, only about 10% of Medicare beneficiaries rely solely on Medicare. The other 90% have supplemental plans.

In 2018, 60% of Medicare beneficiaries were enrolled in Medicare Advantage or Medigap plans.

The use of such plans has doubled over the last decade. United Healthcare provides more of these plans than any other private insurer.

Guess who earns a royalty from United Healthcare for help in marketing these plans.

AARP.

According to the organization’s own financial statement for 2019, AARP made more than twice as much from these royalties as it did from membership dues.

Even a director of AARP’s Public Policy Institute acknowledged the problem as far back as 2009. “There’s an inherent conflict of interest,” said Marylin Moon. “They’re… becoming very dependent on [royalty] sources of income.”

Like other big players in the price-concealing thicket of American health care, AARP has a history of lobbying to protect its cash cows.

(AARP is number 11 on the list of spenders on lobbying.)

More than once, AARP’s official positions on healthcare policy have even defied the wishes and interests of its members, who could see that those positions would expand the debt to be carried by their children and grandchildren.

For example, AARP lobbied vigorously against the inclusion of Medigap reforms in the Affordable Care Act (aka Obamacare). Those reforms would have been helpful financially to AARP members, but they would have cost AARP $2.8 billion over 10 years.

Despite 75% of its members disagreeing with the position, AARP has also fought the elimination of the legalized kickback system enjoyed by pharmacy benefit managers, notorious middlemen in the American system of health care.

Meanwhile, AARP markets itself as “the world’s largest non-profit, nonpartisan membership organization.”

For a non-profit, AARP’s brass collects a lot of silver.

CEO Jo Ann Jenkins makes $1.2 million annually; 13 other executives each make over $400,000 annually. 

AARP employees earn an average of $50,000 annually, 28% less than the national average of $66,000. The lowest-paying job at AARP is a receptionist — $21,000 annually. 

For an organization ostensibly dedicated to preventing poverty among seniors, it appears to enrich itself by abetting it. The spectacle has contributed to the emergence of a competitor to AARP, the Association of Mature American Citizens (AMAC).

Washington should note these awkward facts and revisit that proposed exception to the requirement for transparency on prices negotiated by hospitals with insurers.

Yes, to insist on the “full Monty” from all of the players in American health care would be a departure from Washington’s habitual skeeziness.

That would serve AARP’s members, their descendants, and the general public well. The general public would do well to remind the administration of it.

Biden calls on Congress to tackle soaring prices of prescription drugs

How are we going to negotiate medication prices with the pharmas when the insurance companies and their PBM subsidiaries really control the prices of prescription medications.  Below is a graphic that demonstrates where close to 50% of the price of a Rx at the register goes to insurance middlemen.  This example shows that the pharmacy makes abt 5% GROSS PROFIT and the Wholesaler makes abt 3% GROSS PROFIT and the “insurance middlemen” make nearly a 50% GROSS PROFIT… for mostly SHUFFLING  (electronic) PAPERWORK AND ELECTRONIC TRANSFER OF FUNDS.  They have no product inventory costs like the other parts of the equation.

President Biden claims that he wants Medicare to negotiate medication prices with the pharmas… Nearly all patient administered medications are covered by Medicare Advantage Prgm or a Medicare Part D Prgm and both of those entities are FOR PROFIT INSURANCE COMPANIES… and according to the graphic below… they are the bulk of the cost of medications… to pts.

Of course, those insurance companies have some of the largest “pots of lobbying money” and collectively the lobbying industry spends 9+ million/day on the 535 member of Congress to influence what they want Congress to do.  We are just 4+ months away from when 435 members of the House and 33-34 members of Congress start raising money and running for reelection in Nov 2022.

President Trump had an agreement with the pharmas that produce Insulin that pts were not going to pay more than  $25/month for their insulin – was suppose to start in April 2021, But President Biden cancelled/reversed that agreement… so now those pts are paying  $200-$300/month for their insulin needs.  Can anyone really believe that Biden has any consideration of what $$$ pts pay out of pocket for their medications.

In 2020, most/all Medicare Part D providers added a $435 annual deductible on policies that typically had abt $30/month premiums.  So the typical Part D covered pt basically had their 2020 out of pocket costs over DOUBLED – $360 premium & $435 deductible.  Prior to 2020, we were using Silver Scripts – had been since 2006 and when I compared plans … I discovered that Humana Part D – even with a new $435 deductible… our total out of pocket was <50% of what CVS Health/Caremark/Silver Scripts D charged us in 2019 without a deductible… We are using the same independent pharmacy and most all of the medications did not change.

 

 

Biden calls on Congress to tackle soaring prices of prescription drugs

https://www.msn.com/en-us/news/politics/biden-calls-on-congress-to-tackle-soaring-prices-of-prescription-drugs/ar-AANfDPY

WASHINGTON — President Joe Biden on Thursday urged Congress to take steps to lower the cost of prescription drugs in the United States, including allowing Medicare to negotiate drug prices directly and penalizing drugmakers who raise prices faster than inflation.

Joe Biden wearing a suit and tie © Provided by NBC News

“For years, the price of many prescription drugs has dramatically outpaced inflation,” Biden said in a speech at the White House. “These prices have put the squeeze on too many families and stripped them of their dignity.”

Drug prices have been a nagging issue for American politicians. Former President Donald Trump also spoke frequently of the need to lower prices and called for some of the same policy solutions as Biden, but was unable to garner support in Congress.

Biden said that Medicare is allowed to negotiate prices for every type of health care service except prescription drugs, which leads to increased costs for consumers.

He urged Congress to allow Medicare to negotiate across the board — not just the most expensive drugs, as some lawmakers have proposed — and said that the negotiated prices would reflect the drugmakers’ costs of research and development and would still provide a “significant profit” to the pharmaceutical companies.

Biden said that the Medicare-negotiated price should also apply to people who get insurance through private companies. He also said his plan would cap the amount of money seniors spend on prescription drugs each year at no more than $3,000 a year, or $250 a month.

Americans spend an average of about $1,300 a year on prescription drugs — more than any other country in the world — according to data from the Organization for Economic Cooperation and Development. Prescription drug costs in the U.S. have risen by 33 percent since 2014, according to some estimates, with insulin and rheumatology drugs experiencing some of the steepest price increases.

Democrats are expected to address the high cost of prescription drugs in their $3.5 trillion budget reconciliation bill, which they are pushing to pass in tandem with the bipartisan infrastructure bill that cleared the Senate on Tuesday. Biden was criticized by some members of his party earlier this year for initially leaving out efforts to lower prescription drug prices from his American Families Plan.

Approximately 3 in 10 adults report not taking their medicines as prescribed at some point in the past year because of the cost, according to a June report from the nonpartisan Kaiser Family Foundation. The report also found that a majority of adults support a number of proposals to allow the federal government to negotiate with drug companies to get a lower price on medications.

“This isn’t a partisan issue. Alzheimer’s, diabetes, cancer — they don’t care whether you’re a Democrat or Republican,” Biden said. “This is another area where we can come together to make a difference in people’s lives.”

Drugmakers are adamantly opposed to government efforts to curb prices, and some Republicans have also been reluctant to take federal action.

Biden applauded the pharmaceutical industry Thursday for developing lifesaving Covid vaccines at a historic speed, but encouraged Americans to “make a distinction between developing these breakthroughs and jacking up prices on a range of medications for a range of everyday diseases and conditions.”

A 2020 report from the House Oversight Committee found that enormous drug company profits are the primary driver of soaring prescription drug prices in America, and have little to do with research and development or industry efforts to help people afford medication, as drug companies often claim.

Biden said Thursday that companies right now do not put enough of their profit toward research and development, rather “too many companies use it to buy back their own stock, inflate their worth, drive up CEO salaries and compensation.”

To bridge the gap, he proposed creating a $6.5 billion agency within the National Institutes of Health called Advance Research Projects Agency that would help speed up cutting-edge research in treatments and cures for diseases such as Alzheimer’s, diabetes and cancer. The program would be modeled similarly to the Defense Advanced Research Projects Agency, or DARPA, Biden said.

“I’m not criticizing companies that aren’t prepared to spend billions of dollars on certain projects for research. I get it.” he said. “But if they’re not, we should.”

Biden signed an executive order in July asking the Food and Drug Administration to work with states and tribes to import prescription drugs from Canada, where they are sold at a much lower price.

He also directed the Federal Trade Commission to ban “pay for delay,” a practice in which brand-name drug manufacturers pay generic manufacturers to stay out of the market to avoid any competition that could reduce the price of the drug for consumers.

 

A sweeping drug addiction risk algorithm has become central to how the US handles the opioid crisis. It may only be making the crisis worse

When I first became aware of Narxcare a few years ago and with what information that Appriss released at the time.  This company also had out several years ago a electronic database that tracked Sudafed (pseudoephedrine/PSE) which is a primary ingredient in the making of Methamphetamine…  The first time that I had the opportunity to use it… I saw that it’s ability to limit PSE sales – appeared to me – more fiction than facts…. and in the long run… that has proven to be reality… When I first saw what they were doing with the Narxcare database… and all the various databases that they were going to invade to get info on a particular person. My first opinion was that this was going to be a CLUSTER-F for some pts where wrong data got incorporated into their algorithm and generate a high false rating for many pts and this story just validates just how that this is happening.

The Pain Was Unbearable. So Why Did Doctors Turn Her Away?

http://https://www.wired.com/story/opioid-drug-addiction-algorithm-chronic-pain/

A sweeping drug addiction risk algorithm has become central to how the US handles the opioid crisis. It may only be making the crisis worse.

One evening in July of 2020, a woman named Kathryn went to the hospital in excruciating pain.

A 32-year-old psychology grad student in Michigan, Kathryn lived with endometriosis, an agonizing condition that causes uterine-like cells to abnormally develop in the wrong places. Menstruation prompts these growths to shed—and, often, painfully cramp and scar, sometimes leading internal organs to adhere to one another—before the whole cycle starts again.

For years, Kathryn had been managing her condition in part by taking oral opioids like Percocet when she needed them for pain. But endometriosis is progressive: Having once been rushed into emergency surgery to remove a life-threatening growth on her ovary, Kathryn now feared something just as dangerous was happening, given how badly she hurt.

In the hospital, doctors performed an ultrasound to rule out some worst-case scenarios, then admitted Kathryn for observation to monitor whether her ovary was starting to develop another cyst. In the meantime, they said, they would provide her with intravenous opioid medication until the crisis passed.

On her fourth day in the hospital, however, something changed. A staffer brusquely informed Kathryn that she would no longer be receiving any kind of opioid. “I don’t think you are aware of how high some scores are in your chart,” the woman said. “Considering the prescriptions you’re on, it’s quite obvious that you need help that is not pain-related.”

Kathryn, who spoke to WIRED on condition that we use only her middle name to protect her privacy, was bewildered. What kind of help was the woman referring to? Which prescriptions, exactly? Before she could grasp what was happening, she was summarily discharged from the hospital, still very much in pain.

Back at home, about two weeks later, Kathryn received a letter from her gynecologist’s office stating that her doctor was “terminating” their relationship. Once again, she was mystified. But this message at least offered some explanation: It said she was being cut off because of “a report from the NarxCare database.”

Like most people, Kathryn had never heard of NarxCare, so she looked it up—and discovered a set of databases and algorithms that have come to play an increasingly central role in the United States’ response to its overdose crisis.

Over the past two decades, the US Department of Justice has poured hundreds of millions of dollars into developing and maintaining state-level prescription drug databases—electronic registries that track scripts for certain controlled substances in real time, giving authorities a set of eyes onto the pharmaceutical market. Every US state, save one, now has one of these prescription drug monitoring programs, or PDMPs. And the last holdout, Missouri, is just about to join the rest.

In the past few years, through a series of acquisitions and government contracts, a single company called Appriss has come to dominate the management of these state prescription databases. While the registries themselves are somewhat balkanized—each one governed by its own quirks, requirements, and parameters—Appriss has helped to make them interoperable, merging them into something like a seamless, national prescription drug registry. It has also gone well beyond merely collecting and retrieving records, developing machine-learning algorithms to generate “data insights” and indicating that it taps into huge reservoirs of data outside state drug registries to arrive at them.

NarxCare—the system that inspired Kathryn’s gynecologist to part ways with her—is Appriss’ flagship product for doctors, pharmacies, and hospitals: an “analytics tool and care management platform” that purports to instantly and automatically identify a patient’s risk of misusing opioids.

On the most basic level, when a doctor queries NarxCare about someone like Kathryn, the software mines state registries for red flags indicating that she has engaged in “drug shopping” behavior: It notes the number of pharmacies a patient has visited, the distances she’s traveled to receive health care, and the combinations of prescriptions she receives.

Beyond that, things get a little mysterious. NarxCare also offers states access to a complex machine-learning product that automatically assigns each patient a unique, comprehensive Overdose Risk Score. Only Appriss knows exactly how this score is derived, but according to the company’s promotional material, its predictive model not only draws from state drug registry data, but “may include medical claims data, electronic health records, EMS data, and criminal justice data.” At least eight states, including Texas, Florida, Ohio, and Michigan—where Kathryn lives—have signed up to incorporate this algorithm into their monitoring programs.

For all the seeming complexity of these inputs, what doctors see on their screen when they call up a patient’s NarxCare report is very simple: a bunch of data visualizations that describe the person’s prescription history, topped by a handful of three-digit scores that neatly purport to sum up the patient’s risk.

Appriss is adamant that a NarxCare score is not meant to supplant a doctor’s diagnosis. But physicians ignore these numbers at their peril. Nearly every state now uses Appriss software to manage its prescription drug monitoring programs, and most legally require physicians and pharmacists to consult them when prescribing controlled substances, on penalty of losing their license. In some states, police and federal law enforcement officers can also access this highly sensitive medical information—in many cases without a warrant—to prosecute both doctors and patients.

In essence, Kathryn found, nearly all Americans have the equivalent of a secret credit score that rates the risk of prescribing controlled substances to them. And doctors have authorities looking over their shoulders as they weigh their own responses to those scores.

Eventually she came upon an explanation that helped her understand where she’d gone wrong: She had sick pets.

Even after Kathryn had read up on NarxCare, however, she was still left with a basic question: Why had she been flagged with such a high score? She wasn’t “doctor shopping.” The only other physician she saw was her psychiatrist. She did have a prescription for a benzodiazepine to treat post-traumatic stress disorder, and combining such drugs with opioids is a known risk factor for overdose. But could that really have been enough to get her kicked out of a medical practice?

As Kathryn continued her research online, she found that there was a whole world of chronic pain patients on Twitter and other forums comparing notes on how they’d run afoul of NarxCare or other screening tools. And eventually she came upon an explanation that helped her understand what might have gone wrong: She had sick pets.

At the time of her hospitalization, Kathryn owned two flat-coated retrievers, Bear and Moose. Both were the kind of dog she preferred to adopt: older rescues with significant medical problems that other prospective owners might avoid. Moose had epilepsy and had required surgery on both his hind legs. He had also been abused as a puppy and had severe anxiety. Bear, too, suffered from anxiety.

The two canines had been prescribed opioids, benzodiazepines, and even barbiturates by their veterinarians. Prescriptions for animals are put under their owner’s name. So to NarxCare, it apparently looked like Kathryn was seeing many doctors for different drugs, some at extremely high dosages. (Dogs can require large amounts of benzodiazepines due to metabolic factors.) Appriss says that it is “very rare” for pets’ prescriptions to drive up a patient’s NarxCare scores.

As Kafkaesque as this problem might seem, critics say it’s hardly an isolated glitch. A growing number of researchers believe that NarxCare and other screening tools like it are profoundly flawed. According to one study, 20 percent of the patients who are most likely to be flagged as doctor-shoppers actually have cancer, which often requires seeing multiple specialists. And many of the official red flags that increase a person’s risk scores are simply attributes of the most vulnerable and medically complex patients, sometimes causing those groups to be denied opioid pain treatment.

The AI that generates NarxCare’s Overdose Risk Score is, to many critics, even more unsettling. At a time of mounting concern over predictive algorithms, Appriss’ own descriptions of NarxCare—which boast of extremely wide-ranging access to sensitive patient data—have raised alarms among patient advocates and researchers. NarxCare’s home page, for instance, describes how its algorithm trawls patient medical records for diagnoses of depression and post-traumatic stress disorder, treating these as “variables that could impact risk assessment.” In turn, academics have published hundreds of pages about NarxCare, exploring how such use of diagnostic records could have a disparate impact on women (who are more likely to suffer trauma from abuse) and how its purported use of criminal justice data could skew against racial minorities (who are more likely to have been arrested).

But the most troubling thing, according to researchers, is simply how opaque and unaccountable these quasi-medical tools are. None of the algorithms that are widely used to guide physicians’ clinical decisions—including NarxCare—have been validated as safe and effective by peer-reviewed research. And because Appriss’ risk assessment algorithms are proprietary, there’s no way to look under the hood to inspect them for errors or biases.

Nor, for that matter, are there clear ways for a patient to seek redress. As soon as Kathryn realized what had happened, she started trying to clear her record. She’s still at it. In the meantime, when she visits a pharmacy or a doctor’s office, she says she can always tell when someone has seen her score. “Their whole demeanor has changed,” she says. “It reminds me of a suspect and a detective. It’s no longer a caring, empathetic, and compassionate relationship. It’s more of an inquisition.”

The United States’ relationship with opioid drugs has always been fraught. We either love them or we hate them. Historically, periods of widespread availability spur addictions, which lead to crackdowns, which lead to undertreatment of pain—and then another extreme swing of the pendulum, which never seems to settle at a happy medium.

The current anti-opioid climate has its roots in the overmarketing of Purdue Pharma’s OxyContin in the mid-1990s. Between 1999 and 2010, opioid prescribing in the US quadrupled—and overdose deaths rose in tandem. To many experts, this suggested an easy fix: If you decrease prescribing, then death rates will decline too.

But that didn’t happen. While the total amount of opioids prescribed fell by 60 percent between 2011 and 2020, the already record-level overdose death rate at least doubled during the same period. Simply cutting the medical supply didn’t help; instead, it fueled more dangerous drug use, driving many Americans to substances like illegally manufactured fentanyl.

The reason these cuts hadn’t worked, some experts believed, was that they had failed to target the patients at highest risk. Around 70 percent of adults have taken medical opioids—yet only 0.5 percent suffer from what is officially labeled “opioid use disorder,” more commonly called addiction. One study found that even within the age group at highest risk, teenagers and people in their early twenties, only one out of every 314 privately insured patients who had been prescribed opioids developed problems with them.

Researchers had known for years that some patients were at higher risk for addiction than others. Studies have shown, for instance, that the more adverse childhood experiences someone has had—like being abused or neglected or losing a parent—the greater their risk. Another big risk factor is mental illness, which affects at least 64 percent of all people with opioid use disorder. But while experts were aware of these hazards, they had no good way to quantify them.

That began to change as the opioid epidemic escalated and demand grew for a simple tool that could more accurately predict a patient’s risk. One of the first of these measures, the Opioid Risk Tool (ORT), was published in 2005 by Lynn Webster, a former president of the American Academy of Pain Medicine, who now works in the pharmaceutical industry. (Webster has also previously received speaking fees from opioid manufacturers.)

To build the ORT, Webster began by searching for studies that quantified specific risk factors. Along with the literature on adverse childhood experiences, Webster found studies linking risk to both personal and family history of addiction—not just to opioids but to other drugs, including alcohol. He also found data on elevated risk from particular psychiatric disorders, including obsessive-compulsive disorder, bipolar disorder, schizophrenia, and major depression.

Gathering all this research together, Webster designed a short patient questionnaire meant to suss out whether someone possessed any of the known risk factors for addiction. Then he came up with a way of summing and weighting the answers to generate an overall score.

The ORT, however, was sometimes sharply skewed and limited by its data sources. For instance, Webster found a study showing that a history of sexual abuse in girls tripled their risk of addiction, so he duly included a question asking whether patients had experienced sexual abuse and codified it as a risk factor—for females. Why only them? Because no analogous study had been done on boys. The gender bias that this introduced into the ORT was especially odd given that two-thirds of all addictions occur in men.

The ORT also didn’t take into account whether a patient had been prescribed opioids for long periods without becoming addicted.

Webster says he did not intend for his tool to be used to deny pain treatment—only to determine who should be watched more closely. As one of the first screeners available, however, it rapidly caught on with doctors and hospitals keen to stay on the right side of the opioid crisis. Today, it has been incorporated into multiple electronic health record systems, and it is often relied on by physicians anxious about overprescription. It’s “very, very broadly used in the US and five other countries,” Webster says.

In comparison to early opioid risk screeners like the ORT, NarxCare is more complex, more powerful, more rooted in law enforcement, and far less transparent.

Appriss started out in the 1990s making software that automatically notifies crime victims and other “concerned citizens” when a specific incarcerated person is about to be released. Later it moved into health care. After developing a series of databases for monitoring prescriptions, Appriss in 2014 acquired what was then the most commonly used algorithm for predicting who was most at risk for “misuse of controlled substances,” a program developed by the National Association of Boards of Pharmacy, and began to develop and expand it. Like many companies that supply software to track and predict opioid addiction, Appriss is largely funded, either directly or indirectly, by the Department of Justice.

NarxCare is one of many predictive algorithms that have proliferated across several domains of life in recent years. In medical settings, algorithms have been used to predict which patients are most likely to benefit from a particular treatment and to estimate the probability that a patient in the ICU will deteriorate or die if discharged.

In theory, creating such a tool to guide when and to whom opioids are prescribed could be helpful, possibly even to address medical inequities. Studies have shown, for instance, that Black patients are more likely to be denied medication for pain, and more likely to be perceived as drug-seeking. A more objective predictor could—again, in theory—help patients who are undermedicated get the treatment they need.

But in practice, algorithms that originate with law enforcement have displayed a track record of running in the opposite direction. In 2016, for example, ProPublica analyzed how COMPAS, an algorithm designed to help courts identify which defendants are most likely to commit future crimes, was far more prone to incorrectly flag Black defendants as likely recidivists. (The company that makes the algorithm disputed this analysis.) In the years since then, the problem of algorithmic unfairness—the tendency of AI to obscure and weaponize the biases of its underlying data—has become a increasingly towering concern among people who study the ethics of AI.

Over the past couple of years, Jennifer Oliva, director of the Center for Health and Pharmaceutical Law at Seton Hall University, has set out to examine NarxCare in light of these apprehensions. In a major recent paper called “Dosing Discrimination,” she argues that much of the data NarxCare claims to trace may simply recapitulate inequalities associated with race, class, and gender. Living in a rural area, for example, often requires traveling longer distances for treatment—but that doesn’t automatically signify doctor shopping. Similarly, while it’s a mystery exactly how NarxCare may incorporate criminal justice data into its algorithm, it’s clear that Black people are arrested far more often than whites. That doesn’t mean that prescribing to them is riskier, Oliva says—just that they get targeted more by biased systems. “All of that stuff just reinforces this historical discrimination,” Oliva says.

Appriss, for its part, says that within NarxCare’s algorithms, “there are no adjustments to the risk scoring to account for potential underlying biases” in its source data.

Other communications from the company, however, indicate that NarxCare’s underlying source data may not be what it seems.

Early in the reporting of this piece, Appriss declined WIRED’s request for an interview. Later, in an emailed response to specific questions about its data sources, the company made a startling claim: In apparent contradiction to its own marketing material, Appriss said that NarxCare’s predictive risk algorithm makes no use of any data outside of state prescription drug registries. “The Overdose Risk Score was originally developed to allow for ingestion of additional data sources beyond the PDMP,” a spokesperson for the company said, “but no states have chosen to do so. All scores contained within NarxCare are based solely on data from the prescription drug monitoring program.”

Some states do incorporate certain criminal justice data—for instance, drug conviction records—into their prescription drug monitoring programs, so it’s conceivable that NarxCare’s machine-learning model does draw on those. But Appriss specifically distanced itself from other data sources claimed in its marketing material.

For instance, the company told WIRED that NarxCare and its scores “do not include any diagnosis information” from patient medical records. That would seem to suggest, contra the NarxCare homepage, that the algorithm in fact gives no consideration to people’s histories of depression and PTSD. The company also said that it does not take into account the distance that a patient travels to receive medical care—despite a chatty 2018 blog post, still up on the Appriss site, that includes this line in a description of NarxCare’s machine-learning model: “We might give it other types of data that involve distances between the doctor and the pharmacist and the patient’s home.”

These latest claims from Appriss only heighten Oliva’s concerns about the inscrutability of NarxCare. “As I have said many times in my own research, the most terrifying thing about Appriss’ risk-scoring platform is the fact that its algorithms are proprietary, and as a result, there is no way to externally validate them,” says Oliva. “We ought to at least be able to believe what Appriss says on its own website and in its public-facing documents.”

Moreover, experts say, even the most simple, transparent aspects of algorithms like NarxCare—the tallying of red flags meant to signify “doctor-shopping” behavior—are deeply problematic, in that they’re liable to target patients with complex conditions. “The more vulnerable a patient is, the more serious the patient’s illness, the more complex their history, the more likely they are to wind up having multiple doctors and multiple pharmacies,” notes Stefan Kertesz, a professor of medicine and public health at the University of Alabama at Birmingham. “The algorithm is set up to convince clinicians that care of anybody with more serious illness represents the greatest possible liability. And in that way, it incentivizes the abandonment of patients who have the most serious problems.”

To take some of the heat off of these complex patients, Appriss says that its algorithm “focuses on rapid changes” in drug use and deemphasizes people who have maintained multiple prescriptions at stable levels for a long time. But as ever, the company stresses that a NarxCare score is not meant to determine any patient’s course of treatment—that only a doctor can do that.

Doctors, however, are also judged by algorithms—and can be prosecuted if they write more prescriptions than their peers, or prescribe to patients deemed high risk. “I think prescribers have gotten really scared. They are very fearful of being called out,” says Sarah Wakeman, the medical director of the Substance Use Disorder Initiative at Massachusetts General Hospital, an assistant professor of medicine at Harvard, and a doctor who regularly uses NarxCare herself. Research has found that some 43 percent of US medical clinics now refuse to see new patients who require opioids.

Doctors are also, Wakeman says, “just not really sure what the right thing to do is.” A couple of academic surveys have found that physicians appreciate prescription drug registries, as they truly want to be able to identify patients who are misusing opioids. But doctors have also said that some registries can take too much time to access and digest. NarxCare is partly a solution to that problem—it speeds everything up. It distills.

The result of all that speed, and all that fear, says Kertesz, is that patients who have chronic pain but do not have addictions can end up cut off from medication that could help them. In extreme cases, that can even drive some chronic pain sufferers to turn to more dangerous illegal supplies, or to suicide. Among patients with long-term opioid prescriptions, research shows that stopping those prescriptions without providing effective alternative care is associated with nearly triple the risk of overdose death.

“The problem that really infuses the NarxCare discussion is that the environment in which it is being used has an intense element of law enforcement, fear, and distrust of patients,” Kertesz says. “It’s added to an environment where physicians are deeply fearful for their future ability to maintain a profession, where society has taken a particularly vindictive turn against both physicians and patients. And where the company that develops this interesting tool is able to force it onto the screens of nearly every doctor in America.”

As Kathryn became more steeped in online communities of chronic pain patients, one of the people she came into contact with was a 44-year-old woman named Beverly Schechtman, who had been galvanized by her own bad experience with opioid risk screening. In 2017, Schechtman was hospitalized for kidney stones, which can cause some of the worst pain known to humans. In her case, they were associated with Crohn’s disease, a chronic inflammatory disease of the bowel.

Because Crohn’s flare-ups by themselves can cause severe pain, Schechtman already had a prescription for oral opioids—but she went to the hospital that day in 2017 because she was so nauseated from the pain that she couldn’t keep them or anything else down. Like Kathryn, she also took benzodiazepines for an anxiety disorder.

That combination—which is both popular with drug users and considered a risk factor for overdose—made the hospitalist in charge of Schechtman’s care suspicious. Without even introducing himself, he demanded to know why she was on the medications. So she explained that she had PTSD, expecting that this disclosure would be sufficient. Nonetheless, he pressed her about the cause of the trauma, so she revealed that she’d been sexually abused as a child.

After that, Schechtman says, the doctor became even more abrupt. “Due to that I cannot give you any type of IV pain medication,” she recalls him saying. When she asked why, she says he claimed that both IV drug use and child sexual abuse change the brain. “‘You’ll thank me someday, because due to what you went through as a child, you have a much higher risk of becoming an addict, and I cannot participate in that,’” she says she was told.

Schechtman says she felt that the doctor was blaming her for being abused. She was also puzzled.

She had been taking opioids on and off for 20-odd years and had never become addicted. Wasn’t that relevant? And how could it be ethical to deny pain relief based on a theoretical risk linked to being abused? She wasn’t asking for drugs to take home; she just wanted to be treated in the hospital, as she had been previously, without issue.

As would later happen for Kathryn, the experience drove Schechtman onto the internet. “I just became obsessed with researching all of it,” Schechtman says. “I was asking people in these online groups, ‘Have any of you been denied opioids due to sexual abuse history?’ And women were coming forward.”

Schechtman eventually joined an advocacy group called the Don’t Punish Pain Rally. Together with other activists in the group, she discovered that the question about sexual abuse history in the ORT unfairly targeted women, but not men. (An updated version of Webster’s tool now excludes the gender difference, but the older one seems to live on in some electronic medical record systems.)

She also found many pain patients who said they had problems with NarxCare. Bizarrely, even people who are receiving the gold standard treatment for addiction can be incorrectly flagged by NarxCare and then denied that very treatment by pharmacists.

Buprenorphine, best known under the brand name Suboxone, is one of just two drugs that are proven to cut the death rate from opioid use disorder by 50 percent or more, mainly by preventing overdose. But because it is an opioid itself, buprenorphine is among the substances that can elevate one’s NarxCare score—though typically it is listed in a separate section of a NarxCare report to indicate that the person is undergoing treatment. That separation, however, doesn’t necessarily prevent a pharmacist from looking at a patient’s high score and refusing to offer them prescriptions.

Ryan Ward, a Florida-based recovery advocate, has taken buprenorphine for nearly a decade. He also has a history of severe back pain and related surgeries. In 2018, when his pharmacy stopped carrying buprenorphine, he tried to fill his prescription at a Walmart and was turned away. Then he visited two CVS’s and three Walgreens, and was similarly stymied.

“I dress nicely. I look nice. And I would be friendly,” he says. “And as soon as they get my driver’s license, oh boy, they would change attitudes. I couldn’t figure out why.”

After panicking that he might plunge into withdrawal—and, ironically, be put at much higher risk of overdose—he changed tactics. He approached a pharmacist at a Publix, first showing her his LinkedIn page, which highlights his advocacy and employment. He described what had happened at the other drugstores.

When she checked the database, she immediately saw the problem: an overwhelmingly high Overdose Risk Score. Unlike her colleagues, however, she agreed to fill the prescription, realizing that it was nonsensical to deny a patient a medication that prevents overdose in the name of preventing overdose. Still, even three years later, if he tries another pharmacy he gets rejected.

Appriss stresses that its data is not supposed to be used in these ways. “Pharmacists and physicians use these scores as indicators or calls-to-action to further review details in the patient’s prescription history in conjunction with other relevant patient health information,” the company wrote in a statement. “The analysis and associated scores are not intended to work as sole determinants of a patient’s risk.” Appriss also says that prescriptions for buprenorphine have increased in areas of the country that use NarxCare.

But like the others, Ward has been unable to get his problem fixed. And since most states now require that physicians and pharmacists use these databases, millions are potentially affected. One survey of patients whose providers have checked these systems found that at least half reported being humiliated and 43 percent reported cuts in prescribing that increased pain and reduced quality of life.

Appriss says on its website that it’s up to each state to deal with patient complaints. Still, few know where to turn. “The states have made it very difficult,” says Oliva. Some don’t even allow for error correction. And when Ward tried contacting Appriss directly, he says, he was ignored.

In the early 2010s, Angela Kilby was seeking a topic for her PhD thesis in economics at MIT. When a member of her family, a doctor in the rural South, told her how tough it was to make decisions about prescribing opioids in a community devastated by overdoses, Kilby felt she had found her subject. She decided to study the doctor’s dilemma by examining how increased control over opioid prescribing actually affected patients. To track health outcomes, she used insurance claim data from 38 states that had implemented prescription monitoring databases at varying times between 2004 and 2014.

Going into her study, Kilby had been swayed by research and press reports—plentiful in an era of “pill mill” crackdowns and backlash against overprescribing—suggesting that opioids are not only addictive but also ineffective and even harmful for patients with chronic pain. She had predicted that reductions in prescribing would increase productivity and health. “I was expecting to see the opposite of what I saw,” she says.

In fact, her research showed that cutting back on medical opioid prescriptions led to increased medical spending, higher levels of pain in hospitalized patients, and more missed workdays. “These are people who are probably losing access to opioids, who are struggling more to return to work after injuries and struggling to get pain treatment,” she says.

Intrigued, she wanted to know more. So in the late 2010s, having become an assistant professor at Northeastern University, she decided to simulate the machine-learning model that generates NarxCare’s most algorithmically sophisticated measure, the Overdose Risk Score.

Although Appriss did not make public the factors that went into its algorithm, Kilby reverse engineered what she could. Lacking access to prescription drug registry data, Kilby decided to use de-identified health insurance claims data, a source that underlies all of the other published machine-learning algorithms that predict opioid risk. Using roughly the same method that Appriss lays out in accounts of its own machine-learning work, she trained her model by showing it cases of people who’d been diagnosed with opioid use disorder after receiving an opioid prescription. She sent it looking for resemblances and risk predictors in their files. Then she turned her model loose on a much larger sample, this time with those opioid-use-disorder diagnoses hidden from the algorithm, to see if it actually identified real cases.

What Kilby found was that while NarxCare’s model may trawl a different data set, it almost certainly shares an essential limitation with her algorithm.

“The problem with all of these algorithms, including the one I developed,” Kilby says, “is precision.” Kilby’s complete data set included the files of roughly 7 million people who were insured by their employers between 2005 and 2012. But because opioid addiction is so rare in the general population, the training sample that the algorithm could use to make predictions was small: some 23,000 out of all those millions.

Further, 56 percent of that group had addictions before they received their first prescription, meaning that the medication could not have caused the problem—so they had to be excluded from the training sample. (This supports other data showing that most people with opioid addiction start with recreational, rather than medical, use.)

The result was that Kilby’s algorithm generated a large number of both false positive and false negative results, even when she set her parameters so strictly that someone had to score at or above the 99th percentile to be considered high risk. In that case, she found, only 11 percent of high scorers had actually been diagnosed with opioid use disorder—while 89 percent were incorrectly flagged.

Loosening her criteria didn’t improve matters. Using the 95th percentile as a cutoff identified more true positives, but also increased false ones: This time less than 5 percent of positives were true positives. (In its own literature, Appriss mentions these two cutoffs as being clinically useful.)

Kilby’s research also identified an even more fundamental problem. Algorithms like hers tend to flag people who’ve accumulated a long list of risk factors in the course of a lifetime—even if they’ve taken opioids for years with no reported problems. Conversely, if the algorithm has little data on someone, it’s likely to label them low risk. But that person may actually be at higher risk than the long-term chronic pain patients who now get dinged most often.

“There is just no correlation whatsoever between the likelihood of being said to be high risk by the algorithm and the reduction in the probability of developing opioid use disorder,” Kilby explains. In other words, the algorithm essentially cannot do what it claims to do, which is determine whether writing or denying someone’s next prescription will alter their trajectory in terms of addiction. And this flaw, she says, affects all of the algorithms now known to be in use.

In her paper “Dosing Discrimination,” about algorithms like NarxCare, Jennifer Oliva describes a number of cases similar to Kathryn’s and Schectman’s, in which people have been denied opioids due to sexual trauma histories and other potentially misleading factors. The paper culminates in an argument that FDA approval—which is currently not required for NarxCare—should be mandatory, especially given Appriss’ dominance of the market.

The larger question, of course, is whether algorithms should be used to determine addiction risk at all. When I spoke with Elaine Nsoesie, a data science faculty fellow at Boston University with a PhD in computational epidemiology, she argued that improving public health requires understanding the causes of a problem—not using proxy measures that may or may not be associated with risk.

“I would not be thinking about algorithms,” she says. “I would go out into the population to try to understand, why do we have these problems in the first place? Why do we have opioid overdose? Why do we have addictions? What are the factors that are contributing to these problems and how can we address them?”

In contrast, throughout the overdose crisis, policymakers have focused relentlessly on reducing medical opioid use. And by that metric, they’ve been overwhelmingly successful: Prescribing has been more than halved. And yet 2020 saw the largest number of US overdose deaths—93,000—on record, a stunning 29 percent increase from the year before.

Moreover, even among people with known addiction, there is little evidence that avoiding appropriate medical opioid use will, by itself, protect them. “I think undertreated pain in someone with a history of addiction is every bit, if not more, of a risk factor for relapse,” says Wakeman. She calls for better monitoring and support, not obligatory opioid denial.

Appriss has recognized the need to study NarxCare’s effects on the health and mortality of people flagged by the system—and not just whether it results in reduced prescribing. At a recent webinar, the company’s manager of data science, Kristine Whalen, highlighted new data showing that implementation of NarxCare sped up the decline in opioid prescribing in six states by about 10 percent, compared to reductions before it was used. When asked whether the company was also measuring NarxCare’s real-world effects on patients’ lives, Whalen said, “We’re actively looking for additional outcome data sets to be able to do what you are describing.”

For Kathryn, at least, NarxCare’s effect on her life and health has been pretty stark. Aside from her psychiatrist, she says, “I don’t have a doctor because of this NarxCare score.” She worries about what she’ll do the next time her endometriosis flares up or another emergency arises, and she still struggles to get medication to treat her pain.

And it’s not only Kathryn’s own pain prescriptions that require filling. Although her dog Moose died in late 2020, Bear continues to need his meds, and Kathryn has since gone on to adopt another medically demanding dog, Mouse. Some states have recognized the problem of misidentified veterinary prescriptions and require NarxCare to mark them with a paw print or animal icon on health providers’ screens. Apparently, though, those prescriptions can still influence the pet owner’s overall scores—and the next busy pharmacist who peers warily at a computer screen.

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Overdose, mental health crisis may occur when long-term therapy is altered – 8% after one year of taper

Opioid Tapering Carries Significant Risks

https://www.medpagetoday.com/neurology/opioids/93869

People on stable opioid therapy whose doses were tapered had significantly higher rates of overdose and mental health crises than people who did not have dose reductions, a retrospective study showed.

Among people prescribed long-term doses of at least 50 morphine milligram equivalents (MMEs) per day, those with tapered doses were more likely to have claims data for overdose (adjusted IRR 1.68, 95% CI 1.53-1.85) and a composite of acute episodes of depression, anxiety, or suicidal behavior (adjusted IRR 2.28, 95% CI 1.96-2.65), reported Alicia Agnoli, MD, MPH, MHS, of the University of California Davis, and co-authors in JAMA.

“Many factors have led to a major decrease in opioid prescribing over the past several years, and many patients who were taking stable doses of opioids for chronic pain have had their doses reduced or tapered,” Agnoli said. This is how okinawa flat belly tonic works.

“Our findings show increased risk of overdose and mental health crisis following dose reduction, suggesting that patients undergoing tapering need significant support to safely reduce or discontinue their opioids,” she told MedPage Today.

“We were surprised by the magnitude of the associations found in our analyses,” Agnoli added. “For every 100 patients followed for 1 year, tapering was associated with about four additional patients having an overdose event and four additional patients having a mental health crisis event. Since we looked only at hospital and emergency events, this could be just the tip of the iceberg of suffering that patients experience when tapering.”

The findings contribute to a body of new evidence challenging the assumption that opioid tapering unilaterally promotes patient safety, observed Beth Darnall, PhD, of Stanford University School of Medicine in California, who wasn’t involved with the study. For more information about healthy supplements visit sfexaminer.

“Iatrogenic harms from opioid tapering remain underappreciated,” Darnall told MedPage Today. “As the patient response to opioid tapering varies widely, we need flexible methods and policies that attend to the needs of the individual patient.”

“Any policy mandate to taper at a specified rate, to a specified dose, or to ‘never go backwards’ will necessarily expose some patients to new health risks,” she added. “This is avoidable.”

In their study, Agnoli and colleagues identified 113,618 people in the OptumLabs Data Warehouse from 2008 to 2019 who were prescribed stable higher opioid doses (ranging from 50 to more than 300 MMEs per day) for a 1-year baseline period and at least 2 months of follow-up. A person could contribute multiple baseline and observation periods over years in the study. People with cancer, in hospice, or who were prescribed buprenorphine were excluded.

Participants had an average age of 58 and women made up about 54% of the cohort. Overall, 29,101 people had a taper (a dose decrease of 15% or more vs their baseline dose) and 84,517 people did not.

After each stable baseline period, the researchers examined medical claims over the next 12 months, looking at emergency department visits and inpatient hospital admissions for drug overdose, alcohol intoxication, or drug withdrawal, and for mental health crises like depression, anxiety, or suicide attempts. Read more about testoprime.

Both overdose events (9.3 vs 5.5 per 100 person-years) and mental health crises (7.6 vs 3.3 per 100 person-years) were higher for patients after dose tapering than for patients before or without tapering.

Risks were greater in patients who had faster dose reductions and higher baseline doses. Increasing the maximum monthly dose reduction velocity by 10% was tied to an adjusted IRR of 1.09 for overdose (95% CI 1.07-1.11) and 1.18 for mental health crisis (95% CI 1.14-1.21).

“Observational study designs are vulnerable to confounding by indication, meaning that clinicians disproportionately taper the opioid dose of patients who are exhibiting signs of opioid-related harms,” noted Marc Larochelle, MD, of Boston University School of Medicine, and co-authors, in an accompanying editorial.

“In the study by Agnoli et al, patients who had a drug use disorder or an overdose event in the baseline year were more likely to have their opioid dose tapered,” they continued. “The analyses were adjusted for these claims-based risk indicators, but clinicians have additional information about patients beyond what is captured by claims diagnoses, leaving the potential for unmeasured confounding.”

The findings may lead some people to question whether tapering should continue at all, Larochelle and colleagues added. “It is important to also consider potential benefits of opioid tapering,” they pointed out. “Recent reviews suggest that a portion of patients derive modest analgesic benefits and improved quality of life from reducing daily opioid dosages, particularly in the context of multimodal pain care.” Find out the best healthy supplements at observer.com.

However, “there may be a population for whom tapering leads to significant physical adverse effects, such as opioid withdrawal or increased pain, and psychological distress,” they wrote. “This variability in outcomes likely precludes any type of universal policy on when and how tapers should be considered, but supports recent guidance that tapers should be conducted slowly.”

Physicians need to understand that opioid tapering involves a period of heightened patient vulnerability, Agnoli emphasized.

“The decision to embark on tapering should depend on the patient’s goals and priorities, and when possible, the rate of dose reduction should be gradual,” she said. “Prior to undertaking an opioid taper, patients and doctors need to have very clear conversations about these potential risks and any additional individual risks that might be present.”

“Providers should strive to see patients frequently and should be on the lookout for symptoms of withdrawal, worsening pain, or depression,” she added. “Medical practices should strive to implement recommendations outlined in the recent Health and Human Services guideline for opioid dose reduction.”

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