Conspiracy Theory… or… VIDEO WORTH A MILLION WORDS ?

Pharma Company Funding Anti-Pot Fight Worried About Losing Business, Filings Show

monolopyPharma Company Funding Anti-Pot Fight Worried About Losing Business, Filings Show

https://theintercept.com/2016/09/12/pharma-opioid-marijuana/

Pharmaceutical executives who recently made a major donation to an anti-marijuana legalization campaign claimed they were doing so out of concern for the safety of children — but their investor filings reveal that pot poses a direct threat to their plans to cash in on a synthetic cannabis product they have developed.

On August 31, Insys Therapeutics Inc. donated $500,000 to Arizonans for Responsible Drug Policy, becoming the single largest donor to the group leading the charge to defeat a ballot measure in Arizona to legalize marijuana.

The drug company, which currently markets a fast-acting version of the deadly painkiller fentanyl, assured local news reporters that they had the public interest in mind when making the hefty donation. A spokesperson told the Arizona Republic that Insys opposes the legalization measure, Prop. 205, “because it fails to protect the safety of Arizona’s citizens, and particularly its children.”

A Washington Post story on Friday noted the potential self-interest involved in Insys’s donation.

Investor filings examined by The Intercept confirm the obvious.

Insys is currently developing a product called the Dronabinol Oral Solution, a drug that uses a synthetic version of tetrahydrocannabinol (THC) to alleviate chemotherapy-caused nausea and vomiting. In an early filing related to the dronabinol drug, assessing market concerns and competition, Insys filed a disclosure statement with the Securities and Exchange Commission stating plainly that legal marijuana is a direct threat to their product line:

Legalization of marijuana or non-synthetic cannabinoids in the United States could significantly limit the commercial success of any dronabinol product candidate. … If marijuana or non-synthetic cannabinoids were legalized in the United States, the market for dronabinol product sales would likely be significantly reduced and our ability to generate revenue and our business prospects would be materially adversely affected.

Insys explains in the filing that dronabinol is “one of a limited number of FDA-approved synthetic cannabinoids in the United States” and “therefore in the United States, dronabinol products do not have to compete with natural cannabis or non-synthetic cannabinoids.”

The company concedes that scientific literature has argued the benefits of marijuana over synthetic dronabinol, and that support for marijuana legalization is growing. In the company’s latest 10-K filing with the SEC, in a section outlining competitive threats, Insys warns that several states “have already enacted laws legalizing medicinal and recreational marijuana.”

Subsys, the fentanyl spray Insys makes, is used as a fast-acting pain reliever. Fenatyl is an opioid that has made headlines in recent years as the number of Americans overdosing on the drug has skyrocketed. Fenatyl is 50 times stronger than heroin and has been linked to the death of Prince earlier this year. Last month, two Insys executives pled guilty to a pay-for-play scheme to use speakers fees as a way to get doctors to prescribe Subsys.

Marijuana advocates claim that legalized pot has a variety of medical uses, including pain relief.

It’s not the first time pharmaceutical companies have helped bankroll the opposition to marijuana reform. The Community Anti-Drug Coalition of America, a nonprofit that organizes anti-marijuana activism across the country, has long received corporate sponsorship from Purdue Pharma, the makers of Oxycontin, and Janssen Pharmaceuticals, another opioid manufacturer.

J.P. Holyoak, chairman of the Campaign to Regulate Marijuana Like Alcohol, a group supporting the legalization ballot measure, released a statement condemning the Insys donation. “Our opponents have made a conscious decision to associate with this company,” Holyoak said. “They are now funding their campaign with profits from the sale of opioids — and maybe even the improper sale of opioids.”a

White House Rally To Call Out DEA For Making Mockery Of Opioid Epidemic By Ban Push Targeting Coffee-Related, Natural Herbal Product

White House Rally To Call Out DEA For Making Mockery Of Opioid Epidemic By Ban Push Targeting Coffee-Related, Natural Herbal Product

http://www.prnewswire.com/news-releases/white-house-rally-to-call-out-dea-for-making-mockery-of-opioid-epidemic-by-ban-push-targeting-coffee-related-natural-herbal-product-300326277.html

Seeking a Distraction from Real Crisis, DEA Exploits Concerns About Opioid Epidemic in Bid to Shut Down Kratom; 110,000-Signature Petition to be Presented to White House

… September 13, 2016 News Advisory …


WASHINGTON, Sept. 12, 2016 /PRNewswire-USNewswire/ — Hundreds of Americans from across the U.S. will march outside the White House at 12:30 p.m. EDT Tuesday (September 13, 2016) to protest the unfounded and anti-scientific push by the Drug Enforcement Agency (DEA) to classify kratom, a natural herb in the coffee family, as a Class 1 narcotic.  Organizers of the March will hold a news conference in Lafayette Park near the White House to present the White House with a petition signed by more than 100,000 citizens opposing the DEA’s cynical attack on a legal product that is used without incident by hundreds of thousands of Americans.

What:
Under fire for failing to make headway in the opioid epidemic, the DEA is now seeking to distract the public and lawmakers by focusing unwarranted negative attention on kratom, or Mitragyna speciose, a tree in the coffee family native to Southeast Asia. Kratom leaves have been consumed in countries like Thailand and Malaysia for over 500 years. The herb is now available in the U.S. just like other herbal supplements. Kratom is not an opiate. Many studies have shown kratom to have positive medicinal benefits. Kratom is legal in 44 states. The Florida Department of Law Enforcement released a December 2015 report that found: “Kratom does not currently constitute a significant risk to the safety and welfare of Florida residents.” Nonetheless, on August 31, 2016, the DEA, under fire for its inability to remedy the US opioid crisis, announced its intention to place kratom into Schedule I of the Controlled Substances Act in order to avoid a supposed “imminent hazard to public safety,” which, in reality, does not exist. In truth, kratom has never been present alone in a single documented death and is as about as habit-forming as the coffee to which it is related. By contrast, pharmaceutical drugs are one of the leading causes of death in this country, killing one American every 19 minutes. Prescription opiate pain killers account for more than 475,000 emergency room visits annually.

Who:

  • Travis Lowin director, Botanical Education Alliance (previously the Botanical Legal Defense);
  • Susan Ash, director, American Kratom Association;
  • Andrew Turner, a veteran of Operation Iraqi Freedom who was injured in a subsequent military deployment, Hyattsville, MD;
  • Joe Volpe, a retired school teacher who used kratom to replace prescription pain killers, Philadelphia, PA; and
  • Additional speakers TBD.

When:
12:30 p.m. EDT march and 1 p.m. EDT news conference.

Where:
Starting in front of White House, 1600 Pennsylvania Avenue, and proceeding to adjacent Lafayette Park.

The Botanical Education Alliance (BEA) is an organization dedicated to educating consumers, lawmakers, law enforcement, and the media about safe and therapeutic natural supplements including Mitragyna speciosa, also known as Kratom. BEA’s mission is to increase understanding in order to influence public policy and protect natural supplements. The vision of the Alliance is to create a society where every adult has the right to access safe and effective natural supplements.  www.botanical-education.org/

The America Kratom Association (AKA), a consumer-based non-profit, is here to set the record straight, giving voice to the suffering and our rights to possess and consume kratom. AKA represents tens of thousands of Americans; each with a unique story to tell about the virtues of kratom and its positive effects on our lives. From Lyme Disease to Post Traumatic Stress Disorder and even addiction, kratom can help offer relief.  www.americankratom.org

Coercion to get DNA samples using civil forfeiture monies for funding

DNA Dragnet: In Some Cities, Police Go From Stop-and-Frisk to Stop-and-Spit

https://www.propublica.org/article/dna-dragnet-in-some-cities-police-go-from-stop-and-frisk-to-stop-and-spit

The five teenage boys were sitting in a parked car in a gated community in Melbourne, Florida, when a police officer pulled up behind them.

Officer Justin Valutsky closed one of the rear doors, which had been ajar, and told them to stay in the car. He peered into the drivers’ side window of the white Hyundai SUV and asked what the teens were doing there. It was a Saturday night in March 2015 and they told Valutsky they were visiting a friend for a sleepover.

 

Valutsky told them there had been a string of car break-ins recently in the area. Then, after questioning them some more, he made an unexpected demand: He asked which one of them wanted to give him a DNA sample.

After a long pause, Adam, a slight 15-year-old with curly hair and braces, said, “Okay, I guess I’ll do it.” Valutsky showed Adam how to rub a long cotton swab around the inside of his cheek, then gave him a consent form to sign and took his thumbprint. He sealed Adam’s swab in an envelope. Then he let the boys go.

Telling the story later, Adam would say of the officer’s request, “I thought it meant we had to.”

Over the last decade, collecting DNA from people who are not charged with — or even suspected of — any particular crime has become an increasingly routine practice for police in smaller cities not only in Florida, but in Connecticut, Pennsylvania and North Carolina as well.

While the largest cities typically operate public labs and feed DNA samples into the FBI’s national database, cities like Melbourne have assembled databases of their own, often in partnership with private labs that offer such fast, cheap testing that police can afford to amass DNA even to investigate minor crimes, from burglary to vandalism.

And to compile samples for comparison, some jurisdictions also have quietly begun asking people to turn over DNA voluntarily during traffic stops, or even during what amount to chance encounters with police. In Melbourne, riding a bike at night without two functioning lights can lead to DNA swab — even if the rider is a minor.

“In Florida law, basically, if we can ask consent, and if they give it, we can obtain it,” said Cmdr. Heath Sanders, the head of investigations at the Melbourne Police Department. “We’re not going to be walking down the street and asking a five-year-old to stick out his tongue. That’s just not reasonable. But’s let’s say a kid’s 15, 16 years old, we can ask for consent without the parents.”

In Bensalem Township, Pennsylvania, those stopped for DUI or on the street for acting suspiciously may be asked for DNA. Director of Public Safety Frederick Harran credits the burgeoning DNA database Bensalem now shares with Bucks County’s 38 other police departments with cutting burglaries in the township by 42 percent in the first four years of the program. Plus, Bensalem pays for the testing — which is conducted by a leading private lab, Bode Cellmark Forensics — with drug forfeiture money, making it essentially free, Harran added.

“This has probably been the greatest innovation in local law enforcement since the bulletproof vest,” Harran said. “It stops crime in its tracks…. So why everyone’s not doing it, I don’t know.”

While Harran tells his officers to be careful not to push people to consent, civil rights advocates see a minefield in cases that morph from stop-and-frisk to stop-and-spit.

There are clear precedents for obtaining DNA from people who have been convicted of crimes and from those under arrest. Under the Fourth Amendment, law enforcement must have a reasonable suspicion that a person is involved in a crime before requiring a search or seizure.

But the notion of collecting DNA consensually is still so new that the ground rules remain uncertain. Who can give such consent and what must they be told about what they’re consenting to? Who decides how long to keep these samples and what can be done with them? Maryland’s Supreme Court is the highest to rule on such a case, saying in 2015 that law enforcement could use DNA voluntarily provided to police investigating one crime to solve another, but that case didn’t take on DNA collected outside of an investigation, in chance street or traffic stops.

More challenges seem inevitable, said Jason Kreag, a University of Arizona law professor who’s written about local law enforcement’s expanding use of DNA. Police interviews that lead to DNA collection — particularly involving juveniles—have the potential to create “a coercive environment,” he said. “The laws and the legislatures just haven’t caught up with this type of policing yet.”

Harran echoed that. “There’s no laws, there’s nothing,” he said. “We’re in uncharted territory. There’s nothing governing what we’re doing.” He wants for private database programs to establish their own best practices.

Private DNA databases have multiplied as testing technology has become more sophisticated and sensitive, enabling labs to generate profiles from so-called “touch” or “trace” DNA consisting of as little as a few skin cells. Automated “Rapid DNA” machines allow police to analyze DNA right at the station in a mere 90 minutes. Some states allow “familial searching” of databases, which can identify people with samples from family members. New software can even create composite mugshots of suspects using DNA to guess at skin and eye color.

A demonstration of DNA swab kits from Palm Bay Police Department’s 2011 annual report. (Yvonne Martinez, public infromation coordinator)

Strict rules govern which DNA samples are added to the FBI’s national database, but they don’t apply to the police departments’ private databases, which are subject to no state or federal regulation or oversight. Adam’s DNA, for example, was headed for a database managed for Melbourne by Bode Cellmark Forensics, a LabCorp subsidiary, which has marketed its services to dozens of small cities and towns. The lower standards for DNA profiles included in private databases could lead to meaningless or coincidental matches, said Michael Garvey, who heads the Philadelphia Police Department’s office of forensic science, a public lab.

“No one knows what the rules are about what they’re going to upload into these private DNA databases or not,” Garvey said. “Mixtures, partials — what’s their criteria? It varies.”

When Adam’s father found out the police had taken his son’s DNA, he immediately contacted the Melbourne Police Department to ask what the department intended to do with the sample and on what legal basis it had been taken. As a doctor, he understood what had happened could have far-reaching implications.

“My concern, being in the medical field, is that it’s not just Adam’s DNA,” he said. (ProPublica is withholding his name to protect the privacy of his son.) “It’s my DNA, it’s my wife’s DNA, and our parents. Not to sound bad, but you just get nervous. There’s some collateral damage there.”

Sanders explained that Adam had given his consent, making the sample usable under department policy, though it had not yet been sent to the lab for testing. He said that as long as Adam didn’t get into trouble, the family had nothing to fear.

Unsatisfied and determined to get the sample destroyed, Adam’s dad took the only other step he could think of — he called a lawyer. It was attorney Jason Hicks’ first encounter with a stop-and-spit case. He quickly realized he and his clients were on the edge of a legal frontier.

“First, I was just shocked that it had happened,” he said. “Then I was frustrated by the lack of a vehicle to challenge it.”


Traditionally, certified local, state and federal forensic labs have tested DNA collected for law enforcement purposes, funneling these profiles into the FBI-run Combined DNA Index System, or CODIS.

The FBI’s standards for profiles uploaded to CODIS are rigorous. CODIS will only accept “partial” profiles under certain circumstances, and all samples must be tested by FBI-approved labs. The national database includes DNA from convicted offenders and arrestees in some states, but not from people merely suspected of crimes. State law dictates when databases linked to CODIS must toss out DNA profiles.

Private databases do not have any such constraints. FBI agent Ann Todd said that the DNA profiles stored in private databases would not be eligible for inclusion in the national database because “those profiles do not meet the strict eligibility, quality, and privacy standards set forth in the federal law.”

Smaller jurisdictions used to rely on larger ones for DNA testing, but many public labs have become backlogged as demand for their services has risen. In 2012, New York became the first state to require DNA collection from those convicted of any crime, not just violent ones, and at least 29 states now authorize collection from anyone arrested for certain crimes. Many states have also passed laws requiring DNA evidence from rape cases to be tested within a certain amount of time, increasing pressure on public labs.

Private operators have stepped in to meet the appetite for testing in cities and towns that can’t afford their own labs and have few violent crimes that would rise to the top of a public lab’s priority list. Bode Cellmark Forensics charges about $100 to $150 a swab — little enough for cops to swab everything from the steering wheel of a stolen car to the nozzle of a spray-paint can used for vandalism — and boasts a 30-day turnaround time for results.

Palm Bay, Florida, launched the nation’s first private DNA database program about a decade ago, working in partnership with DNA:SI, a private lab in North Carolina founded by Amway executive Bill Britt. The lab offered its services for free for the first year in exchange for Palm Bay’s spreading the gospel to other police departments. The program’s aim was for high-volume collection and testing to help solve the area’s high-volume crimes, which were mainly property crimes.

Sure enough, the first “match” solved a string of break-ins at the gated community where the city’s then police chief, William Berger, resided. The burglar even hit Berger’s house, slicing through a screen and stealing a couple of floats from his swimming pool. Berger brought in a canine team, which tracked the floats to the woods, then had the floats and the screen door latch swabbed for DNA. Five days later, a young man was caught attempting to shoplift at Wal-Mart. The Palm Bay police officer called to the scene didn’t make an arrest (the store declined to press charges), but the shoplifter consented to a voluntary DNA test. Turned out the shoplifter was also Berger’s burglar.

Encouraged by that success, Palm Bay police collected over 800 reference swabs from crime suspects in the first 10 months of the program, plus over 1,600 crime-scene items and evidence swabs. Five years later, the database contained profiles from about 3,500 people. “We were way ahead of the game,” said Berger.

Since its database remained siloed, apart from interconnected local, state and federal collections of DNA, the department understood that collecting a high volume of samples was critical.

To start, officers swabbed every single crime scene, no matter how minor the crime, said John Blackledge, then Berger’s deputy. Blackledge and his colleagues would decide which crime scene and suspect swabs to send to the lab, and in what order.

“It had to be that there was reasonable suspicion that this person was involved in criminal activity that fit within the interesting cases that we were working,” he said. “On top of that, the officer had to write a clear report that convinced me that this was either a free and voluntary swab, or that we had to get a search warrant.”

Since then, the department’s DNA collection seems to have become more aggressive. Sgt. Michael Pusatere, who now heads the department’s Crime Scene Unit, says officers work to solicit DNA from “repeat offenders” and people with whom the department comes into contact frequently, as well as people hanging out in high-crime areas late at night.

“We try to get as many people as we can into the database,” Pusatere said. “A database of four or five people isn’t really usable within a city of 106,000 people.”

Blackledge said building a private database also allowed the city to collect more DNA from juveniles. When Palm Bay’s program was starting, the Florida Department of Law Enforcement’s DNA database, which feeds into the FBI’s national one, contained profiles from over 297,000 adults, but only 35,000 juveniles. “They’re very reluctant to take juveniles,” Blackledge said. “That’s half of my freakin’ violators!”

In the years since Palm Bay started its program, neighboring police departments in Melbourne, West Melbourne and several small beach communities followed their lead, signing contracts with Bode Cellmark Forensics after DNA:SI went out of business. West Melbourne said it ended its collection program in May because it wasn’t delivering enough hits, but every four to six weeks, Palm Bay and Melbourne submit anywhere from 25 to 100 swabs apiece. They estimated that, collectively, they had amassed 7,000 or 8,000 reference and evidence samples spanning the region.

Many of the reference swabs are so-called “elimination” or “victim” samples, swabs taken from crime victims to eliminate them from the DNA mix during analysis. Others are from so-called “field interviews” — people who volunteer them during traffic stops, street stops and other consensual encounters with police.

Most big-city police departments say they do not solicit voluntary DNA samples under these circumstances — only from victims, or, occasionally, suspects associated with specific crimes. When asked about DNA collection during traffic or street stops, Rana DellaRocco, director of the Forensic Laboratory Section of the Baltimore Police Department, laughed and said, “God, I think if they even tried to suggest that, I think that our ACLU might actually have the top of their heads explode.”

According to a document obtained through a public information request, the Melbourne Police Department collected 307 cheek swabs in 2015, most of which were elimination samples. Fifteen were taken from suspects in connection with a particular crime; nine more were taken when suspects were arrested; and 38 were taken during field interviews unconnected to any particular crime.

Nationwide, local law enforcement agencies that have started DNA collection programs have taken a variety of approaches deciding whose DNA they will seek and under what circumstances.

Only Palm Bay, Melbourne, and West Melbourne said they have asked juveniles to volunteer their DNA without getting their parents’ permission.

Since 2007, the District Attorney’s office in Orange County, California, has offered certain non-violent offenders the chance to have their charges dismissed in exchange for contributing cheek swabs to a special separate DNA database — a “spit and acquit” program, as the local media nicknamed it. As of mid-August, according to the DA’s office, over 145,000 people had voluntarily donated their DNA to this database.

Unlike their Florida counterparts, police in Greensboro, North Carolina — one of 16 departments that make up the North Carolina DNA Consortium — don’t gather samples through street or traffic stops. Instead, they started their program by approaching people who were repeat offenders or in ankle monitor programs, asking them to hand over DNA. Now they get samples from suspects connected to, or arrested for, particular crimes.

Police in Branford, Connecticut, draw a different line in collecting DNA. They’re instructed to request DNA from people they merely observe acting inexplicably or strangely. “Say we’re having a lot of problems with car break-ins, and we see you walking in a neighborhood where there are normally car break-ins, and you’re out at two o’clock in the morning,” said Capt. Geoffrey Morgan of the Branford Police Department. When people don’t offer persuasive answers for why they’re there, officers may get suspicious and ask for a swab. “And you know how many people say, ‘No, I don’t mind’?” Morgan added. “A lot.”

Morgan said his officers always get consent in writing, and often also record the process with their body cameras. Police in Melbourne, Bensalem, and Greensboro say they insist on getting consent, too, but other departments acknowledge their databases include samples gathered without it. West Melbourne police say they’ve collected “abandoned DNA” from chewing gum or cigarette butts left by people who refused to sign consent forms. Fairfax County, Virginia, police try to record consent in writing, but it’s not always possible.

“In some circumstances in the field, Patrol Officers do not always have forms readily available,” public information officer Don Gotthardt said in an email.

Police departments with private DNA databases also vary in how they respond to requests to throw out DNA donated voluntarily.

The North Carolina DNA Consortium will expunge a sample if a person submits a letter asking them to, said Stephen Williams, the Greensboro Police Department’s director of forensic services. But Branford, Connecticut, wouldn’t honor such requests.

“They can ask, but we don’t necessarily have to,” Morgan said. “I mean, if they gave it to us consensually, then they gave it to us consensually.”


Adam hadn’t been charged with a crime, so there was no criminal court that his attorney, Jason Hicks, could approach to have the evidence thrown out. Hicks also couldn’t find any case law emanating from litigation over similar cases.

Hicks zeroed in instead on the consent form Adam had signed and, in particular, whether he had genuinely understood he could refuse the police officer’s request for DNA.

Since Officer Valutsky had told the boys to stay in the car, Hicks reasoned it had been pretty clear to them that they wouldn’t be allowed to leave unless one of them handed over DNA. That sounded more like an illegal detention than a consensual conversation, the attorney charged, one that was not justified by the officer’s reference to previous “suspicious activity” in the neighborhood.

“Law enforcement has to have a reasonable suspicion that those kids are specifically committing a crime,” Hicks said. “Not just that some clowns in the neighborhood had committed some crimes in the past — that doesn’t let them create a police state into infinity.”

When Hicks wrote to Cmdr. Sanders and made this argument, Sanders initially struck a conciliatory note, agreeing to toss the sample even though he disagreed that the police had acquired it illegally.

“As long as Adam is not a frequently seen name in our police reports I would not have a use for his sample,” Sanders wrote to Hicks in a July 16, 2015 email. “Since his encounter with the officers Adam’s name has not resurfaced, nor is there another entry for Adam in our computer system. Therefore, in order to end this situation I will have the items collected in this case removed from our files and destroyed.”

Subsequently, however, Sanders told Hicks that the sample couldn’t be destroyed until the City of Melbourne arranged a new contract with a company that handled the disposal of forensic evidence. He also expressed concern that expunging Adam’s DNA would create a precedent that could jeopardize the legitimacy of the whole DNA collection program. Hicks didn’t care about precedent, just his client.

The dispute meandered on for months, with Hicks checking in every so often with Sanders to ask about Adam’s DNA sample and being told it was still sitting in a pile marked “to be destroyed.”

Finally, on August 23—a year and a half after Adam handed over his cheek swab—Sanders sent word the sample would be destroyed the very next day.

Adam’s family was relieved the wrangling was over, but Hicks remains concerned that police continue to pursue voluntary DNA collection, with few constraints on how they gather genetic material and from whom. “If this is okay, what’s to stop police from walking up to children on a playground or a basketball court and sticking Q-tips in their mouths?” Hicks said. “As a parent, I get concerned about the erosion of the Fourth Amendment over time.”

Adam’s dad still can’t believe his son needs parental consent to go on school field trips or to learn to drive a car, but not to give up his DNA to the police under Florida law.

“For me, the crux of it is, can they ask for an underage kid to consent to something like that without a parent?” he asked. “According to the police department, that seems to be their policy. But to the general public, I think that would be news to them.”

CVS HEALTH… EXTRA CARE … pays you back…

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Companies you’ve never heard of are making a killing off high drug prices

drugrobberyCompanies you’ve never heard of are making a killing off high drug prices

http://nordic.businessinsider.com/scrutiny-express-scripts-pbms-drug-price-fury-2016-9/

It’s easy to see why EpiPen has become the focus of America’s fury over drug prices. It treats potentially deadly allergic reactions – for example, in a child who is stung by a bee – and its price has spiked by over 500% in a few years.

While it’s easy to jump all over drugmakers, like EpiPen’s maker, Mylan, other actors in the healthcare system ought to draw as much scrutiny.

One group of companies, called pharmaceutical benefit managers, or PBMs, serve as middlemen, and they touch every part of the purchase of a prescription drug.

And now there’s a growing realization, from Washington to Wall Street, that PBMs have been a big beneficiary of soaring drug prices burdening Americans – profits of the largest companies have doubled in recent years – even as they pitch their services as critical to controlling costs.

It’s what one Wall Street analyst described as a “perverse incentive” in the business. A recent Morgan Stanley analysis showed that PBMs’ earnings would take a direct hit if drug companies began to slow down on price hikes.

The biggest of these companies is Express Scripts, but PBM services are also provided by CVS Health, UnitedHealth Group, and several smaller companies. Because of their complexity and opacity, they’ve managed to dodge the kind of intense scrutiny that drugmakers are facing.

But that’s changing, and it’s bad news for the industry. PBMs are being sued by some customers for double dealing, and they’re now also starting to draw the attention of Congress. Perhaps the biggest threat of all: They’re facing a backlash from America’s largest employers, some of which are working on a way to rewire the system.

Below, we’re going to try to explain how PBMs work for the more than 260 million Americans they serve, and because unlike the other big companies it is mostly a PBM, we’re going to use Express Scripts to do this.

The ultimate middleman

Pharmaceutical benefit managers started simply enough. In the 1960s, they served a need. As more Americans started taking prescription drugs, insurance companies were overwhelmed processing claims. PBMs offered to do it for them. PBMs pioneered plastic prescription cards and mail-order drug delivery.

They promised Americans they’d negotiate to keep drug prices down. They promised insurers they’d make processing prescriptions a lot cheaper and easier. And they promised drug companies they would favor certain drugs in exchange for rebates and price breaks.

They’re paid fees by the insurers and employers who use their services. But they’re also taking a cut of every sale. That alone isn’t a problem. American business is full of middlemen, and nothing the PBMs do is illegal.

But where the PBMs are starting to get into trouble is that they’re making bundles by keeping each player they deal with – pharmacies, insurers, drugmakers – partly in the dark. And those bundles, you could argue, are coming at the expense of the people who pay for healthcare.

Obama doctors Obamacare

Yes, Obamacare too.

Here’s how a PBM like Express Scripts controls information and pricing.

Let’s say a doctor prescribes you a heartburn drug. Its list price is $300, but the only people who pay that are those without insurance. Because you have insurance, you go to your local pharmacy and pay a $20 co-pay. For you, that’s it. Your insurer might be paying $180 for the drug as part of a large-scale agreement it came to years ago via the PBM. The pharmacy that dispenses it may get only $160 for it. That $20 difference is a spread, and that goes to your PBM as profit. That’s on top of fees your insurer is paying the PBM to administer its prescription-drug program.

That’s the simplest way this goes down.

All the while, the pharmacy has no idea how much your insurer is paying for the drug, and your insurer isn’t exactly sure how much the pharmacy is getting for dispensing the medicine. The drug company, meanwhile, isn’t even getting close to the $300 list price that makes everyone so angry.

Then things get really murky.

If the price of the drug has increased, the PBM can be paid a rebate for the excess, which it pockets. The insurer, which is paying for the drug, won’t know.

“These rebate amounts are less likely to be explicitly shared with a client,” analysts at AllianceBernstein, an investment firm, wrote in a recent note on Express Scripts.

The note was written to answer the question of whether PBMs are “containing pharmacy costs or driving them.” AllianceBernstein’s answer was to put an “underperform” rating on Express Scripts’ stock, warning of the risk to investors as people start to figure all this out.

Express Scripts Chief Medical Officer Steve Miller

Steve Miller, Express Scripts’ chief medical officer.

‘What we don’t want is transparency’

In the middle of the EpiPen news cycle, CNBC interviewed Steve Miller, the chief medical officer of Express Scripts.

“If she wanted to lower the price tomorrow she could,” Miller said of Mylan’s CEO, Heather Bresch.

He continued (emphasis added):

“We love transparency for our patients. Our patients should know exactly what they’re going to pay when they go to the pharmacy counter. We love transparency for our clients – they can come in, they can audit their contracts, they know exactly what they’re going to be required to pay … What we don’t want is transparency for our competitors.”

Did you catch that?

Express Scripts will tell clients how much they should pay, but it is trying hard not to tell anyone how much things cost. The problem is that when people find out, they seem to get very angry.

‘Don’t you find it odd?’

In February, at a congressional hearing about drug prices, Mark Merritt, the PBMs’ lobbyist in Washington, was grilled by Republican Rep. Earl “Buddy” Carter of Georgia.

Carter owns a few small pharmacies, and he was getting very angry about the lists, called formularies, that PBMs develop for their clients. A formulary is a list of drugs that patients will be reimbursed for on a given plan.

PBMs also create maximum allowable cost (MAC) lists, which tell the drug companies and pharmacies how much they’ll pay for a medication. The prices on each list can be different, but only the PBM knows the difference.

“They have one list here that they’re going to reimburse the dispenser at. They have another list that they’re going to charge the insurance company that they’re representing,” Carter said at the hearing. “Don’t you find that somewhat awkward? Don’t you find that to be a situation where the PBM could distort the market greatly?”

Merritt said he did not.

Carter also said that PBMs have caught the ire of states because they were not updating their MAC lists frequently enough. That means that even if a drug’s cost increases for a pharmacy, the PBM still won’t pay more to buy the drug for its clients.

Merritt insisted that it was not accurate.

Carter countered:

“If that’s the case, don’t you find it somewhat odd that [the Centers for Medicare and Medicaid Services] found it necessary to mandate … that these MAC lists be updated every seven days, and that 26 states have passed laws requiring PBMs to update their MAC lists? … I notice that the profits of the PBMs have increased enormously over the past few years – in fact, almost doubled. I find that very disturbing, particularly when you’re talking about spread pricing.”

In a statement to Business Insider, Express Scripts said, “We update [MAC lists] on a regular basis … as need be.” It would not elaborate further.

Earl

Side hustles

Further complicating the issue with drug companies, PBMs have entered into businesses beyond just managing lists and buying drugs. Many have their own specialty pharmacies, which are mail-order pharmacies that manage drugs that are hard to distribute. Express Scripts, for example, has a specialty pharmacy called Accredo Health.

Carter says he has adjudicated claims for customers in his pharmacy, had them rejected, and then seen the PBM call the customer right away to tell them to use its specialty pharmacy.

“A mail-order pharmacy that is owned by the PBM – now, don’t you find that conflict of interest? Don’t you find it a conflict of interest when a PBM not only owns the pharmacy but they’re reimbursing here?” he asked.

What he means is that the PBM helps to manage the drugs on the formulary and negotiates the price of the drug that it could be buying from itself.

Express Scripts also has a business that manages patient-assistance programs called United BioSource. Drug companies use these assistance programs to help patients get around co-pays and often point to them when drug costs go up really fast. Express Scripts picks up a management fee for doling out this cash.

While all this complex stuff is going on in the background, the patient’s price is being held steady. In his CNBC interview, Miller bragged that patients saw their EpiPen co-pay increase from $73.03 to just $73.50.

“We’re really trying to protect our plans,” he said.

What it really does, though, is protect all the players from patient outrage, because rising drug prices mean rising rebates and increasing profits for the PBM.

In a research note, Morgan Stanley analysts walked through what would happen with a single product: Allergan’s chronic dry-eye treatment, Restasis.

The price of Restasis has increased by double digits annually in recent years, and so has the income generated from rebates related to it. If Allergan were to cut back on price hikes, like it just pledged to, those earnings would drop by 15%.

Of course, clients such as insurers don’t know exactly how much drugs cost the PBM once it has negotiated its own rebate with a drug company; clients just know how much they’re paying a PBM.

Are you seeing a trend here? Whether it’s from drug companies like Mylan or PBMs, real prices are just hard to come by. And because their hands are in all corners of the business – the lists that get you to customers, the assistance programs that get customers to pay, the pharmacies that can sell you the drugs – that suits PBMs just fine.

A pharmacy employee looks for medication as she works to fill a prescription while working at a pharmacy in New York December 23, 2009. REUTERS/Lucas Jackson

This is your brain – this is your brain on a PBM

With a market cap of $45.7 billion, Express Scripts is the largest of the PBMs and was created as a PBM, not an insurer or a pharmacy like its two primary competitors, UnitedHealth and CVS Health. The three control most of the PBM industry.

Based in St. Louis, Express Scripts exploded in 2011 when it announced it would purchase Medco Health Solutions for $29.1 billion. In 2010, before that deal, the company’s revenue was $44.97 billion. In 2015, it was $101.75 billion.

We asked Express Scripts if it thought there were any conflicts of interest in the way its business is structured, conflicts that may prompt the company to add a drug to a formulary or stock it in its pharmacy (Accredo Health), for example.

Time and time again, the company said that clients make choices and Express Scripts just gives advice.

Here are a few of the answers we got:

Linette Lopez: If the price of a drug increases, doesn’t payment to your company increase as well?

Express Scripts: All individual client contracts are geared toward driving down the cost of healthcare while creating the best possible outcomes for patients. Express Scripts’ performance is contingent on our ability save our clients money while ensuring that patients have access to the right medications at the best possible price with the greatest level of care.

Lopez: Does Accredo sell drugs that it also provides patient-assistance programs for?

Express Scripts: Pharmaceutical manufacturers choose their PAP providers as well as their distribution channels. There are drugs dispensed by Accredo that have PAPs operated by [United BioSource]. For some products, we determine eligibility and dispense the product, and for others the manufacturer contracts with Accredo to handle only dispensing.

Lopez: For what drug companies does United BioSource administer patient-assistance programs?

Express Scripts: [United BioSource] works with a number of manufacturers to implement PAPs to ensure that uninsured and underinsured patients who meet the qualifications of the program get access to the drugs they need. The number of companies is proprietary.

express scripts revenue

Dealing in the dark

What these answers reveal is that yes, sometimes Express Scripts gets paid for managing patient-assistance programs for drugs it also sells through its own pharmacy. So not only is the situation Carter described possible, patients won’t even know what’s going on because the patient assistance program will mask all the cost for them.

And no, you cannot find out whom Express Scripts managing patient-assistance programs for.

And, by the way, no, Express Scripts does not “find it odd” (as Carter said) that it manages those two lists – one for what drug companies can charge and one for what clients have to pay.

“The client chooses how they would prefer to contract with us or any PBM for its service,” the company told Business Insider. “Spread pricing is aligned with the payer’s desire to control costs and our ability to do so. Through spread pricing, we offer lower rates and leverage our ability to secure better discounts from retail pharmacies over the life of the contract.”

Many clients do not agree with this.

Earlier this year, some of America’s biggest employers – including American Express, Macy’s, Coca-Cola – created an organization called the Health Transformation Alliance with the aim of breaking with “existing marketplace practices that are costly, wasteful, and inefficient, all of which have resulted in employees paying higher premiums, copayments, and deductibles every year.” And they have PBMs in their sights.

Here’s Barron’s magazine on one way they’ll do this:

“They’d do this by rewriting their pharmacy-benefit contracts to eliminate the undisclosed drug-price markups that supply much of the PBM industry’s profits. Instead, the PBMs would mainly receive administrative fees, which would be significantly lower.”

There’s more. Express Scripts gets a significant chunk of its revenue from two clients: the Department of Defense and Anthem Insurance.

But Anthem is suing Express Scripts for breaching its 10-year contract with the company, alleging that it “failed to negotiate new pricing concessions in good faith.” It’s seeking $15 billion in legal damages.

A number of Anthem clients are also suing both Express Scripts and Anthem for the money they spent on overpriced healthcare.

In California, clients are suing Express Scripts for failing “to comply with statutory obligations to provide the state’s clients with the results of a biannual survey of retail drug prices.”

Express Scripts sent us its response to the Anthem case. Basically, it argues that it had a deal, and it accuses Anthem of being the one to violate the agreement.

The response is replete with redactions meant to protect the terms of its contract with the insurer. It’s these redactions, these facts concealed by omissions, that AllianceBernstein believes puts the PBM industry in peril.

“We believe retail spread benefits from a lack of transparency and press/political investigation has the potential to reduce spread. We believe greater awareness of rebate levels or price protection rebates would increase necessary sharing with clients,” the analysts wrote.

In other words, once America finds out how this business works, it’s not going to like how this business works.

Nursing Homes: Need to Learn New Tricks

SRSLY: Homes for the Old Need to Learn New Tricks

https://www.propublica.org/article/srsly-homes-for-the-old-need-to-learn-new-tricks

Pearl S. Buck said that “our society must make it right for old people not to fear the young or be deserted by them, for the test of a civilization is in the way that it cares for its helpless members.” Hubert Humphrey put it differently, suggesting that “the moral test of government is how that government treats those who are in the dawn of life, the children; those who are in the twilight of life, the elderly; and those who are in the shadows of life.” Figures from Gandhi to Winston Churchill weighed in similarly. Point being: a lot of people who are super good at quotes think we ought to treat the elderly with special respect. And, in a nice break from election news, there is some evidence we’re doing a bit of that. According to the Dallas Morning News, infractions for deficient care in nursing homes decreased by 8 percent nationally between 2010 and 2014. In Texas, however, infractions increased 20 percent over that same period. Your four Ws:

What?

 

… the heck is going on with Texas?? (And I’m not just asking because the Washington Post reported that it’s now a swing state. If you saw that one coming, time for a vacay to Vegas.) The Dallas Morning News reported that Texas’s 1,200 nursing homes also reported 3 percent more “severe deficiencies” in nursing home care from 2010 to 2014 — the kind that might lead to serious injury of residents — while the national number declined 16 percent.

Why?

The usual suspect: money. The new figures come from a report commissioned by the Texas Health Care Association, a trade group for nursing homes, which is concerned about a “crisis” in state funding. The Morning News reported that this is particularly notable, given the association’s “traditional reticence” to openly discuss nursing home inspections. Nearly 70 percent of the state’s nursing home residents are on Medicaid and Texas Medicaid reimbursements “are near the bottom in the U.S.” The lack of funding has left Texas nursing home residents with less attention from staff than is the case in other states. Texas nursing home residents get 3.59 hours of attention from staff per day, compared to 4.64 hours in Florida, which has far fewer “immediate jeopardy” infractions, the kind that “if unabated, will cause serious harm or death,” the Morning News says.

What now?

Probably it’ll get worse. The Morning News notes that the next two-year state budget won’t have the cash cushion of the previous two, so lawmakers will have to cut some spending. And however much we may care about the most helpless in society, it just seems like they perpetually stink at lobbying.

What else?

It’s not all bad. The report commissioned by the Texas Health Care Association concluded that, “Significant and decisive changes are necessary to avoid a potential collapse of the long term care safety net in Texas.” So there’s a silver lining; they said “potential collapse.” I mean, wake me up when collapse is imminent, amirite??

They Said It

When you’ve got turnover rates that are 98 percent a year, you’ve got almost an entire building that’s turning over.” —Texas Health Care Association President Kevin Warren, on the extraordinary turnover rate of nursing staff employees at Texas nursing homes.

The search is on….

detective

If you are working with a pain clinic that has ceased to prescribe opiates as a blanket policy, could you please identify the clinic name and location?

The above was posted on another closed FB page… if you know someone or you ARE SOMEONE... post the info here or send it to me steve@steveariens.com and I will forward

How do you UNRING a BELL ?

SRAcrystalball

White House Will Have To Justify Kratom Ban

White House Will Have To Justify Kratom Ban

IMO… people are pretty naive about how the government works… the author of this article seems to think that the White House will have to act on this petition as soon as it hits 100,000 signatures… My money is on the fact that they will wait the full 30 days they have to accumulated 100,000 signatures and then they only have to “give the petition CONSIDERATION”.. Of course, 30 days is the day that this rescheduling will take place .. .and then they have 60 days in which to respond… that puts their response due after THANKSGIVING… election is passed… Congress is out of session… “winter break” and Obama is packing .. headed for the door.  White House’s “consideration”… will probably elect to leave up to the new President and new Congress… and the petition and a decision will be lost in the transition between administrations.  Besides, getting the DEA to reverse their decision 60 days after put in place is probably like UN-RINGING A BELL !

A petition asking the White House to not classify Kratom as a Schedule I drug passed the 100,000 signature mark Thursday, triggering a response from the Obama Administration.

“Please do not make Kratom a Schedule I Substance,” is the name of the petition on the White House petition site. The petition was created Aug. 30 in response to the Drug Enforcement Administration (DEA) decision to temporarily classify the plant Kratom, a Schedule I narcotic.

The DEA filed a Notice of Intent Aug. 31 and caused great outrage among Kratom users not only for temporarily restricting the plant’s availability, but also fornot allowing experts to weigh in on the matter. When scheduling the drug, the DEA traditionally allows for a notice and comment period in which interested parties can make their case to the DEA about why a substance should not be scheduled.

The temporary Schedule I classification of Kratom goes into effect Sept. 30. White House petition response policy states that if a petition gets over 100,000 signatures within 30 days, the White House will respond within 60 days of that threshold having been reached.

Kratom can be found in teas and is known for helping heroin addicts wean themselves off of the deadly drug. The plant’s key chemical properties can be found in energy drinks as well as in pills and powders. Due to the 60 day window in which the White House can respond to a petition and the Kratom ban getting underway Sept. 30, it is unclear if a response will come in time to stop the scheduling.

Regardless of the outcome at the federal level, Kratom has already been banned in Vermont, Indiana, Wisconsin, Tennessee, Alabama, and Arkansas.

 

Discrimination in health care is illegal as a result of the Affordable Care Act

Federal Complaint Says Ga. Insurers Overcharge For HIV Meds

http://news.wabe.org/post/federal-complaint-says-ga-insurers-overcharge-hiv-meds

Public health researchers say health insurers Cigna and Humana are overcharging for HIV treatments. Both companies offer plans under Georgia’s Affordable Care Act exchange.

Doctor Melanie Thompson is with the AIDS Research Consortium of Atlanta, which, along with Harvard’s Center for Health Law and Policy Innovation, filed federal discrimination complaints against the companies after looking into their HIV medication coverage in 2014 and 2015.

“Initially people were so happy to have health insurance, and they went to the pharmacy and came back and said, ‘Wow, they told me I have to pay $800 cash and I just don’t have it.’ So they were out of their drugs,” said Thompson.

She said the risks for patients are huge if they miss HIV treatments, to say nothing of the potential impact on public health.

“People with HIV require a continuous supply of medication. They have to keep the virus suppressed at all times, otherwise the virus can become resistant to drugs and the drugs can stop working,” said Thompson, who added that without suppression, the virus can once again be transmitted to others.

In some cases, Thompson said Atlantans living with HIV are paying up to 40 percent of their income to keep up treatments.

“Most insurers were able to manage these medications in a way that was somewhat affordable, but Cigna and Humana plans really stood out,” Thompson said.

Researchers found that the insurers classified federally recommended HIV medications as belonging to the highest cost-sharing categories, something other companies have managed to avoid doing by offering plans with flat co-pays rather than requiring patients to pay a proportion of these very high-cost treatments.

Discrimination in health care is illegal as a result of the Affordable Care Act. Thompson said they filed complaints with the US Department of Health and Human Services Office of Civil Rights because their analysis proves that people with HIV are being treated differently.

Georgia is one of seven states being impacted by insurers with expensive HIV medication plans. Local advocacy groups have filed similar federal complaints on behalf of people living with HIV in their own states.

Thompson said she’s hopeful the complaints alone are enough to change the insurers’ behavior. She added that some patients may not even realize there are alternatives to the amounts they’re paying.

“People don’t understand the insurance industry to begin with,” Thompson said. “They don’t know how to analyze these plans. It’s not really easy to see that one insurance company treats their drug in a different way.”

In a statement, Humana said their plans comply with federal regulations, and that they will work with HIV/AIDS advocates to mitigate the growing costs of the medications. Humana claims high drug costs have forced them to pass along the expense.

Cigna declined to comment.