The Controversy Over Kratom and… Opioids

Editor’s Note: From my piece last month at  HCPnow

As the U.S. struggles with an opioid epidemic, government officials, doctors and patients are confronting drugs too heavily used and sometimes too often prescribed.

Everyone is searching for alternatives to opioids for patients, many of whom are coping with intense pain. An estimated 91 million people were prescribed opiate painkillers in this country, and 2 million people suffer from substance abuse disorders linked to the medications, according to the National Institutes of Health. 

There are many people seeking different treatments, including supplements, as options to opioids, or trying to treat their withdrawal symptoms from opioids. One of the most controversial is a plant-based supplement, Mitragyna speciosa, known as kratom, derived from a plant native that had been used for thousands of years in Southeast Asia for pain relief.

Kratom has a history of being sold as a dietary supplement and has been used to manage pain. Mitragyna speciosa grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea and has been used for many years in Southeast Asia as an opium substitute.

It’s from a plant, but it still can be an opioid, and produce morphine-like impacts, and that creates a dilemma.

Controversy Over FDA Warnings

Although it has been sometimes promoted as a natural alternative pain remedy, Kratom contains chemicals found in opioids, according to the federal Food and Drug Administration. While a few doctors have encouraged their patients to try kratom and their supporters enthusiastically support it, the FDA has been strongly against it.  Kratom has been usually taken as a powder, and the dosage has had stimulant and sedating properties. Kratom remains legal under federal law, but FDA officials want supplement companies to take kratom off the market. Inspectors also have been removing and destroying shipments of kratom from overseas.

The FDA has issued warnings about reports of injuries and deaths linked to kratom use. At least 44 deaths have been reported involving kratom since 2011, according to the FDA. Because of the reported health risks associated with its use, the FDA has banned the import of kratom.

Still, without question there has been an increase in use of kratom in the U.S, while government agencies have stepped up their concerns. A July 2016 report by the Centers for Disease Control and Prevention (CDC) noted that calls to poison centers about kratom exposure increased ten-fold from 26 in 2010 to 263 in 2015

The FDA also has linked kratom-containing dietary supplements to 28 cases of salmonella poisoning.  While supporters of kratom say there should be recalls of any product that contains salmonella, they oppose using the food safety investigation as a government step toward a mandatory recall of kraton products in the marketplace.

Medical Uses?

The FDA claims kratom is an opioid based on the agency’s extensive computer reviews that show its receptors in the brain also respond to heroin, morphine, oxycodone and other opioids.

FDA Commissioner Scott Gottlieb said there was no FDA-approved medical uses for kratom. “Claiming that kratom is benign because it’s just a plant is shortsighted and dangerous,” Gottlieb said in a statement.  “It’s an opioid. And it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated sold and used recreationally.”

However, a major supporter of kratom says it has a long history of acceptable safety consumer use as an alternative pain management therapy. In addition, it provides a “more favorable safety profile for consumers compared to more dangerously addictive and potentially deadly classical opioids,” says the American Kratom Association. 

The U.S. Drug Enforcement Administration had considered placing kratom in the same category of illegal drugs as heroin and LSD.  There were numerous protests about the proposal, however, including a letter signed by members of Congress, against it, forcing the agency to withdraw it. Some states, however, have taken steps to ban the supplement or classify it as a Schedule One drug, the same as heroin.

What’s Ahead

Gottlieb said the FDA is willing to evaluate further evidence involving kratom. He added: “The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom,” he said. “However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval.”

References:

FDA and NIH statements on kratom:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595622.htm

https://nccih.nih.gov/news/kratom.

American Kratom Association

https://www.americankratom.org/news

Investigating Marijuana-Linked Ingredients for ‘Important Therapies’? FDA says it’s OK with that.

There are more than 80 active chemicals in marijuana. Today, in an “important medical advance,” the FDA approved the first prescription drug made from marijuana, still illegal by federal government standards, based on one of those chemicals.

“This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies,” FDA Commissioner Scott Gottlieb says.

The approved medication, named Epidiolex, is targeted to treat two rare, severe forms of epilepsy in patients 2 years and older, says Gottlieb. The medication is a purified form of a chemical ingredient found in the cannabis plant known as cannabidiol, or CBD. It reduces seizures in some people with epilepsy.

CBD is one of more than 80 chemicals found in marijuana. It doesn’t contain THC, the key psychoactive ingredient in  marijuana. The approval is for a purified form of CBD.

The decision showed a “milestone that  could spur more research” into marijuana, according to Associated Press.

“This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components,” the FDA chief says.

Docs: Head to the Mount Rushmore State! Oh, Jersey, No!

So who says Washington DC. is just for politicians? It’s got doctors, doctors, doctors.

The District of Columbia has the highest number of physicians per 1,000 residents in the country — 6.9 times higher than Nevada, the lowest at 1.20, according to WalletHub’s  just released 2018’s Best & Worst States for Doctors.

WalletHub compared the 50 states and DC on a range of issues including the  average annual wages of physicians to hospitals per capita to quality of public hospital system.

The best state for docs? — South Dakota.

The worst — New Jersey.

Speaking of wallets — docs have plenty of holes in them, WalletHub says.

“The average medical-school graduate left campus with more than $190,000 of debt in 2017. The medical profession has also been undergoing intense transformation in recent years,” wrote John S Kiernan, Senior Writer & Editor for WalletHub. 

“Health-care reform, the rise of branded hospital networks and the retirement of Baby Boomers are all complicating the lives of doctors,” he wrote. — Joe Cantlupe

 

 

Never Again! Enough is Enough! We Call BS! ‘Survivors of a Cruel and Silent Nation’

Parkland, Fla.

Parkland has well-manicured lawns, new developments, and huge parks, with trails and tennis courts and basketball courts and ballfields. At the intersection of Coral Springs and Parkland is a horse riding academy, Malachi Acres, with a boarding stable, amidst the palms.  Town hall is beautiful, and residents talk about the sense of community. A resident recalls how there was a mini-scandal when there were some car break-ins in a neighborhood.  The reason, he said with a near smile: “The owners left their doors unlocked.” It’s that kind of place. A month ago, my wife and I left Parkland, heading to the airport after visiting relatives there. The Lyft driver told us why he moved to Parkland, this proud man from Brazil. For the schools, he said. For the schools.

Yesterday, it was about all of this, a sense of place,  the schools, and something much more profound:  passion, determination, unyielding force. Angry teen-agers with a grudge, clutching a sadness no one should have, fighting to curb gun violence, restrict the access to guns — assault weapons – and vowing, vowing, vowing to make politicians know they will be ousted from office if they don’t comply. So there is no more  terrible nonsense of gun violence that is taking lives, the “17 angels” — the 17 people –  students,  a football coach and athletic director, who were killed at Marjory Stoneman Douglas High School on Valentine’s Day. There were 14 wounded. The gunman was mentioned only in passing yesterday during the March For Our Lives rally, only in a word like horrible, but also as a pathetic reason why, why, why laws must be changed, gun laws, mental health laws, funding, you name it. All our hearts are broken, and we’ve had enough was the refrain, constant and true.

Parkland was center stage as a place, but its students were also taking the center stage  in  a rally in Washington D.C. Parkland is one piece of the gun-control puzzle. So is Chicago. So is New York. So is Miami. So is Los Angeles and everywhere where marches were held.  One bullet that fells any kid in a school, on a street. That’s what they fought against yesterday, mostly these kids, but there was plenty of support, no doubt about it, from parents, teachers, friends, the elderly.  Stop the gun violence. Stop people from having assault weapons.  Down with NRA. Thump the Trump. (ok, my term). Placard after placard. Sign after sign. The message was clear: Lawmakers and the President, if you don’t do enough you will be voted out by their supporters, damn it, when they are old enough to vote.  One student from Parkland told how she thought the privilege of the town helped draw it attention, but the fight  represents all races, all genders, all lifestyles. Those  voices at rallies across the country related personal experiences of friends, relatives, loved-ones cut down in senseless violence, in emotional, drive you to tears speeches. Eyes welling up all over.  Let’s hold those thoughts.

“We are survivors of a cruel and silent nation,” said D’Angelo McDade, 18, of Chicago at the Washington D.C. rally.  “I too, am a victim, a survivor and a victor of gun violence,” McDade said. “We are survivors not only of gun violence but of silence. I come from a place where minorities are controlled by both violence and poverty, leading us to be deterred by success. But today we say, ‘No More.’

No more, he said: violence, no more poverty, no more unjust policies and lack of resources. “You must be the change,” he told the crowd.

In 1970, after National Guard troops shot students at Kent State, we were young and demonstrated with passion and fury. We were convinced the wrongs of America would turn to rights.

We didn’t have social media. We had bull horns.

There’s something magical going  on now amidst the sadness.

These kids are articulate and their speeches are raw and practical. Blunt.  No more BS!

There are still huge bureaucratic mountains to climb, but as the protestors insisted yesterday, this is just the beginning. We’ll be hearing more of the words Ballet Box. — Joe Cantlupe

 

 

 

Did FBI drop the ball? Yes. Florida Gov. Wants FBI Director to Resign

The FBI conceded today that the agency did not follow proper protocols to pursue information on a tipline Jan. 5 about Nikolas Cruz, the self-confessed gunman in the Parkland high school massacre on Valentine’s Day and his “desire to kill people.”

Stunned by the admission, Republican Florida Gov. Rick Scott called for the FBI director to resign, saying: “The FBI’s failure to take action against this killer is unacceptable.

In an extraordinary  statement, the FBI said they did not followup on a call to the FBI’s Public AccessLine (PAL) tipline that reported concerns about Cruz, and his  “gun ownership, desire to kill people, erratic behavior and disturbing social media posts, as well as the potential of him conducting a school shooting.”

“Under established protocols, the information provided by the caller should have been assessed as a potential threat to life. The information then should have been forwarded to the FBI Miami Field Office, where appropriate investigative steps would have been taken,” the FBI said. “We have determined that these protocols were not followed for the information received by the PAL on Jan. 5. The information was not provide to the Miami Field Office an no further investigation was conducted at that time.”

The apparent mishandling of the information only adds to the tragedy in which 17 people were killed by the former student at Marjory Stoneman Douglas High in Florida. The defendant’s lawyer and President Donald Trump has said the 19-year-old Cruz, who had been expelled from the high school, had mental health problems.

News reports today said earlier that a tipster had alerted the FBI in September about a comment Cruz , who allegedly said he was going to be a “professional school shooter.” At the time the bureau checked databases but could not identify it as Cruz, or anyone else, according to the reports.

As a city and a country reels, the FBI is doing some soul-searching.

“We are still investigating the facts. I am committed to getting to the bottom of what happened in this particular matter, as well as reviewing our processes for responding to information that we receive from the public,” FBI Director Christopher Wray said. “It’s up to all Americans to be vigilant, and when members of the public contact us with concerns, we must act properly and quickly.

“We have spoken with victims and families, and deeply regret the additional pain this causes all those affected by this horrific tragedy,” Wray said. “All of the men and women of the FBI are dedicated to keeping the American people safe, and are relentlessly committed to improving all that we do and how we do it.” – Joe Cantlupe

To Tell the Truth: Will the Real Donald Trump Stand Up?

For once, he wasn’t the trash-talking, excitable President and he was down-to-earth. Does Donald Trump mean business and does he seek the “unity we need to deliver for the people” or is he simply a chameleon?

In his 80-minute State of the Union address last night, Trump touched fairly briefly on some healthcare issues, but they were the most volatile impacting the nation — drug abuse and healthcare reform.  And he did so in a presidential manner, not as a street tough.

Among the issues, in order of his presentation:

Obamacare. Trump praised elimination of the “core of disasterous Obamacare – the individual mandate is now gone.”

FDA approvals. He noted the “FDA approved more new and generic drugs and medical devices than ever before in our history,” to speed access to “breakthrough cures an affordable generic drugs.”

Terminal conditions. He said he believes that “patients with terminal conditions should have access to experimental  treatments that could potentially save their lives.”

“People who are terminally ill should not have to go from country to country to seek a cure — I want to give them a chance right here at home,” Trump said. “It is time for the Congress to give these wonderful Americans the “right to try.”

Prescription Drug Prices. “One of my greatest priorities,” Trump said, is to reduce  prescription drug prices. “In many other countries, these drugs cost far less than what we pay in the United States. That is why I have directed my Administration to make fixing the injustice of high drug prices one of our top priorities. Prices will come down,” he said.

Opioid and other drug overdoses. Trump, referring to the “terrible crisis of opioid and drug addiction,” said his administration is “committed to fighting the drug epidemic and helping get treatment for those in need. The struggle will be long and difficult – but, as Americans always do, we will prevail.”

Trump said 64,000 Americans died as a result of drug overdoses in 2016: 174 deaths per day, seven per hour. “We must get much tougher on drug dealers and pushers if we are going to succeed in stopping this scourge,” he said.

Among Trump’s invited guests were Albuquerque Police Officer Ryan Holet, 27, an his wife Rebecca.

Trump said:  “Last year, Ryan was on duty when he saw a pregnant, homeless woman preparing to inject heroin. When Ryan told her she was going to harm her unborn child, she began to weep. She told him she did not know where to turn, but badly wanted a safe home for her baby.

“In that moment, Ryan said he felt God speak to him: ‘You will do it — because you can.’ He took out a picture of his wife and their four kids. Then, he went home to tell his wife Rebecca. In an instant, she agreed to adopt. The Holets named their new daughter Hope.”

About the battle against drug abuse, Trump said: “We will succeed; we will prevail.” – Joe Cantlupe

 

 

 

 

CVS-Aetna Deal Faces Huge IT, Data Challenges

There’s that huge pharmacy chain and the behemoth insurance company, inching toward a partnership that they say will change how we get our drugs and are covered for our care.

Many of the headlines are gone – for now – but it is only the iceberg that we cannot see, of the proposal by CVS, the giant pharmacy, to buy Aetna, one of the nation’s largest insurers, for $69 billion that many say will drastically reshape healthcare, if approved. The proposed merger is designed, the companies say, to “redefine access” to healthcare, provide lower costs to consumers, with a “human touch.” It would combine CVS retail pharmacy services with Aetna’s health insurance business, resulting in a company with an annual revenue of $240 billion – second only to Wal-Mart in the U.S, according to news reports.

Much of the talk, and rightfully so, focuses on the pros and cons related to cost savings to consumers, (still unknown) but below the surface there’s this digital transformation proposed that may touch consumers in a big way: And with plenty of questions expected from regulators that will make change – if it happens at all– come very slowly.

Ankur Laroia, solutions strategy leader at Alfresco Software, says the CVS-Aetna plan has a long journey ahead, but portends potentially exciting but also intriguing and unknown possibilities, fraught with roadblocks. Alfresco is an enterprise open-source software company that focuses on digital transformation.

At the outset, the proposal involves “creation of new computer solutions that leverage big data around the patient/consumer concept and apply AI/ML (artificial intelligence/machine learning) to provide both better quality of life and quality of care,” Laroia says.

ankur_laroia-1.jpg (1).jpeg

Ankur Laroia of Alfresco Software

Such a merger could open up “a whole new segment that can be marketed to try by both technology and services providers,” Laroia adds.

In the meantime, there is the nitty-gritty of working out the details, and some confusion from the consumer perspective, and even among the parties themselves, with the prospect for better consumer quality uncertain at best. The process has to be “well-thought-out and well-orchestrated,” Laroia says. “ “This deal is unprecedented,” Laroia says. “We’ve never had retail and insurance come together. The digital transformation journey for both companies, even if they are under one umbrella, will likely still look very different. You are talking about remapping healthcare.”

Many, Many Questions

There are so many questions within questions, says Laroia, that it may take five to seven years to iron it all out, in his view, and for any final approvals even if it is given the preliminary OK by the Trump administration, which isn’t crazy about tightened regulations.

“A snail’s pace,” he says.

“In the case of CVS and Aetna, they both have digital transformation initiatives underway, with end goals that are very different,” Laroia says. “Aetna is all about the traditional homegrown IT shop. They are very big on IBM, which most insurance companies are. Contrast that with CVS, which has a knockdown drag-out with Walgreens. It’s all about the customer and effective marketing up-selling. They are both leveraging their IT computer frameworks and go about reinventing themselves but for different reasons.”

Not only are they obviously different organizations with a differing customer base, but HIPAA and privacy laws are tough hurdles to overcome for complete integration, never mind what Laroia calls “back office functions” such as HR, finance, and procurement issues.

The data stream possibilities – and question marks – are huge, Laroia says.

“You can’t just take somebody’s retail data and just share it with an insurance company,” Laroia says of the possible roadblocks. “They aren’t insurmountable, but there are also a lot of cultural issues to overcome. And these guys are attached to their own data. Who owns the data, and how is it going to be secure and protected? Aside from the federal requirements, there are stringent state regulations.”

Also, the parties have to be sure of “no leakage of information” – when a consumer goes to CVS and has Cigna or Blue Cross Blue Shield as their insurance providers, for instance, not Aetna, Laroia says.

Once the glitches are – if they can be – worked out, Laroia says, there might be “new, novel ways in which digital transformation concepts and techniques will be applied to create (a) better picture of consumer habits.”

And the floodgates may open about other possible mergers like the one CVS and Aetna want to have – but don’t hold your breath for it happening anytime soon. – Joe Cantlupe

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