“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
PHOENIX — A pain management specialist and a patient suffering from chronic pain say that access to opioids is necessary to people who need them to manage their conditions.
As Arizona and other states work to place more rules on opioid prescriptions, some patients are afraid they are being lumped in with addicts, according to pain management specialist Dr. Tony Bui.
“For the chronic pain patients, it’s been very difficult for them because … they feel pretty marginalized from the restrictive action that the state has taken,” Bui told KTAR News 92.3 FM’s Bruce St. James & Pamela Hughes Show on Thursday.
“We’re talking about people who are not … (experiencing) addiction, but more like dependent on these medications, only because they have pain.”
Lori Cutter, one of these patients, suffers from fibromyalgia, degenerative disk disease and neuropathy.
She told Bruce & Pamela that she spent $14,000 last year out of pocket and went to over 200 doctor’s appointments trying to find ways to manage her pain.
“To get the kind of care that I need, that helps me thrive, I don’t want to just go to the pill,” she said.
She said at one point she was on four to five medications before she and her doctor decided to stick with hydrocodone, a well-known opioid.
Bui said it’s common for people taking these types of pills to have exhausted all other options.
“With the opioid medications, it’s usually for the person who has tried various other medications, or other modalities like injections, or beyond, that haven’t worked for them and they still find themselves very dysfunctional from an activity standpoint,” he said.
Cutter said she has sometimes struggled to find a provider who will write her a prescription for the potentially addictive drug.
“That’s a legitimate fear inside me sometimes … because I don’t know long my doctors will continue to fill that,” she said.
Without the drug, she said, “I don’t think I would be functioning as highly as I am. … There’s days I probably wouldn’t be able to get out of bed or sit at my desk very long.”
Bui said his patients often feel like they are automatically labeled as addicts and are looked down on by society.
Cutter said she feels that stigma every time she reaches for her pill bottle.
“I’m hearing these words, ‘abuser,’ ‘addict,’ because that’s what the media and everything is blowing up right now,” she said.
“I think we need to be celebrated that we are managing life as best we can.”
Tune in to KTAR News 92.3 FM’s Bruce St. James & Pamela Hughes Show each day this week at 10 a.m. for special coverage of Arizona’s opioid epidemic.
To reach the Arizona Opioid Assistance and Referral Line, call 1-888-688-4222, or visit the website for more information.
Health-care companies have said they are not threatened by Amazon.
But in a recent lawsuit, CVS argues that Amazon could pose a threat by negotiating directly with insurers, bypassing its lucrative pharmacy benefits manager, or PBM, business.
Kyle Walsh | CNBC
When word spread that Amazon would move into health care in 2017, health-care executives had a ready answer: We are not afraid.
“I honestly don’t believe that Amazon will be interested in the near future in the next few years in this market,” Walgreens’ CEO Stefano Pessina told investors in an earnings call in July 2017.
“I think we have a lot of capabilities and a value proposition that can compete effectively in the market,” CVS CEO Larry Merlo said back in August.
But recent legal actions tell a different story.
In April, CVS filed a lawsuit against John Lavin, a former senior vice president in charge of CVS Caremark’s retail pharmacy network, after Lavin told the company he was leaving to take a job at Amazon’s pharmacy arm, PillPack. The judge this week ruled in CVS’ favor, preventing Lavin from taking immediate employment at PillPack.
That follows another case from January of this year, where insurance giant UnitedHealth sued one of its employees for attempting to join a different Amazon initiative. That was Haven, Amazon’s joint employer health venture with Berkshire Hathaway and J.P. Morgan.
These lawsuits suggest incumbents are more concerned than they’re letting on in public.
The underlying concern: Amazon going directly to insurers
Amazon has said almost nothing in public about its health-care strategy.
But Amazon could disrupt the space dramatically by negotiating directly with insurance companies on drug pricing, cutting out the existing pharmacy benefits managers, or PBMs. All of that could potentially lower health-care costs for consumers.
Among other functions, PBMs help insurance companies negotiate lower drug costs. Manufacturers arrange discounts, called rebates, with the benefits managers so they can fix a spot for their products on a PBM’s list of preferred drugs. It’s a huge business — CVS’ PBM business represented approximately 60% of its overall revenues in 2018, or around $116 billion, according to a person familiar with CVS’ business.
Amazon PillPack CEO TJ Parker, in a deposition in the Lavin case, admitted to the court that the company had “explored a number of different things.”
But he said the company had “no immediate plans” to compete with CVS Caremark’s core offering, its PBM.
CVS certainly seems to think differently, according to the lawsuit to prevent Lavin from working for PillPack.
“Given its robust infrastructure, operational capacity, and distribution reach, Amazon-PillPack is uniquely positioned to negotiate directly with payers (insurers) and displace CVS Caremark’s mail-based services,” CVS argued in support of its motion for a preliminary injunction.
In other words, CVS worries that Amazon is hiring Lavin to approach its clients — insurance plans — for deals that could undercut its PBM.
In particular, CVS said PillPack is already approaching Blue Cross Blue Shield. (CNBC reported talks between PillPack and the insurance network in May.)
“Most recently, Amazon-PillPack engaged in direct discussions with Blue Cross Blue Shield, a federation of 36 health insurance plans that cover more than 100 million Americans, to provide its members with prescription home delivery,” CVS’ motion reads.
Lavin, who has extensive background working with payers, would be well positioned if Amazon PillPack did decide to take that step toward direct contracting over time.
According to Jefferies’ analyst Brian Tanquilut, who also reviewed the legal documents, there’s a real threat that Amazon could chip away at CVS Caremark’s business over time by going directly to insurers. “The lawsuit shows that pharmacy benefits managers are now also at risk of being dis-intermediated,” he wrote.
To that assertion, a PillPack spokesperson responded: “It is important to keep in mind that what’s being reported here is another company’s speculation about our business strategy for a lawsuit to which neither Amazon nor PillPack is a party.”
“PBMs are going to be more protective of their mail pharmacy business than ever and less welcoming to outsiders like PillPack,” said Stephen Buck, a drug supply chain expert who previously worked at McKesson.
For his part, Lavin said in communications to his former employer that he would not be competing head-on with them but would be negotiating from the opposite side of the table.
“I’ll be … handling [PillPack’s] negotiations with PBMs … in other words, it’ll be the opposite of what I did for CVS,” he noted in an email to CVS’ human resources department that was disclosed during the case.
The judge disagreed and granted CVS’ motion to enforce the noncompete agreement and block Lavin from working for PillPack for 18 months.
In his ruling, Judge John J. McConnell wrote, “Mr. Lavin will also negotiate and build relationships with private Payers and public Payers, both of whom are current CVS clients.” McConnell wrote, “It also appears that PillPack will be looking to negotiate directly with the insurers and others on the Payer level.”
CVS, in a statement to CNBC, denied any claim that it is working to block competition and said that it will continue to work with new players.
“We remain focused on delivering innovative solutions to transform the health care experience, but there is always room for new players in health care, as competition can help lower overall costs for payers and patients,” said a spokesperson for CVS Caremark.
The cultivation, transportation, sale, use, and possession of marijuana is illegal under federal law in the U.S. However, the federal government has articulated that if a state passes a law to decriminalize marijuana for medical or recreational purpose, they can do so if a regulation system for cannabis is in place.
Marijuana is listed as a Schedule I drug under the Controlled Substance Act of 1970—the topmost classification under the legislation. One of the reasons why cannabis still remains illegal at the federal level is because it’s classified as a Schedule | drug, as identified by the DEA, a substance that has a great potential of being abused by its user and has no acceptable medical uses.
However, a recent review from the National Academies of Sciences, Engineering, and Medicine evaluated more than ten thousand scientific studies on the medical benefits of marijuana, one of which was the use of medicinal cannabis to treat chronic back pain.
Furthermore, certain cannabis strains are known to provide a good deal of energy, enabling you to stay active and crush the fatigue keeping you down.
In spite of all the health benefits of cannabis, it’s likely to remain illegal in workplaces, which is why it’s important to know how to detox.
Pink prescription bottle for medical marijuana; image by LexScope, via Unsplash.com.
Individual state laws don’t always conform to federal standards. State-level proposals for cannabis rescheduling have had mixed success.
On November 9, 2016, the use of both medicinal and recreational cannabis was legalized in the states of California, Washington, Colorado, Alaska, Maine, Nevada, Oregon, and Massachusetts.
Another 15 states, including the U.S. Virgin Islands, have also decriminalized. The commercial distribution of marijuana is allowed in all jurisdictions where it’s been legalized, except Vermont and Columbia.
Prior to January 2018, the Cole Memorandum gave some protection against the enforcement of federal law in the legalized states. Later, however, it was rescinded by former Attorney General Jeff Sessions.
The use of marijuana remains federally illegal, but some of its derivative compounds were approved by the FDA for prescription use. Cannabidiol is now sold by various online retailers who claim their products are extracted from industrial hemp; hence legal.
Although the DEA considers non-Epidiolex CBD a Schedule I drug, it has not yet taken any action to shut down these sales.
Top Five Predicted Changes In Cannabis Law
We’re in a time of unparalleled growth and rapid change for the marijuana industry across the U.S.
As we look ahead at problems in the law at both the federal levels and Oregon state, here are five main changes we see on the horizon.
#1: Social Consumption
The Oregon Legislature is considering social consumption bills, which would allow the possession, consumption, and sale of cannabis products at temporary events, as well as licensed cannabis cafes and lounges.
Social consumption bills have previously failed, partly because of the necessary amendments to the Oregon Indoor Clean Air Act that legislators are hesitant to address. As the public hearings have already begun, this issue may grow enough legs for a tailored version of one of the bills in order to pass this session.
#2: Access to Banking
Limited access to financial companies creates a sub-optimal brand model for marijuana businesses and fuels safety concerns.
The SAFE Banking Act is likely to prevent federal banking regulators from hurting banks for working with marijuana-related companies that are obeying state laws.
In March 2019, the House Finance Committee made a vote to pass the bill to the House, with advocates expecting a floor vote in May.
With over 150 co-sponsors and strong bipartisan support to date, the bill is predicted to pass in the House. Also, advocates are hopeful that the support may put enough pressure on the Senate to pass the bill.
#3: Interstate Commerce
The Oregon Legislature is taking a bill into account that will allow for an interstate compact with states having legalized cannabis and that share borders (OR, WA, NV, and CA).
Creating an exchange of marijuana between these states could help combat overproduction problems and spillage into the unregulated market. It could also position Oregon to be a leading cannabis exporter in the future.
#4: Social Equity Issues
A Social Equity Program was first introduced in 2018 by the City of Portland to help small marijuana businesses and those impacted by marijuana prohibition directly.
In addition, a portion of the local tax revenue gained from cannabis sales goes toward grants to minority—and women-owned local marijuana businesses. Oregon, however, has made no movement on prior cannabis convictions’ expungement.
Local jurisdictions in cities like Oakland are setting a precedent on the problem of expungement. We can expect that Oregon will take this issue as a nudge in the right direction.
#5: Federal Legislation
Is 2019 going to be the year of weed?
Ten states, along with the District of Columbia have marijuana laws in place that allow the legal use of cannabis for both recreational and medical purposes.
New York, Connecticut, Illinois, and New Jersey are each expected to legalize marijuana in the coming years. Public support for cannabis legalization is always high, and bills like the STATES Act will exempt legal-marijuana states from federal law enforcement.
We don’t quite have a crystal ball, but the dominoes are lining up with a goal of federal legalization on the horizon!
Wrapping Up
So, these were five of the main predicted changes we see in cannabis law.
The year 2019 feels different.
Cannabis enthusiasts have long celebrated 4/20—the cannabis culture, but now that companies are seeing profit potential, they’re getting involved as well with things like CBD-infused Carl’s Jr. hamburgers and $4.20 Lyft credits.
Cannabis is a huge business, even if it’s not legal everywhere yet. In this post, we tried to give you a comprehensive review of the legality of cannabis by U.S. jurisdiction.
So, what will be the future of cannabis businesses?
Perhaps, only time will tell.
Nonetheless, did you find this article helpful? Share your thoughts and suggestions with us in the comments below!
In the past five to seven years, domestic meth labs have decreased in the U.S. as Mexican drug cartels brought cheaper and purer drugs in. Kara Berg, Lansing State Journal
LANSING — When Battle Creek police and parole officers inspected a home May 6 on the city’s south side, they found something unusual.
The methamphetamine, marijuana and syringes they seized were almost expected, but the one-pot meth cooker was a surprise. It’s something police don’t see often anymore.
As recently as five years ago, meth was commonly made at home in plastic 2-liter pop bottles with ingredients bought at drug stores. Police and first responders would find dumpsites littering rural roadways, or would rush to fires caused by exploded home cookers.
But those days are mostly over, Michigan law enforcement officials say.
Now, the meth is coming from Mexico.
With that comes an increase in meth-related overdoses, said Stephen VerDow, a Michigan Drug Enforcement Administration assistant special agent. The Mexican meth is purer, cheaper and increasingly has been reported to be mixed with fentanyl, a deadly combination.
“Methamphetamine has been a scourge for many years and continues to wreak havoc across the country,” VerDow said.
Why your city might be an ideal target for Mexican cartels
In the past five to seven years, the number of domestic meth labs have decreased in the U.S. as Mexican drug cartels brought in cheaper and purer drugs, VerDow said. The cartels bring the drugs into the U.S. with commercial and personal vehicles, making any cities near major highways – like Lansing, Battle Creek, Howell and Brighton – ideal areas to target.
“The increased commercial vehicle traffic in these areas help them blend in better with legitimate commercial business,” VerDow said. “Drugs can be distributed in very remote areas as well, but the (cartels) want to stay under the radar as much as possible.”
They aggressively and violently market and sell their products, VerDow said, leading to the ability to sell meth in the U.S. with “huge profit margins.”
This has fueled the decrease of what officials call “one-pot” domestic meth laboratories, VerDow said.
Michigan State Police Detective Lt. Bill Eberhardt said the number of one-pot meth labs Tri-County Narcotics, which covers Ingham, Eaton and Clinton counties, responds to have dropped dramatically.
The number of domestic meth laboratories rose throughout the early 2000s and peaked in 2004 before dropping to the lowest numbers since 2000, VerDow said.
Eberhardt said people run less of a risk purchasing the drug than making it. Because of that, Mexican drug cartels are the greatest criminal drug threat in the U.S., according to the DEA’s 2018 National Drug Threat Assessment report.
The mystery of the missing medical records has been solved.
But how do you actually get to them? That’s a whole other problem.
PainMD, a Nashville-area pain management company that recently shuttered clinics and stranded patients without medicine, disclosed in a court filing this week they’ve lost access to countless patient medical records that are stuck in storage units spread across Tennessee, Virginia and South Carolina.
PainMD said it can no longer reach the records because, as the company has been crumbled into bankruptcy while accused of widespread fraud, all the employees with access the storage units have left.
This is a huge conundrum for former patients, many of whom need those records now. Some ex-patients have been without access to their records since six PainMD clinics — recently re-branded under the name Rinova — closed their doors without warning in May.
The closures sent patients searching for new pain clinics, but due to concerns about the opioid crisis, many pain management doctors will only accept new patients with both a medical referral and up-to-date medical records.
PainMD left its patients with neither.
That’s exactly what happened to Esther Jeffries, 59, an ex-patient of the PainMD clinic in Cookeville. Since the clinic closed, Jeffries has been without her medical records and unable to find a new doctor to refill her prescription. Her medication ran out last week.
“I’ve been going through withdrawals. I’ve been sick,” Jeffries said. “I feel like I’m climbing the walls and my husband is about ready to take me to the emergency room to see if I can get any help.”
PainMD accused of injecting patients for pure profit
PainMD and its parent company, MedManagement, once owned or operated as many as 30 clinics in Tennessee, Virginia and North Carolina. Federal and state authorities have sued PainMD and its owners of defrauding the government out of millions by pressuring patients into unnecessary painful injections, then intentionally mislabeling the injections while billing Medicare, Medicaid and TriCare. Three PainMD nurse practitioners were indicted on these same allegations in April.
While these court cases were ongoing, PainMD sold its clinics to company insiders, then re-branded six clinics in Tennessee and Virginia under the new name of Rinova. The Rinova clinics operated for a few more months before abruptly closing on May 8.
Rinova promised to help patients by mailing a final prescription extension and releasing their medical records, but these promises have not been kept. Since the closures, The Tennessean has spoken with at least 25 ex-patients who said they’ve struggled to find a new pain doctor because they can’t access their medical records.
The likely location of those records was revealed last Friday when PainMD filed for bankruptcy, saying it has only $2.8 million in assets but more than $13 million in debts.
Medical records locked in storage
As part of bankruptcy filing, the company revealed that some patient medical records are maintained electronically, but that “many” patient records are kept in file boxes in storage. Medical records and charts are currently kept in at least 23 storage units spread across 10 companies. PainMD claims it can no longer enter any of these storage units because “everyone with access is no longer employed with company.”
That’s a problem for the storage companies too.
Danny Sutton, the owner of SelfStor Solutions in Cookeville, said he rented two units to PainMD, which abruptly stopped paying or answering his calls this month. Sutton is now stuck with two units that he can’t rent because PainMD abandoned stuff inside.
Sutton is legally forbidden from opening the units and checking what was left behind.
“If there are medical records inside, that’s news to me,” Sutton said. “But if they are medical records, there has to be somebody that will be needing those records.”
PainMD could not be reached for comment. Messages left with PainMD’s civil attorney, Jay Bowen, and its bankruptcy attorney, Robert Mendes, were not returned.
The bankruptcy filing also reveals PainMD’s primary owner , Michael Kestner, borrowed $178,000 from the company in 2015. The debt has not been replayed.
Dig Deeper
Opioid crackdown in Tenn.
Brett Kelman is the health care reporter for The Tennessean. He can be reached at 615-259-8287 or at brett.kelman@tennessean.com. Follow him on Twitter at @brettkelman.
The organization’s new opioid recommendations include state-level legislative and regulatory revisions that would foster the goal of a national PDMP database, Steven C. Anderson, NACDS president and CEO, tells Drug Topics.
Proposed PDMP requirements include daily reporting of controlled substance dispensing information to state PDMPs, data standardization to improve PDMP usefulness, a check to the state PDMP by providers prior to issuing a controlled substance prescription, and enabling interstate access to PDMP data.
In Missouri, the only state without a PDMP, NACDS is continuing to work with its two in-state partners on a statewide PDMP that builds on the current county-based program that covers nearly 80% of that state’s population, according to Anderson.
NACDS now recommends that naloxone be coprescribed for some opioid prescriptions. Because certain patient populations are at increased risk of overdose due to the nature of their condition or to the combination of medications they take, coprescribing ensures immediate access naloxone that could prove life-saving in emergencies, Anderson says.
“NACDS will pursue state legislation that ensures all patients taking potentially dangerous combinations have access to naloxone when the initial opioid prescription is filled. NACDS urges the authorization of pharmacists to prescribe and dispense naloxone immediately upon identifying patients at potential risk of overdose, or an individual that presents with possible abuse of heroin,” Anderson says.
NACDS is also urging for reforms in the design of health plans to help identify and treat patients with substance use disorders (SUDs) and is urging improved coverage for pain management treatments other than opioids.
“Opportunities exist to leverage the role of the pharmacist in services that improve access to medications for SUDs and addiction, incentivize screenings for SUDs, and improve access to medication assisted treatment at the physician- and community-pharmacy levels,” says Anderson.
NACDS proposes to pursue federal and state policies that require coverage of alternative, non-opioid drug therapies for chronic pain management at the same formulary and cost-sharing tier. NACDS also proposes to require coverage of complementary or integrated health pain management services, according to Anderson.
Pharmacists’ role in opioid abuse prevention is warranted and welcome—70% of Americans support leveraging pharmacy’s role to help solve issues related to opioid abuse, says Anderson.
In addition, a national survey conducted in January 2019 by Morning Consult and commissioned by NACDS found that, by a 2-to-1 margin, pharmacies and pharmacists are considered to be a solution, not a contributor, to the problem of opioid abuse.
I have been told by pt of Pharmacists/Pharmacies INSISTING that chronic pain pts that have been taking opiates for years NOW REQUIRE THEM TO PURCHASE NARCAN… in order to get their opiate Rx now filled.
At least one pt has told me that husband picked up her opiate Rx at the pharmacy and when he got home they found a Narcan kit in the bag.. Did not tell the pt’s husband that it was in there and no instruction on how to use it.
Pts telling me that they LIVE ALONE and take opiates long term and pharmacist/pharmacies insist on them purchasing Narcan.. and who is going to administer the Narcan if they OD.. which they haven’t done for all the years they have been taking opiates for their chronic pain…
Does this sound like a good way to boost store revenue and “kiss up” to the DOJ/DEA that the chains are doing their part in helping to curtail/address the opiate crisis… which is mostly involving illegal opiate products.
From living with back pain for years to a life-changing procedure. Only the change was not at all what he expected.
NEW BRAUNFELS, Texas — David Winnett has seen a lot. He retired from the Marines as a captain after spending 20 years and countless tours around the world.
“I did three tours in Okinawa. I did a tour down in Guantanamo Bay before 9/11,” said Winnett.
The training took its toll.
“I developed degenerative discs. I started developing severe back pain the last two to three years of my career,” he said.
Push to get patients off pain pills
For years, pain pills helped. Then doctors pushed Winnett to consider an alternative – a spinal cord stimulator (SCS).
“They told me I could relieve the back pain and get off the opiates,” he said.
Stimulators use electrical currents to block pain signals before they reach the brain. Each year, 50,000 are implanted worldwide.
Courtesy of the Mayo Clinic
Mayo Clinic
He scheduled surgery for September 2017, a one-week trial to see if he should get the permanent implant.
“I came out of recovery and, within about a minute of waking up, I felt a very intense pain in my left groin,” he recalled.
He stood up for what he did not realize would be the last time.
“I laid back down and the exact same thing began happening on the other side – intense pain – and then the pain hit my back. It was like someone was stabbing me in the spine. It was just horrible, I just started screaming,” Winnett said. “Around that same time, my legs went to sleep.”
Doctors flew Winnett to Austin for emergency surgery, removing the stimulator first.
“I thought the pain at the clinic in my groin was bad. Oh, no, this was like a thousand times worse,” he said. “The next day I woke up in ICU. The doctor who put the device in came to visit me and he was apologizing to me and I said, ‘Hey doc, that pain, when they took that thing out, was horrendous.’ And he said, ‘Didn’t they turn it off?’ He looks at me. And I think, why didn’t he turn it off?”
He took a video while recovering in the hospital that showed the lights were still flashing, the power to the stimulator was still on.
“It literally felt like I had sparks inside my spine – it was that bad,” he said. “An MRI taken right after they pulled them out in Austin showed that one of the leads had taken a wrong turn. It hadn’t gone straight in.”
Doctors determined the stimulator hit a blood vessel, causing blood to fill his spinal column killing the nerves of his spine. The life-changing surgery changed him in ways he never imagined.
“I’m a paraplegic. This has just been a nightmare.”
Winnett is not alone. Device Events.com found 681 people have been paralyzed by spinal cord stimulators and more than 100,000 other injuries – most since 2008.
Dan Ross, an Austin attorney, represents Winnett and has represented a number of other patients with medical device injuries.
“There are many heartbreaking stories including David’s,” said Ross. “Companies have been successful in getting judges to throw out these cases because they are preempted by a law that doesn’t offer any remedies.”
The device Winnett had implanted was approved a month before his surgery through the pre-market approval (PMA) process, meaning it did undergo some human clinical trials.
People harmed, killed or disabled by a medical device that the U.S. Food and Drug Administration classifies as Class III cannot sue the manufacturer. Class III devices have the highest risk – they include cardiac stents, pacemakers and stimulators.
This is due to a 2008 U.S. Supreme Court ruling. The case Riegel vs. Medtronic granted “pre-emption” protection to makers of devices that undergo PMA. The court ruled that, because the devices undergo clinical trials and studies, they are subject to liability protection.
That means Winnett cannot sue the manufacturer for what happened. It’s a loophole Congressman Lloyd Doggett and others want to fix with the Medical Device Safety Act.
“It’s important that doctors get this information in and that we have the right. Everyone has the right to seek redress for their injuries and that these companies don’t hide behind the FDA,” said Doggett.
Retirement plans altered
It is too late for Winnett.
“I did not plan to spend my retirement this way,” said Winnett. “Ironically, even after this paraplegia, I still have the same back pain because I’m paralyzed below that level.”
He makes the best of each day sharing his story in hopes of helping others know the risks.
“I tried to do the right thing, what’s politically correct nowadays, to get off the opiates. Well, look what happened to me as a result. If I’d had it to do over, I would have slept in that day,” he said.
Comment from NANS
The North American Neuromodulation Society issued a statement about spinal cord stimulation this fall. It can be found here.
It states that “approximately 60,000 SCS therapies were implanted in the U.S. in 2016. Up to one-third of patients implanted with a SCS system will experience a complication, the vast majority of which are minor. “
It goes on to state, “Reported severe neurologic complications, including paralysis, occur in less than 1%.”
Hamilton, Ontario—Despite past reports of serious health issues with proton pump inhibitors (PPIs), pharmacists can offer some reassurance to patients using the drugs to treat gastroesophageal reflux disease or related diseases.
A new study published in Gastroenterology found no evidence that PPI use increases risk for pneumonia, chronic kidney disease, diabetes, or dementia. Results came from a large, multiyear, randomized trial of patients receiving rivaroxaban or aspirin.
McMaster University–led researchers said there is no reason to limit PPI prescriptions because of concerns about long-term harm, although the medication should be used only when the benefits are expected to outweigh the risks and according to recommended dose and duration of treatment.
“Our research provides welcome news for the countless patients who rely on PPIs to control their symptoms, as well as the physicians who prescribe this medication,” said lead author Paul Moayyedi, MB, ChB, PhD, The Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. “To our knowledge, this is the first prospective randomized trial to evaluate the many long-term safety concerns related to PPI therapy. It is reassuring that there was no evidence for harm for most of these events.”
Noting that the drugs are effective at treating acid-related disorders, the study team points out that although the drugs have been shown to be well-tolerated in the short term, observational studies have raised questions about long-term treatment. The trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease was designed to answer those concerns.
The study randomly assigned 8,791 patients to 40 mg of pantoprazole daily and 8,807 to placebo. In addition, participants were divided into groups receiving rivaroxaban (2.5 mg twice daily) with aspirin (100 mg once daily); rivaroxaban (5 mg twice daily); or aspirin (100 mg) alone.
Researchers tracked any development of pneumonia, Clostridium difficile infection, other enteric infections, fractures, gastric atrophy, chronic kidney disease, diabetes, chronic obstructive lung disease, dementia, cardiovascular disease, cancer, hospitalizations, and all-cause mortality every 6 months, with follow-up of a median of 3.01 years.
Results indicate no statistically significant difference between the pantoprazole and placebo groups in safety events except for enteric infections (1.4% vs. 1.0% in the placebo group; odds ratio, 1.33; 95% CI, 1.01-1.75).
Study authors point out that, for all other safety outcomes, proportions were similar between groups except for C difficile infection, which was approximately twice as common in the pantoprazole versus the placebo group; only 13 events occurred, however, so the difference was not considered statistically significant.
“In a large placebo-controlled randomized trial, we found that pantoprazole is not associated with any adverse event when used for 3 years, with the possible exception of an increased risk of enteric infections,” researchers conclude.
