Do OTC Pain Relievers Dull Your Emotions?

By Pat Anson, Editor

Ibuprofen, acetaminophen and other over-the-counter pain relievers may do more than just dull your physical pain. They could also dull your emotional and cognitive senses, according to a new study.

Researchers at the University of California, Santa Barbara reviewed a small body of clinical studies that suggest OTC pain medications have an overlapping effect on us, both physically and emotionally.

One study, for example, found that acetaminophen makes people feel less empathy for others.

Research also found that women who took ibuprofen reported less social anxiety and hurt feelings after being excluded from a game or when writing about a time when they felt betrayed.

Yet another study found that acetaminophen lessens the discomfort of parting with a prized possession. When asked to set a selling price on an object they owned, individuals who took acetaminophen set prices that were cheaper than the prices set by individuals who took placebos.

"In many ways, the reviewed findings are alarming," wrote lead author Kyle Ratner, PhD, an assistant professor of psychology at UC Santa Barbara. "Consumers assume that when they take an over-the-counter pain medication, it will relieve their physical symptoms, but they do not anticipate broader psychological effects.

“Are more regulations needed? Should warnings be expanded on drug labels? At this point, drawing strong conclusions from the existing studies would be premature. Nonetheless, policymakers might start thinking about potential public health risks and benefits.”

Ratner and his colleagues say one place to start is to further study the effects of OTC analgesics on pregnant women. Recent research has found higher rates of autism and attention deficit disorder (ADHD) in young children whose mothers used acetaminophen while pregnant.

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. Ibuprofen is also widely used and can be found in brand name products such as Motrin and Advil.   

“Found in medicine cabinets across the world and used multiple times per week by people of all ages, genders, and ethnic backgrounds, these drugs are woven into modern life. Policymakers should take note of existing findings but not rush to judgment,” said Ratner.

The study is published online in the journal Policy Insights from the Behavioral and Brain Sciences.

Jeff Sessions, Aspirin and Toughing It Out

By Crystal Lindell, Columnist

My first reaction to reading that Attorney General Jeff Sessions thinks pain patients should just “tough it out” was probably not appropriate for this publication.

My second reaction probably wasn’t either.

If you haven’t heard, Sessions hates drugs. Like a lot. He literally once said, “good people don’t smoke marijuana.”

And now, he apparently thinks good people shouldn’t use opioid pain medication.

"I am operating on the assumption that this country prescribes too many opioids," Sessions said during a speech at the U.S. Attorney’s office in Tampa. "People need to take some aspirin sometimes and tough it out.”

Okay. Look. Setting aside the fact that data consistently shows that most people do not start heroin because they received a legitimate hydrocodone prescription, let’s talk about this whole idea of “toughing it out.”

Because that’s the thing about pain, when it’s not yours, it’s incredibly easy to endure. All you really have to do is throw around clichés about being a strong person, and maybe sprinkle in some lame advice about yoga and acupuncture.

Depending on your mood, you might even add in a few judgmental asides about avoiding gluten and getting enough exercise. And just like that: Voila! You’ve dealt with it! Problem solved.

But when it’s your pain. When it’s eating away at your soul, it’s never that easy. And it never gets easy.

Left untreated, the pain that wraps around the right side of my ribs has left me dreaming of drowning in a bottle of Drano just to make it stop. It has buried me in bed and left me for dead, so heavy on my chest that I can’t get up. It has stolen my nights and destroyed my days. And it has done its very best to rob me of my hope. 

In short, it’s been hell. And the words that would make you truly understand how awful it has been do not exist.

But thankfully, I found a doctor who has helped me get through hell and manage my constant pain with opioid pain medications.

And it’s because of those medications that I can live. I can work. I can be a friend, and a sister, and a lover, and a writer, and daughter. I can be connected to the magic of the universe again.

There is so much we can do to fight the opioid epidemic. Those suffering from addiction need long-term treatment that includes professional psychiatric help. They need to be offered medicated withdrawal when needed, and given a strong support system. And they need empathy.

In fact, it’s the same empathy pain patients need, just applied differently.

I don’t expect a man like Jeff Sessions to understand this. He has never been in horrific pain. And honestly, as much as I hate him, I hope he never is.

But if he does wake up with pain one day, and realizes how important it is to treat that pain, I hope he looks back on his life with regret and remorse, as he realizes how incredibly wrong he was to ever suggest that people in pain “tough it out.”

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Sessions Tells Pain Patients to ‘Tough It Out’

By Pat Anson, Editor

Take two aspirin and call me in the morning.

That old cliché is finding new life – at least in the mind of U.S. Attorney General Jeff Sessions --- who suggested twice this week that aspirin is the solution to the nation’s opioid crisis.

"I am operating on the assumption that this country prescribes too many opioids," Sessions said during a Wednesday visit to the U.S. Attorney’s office in Tampa. "People need to take some aspirin sometimes and tough it out.”

During his 25-minute speech, the Tampa Bay Times reported that Sessions veered away from his prepared remarks to cite the example of White House chief of staff Gen. John Kelly, who refused to take opioid painkillers after recent minor surgery.

"He goes, ‘I’m not taking any drugs,’" Sessions said, drawing a laugh while imitating Kelly. "But, I mean, a lot of people — you can get through these things."

"That remark reflects a failure to recognize the severity of pain of some patients," said Bob Twillman, PhD, executive director of the Academy of Integrative Pain Management.

JEFF SESSIONS

"It’s an unconscionable remark," Twillman told the Tampa Bay Times. "It further illustrates how out of touch parts of the administration are with opioids and pain management."

Sessions made similar statements Tuesday night at a Heritage Foundation event marking the birthday of President Ronald Reagan.

"Sometimes you just need to take two Bufferin or something and go to bed," said Sessions, who added that his goal in 2018 was to see a continuing decline in opioid prescriptions, which have been falling since 2010.

“We had a 7 percent decline last year in actual prescriptions of opioids. We think doctors are just prescribing too many,” he said. “These pills become so addictive. The DEA says a huge percentage of the heroin addiction starts with prescriptions. That may be an exaggerated number. They had it as high as 80 percent. We think a lot of this is starting with marijuana and other drugs too.”

Sessions was referring to a single but often-cited survey, which found that most heroin users in addiction treatment also abused prescription opioids. The fact is most addicts try a variety of different substances – such as tobacco, marijuana, alcohol and opioid medication – before moving on to heroin. It is rare for a legitimate patient on legally prescribed opioids to use heroin.  

The Drug Enforcement Administration – an agency that Sessions oversees – has ordered a reduction in the supply of prescription opioids in 2018. That’s in addition to steep cuts in opioid production quotas the DEA imposed in 2017.  The agency ignored dozens of public comments warning that further reductions this year in the opioid supply could create shortages.  

High Dose Opioids Targeted Under New Medicare Rules

By Pat Anson, Editor

The Trump administration has proposed new rules that will make it harder for Medicare patients to obtain high doses of opioid pain medication. If adopted, critics say the regulations could force many high-dose pain patients to be abruptly tapered to lower doses, a risky procedure that could lead to severe pain and withdrawal symptoms, or even illegal drug use and suicide.

The rules proposed by the Centers for Medicare & Medicaid Services (CMS) would also make health insurers the final arbiters in deciding who gets high doses of opioid medication.

"We are proposing important new actions to reduce seniors' risk of being addicted to or overdoing it on opioids while still having access to important treatment options," said Demetrios Kouzoukas, CMS deputy administrator. “We believe these actions will reduce the oversupply of opioids in our communities."

Under the proposal for the 2019 Medicare Part D prescription drug program, a ceiling for opioid doses would be established at 90mg morphine equivalent units (MME).  Any prescription at or above that level would trigger a “hard edit” requiring pharmacists to talk with the insurer and doctor about the appropriateness of the dose.

Medicare officials claim the goal of the rule is to get patients, doctors and insurers to “engage in a dialogue” about the risks associated with opioids. But regardless of how that dialogue goes, ultimately the final decision on whether to override the hard edit would be left to insurers – known as plan sponsors.

"The trigger can only be overridden by the plan sponsor after efforts to consult with the prescribing physician," said Kouzoukas.

The 90mg MME ceiling was established in 2016 by the CDC’s much criticized opioid prescribing guidelines. Those “voluntary” guidelines were only meant as recommendations for primary care physicians, but have been widely adopted as rigid rules by other federal agencies, insurers, state regulators and prescribers.

High Dose Patients at Risk

CMS says 1.6 million Medicare beneficiaries met or exceeded opioid doses of 90mg MME for at least one day in 2016. Many suffer from chronic or intractable pain and have been on high doses for years.

“If this CMS proposal is adopted, it will accelerate an ongoing pattern of involuntary opioid tapers,” says Stefan Kertesz, MD, a practicing physician and professor of medicine at the University of Alabama at Birmingham School of Medicine. “I have great concern for today’s high dose patients, many of whom have complex disabilities. Their disabilities often reflect a combination of underlying physical disease, mental conditions, harm from the health care system and opioid dependence, even if those same opioids confer some degree of relief.

"Over the last year, I have received wave after wave of reports of traumatized patients, with outcomes that include suicidal ideation, medical deterioration, rupture of the primary care relationship, overdose to licit or illicit substances, and often enough, suicide.” 

Those suicides -- such as those of Bryan Spece and Jay Lawrence -- are rarely reported by the mainstream media or acknowledged by anti-opioid activists.

To reduce the risk of these “unintended consequences,” CMS would allow high dose patients to receive a temporary 7-day supply of opioids while they seek an exception to the 90mg MME rule. If approved, patients would then need to get a new prescription from their doctor. The 7-day supply would only be granted once.

Under the proposed rules, CMS would also create a new 7-day limit for initial prescriptions of opioids for acute, short-term pain. CMS would also start monitoring “high risk beneficiaries” who are prescribed opioids and “potentiator” drugs such as gabapentin (Neurontin) and pregabalin (Lyrica). Recent research has shown that combining the medications increases the risk of overdose.

CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.

Public comments on the proposals must be submitted by Monday, March 5, 2018. To submit comments or questions electronically, go to www.regulations.gov, enter the docket number “CMS-2017-0163” in search  and follow the instructions for submitting a comment. 

The 2019 proposed rule changes may viewed by clicking here.

Feds Target Doctors and Pharmacies in New Crackdown

By Pat Anson, Editor

Over the next few weeks, the Drug Enforcement Administration will step up investigations of pharmacies and doctors found to be dispensing or prescribing suspicious amounts of opioid pain medication.

The so-called “surge” -- announced by Attorney General Jeff Sessions – is the latest in a series of steps the Justice Department has taken to combat the opioid crisis.

“Over the next 45 days, DEA will surge Special Agents, Diversion Investigators, and Intelligence Research Specialists to focus on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of drugs,” Sessions said during a Tuesday speech to law enforcement officials in Louisville, KY.

“DEA collects some 80 million transaction reports every year from manufacturers and distributors of prescription drugs.  These reports contain information like distribution figures and inventory.  DEA will aggregate these numbers to find patterns, trends, statistical outliers -- and put them into targeting packages,” Sessions said.

"That will help us make more arrests, secure more convictions -- and ultimately help us reduce the number of prescription drugs available for Americans to get addicted to or overdose from these dangerous drugs.”

But that kind of data mining of opioid prescriptions -- without examining the full context of who the medications were prescribed for or why – can be problematic and misleading.

For example, the DEA last year raided the offices of Dr. Forest Tennant, a prominent California pain physician, as well as two pharmacies regularly used by his patients. Tennant only treats intractable pain patients, many from out-of-state, and often prescribes high doses of opioids and other prescription drugs  because of their chronically poor health. Some of his patients are in palliative care and near death.

Those important facts were omitted or ignored by DEA investigators, who alleged in a search warrant that Tennant had “very suspicious prescribing patterns” and was part of a drug trafficking organization.

“It’s not like he’s just giving out high doses of medication and running a pill mill, like they said. That to me was the most asinine statement in that whole search warrant,” said Riley Holder, a disabled pharmacist with intractable pain who is one of Tennant’s patients.

Tennant has denied any wrongdoing and has not been charged with a crime.

Last August, Sessions ordered the formation of a new data analysis team, the Opioid Fraud and Abuse Detection Unit, to focus solely on opioid-related health care fraud.  He also assigned a dozen prosecutors to “hot spots” around the country where opioid addiction is common. In November, Sessions ordered all 94 U.S. Attorneys to designate an opioid coordinator to help spearhead anti-opioid strategies in their district.

FBI to Target Online Pharmacies

Sessions this week also announced the formation of a new FBI investigative team, called the Joint Criminal Opioid Darknet Enforcement (J-CODE) unit, which will focus on shutting down illegal online pharmacies. Dozens of FBI agents and intelligence analysts are being assigned to J-CODE.  

“Criminals think that they are safe on the darknet, but they are in for a rude awakening. We have already infiltrated their networks, and we are determined to bring them to justice,” Sessions said. “The J-CODE team will help us continue to shut down the online marketplaces that drug traffickers use and ultimately that will help us reduce addiction and overdoses across the nation.”

As PNN has reported, the online pharmacy business is booming. As many as 35,000 online pharmacies are operating worldwide, and over 90 percent are not in compliance with federal and state laws.  Many do not require a prescription, and about half are selling counterfeit painkillers and other fake medications. About 20 illegal online pharmacies are launched every day.

A staff report last week to the U.S. Senate's Subcommittee on Investigations found that it was relatively easy to find and order prescription drugs online. Senate investigators used Google search to find dozens of websites offering illegal opioids for purchase, including fentanyl and carfentanil. They also identified seven individuals who died from fentanyl-related overdoses after sending money and receiving packages from an online seller.

“I’m thrilled this is something the U.S. government is prioritizing and is starting to pay attention to,” says Libby Baney, Executive Director of the Alliance for Safe Online Pharmacies (ASOP), an industry supported non-profit. “The Internet is part of the problem right now when it comes to the opioid epidemic and it should be part of the solution.”

Baney told PNN that when illegal online pharmacies are shutdown, they often reappear under new domain names and website addresses. Many are also located in foreign countries and are outside the reach of U.S. law enforcement.

“It’s a game of whack-a-mole in some respects,” said Baney.  

Last year the Justice Department announced the seizure of the largest dark net marketplace in history, a site that hosted over 200,000 drug listings and was linked to numerous opioid overdoses, including the death of a 13-year old.

Medicare Expands Opioid Monitoring After GAO Report

By Pat Anson, Editor

The General Accounting Office (GAO) – now known as the Government Accountability Office – was established by Congress in 1921 to act as an independent, nonpartisan watchdog of the federal government.  

“We provide Congress with timely information that is objective, fact-based, nonpartisan, nonideological, fair, and balanced. Our core values of accountability, integrity, and reliability are reflected in all of the work we do,” the GAO says in its mission statement. 

Fair and balanced? Not always – at least not when it comes pain patients and their medication.

Two months ago, PNN reported on a GAO audit that recommended the Centers for Medicare and Medicaid Services (CMS) greatly expand its monitoring of Medicare patients who receive high doses of opioid pain medication.  

Over 700,000 Medicare beneficiaries currently receive opioids in excess of 90mg morphine equivalent doses, and the GAO thinks it would be a good idea to have private insurers track these patients and their doctors to look for signs of “inappropriate prescribing.”

Critics say such a policy would have a chilling effect on many doctors, who already fear government sanctions for prescribing opioids.

FOIA Request Rejected

We were struck by a footnote in the GAO report, which indicated the agency had never consulted with pain sufferers, patient advocacy groups or professional organizations that represent prescribers while preparing its audit. But the GAO did reach out to insurers, regulators, law enforcement, addiction treatment specialists, anti-opioid activists, and surgeons who specialize in spinal injections:

"We interviewed officials from the largest six health care plan sponsors: Aetna, Cigna, CVS Health, Express Scripts, Humana, and United Health Group. We also interviewed 12 stakeholders that represent a range of perspectives on opioid use and prescribing patterns in Medicare: AARP, American Health Insurance Plans, American Society of Interventional Pain Physicians, Brandeis Prescription Drug Monitoring Program Training and Technical Assistance Center, Federation of State Medical Boards, National Association of Drug Diversion Investigators, National Association of Medicaid Directors, National Healthcare Antifraud Association, Pew Charitable Trust, Pharmaceutical Care Management Association, Physicians for Responsible Opioid Prescribing (PROP), and one expert on opioid abuse."

The GAO said it did not identify any of the “stakeholders” by name because the interviews were conducted on a not-for-attribution basis to encourage frank discussion. Pain News Network filed a Freedom of Information Act (FOIA) request to get the agency to disclose those names – which was quickly rejected.

“As an agency responsible to the Congress, GAO is not subject to FOIA,” Timothy Bowling, the GAO’s Chief Quality Officer, wrote to PNN. “Please be advised that while conducting the audit engagement above, GAO obligated itself not to disclose any names or identifiable information related to these stakeholder groups.”

This is certainly not the first time pain patients and pain management experts have been denied a seat at the table when federal decisions are made about pain care.

In 2015, the Centers for Disease Control and Prevention failed to consult with patients or practicing pain physicians when it drafted its opioid prescribing guideline. The CDC even refused to disclose who served on its expert advisory panel until it was threatened with a lawsuit.  

Patients and doctors were also excluded from a closed door meeting of the Healthcare Fraud Prevention Partnership -- an obscure federal advisory group – when it met in a 2016 "special session" to discuss Medicare's opioid prescribing policies. More recently, President Trump’s opioid commission released its final report without taking any public testimony from pain sufferers, patient advocates or pain management physicians.

“I find it very disturbing that federal agencies continue to ignore pain care providers and advocacy groups for people with pain when they formulate policies that very clearly will impact those parties. Again and again, they consult with parties that have a vested interest in reducing opioid prescribing regardless of the impact on people with pain," said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“It’s wrong, and everyone with a stake in pain management should demand that they start allowing us to sit at the table, rather than just to be on the menu.”

Medicare Tracking Opioid Prescriptions  

What became of the GOA report and its recommendations? Many are now being implemented by CMS.

In testimony before a House committee this month, a GAO official said CMS had agreed to start collecting data on all Medicare beneficiaries prescribed high dose opioids, as well as doctors who are “inappropriately and potentially fraudulently overprescribing opioids.”  

“A large number of Medicare Part D beneficiaries use potentially harmful levels of prescription opioids, and reducing the inappropriate prescribing of these drugs is a key part of CMS’s strategy to decrease the risk of opioid use disorder, overdoses, and deaths,” said Elizabeth Curda, Director of Health Care for GAO.

“Access to information on the risks that Medicare patients face from inappropriate or poorly monitored prescriptions, as well as information on providers who may be inappropriately prescribing opioids, could help CMS as it works to improve care.”

CMS is also considering rule changes for Part D prescription drug plans in 2019 that would designate most opioids as “frequently abused drugs,” and would require some Medicare beneficiaries to obtain their opioid prescriptions from prescribers and pharmacies selected by CMS.

Opioid Commission Member Calls Panel a ‘Charade’

By Pat Anson, Editor

The Trump Administration and Congress have so neglected the country’s opioid crisis that they have turned the work of the president's opioid commission into a "charade" and a "sham," according to one panel member.

In a wide ranging interview with CNN, former Democratic Rep. Patrick Kennedy lamented a lack of focus and funding the opioid crisis has received since President Trump declared the overdose and addiction epidemic a national public health emergency last October.

"This and the administration's other efforts to address the epidemic are tantamount to reshuffling chairs on the Titanic," said Kennedy.

"The emergency declaration has accomplished little because there's no funding behind it. You can't expect to stem the tide of a public health crisis that is claiming over 64,000 lives per year without putting your money where your mouth is."

PATRICK KENNEDY

Without funding and resources, Kennedy said he believes the opioid commission's work had become a charade.

"I do. I honestly do. It means nothing if it has no funding to push it forward.... this thing's a charade,”” he told CNN. "I have to be true to the way I feel. This is essentially a sham."

President Trump appointed the bipartisan panel in March to give him a list of recommendations to combat drug addiction and the overdose crisis. 

COMMISSION on combating drug abuse and the opioid crisis

After a series of public hearings, the commission released its final report in November, an ambitious list of over four dozen recommendations aimed at treating addiction, preventing overdoses, and further restrictions on opioid prescribing.

But since the report’s release, little money has been set aside by Congress or the administration to implement the panel’s recommendations, except to increase border security and detect illegal drugs.

Last week President Trump proposed cutting the budget of the White House Office of National Drug Control Policy – which oversaw the opioid commission’s work -- by 95 percent.  After a year in office, the president has yet to appoint a permanent director for the office, which currently has a 24-year old deputy chief of staff fresh out of college with no prior experience in management or drug control policy.

"Everyone is willing to tolerate the intolerable -- and not do anything about it," said Kennedy, who is recovering from alcohol and opioid addiction, and is a prominent mental health advocate.

“I'm as cynical as I've ever been about this stuff,” he said. “We've got a human addiction tsunami, and we need all hands on deck."

Bertha Madras, another member of the opioid commission, told CNN the panel has never received any direct feedback from Trump about its work. But she praised the selection of presidential advisor Kellyanne Conway as the key point person for the administration in dealing with the opioid crisis.

"That is really a very significant issue, bringing the implementation directly into the White House, as opposed to having intra-agency meetings," said Madras, a professor of psychobiology at Harvard Medical School. "Having been in government 10 years ago or so, I know how difficult it is to be able to generate change without having executive leadership behind you."

When asked by CNN about Kennedy's critique, she praised him for the "passion and depth he brings to the problem," but said it was premature for her to comment until she sees how much money is eventually allocated for the opioid crisis.

Senator’s Letter Ignores Constituent’s Chronic Pain

By Pat Anson, Editor

Pain News Network received hundreds of comments and emails from readers responding to the open letter we published from Charles Malinowski, a 59-year old California man who suffers from Reflex Sympathetic Dystrophy (RSD) and other chronic pain conditions.

Malinowski is no longer able to obtain opioid medication and blames the CDC opioid guidelines for his “unspeakable and crippling pain.”

CHARLES MALINOWSKI

“Within 60 days I expect that the CDC will have effectively killed me. I honestly don't see myself being able to tolerate the pain any longer than that,” Malinowski wrote in his letter. “Congress, in going along with this blindly, will be explicitly complicit in this negligent homicide - or homicide by depraved indifference, take your pick.”

Malinowski’s letter to Senator Kamala Harris (D-CA) hit home with many readers, who say they’ve been abandoned by doctors who are fearful of prescribing opioid medication.  

“You are correct in saying the CDC is in effect murdering us. I too suffer from chronic pain and am unable to obtain pain meds from a doctor due to CDC guidelines,” wrote one reader.

“I just read your letter and cried all the way through it. My son in law will turn 50 this month and has been living with RSD for over 8 years. His story is a carbon copy of yours. Since the change in his meds about a month ago, (he) is now showing signs of heart trouble,” wrote Jo Ellen.

“Charles you are not alone and this attack on pain patients is affecting every pain patient nationwide,” wrote Pam. “This is terrorism at its finest folks. How many more pain patients will die due to a fictitious opioid epidemic?”

“I’m stuck in bed suffering inhuman pain 24-7 days a week. I’m lucky I have sanity now to write this. For 17 years I was under the watchful eye of a very educated doctor. Now abandoned by all in the medical field,” wrote Christine.

“This exact thing happened to my husband. He unfortunately passed away from a heart attack 6 months later,” wrote Sharon. “I pray your letter falls into the correct place to save your life and many others that are now in the same situation.”

And what about Sen. Harris, who Malinowski wrote his letter to?

She sent him a form letter that completely ignored his severe pain and life-threatening situation. It focused instead on combating opioid abuse and treating addiction.

“Thank you for reaching out to me to express your concern about the opioid crisis,” Sen. Harris wrote. “This administration and Congress must treat opioid abuse as a public health crisis. We need more funding to combat the opioid epidemic that is threatening millions.”

Malinowski replied to Sen. Harris with a second letter.

“I was very disappointed to discover that your response to me was an apparent boilerplate letter about continuing the already out-of-control hysteria over the so-called opioid epidemic,” Malinowski wrote. “My letter had nothing to do with controlling the illicit dispersal of opioids.

SEN. KAMALA HARRIS (D-CA)

"My letter was about the new CDC opioids guidelines being a literal death sentence for people like me. This is a literal death sentence because medication we depend upon is being withheld from us in a grossly and medically irresponsible manner. How you could have completely missed the blatantly obvious topic of my letter and responded so completely off-topic is simply beyond me. I think your response was shamefully ignorant and completely irresponsible.”

Unfortunately, this is not the first time we’ve heard from patients who wrote to their senator or congressman about the poor state of their pain care and gotten a form letter in response about the “opioid epidemic.” Which is no reason to stop trying or holding politicians accountable.  

“I want to hear from you. Contact me,” Sen. Harris says on her homepage. 

PNN tried to contact you, Sen. Harris. We emailed, called and left messages at your offices in Washington and Los Angeles several times in the last two weeks. Not only were we unable to speak to anyone on your staff, we couldn't even get someone to answer your phone. And we have yet to get a reply.

Neither has Charles Malinowski.  

(Update: On January 26, I finally received a reply from Sen. Harris.  But her emailed letter was yet another misdirected form letter. It thanked me for reaching out "to share your views opposing abortion."   

Tom Petty Overdosed on Opioids and Anxiety Medication

By Pat Anson, Editor

Tom Petty died from an accidental overdose caused by a potent cocktail of opioid painkillers, anti-anxiety medication and an anti-depressant that the singer was taking for chronic pain and other illnesses, according to autopsy findings and family members. Two of the drugs detected were illegal fentanyl analogues.

The 66-year old rock legend died last October after suffering cardiac arrest and collapsing at his home in Malibu. He had just completed a grueling tour to mark the 40th anniversary of his band, Tom Petty and the Heartbreakers.

In autopsy results released Friday, the Los Angeles County Coroner listed Petty’s cause of death as  "multisystem organ failure due to resuscitated cardiopulmonary arrest due to mixed drug toxicity."

Toxicology tests showed the presence of two prescription opioids (oxycodone and fentanyl), as well as two benzodiazepines (temazepam and alprazolam) for anxiety and the anti-depressant citalopram. Doctors have long warned that such a combination of prescription drugs can be deadly, leading to respiratory depression and overdose.

In addition, the coroner also listed two chemical cousins of fentanyl: acetyl fentanyl and despropionyl fentanyl. They are not prescription drugs, but are illegal synthetic opioids increasingly appearing on the black market in counterfeit medication.  The brief statement by the coroner did not point this out, nor did it list the blood levels at which any of the drugs were detected.

TOM PETTY

Petty’s wife Dana and daughter Adria released a statement saying the singer was prescribed "various pain medications for a multitude of issues including fentanyl patches," and that he suffered from emphysema, knee problems and a fractured hip.

“Despite this painful injury he insisted on keeping his commitment to his fans and he toured for 53 dates with a fractured hip and, as he did, it worsened to a more serious injury. On the day he died he was informed his hip had graduated to a full on break and it is our feeling that the pain was simply unbearable and was the cause for his over use of medication," the statement said.

“On a positive note we now know for certain he went painlessly and beautifully exhausted after doing what he loved the most, for one last time, performing live with his unmatchable rock band for his loyal fans on the biggest tour of his 40 plus year career. He was extremely proud of that achievement in the days before he passed.”

The family said it recognized Petty’s overdose may “spark a further discussion on the opioid crisis” and perhaps save some lives. “Many people who overdose begin with a legitimate injury or simply do not understand the potency and deadly nature of these medications,” they said.

Fentanyl and benzodiazepines were also linked to the deaths of the pop star Prince and the rapper Lil Peep.

In 2016, the Food and Drug Administration expanded the warning labels on all opioids and benzodiazepines because of the risk they pose when used together.

"It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together," said then FDA Commissioner Robert Califf, MD. "We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or CNS (central nervous system) depressants more generally – together outweigh these serious risks."

GOP Report Blames Medicaid for Opioid Crisis

By Pat Anson, Editor

A new congressional report claims there is “overwhelming evidence” that Medicaid has  contributed to the nation’s opioid crisis by making it easy for beneficiaries to obtain and abuse opioid prescriptions.

The lengthy report, called “Drugs for Dollars: How Medicaid Helps Fuel the Opioid Epidemic,” was prepared by the Republican controlled Senate Homeland Security and Governmental Affairs Committee. Democrats on the committee complained the report was concocted to discredit and demonize Medicaid expansion under the Affordable Care Act, also known as Obamacare.

The report cites 1,072 people since 2010 that have been convicted or accused of using Medicaid to improperly obtain prescription opioids.  That is only a tiny fraction of the nearly 70 million people enrolled in Medicaid, but the report nevertheless draws some sweeping conclusions.

“Overwhelming evidence shows that Medicaid has inadvertently contributed to the national tragedy that is the opioid epidemic, and has taken a toll that is playing out in courtrooms across the nation,” the committee staff reported.

“Other well-intended government programs, such as Medicare, may provide similar incentives for rational actors to engage in bad behavior with highly addictive opioids. These issues hold major ramifications for public policy, along with the nation’s health. They deserve serious consideration and a sober national debate, one we hope this staff report will help to initiate. The victims of this terrible epidemic deserve no less.”

The report cites dozens of examples of doctors and beneficiaries abusing the system, such as a $1 billion scheme to defraud Medicaid and Medicare that involved numerous health care providers.

Committee staff also claimed that drug overdose deaths were rising nearly twice as fast in Medicaid expansion states as in non-expansion states. About 12 million more Americans receive Medicaid coverage under Obamacare.

“While there is clearly no single cause to the epidemic, evidence has emerged that Medicaid is playing a perverse and unintended role in helping to fuel and fund the opioid epidemic,” Sen. Ron Johnson (R-WI) wrote in a letter to Eric Hargan, the Acting Secretary of the Department of Health and Human Services.

“The data uncovered in this examination point to a larger systematic problem – because opioids are easily obtained and inexpensive through Medicaid, the structure of the program itself creates a series of incentives for beneficiaries to use opioids and sell them for potentially enormous profits.”

‘Total Hogwash’

The committee’s ranking Democrat, Sen. Claire McKaskill of Missouri, called the report misleading.

"This idea that Medicaid expansion is fueling the rise in opioid deaths is total hogwash," McCaskill said in a statement. "It is not supported by the facts. And I am concerned that this committee is using taxpayer dollars to push out this misinformation to advance a political agenda."

“Separate scientific studies conducted by other authors show that (the) opioid epidemic predates Medicaid expansion and that recent increases in overdoses stem from fentanyl and heroin, not prescriptions obtained through Medicaid.  Unlike the report released by the majority staff today, these studies were both scientific and comprehensive.”

The report’s conclusions were also questioned by a longtime critic of opioid prescribing.

“I believe the access to prescribers that Medicaid, Medicare and commercial insurance offers does increase the likelihood that someone might develop a disease often caused by prescriptions,” said Andrew Kolodny, MD, founder and Executive director of Physicians for Responsible Opioid Prescribing (PROP).

“But I do not believe that Medicaid should be singled out in this regard. Opioid overdoses have been increasing in people with all types of insurance and in people from all economic groups, from rich to poor.”

A report released this week by the Kaiser Family Foundation found that states with above average overdose death rates includes 18 states that expanded their Medicaid coverage and 8 states that did not.  Overall, Medicaid covers nearly 40% of the two million Americans estimated to have opioid addiction.

Opioid Medication Has Been a Godsend to Me

Susan Lay, Guest Columnist

I have been on pain medication for over 30 years, starting with Vicodin. My doctor at the time wasn't concerned about the hydrocodone in Vicodin as much as he was the amount of acetaminophen in it, as it could destroy my liver.

He sent me to an anesthesiologist, who has been my pain doctor for over 20 years. After all the nerve blocks, physical therapy, imagery, TENS unit, spinal cord stimulator, pain pump, etc., I was given Roxicodone. Afterwards, OxyContin was created and then time released OxyContin.

I couldn't tolerate them, so he gave me fentanyl patches (which were new on the market) with fentanyl lozenges for breakthrough pain. My insurance eventually denied the lozenges. The patches were wonderful because I had no feelings of being “high” like other drugs. They made it possible for me to continue working and have a life. I have used the patches since that first day and they've been a Godsend.

Subsys spray was prescribed for breakthrough pain about 6 years ago, but at $22,000 a month, my insurance only paid for a year.

I'm so fortunate to still have the same doctor, although he's getting older and will retire soon. My main issue has been with pharmacies. I live in a very rural area of California and about 2 years ago my regular pharmacy refused to fill any opioids due to DEA and other concerns. My doctor has continued to write scripts for me, but I found them extremely difficult to fill. All the pharmacies I tried, including Walmart, Rite Aid, Walgreens and Safeway, denied me. Some felt uneasy, would only fill a script for 2 months, or just plain would not fill them!

SUSAN LAY

I tried mail order prescriptions, but they eventually stopped. I tried a small pharmacy 2 hours away, but had to talk the pharmacist into it, after he requested 6 months of medical records and advised me they would only fill my prescriptions every 30 days, with no early refills for vacations.

All has been good this past year, although I don't know if my insurance will continue to cover my meds. I'm 70 and on Medicare Part D. I've never increased the amount of patches or strength I use. I have Dilaudid for breakthrough pain, which doesn't help much, but some. I do what many other pain patients do to get their medication: drive for hours to my doctor once a month, undergo drug tests, sign pain contracts, and use no alcohol. I must go to office if they call for a drug count.

I discovered withdrawal from the fentanyl patches isn't as horrible for me as it is for addicts who just want to get high. I've had to go without for 5-6 days a few times, when the pharmacy was closed or I couldn't get to the doctor. My doctor explained that those in real pain are wired differently and withdrawal is usually easier. He did give me a script for methadone if I'm ever in that position again.

I feel extremely lucky to have a doctor who actually cares enough to help his patients. His contract says if any patient must go off opioids (for missing an appointment, using alcohol or whatever) he will assist us through withdrawal so we don't suffer.

It's the insurance and pharmacies that are causing us so many problems. Does anyone in other states have these issues? Marijuana is legal in California and we're a progressive state, yet even in my small rural area we're having major issues. Several pharmacies have closed, due to scrutiny by the DEA and other government involvement. It's not worth it to be constantly going through records and double-checking the way they do things.

Insurers and pharmacists have more power than doctors. Even with an honest and necessary prescription, they continue to over-ride doctors’ decisions. Pharmacists refuse to fill for quantities doctors have written, even when insurance agrees with that quantity. When a doctor speaks to the pharmacist, it makes no difference. When did pharmacists become doctors? The same goes for insurance companies that now refuse to pay for prescriptions they've covered for years.

I just don't get it. I'll do anything I can to fight FOR chronic pain patients and AGAINST those who don't give a damn about us and think if you use opioids you're a drug addict!

Susan Lay is a retired nurse and day care operator. She lives with chronic shoulder and knee pain.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Surgery Patients Rarely Misuse Opioid Meds

By Pat Anson, Editor

A large new study published in the British Medical Journal is debunking some popular myths about the causes of opioid addiction.

One such myth is that many hospital patients abuse and become addicted to opioid pain medication while recovering from surgery.

But in a data analysis of over 568,000 patients who were prescribed opioids for post-surgical pain, researchers at Harvard Medical School identified only 5,906 patients (0.6%) who were later diagnosed with opioid dependence, abuse or a non-fatal overdose -- collectively known as opioid misuse.

Of those, only 1,857 patients (0.2%) showed signs of misuse in the first year after surgery – suggesting that the dependence or abuse that others later developed may have had little or nothing to do with the surgery itself.

But the remarkably low rate of opioid misuse by surgery patients was not the primary focus of the study. What researchers really wanted to know is whether the dose and duration of an opioid prescription influences future chances of abuse and addiction.

And here another myth was dispelled.

Researchers found that high doses of opioids after surgery appear to have little impact on misuse rates. Their findings show that how long a patient takes opioids is a more reliable predictor of misuse than how much medication they took. Dosage only emerged as a risk indicator for those who took opioids for extended periods.

"Our results indicate that each additional week of medication use, every refill is an important maker of risk for abuse or dependence," said study co-author Denis Agniel, a statistician at the RAND Corporation and a part-time lecturer in the Department of Biomedical Informatics at Harvard Medical School.

Researchers found that each additional week of opioid use increased the risk for dependence, abuse or overdose by 20 percent. And each refill boosted the risk by 44 percent.

But the risk of misuse still remains small. For those who had a single prescription with no refills – the vast majority of patients -- misuse occurred at a rate of only 145 cases per 100,000 patient years. The rate was still minuscule for those who refilled a prescription -- 293 cases per 100,000 patients years.

And for patients who took high doses for short periods -- two weeks or less -- the risk of misuse was no greater than those who took an average dose.

Agniel and his colleagues say their research indicates that opioids -- even at high doses -- can be safely prescribed to patients with post-surgical pain.

“These findings suggest a more nuanced understanding of the relationship between duration and dosage with a focus on early appropriate treatment of pain (including higher doses) for a limited time,” researchers concluded.

“Such findings suggest that optimal post-operative prescribing, which maximizes analgesia and minimizes the risk of misuse, may be achieved with moderate to high opioid dosages at shorter durations, a combination that merits further investigation in population-based and clinical studies.”

Anti-opioid activists and government regulators have long made sensational claims that even just a few painkillers can lead to addiction and death.

“The bottom line here is that prescription opiates are as addictive as heroin. They’re dangerous drugs,” former CDC Director Thomas Frieden told the Washington Post in 2016. “You take a few pills, you can be addicted for life. You take a few too many and you can die.”

The Harvard Medical School study was not the first to find that long term opioid use after surgery is rare. A 2016 Canadian study found that less than one percent of older adults were still taking opioid medication a year after major elective surgery.  

Many patients are dissatisfied with the quality of their pain care in hospitals. In a survey of over 1,200 patients by PNN and the International Pain Foundation, 60 percent said their pain was not adequately controlled in a hospital after surgery or treatment. And over half rated the quality of their hospital pain care as either poor or very poor.

Why I Am Closing My Pain Practice

(Editor’s note: Patient abandonment is a serious and growing problem in the pain community. Thousands of patients have been discharged by doctors who have grown fearful of treating chronic pain and losing their medical licenses for prescribing opioid medication. We were recently contacted by a nurse practitioner, who offered her perspective on this disturbing trend. The author asked to remain anonymous.)

I am a nurse practitioner who has been in the field of pain management for the past 4 years. Prior to that, I spent years as an intensive care unit nurse and in primary care as an advanced registered nurse practitioner (ARNP).

Working with chronic pain patients has been the highlight of my professional career. I absolutely love my job and about 99% of my patients. I have had two complaints about me made to the Washington State Department of Health, both of which accused me of prescribing too much opioid medication to my patients. Both complaints were investigated by the state and I was found to be practicing within the standards of care -- and essentially told to continue. Which I did.

Then the Seattle Pain Centers closed in 2016, leaving thousands of untreated pain patients in the Puget Sound area. I inherited some of their patients. I felt like I had been "vetted" by the state, and believed that if I continued to do everything according to the law, I would be safe from any legal action.

In my practice, we fight ALL THE TIME for our patients, against the state, insurance companies, pharmacies and even the patient's families sometimes (when they don't understand). I'm not afraid of a good fight, because I have seen patients’ lives turned around when they are finally given the correct amount of opioids. I believe in opioid therapy.

Of course, all the tools in the box should be used, and I refer routinely to physical therapy, interventional pain specialists, surgeons, acupuncturists, chiropractors and others, in addition to prescribing opioids for pain.

Now I find how naive I have been. I have been to national conferences to learn more about pain management, and have heard the top doctors and researchers talk. One of these giants, Dr. Forest Tennant, was recently raided by the DEA. With Jeff Sessions as Attorney General, there is apparently more money being allotted to these raids and more are promised in the future. I also went to a website called "Doctors of Courage" and learned more about the DEA.

My interpretation of the facts is that it doesn't matter if I practice legally anymore. The DEA will look at my prescribing patterns, and tell me that I MUST have known that the ONLY reason any patient would get that much medication is if they are selling it on the street. And therefore, I am a "drug trafficking organization.” The Justice Department takes over the case and the provider is prosecuted.

If convicted, which seems to be the case recently, the provider becomes a felon and serves a prison term. Medical license is lost, time is served and because it is a "drug crime," asset forfeiture law may be used to confiscate everything I own.

'My Fear Is Very Real'

I am married, with a daughter still at home. I cannot do this to my family. So I am joining the legions of others who are closing their pain practices. I have just begun to tell my patients, and have had many, many tears, thoughts of both suicide and homicide, and one very special patient who told me that she will no longer be able to keep her service dog because she will be unable to care for him.

This whole thing is making me literally sick to my stomach. I've cried a million tears for my patients already, and I'm just beginning. I will be carefully weaning them all down to 90 MED per day over the next 6 months, or arranging transfer of care to anywhere the patient would like. What a joke that is -- there is no one else prescribing effective doses of opioids for chronic pain patients. If I am to be thrown in prison, it should be for that -- not for keeping them on therapy that enriches their lives.

I keep asking my husband to tell me that I am overreacting, but as wonderful and encouraging as he has always been, he is scared too.

Please tell all patients that what may have started merely as a provider being paranoid about his or her license has recently morphed into something truly dangerous for us. I will be absolutely no good to anyone, once locked up. If I can stay clear of the DEA's witch hunt, perhaps I can remain a voice of advocacy for pain patients. God help us all.

Please don't use my name if you post this. I can tell you, my fear is VERY real, and I don't want to call any attention to my practice right now. Thank you for understanding.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA: Opioid Cold Meds Too Risky for Kids

By Pat Anson, Editor

The Food and Drug Administration has ordered stronger warning labels for cough and cold medications containing opioids and said they should no longer be prescribed to patients younger than 18. The agency also signaled it that it could enact new limits on the dose and duration of other types of opioid prescriptions.

“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction,” said FDA Commissioner Scott Gottlieb, MD. “It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population.”

The FDA action involves nine different types of cough and cold medicines, four of which contain codeine and five that have hydrocodone. The brand names include Tuxarin ER, Tuzistra XR, Triacin C, FlowTuss and Zutripro. Several of the medications also come in generic form.

The FDA said it conducted an extensive review of the products and convened a panel of pediatric experts, who said the risk of misuse, abuse and addiction outweighed the benefits in patients younger than 18.

“These products will no longer be indicated for use in children, and their use in this age group is not recommended.  Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated.  For those children in whom cough treatment is necessary, alternative medicines are available,” the FDA said in a statement.

The agency also ordered stronger “Black Box” warning labels on opioid cough and cold medicines to make them more consistent with safety warnings that come with opioid pain medications.

‘Too Many People Prescribed Opioids’

The FDA this week also released its 2018 Strategic Policy Roadmap, which outlines four priority areas in the year ahead.

The agency's first goal is to reduce the abuse of opioid medication. The FDA said opioid addiction and overdoses were claiming lives at a “staggering rate” of 91 deaths every day – although it failed to point out that most of those deaths involve illegal opioids such as heroin and illicit fentanyl, not prescription pain medication. Also unmentioned in the “roadmap” is that opioid prescriptions have been declining since 2010.

“Too many people are being inappropriately prescribed opioid drugs. When these prescriptions are written, they are often for long durations of use that create too much opportunity for addiction to develop,” the FDA said.

“We need to take steps to reduce exposure to opioid drugs by helping to make sure that patients are prescribed these drugs only when properly indicated, and that when prescriptions are written, they are for dosages and durations of use that comport closely with the purpose of the prescription.” 

Several states have already enacted limits on opioid prescriptions for acute, short term pain. Minnesota, for example, recently adopted strict new guidelines that limit the initial supply of opioids for acute pain to just three days. 

An Open Letter to My Senator: CDC Has Killed Me

(Editor’s Note: Charles Malinowski is a 59-year old Paso Robles, California man who lives with Reflex Sympathetic Dystrophy (RSD), degenerative disc disease, ankylosing spondylitis, spinal stenosis and other chronic pain conditions.  He recently wrote this open letter to U.S. Senator Kamala Harris (D-CA). We thought his letter worth sharing with PNN readers.)

Dear Senator Harris,

The CDC has killed me!

Let me repeat that: The CDC has killed me!

I have a severe neurological condition that causes me unspeakable and crippling pain. Pain medication is literally the only thing keeping me alive. But with the issuance of the CDC’s short sighted, so-called voluntary opioid prescribing guidelines -- which are being rammed down the throats of medical providers -- my pain management doctor has cut me off of opiates.

For the last 10 years, I have been subjected to nearly every type of physical therapy, medical treatment and medication applicable to my affliction. The one and only thing that has ever had any demonstrable benefit in even temporarily suppressing my pain to a tolerable level has, unfortunately, been opiates.

In early October, I was told that I would have to stop taking either the oral opiates or the intrathecal opiates, as it was now illegal for a person to receive two different types of opiates via two different delivery methods concurrently. This was a major problem, as even with both oral and intrathecal opiates, my pain was severely under-managed to the point where I was almost completely bedridden. I left the house only to go to doctor's appointments.

When I was told that my pain management regimen - specifically the opiates - was going to be cut in half, even though my pain was already grossly under-managed, I spoke out about this.

CHARLES MALINOWSKI

As a result, not only was I cut off from the oral opiates, I got kicked out of the pain management practice where I have been a patient for more than seven years. The doctor said he didn't want to risk his license - but was perfectly willing to risk my life - over the CDC opioid guidelines.  These guidelines are supposed to be voluntary and are not supposed to take desperately needed pain medication away from legitimate chronic pain sufferers such as myself.

I expect that within 60 days, I will be dead from either heart failure or a stroke due to my body's inability to cope with the stress of the unrelenting pain. My neuropsychologist, who has been treating me for nearly 10 years, has consistently rated my level of pain as moderate to extreme, even while being medicated with both oral and intrathecal opiates, which I am now denied.

I'm not dead yet, but within 60 days I expect that the CDC will have effectively killed me. I honestly don't see myself being able to tolerate the pain any longer than that.

Congress, in going along with this blindly, will be explicitly complicit in this negligent homicide - or homicide by depraved indifference, take your pick - of one Charles James Malinowski, that being myself.

I would like to thank you, Senator, and all the rest of your colleagues for murdering me.

To help ease your conscience, it is not just me that Congress is complicit in murdering, but thousands, possibly tens of thousands of people in like positions.

Sincerely,

Charles Malinowski

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.