FDA Warns Veterinarians of Pet Owners Abusing Opioids

By Pat Anson, Editor

Doctors and patients aren’t the only ones under scrutiny for prescribing and using opioid pain medication. Pet owners are also coming under suspicion for diverting and abusing opioids intended for their animals.

The Food and Drug Administration today warned veterinarians to be cautious when prescribing opioids and be on the alert for people who may be using their pets to gain access to the drugs.

kitten-569956_640.jpg

“We recognize that opioids and other pain medications have a legitimate and important role in treating pain in animals – just as they do for people,” FDA commissioner Scott Gottlieb, MD, said in a statement.

“But just like the opioid medications used in humans, these drugs have potentially serious risks, not just for the animal patients, but also because of their potential to lead to addiction, abuse and overdose in humans who may divert them for their own use.”

Only one opioid is currently approved by the FDA for use in animals, a potent fentanyl medication for post-surgical pain that is sold under the brand name Recuvyra.  

The maker of another fentanyl based product -- carfentanil -- voluntarily surrendered approval for the drug in March because of growing signs it was being diverted. Carfentanil is so potent it was used by veterinarians as an anesthetic on elephants.   

With few options to choose from, some veterinarians are legally prescribing tramadol and others opioids intended for humans to relieve pain in pets. The FDA is recommending veterinarians use alternatives to opioids whenever possible and look for signs of opioid abuse by pet owners and their own employees.

“We’re advising veterinarians to develop a safety plan in the event they encounter a situation involving opioid diversion or clients seeking opioids under the guise of treating their pets; and taking steps to help veterinarians spot the signs of opioid abuse,” Gottlieb said.

Possible warning signs of opioid abuse are suspicious injuries to animals, a pet owner asking for specific medication by name, or asking for refills of lost or stolen medication.

Gottlieb’s statement was released one week after a small study published in the American Journal of Public Health suggested that some pet owners are purposely injuring their animals to gain access to opioids.

"Our results indicate that we should be paying more attention to how opioid abusers are seeking their drugs -- including through veterinary clinics," said Lili Tenney, deputy director of the Center for Health, Work & Environment at the Colorado School of Public Health.

In a survey of 189 Colorado veterinarians, 13 percent reported they had seen a client who they believed had purposefully injured a pet or made them ill. Nearly half the vets said they knew of a pet owner or employee who was abusing opioids; and 12 percent suspected a staff member of diverting opioids or abusing them.

Colorado and Maine require veterinarians to look at a pet owner’s medication history before dispensing opioids or writing a prescription.  Over a dozen states require veterinarians to report when they prescribe opioids to a prescription drug database.

An Open Letter to Attorney General Jeff Sessions

By Fred Brown, Guest Columnist

Dear Honorable Attorney General Jeff Sessions,

Why are there are so many federal agencies, like the CDC, DEA and Justice Department, that want to take away my opioid medication?  I have a right to be treated humanely, don’t I?

I am an American citizen who has dealt with some serious and painful medical issues. Over 20 years ago, I was referred to a board-certified pain management physician.  This was due to two failed cervical surgeries that left me with chronic back pain. I had two additional surgeries to fuse my spine after the first two operations, which only made my pain even more severe. The pain physician recommended I should begin a treatment regimen that included low doses of opioid medication.  

These medications helped me to continue working and have a certain quality of life.  I knew from discussions with my physician that, over time, I would need to increase the dose as my body would become dependent on opioids. This has been necessary and over many years these medications helped me live my life.

I have tried other medical modalities such as physical and occupational therapy, biofeedback, acupuncture, counseling, and other alternative treatments.  Further, before starting on opioids, I tried various non-narcotic medicines which did not work.    

Mr. Attorney General, earlier this year, you gave a talk in Tampa and said, “People need to take some aspirin sometimes and tough it out.” 

Perhaps if someone was experiencing mild discomfort, aspirin will work.  However, when one is living with severe chronic pain, 24-hours a day, seven days a week, they very likely need strong opioids prescribed by their physician.

Opiates help patients like me get relief from severe pain. They do not take away the pain, but they help reduce it and enable us to have some quality of life.  

 ATTORNEY GENERAL JEFF SESSIONS

ATTORNEY GENERAL JEFF SESSIONS

The “pill mills” have hurt many people, and most certainly the DEA should do everything it can to close them down.  But at the same time, certain patients must have high dosages of these medications. Each of us have a different metabolism and what may work for one person at one dose level may not work at all with another patient.  

When a government agency such as the DEA goes after physicians who are trying to help legitimate patients, without any idea of the patients’ history is and why they are on high doses, that is entirely wrong and inhumane!

Why are so many agencies, along with Congress, trying to keep these medications at lower dosages that will cause me to live with increased pain?  Does our nation intend to condemn citizens who have painful and excruciating disabilities to a life of agony?

I am aware the CDC made some serious mistakes when it released the 2016 Opioid Prescribing Guideline.  Some physicians believe the guideline is law and began to lower the doses of patients or even discharge them from their practice. It took CDC researchers years to admit they significantly inflated deaths from opioid prescriptions because they misreported deaths due to illegal fentanyl. 

Opioid prescriptions have been declining since 2011, while overdose deaths and suicides are at an all-time high!  This is not accidental.  CDC, FDA and DEA are chasing the wrong opioid epidemic and needlessly ruining lives of people in pain.

Mr. Attorney General, was our nation founded on the premise that our fellow citizens should live in chronic severe pain? I do not believe our Founding Fathers would want this. 

2017-10-31_16-53-42_807 (2).jpg

Fred Brown lives in central Florida. Fred is disabled because of spinal fusion with laminectomy syndrome, cervical radiculitis.  He also has severe arthritis in bilateral knees with a failed knee replacement.  In addition to pain management, Fred uses "diversion of the mind" as a way of dealing with much discomfort. 

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.

The New Face of the Opioid Crisis

By Pat Anson, Editor

Caylee Cresta doesn’t have any illusions about being the next Internet star or YouTube sensation. But the 23-minute video she posted on what it’s like to be a chronic pain patient during an age of opioid hysteria has become a hit in the pain community.

“This video should be made to go viral,” one fan said.

“Caylee you did an amazing, persuasive presentation. Maybe you should be a lobbyist!” another one wrote.

“Single best piece of chronic pain patient advocacy I have ever seen. Absolutely brilliant!” wrote Chuck Malinowski.

Caylee’s video is not addressed to the pain community, but to the public at large. The 26-year old Massachusetts woman with fiery red hair looks directly into the camera and earnestly asks people to set aside their misconceptions about pain, addiction and the opioid crisis.

“I do not suffer from addiction and yet stigma will tell you that I do.  And that is a myth that we are going to change,” she says. “Don’t ever brush off the plight of the chronically ill because your lives can change in an instant, just as ours have.

“The fight against opiates is an uneducated one. This is a movement that lacks understanding in its most basic form. Every lawmaker is taking on this fight without ever consulting even a single chronically ill person. What does that mean? That means that the people who depend on these medications aren’t even being considered when taking them away.”

In her video, Caylee spends little time discussing her own experience as a pain patient. While still in high school, Caylee developed a rare and incurable neurological disorder called Stiff-person syndrome, which is characterized by strong muscle spasms and stiffness. The spams are so severe her lungs have collapsed twice.

“I’ll get such strong spasms in my throat and chest cavity that they create so much air that can’t escape (my lungs) that it just made them literally pop,” she told PNN. “My muscle spasms can break my bones, they’ll get that strong.”

Caylee’s symptoms were usually dismissed by doctors and it took years for her to get a proper diagnosis. Last year, a doctor at a pain clinic dropped her as a patient after getting a warning letter from Medicare that she was prescribing too many opioids. Caylee went without opioids for months, which is when her lungs burst.

Living in Fear

Although Massachusetts has a reputation as having some of the best healthcare in the world, Caylee now drives 3 hours one-way to see a neurologist in Connecticut.

“Any other doctor that I’ve seen over the years has literally looked at me and in one way or another and said, ‘Your prognosis is so dim. It’s so rare.’ They’re not even willing to take me on as a patient. My doctor has stuck by me and tried everything there is to try,” she says. 

Caylee has tried stem cells, chemotherapy and many other treatments. The only thing that works is opioid medication. Although she is once again able to get prescriptions for opioids, she often has trouble getting them filled. She and her husband went to 20 pharmacies one day before finding a pharmacist willing to fill her script.

“You live every single day in fear.  Every time you fill your prescription you go, okay, I’m going to have a life for another month. But you live that whole month with such anxiety and wondering what’s going to happen next,” she said. 

Caylee hopes her YouTube video will help educate the public about the daily challenges of being in pain and give some hope to pain sufferers.

“I want to fight for people going through this. I truly want to fight for them. I just want to let people know that they’re not alone. I want them to know that we’re all in this together,” says Caylee.

“What is probably the most humbling is when I get messages like ‘I would do anything for the world to be able to see this’ or ‘I would do anything for this to go viral and for people to understand what we go through.’ When I get messages like that, that let me know that these people feel like somebody is speaking for them, that touches me in a way that I can’t even explain.”

Wallowing in Pain

By David Hanscom, MD, Guest Columnist

One of the most powerful ways to bond with others is by sharing emotional or physically painful experiences.  It is common for people suffering from chronic pain to discuss it with their family, friends and colleagues.

Between searching for a cure and talking about it, a fair amount of their consciousness is focused on pain. But the unconscious brain, which pain is a part of, is much more powerful than the conscious brain. You can’t consciously fix or control it. But you can direct it. Your brain changes every second and will develop wherever you place your attention. The more you focus on your pain, the more you will reinforce it.

Many of us in the medical profession were trained to have our pain patients keep a diary of the pain. But it has now been shown in some studies (here and here) that a pain diary is often associated with a delay in recovery. Focusing on the pain and documenting it may only reinforce pain circuits.

One of the most powerful strategies we have seen in treating pain is when we don’t allow patients to discuss their pain with anyone – expect with medical providers. People can become so wrapped up in their pain that they lose themselves in it. They become their pain.

burnout-384083_640.jpg

I had no idea how much time patients spent discussing their pain until I asked them not to. For some, it felt like I had just dumped a bucket of ice water over their head.

They’ll say, “I feel shallow and phony by not sharing what is really going on with me.” That is a sure sign that he or she has become their pain.

We have witnessed several things occur when people successfully stop discussing their pain. The pain may not immediately abate, but they feel lighter.

For starters, do you really think your pain is that interesting to those who aren’t in pain? There is nothing that they can do about it and although they may sympathize, it is incredibly frustrating to repeatedly hear the same story.  Often my patients don’t appreciate the effect their story has on others. People that they enjoyed in the past drift away, furthering their social isolation.

And what about your poor family? They can’t escape as easily. Instead of you being a source of inspiration, peace, love and joy, you bring the whole house down. It isn’t a psychological issue. The effect occurs through mirror neurons, where you are stimulating the negative parts of the brains of those close to you.

Bonding with Pain

Another harmful aspect of repeatedly discussing your pain is that you will bond with those who are also focused on their pain. The bonds are deep and real and stronger than many human connections.

One extreme example of the strength of the need for social interaction involved a patient who we discovered was being violently abused by her boyfriend. We had to call the authorities. But she kept going back to him. One of my staff finally asked her why she put up with being beat up so badly. Her reply was, “It’s the only time that I have his full attention.”

You’ll be almost guaranteed to remain in pain if you are also contributing to another person’s suffering. One of the most basic parts of being human is giving back and that energy is almost impossible to connect to while you are in the abyss of pain. You are taking from those around you and not giving back.

Even deeper though is that the bond forged by pain is so strong that many don’t want to give up their pain. It’s the one greatest obstacle to healing. Being in a victim mode, in any realm, is so powerful that no one willingly wants to let it go. I run across this resistance multiple times per week. It took me many years before I realized that some patients had become addicted to being in pain and were resistant to change. If a patient doesn’t want to even learn the basic concepts behind solving chronic pain, there is nothing that I can do for them.

Our team has attempted to work with several online pain groups, where a lot of energy is spent on complaining about pain, circumstances and medical care. The complaints are generally legitimate, but little time is spent on discussing real alternatives. When we have suggested that there is a viable solution, we are quickly and consistently blocked.

We’ve also asked our patients to never complain or engage in pain behavior, such as groaning, grabbing their back, etc. If you are having a bad day at work or dealing with an unpleasant aspect of your pain, why bring it home? It is supposed to be your haven of safety and relaxation.

Don’t Share Your Pain

We have been surprised how difficult it’s been for some people to quit complaining.  It’s also been surprising how effective this simple strategy has been in moving people forward on their healing journey. At a minimum, their family is happier and everyone’s mood improves. It’s a great start.

Last week I had five different patients become free of pain. All of them had been suffering badly for many years and the change occurred within a couple of months. One person dramatically improved within a couple of weeks. All were beside themselves trying to express how excited and happy they were to be free of pain. Not discussing their pain was a significant step for each of them.

If you are one who feels like that you have to share your pain, then be honest with yourself about not wanting to give it up. It will save you and everyone else a lot of time and money not making the effort to help you heal when you actually don’t want to. Not sharing your pain is a simple beginning and will give you insight on where you are at with regards to healing.

Many people are incensed at the idea that they don’t want to give up their pain. The response is often that the medical profession just isn’t doing its job and fixing them. Whether that is true or not isn’t the point. The key is that you aren’t willing to learn the most recent concepts about overcoming pain. There isn’t any risk and you are already spending a good deal of time searching for an answer.

If you really think you aren’t attached to your suffering, then try this simple test:  Don’t talk about your pain.

David Hanscom.jpg

Dr. David Hanscom is a spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery. In his book Back in ControlHanscom shares the latest developments in neuroscience research and his own personal history with pain.

More information can be found on his website.

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.

When Will They Start Listening to Pain Patients?

By Ann Marie Gaudon, PNN Columnist

It’s often suggested that pain patients and their advocates write or call elected officials, government regulators and physicians’ organizations to protest the sorry state of pain care in the U.S. and Canada. Many of us do just that and wind up feeling ignored or dismissed.

I have now corresponded with two different physicians at the College of Physicians and Surgeons of Ontario (CPSO), only to be passed onto their “Director of Strategy” (a fancy pants title no less).

The CPSO is the body which governs physicians in Ontario and it has rigidly enforced Canada’s 2017 guideline for opioids. They have monitored patient files, hauled over 80 doctors in to investigate “overprescribing” and basically terrorized doctors for prescribing opioids.

The doctors in turn deny and restrict opioid medications to their patients out of fear for losing their licenses.

I have asked the CPSO these questions:

bigstock--157700663.jpg
  • What evidence do you have to indicate the long-term use of opioids increases pain?
  • Why is the chronic pain population being penalized for overdose deaths due to illicit street drugs?
  • Why are you not listening to chronic pain researchers, physicians and patients?
  • Does a decrease in opioid prescriptions and an increase in overdose deaths suggest a statistically significant relationship?
  • How is it ever acceptable for pain patients to be dictated to by non-pain specialists?

I have provided no less than 27 references to show that there was never a connection between chronic pain patients and those dying from overdoses. However, no one has provided me with answers to my questions -- not even fancy pants.  In fact, the CPSO continues to disseminate disingenuous information about pain management, opioids, addiction and overdoses.

And remember folks, these are the people who took an oath to care for the suffering. That would include all of us pain patients -- or one would think. To put out genuine effort and have nothing but deaf ears returned is sickening -- pun intended.

Health Canada also hasn’t answered my questions and continues to make baseless claims such as "high rates of opioid prescriptions are a contributing factor to Canada's opioid crisis." Predictably, when the media hears that, they rush to publish the news that Health Canada plans to “severely restrict marketing of opioids” -- as if that will have any effect on those dying from overdoses. It will not. The non-pained public laps it up.

I also wrote to my representatives in Parliament. MPP Michael Harris did not respond in any way. MP Marwan Tabbara responded with a boilerplate letter about the opioid crisis, yet when I asked for a purposeful response, none was forthcoming.

Dr. Helena Jaczek, Ontario’s Minister of Health, did not address my concerns either. A representative of Health Quality Ontario did respond to me quickly, yet when I replied with additional concerns, I had no further correspondence.

I’m aware that our friends in the U.S. are certainly not being heard either. Scores of you sent letters and emails commenting on the open letter that desperate pain sufferer Charles Malinowski sent to California Sen. Kamala Harris, who replied with a boilerplate letter filled with hype and hysteria about opioids and how more funding was needed to treat addiction.

Another example is when over 100 comments were submitted to the DEA asking it not to cut the supply of opioid medication because it could lead to shortages and worsen the quality of pain care. The DEA’s response? The agency said the comments dealt with medical issues that were “outside of the scope” of its order. Then it cut the supply anyway.

A genuine letter is sent and verbal diarrhea is returned. I can assure you that this phenomenon is not just “Made in America.” 

If you’ve written or tried to be heard and have gotten nowhere, that is no reason to stop trying to hold governments and physician groups accountable for their shameful disregard for pain patients. We have just had a shakeup in Ontario’s government, so it's all new players now. Will they help? I intend to find out.

Who is with me? More than ever pain patients and advocates need to stick together, focus and move toward effective change. Don’t make quitting an option. If you live in Canada and are a pain patient having unethical treatment forced upon you, please join us at this Facebook page. 

headshotJuly2018circle.jpg

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for 33 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website.

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.

Now Is the Time to Advocate

By Barby Ingle, PNN Columnist

I have written many articles on patient advocacy and it is still one of the topics I am most asked about. Now through the first week of September is the perfect time to visit with your state legislators and congressional representatives. I have appointments with three coming up in the next few weeks myself.

They need to hear from their constituents. The need to learn about issues facing people who vote in their districts and state. They need to know who makes up the pain community so that they can better represent and REMEMBER us when it is time to vote on legislation that may help or hurt our access to proper and timely pain care.

How do you get an appointment? Look up the website for your legislator or congressman and request a meeting. Sometimes you can make an appointment directly through the website, but I believe the best way is to call and set it up, followed by a written request or confirmation of the appointment.

You may be scheduled with the lawmaker themselves or a staff member who assists them with a particular issue. In our case, it is usually the staffer who handles health or insurance issues.

These appointments can take place in Washington, DC or in your home state. The U.S. House (but not the Senate) is in recess until after Labor Day, so most representatives are in their districts campaigning for the midterm elections. Many are taking meetings and doing town halls.

agreement-3489902_640.jpg

When you call for a meeting, you may get voicemail. Leave a message! If you don’t get a return call in a few days, call again. If someone answers, call and ask to speak with the scheduler.

It’s impressive to friends, family and other pain community members when you actually follow through with a meeting. It is something that anyone can do, but few actually try. Most rely on others to make it to these meetings.

You need to focus on what you'll talk about before the meeting. If you get an appointment, dig in and study. Do your homework and research legislation so you can explain why you support or oppose it. Share your personal story in a highlight reel fashion. You might have a 20+ year story of living with chronic pain and illness, but you should get it down to no more than 2 minutes. Highlight the challenges you faced and where you are now in the chronic care process.

Make an Ask

The main purpose of your first meeting will be to familiarize yourself with your senator, representative or legislator and make a memorable connection. Stay on topic, stay timely and “make an ask” – ask them to do something specific for you.

These meetings typically last 15 to 20 minutes. Don’t bring a truck load of supporting materials. Discuss no more than 3 topics at the meeting and leave a one-page fact sheet for each topic. You want them to know that they can use you as a resource, so include a calling card with your contact information.

If you are asked about a fact that you don’t know the answer to, just say, “I don’t know.” It is better to be truthful than to make something up and risk losing credibility. You can always follow-up later with the information they seek.

You are there to make an ask, so set a reasonable deadline for them to respond to you with the answer. They may say right away they won’t support or oppose a bill and why. Don’t argue with them if they do. Use it as a teachable moment as to why you hope they will reconsider and how their decision will affect you and others like you in the pain community. If they haven’t taken a position on the issue in the past, it is not likely that they will commit to one in this meeting.

When you get home, always send a short thank you letter to the representative or staffer who was there. Also include any follow-up answers you promised. Remember, if you met with a staffer, they are there to filter out the messaging and bring back the best info they can to the representative.

 our 2017 MEETING WITH WITH REP. ANDY BIGGS

our 2017 MEETING WITH WITH REP. ANDY BIGGS

If you do get an actual face-to-face chat with your senator or representative, you are lucky. In 2017, we were fortunate to get a meeting with Arizona Rep. Andy Biggs (pictured above).  A personal meeting like that demonstrates to lawmakers there is a constituency for chronic pain and illness that is active in their district and needs to be listened to.

After your first meeting, get ready for the next one. Stay in touch with the staffers and representatives, and when it comes time for them to act or vote, there is a better chance they will remember you and your story and do something that helps the pain community in a positive way.

Hearing directly from patients and caregivers goes a long way in helping us get access to proper and timely pain care. They need to know that we care, so they should care too.

Barby Ingle.jpg

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website. 

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.

I Thank God for Opioid Medication

By Carmen Littizzio, Guest Columnist

I was born with a rare genetic defect called Arnold Chiari Syndrome, which blocks the flow of cerebral fluid and causes pressure to build in my brain. I had brain surgery to treat it in 1999, when I was 44 years old.  

During this surgery they cut off a portion of the skull in the back of my head to make more space for cerebral fluid to flow. Lack of fluid in the brain and spinal cord causes intense pain for me from the waist down.  At times I’m not able to walk and have painful electrical sensations that are torturous.

Nineteen years after the surgery, I still suffer from high pressure headaches, chronic leg pain, thigh and buttock pain, and other symptoms. The high cerebral pressure has also caused other problems, such as retinal detachment in both eyes, vomiting, vertigo and vision issues. 

In 2008, when I was 53, I developed a crowding in my spinal cord the same as I had in the brain and had to have a spinal cord decompression. They put a titanium plate with four screws into my back to hold it all together.

This operation was so intense that for days after the surgery, I just wanted to die. It was a living hell.

I survived with the help of morphine, but eventually went back to my old pain medication, which consisted of Neurontin, Topamax, Elavil and Diamox -- all in very high doses.

 CARMEN LITTIZZIO

CARMEN LITTIZZIO

In 2009, my body started shutting down because of those meds and I was unable to urinate. I had a permanent catheter put in and all those medications were stopped. I started taking Percocet for pain. After 4 months, I began urinating again and never wanted to go back to those other meds. 

I was told of the dangers of long term opioid use, but decided to risk it for some quality of life. My other choice was to sit in a wheelchair for the rest of my life, be able to do nothing, and still die young because of being so sedentary. 

I am now 63 and next year it will be 20 years since the brain surgery. I take a time released OxyContin in the morning and evening, and oxycodone for breakthrough pain and the headaches. 

I am entering my senior years, but still walking on my own and enjoying my children and 5 grandchildren. I don't know how much longer I will live, but I feel like I’ve won the war. What war? The war for quality of life. I thank God for opioid medication. I have never been high or abused my medications. 

I feel very bad for those that abuse narcotics or overdose.  But why should I pay the price for their inability to use self-control? We don't take alcohol off the market because we have alcoholics and drunk driving.

There are many people like me that have chronic pain and illness, and we are paying the price for those who abuse. It’s not right and not fair that we should be made to stop living because of their issues.  Nobody has the right to choose for me. 

bigstock-Tell-Us-Your-Story-card-with-c-78557009.jpg

Carmen Littizzio lives in Maine.

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.

Prescription Pain Creams Flagged for Medicare Fraud

By Julie Appleby, Kaiser Health News

Medicare pays hundreds of millions of dollars each year for prescription creams, gels and lotions made-to-order by pharmacies — mainly as pain treatments. But a new report finds that officials are concerned about possible fraud and patient safety risks from products made at nearly a quarter of the pharmacies that fill the bulk of those prescriptions.

“Although some of this billing may be legitimate, all of these pharmacies warrant further scrutiny,” concludes the report from the Office of the Inspector General for the Department of Health and Human Services.

In total, 547 pharmacies — nearly 23 percent of those that submit most of the bills to Medicare for making these creams — hit one or more of five red-flag markers set by investigators.

Those included what the researchers called “extremely high” prices; large percentages of Medicare members getting identical drugs — 16 of the pharmacies billed for identical drugs for 200 or more customers; “greatly increased” year-over-year billing — 20 pharmacies increased their billing by more than 10,000 percent; or having a single medical provider writing more than 131 prescriptions.

More than half of those pharmacies hit two or more measures — and 10 hit all five.

bigstock-Increasing-Health-Care-Costs-6790984.jpg

One Oregon pharmacy, for example, submitted claims for 91 percent of its customers. A pharmacy in New York submitted 5,342 prescriptions ordered by one podiatrist, while a Florida pharmacy saw its Medicare billing for such treatments go from $7,468 in 2015 to $1.8 million the following year.

Many of the pharmacies are clustered in four cities: Detroit, Houston, Los Angeles and New York.

The report comes amid ongoing concern by Medicare officials about these custom-made — or compounded — drugs. In addition to questions like those raised in the report about overuse and pricing, safety has been a key issue in recent years. A meningitis outbreak in 2012 was linked to a Massachusetts pharmacy that did not maintain sterile conditions and sold tainted made-to-order injections that killed 64 Americans.

When done safely, pharmacy-made compounded drugs provide a legitimate option for patients whose medical needs can’t be met by commercially available products mass-produced by pharmaceutical companies. For example, a patient who can’t swallow a commercially available prescription pill might get a liquid version of a drug.

State boards of pharmacy generally oversee compounding pharmacies, and the drugs they produce are not considered approved by the Food and Drug Administration.

Rising Cost of Compounded Drugs

The new report focuses on concerns with compounded topical medications.

Medicare spending for such treatments has skyrocketed, rising more than 2,350 percent, from $13.2 million in 2010 to $323.5 million in 2016. Price hikes and an increase in the number of prescriptions written drove the increase, the report said.

It is not the first time the inspector general has looked at compounded drugs. A 2016 report found that overall spending on all types of compounded drugs — not just topical medications — rose sharply.

The U.S. Postal Service inspector general and the Department of Defense also have raised concerns about rising spending and possible fraud for compounded drugs.

In response to those previous reports, the International Academy of Compounding Pharmacists, the industry’s trade group, has said that legitimately compounded drugs “can dramatically improve a patient’s quality of life,” noting that proper billing controls need to be in place. The inspector general’s report in 2016, it added, found that “such controls are not in place.”

This report, which the compounding trade group has not yet reviewed, focuses on topical drugs and a subset of the 15,290 pharmacies that provide at least one such prescription each year. It looked at billing records from the 2,388 pharmacies that do at least 10 such prescriptions a year — providing 93 percent of all compounded topical drugs paid for by Medicare.

file000833745487.jpg

Most of the prescriptions were for pain treatment, made from ingredients such as lidocaine, an anesthetic, or diclofenac sodium, an anti-inflammatory drug.

On average, those compounds were more expensive than non-compounded drugs with the same ingredients.

For example, Medicare paid an average of $751 per tube of compounded lidocaine, and $1,506 for the diclofenac, according to the inspector general’s report. Non-compounded tubes of those drugs averaged $445 and $128, respectively.

FDA Commissioner Scott Gottlieb recently outlined new efforts his agency is taking to oversee compounded drugs in the wake of legislation passed by Congress following the meningitis outbreak.

“The FDA is inspecting compounding facilities to assess whether drugs that are essentially copies of FDA-approved drugs are being compounded for patients” who could otherwise take a product sold commercially, he said in a statement issued on June 28.

Gottlieb also said the FDA plans to make more information available to patients and their doctors about compounded topical pain creams, including information about their effectiveness and any potential safety risks.

Not being effective is a safety risk, noted Miriam Anderson, a researcher with the inspector general’s office who helped write the report.

The report urged the Centers for Medicare & Medicaid Services to clarify some of its policies to emphasize that insurers can limit the use of compounded drugs by requiring prior authorization or other steps. The agency concurred with the recommendations, according to the report, including the need to “follow up on pharmacies with questionable Part D billing and the prescribers associated with these pharmacies.”

Anderson said the inspector general’s office is continuing to probe the issue.

“We will investigate a number of leads on specific pharmacies and prescribers who were identified as having these questionable patterns,” she said. “Whenever we see that kind of increase in spending, it raises concern about fraud, waste and abuse.”

Kaiser Health News’ coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Why ‘The Bleeding Edge’ Gave Me a Panic Attack

By Emily Ullrich, Guest Columnist

If you haven't seen it yet, you've likely heard the buzz about The Bleeding Edge on Netflix. This documentary should be seen by every adult in America, not just chronically ill or chronic pain patients.

The Bleeding Edge gives insight and affirmation to those of us who have dealt with the medical system a little too much and demonstrates how important self-advocacy is. If you haven't seen it yet, don't let what I'm about to tell you deter you. I've seen it twice now. The first time I watched it, I had a full-on panic attack because it reminded me of the infuriating ordeal I went through dealing with the American medical system.

I wanted to watch the film again, hoping I would be able to watch it more objectively. I made it through the second time without a panic attack, but I was still yelling at the screen.

The film covers an array of medical device errors and malfunctions. But more importantly, it also delves into the mistakes and oversights that the FDA, CDC, American Medical Association and others have made (and continue to make) at the expense of our health because it's more lucrative to make us sick than it is to ensure our safety.

One of the main topics in The Bleeding Edge is the autoimmune disorders that many women developed after the implantation of the Essure birth control device. I was especially stricken by this story.

My first experience with chronic pain was pelvic pain, due in part to endometriosis. I started having my periods when I was 11 years old, and by age 12 was literally passing out because of the severe pain I had when menstruating. I saw doctor after doctor, and every one of them told me the same three things:

“This is normal.”

“At least part, if not all of this, is psychological.”

“Take ibuprofen and a hot bath, and you'll be fine.”

Of course, they were all wrong.

By age 19, I went to probably my twelfth doctor. She decided, in her infinite and culturally superior attitude, that since I had two sexual partners in my lifetime that I must be promiscuous. And if I continued this reckless behavior, she would not be able treat me and would be forced to tell my parents. When I told her I didn't need to be judged or lectured, she clucked her tongue and shook her head, as though I was a lost cause.

Many years and irresponsible, uncaring and uninformed doctors later, at age 31, I went to a doctor who told me I probably had endometriosis and performed a laparoscopic procedure to confirm this diagnosis. The procedure was also supposed to remove it and I was supposed to feel better. It didn't.

As I aged, it got worse. And as I moved around the country, I had to go through the degrading and exasperating experience of finding a doctor who believed me and believed in endometriosis. Many OB/GYN's and MD's still do not.  Even now, I see doctors on occasion who refer to it as a “garbage pail diagnosis.”

The Mirena IUD

At age 36, I was finally referred to a pelvic pain specialist. He believed in my pain and suffering and wanted to help. I cried because he was so nice.

After a fourth endometrial ablation surgery, he suggested the Mirena IUD as a long-term solution to my problem. He said it would not only prevent pregnancy but would be effective in reducing or eliminating my periods. As I lay back to have the IUD inserted, he assured me that it would not be painful that I would merely feel a “slight pinch.”

I never felt ANYTHING as excruciatingly painful. The doctor mistakenly punctured the fundus of my uterus. So, he casually penetrated me again with the same invasive tools, pulled the IUD out, opened a new one and attempted to place it. My uterus simply spat it back out at him. He said, laughing, “Your body doesn't seem to like this! Wanna try it again?”

I should have listened to my body and said no. But he tried again and finally placed it. For the next nine months. I bled profusely every day and the pain was worse than ever. I called and visited the doctor numerous times throughout these months, and every time he assured me the bleeding would stop and I should be patient.

Finally, I marched into an appointment and demanded he remove it. He did, and although I had pain for the next few days, it finally got a little better.

My point in all of this is that I now have about 15 chronic pain conditions. And with each one, I have a similar horror story. I feel a connection to the women who had the Essure device and who later developed autoimmune illnesses because of it. I will never know if any of my ongoing list of health problems stemmed from the Mirena, but I do know that after my bad experience with it and a few other attempted medical devices, my body doesn't respond well to foreign objects.

We are all different chronic pain snowflakes, if you will, and different treatments work for different people. However, as one goes through the process of repetitive ER visits, hospital admissions and doctor's appointments, we get to know what we can and cannot tolerate pretty well.

The pain patients' mantra of “Be Your Own Best Advocate” could not be hammered home better than it was watching The Bleeding Edge. The film struck a deep chord within me about the irresponsibility of our government, medical companies and doctors, as well as their willingness to suspend disbelief if it is easier and more financially convenient, even if it's at the cost of people's lives.

It is very much like the movement to stop the use of opioids, a proven and mostly safe class of pain medication, while encouraging the use of under-tested drugs with bad side effects that are often prescribed off label to treat conditions they were never intended for. It doesn't matter anymore if the patient has a better life or not. It only matters that the medical system drains our wallets and souls, while selling theirs.

Still, after all of this, we have to fight. We have to because no one else is going to do it for us. We have to do our own research and educate ourselves about medical devices and treatments.

As The Bleeding Edge demonstrates, when you can buy stock in healthcare companies, when government became controlled by corporations, and when doctors get paid for using and recommending their products, we lost the ability to trust them. 

.jpg

Emily Ullrich lives with Complex Regional Pain Syndrome (CRPS), Sphincter of Oddi Dysfunction, Carpal Tunnel Syndrome, endometriosis,  Interstitial Cystitis, migraines, fibromyalgia, osteoarthritis, PTSD, insomnia, bursitis, depression, multiple chemical sensitivity, and chronic pancreatitis.

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.

Magnetic Gel Could Someday Treat Chronic Pain

By Pat Anson, Editor

Magnet therapy has been used for thousands of years to treat arthritis, inflammation and other chronic illnesses. Today therapeutic magnets can be found in bracelets, shoes, clothing, mattresses and dozens of other products, sold by companies that claim magnets relieve pain, improve blood flow and even flush out toxins.

It's a controversial theory and there is little science to support the medical use of magnets. One critic has even called magnet therapy “a billion-dollar boondoggle.”  

But maybe there’s something to it after all.

UCLA researchers have demonstrated that a gel-like material containing tiny magnetic particles can be used to relieve chronic pain caused by disease or injury. In a study published in the journal Advanced Materials, they say the biomechanical force of magnets can be used on damaged cells to help them heal.

"Much of mainstream modern medicine centers on using pharmaceuticals to make chemical or molecular changes inside the body to treat disease," says principal investigatorDino Di Carlo, PhD, a UCLA professor of bioengineering. "However, recent breakthroughs in the control of forces at small scales have opened up a new treatment idea -- using physical force to kick-start helpful changes inside cells. There's a long way to go, but this early work shows this path toward so-called 'mechanoceuticals' is a promising one."

Di Carlo and his colleagues used magnetic particles inside a gel to manage cell proteins that control the flow of calcium ions. The proteins are on the cell's membrane and play a role in the sensations of touch and pain. When damaged by injury or disease, these “excitable” neuron cells continually send pain signals.

"Our results show that through exploiting 'neural network homeostasis,' which is the idea of returning a biological system to a stable state, it is possible to lessen the signals of pain through the nervous system," said lead author Andy Kah Ping Tay, a recent UCLA doctoral graduate. "Ultimately, this could lead to new ways to provide therapeutic pain relief."

 UCLA IMAGE

UCLA IMAGE

To make the magnetized gel, UCLA researchers used hyaluronic acid, a gel-like material found naturally in the spinal cord and brain. Hyaluronic hydrogel can also be produced artificially and is used in cosmetics and other beauty products as a filler and moisture barrier.

The researchers put tiny magnetic particles into the gel and then grew a type of primary neural cell -- dorsal root ganglion neurons – embedded inside the gel. In laboratory tests, they applied a magnetic field to generate a pulling force on the particles, which was transmitted through the gel to the embedded neurons.

The researchers found that the magnetically induced pulling led to an increase in calcium ions in the neurons. When they increased the magnetic force steadily over time, the neurons adapted to the continuous stimulation by reducing the signals for pain. In effect, researchers created a form of neuromodulation using magnets -- an old theory put to a new use.

In addition to treating pain, researchers say the magnetic gel could be modified with different biomaterials to treat heart disease, muscle disorders and other health conditions.

The UCLA research was funded by a New Innovator Award grant from the National Institutes of Health.

Grieving a Former Life

By Pamela Jessen, Guest Columnist

Once upon a time, there was a woman named Pamela. She was a strong, vibrant woman who worked as an operations administrative assistant for a company called FGL Sports, which operated a chain of sporting goods stores in Canada. Pamela took care of the administrative needs of the director and senior management team. 

Unknown to these people, Pamela lived with fibromyalgia and osteoarthritis. She did her job so well that she was able to keep these illnesses hidden for a long time, but they gradually started to get in the way of her work. Pamela eventually had to leave her job and go on permanent disability.

That was really devastating for Pamela because work was her life! She loved everything she did, from organizing training meetings and corporate functions to keeping her boss’s life on track. 

Once she was no longer working, a lot of negative feelings started to dwell up inside Pamela. She started feeling depressed, angry, sad and lonely. These were natural responses to having a chronic illness, but it was also frustrating to have to deal with them on top of not actually having a job to go to.

Pamela felt herself getting more depressed and sometimes it was easier to just stay in bed and sleep rather than get up and face life. She knew this wasn't good, but there really wasn't any reason to get up anymore.

640px-Sad_Woman.jpg

Well, of course, that woman was me. It was a difficult phase of my life, as work had always been my passion. I was an administrative specialist in retail support for most of my career and I loved what I did. Every day was a treat. Unfortunately, my body just couldn’t keep up with me. The pain and exhaustion that goes along with fibromyalgia and osteoarthritis took over my body and I had to surrender to it. There simply was no other choice. 

After some time, I took a chronic pain management course and started feeling better mentally. This course explored the various stages of grief we go through when you experience a job loss because of illness and disability, and I realized that was exactly what had happened to me. I had been grieving. 

There are five stages of grief: denial, anger, bargaining, depression and acceptance. The instructor asked us what we had to give up in our lives because of chronic illness. He had us make a list and to really think about what was on that list. Mine, of course, was my job and the volunteering that I loved to do. 

I knew going back to work wasn't going to happen again, but I was sure there must be a way I could use my volunteer skills on my terms. Then one day I noticed an advertisement in my local paper for an organization called Patient Voices Network in British Columbia and it looked perfect for me. The group was looking for volunteers who could be the voice of the patient when health care providers needed that voice in their engagements. I attended an orientation session and before I knew it, was attending my first assignment! I loved it from the start and have been an active participant ever since. 

Currently, I am the co-chair of the Oversight & Advisory Committee for Patient Voices Network. I also sit on the Clinical Resources Committee for the BC Emergency Physicians Network. 

It’s amazing how getting involved again in something you love can bring the grieving process full circle to acceptance. I realized that I had given up a lot because of fibromyalgia and osteoarthritis. But by accepting my new limitations, I actually gained a whole lot more.

0.jpg

Pamela Jessen lives in Langford, British Columbia. She has a blog called There Is Always Hope, where she writes about living with invisible illness.

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.

Long-Term Opioid Use Rare After Wisdom Teeth Removed

By Pat Anson, Editor

Anti-opioid activists have long claimed that thousands of young people have become addicted to opioid pain medication after having their wisdom teeth removed.

“Would you give your child heroin to remove a wisdom tooth?” is how a provocative 2016 anti-opioid billboard in New York City’s Times Square put it.

But a large new study published in JAMA found that the risk of long-term opioid use after wisdom tooth removal is relatively rare – although still a cause for concern.

The study of over 70,000 teens and young adults found that only 1.3% were still being prescribed opioids months after their initial prescription by a dentist. The risk of long-term use was nearly 3 times higher for young people prescribed opioids than for those who were not (0.5%).

Although the overall risk of long-term use is small, researchers say the sheer number of wisdom tooth removals warrants caution when prescribing opioids.

"Wisdom tooth extraction is performed 3.5 million times a year in the United States, and many dentists routinely prescribe opioids in case patients need it for post-procedure pain," said lead author Calista Harbaugh, MD, a research fellow and surgical resident at the University of Michigan’s Institute for Healthcare Policy and Innovation.

zahnreinigung-1514692_640.jpg

"Until now, we haven't had data on the long-term risks of opioid use after wisdom tooth extraction. We now see that a sizable number go on to fill opioid prescriptions long after we would expect they would need for recovery, and the main predictor of persistent use is whether or not they fill that initial prescription."

Harbaugh and her colleagues looked at insurance claims for opioid prescriptions between 2009 and 2015. Hydrocodone (70%) was the most common opioid prescribed after wisdom tooth removal, followed by oxycodone (24%). Long-term opioid use was defined as two or more prescriptions filled in the year after wisdom tooth removal.

But other factors besides dental surgery raised the risk of long-term opioid use. Teens and young adults who had a history of chronic pain or mental health issues such as depression and anxiety were more likely to go on to regular use after filling their initial opioid prescription.

"These are some of the first data to the show long-term ill effects of routine opioid prescribing after tooth extractions. When taken together with the previous studies showing that opioids are not helpful in these cases, dentists and oral surgeons should stop routinely prescribing opioids for wisdom tooth extractions and likely other common dental procedures," said senior author Chad Brummett, MD, co-director of the Michigan Opioid Prescribing and Engagement Network.

There are no specific prescribing guidelines for wisdom tooth removal. The American Dental Association recommends that dentists first consider non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief. It also supports the CDC opioid guidelines, which recommend that opioids be limited to no more than 7 days' supply for acute pain.

A small 2016 study found that over half the opioids prescribed to patients after wisdom tooth removal or dental surgery go unused, with many of the leftover pills being abused or stolen by friends and family members. On average, dental patients received 28 opioid pills and – three weeks later – most had pills leftover.