Is There a Fibromyalgia “Brain Signature”?

https://www.medpagetoday.com/resource-centers/contemporary-fibromyalgia-approaches/fibromyalgia-brain-signature/884

Fibromyalgia currently lacks a clear-cut, objective method to confirm its diagnosis, complicating clinicians’ jobs and frustrating patients. However, researchers may be getting much closer to identifying neurophysiological markers that are diagnostic of fibromyalgia.

Patients with fibromyalgia experience widespread pain, altered cognition, fatigue, and sleep dysfunction. On top of these burdensome symptoms, it often takes several years, several doctors, a few misdiagnoses, and numerous tests before a diagnosis of fibromyalgia is confirmed. What’s worse, these patients might have to fight an uphill battle to convince clinicians, family, friends, and coworkers that their condition is a “real” one.

To provide an objective diagnostic marker for fibromyalgia, researchers recently used a multisensory approach to identify a brain signature that distinguishes individuals with fibromyalgia from individuals without it.

Of the 72 subjects who participated, all of whom were women, 37 had a confirmed diagnosis of fibromyalgia according to the 1990 American College of Rheumatology criteria.

The other 35 were healthy controls matched for age, education status, and handedness (all were right-handed).\

Participants were exposed to visual and auditory stimulation and were asked to perform a finger opposition task.

A functional magnetic resonance imaging (fMRI) based neurologic pain signature (NPS) (previously validated to predict experimental pain and discriminate it from other unpleasant/arousing emotional experiences) was applied to the subjects during pain processing.

In addition, researchers discriminated patients with fibromyalgia from healthy controls using activation patterns during painful pressure (FM-pain) and during nonpainful multisensory stimulation.

Patients with fibromyalgia experienced greater NPS than healthy participants when exposed to the same painful stimuli. Furthermore, when pattern response values were combined for the NPS, FM pain, and multisensory patterns using logistic regression, this combined classifier was able to discriminate patients from healthy participants with 92% sensitivity (confidence interval [CI], 84% – 98%) and 94% specificity (CI, 87% – 100%).

Tor Wager, PhD, director of the cognitive and affective neuroscience laboratory and professor in the department of psychology and neuroscience and the Institute for Cognitive Science at the University of Colorado, Boulder, and author of the study, said, “Abnormal responses to multisensory events was the strongest individual predictor of whether a person had fibromyalgia. This suggests it is a systemic, rather than pain specific, neurological disorder.”

The identification of a fibromyalgia-specific brain signature has the potential to launch the medical community far ahead of the past notion that the condition was in patients’ heads. According to Daniel G. Arkfeld, MD, associate professor of clinical medicine at the Keck School of Medicine of the University of Southern California (USC), and director of rheumatological education at the Keck Hospital of USC, “It is an old idea that fibromyalgia is a made-up disorder and doesn’t exist. Results of studies such as this, as well as others that have shown high levels of substance P [a pain-promoting or algesic neurotransmitter] in the spinal fluid of patients within fibromyalgia,

Show that there is a neuropathophysiologic basis for the unique syndrome of fibromyalgia.”

The use of such a brain signature has implications beyond improving fibromyalgia diagnosis. “There is a need for objective measures in fibromyalgia. This research may help point toward appropriate targets for a more directed approach in treating fibromyalgia,” said Dr. Arkfeld. Dr. Wager concurred, “We need to diagnose patients and group them based on the underlying neuropathology. Then we have a better chance of finding the best treatments based on an individual’s biology.”

In other words, the use of fMRI technology to observe brain patterns in real time when patients with fibromyalgia are experiencing pain and multisensory stimulation may allow patients to be diagnosed using objective measures, and may also lead to advances in fibromyalgia treatment due to the enhanced understanding of the disorder it affords. There may come a time in the not-so-distant future when fibromyalgia enters its own era of targeted medicine, with therapies tailored to individual disease characteristics such as those included in the brain signature.

FDA Warns About Dangers of Epidural Steroid Injections for Back Pain

www.fibrowomen.com/fda-warns-about-dangers-of-epidural-steroid-injections-for-back-pain/

The Food and Drug Administration has just issued what’s called a “Medwatch Alert” warning that Epidural steroid injections or “ESIs” for back and neck pain can be extremely dangerous.

The alert says: “Injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”

Epidural steroid injections – and catastrophic injuries from them – were the subject of my debut investigation for The Dr. Oz Show almost exactly a year ago. (You can watch the video here and read the web article here.) The epidural space is an area between the spinal cord and the bony structure of the spine.

Our investigation revealed that the steroids – called corticosteroids – used for epidural injections are not even FDA approved for this purpose and yet ESIs are done nearly 9 million times a year, according to an analysis by Dr. Laxmaiah Manchikanti.

In addition to informing the public via its Medwatch Alert, the FDA said, “We are requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.”  Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

The new warning will be a more prominent reminder to doctors that injecting steroids into the epidural space, just outside the spinal cord, has risks. But the warning failed to list all of the possible adverse reactions. Those reactions are named in the fine print of current drug labels, and include: “arachnoiditis, bowel/bladder dysfunction, headache, meningitis, parapareisis/paraplegia, seizures, sensory disturbances.”

In 2009, the FDA convened a group to study the safety of some types of epidural steroid injections. In its new notice, the FDA said that group’s recommendations still are not ready and will be released when they are.

Click here to get this shirt

 

Dennis Capolongo of the EDNC, a group that has been campaigning against epidural steroid injections for years, called the FDA’s new warning “bitter sweet” because it did not go further.  Capolongo wants the FDA to go beyond telling doctors that injecting steroids into the epidural space COULD have severe side effects and instead state that they MUST NOT do it.

In February of this year, Australian and New Zealand health authorities came out with exactly that stronger language, stating that steroids like this, “MUST NOT be used by the intrathecal, epidural, intravenous or any other unspecified routes.” The South African government issued similar warnings, according to Capolongo.

Since the FDA is still actively studying these procedures, it will be interesting to see if the agency takes any further steps. If and when it does, you can bet I’ll pass the information along.

 

 

 

 

 

Want to have this shirt? Click here to visit our AWARENESS SHOP

#CVS Health…where health is everything… especially a healthy bottom line

 

 

 

 

 

 

 

 

 

No automatic alt text available.

opioid committee defeated!

aimed to enhance patient safety and reduce the risk of unintentional overdose and death

Hi Steve, just wanted to let you know that it happened to me now too – got a letter from my dr and he is stopping prescribing any opiates here in Ohio. Here’s what the letter he sent me reads: As your ongoing primary care provider I deeply value your trust and reliance on me. Being a dedicated professional, I am committed to delivering excellent care to my patients. As you may be aware, the opioid crisis is significantly impacting our community. The Ohio State Medical Board and Ohio Board of Pharmacy have recently issued additional rules regarding controlled medication prescribing, aimed to enhance patient safety and reduce the risk of unintentional overdose and death. Accordingly, UH(University Hospital) is taking a strict stand with regard to patient safety and the usage of controlled medications, including pain medications and anxiety medications (e.g. opioids and benzodiazepines).(Note I do not take any anxiety meds) Given the importance of optimal symptom management, along with challenges in complying with the new regulatory requirements, I will no longer be prescribing controlled medications. As a result, I would like to refer you to a provider who specializes in the treatment of your symptoms, and can reevaluate and potentially establish a new plan of care. Since I would like to discuss specific referrals with you, please call the office to make an appointment at your earliest convenience. I look forward to continuing as your primary care physician for all of your general medical needs, and I look forward to seeing you soon.

 

I think you are probably right – however my dr has been being pressured by DEA for almost 2 years now – he wasn’t keeping records as good as he should have been initially and got that squared away but they kept coming back – he’s 3 years away from retirement and now Ohio just instituted new laws making it even more restrictive so knowing all of this I honestly can’t blame my doc for making this change so he can finish out his last couple years and then retire. But sadly 2 months ago he told me he wasn’t going to leave me high and dry but now he’s gone back on his word. I don’t have the money to be a test patient with laws though I am disabled and could file against the laws Ohio is setting up.

Sure sounds like to me that this is another hospital/corporation that has decided to CYA themselves and mandate all their employee/prescribers to stop prescribing all controlled substances.  To me.. that sounds like practicing medicine without a license and since the vast majority of pts taking controlled substances are dealing with a protect class under the Americans with Disability Act.  One would suspect that the hospital/corporation has “deep pockets” and I suspect that there are other state/fed laws that are being violating and who knows if the laws/regulations that Gov Kasich and the bureaucrats have enacted are actually constitutional ?

 

Breakthrough Blood Test Shows the ‘Color of Pain’

https://www.painnewsnetwork.org/stories/2018/5/7/breakthrough-blood-test-shows-the-color-of-pain#

A revolutionary new blood test developed by Australian researchers could give doctors instant insight into the severity of chronic pain by identifying colored biomarkers in the blood.  The “painHS” test uses advanced light spectrum analysis to identify the molecular structure of pain in immune cells.

“We are literally quantifying the color of pain,” explains neuroscientist Mark Hutchinson, PhD, a professor at the University of Adelaide Medical School in Australia.  “We’ve now discovered that we can use the natural color of biology to predict the severity of pain. What we’ve found is that persistent chronic pain has a different natural color in immune cells than in a situation where there isn’t persistent pain.”

Hutchinson and his colleagues discovered molecular changes in the immune cells of chronic pain patients. These pain biomarkers can be instantly identified through hyperspectral imaging, giving doctors the ability to measure a patient’s pain tolerance and sensitivity.

The test could potentially provide physicians with the first biology-based test to measure pain as the “5th vital sign” and to justify prescribing pain medication or other therapies.

bigstock-woman-assistant-in-laboratory--118996760.jpg

Hutchinson was quick to point out that the test is not intended replace a patient’s description of pain to their physician.  Pain is subjective and varies from patient to patient, depending on their medical condition and many other factors.  Current tests used to measure pain in adults, such as the sad and smiley faces of the Wong-Baker pain scale, are so simple they were initially developed for young children.

“Self-reporting (by patients) is still going to be key but what this does mean is that those ‘forgotten people’ who are unable to communicate their pain conditions such as babies or people with dementia can now have their condition diagnosed and treated,” said Hutchinson, who believes the test could also revolutionize pain treatment in animals.

“Animals can’t tell us if they’re in pain but here we have a Dr. Doolittle type test that enables us to ‘talk’ to the animals so we can find out if they are experiencing pain and then we can help them.”

Hutchinson says the test could also help speed the development of new drugs that could target particular kinds of chronic pain, and could eliminate the need for placebos in clinical trials by giving an instant indicator of a treatment’s effectiveness.

“We now know there is a peripheral cell signal, so we could start designing new types of drugs for new types of cellular therapies that target the peripheral immune system to tackle central nervous system pain,” he explained.

Hutchinson thinks the “painHS” test could be widely available to pain specialists and general practitioners in as little as 18 months and could provide a cost-effective tool to measure the severity of pain in patients with back problems, cancer, fibromyalgia, migraines and other conditions.

Several other blood tests have already been developed to diagnose patients with specific chronic pain conditions such as fibromyalgia.

IQuity Labs recently introduced a blood test that can identify fibromyalgia by analyzing ribonucleic acid (RNA) in blood molecules. EpicGenetics launched the first fibromyalgia blood test in 2013. That test looks for chemokines and cytokines, which are protein molecules produced by white blood cells.

Dr Kline discussing Pain Management Clinics May 15th 8 PM EDT

Image may contain: text

Prescription Drug Dispensing Errors Kill 100,000 People Per Year In US

http://sacramento.cbslocal.com/2018/05/15/pills-prescriptions-kill-us/

DALLAS (KTVT) – The investigative team at KTVT-TV has learned there are more than 2.3 million prescription drug dispensing errors made every year in pharmacies across the United States.

About 100,000 patients die every year because of a pharmaceutical mistake according to reports published by the National Center for Biotechnology Information.

PHARMACY DISPENSING ERRORS

Lake Towakoni resident Linda Lilley thought she was taking her pain medication Gabapentin, but she says her bottle contained Gemfibrozil- a cholesterol medication which looked very similar to Gabapentin.

The bottle had a correct manufacturer label but she says the pharmacist put the wrong label on it.

pharmacy bottle Prescription Drug Dispensing Errors Kill 100,000 People Per Year In US

She got so sick she says she eventually could not move. She needed help doing day-to-day chores.

“I felt nauseated,” she said. “By the third day, I was debilitated.”

The pills looked so similar that Lilley did not suspect anything was wrong. Finally, one morning, she looked at the bottle closely and discovered the mistake. She immediately stopped taking the medication; however, by that time, she had taken the wrong drug for 12 days, three times a day.

EFFECTS OF MEDICATION MISTAKES

Since 2016, KTVT learned the State of Texas has disciplined nearly 200 pharmacists for making errors. The documents obtained by KTVT show some striking examples of dispensing mistakes.

A wrong dose of medication sent a 3-month-old to ICU for five days. The infant was given 100 times the prescribed amount.

Another example indicated a wrong strength of a drug rushed a 7-year-old to the ER with heart problems.

A wrong drug left another patient with an increased risk of cancer.

A patient was prescribed “cyclosporine” but instead, the pharmacist filled “Cyclophosphamide.”

WHAT IS GOING ON?

The similarity in names is one of the biggest causes for confusion, experts told KTVT.

Dr. Marv Shepard, the former Chairman of the Pharmacy Administration Division of the College of Pharmacy at the University of Texas in Austin, says errors typically occur because pharmacists are overworked.

“They’re having trouble because of the pressures of the environment,” he told KTVT. Dr. Shepherd says the stress of staying open 24 hours can be overwhelming.

He says the typical pharmacy stocks up to 5,000 drugs, dispenses 300 prescriptions daily and makes two to four mistakes every day.

Dr. Shepard believes it results in about 100,000 deaths in the U.S. “It’s huge, it’s a big problem,” he added.

He says the two most common drugs involved in dispensing errors are insulin and anti-coagulants. And most of these occur in just about every well-known pharmacy you can think of. KTVT reached out to some of the pharmacies listed in disciplinary actions by the State of Texas.

CVS PHARMACY STATEMENT

The health and well-being of our patients is our number one priority and we have comprehensive policies and procedures in place to ensure prescription safety.  We regularly seek out new technology and innovations to improve our systems, we engage with industry experts for independent evaluations of our dispensing procedures, and we are committed to continually improving our processes to help ensure that prescriptions are dispensed safely and accurately.  Prescription errors are a very rare occurrence, but if one does happen, we do everything we can to learn from it in order to continuously improve quality and patient safety. 

WALGREENS PHARMACY STATEMENT

The quality and safety of our pharmacy services is the top priority for Walgreens, and we take any prescription error very seriously. That’s one reason we have a multi-step prescription filling process with numerous safety checks in the process to minimize the chance of human error. We also encourage patients to check with our pharmacists or their health care providers if they have a question or concern about their medications. Together, we can help ensure our patients get the best care.

WALMART STATEMENT

We work hard every day to ensure we live up to the high standards we set for ourselves and that our customers expect. We have quality control measures in place to help ensure that any medications we provide our customers are the medications prescribed.

Despite the stacks of disciplinary actions KTVT received from the state, Dr. Shepherd says most errors are never reported.

MANUFACTURER’S MISTAKE

KTVT learned it is not just pharmacies making mistakes. While it is rare, drug manufacturers have also put the wrong medicine in a sealed bottle and then sent the bottle to pharmacies.

That is exactly what happened to Karin Bollinger.

For 30 days, Bollinger, a Dallas resident, thought she was taking Clopidogrel, her prescribed blood thinner. But instead, the bottle contained Simvastatin, a cholesterol drug. She too suffered serious side effects.

”I had lost about 17 pounds in 12 days,” she said. “I had a horrible rash, blisters, and ulcerations across my chest.”

Bollinger eventually received a recall letter from the maker warning her about the mix-up in the manufacturing process, but that was months later.

“The drug mistake had been made,” Bollinger said.

The KTVT asked the manufacturer, International Labs, to respond to the error but it did not want to comment on the case.

READ FDA RECALL LETTER HERE

WHAT IS BEING DONE

Experts say the industry is cracking down on errors at the manufacturer and pharmacy level. The FDA has created a commission to change the names of similar sounding drugs. Electronic prescriptions have helped with handwriting mishaps. In addition, barcode technology has also helped lower dispensing errors.

screen shot 2018 05 14 at 6 31 01 pm Prescription Drug Dispensing Errors Kill 100,000 People Per Year In US

bad handwriting prescription

Both Bollinger and Lilley say their experiences have taught them to always double check their prescriptions.

“We all need to be aware of it. Look at your medications,” Lilley said. That is the only way to stay safe she added.

“This has taught me to check every one of my medications,” Bollinger said.

WHAT CAN YOU DO?

When you leave the pharmacy and tear the insert off of the bag containing your medicine, make sure you check the description of the drug on the insert and compare it to what is in the bottle.

Reynolds signs bill intended to curb opioid overdose deaths

http://www.miamiherald.com/news/article211116604.html

Doctors in Iowa will be required to screen patients’ risk of addiction before prescribing some painkillers under a law signed Monday by Gov. Kim Reynolds.

The law, an attempt by lawmakers to curb Iowa’s growing opioid problem, mandates the tracking of prescription drugs through a software system that should automatically flag patients believed to have a high risk of abusing painkillers. The measure seeks to reduce so-called “doctor shopping,” where a patient visits multiple physicians seeking prescriptions.

Reynolds signed the law at a Dubuque medical center that offers treatment for opioid addiction.

“Opioid-related deaths have more than doubled over the past decade,” the Republican governor said. “With this legislation, we are taking the first step to reverse this heart-wrenching trend.”

Medical experts warn the state must be careful to avoid a spike in illegal drug use, an unintended consequence of limiting opioid medication.

Lawmakers have taken some steps in recent years to address opioid abuse. In 2016, they expanded access to a drug used to treat overdoses. Grants also are increasing access to treatment for those addicted to opioids. But there’s been a push to do more as opioid-related deaths increase.

Opioid patients will now be assigned a number similar to a credit score that indicates their risk for abusing opioids — which include prescription pain relievers, such as oxycodone, and illegal substances, such as heroin. High risk patients would be scrutinized by doctors and pharmacists.

“The higher the number, the higher the risk,” said Andrew Funk, executive director of the Iowa Board of Pharmacy.

Iowa will join 38 other states that require the use of a prescription monitoring program, according to the National Alliance for Model State Drug Laws. Iowa’s neighboring states of Minnesota, Wisconsin and Illinois have mandatory review programs. Nebraska and South Dakota have optional programs, while Missouri lacks a robust statewide program.

Prescription management programs need to be linked to other efforts to combat opioids, said Silvia Martins, a Columbia University assistant professor who co-authored a recent study examining whether such programs decrease overdose deaths. The study, published earlier this month, encouraged states to have mandatory programs like Iowa’s where doctors review patient data before writing prescriptions. Providing adequate access to treatment is also critical.

“It has to be a multipronged approach,” Martins said.

States can’t only focus on legal access to opioids. Martins said some states see a spike in heroin overdose deaths after taking steps to reduce legal prescriptions for opioids.

Iowa had 98 deaths linked to heroin last year, part of 309 overall opioid-linked deaths, based on preliminary data from the Iowa Department of Public Health. Iowa had more than 50 opioid-linked deaths in the first four months of 2018. Nationally, more than 115 people die each day from opioid overdoses, according to the Centers for Disease Control and Prevention.

The law, which goes into effect in July, also provides immunity from prosecution to anyone who calls 911 to report an overdose.

Critics question whether Iowa’s opioid legislation goes far enough. The new law doesn’t place any limits on how many doses of opioids can be prescribed or directly address the spread of illicit drugs.

Democrats unsuccessfully attempted to add a needle exchange program, which could help slow the spread of hepatitis C and HIV from illicit drugs. State Epidemiologist Patricia Quinlisk said such programs are a “proven method” to get people with drug addiction into treatment.

Rep. David Heaton, a Mount Pleasant Republican who isn’t seeking re-election, said he’s also concerned that the private companies that run Iowa’s Medicaid system “drag their feet” on providing authorization for medicine to help curb addiction.

“My hat’s off to all of us on passing a good start,” Heaton said in floor debate. “But there’s a lot of work to be done.”

July 9, 2018 the Food and Drug Administration is holding public meeting on chronic pain treatment

on July 9, 2018 the Food and Drug Administration is holding public meeting on chronic pain treatment for adults and pediatric patients.  Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting and an opportunity for public comment on “Patient-Focused Drug Development for Chronic Pain.” The public meeting will provide patients (including adult and pediatric patients) with an opportunity to present to FDA their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to accessing treatments. FDA is particularly interested in hearing from patients who experience chronic pain that is managed with analgesic medications such as opioids, acetaminophen, nonsteroidal antiinflammatory drugs (NSAIDs), antidepressants; other medications; and non-pharmacologic interventions or therapies. DATES: The public meeting will be held on July 9, 2018, from 10 a.m. to 4 p.m. Submit either electronic or written comments on this public workshop by September 10, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information.

 

 

Read more at: https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-10284.pdf