Today's post from indypodiatry.com (see link below) is a useful list of tips to avoid foot problems with neuropathy. The lack of sensation in toes and feet; or even the excess sensation in the same areas can lead to misleading signals and all kinds of accidents and mishaps. For these reasons it's important to take care of your feet and keep an eye out for injuries you may not be feeling or noticing. It's not a comprehensive list but there are some sensible ideas here. 
Michael J..Helms:DPM Shelley F Bowers DPM
One of the potential problems associated with diabetes is the loss of the ability to feel things in the feet. This condition results in an inability to feel pain or other stimulus. This condition is known as diabetic peripheral neuropathy.
Our ability to feel pain is an important protective mechanism. Pain warns us to move our feet away from a hot register. It tells us we stepped on a piece of glass and we need to get the glass out of our foot. Pain let’s us know when we break a bone in our foot and prompts us to get treatment. Diabetics with neuropathy lack the important feedback of knowing when there is an injury to the foot. A diabetic with neuropathy can break a foot bone and not be aware of this because they do not feel the pain. The results can be devastating, including the potential loss of a foot or leg to amputation.
Steps to Avoid Serious Foot Problems
If you have diabetes and a loss of protective sensation there are steps you must take to help you avoid serious foot problems. Here is a list of important tips to help guide you:
Inspect your feet daily. Since you cannot feel when a problem is present you need to use your vision to replace your loss of sensation. Use a mirror to see the bottom of your feet. Call Drs. Helms or Bowers if you find new redness, swelling, bruising, cuts or other changes.
Always wear shoes, even around your home. The shoes will act as a protective barrier.
Change into different shoes once or twice each day. This allows for changing pressure point on the bottom of your feet and decreases the risk of developing a callus or sore on your feet.
Make sure your shoes fit well and are not overly worn. You should be professionally fit, either in our office or at stores where the sales staff knows how to measure feet and has experience working with diabetic patients. Our office can direct you to the appropriate stores.
Use open toe support hose. If you wear support hose prescribed by one of your doctors, make sure you use the type with open toes. This can help prevent possible irritation or the development of sores on your toes.
Always wear special shoe inserts made by your doctor. If Dr Helms or Dr Bowers has made or dispensed special shoe inserts, be sure to always wear these in your shoes. These inserts can help prevent foot sores or foot ulcerations.
Ask Dr Helms or Dr Bowers about personal digital thermometry. This is a simple, at home tool you can use to help detect many diabetic foot problems in their early stages. Early detection will lead to treatment that might prevent foot sores, ulcerations or amputations.
Exercise on a regular basis. Studies have shown that patients with diabetic loss of protective sensation that engage in aerobic exercise have fewer amputations.Be sure to clear this with your medical doctor before beginning a new program. Also, be sure to discuss appropriate exercise shoes and socks with Dr Helms or Dr Bowers.
NEVER trim your own calluses or corns. Corns and calluses occur in places where there is rubbing or too much pressure. Corns and calluses need to be trimmed back on a regular basis because they can lead to diabetic foot ulcers. These should only be trimmed by your podiatrist.
Do not have pedicures. Diabetics with loss of protective sensation should have their toenails trimmed at the podiatrists office.
http://www.indypodiatry.com/diabetic-neuropathy.php
Today's post from psnc.org.uk (see link below) is a British view and advice to pharmacists on the changing status of Lyrica, as Pfizer's patent has now run out and generic versions will be coming onto the market. Pfizer in their wisdom, have decided to maintain a Lyrica patent for patients with neuropathy, at least until July 2017. This will effectively prevent other companies from bringing out a generic version until that date. Now in 2013, Pfizer were quite clear that pregabalin (Lyrica) was in their own eyes unsuitable for diabetes and HIV-related neuropathy patients. This was mainly due to adverse study outcomes and many court cases relating to side effect issues. The point is: what's changed? the answer: probably nothing: they still won't approve Lyrica for HIV and diabetes neuropathy patients and the FDA backs that up completely. So is this just a corporate move to prevent rivals from bringing generic Lyrica to the market too quickly? More importantly for neuropathy patients; will generic pregabalin (lyrica) be any more effective and any less dangerous for patients in the future. We'll have to wait and follow the recommendations for the US FDA and similar authorities across the world but until then, if your doctor is still prescribing Pregabalin (Lyrica) (generic or not) for your neuropathic problems, you need to have a serious discussion as to whether this is in fact, the best option.
January 29, 2015
Pregabalin (Lyrica) patent is changing and generic pregabalin is becoming available. The NPA have issued advice (shown below) regarding the licencing of the products.
The NPA have also informed us that are also in the process of discussing this issue with the MHRA and Pfizer.
Dear Pharmacist
You may find in the coming months that generic pregabalin is available to order. I would like to highlight to you that although the patent for pregabalin expired in July 2014, this patent expiry related to the use of pregabalin in epilepsy and generalised anxiety disorder; Pfizer will retain a patent for the use of pregabalin in the treatment of peripheral and central neuropathic pain in adults until July 2017.
This means that until July 2017, generic manufacturers of pregabalin will only be able to obtain a licence for pregabalin for use in epilepsy and/or generalised anxiety disorder and Lyrica, Pfizer’s branded product, will remain the only product licensed for use in pain as well as epilepsy and generalised anxiety disorder.
Pfizer has indicated that it will contest any challenges to the patent for pain.
To avoid any possible patent infringement by pharmacists, steps will need to be taken to ensure that where generic pregablin is requested on a prescription the correctly licensed product is supplied. This may mean contacting the prescriber and establishing the indication and requesting that the prescription is amended and ordered by brand as Lyrica if necessary.
Although generic pregabalin is unlikely to differ clinically from the branded Lyrica, supplying the generic version of pregabalin for neuropathic pain may have the following implications for pharmacists:
Generic pregabalin preparations will not include information relating to neuropathic pain in the patient information leaflet and pharmacists will be supplying a product off-licence
Supplying generic pregabalin for neuropathic pain would not be in line with Medicines and Healthcare products Regulatory Agency’s risk hierarchy guidance for the supply of unlicensed medicinal products, which states that a UK-licensed product should always be supplied for the correct licensed indication
Using generic pregabalin for neuropathic pain may be deemed by Pfizer to be a patent infringement by all parties concerned, including the prescriber and the supplying pharmacist
Currently, reimbursement for NHS prescriptions for pregabalin is based on Lyrica. This may change when generic versions become available meaning that pharmacists may not be correctly reimbursed where Lyrica is supplied against a generically written prescription for pregabalin. I advise that where generic prescriptions for pregabalin are received, the prescriber is contacted to ascertain the indication. Where the indication is for neuropathic pain, the prescription should be returned to the prescriber for amendment to Lyrica. Prescriptions for pregabilin for epilepsy or generalised anxiety disorder can be dispensed with either Lyrica or appropriately licensed generic versions.
When supplying pregabalin for the treatment of epilepsy, pharmacists should also consider MHRA guidance issued in 2013 regarding the generic prescribing of antiepileptics. The guidance states that pregabalin does not generally need to be prescribed by brand for the treatment of epilepsy unless there are specific concerns such as patient anxiety and a risk of confusion or dosing errors.
For further information on this or any other query please contact the NPA Pharmacy Services Team on 01727 891 800 / 08447 364 201
or email pharmacyservices@npa.co.uk .
http://psnc.org.uk/sunderland-lpc/our-news/pregabalin-lyrica-licensing-differences-bewteen-lyrica-and-generic/
Today's post from neuropathyjournal.org (see link below) is the story of one man's fight to get his neuropathy and the cause of that neuropathy, recognised both in the courts and by the doctors who treated him. Since he began to publicly fight for recognition of Agent Orange as being a direct cause of nerve damage, many others have also come forward and the authorities have been forced to acknowledge a painful fact. Of course, the words 'Vietnam, veterans, chemical warfare and disease as a result', are highly sensitive in certain circles but in the end the truth will always out. It shows us all that although we share the same damage to our nervous systems and resulting pain and symptoms, the journey to get there is enormously varied. The point is that, irrespective of the cause, be it HIV, alcoholism, Agent Orange, diabetes or any of the other 100 causes of neuropathy, we all deserve the same treatment and 100% effort of our doctors and social support services. The fact that we don't all get equal treatment shows just how far we have to go. We need to speak up individually and advocate, if we feel we're being ignored, or denied appropriate medical treatment or social support.
By LtCol Eugene B Richardson, USA (Retired) BA, MDiv, EdM, MS4
His nightmare began in 1969 – one year after leaving the Vietnam War. Symptoms of autonomic and polyneuropathy neuropathy affected his breathing with upper body paralysis that brought him to his knees and affected other parts of his body; mysterious chest pains, electric shocks, painful skin, physical exhaustion, unexplained silent tachycardia, urinary and digestive problems all contributing to his nightmare. It would not be until 35 years later in 2004, that a diagnosis was provided and treatment began to stop the damage and provide some relief.
An Army officer, he struggled for 18 years of his Army career with severe electric shocks that began, uncharacteristically, in his upper body. Occasionally the symptoms would disappear and he would think the nightmare was over but it was not to be – the cycle would always begin again. The loss of stamina and periods of total exhaustion – the perception by others that it must be psychological – left him unable to continue. His distinguished military career came to a screaming halt. With medical records that contain many negative comments about his condition and his cycle of pain and symptoms, he retired from the Army in 1987. His dream was over and he hoped his nightmare would go away!
Still reeling from the circumstances of his retirement, he began working in operations for retirement homes and services for the aging in Florida. For 14 years he held his head high, managed to keep smiling and performing his work with distinction, becoming a VP while avoiding those who felt his continuing cycle of symptoms was due to his inability to ‘handle stress’. He even had forced temporary salary and time reductions as punishment for being hospitalized with heart problems so that he would learn how to “not work so hard.”
By 1999, his condition made breathing and speaking simultaneously very difficult; his skin was so sensitive that he would scream when sheets or clothing touched him. He built a PVC frame around his body so he could sleep. Walking became difficult due to the transient paralysis of his legs and he used a wheelchair off and on; it was difficult to stand because of the bone pain and sometimes too painful to even sit. Some doctors even made fun of the fact he carried a pillow to sit on or made fun of his using a cane, because all tests were “normal.”
For thirty five years his doctors kept saying, “All tests are normal”. The electric shocks slowly spread from his left arm and scapula to his other arm, his feet, legs, and eventually to every part of his body – decades of torture. Eventually, the periods of temporary paralysis and other major system failures made working impossible; he was forced to retire again in 2000. He was convinced, “I had descended into hell” and yet most of the time he kept smiling as he struggled to function daily.
Objective tests in 2000 confirmed significant damage to his peripheral nervous system even though, unbelievably, some experts were still denying the reality of his symptoms. He felt medically isolated and psychologically devastated when his decade’s long history and the objective tests were ignored by an expert. “Not all of these symptoms are neuropathy”, said one expert.
Then in April 2004 based on a medical article by Norman Latov MD PhD (Columbia University, New York) with contributions by Alan Berger MD (University of Florida, Jacksonville) and Walter Bradley MD (University of Miami) plus 18 other neurologists, he began receiving gamma globulin treatments (IVIg) and has had positive results. Every symptom back to 1969 responded eventually in some way to the infusion. Today he receives this infusion every twenty one days.
Then as if this was not enough, many mistakes were made on the initial attempts at infusion (too fast, to high liquid volume, need for Lasix as kidneys could not handle the fluid volume) that for nine months mistakes almost cost him his life. Yet he responded to the treatment and eventually all this was adjusted after nine months of trial and error and a change of neurologists’ as well as two changes in the infusion site following a trip to the emergency room when the infusion was refused by a hospital and delayed for 42 days. He almost did not make it and was rushed to the emergency room at another hospital where his wife found IVIg.
Then Medicare refused to pay for the treatment, as they stated that it was medically unnecessary and to this day getting his infusion and the product that works for him, is a challenge. In 2009 he was forced to travel two and a half hours to get the infusion at the only location in Florida who would give it to him.
In 2010 he had no choice but to move to Fort Lauderdale to reduce his travel time. He has testified before Congressional Representatives on this issue and helped in the filming of a documentary, “Dying for Help”.
By 2005 his extensive medical history and continued testing confirmed autonomic neuropathy – challenging decades of denial by experts in the medical system who ignored four other doctors who stated that symptoms were present. In 2007, his neurologists told him that he had small and large fiber neuropathy, motor, sensory and autonomic. With all other causes of his neuropathy ruled out by medical testing, he was told in 2009 by his treating Neurologist that there was an “extremely high probability that his current diagnosis and medical condition is due to a toxic polyneuropathy because of exposure to Agent Orange in Vietnam”. He wants to know what took them so long.
On January 7, 2010, Veterans Affairs finally confirmed a total permanent service connected disability using half of his diagnosis. Lt. Col Eugene Richardson, USA Retired, has spent 45 years living, and coping, with the symptoms of his progressive neuropathy and the devastation from Agent Orange.
In 2013 the Veterans Affairs Administration (VA) began recognizing that exposure to Agent Orange (AO) causes Chronic Peripheral Neuropathy. However the Institute of Medicine (IOM) added a requirement of early on-set to connect the condition with AO exposure. Yet during the decades of the Vietnam War and after, even until 2004 clinical diagnosis and recognition of the symptoms of Peripheral Neuropathy are just now being recognized and diagnosis and treatment are difficult.
For decades with the symptoms clearly recorded in LTC Richardson’s medical records, the VA denied all of this information for six years, relating it to other conditions and then repeated misstatements of fact four times about the clear statements in his service medical records. Why?
(Note: Recommend that Veterans include a copy of this document showing the bogus nature of the early onset requirement. Reference is made to: “One Man’s Journey with Neuropathy” the experience of LtCol Eugene B Richardson, USA (Retired) with currently 100% VA disability due to Chronic Neuropathy after service in Vietnam in 1967-68.)
In 2014 by medical testing at the VA Hospital in Miami, it was again confirmed that he had been dealing with a severe motor and sensory neuropathy with Autonomic symptoms with damage to both the axon and myelin resulting in his severe disabilities.
After waiting for three years for a VA Hearing before an appeals Judge regarding the effective date of his disability, he appeared before this Judge on July 8, 2015. At the root of his case was the fact that he never received the 2007 document until it was too late to respond and the fact that the VA had made four misstatements of fact that his Neurologist pointed out in an affidavit in 2008.
Before going into the hearing he was told that the VA would be forced to go against their own laws to approve his appeal! He had not appealed the 2007 Statement of the Case in time. Not very encouraging. Physically and emotionally exhausted by the long trip to Fort Lauderdale to Tampa and the reliving in this process the decades of the emotional pain of his disease and raw memories of the war, exhausted he almost quite. But then found the strength to go before the Judge determined to at least have his say. To his surprise the Judge was very supportive and understanding! To make a long story short, she reviewed the Statement of the Case that the VA sent in 2007, noting that it had been sent to an incorrect address! In addition the Clear and Unmistakable Errors (CUE) made by the VA at the first response to his claim in 2006 were recognized. Mysteries solved and on August 25, 2015, over ten years since filling the claim, the effective date of the claim was set at the original date of filing in 2005 for the 100% VA recognized service connected disability!
This case is an example of the false premise on which current VA law of ‘early onset’ is based claiming that “a neuropathy could have been diagnosed and recognized at the 10% disabling level during the years during and following the Vietnam War. In this case there was clear evidence of the symptoms in his service medical record, but they were never recognized as related to neuropathy and in the initial rejection of the claim in 2006, the VA even misquoted the information from his medical records denying that it was in fact in the records in the official VA documents! You tell me what is wrong.
Same Lesson Learned: “Veterans must never give up in the face of often unhelpful VA laws and those who were praying for me, may never know how this helped, for the strength I found came from outside myself on this day and it was the same strength found in this decades long journey!”
Lt. Col. Richardson is a graduate of the Command and General Staff College and attended the U.S. Army War College for senior officers. He holds a Bachelors of Arts in Philosophy, Bachelors of Divinity and a Masters of Divinity in Pastoral Care and Counseling,, a Masters of Education in Adult Education, a Masters of Science in Management and a Master of Science in Counseling. With decades of experience as an educator, counselor, and pastor, he uses his vast knowledge and experience to provide straight answers and insight to those suffering with any form of neuropathy.
Before he became too disabled to continue, he led three neuropathy support groups in Florida and taught a seminar, “Coping with Chronic Neuropathy”, which is endorsed by board certified neurologists at major universities. This seminar became a DVD production produced by professional volunteers in November 2010 at Afterhours Music, Inc. of North Miami, Florida. It is distributed FREE of charge using donated funds through the Network for Neuropathy Support, Inc., dba Neuropathy Support Network, a non-profit Florida Corporation.
In 2014 the DVD was revised to insure ALL neuropathy organizations can make it available to ALL neuropathy patients.
In June 2010 he received the annual national award in recognition of his work in helping other neuropathy patients and veterans from the Neuropathy Action Foundation, Inc. of Scottsdale, AZ.
Besides providing daily volunteer advocacy, information and counseling to neuropathy patients via the internet, in March 2011 between resting to recover from his daily bouts with exhaustion, he launched a website for neuropathy patients called the Neuropathy Support Network. In 2015 with the help of neuropathy patient David Morrow, he launched a companion linked website called the Neuropathy Journal. The website contains volumes of information for patients and professionals and the content is reviewed and approved by medical professionals.
How does he view all of this fun? How does he cope with the few ‘professionals’ who have refused to note or provide information on the DVD or even out of jealousy attacked his work for neuropathy patients? He is making lemonade out of the lemons of life as Mom and Dad taught me and God as His soldier has ordered me to do.
SPECIAL QUESTION: What was the chance that David Morrow, now our Senior Vice President of the NSN, a Cancer patient with the right skills and I, would meet on that day and hour, in the infusion room of Imperial Point Medical Center Pompano Beach, Florida, in that situation when he needed to talk about his Neuropathy and I needed someone to help with the DVD production “Coping with Chronic Neuropathy” . I knew nothing about distribution and needed someone who could design our website (for free)! I was a counselor and teacher and I knew nothing about all of these challenges. About a trillion to one? The Bible says: “All things work together for good to them that love God”. Someone bigger than us both had a hand in this meeting. As a patient with a Chronic illness, never stop looking for opportunities to fight back and bring new meaning into your life through your illness. View Patients Helping Patients.
NOTE: Copyright 2010-15 Network For Neuropathy Support, Inc. dba Neuropathy Support Network.. This article may be reprinted or published for educational purposes as long as the printing or publishing is not for profit and acknowledgement is granted the author. Contact him at E-mail: gene@neuropathysupportnetwork.org
PATIENT TO PATIENT – Disclaimer: Patient to Patient articles are intended to be educational, not diagnostic or prescriptive and the patient is encouraged to seek help from their own private physician.
About the Author
Col Richardson has suffered with severe neuropathy for over 45 years. A 27 year military veteran and veteran of the Vietnam War, he was diagnosed with a progressive chronic peripheral neuropathy resulting in severe disability. This diagnosis has been confirmed as due to exposure to Agent Orange. It was not until 2010, 42 years after his exposure to Agent Orange, that his diagnosis was recognized by Veterans Affairs as service connected.
https://neuropathyjournal.org/one-mans-journey-with-neuropathy-2/
Today's post from hcplive.com (see link below) will not come as news to most people living with HIV. It has long been stated that between a quarter and a third of people with HIV also eventually develop neuropathic problems. However, this article doesn't really go into the question as to why this happens. The accepted view is that it's a consequence of antiretroviral medications (especially the older ones) but the number of people who suffer from neuropathy whilst being on modern HART drugs is growing. Other people think that the virus itself must play a role in attacking the nervous system, or a combination of both HIV and the drugs used to treat it. Either way, it is a significant side effect of living with HIV and one which shouldn't be underestimated. Whatever the cause, it's the treatment you should be concentrating on. Finding the right medication for you to be able to live best with the symptoms, is the key and what your specialists should concentrate on.
Peripheral Neuropathy in a Third of HIV Patients
Signs of peripheral neuropathy (PN) were detected in a third of men after almost 4 months of HIV, according to research published in the Journal of Acquired Immune Deficiency Syndromes.
A multifaceted team of researchers studied 58 antiretroviral-naïve male patients with laboratory-confirmed HIV infections by examining blood and cerebrospinal fluid (CSF). Study participants were an average age of 36 years with a median CD4+ T-cell count of 575 cells per microliter, which was evaluated at 107 days post-HIV transmission (DPT).
Primary HIV infection (PHI) was used to measure baseline, and was defined as within the first 12 months after HIV transmission. The infection’s timeline was confirmed by observing antibody seroconversion, nucleic acid testing, or less sensitive enzyme immunoassay result. In other cases, DPT was defined by estimating the halfway point between the last negative and first positive HIV test.
Study participants were evaluated based on general medical, neurological, and psychological examinations, PN symptom testing, stricter symptomatic PN (SPN) testing, intravenous drug use, and laboratory assessments. The laboratory testing included blood and CSF testing, lumbar punctures, lymphocyte count measurements, and HIV RNA levels.
The researchers found 20 participants (35%) met criteria for PN after an average of 107 DPT. PN subjects tended to be older (median age 40 years) compared with no PN (NPN) patients (median age 34 years). SPN was found in 13 of those subjects (65%) and 6 patients (30%) had bilateral findings. Seven patients had unilateral findings, and in the remaining 7 subjects, the laterality was not specified.
There was no difference between median ages, days post HIV transmission, blood CD4 or CD8 counts, CSF or plasma HIV RNA levels, CSF white blood cell counts, CSF to blood albumin ratio, or neurological or psychological performances among PN subjects and NPN subjects. Typical symptoms of PN found in 13 PN subjects included “foot tingling and numbness.” No differences were distinguished between NPN and SPN subjects.
However, PN and SPN patients had elevated CSF neopterin, SF monocyte chemoattractant protein-1, and blood neopterin levels when compared to NPN subjects. PN subjects were found to have a higher percentage of activated phenotype CSF CD8+T lymphocytes than NPN study participants.
“PN is a frequent neurological disorder reported in HIV, classically in the setting of chronic untreated HIV infection or after exposure to certain antiretroviral medications,” the authors concluded. “However, we found that signs (35%), or signs and symptoms (22%), of PN were evident in a cohort of ART-naive subjects recruited to a neurological study at a median of 3.5 months after initial HIV transmission. We further examined mechanisms for peripheral nerve dysfunction identified during this stage, revealing that markers of systemic and central nervous system immune activation are elevated in subjects with signs of PN compared with those with NPN.”
http://www.hcplive.com/articles/Peripheral-Neuropathy-in-a-Third-of-HIV-Patients
Today's post from the reliable drugs.com (see link below) takes a look at a new initiative by a European pharmaceutical company (the makers of Tapentadol (Palexia) amongst others) to help chronic pain patients better assess the extent of their own pain. By means of an online questionnaire and many patient own testimonies, the idea is to help patients put their pain in context and provide information that will be both useful to themselves and their doctors. This blog never advertises on behalf of commercial companies but this does seem to be of genuine benefit to people living with neuropathy.
Pharma Website Addressing Pain Perception Debuts "My Pain Feels Like…" - Pain Perception is as Individual as Pain Patients
AACHEN, Germany, October 8, 2013
- A new website helps pain patients to better express and explain how their pain feels like
Pain can appear in many forms and affects people in different ways. One kind of long-lasting or chronic pain results from a damaged nerve that sends incorrect pain messages to the brain. This pain is called neuropathic pain or nerve pain.
Over 26 million people worldwide suffer from neuropathic pain[ 1 ] but only 40-60% of patients achieve adequate pain relief.[ 2 ]
The majority, approximately 60%, of neuropathic pain is localised[ 3 ] (localised neuropathic pain, LNP) and is often described as a burning, shooting, lancinating, electric shock like.[ 4 ] But more frequently patients are trying to describe their pain in their own words by using their individual, often very pictographic language.
A correct and early diagnose is crucial to find the right treatment. Therefore patients need to describe their symptoms in as much detail as possible to their doctor.
At the new website http://www.mypainfeelslike.com patients find a questionnaire that helps them to describe in detail how their pain feels like, how it affects their life and where the pain is allocated.
"My pain feels like…" has been developed by Grünenthal GmbH in collaboration with the Montescano Pain School, Italy. For more information please visit http://www.grunenthal.com
About Grünenthal
The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain treatment, its objective is to become the most patient-centric company and thus to be a leader in therapy innovation. Grünenthal is one of the last remaining five research-oriented pharmaceutical companies with headquarters in Germany which sustainably invests in research and development. The research and development costs amounted to a preliminary of about 26 percent of revenues in 2012. Grünenthal's research and development strategy concentrates on selected fields of therapy and state-of-the-art technologies. We are intensely focused on discovering new ways to treat pain better and more effectively, with fewer side-effects than current therapies. Altogether, the Grünenthal Group has affiliates in 26 countries worldwide. Grünenthal products are sold in more than 155 countries and today approx. 4,400 employees are working for the Grünenthal Group worldwide. In 2012, Grünenthal achieved preliminary revenues of € 973 mn. More information: http://www.grunenthal.com.
References:
1 Pal M et al (2009). Vanilloid receptor antagonists: emerging class of novel anti-inflammatory agents for pain management. Curr Pharm Des 15:1008-26
2 Dworkin RH, O'Connor AB, Backonja M, et al (2007). Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain;132:237-51
3 Mick G et al (2012). What is localised neuropathic pain? A first proposal to characterise and define a widely used term. Pain manage 2(1), 71-77
4 Woolf C et al (1999). Neuropathic pain: aetiology, symptoms, mechanisms, and management. Lancet; 353:1959-64
Contact: Jeanette Hübsch, Grünenthal Europe & Australia
Phone: +49-241-569-1487, email: jeanette.huebsch@grunenthal.com
Posted: October 2013
http://www.drugs.com/news/pharma-website-addressing-pain-perception-debuts-47995.html
Today's short post from sciencedaily.com (see link below) raises more questions than answers as far as this blog's concerned and doesn't necessarily appreciate the nature of chronic nerve pain. Any article that suggests: "For less severe (nerve) pain, many over-the-counter medications, such as ibuprofen or naproxen, may be as effective as an opioid" has to be suspect because it just can't be true. Neuropathy patients are prescribed opioid drugs for their pain when all else has failed and to suggest that over-the-counter analgesics may be just as effective, shows lack of understanding of how nerve pain works on the brain and nervous system. That said, any article that threatens opioid users with a much increased risk of death has to be taken seriously, read and examined. It feels like an article that is written in response to the current 'crisis' with medication overdose problems and Professor Ray doesn't leave any doubt as to which side of the fence he sits on. He states: "We found that the opioid patients had a 64 percent increased risk of death for any reason and a 65 percent increased risk of cardiovascular death," but doesn't deliver the scientific evidence or context behind their findings. Should we be worried about this sort of headline? Of course we should but then we need to know how the conclusions have been reached. If you are a neuropathy patient in severe pain and having to rely on opioids to dampen that pain, then I suggest you have another talk with your prescribing doctor or specialist if you're worried. 99% of opioid users don't want to be taking opioids but have no choice and they take their medication with the greatest care and will do anything to avoid becoming addicted or harming themselves. They form a partnership with their doctors and their medication use is controlled and checked regularly to avoid any problems. The 1% who don't are the ones behind the current prescription drug hysteria...sledgehammer to crack a nut much!!!
Long-acting opioids are associated with a significantly increased risk of death when compared with alternative medications for moderate-to-severe chronic pain, according to a Vanderbilt study released today in JAMA.
Not only did long-acting opioids increase the risk of unintentional overdose deaths, but they were also shown to increase mortality from cardiorespiratory events and other causes.
Lead author Wayne Ray, Ph.D., and colleagues with the Vanderbilt Department of Health Policy studied Tennessee Medicaid patients between 1999-2012 with chronic pain, primarily back and other musculoskeletal pain, who did not have cancer or other serious illnesses.
Researchers compared those starting a long-acting opioid to those taking an alternative medication for moderate-to-severe pain.
Alternative medications included both anticonvulsants -- typically prescribed to prevent seizure activity in the brain, treat bipolar disorder or neuropathic pain -- and low doses of cyclic antidepressants, which are taken for depression, some pain and migraines.
"We found that the opioid patients had a 64 percent increased risk of death for any reason and a 65 percent increased risk of cardiovascular death," said Ray, professor of Health Policy at Vanderbilt University School of Medicine.
"The take-home message for patients with the kinds of pain we studied is to avoid long-acting opioids whenever possible. This is consistent with recent Centers for Disease Control and Prevention guidelines. This advice is particularly important for patients with high risk for cardiovascular disease, such as those with diabetes or a prior heart attack."
If a long-acting opioid is the only option for effective pain relief, patients should start with the lowest possible dose and only gradually increase it, he said.
The study group had a collective 22,912 new episodes of prescribed therapy for the medications, with 185 deaths in the long-acting opioid group and 87 deaths in the control group.
Long-acting opioid users had 69 excess deaths per 10,000 users. In other words, for every 145 patients who started a long-acting opioid, there was one excess death.
"We knew opioids increase the risk of overdose. However, opioids can interfere with breathing during the night, which can cause heart arrhythmias," Ray said.
"We were concerned that long-acting opioids might increase cardiovascular death risk, which is what we found. Because most patient populations have more cardiovascular deaths than overdose deaths, our finding means that prior studies may have underestimated the harms of long-acting opioids."
Ray said the findings add urgency to measures to restrict long-acting opioid use to those for whom benefits outweigh harms.
"Data are limited as to the best medicine for the kinds of pain we studied, such as back pain, although for pain involving the nerves, the non-opioids may be better," Ray said. "For less severe pain, many over-the-counter medications, such as ibuprofen or naproxen, may be as effective as an opioid."
Story Source:
The above post is reprinted from materials provided by Vanderbilt University Medical Center. Note: Materials may be edited for content and length.
Journal Reference:
Wayne A. Ray, Cecilia P. Chung, Katherine T. Murray, Kathi Hall, C. Michael Stein. Prescription of Long-Acting Opioids and Mortality in Patients With Chronic Noncancer Pain. JAMA, 2016; 315 (22): 2415 DOI: 10.1001/jama.2016.7789https://www.sciencedaily.com/releases/2016/06/160614121312.htm
Today's article by Natacha Pires from the American Neuropathy Association (see link below) focuses on a growing problem across the world, where resources are being stretched and cut by the current financial crisis. The cynics among you may wonder if the cut-backs are not just an excuse to pass more costs onto the 'consumer', in this case patients. After all, insurance companies are not known for their philanthropy! The article talks about the situation in the U.S.A. where 'specialty tiering' is making insurance policies much more expensive for people with long term illnesses. However, wherever you come from, you may soon notice similar changes in systems and policies which make it financially more difficult to get the necessary treatment for HIV and neuropathy.
Cost-Shifting Strategy Threatens Access to Neuropathy Treatments
By Natacha T. Pires, M.B.B.S. August 30, 2011
Challenging economic conditions have health advocates increasingly concerned about specialty tiering—a cost-shifting strategy being used by insurers to saddle patients with an unfairly large share of drug costs—and its potential to impede access to life-saving treatments.
What is Specialty Tiering?
As prices of specialty drugs (or prescription medications that are used to treat complex, chronic diseases and require special administration) rise, efforts to shift more of the costs to patients are rampant. Some 90% of Medicare Part D prescription drug plans1 and some 10% of commercial health plans—covering more than 20,000,000 Americans—have created a special pricing tier for specialty and injectable drugs known as specialty tier (or Tier 4). Instead of paying a fixed co-pay amount, people with these plans pay co-insurance, somewhere between 25% and 33% of the cost of the medication each month. This can mean hundreds or even thousands of dollars more per month in out-of-pocket expenses for some people.
The report How Much Does that Medication Cost?, released earlier this month by NERA Economic Consulting (commissioned by Pfizer Inc), analyzed Medicare Part D beneficiaries' knowledge of the out-of-pocket costs associated with drugs placed on specialty tiers:
•Many survey respondents were unaware that Part D insurance plans charge differently for expensive medicines used to treat complex, chronic diseases. Half of the survey respondents mistakenly believed their plan would require them to pay a co-pay rather than coinsurance for a drug on the specialty tier.
•Respondents also underestimated the amounts they would have to pay out-of-pocket for specialty tier drugs.
•The findings suggest that most beneficiaries are unlikely to anticipate the financial impact of being prescribed a specialty tier drug or having a current medication moved to that tier.
How Can Specialty Tiers Impact Access to Your Neuropathy Treatments?
Specialty tiers can cause serious financial hardship for people with a chronic neuropathy who rely on specialty drugs, including biologically derived therapies such as intravenous immunoglobulin (IVIG), to maintain their daily activities and improve their quality of life.
Due to the shift in costs from health plans to patients caused by specialty tiers, medications can become prohibitively expensive—which can be catastrophic for patients. Tiers are intended to offset a health plan’s costs for expensive specialty drugs while encouraging lower utilization of such drugs. However, this can be counterproductive and raise overall healthcare costs if the tiers lead to non-adherence to therapy and excess hospitalization.
Specialty-tier medications often do not have generic alternatives and are the only drug available, leaving patients with no effective alternative therapy. For example, the impact of specialty-tiers on intravenous immunoglobulin (IVIG) therapies is of particular interest to our community. The burdensome coinsurance rates for these drugs forces patients to pay out-of-pocket expenses ranging from $652.00 to $8,344 per month.2
How is The Neuropathy Association Fighting for YOU?
The Neuropathy Association is working with patient and professional advocacy organizations as well as policymakers to introduce legislation that prevents health insurers from moving vital medications to Tier 4 status. The objective: Ensure patients’ ability to afford the life-saving medications they need.
New York is the only state with a law preventing specialty tiers. Legislation is being introduced in as many states as possible to ban specialty tiers due to their discriminatory nature. States where bills have been, or are being, introduced include: AZ, CA, FL, GA, HI, MD, MN, NE, NM, PA, and VA. If passed, these bills would put a cap on the amount of co-pays and limit the amount of out-of-pocket expenditures for high-cost medications. The California legislation would also prevent private insurers from creating specialty tiers through co-insurance. Federal legislation will be introduced to reverse the trends in Medicare, as well as the specialty tiers affecting our military (under the TriCare program) and federal employees (under the Federal Employees Health Benefit program).
While we continue to work on this issue, we’d like to hear about how specialty tiering is affecting you. Please write to us at editor@neuropathy.org. And, be sure to review your health plan choices carefully during open enrollment (begins on October 15th and ends on December 7th).
References:
1. “Drugs On Specialty Tiers” by Elizabeth Hargrave, Jack Hoadley, and Katie Merrell, for MedPac, February 2009, No. 09-1.
2. John E. Dicken, Director of Health Care for the Government Accounting Office (GAO). March 17, 2010.
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