Vitamin B6 Overdosing Can Lead To Neuropathy

Today's post from peoplespharmacy.com (see link below) is a bit of a wake-up call for people who regularly use vitamin supplements - too much of a particular vitamin can have the opposite effect to that which you hoped for. You will also see Vitamin B widely recommended as a help when you have neuropathic problems but that is generally B12 and even then, it should only be used when you have a deficiency already. Doctors are sometimes reluctant to routinely test for vitamin deficiencies but it's not that difficult and in the case of neuropathy, it can provide important information. The lesson here is that you should find out exactly what you're lacking in the vitamin department and then supplement as necessary (or improve your diet). Overdosing on a particular vitamin can be dangerous and even checking how much (vitamin B types in this case) is in your daily multi-vitamin may prevent you taking in too much. As a general point, if you take Vitamin B12 supplements, don't forget that you need folic acid too, in order for the body to absorb it efficiently. Many products have folic acid 'in-built' but if not, you will need folic acid supplements to achieve the right effect.
In general, always get the advice of your docotr or a qualified nutritionist before deciding to supplement your diet - it could save you both money and health problems.

Excess Vitamin Caused Neuropathy

November 21, 2010

 

Q. When I was a teenager I had a brief bout with acne. A friend of my mother said I should take baker's yeast. I took it for two weeks and it cleared up my skin. I hated the taste, though, so I switched to brewer's yeast tablets. I have been taking five a day for 40 years.

Over the last few years I have had trouble with numbness in my feet. It's a weird sensation, as though there were plastic wrap around them. A neurologist sent me for a battery of blood tests to rule out a vitamin B6 deficiency. He said it could cause peripheral neuropathy like mine.
My test results came back sky high. My B6 levels were seven times normal. Brewer's yeast is high in vitamin B6. It turns out that either too little or too much of this vitamin can cause peripheral neuropathy.

A. Neurologists consider the nerve damage that occurs from vitamin B6 (pyridoxine) toxicity as a stocking-glove phenomenon. The numb sensation you described was a red flag. People are usually advised to keep their vitamin B6 intake under 100 mg daily.

http://www.peoplespharmacy.com/2010/11/21/excess-vitamin-caused-neuropathy/

Neuropathy - A Diagnostic Process

Today's long post comes from agingwellmag.com (see link below) and may take some time to read but it is packed with very useful information. It talks about how health professionals need to assess their patients when it comes to neuropathy. It also explains clearly what sorts of neuropathy to look for and how they are characterised. Knowing that the patient's story is a very important element of such a diagnosis, helps the patient to come to terms with what at first, seems a very strange set of symptoms indeed. Knowing what the doctor is looking for will help the patient understand what's happening to his/her body and nervous system. Worth a read if you're in a diagnosis process, or even if a diagnosis has been difficult to establish.

Diagnosing Peripheral Neuropathy

By David Yeager
Aging Well
Vol. 5 No. 4 P. 14

The diagnosis for older adults can be particularly challenging. Physicians need to become more efficient in their patient workups.

Peripheral neuropathy afflicts as many as 8% of people over the age of 55, and the numbers are increasing. There are more than 100 known causes, and each type has its own characteristic symptoms, development pattern, and prognosis. For this reason, confirming a diagnosis and developing a treatment plan can be highly challenging.

To complicate matters, there are only a few diagnostic tests for peripheral neuropathy that are supported by significant research-based evidence, and there is no standard diagnostic protocol. Faced with an indeterminate set of symptoms, physicians may be inclined to order a wide variety of tests, sometimes at great expense and with little clinical benefit. In fact, physicians often forgo less expensive, more reliable tests when attempting to confirm a peripheral neuropathy diagnosis.

A University of Michigan Medical School (UMMS) study of 1,031 patients with confirmed neuropathy diagnoses published in the January 23 issue of the Archives of Internal Medicine found that 23.2% of patients received an MRI of the brain or spine, contributing to significant expenditures during the diagnostic phase of neuropathy treatment. More surprisingly, only 1% of patients received inexpensive and far more reliable blood glucose tolerance tests. The study also found that physician test-ordering patterns were highly variable.
Know the Patient’s History
If peripheral neuropathy is suspected, it may take some detective work to determine the underlying cause. The first step is to take a thorough patient history. Many underlying causes can be deduced just by asking questions.
“Far and away, the most important thing is a good history,” says Brian Callaghan, MD, an assistant professor of neurology at UMMS and lead author of the recent study. “The vast majority of causes are determined based on talking with the patient and, if you don’t figure it out based on talking to patients, the chance that testing is going to help with the diagnosis is small.”
Factors such as alcohol use, vitamin B12 deficiency, heredity, and diabetes can influence whether a person develops peripheral neuropathy. Diabetes is a particularly significant factor; it’s estimated that as many as one-half of people with diabetes develop some form of neuropathy.

Callaghan says some of the common, relatively inexpensive tests that can detect some of these problems, such as glucose tolerance testing, serum B12 testing, and serum protein electrophoresis (SPEP) with immunofixation electrophoresis (IFE), are the ones with the strongest clinical evidence to support their use in diagnosing peripheral neuropathy. Screening for common causes improves care and reduces treatment costs by diminishing reliance on more expensive tests and reducing treatment costs over time.

“If those disorders are picked up early, and that’s usually through a primary care physician, then [the patient] may never need to see a specialist. And also, if these diseases are picked up early, then the morbidity decreases,” says Annabel Wang, MD, an associate professor of neurology and director of the Neuromuscular Diagnostic Laboratory at the University of California, Irvine ALS and Neuromuscular Center. “Whereas, if you’re an unrecognized diabetic, it could take four or five years for someone to figure out that you have diabetes; then you have four or five years’ additional damage and therefore more complications and more secondary issues that develop.”

Common symptoms of peripheral neuropathy are pain; tingling; loss of sensation, usually more in the toes than the fingers; distal weakness; and difficulty walking. However, symptoms may not be as straightforward in older patients. Observing a patient’s difficulty extending the toes, flexing the foot, or determining whether the toes are moving up or down could be indicative of peripheral neuropathy. A diminished ability to feel cold or a pinprick or the absence of normal reflexes is also consistent with a neuropathy diagnosis.
If the history and exam point to peripheral neuropathy, the goal is to clinically characterize it as much as possible. Determining whether it’s acute or chronic is straightforward: if the symptoms have progressed during a period of time that exceeds three to six months, it’s chronic. The next step is to determine whether the neuropathy is axonal or demyelinating, which can partly be determined by electrodiagnostic studies. Frequently, an electromyogram (EMG) is used to test nerve conduction.

“EMG does not have to be performed in a patient who has a typical presentation and is, for example, diabetic,” says Gil I. Wolfe, MD, FAAN, chair of the department of neurology at the Jacobs Neurological Institute of the University at Buffalo School of Medicine, State University of New York. “There is a typical clinical pattern for the most common form of diabetic neuropathy, a distal axonal polyneuropathy, which is readily recognized by neuropathy experts. One can argue that you don’t have to do an EMG in this situation. Not only is this of economic benefit to the overall health system, but it also eliminates subjecting our patients to what can be a painful test. But in many other situations, EMG provides crucial information in characterizing neuropathy, especially whether it is an axonal or demyelinating process.”

Once it has been determined whether the neuropathy is axonal or demyelinating, the search for an underlying cause can continue. Wolfe says it’s important to note that many medications can cause an axonal neuropathy pattern, even commonly used ones such as antibiotics, so taking a detailed medication history is of the utmost importance.

Digging Deeper
Because there are different types of neuropathy, patients may exhibit a wide variation in symptoms. Wolfe says most neuropathies are axonal, which generally requires more diagnostic evaluation to determine the cause. Deciding which tests are appropriate depends on the suspected cause.

“I think the most important thing is to remember that there are different types of neuropathies. Neuropathies can be only sensory and only cause symptoms or they can also be only motor so they only cause weakness without sensory symptoms,” Wang says. “And then there’s an entity called small fiber neuropathy, where there may be pain and temperature loss or just a lot of pain, and the changes in vibration or the reflexes may be absent. Those are the cases that perhaps are missed and perhaps are very early neuropathies.”
Neuropathies may be classified as primarily small fiber; primarily large fiber, which includes loss of position sense, loss of vibratory sense, and some degree of loss of light touch; or both. Small vs. large fiber can be identified to some degree based on the patient’s history and examination. In addition, Wolfe says fasting glucose/two-hour glucose tolerance tests, HIV tests, urine protein electrophoresis tests, hepatitis B and C serologies, thiamine/pyridoxine tests, and celiac serologies may be used to diagnose small fiber neuropathies. Those tests, as well as vitamin B12 testing with methymalonic acid/homocysteine levels, SPEP with IFE testing, metabolic panels, lipid and cholesterol levels, syphilis serologies, Lyme serologies, urine heavy metal levels, and many others can be used to test for suspected large fiber neuropathies.

However, aside from the glucose, B12, and SPEP tests, none of these tests is supported by the American Academy of Neurology (AAN) Practice Parameter for evaluating distal symmetric neuropathies. Wolfe says the only reason to use some of these tests is if the neuropathy is unclassified and cancer or an immune-related condition is suspected. They should never be used on a routine basis.
Another important factor to consider is heredity. The AAN Practice Parameter supports some genetic testing but only in cases where certain hereditary causes are suspected.5 In older patients who develop neuropathy, heredity’s role can be easy to miss.

“There is a sector of these late-onset neuropathies that on initial inspection may look acquired, but very well may be hereditary,” Wolfe says. “And you shouldn’t discard the possibility that a neuropathy is hereditary just because it started in somebody after age 50. Some of those patients may very well have a hereditary process, either because of certain ion channel mutations or because of Charcot-Marie-Tooth disease type 2.”

Beware of Diminishing Returns
Because physicians try to render treatment based on the symptoms’ origin, many will continue to order tests when a cause is not found. But despite all of the tests that could potentially be ordered, Wolfe estimates that 20% to 25% of neuropathies end up being unclassified, and most unclassified neuropathies are seen in older patients. Although there are some factors associated with neuropathy that have only recently been understood, such as copper deficiency, most of the increase in neuropathy cases is due to diabetes.

“We can sometimes get in more trouble by ordering more tests,” Callaghan says. “We really need to focus on diabetes and taking a good history from our patients. Those are the things that are really going to make a big difference.”
The most important consideration in deciding which tests to order is how they will affect patient care. Unfortunately, other than treating pain, there are not many treatments for neuropathy. Callaghan says most of the 40 to 50 tests that can be given for neuropathy are very low-yield tests. Many not only have minimal influence on how treatment is rendered, but they don’t even affect the way the physician thinks about the patient’s condition. He cites MRI as the top example because it looks at the central nervous system and is rarely indicated for a patient with a peripheral nerve problem.

Thyroid and rheumatological studies are also relied on too heavily. Although these tests are frequently ordered, Callaghan says they rarely affect patient management. In the near future, he will be publishing a paper with his findings.
Callaghan says too much testing can make it more difficult to determine an underlying cause, especially if a test has a high false-positive rate or multiple tests produce conflicting results. One problem he has noted in his research is that physicians are apt to order a battery of tests as a rule rather than as the exception. He recommends sticking with the tests that have the best levels of evidence and ordering additional testing only if something unusual is suspected.
“For example, there are some warning signs that you might not be dealing with a garden-variety neuropathy, such as if the neuropathy comes on quickly, is very asymmetric side to side, or involves weakness more than sensory changes. Those are examples of things that might make you order more diagnostic testing,” Callaghan says. “But in most patients, the current evidence would suggest that you probably should only get a few tests.”

One factor that may help to reduce unneeded testing is patient education. Wang says it’s important to address patient questions about diagnosis and treatment as completely as possible. Patients who don’t fully understand the condition and how it’s treated may have more anxiety about it, which may make them more likely to push for additional testing.

“The fear is not knowing what’s going to happen to them, and that probably creates a lot of unnecessary workups,” Wang says. “Whereas, if they had an evaluation and they feel that they understand what their disease process is, they don’t feel that they’ve been abandoned. That in itself can save a lot of money.”

However, the main responsibility in the use of testing lies with physicians. Wolfe says physicians need to become more efficient in working up patients. Many lab tests currently ordered on a routine basis have low clinical efficacy and therefore low cost-efficiency. He believes this is an area that can be improved with better research into which tests are effective.

Callaghan agrees that much more research is needed to define the roles of all diagnostic tests that are ordered for peripheral neuropathy. He says the AAN guidelines are highly useful and that physicians should avoid using nonrecommended tests for routine screening. However, physicians can be slow to change the way they practice, especially if a new approach calls for doing less rather than more. Even though guidelines are available, many physicians continue to routinely order high-cost, low-yield tests.

“I think there are two big obstacles. One is defining what really should be the best diagnostic approach, and No. 2 is altering physician behavior. And those are both difficult to do,” Callaghan says. “Despite the guidelines that are out there, we’re not necessarily practicing according to those guidelines.”
— David Yeager is a freelance writer and editor based in Royersford, Pennsylvania.

Tips for Evaluating Peripheral Neuropathy
Because peripheral neuropathy is extremely common in older patients and may produce a wide variation in symptoms, it can be difficult to diagnose. Adding to the challenge is the dizzying variety of tests that can be done to check for underlying causes. The following basic principles, however, can help physicians provide more effective care:

• A thorough patient history and examination are likely to provide the most useful information for determining whether the patient has peripheral neuropathy. Alcohol use, heredity, new medications, and especially diabetes can be contributing factors. Pain, tingling, loss of vibratory sense, loss of temperature sense, loss of proprioception, and distal weakness are common symptoms.

• Follow the American Academy of Neurology (AAN) Practice Parameter for evaluation of distal symmetric polyneuropathy when ordering tests. Currently the AAN guidelines support the use of fasting glucose/two-hour glucose tolerance testing, vitamin B12 testing with methymalonic acid/homocysteine levels, and serum protein electrophoresis with immunofixation electrophoresis testing for initial investigation of peripheral neuropathy.

• Order additional testing only if an extenuating circumstance, such as cancer, is suspected or if the patient exhibits atypical symptoms. Testing outside of these parameters is unlikely to improve clinical outcomes or change patient care. Twenty percent to 25% of neuropathies will have undetermined causes.

• Communicate with patients throughout the evaluation process. Patients’ anxiety may lead them to request additional testing if they don’t understand the appropriate steps for diagnosis and treatment or how those steps relate directly to their personal care.
— DY

http://www.agingwellmag.com/archive/070912p14.shtml

Pain Product Warnings August 2012

One thing this site, (updates.pain-topics.org - see link below) does very well, is keep people up to date with the latest developments in drugs that pertain to their own illness. The world of Big Pharma and governmental health departments is constantly changing and things you take for granted regarding your medications can change very quickly.

Aug 2012 – Pain Product Announcements; Warnings
Wednesday, August 1, 2012

Featured Items: generic pregabalin approved; FDA REMS approval for long-acting and extended-release opioids; makers of unapproved oxycodone products warned to stop; defective
All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Generic Pregabalin – Several Firms Receive FDA Approval     

Teva Pharmaceutical Industries, Lupin Ltd, and Watson Laboratories all received a July 2012 FDA approval of their application to produce pregabalin, the generic equivalent of Lyrica. The drug is indicated for neuropathic pain of diabetic peripheral neuropathy, post-herpetic neuralgia, and fibromyalgia, as well as adjunctive treatment for adults experiencing partial onset seizures. The capsules will be available in 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg strengths. For administration and safety information, see the pregabalin Medication Guide.

REMS Approval for Long-Acting and Extended-Release Opioids
      After 3 years in development, the FDA has approved a shared Risk Evaluation and Mitigation Strategy (REMS) for the makers of all extended-release (ER) and long-acting (LA) opioid analgesics. The program is part of the FDA’s overall plan to reduce opioid prescription abuse while providing safe access to patients who need opioids to treat moderate to severe chronic pain. The educational component of the program includes prescriber training, patient counseling information, and a medication guide for each opioid product. Healthcare professionals will learn strategies for analyzing the risks and benefits in appropriate patients, as well as techniques for monitoring and counseling patients. Read the Pain-Topics UPDATE on the REMS approval for more information and links to useful resources.

Unapproved Oxycodone Products – FDA Instructs Makers to Stop     

Consistent with the FDA’s ‘Unapproved Drugs Initiative,’ the FDA issued a July 2012 Federal Register Notice advising companies that are manufacturing and distributing unapproved oxycodone products to stop these activities. This action is intended to protect consumers from immediate-release oxycodone drug tablets, capsules, and oral solutions that have not received FDA evaluation for safety and efficacy. The manufacturers were given 45 days to cease production and 90 days to discontinue shipment of existing drugs. See the FDA News Release for questions regarding this action and a list of National Drug Code (NDC) numbers for the unapproved single-ingredient oxycodone products.

http://updates.pain-topics.org/2012/08/aug-2012-pain-product-announcements.html

What Sort Of Pain Are Opioids Suitable For?

Today's post from updates.pain-topics.org (see link below) talks further about the recent petition to the FDA, to limit opioid use for non-cancer pain patients to 90 days after first use. For people who have severe neuropathy, this may be a very bad move if accepted because after opioids in those cases; what then? If you are an opioid (also Oxycontin) user, it may be worth keeping an eye on the progress of this petition.

What is Noncancer vs Cancer Pain?
Tuesday, August 7, 2012

By guest author Lynn Webster, MD, at the LifeSource Blog The following UPDATE is from an article by Dr. Webster titled “Rethinking the Hierarchy,” in which he discusses differences between noncancer and cancer pain — most especially, the lack of true differences — when it comes to treatment with opioid analgesics for chronic pain. It is reprinted with permission from a posting on August 3, 2012 at the LifeSource Blog

For a riveting read, see “The Emperor of all Maladies: A Biography of Cancer,” by Siddhartha Mukherjee. The book chronicles the history of humankind’s most feared disease, including a multitude of treatment failures. The word cancer conjures a picture of death to many people. Not only was cancer nearly always terminal, but dying in pain was expected, the norm.

Today, many cancers are curable. The Centers for Disease Control and Prevention estimates that 66% of people diagnosed with cancer are still alive five years after their diagnosis. Early detection and treatment have made these encouraging statistics possible.

The idea that people with cancer will necessarily suffer severe pain is also something our society no longer accepts. Use of opioids, the strongest medications we have to treat pain, is not questioned for cancer pain, even for patients expected to survive. This represents progress in our state of compassion and our standard of medical care.

However, the national dialogue on appropriate opioid prescribing is less compassionate when it comes to other types of moderate-to-severe pain. A petition is on its way to Food and Drug Administration (FDA) urging that opioids not be used past 90 days for chronic pain — chronic, noncancer pain, that is. This well-meant policy intended to reduce the availability of opioids for abuse and overdose is likely to backfire, because it is not based on sound science or compassionate care.

Cancer or cancer therapy can cause tissue injury. But is the tissue or injured nervous system caused by cancer different than that caused by trauma, diabetes, shingles, or arthritis? No. There is no valid scientific explanation for the separation. Pain is pain.

The majority of chronic noncancer pain patients will not need or tolerate opioids long term, but some suffer severe pain that is unrelenting. This pain is just as intense as pain from cancer and doesn’t stop when the clock has run out on the opioid prescription. Evidence suggests that this subset of patients who are able to remain on opioids past six months do benefit from them. Physicians must retain the flexibility to treat these patients whose pain is not relieved by other currently available methods.
Because, historically, we expected a person with cancer to die, it was permissible to treat their pain with opioids, an inherently short-term use, we reasoned. Now that many patients with cancer survive long term, there is a lingering sense that their pain is more noble, more deserving of treatment than patients whose pain does not involve a malignancy. This is not fair. It is based on prejudice. It may, indeed, be open to legal challenge.

As one of my patients recently said: “Why is it that cancer patients’ pain is somehow worse than mine?”

We all want to stop prescription drug abuse, but public policy cannot be built on selectively targeting a group of patients to prevent others from selling or diverting their drugs for nonmedical use. For that matter, patients who now survive cancer should also be screened and followed clinically to make sure they do not develop problems with abuse or addiction to medication.
The artificial distinction of cancer vs. noncancer pain is more about attitudes, emotions and politics than science. Our sense of compassion should not stop at the word non.

About the Author: Lynn R Webster, MD, is cofounder of LifeSource, a non-profit foundation established in 2006 to provide education about pain-related issues, as well as to fund and conduct research. He is board certified in anesthesiology and pain medicine and also certified in addiction medicine. He earned his doctorate of medicine from the University of Nebraska and completed his residency in the University of Utah’s Department of Anesthesiology. Dr. Webster has made frequent media appearances and conducted lectures addressing issues of pain and opioid therapy, and is the incoming president of the American Academy of Pain Medicine. The LifeSouce website can be accessed at http://www.yourlifesource.org and the blog is at http://yourlifesource.org/blog/.


 http://updates.pain-topics.org/2012/08/what-is-noncancer-vs-cancer-pain.html

Responsible Opioid Prescription For Neuropathy Pain

Today's post from updates.pain-topics.org (see link below) talks about something that many neuropathy patients have issues with and that's the effects of long-term opioid use. Unfortunately, for many people with neuropathy, the pain is just too great to be able to function normally. All of the usual medication options have been tried and have failed and the only possible pain control left is opioids. The problem is their addictiveness and the fact that some of the general population have taken to using them recreationally. Whatever the outcome of various debates around this subject; if you take opioids you need to know that someone qualified is monitoring your progress so that addiction problems can be minimised but for many people, not taking them is not an option.

Opioids on Trial, But Where’s the Evidence?
Wednesday, August 8, 2012

A recent Citizen Petition to the United States Food and Drug Administration (FDA) by Physicians for Responsible Opioid Prescribing, or PROP, requests labeling changes for all opioid analgesics when it comes to their prescription for noncancer pain. The changes would limit the dose, impose time limits, and restrict opioid use for only severe pain.

The Petition raises some important questions about the safety and efficacy of opioid analgesics as they are currently FDA-approved and prescribed. And, the urgency of an investigation was heightened by the fact that a Congressional committee has joined the petitioners in demanding action from the FDA. But, a critical question is whether there is sufficient evidence of reasonable quality for the FDA to act on the Petition at this time.

A Crisis of Confidence in Evidence
At every turn these days, opioid analgesics seem to be on trial, whether in the court of public opinion fueled by mass media, in the U.S. Congress and state legislatures, in various government agencies, and among select groups of healthcare professionals. Yet, what may be most at stake here is a crisis of confidence in scientific methods of inquiry and the reliance on valid research evidence as proof when it comes to making judgments that guide clinical practice in pain management.

Since our inception in late 2005, the mission of Pain Treatment Topics has been to focus on principles of evidence-based pain management. In Part 11 of our ongoing series, “Making Sense of Pain Research”, we examined several questions: What qualifies as evidence? What are the requirements of evidence as proof? How much proof is necessary for reaching valid and just clinical decisions?

We reminded readers, “Just as juries need good evidence to reach prudent verdicts, healthcare providers need good evidence as a guide for better decision-making in treating patients with pain.” However, due to the nature of scientific inquiry and research methods, absolute certainty is an illusion and research outcomes must be used circumspectly and wisely for reaching judicious conclusions affecting patients’ health and well-being.

We say all of this because, as much as anything, the PROP Petition  raises questions about how pain research evidence could and should be interpreted and used for influencing decision-making and change. And, it also raises questions regarding the quality, quantity, relevance, and validity of evidence necessary for establishing an acceptable level of proof in pain management.

In previous UPDATES, we have dissected, discussed, and/or challenged much of the evidence that is used in the PROP Petition to support their requested changes to opioid-product labeling. This and additional evidence also is discussed in a recent guest author UPDATE  by Bob Twillman, PhD, FAPM, and further opinions debating claims of the Petition are offered elsewhere by clinical pharmacy specialist, Jeffrey Fudin, RPh, PharmD, DAAPM, FCCP

In short, there does not appear to be a body of good, clear, and convincing evidence at this time to support the requests in the Petition, let alone any evidence beyond reasonable doubt for passing judgment. However, this is not to say that the petitioners’ assertions are frivolous or unworthy of further investigation and discussion.
In fact, the FDA has posted the Petition at the U.S. government site — www.Regulations.gov — and is accepting public commentary. The URL link is: http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-0818-0001

Document Name: Physicians for Responsible Opioid Prescribing - Citizen Petition
Document ID: FDA-2012-P-0818-0001
Docket ID: FDA-2012-P-0818

We should note that commenting is not limited to Americans, and persons from all parts of the world may have much at stake here. Changes to opioid labeling and prescribing in the U.S. may inspire other countries to re-examine how these medications should best be prescribed in their own populations. We would encourage any and all persons with something to say on this matter, pro or con, to submit a comment.

Here is the text of the public comment letter that we submitted to the FDA on August 6, 2012; Tracking ID# 810c2f4b….

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TO: FDA Docket ID: FDA-2012-P-0818 at www.Regulations.gov
RE: Physicians for Responsible Opioid Prescribing - Citizen Petition
FR: Stewart B. Leavitt, MA, PhD, on behalf of Pain Treatment Topics
On July 25, 2012, Physicians for Responsible Opioid Prescribing (PROP) and allied signatories submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) requesting certain changes to opioid analgesic labeling. These would limit opioid dosing, impose time limits, and restrict opioid use in noncancer conditions to only severe pain.

The Petition appears to be most concerned with opioid analgesia for chronic noncancer pain, and excludes cancer-related pain, but there is some confusion as to whether the label changes would apply also to acute pain. In any event, it seems that the broad and implicit hypothesis underlying the Petition might be stated as this:

Compared with opioid analgesic prescribing practices following indications on current product labeling, patients would be afforded superior effectiveness and safety if opioids were restricted to a dose of ≤100 mg/day of morphine or its equivalent for no more than 90 continuous days and only for severe pain in the case of noncancer conditions.

If this hypothesis is true, countless patients are possibly being mistreated or harmed by current prescribing practices, and it would be important to know if any or all of the Petition’s recommendations should be adopted. As it presently stands, however, there are some serious concerns regarding acceptance of the Petition and its implicit hypothesis:

• The hypothesis has not been directly tested by adequate, prospective clinical research trials of any quality or sufficient quantity.
• Current best evidence submitted by the petitioners under their “Statements of Scientific Basis for Petition” has been challenged in terms of its relevance, adequacy, and/or validity [Twillman 2012, ref below].
• Limited clinical evidence presented at a recent FDA-sponsored Workshop last May, 2012, to assess analgesia for chronic pain was largely of lower quality — observational or epidemiological — and generally equivocal or inconclusive regarding the absolute benefits vs risks of long-term opioid therapy at any dose for various types of pain conditions [FDA 2012].

Therefore, the Petition proposes a hypothesis that raises important questions but, in itself, is untested and unproven. And, it seems apparent that, at this time, changing opioid-product labeling in accordance with the Petition’s requests could be tantamount to enrolling millions of persons with pain — unknowingly and non-consenting — as participants in a clinical experiment to test an unfounded medical theory.

Certainly, the clinical, scientific, ethical, and legal implications of this are daunting, and memory of egregiously cruel human experiments in history would seem to preclude the labeling change at present. Unintended consequences of the label change could possibly be significantly adverse and harsh.

Still, in the court of scientific inquiry there seems sufficient evidence for reasonable suspicion that some, if not all, of the Petition’s perspectives could merit further investigation. Government research-oriented agencies might be encouraged to examine these issues further and to fund the necessary well-designed clinical investigations.
First, however, it would be necessary to operationally define what is specifically meant in the Petition by such terms as: safety, effectiveness, noncancer, and severe pain. And, to better justify for testing the assignation of ≤100 mg/day morphine or equivalent and 90 days duration as threshold points.

Surely, opioid analgesics are not the only or best solution for all types of pain, whether acute or chronic, cancer or noncancer, and in all patients. Ultimately, the goal is to afford patients the best possible pain management, and to identify those patients who might benefit most from opioid analgesia at any dose and/or for any length of time.

References:
> Twillman R. Group Petitions FDA to Change Opioid Label. Pain-Topics UPDATES. 2012(Aug 2); available online at: http://updates.pain-topics.org/2012/08/group-petitions-fda-to-change-opioid.html
> FDA (U.S. Food and Drug Administration). Assessment of Analgesic Treatment of Chronic Pain: A Scientific Workshop. 2012(May); available at: http://www.fda.gov/downloads/Drugs/NewsEvents/UCM309444.pdf

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Our purpose in commenting was not to challenge particular research referenced in the Petition or the specifically requested changes; rather, to address issues of scientific method and the uses of evidence as proof. Quite simply, a new clinical hypothesis requires some basis in science or prior evidence to justify testing — which might be met by the limited evidence cited in the Petition — but the hypothesis itself should not be not put into practice until it has been tested and proven valid. Essentially, if opioid labeling were changed at this time in accordance with the Petition it would be “putting the cart before the horse” from an evidence-based medicine perspective.
In his recent guest author Pain-Topics UPDATE, Dr. Twillman, PhD, FAPM, did a thorough job of discussing and questioning the evidence base behind the Petition. In fair balance, immediately after we posted the Twillman UPDATE, we alerted Andrew Kolodny, MD, of the article; he is president of PROP and a principal signer of the Petition. We extended to Dr. Kolodny, and any fellow cosigners of the Petition, an open invitation to submit for publication a rebuttal UPDATE article commenting on Twillman’s critique and/or further presenting their own perspectives. [ADDENDUM: Dr. Kolodny did respond to us later today:

Congress Embraces the Petition
On July 26, 2012 — just one day after the Petition was filed with the FDA — Congresswoman Mary Bono Mack and 5 fellow members of the Congressional Caucus on Prescription Drug Abuse sent a public letter  to Margaret Hamburg, MD, FDA Commissioner, essentially endorsing the Petition and embracing all of its recommended labeling changes. The letter concludes:

“We believe that if a labeling change were made to opioid analgesics to reflect the uncertainty and lack of evidence surrounding safety and effectiveness of these drugs for treatment of chronic non-cancer pain, physicians would think twice before prescribing these highly addictive narcotics for ‘moderate’ pain such as a toothache or sore knee. While those who seek treatment for cancer pain and other diseases that cause “severe” pain would not be affected, the number of individuals prescribed opiate painkillers without evidence of the long-term safety and effectiveness may decrease and limit those susceptible to developing opioid dependence.”

To our knowledge, none of these elected officials has extensive medical training or expertise in the assessment of research evidence. Their statement reflects some bias in the use of emotion-laden terms — eg, “highly addictive narcotics” and “painkillers” [discussed previously in an UPDATE  — and, they appear to advocate against even the short-term use of opioids for acute pain, such as a toothache, which is an unclear aspect of the Petition. The Caucus members also seem to have accepted the false argument of the petition, that a lack of evidence is, in itself, acceptable evidence for advocating against the long-term effectiveness and safety of opioids for noncancer pain.
Still, this letter commands the attention of the FDA, since it ends with, “For these reasons, we request an expedited review of the Citizen Petition submitted to FDA, and look forward to a timely response.”

What Happens Now?
In fairness, the letter from Congresswoman Mack and colleagues was merely instructing the FDA to look into the matter and report back. The FDA already held a Workshop last May exploring analgesia for chronic pain, but this letter probably motivated the agency to accept and post the Petition at the government regulations website on July 30, 2012, for further public comment. Again, that site can be accessed .
We have from time to time been critical of the FDA; yet, we know that the agency performs a vital function and is staffed with well-trained and dedicated physicians and scientists. They understand the ins and outs of pain research and are unlikely to be swayed by low-quality, biased, or inadequate evidence.
In our opinion, there is more at stake here than the fate of opioid analgesics prescribed for chronic noncancer pain. Conflicts of dogma versus science are at the core of many practices in the pain management field; yet, low-quality evidence and fallacies of logical thinking sometimes appear to be winning the battle.
Furthermore, some of the nuances and ramifications of the petitioned label change must be considered:

• Some have argued that changing the label would stop pharmaceutical companies from promoting opioids for uses beyond the new, more limited indications, but, if deemed necessary, practitioners could still prescribe the medications off-label at any dose and for any duration of time in noncancer pain.
  
  However, off-label applications of medications are usually discouraged and can be risky; prescribers know that they could face regulatory scrutiny or liability issues if something goes wrong and they have not followed FDA-approved indications on labeling. The Congressional Caucus members are aware of this when they state, “…physicians would think twice before prescribing these highly addictive narcotics.”      
• This further raises the question of addiction to opioid analgesics among legitimate patients with pain. Evidence regarding this is discussed by Twillman in his UPDATE, and this still appears to be an unresolved issue needing further definition, investigation, and clarification. Yet, the Caucus members seem to accept the notion that restricting opioid prescribing, “may decrease and limit those susceptible to developing opioid dependence.” By dependence, we presume they mean “addiction” here, rather than the physiological dependence on opioids that naturally develops in many cases; although, whether or not they fully understand the distinctions seems unknown.      
• In reaction to the Petition, some professionals have questioned whether public and private healthcare insurance plans would continue to pay for opioid prescriptions that did not adhere to new restrictions indicated on labeling. If not, patients with chronic pain would need to personally absorb the financial burden associated with off-label opioid prescribing, which in many or most cases could preclude or curtail their ongoing access to these medications. Any answers to insurance coverage questions at this time would be speculative.     
• Most worrying are questions not even raised and addressed in the Petition or by Congressional Caucus members. What should take the place of opioid analgesics for chronic noncancer pain? What are the better, safer, tried and proven therapies?

There are no easy answers to questions and evidentiary dilemmas posed by the Petition. Our own recommendation is that, if the Petition is to be serously considered and judged, there first must be an objectively thorough review and critical assessment of all relevant evidence regarding this issue — pro and con. And, hopefully, these inquiries and further dialogue will be fair-balanced and steered by science — embracing principles of evidence-based medicine — rather than driven by dogma and demagoguery.

http://updates.pain-topics.org/2012/08/opioids-on-trial-but-wheres-evidence.html

Kinesio Tape: Any Good For Neuropathy?

You can't avoid Kinesio tape, wherever you look on sports programmes these days. Today's post from updates.pain-topics.org (see link below) looks at the plusses and minuses of this material as regards muscular and skeletal pain. because so many people with neuropathy suffer abnormal strains on their joints and weakening of their muscles, it may be worth investigating this stuff further. However unlikely it may seem, anything that protects vulnerable areas for neuropathy patients may be worth a try. According to this article however, the jury seems out as to whther it's just fantastic marketing or not. Please contact the blog if you have had any experience with this sort of tape.

Kinesio Tape for Pain? The Science is Sticky.

Wednesday, August 15, 2012

 

Anyone who watched even snippets of the recent Olympic Games on TV probably noticed the intriguing, brightly-colored strips of tape adorning shoulders, arms, legs, abs, or other anatomy of many athletes. Apparently, the stretchy cotton bands called Kinesio® Tape are liberally applied when and wherever performance-robbing musculoskeletal pain strikes. But, is this product a clever marketing ploy, a sporty fashion statement, a colorful placebo, or the real deal? And, is this something that non-athletes with pain should look into?

According to news articles and information at the Kinesio website, the tape was designed several decades ago by Kenzo Kase, a Japanese chiropractor and acupuncturist, to support injured muscles, increase range of motion, and decrease pain. Ostensibly, Kase considered rigid athletic tapes inadequate and believed his patients needed something with “a texture and elasticity very close to living human tissue.”

According to Michael Good, International Director of the Kinesio Holding Corporation, the tape has been used in Olympic competition since 1988, but according to news reports it got a huge boost when the company donated 50,000 rolls of the product to 58 countries for use on athletes at the 2008 Beijing Olympics. Sales of the product tripled soon afterward.

At the recent London Games, Kinesio Taping was even more conspicuous among athletes in almost every sport. It is apparently waterproof (many swimmers were wearing it) and sweat-resistant; one of the Chinese sand volleyball players was adorned in so much tape that she looked like a living billboard for the product. Having all of those Olympians wearing the tape will probably boost sales even further, Good observes.

According to the company website, Kinesio® Tape is used to re-educate the neuromuscular system, reduce pain, optimize performance, prevent injury, and promote improved circulation and healing. Another promotional website for the product  goes so far as to claim:
 
“Kinesio Tape is used for anything from headaches to foot problems and everything in between. Examples include: muscular facilitation or inhibition in pediatric patients, carpal tunnel syndrome, lower back strain/pain (subluxations, herniated disc), knee conditions, shoulder conditions, hamstring, groin injury, rotator cuff injury, whiplash, tennis elbow, plantar fasciitis, patella tracking, pre- and post-surgical edema, ankle sprains, athletic preventative injury method, and as a support method.”

However, some clinicians are not impressed with such claims, or the tape. In one of the news articles, Amy Powell, MD — associate professor of sports medicine at the University of Utah School of Medicine and board member of the American Medical Society for Sports Medicine — observes that results in actual patients are inconsistent.

Powell states that there is a set of people, primarily with shoulder injuries, who respond well, “but it could also be the idea that any kind of tape would offer them structural support in the shoulder.” She believes the tape might be useful, especially in helping patients to do their physical therapy, but it probably is not the miracle product that Kinesio claims. “I think the company advertises it as more of a cure, but I see it as more of an aid,” she says.

However, some researchers think the company might be making lofty medical claims for what is, essentially, a piece of sticky, stretchy cloth. A team of investigators from New Zealand reported last February 2012 on a first-ever meta-analysis of evidence for the effectiveness of Kinesio Tape [Williams et al. 2012, see ref below].

Their search discovered 97 studies examining the product of which only 10 met inclusion criteria for analysis; ie, the articles reported data for effects of Kinesio Tape on a musculoskeletal outcome and had a control group. Two studies investigated sports-related injuries (shoulder impingement), and just one of these involved injured athletes. Trials involving musculoskeletal outcomes in healthy participants were included on the basis that these outcomes may have implications for the prevention of sports injuries.

The researchers’ analysis found that the efficacy of Kinesio Tape in pain relief “was trivial given there were no clinically important results.” Furthermore, there were inconsistent results for range-of-motion outcomes, with small beneficial effects seen in 2 studies, but insignificant results in 2 other studies. There were some likely beneficial effects relating to grip force, muscle strength, and muscle activity, but it was unclear whether the changes were beneficial or harmful.

The researchers conclude that “there was little quality evidence to support the use of [Kinesio Tape] over other types of elastic taping in the management or prevention of sports injuries.” Although, they concede that, based on all of the anecdotal support for the product, further well-designed experimental research might be warranted.

In one of the news articles, Kinesio’s Michael Good agrees that the science has not caught up with the anecdotal evidence of positive results that athletes have reported with the product. Meanwhile, Dr. Powell says that the lack of hard evidence may not matter in the athletic community, “Anything that [athletes] perceive as an edge, they'll try, whether it's scientific or not. And the athletes are convinced that [Kinesio tape] is really helpful,” she says. “It wouldn't be the worst placebo in the world; it's not doing any harm.”

So, perhaps Kinesio is just “placebo tape” after all. To some it may not matter, but for those who prefer evidence-based medicine the efficacy of this product seems undetermined, and this does not recommend clinical use of the product in patients with pain.

And, there is another sticky issue [excuse the pun]. As with other unproven complementary modalities, successful application of the therapy may depend highly on the individual skills of specially qualified practitioners.

Through a self-started international association, Kinesio promotes its proprietary Kinesio Taping Method and sponsors “Certified Kinesio Taping Practitioner” training programs. This is probably quite a profit center for the company, and might be a way of claiming that if the tape does not work as promised the person applying it is probably not adequately trained. However, the company further protects its product claims (and the need for continuing training) by stating at the website, “Even certification is only the beginning of a lifelong process of learning.”

REFERENCE: Williams S, Whatman C, Hume PA, Sheerin K. Kinesio Taping in Treatment and Prevention of Sports Injuries: A Meta-Analysis of the Evidence for its Effectiveness. Sports Med. 2012(Feb);42(2):153-164

http://updates.pain-topics.org/2012/08/kinesio-tape-for-pain-science-is-sticky.html

The Painkiller Cannabis

Today's post from sciencedaily.com (see link below) is yet another justification of the use of cannabis or cannabinoid products to treat chronic pain. It seems the world is slowly coming to the conclusion that there is considerable benefit to be gained by using the drug in one way or another to control pain. The only problem is stereotypical political prejudices which refuse to change with the times, irrespective of the amount of scientific evidence presented. Fortunately, quite a few countries and even states within countries, are taking a sensible stance and accepting that the relief of long term pain may be more important than outdated laws. That said, you have to be able to take cannabis, either smoked, or otherwise and not everybody can do that comfortably.

Cannabis as Painkiller

ScienceDaily (Aug. 7, 2012) 

 Cannabis-based medications have been demonstrated to relieve pain. Cannabis medications can be used in patients whose symptoms are not adequately alleviated by conventional treatment. The indications are muscle spasms, nausea and vomiting as a result of chemotherapy, loss of appetite in HIV/Aids, and neuropathic pain.

This is the conclusion drawn by Franjo Grotenhermen and Kirsten Müller-Vahl in issue 29-30 of Deutsches Ärzteblatt International.

The clinical effect of the various cannabis-based medications rests primarily on activation of endogenous cannabinoid receptors. Consumption of therapeutic amounts by adults does not lead to irreversible cognitive impairment. The risk is much greater, however, in children and adolescents (particularly before puberty), even at therapeutic doses.

Over 100 controlled trials of the effects of cannabinoids in various indications have been carried out since 1975. The positive results have led to official licensing of cannabis-based medications in many countries. In Germany, a cannabis extract was approved in 2011 for treatment of spasticity in multiple sclerosis. In June 2012 the Federal Joint Committee (the highest decision-making body for the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany) pronounced that the cannabis extract showed a slight additional benefit for this indication and granted a temporary license until 2015.

http://www.sciencedaily.com/releases/2012/08/120807101232.htm

A Great Letter About Chronic Pain

This post comes from a FaceBook site (see link below) and is unapologetically, a repeat of an earlier post on this blog. It's a letter that is obviously still doing the rounds on the internet but it is so well-written, also for people with severe neuropathy, that it has to be worth repeating once more. It is self explanatory but may just be worth printing out for friends and family if you suffer from neuropathic pain. The author is anonymous but he or she has my thanks.

Letter to People without Chronic Pain

 Posted by guest on May 22, 2006

Having chronic pain means many things change, and a lot of them are invisible. Unlike having cancer or being hurt in an accident, most people do not understand even a little about chronic pain and its effects, and of those that think they know, many are actually misinformed.

In the spirit of informing those who wish to understand …… These are the things that I would like you to understand about me before you judge me…

Please understand that being sick doesn’t mean I’m not still a human being. I have to spend most of my day in considerable pain and exhaustion, and if you visit, sometimes I probably don’t seem like much fun to be with, but I’m still me– stuck inside this body. I still worry about school, my family, my friends, and most of the time – I’d still like to hear you talk about yours, too.

Please understand the difference between “happy” and “healthy”. When you’ve got the flu, you probably feel miserable with it, but I’ve been sick for years. I can’t be miserable all the time. In fact, I work hard at not being miserable. So, if you’re talking to me and I sound happy, it means I’m happy. That’s all. It doesn’t mean that I’m not in a lot of pain, or extremely tired, or that I’m getting better, or any of those things. Please don’t say, “Oh, you’re sounding better!” or “But you look so healthy!¨ I am merely coping. I am sounding happy and trying to look normal. If you want to comment on that, you’re welcome.

Please understand that being able to stand up for ten minutes doesn’t necessarily mean that I can stand up for twenty minutes, or an hour. Just because I managed to stand up for thirty minutes yesterday doesn’t mean that I can do the same today. With a lot of diseases you’re either paralyzed, or you can move. With this one, it gets more confusing everyday. It can be like a yo-yo. I never know from day to day, how I am going to feel when I wake up. In most cases, I never know from minute to minute. That is one of the hardest and most frustrating components of chronic pain.

Please repeat the above paragraph substituting, “sitting”, “walking”, “thinking”, “concentrating”, “being sociable” and so on … it applies to everything. That’s what chronic pain does to you.

Please understand that chronic pain is variable. It’s quite possible (for many, it’s common) that one day I am able to walk to the park and back, while the next day I’ll have trouble getting to the next room. Please don’t attack me when I’m ill by saying, “But you did it before!” or Oh, come on, I know you can do this!” If you want me to do something, then ask if I can. In a similar vein, I may need to cancel a previous commitment at the last minute. If this happens, please do not take it personally. If you are able, please try to always remember how very lucky you are–to be physically able to do all of the things that you can do.

Please understand that “getting out and doing things” does not make me feel better, and can often make me seriously worse. You don’t know what I go through or how I suffer in my own private time. Telling me that I need to exercise, or do some things to get my mind off of it¨ may frustrate me to tears, and is not correct if I was capable of doing some things any or all of the time, don’t you know that I would? I am working with my doctor and I am doing what I am supposed to do. Another statement that hurts is, “You just need to push yourself more, try harder…” Obviously, chronic pain can deal with the whole body, or be localized to specific areas. Sometimes participating in a single activity for a short or a long period of time can cause more damage and physical pain than you could ever imagine. Not to mention the recovery time, which can be intense. You can’t always read it on my face or in my body language. Also, chronic pain may cause secondary depression (wouldn’t you get depressed and down if you were hurting constantly for months or years?), but it is not created by depression.

Please understand that if I say I have to sit down/lie down/stay in bed/or take these pills now, that probably means that I do have to do it right now – it can’t be put off or forgotten just because I’m somewhere, or am right in the middle of doing something. Chronic pain does not forgive, nor does it wait for anyone.

If you want to suggest a cure to me, please don’t. It’s not because I don’t appreciate the thought, and it’s not because I don’t want to get well. Lord knows that isn’t true. In all likelihood, if you’ve heard of it or tried it, so have I. In some cases, I have been made sicker, not better. This can involve side effects or allergic reactions. It also includes failure, which in and of itself can make me feel even lower. If there were something that cured, or even helped people with my form of chronic pain, then we’d know about it. There is worldwide networking (both on and off the Internet) between people with chronic pain. If something worked, we would KNOW. It’s definitely not for lack of trying. If, after reading this, you still feel the need to suggest a cure, then so be it. I may take what you said and discuss it with my doctor.
If I seem touchy, it’s probably because I am. It’s not how I try to be. As a matter of fact, I try very hard to be normal. I hope you will try to understand. I have been, and am still, going through a lot. Chronic pain is hard for you to understand unless you have had it. It wreaks havoc on the body and the mind. It is exhausting and exasperating. Almost all the time, I know that I am doing my best to cope with this, and live my life to the best of my ability. I ask you to bear with me, and accept me as I am. I know that you cannot literally understand my situation unless you have been in my shoes, but as much as is possible, I am asking you to try to be understanding in general.

In many ways I depend on you – people who are not sick. I need you to visit me when I am too sick to go out… Sometimes I need you help me with the shopping, cooking or cleaning. I may need you to take me to the doctor, or to the store. You are my link to the normalcy of life. You can help me to keep in touch with the parts of life that I miss and fully intend to undertake again, just as soon as I am able.
I know that I have asked a lot from you, and I do thank you for listening. It really does mean a lot.

AUTHOR UNKNOWN**********************************

TIPS FOR DEALING WITH PEOPLE IN PAIN

1. People with chronic pain seem unreliable (we can’t count on ourselves). When feeling better we promise things (and mean it); when in serious pain, we may not even show up.

2. An action or situation may result in pain several hours later, or even the next day. Delayed pain is confusing to people who have never experienced it.

3. Pain can inhibit listening and other communication skills. It’s like having someone shouting at you, or trying to talk with a fire alarm going off in the room. The effect of pain on the mind can seem like attention deficit disorder. So you may have to repeat a request, or write things down for a person with chronic pain. Don’t take it personally, or think that they are stupid.

4. The senses can overload while in pain. For example, noises that wouldn’t normally bother you, seem too much.
5. Patience may seem short. We can’t wait in a long line; can’t wait for a long drawn out conversation.

6. Don’t always ask “how are you” unless you are genuinely prepared to listen it just points attention inward.

7. Pain can sometimes trigger psychological disabilities (usually very temporary). When in pain, a small task, like hanging out the laundry, can seem like a huge wall, too high to climb over. An hour later the same job may be quite OK. It is sane to be depressed occasionally when you hurt.

8. Pain can come on fairly quickly and unexpectedly. Pain sometimes abates after a short rest. Chronic pain people appear to arrive and fade unpredictably to others.

9. Knowing where a refuge is, such as a couch, a bed, or comfortable chair, is as important as knowing where a bathroom is. A visit is much more enjoyable if the chronic pain person knows there is a refuge if needed. A person with chronic pain may not want to go anywhere that has no refuge (e.g.no place to sit or lie down).

10. Small acts of kindness can seem like huge acts of mercy to a person in pain. Your offer of a pillow or a cup of tea can be a really big thing to a person who is feeling temporarily helpless in the face of encroaching pain.

11. Not all pain is easy to locate or describe. Sometimes there is a body-wide feeling of discomfort, with hard to describe pains in the entire back, or in both legs, but not in one particular spot you can point to. Our vocabulary for pain is very limited, compared to the body’s ability to feel varieties of discomfort.

12. We may not have a good “reason” for the pain. Medical science is still limited in its understanding of pain. Many people have pain that is not yet classified by doctors as an officially recognized “disease”. That does not reduce the pain, – it only reduces our ability to give it a label, and to have you believe us.

AUTHOR UNKNOWN

http://www.facebook.com/notes/neuropathy-talk-on-line/a-letter-to-people-without-chronic-pain/10150525210097821

Is Nerve Transfer Surgery An Option For Neuropathy?

Some of you may have heard whispers about possible nerve transfer surgery across the internet but you shouldn't really get your hopes up for many of the reasons explained in today's article from sciencedaily.com (see link below). In general, this sort of surgery is only effective for nerve injury (severance in an accident for instance) and  performed as quickly as possible after the original injury. People with HIV-related peripheral neuropathy would probably not be able to benefit from such a procedure because of the long-term nature of the disease and the fact that peripheral nerve damage usually doesn't just affect one nerve.  Nevertheless, this is an interesting article which helps widen our knowledge about how nerve damage can be treated.

Nerve Transfer Surgery Success

ScienceDaily (Aug. 1, 2012) 

A study in the August issue of the Journal of the American Academy of Orthopaedic Surgeons (JAAOS) by Hospital for Special Surgery researchers aims to raise awareness of this type of surgery among health care providers. In recent years, great strides have been made in nerve transfer surgery, allowing many patients with a nerve injury in their upper extremity to have a remarkable recovery and improved functional outcomes.

"It's obvious that many physicians don't know what can be done, because often patients are referred too long after their injury. If we get these patients late, any nerve surgery is less likely to work," said Steve K. Lee, M.D., director of Research at the Center for Brachial Plexus and Traumatic Nerve Injury at Hospital for Special Surgery (HSS), lead author of the study. "A big thrust of this paper is to get the information out there that we need to see these patients earlier for better outcomes."

Nerve injuries can be caused by a variety of events, including car and motorcycle accidents, sporting accidents, falls from heights such as construction accidents, and surgeries for head and neck cancer. Once a nerve is cut from a muscle, it has to be reinnervated within about 18 months before the muscle atrophies. Since nerves only regenerate one millimeter per day, sometimes they cannot regenerate and reach the muscle before it wastes away.

"It has been shown that if you do nerve reconstruction work and surgery before six months after a nerve is severed, then patients do far better," said Dr. Lee, who is also Associate Professor of Orthopedic Surgery at the Weill Cornell Medical College and Associate Attending Orthopedic Surgeon at Hospital for Special Surgery. "If it has been more than 18 months, even if the nerve regeneration length is two centimeters, it may still be too late."

Nerve transfer surgeries are needed when a nerve end is nonfunctional or when nerve reconstruction would require an excessively long nerve graft. In the upper extremity, nerve transfers are most commonly used for injuries involving the brachial plexus, a network of nerves that run near the neck and shoulder. Other indications include complex injury to peripheral nerves, especially associated with fractures and dislocations, lacerations, injuries from projectiles and cancer.

In brachial plexus reconstructive surgery, which can take up to 12 hours, surgeons take nerves that have less important roles or are redundant and transfer them to restore function to a severely damaged nerve. Doctors use functioning nerves close to the target muscle and plug these nerves into the injured, nonfunctioning nerve. The rewired nerves then learn how to supply a new function. One of the most common transfers is to take part of the ulnar nerve that is involved in controlling the hand and rewiring this nerve so that it is hooked up to muscles that bend your elbow. "If you take a little part of these nerves, it doesn't affect the hand," said Dr. Lee.

The JAAOS study provides a review of the various techniques used for nerve transfer and details patient outcomes. Orthopedic surgeons, plastic surgeons and neurosurgeons perform the bulk of nerve transfer surgeries, but it is important for a variety of health care professionals to know what nerve transfer surgery can achieve.

"If a doctor has a patient who has one of these injuries and they read this paper, they will know that these surgeries can work. They will know what can be done rather than saying 'let's wait and see if it will heal by itself,'" said Dr. Lee. "This study is very important educationally for orthopedic surgeons and for anybody taking care of patients with nerve damage. Trauma surgeons, general surgeons, rehabilitation doctors, neurologists and physical therapists should know about this."

Scott Wolfe, M.D., director of the Center for Brachial Plexus and Traumatic Nerve Injury at HSS, was a coauthor of the study.

The Center for Brachial Plexus and Traumatic Nerve Injury at Hospital for Special Surgery is a national resource for men and women of all ages, providing diagnostic and reconstructive options for patients with injuries to or dysfunction of the peripheral nerve and brachial plexus. Using a multidisciplinary approach, the center utilizes the expertise of a wide range of health care professionals including orthopedic surgeons, physiatrists, neurologists, radiologists, psychiatrists, rheumatologists, pain management specialists, physical therapists and anesthesiologists, so that patients can benefit from a coordinated treatment experience.

http://www.sciencedaily.com/releases/2012/08/120801093425.htm

EMG And Nerve Biopsy: A Personal Experience



 Today's post comes via the Neuropathy Association (see link below) and is an excerpt from a book written by Ellen Schechter. The excerpt describes her experiences with EMG's and nerve biopsies; something I am sure many readers will be familiar with. I have attempted to get in contact with the author to get permission to reproduce this but so far have failed to get an answer. If anyone connected to Ellen Schechter  sees this and objects to its appearing here, of course I will remove it immediately. I hope that doesn't happen because it takes a light-hearted look at something that we all know can be extremely unpleasant.

Something Terrible: An Excerpt From "Fierce Joy
May 31, 2012

Editor’s Note: The Neuropathy Association is pleased to share with you this excerpt from acclaimed writer Ellen Schecter’s recently published memoir, “Fierce Joy.” An award-winning children’s book and television writer before her illness, Ellen chronicles her diagnosis with chronic inflammatory demyelinating polyneuropathy (or CIDP--an autoimmune form of neuropathy), tells how she found a way to be sick without suffering, and shares how she transformed the loss of her place in the world of work into a quest for her soul in "Fierce Joy."

After nearly two years of silently enduring these mysterious, increasingly severe symptoms, I both want--and fear--a diagnosis. No one--even Jim--knows anything about this strange pattern of pain, including my internist, whom I rarely see. In truth, I don’t want to know what this physical cacophony means, yet feel a growing need for someone to name and explain the strange and frightening sensations crawling over my body. When I finally describe it all to my doctor, he packs me right off to a neurologist he describes as “brilliant, no-nonsense, and thorough.”

Right, except he forgets to mention that Dr. Linda Lewis is also a very attractive, energetic Amazon of a woman—over six feet, with prematurely white hair cut short and blunt; big gray eyes behind glasses that make them even bigger; thick black lashes and brows in a strong face with wide cheek- bones and a generous mouth. Her large, strong hands look capable of doing anything well, from setting broken bones to rappelling down mountains. She listens carefully to my strange conglomeration of maladies.

When I finish, she makes a sketch in red ink on one of those human- body outlines doctors often keep close at hand for recording afflictions. It mirrors my mental picture of my pain, which feels so tangible that I envision it as a network of chartreuse neon lines crisscrossing my body. Now there’s my pain, in red ink, on paper: my own painful sensations—heard, understood, recorded. I feel a burden lift.“

You probably thought you were crazy, but you’re not,” Dr. Lewis says. I feel my shoulders drop away from my ears even more. “These sensations may seem peculiar and unrelated to you, but they draw a very clear picture for me. They follow the nerve roots all over your body.”

So it’s real. Here is objective confirmation. I’m not a hypochondriac. I take a deep breath for the first time in months. She understands me. And my pain. I will be eternally grateful just for that.

But a split-second later, it slams into me: corroboration is cold comfort. Something is actually wrong. While I struggle with this paradox, Dr. Lewis writes a flurry of blood test and laboratory slips, then hands them to me. “These tests are used to diagnose nerve disease. Maybe they’ll make the picture clearer. Come back when I get the results, and we’ll see.”

I want to get the tests over with ASAP, but it takes a lot of jiggling with my schedule to do the most complicated one. Jim and I take turns dropping the kids off at The Calhoun Early Childhood Center on 81st and West End—the school that looks like a television screen—then he rushes off to court, and I race around to script conferences and production meetings for Reading Rainbow, the PBS children’s series I write. I can’t schedule anything until we button down an outline for our newest show growing out of Keep The Lights Burning, Abbie, based on a beautiful book about lighthouse keepers in 1856 on the rocky coast of Maine. It involves a conversation with LeVar Burton, our star, a script conference with the producers and production team, and setting deadlines for my script de- livery, etc. As Head Writer, I’m responsible not only for my own scripts, but for the other writers’ work, which means even more reading and face- to-face meetings. I also have to squeeze in as much of my writing as I can before the kids get home from school.

We have a lovely housekeeper, Mrs. Sarah Parker, who takes the kids on play dates and to the playground in Riverside Park. I try to spend as much time as I can with them, alone and together—and I hate to miss our Mommy-and-kids playgroup, which began when Alex, then Anna, were infants. And then there are my ballet classes (I’m not good, but I love the discipline), lunches or coffee grabbed with my friends Jane, Sarah, and Isabel, and . . . and . . . I literally have no time to be sick.

I finally make a late afternoon appointment at the Neurological Institute and quickly learn to loathe the EMG, or electromyography. First I ride the elevator to a suspiciously quiet floor in the Neurological Institute. When asked, I shed my clothes and identity as I don a frumpy hospital “gown.” Then I wait an unconscionable length of time in a frigid cubicle until a white-coated man, whose badge identifies him as a PhD, appears, his credentials on his bad. With no greeting or explanation, no apology for the delay, he orders me to lie down on a narrow examining table, grunts “Don’t move,” and—with absolutely no preamble—jabs long pins attached to electrodes and wires deep into the most painful parts of my muscles until they make contact with my most painful nerves. In my efforts not to scream or kick, I force myself to think about something—anything—else. Dr. Josef Mengele, the Nazi doctor who took pleasure in torturing his patients, comes immediately to mind.“

We will now begin the procedure,” he announces to a spot some- where near the overhead light fixture. He still has not looked once at my face.
Begin? I thought it was over.

“Do not move,” he repeats. I wouldn’t dare.
With this, he turns on electric currents that feed into the needles stuck in my legs. Then he blandly records my pain as a wavy graph on what looks like a TV screen. It now feels as if my legs are hard-wired into electrical sockets. Or, fifty times the way it feels when I crack my elbow exactly wrong on the edge of my desk. Or, like the neurological equivalent of the electric chair. I do not die, though it crosses my mind as an attractive alternative.

I think I’m a wuss about all this, until Dr. Lewis later tells me that a well-known professional football player tore the electrified pins from his legs and ran cussing from the Procedure Room because he couldn’t bear the pain.

Finally, before I start to smoke, Dr. Mengele turns off the machine, removes the pins, and leaves the room without a word. As I dress with shaking hands, I remind myself that this modern medical variation on the medieval rack is designed to yield objective and presumably helpful measurements of how quickly my nerves receive and relay information to and from my muscles and spinal cord.

Dr. Lewis sounds undaunted when she calls to tell me the test results are equivocal. They reveal no clear pattern of nerve damage. Then she announces, in what I’m learning is her characteristically cavalier fashion, that it’s time for a nerve-and-muscle biopsy. The following week, I meet with Dr. David Younger, a lively, handsome and yes, young, neurosurgeon, who ex- plains that he will remove about a tablespoon of muscle and a smidgen of a nerve—the sural nerve—from the back of my left calf for examination under a microscope. Unfortunately, I must be fully conscious during the operation so he will know when he cuts the nerve. I’m gratified to discover that nice neurosurgeon is not an oxymoron, as he is warm and funny.

Barely a week later, I’m in an operating room, lying prone on a narrow padded table that looks more like my Nana’s ironing board than any Hollywood version of an O.R. I’ve ever seen. In fact, nothing’s what I expected: the small white-tiled room looks like a kitchen; the nurse has a beard and tells me how much his little girl likes Reading Rainbow; and Dr. Younger not only has split-second comic timing but a soul.

The biopsy turns out to be an excruciating procedure. It takes far more searching than any of us like to find that skinny skein of nerve, but while the surgeon is digging around in my left calf, we chat quietly about religion, Brahms, and this-and-that. The nurse holds my hand whenever he’s not busy, and we all make awful puns about having a lotta nerve, lacking nerve, being nervous, etc. But when Dr. Younger finally finds and severs the sural nerve, there’s absolutely no doubt: I shriek. Pure pain explodes in my leg, drills up my spine, and makes me puke.

Yet even in hell there are funny moments. When I croak, “How come I throw up when you cut a nerve in my leg?” Dr. Younger doesn’t miss a beat: “Don’t you know the leg bone’s connected to the stomach bone?” Then he comes closer and says, “Local anesthesia blocks some transmission of pain to your brain. But your body always knows when it suffers an insult like this—and it rebels.”

http://www.neuropathy.org/site/News2?page=NewsArticle&id=8255