Vicki Finlayson and Low Dose Naltrexone

Before naltrexone relieved pain and symptoms of Multiple Sclerosis,

she had used Oxycontin and morphine for a year and a half

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While prescribing low dose naltrexone (LDN) for patients with pain in recent years, I have become deeply impressed with it. Of course, it is inescapable to get very far on the internet without seeing a flood of videos and comments on the use of low dose naltrexone for Multiple Sclerosis. I once spent an entire afternoon reading the literature and watching the videos of patients, doctors, and researchers. How I wish I had the links so I could post them here now! The stories of Dr. Pat Crowley sitting at his desk as his patients in County Kilkenny, Ireland, described the successes they had had with multiple sclerosis touched my heart deeply. Naltrexone is not a cure but its beneficial effects on the immune system have been described here and were first noted by Dr. Bihari in 1985. Dr. Crowley sees results in at least 70% of patients, particularly with neurogenic bladder.

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Vicki Finlayson has had a remarkable recovery from severe Multiple Sclerosis. I hope you will watch her interview here. It was recorded October 2008 at the Fourth Annual LDN Conference held for the first time on the West Coast at the University of Southern California, and is recounted below. Since then she has made it her mission to advocate for clinical trials of this medication but it has been difficult for patients to find doctors who will prescribe it.

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Has medicine come to the point where we no longer listen to patients, only to drug representatives that are only allowed by Congress and the FDA to discuss what has been fully approved with all its risks and benefits? Well….frankly, we are not always told all risks nor are they always discovered until years later. Naltrexone is an opiate antagonist. It will block morphine and similar pain medication. In much higher doses it has been approved for safety by the FDA in 1984 as treatment for opiate addiction, and in 1995, FDA approved for treatment of alcohol dependence. Doctors have been reserved about prescribing it off label for patients who request low doses of naltrexone for medical conditions such as Multiple Sclerosis. But the tradition of using medication “off label” for uses not approved by FDA is still alive. Weighed against the dangers of the illness relative to a small dose of a medication that appears to be benign, it appears to be a worthy endeavor to test.

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How tragic is it to hear a person with Multiple Sclerosis have to define their day in the world by how far apart the bathrooms are when needed for neurogenic bladder? That is the story that urged one Scottish research doctor to pay attention when his patient said low dose naltrexone cured his neurogenic bladder. That changed that doctor’s research career. When years of fatigue and heat intolerance may soon be gone because of this small dose, how can a doctor turn down trying it for a patient? I did a few years ago, to my everlasting regret. I know better now. In my defense back then, I had not heard any information from that patient or anyone about its favorable off label use.

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Vicki’s Story

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Vicki Finlayson had Multiple Sclerosis for 12 years and was very disabled for several of those years with Secondary Progressive Multiple Sclerosis.

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She tells how she was on Avonex for 6 years that caused flu-like symptoms so severe she was in bed for two days after each injection. She was so disabled her husband had to help her dry her hair. The medications used for Multiple Sclerosis caution about suicide risk and her husband hid knives at night for fear of what she would do to herself. She was unable to work, on medicare and social security disability. She missed the ability to work and says, “I lost so much dignity, I lost my sense of everything my parents ever taught me.”

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She detoxed herself off of opioid medication that had been prescribed for pain. Her doctors failed to help her do that. Apparently, she says, they had no experience with how to take her off those medications. And she began to take low dose naltrexone 4.5 mg. It took away all of her symptoms, including heat intolerance.

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She is delighted to be off of disability and back to work selling durable medical equipment to doctors. And she has been inspired since then to help others by raising money for research on use of low dose naltrexone for Multiple Sclerosis.

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Here is how she did it

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She walked 56 miles from her home in Auburn California to Sacramento in scorching hot 100 degree weather – without any heat intolerance that she had had for years before – to try to get the ear of the governor. She held fund raisers. And she got the attention of Dr. Bruce Cree of the UCSF Multiple Sclerosis Clinic to do the first academic trial on use of low dose naltrexone in Multiple Sclerosis, research which apparently was funded by her efforts. She is indefatigeable in her effort to help others.

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Dr. Cree’s poster presentation on the positive research outcome is here along with other scholarly publications on naltrexone. The publication can be read here: “A rapid on-line publication of the first randomised controlled trial of low dose naltrexone in MS in the Annals of Neurology has been reported prior to hard copy publication. The study randomised 80 people with MS to receive LDN or placebo in a cross-over study where people took the LDN or placebo for eight weeks, then swapped to the other study drug. This appears to be the first drug trial in MS that was not funded by the pharmaceutical industry, but by the participants themselves.”

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He closes with: “In conclusion, in this exploratory, single center study, 8 weeks of treatment LDN was associated with symptomatic benefit with respect to mental health, pain and perceived cognitive deficits in MS. Confirmation of these findings in a multicenter trial will be necessary to make definite conclusions about the possible symptomatic benefit of LDN in MS. A longer duration of treatment is necessary to determine whether LDN has any benefit with respect to physical outcome measures.”

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Here is a link to more clinical trials on low dose naltrexone, and here is a

summary of the first European LDN conference in April 2009 at Glasgow University.

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Vicki is very realistic about the chance of this work being extended by any university, NIH or the National Multiple Sclerosis Society. They rely on tens of millions of dollars to do the costly multi-center long term drug studies that must be done for this condition. That will not happen with a drug that is inexpensive, generic, and holds no promise from which any pharmaceutical company may ever hope to profit. Without such double blind studies, many, if not most doctors would be unlikely to prescribe this simple, inexpensive, low dose medication.

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Please see comments, below, that point to an excellent resource called LDNAware.org. “This website is your worldwide gateway to Low Dose Naltrexone information, resources and events.  LDN Aware is a volunteer group devoted entirely to spreading knowledge and raising public awareness about LDN as a treatment for autoimmune disease, cancer and HIV/AIDS.”

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“Never doubt that a small group of thoughtful committed citizens can

change the world; indeed, it’s the only thing that ever has.”

- Margaret Mead

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The material on this site is for informational purposes only, and

is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

Rational Polypharmacy

Naltrexone is a remarkable drug for intractable pain

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I first saw this RN in June 2006.

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She is now 60 years old.  She was an OR scrub nurse for almost 30 years, but was disabled for the last 5 years before seeing me. She had Reflex Sympathetic Dystrophy [RSD] of both legs with “arthritis” of the feet/ankle that felt like she was “90 years old” with cold allodynia. Allodynia is pain from a stimulus such as light touch or a breath or air that is not normally painful. Imagine a light touch that feels like severe nerve pain, one of the most disturbing pains a person could have. The temperature of her feet was 81 degrees, hands 92 degrees.

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Pain of both feet felt like a vise grip, gnawing, penetrating, “like broken bones in the feet,” variable at different times but always worse as the day progressed, with a crushing sensation that penetrated through foot and ankle. She was unable to tolerate socks or anything on her feet after 5 pm, unable even to tolerate air on the area, unable to tolerate coolness below waist, but felt hot above waist. She wore a blanket and covers on the hottest 120 degree days, and forced herself to tolerate touch at the legs in order to desensitize them, as we instruct patients to do. She felt constant tingling numbness of the soles of feet for 3 years, with weakness, stiffness “almost solid” like a block. Spasm in soles of feet had resolved the last 6 months before seeing me.

Pain ranged from 2 to 9 on a scale of 10, where 10 is the worst pain imaginable, worst after 5 pm. Average pain was 3. It interfered with sleep at times, and she used a tented frame to keep blankets off her feet, preheated the bed to avoid any coolness, and avoided cold under all circumstances. In the morning, the joints felt like she had a broken ankle. She would massage the feet with lotion, put on alpaca socks, and slowly begin to walk. Then tried to mobilize the joints. Walking made pain worse though walking had always been a favorite activity.~

Before seeing me she had had more than 10 sympathetic blocks, was hospitalized 11 days due to headache from prednisone 60 mg that had been trialed to relieve her pain. She had been prescribed Procardia to relieve the “vascular” disease that she did not have but the drug led to gangrene of the gall bladder; she had been prescribed almost every “adjuvant” used to relieve pain and as much as 9 grams of Neurontin daily, all of this to attempt to relieve the severe pain in her legs and feet.

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This is how she got better

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When I first saw her in 2006, I prescribed low dose oral ketamine that gave relief lasting up to 3 hours from each dose. She then requested referral to Dr. Schwartzman, chief of neurology at Drexel University in Philadelphia, for continuous 5 day ketamine infusion that was done May 2007. She was pain free but it completely lost effect after 8 months, despite booster infusions every 4 to 6 weeks for 4 hours daily over 2 days during those 8 months. After insurance the cost out of pocket was $45,000 in 2007 alone. Dr. Schwartzman had nothing more to offer after it failed and said most patients have relief for less than 6 months if at all.

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In March 2007, I started her on a combination of Namenda 55 mg daily with lamotrigine 350 mg daily that relieved 90% of the pain, but once every 6 to 8 weeks she needed 12.5 to 25 mg low dose oral ketamine for breakthrough pain. Even more rarely, she used oxycodone 10 to 20 mg.

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In October 2008, adding naltrexone 1 mg by mouth, she became pain free. Since then she has not needed anything for breakthrough pain and on 3/5/09, she reported that her last use of ketamine and oxycodone occurred with the addition of low dose naltrexone.

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In 2009, she hiked 30 miles down the Grand Canyon and back up in 3 days.

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Naltrexone was later increased to 4.5 mg as she completely tapered off lamotrigine.

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By December 2009, the RSD was 98% better and she reported that it was not pain anymore. Medications then were naltrexone 12.5 mg at bedtime and Namenda 55 mg daily in divided doses. She had just a “remnant” of a little buzz, but no crushing except when active, late in the day.

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A few months later she slowly tapered off Namenda with no increase in pain.

She hikes 2 miles 3 to 4 times a week, does Iron Mountain once a week, does “Silver Sneekers” exercise 1 hour 3 times a week and sleeps well 8 to 10 hours a night without a sleeping pill.

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She remains on low dose naltrexone as her sole medication for this

previously disabling neuropathic pain syndrome~

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She has returned to part time work and spends a few weeks a month traveling the world, hiking, volunteering, sightseeing.

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Naltrexone

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I have found that naltrexone is a remarkable medication for various pain conditions, and going through the steps of rational polypharmacy may be very rewarding for some patients though at times it may work all on its own. It has caused me to completely reassess how I approach the treatment of intractable pain – not just RSD or CRPS but arthritis, sciatica and various forms of mechanical pain. And it has led to further changes in the timing and dosing of naltrexone based upon the experiences patients have reported back to me over the years. It is hoped that further research will lead to better understanding of how naltrexone acts upon pain pathways. Surprisingly we already know quite a fair amount.

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My deepest gratitude to Dr. Jau-Shyong Hong, Chief of Neuropharmacology at NIH, whose many generous discussions, emails and research publications have helped me to understand it’s profound anti-inflammatory effect in the central nervous system through its actions on microglia. I previously posted a discussion of mechanisms of naltrexone and dextromethorphan in greater detail here. Naltrexone and dextromethorphan are classified as morphinans, morphine-like. They suppress Superoxide, a free radical that destroys neurons which may cause or contribute to Alzheimers and Parkinsons Disease. That research goes back to the late 1980’s and continues to grow. Phase II studies with morphinans are now being done on those conditions. Studies are also going on now with naltrexone/Wellbutrin combination for weight loss. The drug is called Contrave, from Orexigen Therapeutics Inc. and the dose I believe is 32 mg naltrexone – I do not know how they decided upon that dosage.

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In my experience, naltrexone is a very benign drug at these low doses, though colleagues who prescribe 400 mg for the FDA approved use at that high dose may see some liver toxicity. I always begin at 1 mg or 4.5 mg, depending upon whether or not the patient is a slow drug metabolizer, i.e. may lack one of the CYP P450 chromosomes for metabolizing drugs. I have long suspected it also has an effect on the hypothalamus because a few patients with profound postmenopausal hot flashes have reported that is no longer a problem and that their husbands simply cannot believe the bonus, and this may explain the effect upon appetite that Orexigen has found. At higher doses than I generally use there may be some constipation which is treatable. It may cause vivid dreaming in some, and a small percentage may have insomnia for a few days. Pharmacology and safety is discussed here.

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Stay tuned. I’ll be adding more case reports of different pain conditions in the near future. They are truly fascinating. It has changed my entire approach to treating pain.

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Cost

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Wouldn’t it be nice if NIH funded more for pain research? Imagine how much money that would save the country and save the lives of each person with disability who could recover? As I posted here, the American Pain Society has shown that NIH spends 0.67% of its budget on pain research – less than 1% – though 10 to 20% of the population in the US suffers from chronic pain, an estimated 60 million Americans, and pain conditions are more prevalent among the elderly.

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I am told by my pharmacist that perhaps 70% of the time insurance will approve coverage for compounded low dose naltrexone. It is very affordable but some insurance carriers deny payment for naltrexone. Medicare will not pay for compounded medication either. Compare this low cost compound to the wholesale price for 100 tablets of Oxycontin, $1300, which may not be relieving pain – then multiple that by 2 or 3 each month for one patient. Imagine if the $22 billion of federal money for health insurance technology, for software which is untested and will expire in a few years, instead went into NIH funding for pain research. What a lovely thought. 

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The material on this site is for informational purposes only, and

is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Anti-inflammatory medication — salsalate, from the aspirin family —

helped poorly controlled Type 2 diabetics lower their blood sugar substantially.

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Fasting blood sugar dropped from 150 to 110

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This is a very interesting report of studies being conducted on fat to unlock the mystery of why it triggers inflammation that leads to heart disease and diabetes. Some startling conclusions are arising from these multi-center studies and the news release nicely summarizes them.

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Although the article does not quote the journal referenced, it does discuss the research being done at Albert Einstein College of Medicine as well as the NIH funded study at 21 medical centers around the country that are now recruiting Type 2 diabetics.

You might find out if a center nearest you is recruiting and be sure to discuss salsalate with your treating doctor before you consider trying it.

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The material on this site is for informational purposes only, and

is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

~

Thi

Analgesic Use and the Risk of Hearing Loss in Men

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Dr. Sharon G. Curhan of Brigham and Women’s Hospital in Boston and her colleagues studied 26,917 men aged 40-74 years at baseline in 1986 and every two years. These were men enrolled in the Health Professionals Follow-up Study. Regular use of analgesics was defined as 2+ times/week.

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Among all men who used aspirin at least twice a week, there was a 12% increased risk of hearing loss.
Among those who used ibuprofen and related analgesics, there was a 21% increase.
And for those who used acetaminophen, a 22% risk.

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But the risk was much higher when they considered only men younger than 50.

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In that group, there was a
33%  increased risk for aspirin use,
61% increase for ibuprofen and related NSAIDs, and
99% increase for acetaminophen.

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The younger the man and the more years used, the greater the risk of hearing loss.

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The study involved only male Caucasians, thus no conclusions can be drawn on risk of use for women and other racial groups.

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Some supplements can be extremely helpful for conditions I follow in my practice, while others may harm. Go to this constantly updating link to enlarge a brilliant and very useful bubble graph “like painting with data”— or view a static, fixed copy below.

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“This image is a “balloon race”. The higher a bubble, the greater the evidence for its effectiveness. But the supplements are only effective for the conditions listed inside the bubble.” Try it! And when you click to the right of their active link to select a medical condition, it will suggest a supplement that has been shown to help. Then return back here, below the graphic to check on cautions and toxicity that importantly is not mentioned in their work.

As explained for the graph, “This visualisation generates itself from this Google Doc. So when new research comes out, we can quickly update the data and regenerate the image.” The Google Doc is a spreadsheet of references from large human, blind placebo-controlled trials only, sourced from PubMed and Cochrane that publishes leading medical research.

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CAUTION: Toxicity is still important. For example, even though licorice is helpful for coughs, it may seriously increase blood pressure. Valerian may help sleep but may be toxic to liver and may have a withdrawal syndrome.

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Make sure you check here to review the benefits and toxicity to see how supplements may alter your chemotherapy or medication for heart and blood pressure. Another review here: Use of Herbal Products and Potential Interactions in Patients With Cardiovascular Diseases.

The paper lists several common common drug-herb interactions: Grapefruit juice can be especially risky, increasing your dose of statins and calcium-channel blockers by slowing the metabolism of those prescriptions. St. John’s Wort raises blood pressure and heart rate;  garlic and ginger increase the risk of bleeding in patients on blood thinners. Soy milk and green tea can decrease the effectiveness of warfarin. Ginkgo biloba, ginseng, echinacea, aloe vera and licorice are also discussed.~

A recent multi-center, double blind, randomized trial of Ginkgo Biloba involving 3,019 subjects over a median of 6.1 years showed that it fails to help memory. Further, a new report in the Journal of Natural Products summarizes beneficial uses but also discusses toxic effects on heart and brain due to the ginkgotoxin. The authors recommend that sales should be restricted. Toxicity to the heart may occur from heart block, ventricular fibrillation and death. And it may lower the seizure threshold in persons with epilepsy. The toxin depletes vitamin B6 in the brain, impairs glutamate metabolism, and triggers seizures via an imbalance in neurotransmitters: high glutamate and low GABA. It has been shown to induce metabolism of epilepsy medication, thus dropping blood serum levels below therapeutic range further increasing risk of seizure.

Remember to ask your doctor how these may interact with your medication.

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Check here on Vitamin D, a steroid hormone that is anti-inflammatory. Vitamin D is one of the hottest topics in kidney research and hypertension today, as discussed here. And hypertension is important. The latest research on Alzheimers Disease in the last two years from Columbia University Medical School in NYC tells us that risk factors for Alzheimers Disease are the same as for coronary heart disease: exercise, hypertension, cholesterol, obesity, diabetes, smoking. Besides, low vitamin D increases risk of cancer of breast, colon, prostate among many other functions. “Vitamin D insufficiency is associated with suboptimal health.“

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The material on this site is for informational purposes only, and

is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

What you can do

“Moving is the best medicine”

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For headache and neck and shoulder pain

As reported in the leading headache journal, Cephalalgia, office workers with headache, neck and shoulder pain took part in an education and relaxation program in an Italian study over eight months. They kept diaries and did posture and relaxation exercises every two to three hours. Compared to a control group, headache and neck and shoulder pain decreased by more than 40% and use of analgesic drugs was cut in half.

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For Arthritis Pain

This is an excellent article from Nature Reviews Cardiology, 18 August 2009, and offers doctors CME 0.75 AMA PRA Category 1 Credits. Click blue link below for complete article.

Vitamin D status and arterial hypertension: a systematic review

Stefan Pilz¹, Andreas Tomaschitz¹, Eberhard Ritz² & Thomas R. Pieber¹

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A short excerpt is included here:

Vitamin D deficiency is common and is primarily caused by a lack of ultraviolet-B (UVB) radiation from reduced sun exposure, and the consequent limiting of vitamin D production in the skin. The vitamin D endocrine system regulates about 3% of the human genome. Observational data support the concept that vitamin D is involved in the pathogenesis of cardiovascular diseases and arterial hypertension. The antihypertensive properties of vitamin D include renoprotective effects, suppression of the renin–angiotensin–aldosterone system, direct effects on vascular cells, and effects on calcium metabolism, including prevention of secondary hyperparathyroidism. The results of clinical studies largely, but not consistently, favor the hypothesis that vitamin D sufficiency promotes lowering of arterial blood pressure. Randomized, placebo-controlled trials are greatly needed to clarify and definitively prove the effect of vitamin D on blood pressure. In general, the antihypertensive effects of vitamin D seem to be particularly prominent in vitamin-D-deficient patients with elevated blood pressure. Thus, in view of the relatively safe and inexpensive way in which vitamin D can be supplemented, we believe that vitamin D supplementation should be prescribed to patients with hypertension and 25-hydroxyvitamin D levels below target values.

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Vitamin D metabolism

In humans, the primary source of vitamin D is UVB-induced conversion of 7-dehydrocholesterol to vitamin D in the skin.¹ Just 10–20% of our vitamin D comes from dietary sources, such as fish, eggs, or vitamin-D-fortified milk (Figure 1).¹ Vitamin D is hydroxylated in the liver to 25(OH)D—the main circulating vitamin D metabolite, which is largely bound to vitamin D binding protein in serum, and is used to classify vitamin D status: vitamin D sufficient (25[OH]D 30 ng/ml [or 75 nmol/l]), vitamin D insufficient (25[OH]D 20–30 ng/ml [or 50–75 nmol/l]), and vitamin D deficient (25[OH]D <20 ng/ml [or <50 nmol/l]).¹ These cut-points are currently the most commonly used classification of vitamin D status, but some debate about exact threshold values still exists. Some researchers consider 25(OH)D levels of 10–20 ng/ml (25–50 nmol/l) as vitamin D insufficient and levels below 10 ng/ml (25 nmol/l) as vitamin D deficient, whereas others use a cut-off level of 40 ng/ml (100 nmol/l) to define sufficient vitamin D status.^{9, 10} 25(OH)D is transformed by renal or extrarenal 1-hydroxylase into 1,25-dihydroxyvitamin D (1,25[OH]2D), which circulates at much lower serum concentrations than 25(OH)D, but has a much higher affinity to the vitamin D receptor (VDR).¹¹ Serum levels of 1,25(OH)2D are mainly determined by renal 1,25(OH)2D production, which is closely related to calcium homeostasis, and is upregulated by parathyroid hormone, the concentration of which increases when calcium levels are low.^{1, 12} In addition, other factors such as fibroblast growth factor 23 and Klotho, which suppress 1-hydroxylase expression, have also been shown to regulate the renal conversion of 25(OH)D to 1,25(OH)2D.¹³ Studies have, however, shown that many other cell types, including those of the vascular wall, express 1-hydroxylase with subsequent intracellular conversion of 25(OH)D to 1,25(OH)2D, which exerts its effects at the level of the individual cell or tissue before being catabolized to biologically inactive calcitroic acid.^{1, 12, 14} These intracellular tissue levels of 1,25(OH)2D are determined by the concentration of circulating 25(OH)D, which is, therefore considered the best indicator of whole-body vitamin D status. Importantly, extrarenal 1-hydroxylase expression also underlies various regulatory mechanisms. In this context, extrarenal 1,25(OH)2D production in macrophages is stimulated by Toll-like receptor as part of the innate immune response against intracellular bacteria.¹⁵ Another example of extrarenal regulation of 1-hydroxylase is the increased production of 1,25(OH)2D by keratinocytes in wounds, which could be induced by transforming growth factor 1.¹⁶ 25(OH)D serum levels, therefore, provide a good estimate of vitamin D status, but regulation of 1-hydroxylase activity should also be considered.

1,25(OH)2D binds to the VDR and, after forming a heterodimer with the retinoid X receptor (RXR), binds to specific DNA sequences—the so called ‘vitamin D responsive elements’. These sequences are located in the promoter regions of various vitamin-D-dependent genes that are either upregulated or downregulated by the RXR–VDR complex.^{1, 12, 14} Approximately 3% of the human genome is directly or indirectly regulated by the vitamin D endocrine system, which supports the idea that vitamin D insufficiency has widespread adverse consequences for human health.¹⁴ In addition to cardiovascular pathology, vitamin D insufficiency can cause musculoskeletal, malignant, metabolic, or immunological diseases.^{1, 12, 14}

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Vitamin D Anti-hypertensive effects

(click link for slide)

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*25 percent of households have trouble paying

*40 percent expect to delay care this summer

*Baby boomers hardest hit

“The percentage of households that had difficulty in paying for care in the last year was statistically unchanged between March and April (about 25 percent).”

They found 40 percent of all households planned to postpone care in the coming three months, with about 15 percent planning to put off routine doctor visits.

Baby Boomers were four times more likely than seniors to have trouble paying for healthcare, according to the report.

Not surprisingly, those on Medicare “were the least likely to delay care.” Youth were also less likely, probably because they have fewer health problems.

New Poll Shows 76% Support For Choice Of Public Plan

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Excerpts from the Huffington Post summary:

New poll numbers from NBC/Wall Street Journal produce two major and potentially conflicting story lines when it comes to the Obama administration’s efforts for a health care overhaul.

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• 76 percent of respondents said it was either “extremely” or “quite” important to “give people a choice of both a public plan administered by the federal government and a private plan for their health insurance.”

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• [O]nly 33 percent of respondents said they thought the president’s health care plan, to the extent they knew of it, was a “good idea”

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• But when read a description of the general outline — requiring insurance companies to cover pre-existing conditions, an employer mandate, tax credits for lower income families to buy coverage, and tax increases on wealthier Americans to pay for it – the number of respondents in support rose to 55 percent.

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Public option is not Single Payer. People know that “For profit” is not “For them.” Only a single payer plan such as Medicare lifts the burden from small and large business, puts people first over profit, and cuts out the middle men that crush the country’s financial future. It’s not perfect, but there is no rescission of coverage, no denial for pre-existing conditions, no inequality.

For all the denials from your PPO and the unaffordable medications you cannot receive, how many billions do insurance companies and pharmaceutical firms pay for advertising? Do you think your rates will stay the same if you had cancer or some critical illness that cost hundreds of thousands of dollars? How many months would you have to wait to get disability coverage? How much competition would there be for the shrinking public dollar then as the population expands and more need the same helping hand? Healthcare identity theft is increasing at a startling rate. If someone stole and used your insurance, as it now stands, your insurance company would hold you responsible for the hundreds of thousands of dollars of care they received. This black market would not exist if we had Single Payer insurance.

A fellow I know from England says that whenever anyone had a complex problem, they knew they’d get better care at the National Health Service Hospital, even though they could easily afford private care. Doctors there could participate in both plans. Private patients who paid more would be seen first, and others would wait to be seen as time permitted.

Before this all hardens into cement and we are stuck with business as usual and uncompromising profiteering, Robert Reich explains: How Pharma and Insurance Intend to Kill the Public Option, And What Obama and the Rest of Us Must Do.

Test yourself to see how difficult the decision is.  The Price of Life: When Healthcare Meets Money. Ask who would you want making these difficult decisions? A a select panel of expert physicians or Big Insurance? From COMMENTS on the article:

I don’t mind commenting on this subject.

The ‘Price of Life’ from a scientific or Human perspective:

If viewed from the drug manufacturer’s perspective, then it would be economic; return on investment.

But they have no power as to the availabililty of the product, except to the minority of patients who can pay. Not economically viable.

The target therefore, is private health organisations or health trusts

Whilst the former surely has the ability to pay, directly or from health insurance, they will still make up only a minority of the target population this drug was intended for.

The economics of research, development, manufacture and distribution must reflect the true target: Government funded health-care.

This was the intended target from the beginning. And it is based on guilt, an emotion large Corporations generally don’t feel.

The marketing fact is, ” We have invested an enormous amount of capital in a drug that never before existed, and if you can’t or refuse to provide this new medication, then it is you who must bear the consequences.”

Meaning criticism and real life consequences.

So, the guilt remains with the provider, and the carer. NOT the developer.

Limited resources, and TRIAGE.

The big Pharmaceutical Companies have access to the enormous funds required to develop new drugs.

But the balance between who pays and who benefits will be a major obstacle, until a public funded organisation can provide a similar service for free.

ISN’T THAT WHY WE ARE SCIENTISTS?Are we doing it for the money, or from intellectual morality?

You know that without Single Payer, Big Insurance will be making the decisions and you may lose your life, only their decision will be weighed against their profits.

Either way, unless you are independently wealthy, someone must make the hard choices. Unlimited cost is not a choice that can go on indefinitely. We’ve come to the end of the money line. We are paying top dollar for two wars, for worldwide economic crises brought on by mass greed and theft, and Big Insurance and Big Pharma want things to benefit them, not you, just like it always has. The public does not have a chance against their wealth and influence over Congress.

Game over before it begins. I can’t wait to hear laughter on the end of the line next time my patient’s medication is denied.

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Posted in Controversy, Insurance, Politics of Pain Tagged: Public Health Insurance ]]> http://painsandiego.com/2009/06/18/new-poll-shows-76-support-for-choice-of-public-plan/feed/ 2 painsandiego cement truck believerjerk http://painsandiego.com/2009/06/17/md-haunted-by-the-dirty-work-of-managed-care-ppos-that-deadly-piece-of-paper-denied/ http://painsandiego.com/2009/06/17/md-haunted-by-the-dirty-work-of-managed-care-ppos-that-deadly-piece-of-paper-denied/#comments Thu, 18 Jun 2009 06:22:48 +0000 Nancy Sajben MD http://painsandiego.com/?p=2065 ]]> ·

“I know how managed care maims and kills patients”

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I will never forget the laughter of a “medical” reviewer two weeks ago as he denied medication to my patient that the same PPO had been authorizing for years. My patient has been haunted by the man’s laughter since then. Denial of continuing medication is happening more and more despite California law that “grandfathers” in ongoing care for previously covered medication. See my post here.

It is “DESUETUDE.” It refers to the condition where a law has gone unenforced for so long that it is considered ‘obsolete.’ The law has not been repealed, but — here’s the clincher — the law has “collapsed into unenforcibility.” (quote from William Lamers, Jr, MD)

For years we have had spreadsheet medicine: Denial only for medication that is costly. It’s getting worse, more brazen.

Now that much new medication is unaffordable, priced far beyond the rate of a decade of inflation, what do we do with lawmakers that will not negotiate volume discount prices with pharmaceutical companies? How long will the middle class be able to afford common medication?  There isn’t another first world country on the planet that does not negotiate volume pricing.

Why are safe older pain medications being taken off the formulary?

Did you know that prices on best selling medicines may go up as much as 20 to 30% each year, though they’ve been on the market for years?

What is worse, managed care bloodlessly denies life saving procedures. A bloodless coup that rarely makes the news.

Physician Confesses to Congress, Choking Back Tears

Dr. Lynn DiPino [spelling?], former medical reviewer for Humana went before Congress to make “a public confession.”

This doctor, who acted as a reviewer for an insurance company, denied life saving surgery for a man and thus caused his death, saving “the company half a million dollars.”

Her decision to deny surgery insured her continued advancement in healthcare. “I went from making a few hundred dollars a week as a medical reviewer to an escalating six figure income as a physician executive.” “I was told repeatedly I was not denying care, I was simply denying payment. I know how managed care maims and kills patients. So I am here to tell you about the dirty work of managed care.”

As the video continues on the origins of managed care, it goes back to February 17, 1971, when Ehrlichman discusses Kaiser HMO with President Richard Nixon : “All the incentives are for less medical care because the less care they give, the more profit they make.”

Nixon smiles, his eyes narrow as if he is savoring fine wine, and says, “Not bad.”

Health Insurers Refuse to Limit Rescission of Coverage

withering criticism from Republican and Democratic Congress members

Today in Los Angeles Times

Even Republicans were appalled when “[e]xecutives of three of the nation’s largest health insurers told federal lawmakers in Washington on Tuesday that they would continue canceling medical coverage for some sick policyholders, despite withering criticism from Republican and Democratic members of Congress who decried the practice as unfair and abusive….

An investigation by the House Subcommittee on Oversight and Investigations showed that health insurers WellPoint Inc.[parent of Blue Cross of California], UnitedHealth Group and Assurant Inc. canceled the coverage of more than 20,000 people, allowing the companies to avoid paying more than $300 million in medical claims over a five-year period.

It also found that policyholders with breast cancer, lymphoma and more than 1,000 other conditions were targeted for rescission and that employees were praised in performance reviews for terminating the policies of customers with expensive illnesses.

("Um . . I know this is a bad time but . . . .you're not covered.") shamelessly stolen from crooksandliars.com

…Rescission was largely hidden until three years ago, when The Times launched a series of stories disclosing that insurers routinely canceled the medical coverage of individual policyholders who required expensive medical care.

…A Texas nurse said she lost her coverage, after she was diagnosed with aggressive breast cancer, for failing to disclose a visit to a dermatologist for acne.

The sister of an Illinois man who died of lymphoma said his policy was rescinded for the failure to report a possible aneurysm and gallstones that his physician noted in his chart but did not discuss with him.

The committee’s investigation found that WellPoint’s Blue Cross targeted individuals with more than 1,400 conditions, including breast cancer, lymphoma, pregnancy and high blood pressure. And the committee obtained documents that showed Blue Cross supervisors praised employees in performance reviews for rescinding policies.

One employee, for instance, received a perfect 5 for “exceptional performance” on an evaluation that noted the employee’s role in dropping thousands of policyholders and avoiding nearly $10 million worth of medical care.

…Late in the hearing, Stupak, the committee chairman, put the executives on the spot. Stupak asked each of them whether he would at least commit his company to immediately stop rescissions except where they could show “intentional fraud.”

The answer from all three executives:

“No.”

Rep. John Dingell (D-Mich.) said that a public insurance plan should be a part of any overhaul because it would force private companies to treat consumers fairly or risk losing them.

“This is precisely why we need a public option,” Dingell said.

…In November 2007, The Times reported that insurer Health Net Inc. paid bonuses to employees based in part on their involvement in rescinding policies. According to internal corporate documents disclosed through litigation, Health Net saved $35 million over six years by rescinding policies.

The disclosures in part led an arbitration judge to levy $9 million in damages against Health Net in a case involving the company’s rescission of the policy of a woman diagnosed with breast cancer.

At the time, Blue Cross told The Times that it did not link employee performance reviews to rescission. Blue Cross also said at the time that it had conducted audits to ensure that claims reviewers were not given any “carrots” for canceling coverage.

The company reiterated that position Tuesday in spite of the committee’s disclosure of two employee performance evaluations from 2003 discussing rescission levels and savings.

§

Gene Wilder

§

Gimme Some Money

by Spinal Tap

·

Chronic use of opioid pain medication

causes molecular and genetic changes that result in pain

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A brief update

American Pain Society May 2009 Symposia: Anti-analgesic Effects of Mu-opioids: Molecular and Genetic Mechanisms

The clinical benefits of opioid analgesics have not been fully realized due to substantial side effects, which include tolerance, dependence and opioid-induced hyperalgesia. Although the precise molecular mechanism of these phenomenon is not understood yet, it is generally thought to result from cellular excitatory effects of mu-opioids which contrast the major inhibitory effects.

Mark Hutchinson, PhD, discussed the new discovery that every clinically relevant class of opioid analgesics non-stereoselectively activates glial cells through TRL4 receptor. Activation of this receptor, primarily expressed by microglia, leads to the release of proinflammatory mediators that counter-regulate acute opioid analgesia.

How can opioid-induced glial activation oppose & augment different aspects of opioid action?

Opioid analgesia is opposed by opioid-induced spinal glial activation since increased neuronal excitability leads to elevated nociception. Increased brain opioid-induced glial activation also leads to increased neuronal excitability & within reward & dependence centers this is believed to increase opioid reward & dependence. Therefore analgesia is decreased & reward/dependence is increased.

~

Counteracting hyperalgesia with naltrexone and dextromethorphan

In summary, Dr. Hutchinson describes the TRL4 receptor where opioids act to induce activation of microglia, releasing proinflammatory mediators that counteract analgesia and produce more pain.

Naltrexone, a mu opioid antagonist, has profound anti-inflammatory effects centrally on the microglia to produce analgesia.  This mechanism of action of low dose naltrexone is discussed here.

Dextromethorphan acts centrally on microglia by the same mechanism, producing analgesia.  Both naltrexone and dextromethorphan are classified as morphinans, morphine-like.·

More is less:  increasing the dose causes pain.

A steep road to climb, much less to understand.

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Persistent pain has a prevalence of 1 in 5 of the population

at an annual cost of $1.85 billion per 1 million population.

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Does Pain Management Have a Place in American Healthcare?

Pain focused courses foster affective awareness and shape values formation in medical learners.

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Symposium on Pain Management Aimed at Medical School Students

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Yale’s Medical Bulletin, Published: May 16, 2008

New Haven, Conn. — Physicians-in-training learned about an important aspect of patient care — pain management — at a symposium held recently at the Yale School of Medicine.

In recent years, pain has been designated as one of the vital signs indicating a patient’s well-being by the Joint Commission on the Accreditation of Healthcare Organizations, and pain management is being widely accepted as a basic human right. Yet only 3% of the nation’s medical schools, including Yale, currently have a separate course in pain management. [emphasis mine]

As a first step in its efforts to include separate training in pain management as part of its curriculum, the School of Medicine recently hosted the inaugural Yale Multidisciplinary Pain Management Symposium. The event was organized by student Ninani Kombo under the guidance of faculty adviser Dr. Nalini Vadivelu, associate professor of anesthesiology, with support from the medical school’s Offices of Education and of Student Affairs, as well as the Graduate Professional Student Senate.

The symposium featured presentations on “Pain Pathways,” “Clinical Perspectives in Pain Management,” “Interventional Pain Management,” “Psychology and Pain Management” and “Legal Considerations of Pain Management.” The speakers included Vadivelu, Dr. Sam Chung and Dr. Raymond Sinatra of the Department of Anesthesiology; Dr. Michele Johnson of the Department of Interventional Radiology; Layne Goble, a psychologist at the West Haven Veterans Hospital; and Robert Burt, the Alexander M. Bickel Professor of Law at Yale Law School.

Two physicians also brought in patients so the students could talk with them and learn more about their personal experiences and challenges in living with chronic pain. One, who suffers from migraines, is a patient of Dr. Bahman Jabbari, professor of neurology; and the other, who has sickle cell anemia, is a patient of Dr. Thomas Duffy, professor of internal medicine and hematology.

Plans call for the symposium to continue as an annual event, and to be included within the neurology module of the second-year medical curriculum.

“This will continue to be a multidisciplinary pain symposium and in true Yale medical school tradition it will be organized by medical student volunteers,” says Vadivelu, who will continue to serve as faculty adviser for the initiative. “In the near future, the pain management curriculum may be expanded to include didactic case studies in pain management during the third and fourth years of medical school.

“This commitment,” she adds, “makes Yale School of Medicine one of the leaders among U.S. medical schools in formal pain management education.”

PRESS CONTACT: Office of Public Affairs 203-432-1345

A letter from Yale professors April 2009, to the Editor of the Journal of the Association of American Medical Colleges

The Urgent Need for Pain Management Training

Vadivelu, Nalini MD; Kombo, Ninani; Hines, Roberta L. MD

To the Editor: Approximately 50 million people in the United States suffer from persistent pain,¹ and pain treatment cuts across most medical disciplines. Despite huge strides in understanding pain, there is a major gap between that understanding and pain diagnosis and treatment. In the 21st century, pain management is being accepted as a basic human right.² Thus, it is even more important to train medical students to be competent in the areas of pain assessment and treatment. However, few physicians graduating from U.S. medical schools have had comprehensive multidisciplinary pain education as part of their medical school curricula. This was shown in an AAMC survey in 2000-2001, which found that only 3% of medical schools had a separate course in pain management in their curricula¹; the situation is not much better today. [emphasis mine] Although a free, Internet-based CD-ROM textbook on pain was developed for medical students in 2003 by the American Academy of Pain Medicine, we feel there is an urgent need for formal pain management training within the medical school curriculum.

Pain education in medical schools could be in the form of pain symposiums, pain workshops, lecture series, and clinical rotations in pain management, according to what is available and feasible in each school. Interinstitutional elective rotations in pain management and summer research projects with resulting research publications in pain should also be encouraged. Funding for the latter is available from, for example, Foundation for Anesthesia Education and Research grants to medical students from the American Society of Anesthesiologists. We at Yale have incorporated formal pain education into our curriculum using a multidisciplinary pain symposium at the second-year level with case studies for third- and fourth-year students.

We believe that medical schools worldwide should establish formal pain management education in each year of their curricula. [emphasis mine] This will enable graduating physicians everywhere to be well equipped to ease their patients’ pain.

Nalini Vadivelu, MD

Associate professor, Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut; (nalini.vadivelu@yale.edu).

Ninani Kombo

Fifth-year medical student, Yale University School of Medicine, New Haven, Connecticut.

Roberta L. Hines, MD

Professor and chair, Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut.

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

The War on Drugs Sold so Well That Persons With Pain

Often Cannot Get Pain Medication or Treatment

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Don’t read this. It will upset you.

The federal government has always been more interested in addicts than in persons who are disabled with intractable pain. Billions are spent to imprison addicts rather than pay for addiction programs which would be far less expensive.

Only 3% of medical schools have a course in pain management, Yale announced in 2008. According to the International Association for the Study of Pain, the IASP, education on pain is poor “at either the preclinical or clinical levels and information is poorly integrated.” Fewer than 3% of recent graduates have had a few hours of training. This means that unless your doctor is among that small 3% that has recently graduated, they have had no training in pain control. None. And the FDA ignores the extensive training of pain specialists when approving limitations on new medications.

Worst of all, NIH spends 0.67% of its budget on pain research – less than 1% – though 10 to 20% of the population in the US suffers from chronic pain, an estimated 60 million Americans, and the conditions are more prevalent among the elderly. Addiction funding is the only reason neuroscientists in the early 1970’s were able to identify opioid receptors and then to clone them, which legitimized pain in cancer patients and led to use of opioids for cancer pain in the 1970’s and for noncancer pain in the 1990’s.

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Pain Epidemic:

Does Pain Management Have a Place in American Healthcare?

Today, there is too much reliance on opioids for pain because there is little or no NIH research on alternatives. Or maybe because your doctor does not know any other treatment than to prescribe an opioid. Or because Medicare will not pay for the amount of physical therapy you need. Opioids are overprescribed. This increases the risk of opioids being diverted and falling into the hands of addicts, leading to deaths and headlines that will no doubt limit your ability to be treated for pain. How many of you know Medicare has been limiting physical therapy for years? If you use all your treatment by mid February, they will not pay for more no matter how often you fracture your hip or herniate a disc. Is it right for them to pay for opioid pain medication and not physical therapy?

Just think of it. Before the early 1970’s, we had no pain societies, no hospices, no use of opioids for cancer patients (unless they happened to be hospitalized), no oral opioids, no oral morphine — why the very thought that oral morphine could work was argued against vehemently by the chief of the pain service at Memorial Sloan Kettering Cancer Center in NYC, in December 1975 at the first meeting of the IASP. The first meeting. 1975. Think of it. He argued that oral morphine would be metabolized so rapidly that it would pass out of the body and not be there to help.

William Lamers, Jr., MD

In the early 1970’s if you had pain, you were not legitimate because we simply did not know there were such things as opioid receptors nor did we have oral opioid medication.

Now re-imagine that vehement argument in 1975 again, knowing that my dear friend William M. Lamers, Jr., MD, was the first in the world to use oral morphine when he founded home hospice in America 5 or 6 years before that date. He invited Dr. Cicely Saunders to California to teach her how to use oral morphine at her hospice, and following that, St. Christopher’s Hospice in London stopped using the ineffective Brompton’s Cocktail that caused so many side effects with so much less pain relief. Their research a few years later enabled Dr. Robert Twycross from St. Christopher’s Hospice to stride to the stage in 1975 at the IASP meeting, and report their work with oral morphine, to the applause of the Brits.

Let me be clear, I am gravely concerned that the use of opioids for nonmalignant pain will lead to a dire problem with opioid induced hyperalgesia in our large population of pain patients. Opioids create pain at the same time they relieve pain.

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We Are Not Getting Access to Effective Nonopioid Treatments

Worst of all, unless opioids are low cost, your insurance – PPO, Medicare, Medicaid – will not authorize several profoundly important nonopioid medications that I find has helped and/or relieved intractable disabling pain in many of my patients:

• Namenda an NMDA antagonist that was shown in European research in 2001 to be effective for severe pain at a dose of 55 mg per day; in the US it is approved only for dementia at a dose of 20 mg per day. Insurance will not cover the dose needed; patients cannot afford it.
• Compounded capsules and ointments may be the only thing that helps others, but are often not approved.
• Naltrexone and other morphinans – see my post on naltrexone -  may relieve disabling pain, but compounded medications are often not approved
• Medical marijuana research has been forbidden by the federal government despite active research and use of approved compounds in Canada and UK for severe intractable pain. Marijuana is in a class of chemicals called cannabinoids. Our brain makes cannabinoids and has receptors where they act. A synthetic cannabinoid  is FDA approved in the US for chemotherapy induced vomiting. The cost of one mg capsules is $400 for 20 – who can afford that?  In Canada, it is used for pain patients at bedtime to relieve severe pain that prevents sleep. Yet in California where inexpensive medical marijuana is legal, the Obama Department of Justice has continued the prosecution of Charles Lynch, a legitimate marijuana dispensary owner.  He was convicted on federal drug charges despite carefully following state and local law in setting up and running his business and being fully licensed by the state. He had the full support of the mayor and city council, yet he was sentenced to a year and a day in jail last week – the Obama DOJ pushed for a mandatory 5 years jail. Federal law prevented him from testimony in his own defense, presumably because federal law excludes states rights and the issue that marijuana sales may interfere with interstate commerce. For discussion of this and the bill introduced Thursday by Rep. Barney Frank, HR 2835, to legalize medical marijuana, see here. There was a time in the recent past when hospice doctors in the US made marijuana suppositories to relieve severe pain and nausea in dying cancer patients. In Mexico, marijuana is used in ointments by the elderly to relieve arthritis pain. 100 years ago, it was mentioned in some medical textbooks in America. And U.S. Rep. Mark Kirk calls for 25 years in prison for first time trafficking offense.
• Marijuana: Effective for severe pain, safe, nontoxic, inexpensive and illegal.
• The legal status of prescribing as well as the legal status of using marijuana is needlessly complicated. The Federal Government is clear… prescribing and use are both criminal offenses. Nothing is for certain except that the legal status is a mess.
• Unrelieved suffering leads to an intensification of pain that may result in depression, withdrawal, irritability, anger and sometimes even hostility to caregivers.

NSAID –  nonsteroidal anti-inflammatory drug – use is discouraged in the elderly.  NSAIDs pose severe risk to the elderly and cannot be used in others due to heart disease, gastric intolerance, ulcers, GERD, anemia, bleeding, kidney disease, asthma, and those who are on various medications such as Plavix or Coumadin. Further, heavy NSAID use leads to higher dementia risk (see my post on this).

Some nonopioid alternatives cannot be used in those with liver or kidney conditions, men over 50 who still have a prostate, persons who wish to avoid suddenly becoming obese (Lyrica), those with allergies or intolerance to their side effects because the drug makes the fall backwards or suppresses their bone marrow.

Worse than those issues, we have only a few opioids which work on specific opioid receptors, some are more specific for neuropathic pain or for allodynia, yet since September 2008, the FDA has removed several of the older opioids from the shelf with no reason given to pharmacists or MD’s. I have spent hours calling pharmacies to see if they stock a medication I wrote for a patient hours before they left the office holding their specialized prescription. You know very well that if a patient called asking about opioids in stock they’d be looked upon as an addict, and many pharmacies will not stock opioids with the excuse they would be robbed. No matter you are in severe pain, you must wait 72 hours until they stock it. 

Even with insurance, your PPO will not authorize many if not most of the medications I prescribe and the cost of medication is surely the #1 reason.  That is true for opioids and nonopioid medication I use for pain control. Many are off label for pain, others are off label for anyone  who does not have cancer despite severe disabling pain, therefore not covered. If you are wealthy, you can purchase any medication prescribed.

Opioids are a distinct issue and outrageously expensive compared to the pennies cost of the raw drug. There is never a discussion of reducing costs of new drugs. Imagine $45 per unit, used 12 or 20 times per day in extreme, rare cases. Then imagine your PPO allowed prior authorization for 1 year, but then it was 6 months, then 2 months. What will happen next month? Hours and hours of non-reimbursed physician time is spent on these.  They could just save us all time if they published a list telling us what they will never ever ever reimburse no matter what. No wonder a radiologist or cardiologist or a doctor who does procedures makes millions every year. They don’t have to deal with the deafening “no.” The California law is never enforced that guarantees continuation of medication that is being used and that has been approved in the past for years. Requesting an independent appeal is a sham, the fox guarding the henhouse, paid by the same company that refused authorization.

The FDA has limited use of short acting fentanyl to cancer pain, thus PPO’s will often not authorize it without a cancer diagnosis.  News flash: there is no such thing as cancer pain. Patients without cancer have the same categories of pain that you do: involving abberent signals from nerve, viscera or other tissues. At the American Pain Society’s annual meeting in San Diego, May 2009, an FDA official admitted there were only 3 pain specialists on a panel of 11 MD’s that reviewed short acting fentanyl. It is likely the other 8 had no training in use of opioids.  Fewer than 3% of medical schools spend less than 30 hours over 4 years teaching pain management to medical students, and that is only in recent years, which means almost all physicians in practice today have had no training in use of opioids. Oncologists included. Do they think that pain specialists who have spent decades in the field have no understanding of opioids? If so, then why do they not limit all strong opioids to persons with cancer? or is this coming? Politicians do not like headlines about addicts who overdose themselves.

The special case of Subutex and Suboxone which is buprenorphine alone or with naloxone. Buprenorphine is an old drug, a long acting opioid that has unique effect at kappa opioid receptors and it is said it may help allodynia better than other opioids. PPO insurance will not authorize Subutex (buprenorphine) for my patients with pain, or if they do, they will authorize only one of the two, Subutex, but not the other, even though the one they will pay for causes intractable migraine but not the other. In Europe, both are approved for pain or for addiction, just like we use methadone here.  But our FDA has limited use to addicts, though it is an important opioid that we might use for pain. This means PPO insurance will not pay for it. This new formulation of Suboxone or Subutex in a sublingual tablet means it is very expensive, and I have patients in pain, weeping that they cannot afford it and must go back on their Oxycontin that works less well.

Unique issues for oral short acting fentanyl and Subutex or Suboxone: both will absorb directly in the mouth which is important for some persons with colitis, abdominal surgery, bariatric surgery, other conditions with poor GI absorption of tablets such as celiac disease, and those who are unable to use fentanyl patches due to skin allergies.

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Need for Balance between Risk of Substance Abuse

vs  Suffering and Disability Caused by Untreated Pain?

The FDA and Congress voice concern about addiction, but how much do they care about pain? Actions speak louder than words and the lack of NIH funding for pain research is shocking. Pain does not make newspaper headlines though pain is the #1 reason people seek medical help, more so as the population ages.

Here are more policy and headline issues that will make it harder for people with pain to get the care they need:

FDA, Pain Docs Look to Cut Abuse of Pain Killers “FDA said it was working on a plan to make it tougher for people to abuse certain prescription painkillers….” From the comments: “Regardless of great efforts to reverse this trend, physicians who legitimately prescribe opioids for pain may still feel ‘damned if they do and damned if they don’t.’ It seems as though we have simultaneously raised consciousness of the need for pain control and increased the risks to physicians of being part of the solution. If this dilemma is not resolved, advancing the cause of pain management as a fundamental human right may, in part, serve to polarize the medical community.”

F.D.A. to Place New Limits on Prescriptions of Narcotics “This is going to be a massive program,” according to Dr. John K. Jenkins, director of the F.D.A.’s new drug center.”  ”…a law passed in 2007 gave the agency a new, intermediate weapon — Risk Evaluation and Mitigation Strategies. Known as REMS, these programs allow the agency to place strong restrictions on the distribution of certain drugs.”

Increased Scrutiny of Opioids Could Alter Prescribing Practice “If a formal risk reduction plan for opioid painkillers increases the regulatory burden on physicians, they may simply stop prescribing such drugs, to the detriment of patients in severe pain, the FDA was told Thursday.” Most physicians have no training in pain management, yet instead of requiring more education, regulation of doctors makes it harder to treat persons with legitimate pain and may have no effect on addicts and illegal diversion that they are really trying to regulate. Suggestions were made at a public hearing, quoted here:

• If a REMS does end up imposing requirements on physicians, positive incentives should be put in place to fund and support training in pain management, such as waiving the fee clinicians now must pay to the DEA for the privilege of prescribing Schedule II drugs
• But clinicians do not currently have the tools to enforce proper distribution and use of narcotics, and need more support and training, said Jennifer Bolen, founder of the Legal Side of Pain and the Pain Law Institute. ”It’s dangerous and irresponsible to use physicians to teach the law,” Bolen said. She said state medical licensing boards, health insurance plans, and law enforcement officials must play a big role in enforcing the REMS.
• But the FDA is not a criminal enforcement agency, said John Jenkins, M.D., director of the Office of New Drugs at the FDA.
• One suggestion from a number of speakers is that the FDA require opioid manufacturers to put serial numbers or microchips in opioid tablets, linked to the prescription that released them to a patient. That way, if law enforcement officials seize pills, the prescriber and patient can be easily traced.
• The FDA is already considering serial numbers on some classes of medication for a different reason — to confirm the integrity of the supply chain.
• Other speakers suggested creating opioid medications that are “less abusable” such as crush-proof pills. However, formulations intended to thwart abuse have been tried before. That was the original intent behind Oxycontin, the brand of extended-release oxycodone that ended up widely abused.While it’s up to the FDA to decide what a REMS will look like, it’s the responsibility of drug companies to enforce the new regulations.
• the two-day hearing was peppered with emotional testimonies from people whose family members overdosed on opioid drugs that they obtained illegally.
• the FDA might convene an advisory committee before any REMS is finalized.

Addiction is a very important issue. Families are best in a position to see what is happening to members who have addiction problems, but addiction programs are poorly funded and many Americans are uninsured, especially the young who are most vulnerable to chemical dependency. Can families help someone who does not want to be helped?

I want to make it very clear that all of us, myself included, are responsible for reducing addiction, misuse of prescription drugs, and diversion in this country. Yes, that means anyone who gives someone else a pill from their prescribed medication, no matter how harmless it may seem. If that is a pain drug, your pain specialist can go to jail for 30 years even if he or she did not know about it. Never give one of your prescription pills to anyone else.

Designing high tech remedies to prevent opioid tablets from being injected or inhaled by addicts will increase the cost of your pain medication.  It is already difficult to afford without new technology, and why is it so expensive since many are now old drugs and the raw material costs pennies?

If we become disabled or develop chronic pain, there is often no money for the multidisciplinary approach to pain management that is essential for treatment: extreme limits on physical therapy, no cognitive behavioral therapy, no coverage at all for many medications that I prescribe. Some of my patients who are still working are afraid they will be laid off at work if they limp, are slow or show they have pain. This is not unlike my cancer patients who fear public knowledge they have cancer. But the rising insurance cost to their employer is Darwinian evolution at its cruelest, untouched by the human mind and heart. Free for the rich, for profiteering off the most vulnerable.

Cost of high tech pills to deter addicts. We thank the FDA for their guidance in requiring opioid manufacturers to make it more difficult for addicts to abuse these drugs, but does the cost of that new technology make these medications unaffordable for the average person, especially the disabled and elderly who may need them more than others. Is the FDA pulling older and more affordable opioids off the shelf because they do not have this new technology? Is the cost of medical care and denial of coverage being driven by the 5% of addicts in this country, by expensive prison empires to house them, by headlines and politicians?

Cost is the issue that limits care. When Medicare & PPO coverage is cut for all of us, will the cost of drugs be one of the major reasons? Answer: it already is.

Remember, the FDA does not have a majority of pain specialists on pain-related advisory committees, only 3 out of 11 MD’s sat on the FDA committee that limited use of short acting fentanyl medication for cancer pain. Opioids may be an essential option for some of my patients yet their PPO will not pay for it — it’s restricted to cancer patients. PPO’s will not pay for many nonopioids used for pain either.

Does the FDA think oncologists know more about treating pain than a pain specialist? The answer is definitely no! Oncologists do not, and some abuse their power to prevent pain relief. Research has shown severe untreated pain in 34% of cancer patients among oncology specialists in the Northeastern US, and likely far more in other areas. There are many untold stories about oncologists who do not treat pain or who use poor practice treating pain, even at major cancer centers. Pain is not their priority and most spend no time learning the needed expertise.

So no coverage for PT, for off label medication, for compounded medication, for opioids restricted to cancer pain, for expensive medication, and increasing regulation for older and more affordable opioids if they have not been pulled off the shelf by the FDA.

Cost cuts imposed major losses in pain management. PPO cuts were severe at least as far back as the mid 1980’s. In 1990, UCLA closed its Anesthesiology Interdisciplinary Pain Center, only 15 years after the first international pain society meeting. Laid off with two weeks notice was the President of the American Pain Society and distinguished researchers in the field. Soon after that, in the hallways of the annual pain society meeting, whispered rumors spread that almost all university centers had closed their interdisciplinary pain centers. Only a few remained, but there was silence on the subject from the platforms and leadership and media. UCLA paved over the only therapeutic swimming pool in the greater Los Angeles area in order to build yet another radiology center.

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The Era for Procedures

There has been a rapid increase in interventional procedures with almost all pain specialists shifting to high reimbursement and easily funded techniques, but where’s the science? Read the practice guidelines of the Academy of Neurology and American Pain Society on epidurals and nerve blocks. Where are the studies that show their benefit? Are they suitable as the best choice?

Pain management requires individualized care that involves analysis and specific treatment based upon many factors. Medicare and PPO’s will pay for procedures which are inversely proportional to the time needed for analysis. There is no single evidence based protocol that can be applied to every one such as there is for chest pain.

With so little research funding and so little training going into pain management,  politics may make the treatment of pain subject to more and more irrational or unaffordable choices.

The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

To Find My Home Page, click here:  Welcome to my Weblog on Pain Management!

Posted in Chronic Pain, Controversy, Epidural Injections, Hospice, Medications, Nerve Blocks, NSAIDs, Pain Management, medicine, Politics of Pain, Procedures, Research Tagged: addiction, buprenorphine, Controversy, FDA, headlines, History of pain, Hospice, IASP, morphinans, Morphine, NIH, Opioids, Research, William Lamers MD ]]> http://painsandiego.com/2009/06/13/fda-restricting-opioids-patients-lose-nih-does-not-fund-pain-research/feed/ 4 painsandiego Bill Lamers MD Aurora Borealis green Cloud http://painsandiego.com/2009/05/26/ketamine/ http://painsandiego.com/2009/05/26/ketamine/#comments Wed, 27 May 2009 05:39:52 +0000 Nancy Sajben MD http://painsandiego.com/?p=1301 ]]>

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Low Dose Naltrexone

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Low dose naltrexone, or LDN, has been prescribed “off label” for persons with many conditions including intractable pain, chronic fatigue syndrome, complex regional pain syndrome, RSD, Multiple Sclerosis, Parkinsons Disease, IBS, inflammatory bowel disease, autoimmune diseases and Crohn’s Disease to mention only a few. Low dose naltrexone is not a cure but may be potentially helpful for selected persons with these conditions. It appears to have little or no toxicity at this low dose – a few persons report transient insomnia, nausea or vivid dreams.

Naltrexone and dextromethorphan are both classified as morphinans. This discussion relates to both medications. Refer to the paper titled Morphinan Neuroprotection by Zhang, below.

How does it work?

Naltrexone and dextromethorphan inhibit Superoxide, a free radical, and reduce the toxicity of peroxynitrate metabolism and the excitotoxic effects of glutamate. The mechanism of action occurs at the microglia in spinal cord and brain where they are neuroprotective. Microglia are the immune cells of the central nervous system. Microglia are not only the hallmark of pathology in Multiple Sclerosis but they also play a major role in pain and other degenerative neurological conditions. Reducing the damaging effect of these potent neurotoxins improves function of the immune system and various organ tissues including the spinal cord and brain.

There is evidence that they also increase the release of neurotrophic factors BDNF and GDNF (Jau-Shyong Hong, PhD, at the NIEH/NIH, personal communication).

Chronic pain alters central processing by changing the neurochemistry and the anatomy. This can lead to premature aging of the brain with loss of gray matter and brain atrophy as reported on MRI’s of persons with chronic low back pain. This may also occur in other stress-related disorders, such as chronic depression or post-traumatic stress disorder.

There has been a blossoming of basic neuroscience research on microglia that began in the 1980’s. At the American Pain Society meetings in San Diego in May 2009, there were hours of lectures for several days on the basic science of microglia and pain mechanisms.  This confirms the experience that I have seen clinically.

I am grateful to have the guidance of patients, physicians, and scientists in learning about the use and mechanisms of low dose naltrexone, with special thanks to Dr. Jau-Shyong Hong, PhD, Chief of Neuropharmacology at NIEH/NIH. He is one of the country’s leading experts on microglia, opioid antagonists and morphinans and has published some of the references below.

New science shows naltrexone to be a potent anti-inflammatory — much stronger and with a much different mechanism than the weaker cox inhibitors such as ibuprofen, Vioxx, Celebrex, Naproxen with none of those adverse side effects. Dr. Hong reports that in animal studies, dextromethorphan is even stronger than naltrexone.

Naltrexone is one of a few compounds called morphinans, meaning it has a structure similar to morphine, but naltrexone blocks morphine-like medication:  it is an antagonist.  For detailed discussion of morphinans refer to the article by Zhang et al, listed below.

There are links to further understand the basic science in medical publications and references below. We all owe thanks to patients whose clinical recovery with the use of low dose naltrexone has kept this work alive since its effect on the immune system in Multiple Sclerosis and HIV/AIDS was discovered by Bernard Bihari, MD, in 1984. He was a Harvard trained academic neurologist based in NYC. Their testimony can be found in the book mentioned below or in many web sources. The excitement of their recovery and their fundraising prompted UCSF and Stanford to begin double blind studies now 25 years later.

Recent clinical research

In 2009, Drs. Younger and Mackey of Stanford Pain Center reported a double blind study of low dose naltrexone in persons who had fibromyalgia more than 10 years and showed 30% improvement in pain and fatigue. They now plan a larger study. Bruce Cree, MD, of the UCSF Multiple Sclerosis Clinic in 2008 reported improvement using low dose naltrexone in a masked placebo controlled study to evaluate quality of life in MS [reference below] testing only pain, cognitive function and mental health. They propose doing a larger study to measure other functions in MS. In the 2007 study by Jill Smith, MD, at Hershey Medical Center [reference below], 67% of persons with Crohn’s Disease achieved remission in a few weeks, and total 89% had a response to therapy. As described in their publication: “Endogenous opioids and opioid antagonists have been shown to play a role in healing and repair of tissues.” Dr. Smith has received a $500,000 grant from NIH to continue research on low dose naltrexone for Crohn’s Disease.

Multicenter studies on LDN for persons with Multiple Sclerosis have been done in Italy and Scotland.  New research is starting in Scotland that will include study of the toxicity of peroxynitrate metabolism in MS first proposed by a Nobel winning scientist in 1991, see the reference on peroxynitrate metabolism and Dr. Gilhooly’s references, below.  Scotland has the highest incidence of MS in the world, even higher than Great Britain and Ireland.  Dr. Gilhooly’s patients reported remarkable improvement in function on LDN that led to him starting this work.

My experience prescribing LDN

I have been prescribing naltrexone for 6 years in ultra-low microgram doses, and more recently prescribing low dose naltrexone at doses of 1 to 4.5 mg.  It is one of the most exciting developments in pain medicine and neurodegenerative diseases that I have ever seen.  It was previously unimaginable to me to see some persons with intractable pain now pain free and off opioids because of low dose naltrexone or a similar medication that will soon be posted on this weblog.

I have not yet been able to predict who will respond to low dose naltrexone with decrease in symptoms, but many patients have had profound relief. Often it may reduce intractable pain to zero despite failing to respond for many years to all known therapies. Inability to predict a response to pain is true of many classes of medication that we trial “off label” for pain relief and even those that are FDA approved for pain. Paradoxically, the same is true for morphine and similar strong opioids.  In fact, opioids relieve pain and opioids create pain at the same time, and it is not uncommon for pain specialists to see individuals with severe pain despite using high dose opioids.

“Off label” use means it is not FDA approved for these purposes.  Instead, low dose naltrexone is used in small doses of 1 to 4.5 mg at bedtime that must be made by a compounding pharmacist, rather than the 50 mg tablets or higher doses that are FDA approved for prevention of addiction and alcoholism.

Many thanks to the sponsors and speakers of the Fourth Annual Conference on Low Dose Naltrexone which was held for the first time on the West Coast at USC on October 8, 2008 – they have provided other references attached below.

Naltrexone became available as a generic drug many years after 1984, and thus there is no profit in this use for pharmaceutical companies.  Only recently, has the science progressed enough to understand its new uses.  Therefore what you may read in various sources on the web may be the “old science,” whereas the articles below are the “new science.”

I will be updating this page in the near future but wanted to make these recent publications and documents available now.

I strongly recommend this book:

The Promise of Low Dose Naltrexone Therapy

by Elaine A. Moore & Samantha Wilkinson, McFarland & Company Inc., 2009

“Grounded in clinical and scientific research, this book describes the history of naltrexone, its potential therapeutic uses, its effects on the immune system, its pharmacological properties, and how the drug is administered. It also lists … patient resources, and includes interviews with LDN patients and researchers.”

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Download sizes are in parentheses to the right of each download link.

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Morphinan Neuroprotection by Zhang, Hong, Kim, et al, Crit.Rev.Neurobiol. 16(4):271-302, 2004 (PDF)  450k

Microglia Mediated Neurotoxicity Molecular Mechanisms. Block Zecca Hong, Nature Reviews Neurosci 8:57, 2007 (PDF) 529k

Peroxynitrites in MS,  Dr Tom Gilhooly, Scotland, USC 4th Annual LDN Conference 2008 (PDF)  77k

LDN research on MS in Scotland Dr Tom Gilhooly, USC 4th Annual LDN Conference, 2008 (Powerpoint)  12M

LDN In MS, Bruce Cree MD, UCSF Poster, 2008 (PDF)  154k

A Pilot Trial of LDN in Primary Progressive MS, Gironi et al, Multiple Sclerosis 14:1076–1083, 2008 (PDF)  222k

LDN for Treatment of MS – Clinical Trials Are Needed, Patel, Ann Pharmacotherapy 41 (9):1549, 2007 (PDF)  114k

LDN Improves Active Crohns Disease, Jill Smith MD et al, Am J Gastroenterology 2007 (PDF) 121k

LDN Immune System Autism & HIV, Vojdani, USC 4th Annual LDN Conference, 2008 (Powerpoint)  5.7M

LDN Immune System Autism & HIV, Vojdani Part 2, USC 4th Annual Conference, 2008 (Powerpoint)  3.6M

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The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

Posted in Chronic Fatigue, Chronic Regional Pain Syndrome, Crohn's Disease, CRPS, Dextromethorphan, Fibromyalgia, Low Dose Naltrexone LDN, Naltrexone, RSD Tagged: Chronic Fatigue, Crohn's Disease, CRPS, Dextromethorphan, Fibromyalgia, LDN, Low Dose Naltrexone, Multiple Sclerosis, Naltrexone, Pain, Parkinson's Disease, RSD ]]> http://painsandiego.com/2009/05/26/low-dose-naltrexone-ldn/feed/ 1 painsandiego Lavender sprig The Promise of Low Dose Naltrexone Therapy Lavender field http://painsandiego.com/2009/04/25/mayo-clinic-health-manager-a-free-tool-to-manage-your-familys-health-online/ http://painsandiego.com/2009/04/25/mayo-clinic-health-manager-a-free-tool-to-manage-your-familys-health-online/#comments Sat, 25 Apr 2009 20:57:31 +0000 Nancy Sajben MD http://painsandiego.wordpress.com/?p=672 ]]>

The Mayo Clinic has announced a Health Manager, hosted and powered by Microsoft Healthvault, to help you manage your own and your family’s health and medications.  It is a “security enhanced” online interactive personal guidance system that allows you to track and graphically monitor specific problems, and access Mayo Clinic advice about diagnoses and treatments.

You can enter your physician’s names and telephone numbers, organize immunizations, charts, chemistry studies, and tests then customize and print relevant information to take to your doctors.  In coming months, persons with Type 2 diabetes, hypertension or high cholesterol will find help managing those conditions, and the site will be updated regularly to reflect best practices in health care.

This allows you to become more pro-active in your care, print out material to take with you to your doctor, and get the most out of your doctor’s visits.

Warnings about electronic health records:  Inaccuracies can have serious consequences and a list of medical conditions should have starting and ending dates on them, as this article points out. ”For example, … an inaccurate diagnosis of gastrointestinal bleeding on a heart attack patient’s personal health record could stop an emergency room doctor from administering a life-saving drug.” If a doctor knew that was 20 years ago, not 2 years ago, that may be a mortal difference.

Yes, you type that in.  Be careful.  One small zero, one typographical error, one person’s life.

I would raise a word of caution that no personal information is that safe on the web. Even top secret military websites have been hacked.  Consider using code names, or at the least make certain that no medical record numbers are on any of those reports.  Use long passwords and change them often.   That would help.  Medical Identity Theft is a very real issue that may never be untangled if it were to occur.

Here’s more on that from today’s Wall Street Journal; note comments below the article:  Are Electronic Health Records Worth the Risks?

Risks for Patients —Liability for Doctors:

More importantly, this excellent article by Dana Blankenhorn in ZDNet Healthcare points out the 2008 Riegel vs. Medtronic decision … gave tech companies immunity from most state lawsuits, if their software is placed into a device.

….The Journal of the American Medical Association, which has its own problems with criticism, has now published an editorial decrying the immunity, which is based on a doctrine called “learned intermediaries.”  Present law assumes that faults lie with the user, writes Ross Koppel … a sociologist at the University of Pennsylvania. “Health IT vendors claim that, because they cannot practice medicine, clinicians should be accountable for identifying errors resulting from faulty software or hardware,” he said in a press release.

~~~“But errors or lack of clarity in HIT software can create serious, even deadly, risks to patients that clinicians cannot foresee.”~~~

In his article, Koppel and David Kreda, a Philadelphia software designer, offer examples of software bugs causing mistakes in drug administration, and failures to carry over warnings about drug allergies to the clinicians using them.

All this hit like a thunderclap for Scot Silverstein of Drexel, the health IT skeptic profiled here last month, who blogs at Healthcare Renewal under the nom de blog MedinformaticsMD.

~~~ Along with your patients you are nonconsented beta testers and experimental subjects

of the health IT industry,

and potential victims of the computer industry’s arrogance and dysfunction.~~~

Silverstein believes that legal threats are necessary to end the “mission hostile user experience” he finds so often.

Dr. Koppel writes “Even when their products are implicated in harm to patients, manufacturers of healthcare information technology (HIT) currently enjoy wide contractual and legal protection that renders them virtually “liability-free.”  His work on the benefits and the liabilities of HIT has been the subject of international focus.

In one example, a trauma team did manage to catch an error in a piece of faulty vendor software that miscalculated intracranial pressures. Had they not, patients would have been severely threatened and the hospital would have been responsible for the resulting harm. “From an equity standpoint,” says Dr. Ross Koppel, “This is unacceptable.”

Other examples of internal software mistakes include confusing kilograms and pounds used to derive medication doses based on a patient’s weight, and software that erroneously remove warnings about fatal drug allergies. In both cases “learned intermediary” clauses hold that clinicians are responsible for noticing the mistake before prescribing.

Equally unfortunate and unacceptable are the provisions in most HIT contracts that prohibit healthcare organizations from openly disclosing any problems caused by vendor software, even to the other HIT licensees using the same products, e.g., clinicians, hospitals. Such stipulations defeat patient safety efforts and are contrary to the principles of evidence- based medicine, says Koppel.

The authors also identify circumstances where HIT vendors should not be held accountable for patient safety failures arising from their products’ misbehavior, e.g., user misuse and medical circumstances not knowable in advance. “Legal and contractual changes must not reduce incentives to vendor innovation,” said Koppel. “We must achieve a better balance among patient safety concerns, fairness to clinicians, vendor responsiveness, and vendor marketing.” The authors suggest moving the HIT industry toward this balance may require several changes to the status quo, including:

• State and national organizations with responsibility for inspecting hospitals would have additional power to set rules affecting HIT contract terms.
• Professional medical organizations taking a stand that HIT contracts containing blanket “hold harmless/learned intermediary” clauses are inconsistent with professional practice. Vendors would then have to focus more strongly on patient safety concerns.
• Healthcare professionals and their associations lobbying Congress for changes in federal law that would recognize a range of HIT vendors’ safety responsibilities–much as with auto manufacturers and seatbelt laws.
• Altering legal standards to facilitate rather than frustrate disclosure of HIT product shortcomings that have patient safety implications.

The American Recovery and Reinvestment Act of 2009 (ARRA) – What it means for doctors

The New England Journal of Medicine this month published a detailed article on Health Information Technology [HIT] pointing out the “significant barriers to their adoption and use: their substantial cost, the perceived lack of financial return from investing in them, the technical and logistic challenges involved in installing, maintaining, and updating them, and consumers’ and physicians’ concerns about the privacy and security of electronic health information.”

Experts estimate the cost of a system for a medical office to be about $40,000 — startling indeed.  That may explain why so few have invested.  And there will be sticks and carrots to get this going. Starting in 2011, doctors will receive financial incentives from Medicare for the “meaningful use”  of a “certified” system “that can exchange data with other parts of the health care system.”  And if they do not have a system, reimbursement from Medicare and Medicaid will be reduced.  Obviously this does not apply to private insurance, nor does it apply to the growing numbers of doctors who opt out of Medicare because of low reimbursements that are not adequate to cover overhead.

To get the most out of the fiscal incentive, an MD must have the system fully operational by 2011. The incentives are reduced every year until they end in 2016.

The law currently requires health care organizations to promptly notify patients when personal health data have been compromised.  But should tech companies be given immunity from lawsuits if their software causes problems in your health or if data is not secured, resulting in Medical Identity Theft?

Enjoy this music:  Louis Armstrong  and don’t miss the video.  It’s magical.

What a Wonderful World

The bright blessed day, the dark sacred night.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

Background:

Several past studies have shown NSAIDs delay or prevent dementia, but there have been contradictory results.  Last year Neurology published a study of 49,349 patients’ usage ranging from ≤1 year to ≥7 years done at Boston University and Bedford VA. They showed long term use of NSAIDs protects against Alzheimers:

Compared with no NSAID use, the relative risk of Alzheimer’s disease decreased from 0.98 for ≤1 year of use (95% CI 0.95 to 1.00) to 0.76 for >5 years of use (95% CI 0.68 to 0.85).

Among patients who specifically cited use of ibuprofen, the risk of Alzheimer’s disease declined from 1.03 (95% CI 1.00 to 1.06) to 0.56 (95% CI 0.42 to 0.75).

Ibuprofen came out ahead in that study perhaps because it is the most commonly used.

They also sought to answer whether NSAIDs known to suppress Aβ1-42 amyloid would more likely protect .  Aβ1-42 amyloid is a major component of plaques found in Alzheimer’s Disease.

Aβ1-42 amyloid suppressors include ibuprofen, diclofenac, flurbiprofen — but as for suppressing Alzheimer’s, these were found to be no different than other NSAIDs, putting that theory to rest.

Risk of dementia and Alzheimer’s Disease with prior exposure to NSAIDs in an elderly community-based cohort:

This new study by Breitner  et al, from the University of Washington School of Medicine was published online April 22, 2009, before the print edition in Neurology.  

Their outcome contradicts earlier protective studies possibly because they started with an older cohort, healthy adults 65 and older, which “could be enriched for cases [of Alzheimer's] that would otherwise have appeared earlier.”

They prospectively followed 2,736 persons in a Seattle health plan.  Before starting the study, they reviewed pharmacy records as much as 17 years earlier.

Findings:

12.8% of the study participants [were] heavy NSAID users at baseline. Heavy use was defined as taking 500 or more standard daily doses over a two-year period.

Another 3.9% of participants became heavy users during follow-up.

Ibuprofen, naproxen, indomethacin, and sulindac accounted for about 80% of all NSAIDs used.

Through follow-up, 476 participants developed dementia; for 356 of them, it was Alzheimer’s disease.

After controlling for age, gender, education, APOE status, hypertension, diabetes, obesity, osteoarthritis, and physical activity, the risk of developing all-cause dementia was 66% higher among heavy users than among those with little or no NSAID use (HR 1.66, 95% CI 1.24 to 2.24).

The risk of developing Alzheimer’s disease was 57% higher (HR 1.57, 95% CI 1.10 to 2.23).

Strengths of the study: the community-based sample, biennial assessment of dementia, rigorous exposure classification, and large numbers of dementia cases, outweigh the limitations.

Limitations:  lack of generalizability to a younger patient population, the lack of exact dosing information, and the possibility of bias from unmeasured confounders.

Can we draw conclusions on one study alone? We know that exercise is protective against Alzheimer’s Disease and pain may have prevented this older age group from being active. Though they did control for that, this research needs to be supported by further studies. What is helpful is to remain as active as you can.  Keep and maintain every bit of function you can and get help for depression and anxiety as they may profoundly affect memory, morbidity and mortality.  For a review of the literature on the morbidity and mortality of stress and mood, refer to my post on Cognitive Behavioral Therapy and the importance of a positive outlook.

The brain makes new neurons – neurogenesis.  I will write more in the future on exercise, mood, stress, brain atrophy and memory loss.   Exercise improves depression and anxiety, and exercise stimulates neurogenesis.  It appears that the action of antidepressants also may be to stimulate neurogenesis.  Chronic low back pain has been reported to cause brain atrophy.  Chronic depression leads to brain atrophy and memory loss with atrophy occurring in the hippocampus, the area essential for memory.  This important publication from Vancouver reviews the topic in great detail and proposes a hypothesis:  Antidepressant effects of exercise: Evidence for an adult-neurogenesis hypothesis?

Further medication is being tested to reduce neuronal cell death that leads to Alzheimer’s Disease, using a very simple compound that blocks free radicals and inflammation.  More on this later.

The material on this site is for informational purposes only, and

is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

Insurance Industry Opposes Physician’s Choice of Medication for Pain Relief

The best or just the cheapest?

Before I define “step therapy,” let me introduce Forgrace.org, a nonprofit organization “Dedicated to Ensuring the Ethical and Equal Treatment of All Women in Pain.”   Based in Los Angeles, the organization was formed in 2002 by John Garrett, Executive Director, and his partner Cynthia Toussaint, an accomplished ballerina who has suffered with CRPS (and later fibromyalgia) for 26 years. Thanks to their leadership advocating for health care reform in California, today they announce that

For Grace and HAAF’s bill, AB 1144, was heard by the California Assembly Health Committee in Sacramento yesterday (April 21) and it passed overwhelmingly with a vote of 14-2.  There was strong opposition from the health insurance industry – and this effort will be an uphill climb as we move the bill along to the Senate.

Also, today, ABC News national covered the issue of “step-therapy” (also known as “fail first”) along with our bill, that if signed by Gov. Schwarzenegger, will abolish this unethical prescription practice that negatively impacts women in pain.  Ms. Toussaint pitched this story, consulted and interviewed for it.

Because of its importance to every single one of my patients whose lives hang by the constant threat of an indifferent refusal by insurance carriers to continue providing medication that they require, I am posting almost the entire ABC News article titled “Patients Irate With Insurers’ ‘Fail First’ Policy“ by Dan Childs

What Is Step Therapy?

The basic idea behind step therapy is to start with the most cost-effective and safest treatment, progressing to more costly or risky therapy only if the current treatment is not effective. In theory, proponents say, the strategy both minimizes risks to the patient and keeps overall costs under control.

Robert Zirkelbach, spokesman for America’s Health Insurance Plans, said that when it comes to the bigger picture, step therapy is a key element in making the country’s health care system more efficient by creating a standard system of care from state to state. He said that this saves costs, and it also ensures that patients get access to therapies that have been proved to be medically effective.

“We see individuals with the exact same illnesses get drastically different treatment depending on where they live,” he said. “Right now there is no correlation between the money being spent and the health outcomes being advanced. Our goal is to help guide the patient.”

Dr. Forest Tennant, head of the Veract Intractable Pain Clinic and editor of the trade magazine Practical Pain Management, is also Cook’s doctor. He agreed that in theory, step therapy is not a bad strategy. And he added that doctors have traditionally employed a form of step therapy, in which they would gradually increase the dose of a given medication for a patient who was not responding until they were able to achieve the desired effect.

Doctors Employ Different ‘Step Therapy’

And even when it comes to designing a course of treatment, Tennant agreed that a cheaper approach is preferable, as long as it works for the patient.

“Given the cost of some of the medications I prescribe, I also want the patient to try the cheaper medication first.”

But he said that the step therapy used by the health insurance industry is different in that it may actually place a preferred therapy out of reach of a patient. Particularly vulnerable may be pain patients like Cook and Toussaint, who have experienced success with a given medication but are switched to a different drug by an insurer.

“What we have today is a situation where a patient is knocked around in the system, usually after they’ve already tried something that works for them but which they can’t have,” he said. “All of a sudden, the drug that they have been taking for quite some time is pulled away from them — because it is more expensive, usually.

The Best — or Just the Cheapest?

To view some of Ms. Toussaint’s presentation to the media, including her “fail first” experiences… on the second page of their “Videos” go here.

Her focus has now shifted to bringing a single-payer, universal health care plan to all in California which will provide a model for the rest of the country.

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

I don’t know how the Great Recession may be affecting your mood, but for those with chronic pain, it is often difficult to nurture and maintain a positive attitude.  Especially at times when we need the most help, we may be most reluctant to appreciate the benefits of Cognitive Behavioral Therapy, but that’s how we get help to reorder our thoughts in positive ways that are healing.  London’s syndication, The Independent, reviews recent research that tells us how much our attitude is harming ourselves.  Don’t forget, it harms everyone you love and constricts their lives too.  But the right frame of mind can lower your pain and other health risks.

PAIN

People showing dispositional optimism may be better able to cope with pain and need less medication. A study at Michigan State University on cancer patients shows that those who were more optimistic tended to report less severe pain. A study at the University of Alabama showed that patients who were optimistic used less medication for pain relief. “More optimistic adolescents are better able to match their medication use to their pain severity. Future research should examine how other psycho-social factors might influence pain medication use in adolescents and adults, and clinicians should take into account psychosocial factors when working with pain populations.”

CANCER

Women who are happy and optimistic may have a lower risk of developing breast cancer. The research also show that adverse life events, such as loss of a loved one or divorce , can increase the risk. Results from the study at Ben Gurion University in Israel show that exposure to more than one adverse life event was associated with a 60 per cent increased risk of disease, while happy and optimistic women were 25 per cent less likely to have the disease. “A general feeling of happiness and optimism seems to play a protective role,” say the researchers. “The relationship between happiness and health should be examined in future studies and possible relevant preventive initiatives should be developed,” say the researchers.

MORTALITY

A review of research into the association between positive wellbeing and mortality shows a signifciant link. The University College London analysis of 35 studies showed that positive psychological wellbeing was associated with an 18 per cent reduced mortality in healthy people and a 24 per cent lower risk in sick people. “Positive feelings – emotional well-being, positive mood, joy, happiness, vigour, energy – and life satisfaction, hopefulness, optimism, sense of humour, were associated with reduced mortality. Results suggest that positive psychological wellbeing has a favourable effect on survival in both healthy and diseased populations.

HEART DISEASE

The positive-minded have a 55 per cent lower risk of dying from heart disease, according to the results of a study which followed 500 men aged 54 to 84 for 15 years. “Our results demonstrate a strong and consistent association between dispositional optimism and lower risk of cardiovascular mortality,” says the researchers from The Netherlands Institute of Mental Health, Delft. Just how low optimism may lead to cardiovascular death, is, say the authors, an intriguing, but unanswered question. One possible mechanism, they say, is that optimism is related to better coping behaviour. Another study at the University of Pittsburgh, and based on 200 women diagnosed with thickening of the arteries, showed that over a 15-year period, the disease progressed more slowly in those women classed as optimists. Other research has shown that optimists have a lower risk of rehospitalisation after coronary artery bypass graft surgery.

The article also covers the field of research as it applies to blood pressure, longevity, infections, even the common cold……..

Practice makes perfect.  Take time out to give yourself some love.  Doctors too.

And read Diana’s blog to see how the addition of 3 kittens have added so much to her family’s mood.  Even if you can’t have a pet, you can still enjoy a friend’s.

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

Desert Fairy Duster

This Medical Library may be helpful to you, allowing you to search for the explanation of Medical Conditions, Medications, Procedures, Tests, and general questions.  Most of those are self explanatory with the exception of the last category, general questions, were you will find:

Advance Directives & Do Not Resuscitate Orders Handout

[Advanced Directives by State   -   End of Life Choices: CPR & DNR   -   Tool Kit for Health Care Advanced Planning  -  Alternative & Complementary Therapies]

Brain & Nervous System

Caregiving a parent with dementia

Caregiving a person with Multiple Sclerosis

Clinical Research Protocols

First Aid including CPR

First Aid for Seizures

Smoking Cessation

Overall this is a useful site and I am happy to make it available in one place though I may not agree fully with everything it says.

It saves time with topics linking you to such places as Merck Manual, Medline Plus, government sites, Medical Centers and NIH where they are recruiting for research protocols, American College of Emergency Physicians, National Hospice and Palliative Care Organization, Family Caregiver Alliance, American Bar Association Commission on Law & Aging, National Center for Alternative and Complementary Medicine, and many many others.   In sum, good people. Useful.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

This service should not be used in place of a visit, call, consultation with or the advice of your healthcare provider.

Communicate promptly with your provider with any health related questions or concerns.

Tidy Tips - a desert flower

Posted in Advanced Directives, Caregiving, DNR, Epidural Injections, First Aid, Medical Conditions, Medications, Nerve Blocks, Procedures, Research, Smoking Cessation, Tests, Vitamins & Herbs Tagged: Advanced Directives, Caregiving, Conditions, DNR, First Aid, Medical Library, Procedures, Research, Smoking Cessation, Tests ]]> http://painsandiego.com/2009/04/22/medical-library/feed/ 0 painsandiego desert-fairy-duster tidy-tips-desert-flower1 http://painsandiego.com/2009/04/19/lumbar-epidural-injections-sympathetic-nerve-blocks/ http://painsandiego.com/2009/04/19/lumbar-epidural-injections-sympathetic-nerve-blocks/#comments Sun, 19 Apr 2009 07:39:46 +0000 Nancy Sajben MD http://painsandiego.wordpress.com/?p=403 ]]> Nerve Block Therapy for Low Back Pain: Show Me the Money and the Science, is the title of an article published in 2002, in the American Pain Society journal Pain.  The author reviewed current studies and questioned the value of lumbar epidural injections and sympathetic nerve blocks.

The scientific evidence to prove efficacy simply was not there.  More importantly, even with fluoroscopy and accurate placement of the needle, the solution reached the desired area only 26% of the time.  The author called for research to test efficacy.

From the current review, we must conclude that lumbar epidural steroid injections and sympathetic nerve blocks produce a large amount of money, with very little science to support their application. Does this mean they are useless? Obviously not; these techniques have some value in acute pain management and should not be completely abandoned. However, their use as a mainstream ( almost knee-jerk ) intervention for acute or chronic low back pain does not appear to be at all justifiable at the scientific level.

The fundamental recommendation is quite obvious. Those pain specialists who use these techniques on a regular basis need to support and initiate some clinical research trials that adequately test these procedures’ efficacy. Without this, the routine application of epidural steroid injections and lumbar sympathetic nerve blocks for acute or chronic low back pain is not evidence based. Therefore, when can it be recommended remains an empirical question.

More recently in March 2007, the American Academy of Neurology studied the issue in depth and published  Practice Guidelines on the Use of Epidural Steroid Injections to Treat Radicular [sciatic] Lumbosacral Pain.

They also found no Level A quality research and did not recommend routine use:

Based on the available evidence, the Therapeutics and Technology Assessment subcommittee concluded that

1) epidural steroid injections may result in some improvement in radicular lumbosacral pain when assessed between 2 and 6 weeks following the injection, compared to control treatments (Level C, Class I-III evidence). The average magnitude of effect is small and generalizability of the observation is limited by the small number of studies, highly selected patient populations, few techniques and doses, and variable comparison treatments;

2) in general, epidural steroid injection for radicular lumbosacral pain does not impact average impairment of function, need for surgery, or provide long-term pain relief beyond 3 months. Their routine use for these indications is not recommended (Level B, Class I-III evidence);

3) there is insufficient evidence to make any recommendation for the use of epidural steroid injections to treat radicular cervical pain (Level U).

This subject will be an intense topic of interest for the Anesthesiology Subcommittee at the annual meeting of the American Pain Society that meets in San Diego May 2009.   At best, epidural injections and nerve blocks are temporizing measures.  If the first one is less than effective, they are often done in a series of three.  One risk of frequent steroid injections is osteoporosis.

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

If you know the name of the photographer I will happily post the name here for attribution.

Posted in Back Pain, Chronic Pain, Epidural Injections, Nerve Blocks, Procedures Tagged: Back Pain, Epidural Injections, Nerve Blocks, Procedures ]]> http://painsandiego.com/2009/04/19/lumbar-epidural-injections-sympathetic-nerve-blocks/feed/ 2 painsandiego lion-cover http://painsandiego.com/2009/04/18/poetry-of-pain/ http://painsandiego.com/2009/04/18/poetry-of-pain/#comments Sat, 18 Apr 2009 08:46:39 +0000 Nancy Sajben MD http://painsandiego.wordpress.com/?p=300 ]]> There is a pain — so utter

There is a pain — so utter –

It swallows substance up –

Then covers the Abyss with Trance –

So Memory can step

Around — across — upon it –

As one within a Swoon –

Goes safely — where an open eye –

Would drop Him — Bone by Bone.

∞

Pain—expands the Time

Pain—expands the Time—

Ages coil within

The minute Circumference

Of a single Brain—

Pain contracts—the Time—

Occupied with Shot

Gamuts of Eternities

Are as they were not—

After Great Pain, a Formal Feeling Comes

After great pain, a formal feeling comes

The Nerves sit ceremonious, like Tombs

The stiff Heart questions was it He, that bore,

And Yesterday, or Centuries before?

The Feet, mechanical, go round

Of Ground, or Air, or Ought

A Wooden way

Regardless grown,

A Quartz contentment, like a stone

This is the Hour of Lead

Remembered, if outlived,

As Freezing persons recollect the Snow

First-Chill-then Stupor-then the letting go

∞

Pain — has an Element of Blank –

Pain — has an Element of Blank –

It cannot recollect

When it begun — or if there were

A time when it was not –

It has no Future — but itself –

Its Infinite contain

Its Past — enlightened to perceive

New Periods — of Pain.

∞

The Master

He fumbles at your spirit
As players at the keys
Before they drop full music on;
He stuns you by degrees,

Prepares your brittle substance
For the ethereal blow,
By fainter hammers, further heard,
Then nearer, then so slow

Your breath has time to straighten,
Your brain to bubble cool,–
Deals one imperial thunderbolt
That scalps your naked soul.

When winds take Forests in their Paws–
The Universe is still.

∞

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

This is a Cinderella story that will melt the most cynical heart.

Susan Boyle, the British singer, is an instant sensation!

Over 85.2 million viewers have seen her on YouTube in just one week – a record -

to watch her sing “I Dreamed A Dream“ from Les Miserables.

Born with brain damage, she was taunted all her life because she is slow.

Asked how she had the confidence to sing in front of a large audience, she says:

” I just had the ability to keep going.  You have to keep going.”

~~~~~~~~~

…..a beautiful, inspiring video

of Nick Vujicic, born with no limbs, speaks to students

whose tears run down their cheeks, whose love pours out to him.

Nick has found the purpose of his life and has become strong

through the agony of learning how to overcome what had defeated him from birth.

The miracle we are looking for is inside each of us.·

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

Posted in Anxiety, Depression, Inspiration, Music Tagged: Anxiety, Depression, Inspiration ]]> http://painsandiego.com/2009/04/18/290/feed/ 0 painsandiego keep-calm-and-carry-on http://painsandiego.com/2009/04/17/vitamins-and-herbs/ http://painsandiego.com/2009/04/17/vitamins-and-herbs/#comments Fri, 17 Apr 2009 19:49:21 +0000 Nancy Sajben MD http://painsandiego.wordpress.com/?p=228 ]]>

Rum Soaked Salmon with Apple Ginger Puree from Dan Atkinson's Salmon House on the Hill Cookbook

Most doctors have little if any training in vitamins and supplements

except as they relate to their specialty.

My field of neurology concerns itself with metabolic and nutritional diseases more than most areas of expertise, and I have an interest in several vitamins because of research related to major causes of mortality in the United States.

During the period I taught at a cancer center, I was concerned that research protocols may be misleading as these supplements were not accounted for, however since that time in the mid 90’s, I’m glad that public interest has pushed this field into the fore.  Major cancer centers now have active research in Complementary and Integrative Medicine (CAM) because there are risks and benefits, and some have significant herb-drug interactions as discussed below.

Check your vitamins and supplements for toxicity

Because of the growing science on toxicity, usefulness, and drug interactions, if you use vitamins, review each one carefully with your physician and with the websites listed in the column on your right. Some “vitamins” are simply brand names that have over 20 different vitamins, minerals and various ingredients.  This means you must review each one for current research benefits and risks.

At special risk for vitamin deficiencies are those who have highly restricted diets, abdominal resection, intestinal conditions, colitis, Celiac Disease, gastric bypass, HIV, or the elderly.

Pregnant women have special needs that are essential not only for their own health but to reduce the risk of neurological defects in the fetus.  It is essential in their case to work closely with their obstetrician, especially if morning sickness prevents them from taking their daily supplement.

Resources

One of the best resources I have found is Memorial Sloan Kettering Cancer Center’s Herbs and Botanicals, also linked on the column at right.  Their website is updated frequently with an excellent review of the literature.  It is hosted by a senior physician who has specialized in the field for decades and is actively involved in research at their center as well as NIH.

MD Anderson Cancer Center’s Complementary/Integrative Medicine Education Resources website and Columbia University’s Rosenthal Center for Complementary and Alternative Medicine are two others, but there are other resources on the web and books that are excellent.

Recipe for Rum Soaked Salmon with Apple Ginger Puree is found here.

VITAMINS & SUPPLEMENTS

Vitamin D has become a major research topic in recent years.  It may play a more important role than any listed below.   I have written separately on it and its controversy in greater detail.  Please refer to the last post by scrolling down.

Fish Oil

Omega 3 Fish Oils are polyunsaturated fatty acids that are essential for health yet cannot be made by the body.  Unless you eat several servings per week of fatty fish or wild salmon, not farmed salmon, it is one of the most important supplements that any adult of any age can take.  They are needed for building cell membranes in the brain but our body does not make them.   Fish oil helps your lipid profile by reducing triglycerides as much as 45%.  It reduces platelet clotting, lowers risk of heart attack and cardiac arrhythmia, and is an important anti-inflammatory reducing pain for many particularly those with arthritis.  One of the best references on Omega 3 Fatty Acids is by  Dr. Frank Sacks, Professor of Cardiovascular Disease Prevention, Department of Nutrition, Harvard School of Public Health.   He mentions high doses “are used to treat depression. New studies are identifying potential benefits for a wide range of conditions including cancer, inflammatory bowel disease, and other autoimmune diseases such as lupus and rheumatoid arthritis.”

One high quality fish oil, Lovaza, has been approved by the FDA and is prescription only.  Fish oil and cod liver oil available over the counter should be checked for adequate dosages of EPA and DHA that will vary with your needs as determined by your lipid profile, and should be purified to remove cholesterol, dioxin, PCB’s and other pesticides.

Co-Enzyme Q10 is also called CoQ10.  CoQ10 is present in every cell of the body which is why it is also called ubiquinone.  It is important in the electron transport chain to produce intracellular energy.

Statins deplete CoQ10. Vitaline’s CoQ10 product has been used in NIH funded trials for cardiovascular, neurological and brain disorders. Two mitochondrial disorders have been shown to benefit from Co-Q10: migraine and Parkinsons Disease.

My preferred manufacturer is Vitaline because of their research with NIH which requires that they validate and verify dosages.  Their website discusses other advantages and gives guidance on dosages that have shown benefit for various conditions. They offer a discount of 25% if you request scheduled delivery every 3 months.  Use the code code DEF25.  Their product is in the form of wafers that are about the size of a quarter and are very easy to break into 2 or 4 with your hands.

Vitamin B supplements in the elderly may help reduce the risk of dementia and B12 deficiency may result in neurological conditions such as peripheral neuropathy, dementia, hematologic and psychiatric disorders, Subacute Combined Degeneration of spinal cord & brain, increased fracture risk, and may increase the risk of cardiovascular diseases.  A good B complex vitamin is not likely to harm and may benefit.    The best source of all is food:  leafy green vegetables, beans and peas.

B Vitamins

Thiamine (Vitamin B1) in high doses of 300 mg per day may reduce kidney disease in type 2 diabetes and may prevent early diabetic cardiomyopathy (heart disease).  As many as 70% to 90% of people with diabetes, both type 1 and type 2, are thiamine deficient.  The research is still a little early to draw firm conclusions.  It is being done by Charity Diabetes UK which finds that “thiamine works by helping protect cells against the harmful effects of the high blood sugar levels.”

Vitamin A is associated with a 45% risk of hip fracture.  There are four major adverse effects of high levels: birth defects, liver abnormalities, reduced bone mineral density that may result in osteoporosis, and central nervous system disorders.

Vitamin E may actually increase mortality and there are significant risks to its use including increased risk of some cancers.  Several studies were reviewed by one of the foremost science writers, Jane Brody, in the New York Times on March 23, 2009.  It does not reduce the risk of cardiovascular disease, stroke, dementia, mild cognitive impairment, and there is no evidence that it slows the progression of macular degeneration.  In the Physicians’ Health Study II it has been shown to actually increase the risk of hemorrhagic stroke since it decreases the clotting tendency of blood.

Vitamin C was recently shown to markedly increase the growth of cancers. It’s healthy for them too.  It blunts the effect of cancer drugs by as much as 30 to 70% depending upon the drug tested.

Zinc may prevent the absorption of copper which is necessary for the brain and spinal cord thus resulting in progressive neurological conditions.  Herb-drug interaction reduces the bioavailability of some antibiotics, tetracycline and fluoroquinolones.  Intake of 100-300 mg/day may result in chronic toxicity including copper deficiency, depressed immune function, headache, chills, fever, and fatigue.  It concentrates in the prostate and consumption of more than 100 mg per day may increase risk of prostate cancer.

It may be useful for tinnitus and for short term use to reduce symptoms of the common cold when used topically or in lozenges

HERBS & BOTANICALS

Don’t forget seeds, beans and whole grains that help digestion and keep the system moving!

This is a very brief summary of a few of the more commonly used herbs.  Please refer to Memorial Sloan Kettering Herbs and Botanicals website for detailed information on risks and benefits.

Arnica – a topical anti-inflammatory may help sprains and osteoarthritis.

Aloe Vera – apply immediately after sunburn or burning the skin to prevent blister formation

Chamomile – calming sedative, may use for intestinal colic or gas

Cat’s Claw - anti-inflammatory activity may be caused by the inhibition of TNF-alpha production.  It may be useful for refractory oral ulcers of unknown etiology in persons with HIV/AIDS that have not responded to other known remedies.

Echinacea may shorten the duration of common cold, useful in sinusitis, and respiratory infections.  Because of the lack of standardization of various products, I recommend a high quality organic liquid product by HerbPharm. Avoid use in autoimmune conditions, Multiple Sclerosis, HIV/AIDS.  “Echinacea was shown to stimulate phagocytosis, enhance mobility of leukocytes, stimulate TNF and interleukin 1 secretion from macrophages and lymphocytes, and improve respiratory activity… both in vitro and in vivo.”

Goldenseal is anti-inflammatory, antimicrobial with activity against pathogens such enterotoxigenic E. coli and V. cholera that may be useful for bacterial sinusitis and respiratory infections.   Warning it may prolong the QTc interval in persons with heart disease or those on methadone and it is contraindicated in persons with hypertension.  A high quality organic liquid product is made by HerbPharm.

Red Yeast Rice, a naturally occurring statin, the same as Lovastatin, often used in China.   Make sure your doctor knows this and monitors liver function.  Statins may cause severe muscle and joint pain that may potentially lead to rhabdomyolysis (sudden death of muscles), kidney failure, vasculitis, lupus-like syndrome, and many other symptoms, however most people tolerate them without side effects and they have dramatically reduced the incidence of heart attacks and stroke.  They may also reduce the risk of dementia including Alzheimer’s type dementia.

Turmuric (Curcumin) – may alleviate irritable bowel syndrome and ulcerative colitis.  There is a suggestion of improved cognitive performance from epidemiology studies but studies show no benefit for Alzheimer’s Disease.  Avoid use if you have gallstones.  It may inhibit the action of some chemotherapy drugs, such as used for breast cancer, but may be beneficial for certain cancers and other chemotherapy drugs.

Wheat grass- a natural source of vitamins and minerals (Chlorophyll, Vitamins A, C, E, K and B-complex, Iron, Calcium, Magnesium,  Selenium,  Amino acids); may have antioxidant effects.

Willow Bark – contains salicin, the precursor of aspirin

Arnica

The Sunshine Vitamin Controversy

What should normal values  be for calcium homeostasis?

My attention was drawn to Vitamin D several years ago when a review appeared in the journal Neurology, published by the Academy of Neurology, that linked low levels of Vitamin D to Multiple Sclerosis.  The article was unusual for its length and the breadth of research cited over several decades.  More recently, a Johns Hopkins article published “the most conclusive evidence to date” that Low Vitamin D Levels Pose Large Threat to Health.

New publications on Vitamin D seem to appear every week with the focus on levels of 25-hydroxyvitamin D, also written as 25(OH)D. Its half life in serum is ~ 10 days to 3 weeks.

The biologically active form 1,25-dihydroxyvitamin D, written as 1,25(OH)D²,  is made in the kidneys and has a much shorter serum half-life of ~ 4-6 hours, thus making it less useful as a serum marker for measuring.

Sources & Metabolism: Vitamin D is a fat soluble vitamin that’s absorbed in the small intestine from  foods such as egg yolks, fatty fish, fish liver oils, fortified milk, margarine, and cereals.  Bile salts are required for absorption.  Sunlight stimulates the skin to synthesize vitamin D, but exposure of hands and face as little as 15 minutes may not be sufficient and it is not as effective for everyone.  It won’t work in winter months, it won’t work for the aged, for those who have pigmented skin, and it won’t work for those who cover their skin.

Vitamin D Metabolism

The Controversy –  How Do We Determine Normal Values?

Surprisingly, in a well designed multicenter study of healthy young Hawaiians in their 20’s who were exposed to at least 29 hours of sun per week, 51% were found to have vitamin D deficiency using the usual cut off of 30 ng/ml for normal.  This study from 2007 found the mean concentration of 31.6 ng/ml, and the highest of 62 ng/ml.  It raises the question whether

“it seems prudent to use this value [60 ng/ml] as an upper limit when prescribing vitamin D supplementation,”

rather than the generally published normal range of 30 to 80 ng/ml or even 100 ng/ml quoted in some labs.  This study is important in discussing the controversial question of what normal values should be for calcium homeostasis and reviews several possible explanations for inadequate production of D3 including genetic differences.

They note the highest reported values in “Nebraska outdoor workers… were between 81 and 84 ng/ml” but the assay system differed compared to theirs and results in a higher value.   Reviewing this study that was published in the Journal of Clinical Endocrinology & Metabolism has allowed me just now to readjust my own patient practice.

Laboratory Testing:  results can differ from one laboratory to another.  My hospital sends specimens to ARUP for testing, whereas Quest has acknowledged errors in laboratory testing and problems with standardization as reported by the New York Times here.

Function:  It is important for absorption of calcium and phosphorous from the small intestine, for bone health, osteoporosis, risk of falls, certain cancers(colon, breast, prostate), and possibly 6 to 7 years of longevity.  Deficiency of vitamin D is associated with suboptimal health and possibly increased pain; it is linked to infections, gum disease, hypertension, diabetes, coronary disease, neurological diseases such as Multiple Sclerosis, Parkinson’s Disease, dementia and Alzheimer’s Disease though it may not be causal. Its receptor is found all over the body including the brain.

I recommend this review by one of the best web resources at Memorial Sloan Kettering Cancer Center Herbs & Botanicals.

They quote a reference showing it reduces postmenopausal weight gain and “In adults with impaired fasting blood glucose, giving calcium and vitamin D reduced increases in plasma glucose and insulin resistance….”

It is the only vitamin that is a steroid hormone, and my interest increased on learning that it functions as an anti-inflammatory.  But as I tested blood levels for 25(OH) vitamin D and parathyroid hormone (PTH), I discovered more than 90% of my patients had vitamin D deficiency and a few had hyperparathyroidism.  There are four parathyroid glands next to the thyroid, and for some reason doctors have rarely tested their hormone levels.

***Persons with hyperparathyroidism should NOT take calcium or vitamin D.

It may lead to kidney stones and bone pain:  stones, bones and groans.***

Evidence for Optimizing Vitamin D Concentrations

On the other hand, if vitamin D is low, there is some evidence that replacement with vitamin D3 so that blood levels are in the high normal range, may help pain.  That is, it may raise the pain threshold and possibly have other benefits for health and longevity. It is desirable to avoid toxic levels of D as it causes hypercalcemia with depression, drowsiness, weakness, headache, polydipsia,  bone loss, and metastatic calcifications of many organs, soft tissues and blood vessels.  The generally quoted range of normal for 25(OH) vitamin D is 30 to 80, that varies with the lab.

Doesn’t that photo of the Great Western Divide make you want to get outside into the sun?

Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes was reviewed by Heike Bischoff-Ferrari et al, in 2006,  though it has been superseded by much additional work since then.

To quote from their article:

This review summarizes the evidence for optimal serum  25(OH)D concentrations. The endpoint selection for this review was based the strongest evidence to date—ie, that from RCTs [randomized controlled trials], consistent evidence from prospective and cross-sectional epidemiologic studies, and strong mechanistic evidence or dose response relations.  BMD [bone mineral density], fracture prevention, lower-extremity function, falls, oral health, and colorectal cancer met these criteria. Weaker evidence exists of a beneficial effect of vitamin D on other diseases, including multiple sclerosis (15), tuberculosis (16), insulin resistance (17, 18), cancers other than colorectal (19 –22), osteoarthritis (23, 24), and hypertension (25–27), but these diseases are not considered here.

They did not review pain studies.  I would add that “weaker” evidence merely means that it must be confirmed by more studies, not that it excludes those conditions.  There is an epidemic of vitamin D deficiency in the country, and the incidence is very high in pain clinics as reported in several studies.

A new multi-center epidemiology study  ”Demographic Differences and Trends of Vitamin D Insufficiency in the US Population, 1988-2004“  by Ginde, et al, in 2006,  ”demonstrate a marked decrease in serum 25(OH)D levels from the 1988-1994 to the 2001-2004 NHANES data collections.”  And like others before them, they point out:

“Current recommendations for vitamin D supplementation are inadequate to address the growing epidemic of vitamin D insufficiency.”

Summary:

Make sure your doctor checks both your 25(OH)Vitamin D and parathyroid hormone level (PTH) – not thyroid – to determine if you have hyperparathyroidism or if you have normal or low vitamin D.  That will determine if you need replacement or if you should stop using calcium and D as it will cause kidney stones and calcium deposits on your bones leading to pain.

If vitamin D levels are low it may result in increased physical pain and may cause or aggravate many medical conditions.

If PTH levels are high indicating hyperparathyroidism it will cause new painful conditions.

Intake does vary with the patient, the season, the age, but the recommended daily allowance may perhaps be double what it is now.  It is unclear when the federal government will adjust that dosage.   As always, your physician’s recommendation will be based upon blood levels of 25(OH)D and PTH.

Do not make changes in your dosage without careful evaluation.

Could this possibly be one of the most important areas of research this century?

The material on this site is for informational purposes only, and

is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~

Chronic pain is often much more difficult to treat than cancer pain.  It is tragic that < 1% of NIH budget goes for pain research, though 10 to 20% of the population in the US suffers from chronic pain, an estimated 60 million Americans, and the conditions are more prevalent among the elderly.  Persons of all ages that I see tend to be more debilitated, often with anywhere from 3 to 11 different identifiable pain syndromes.

Many, including physicians, mistake pain as a symptom, failing to understand the reorganization that has occurred in the central nervous system due to neuroplasticity; and they overlook the associated comorbidity causing insomnia, weight gain due to medication or inactivity, depression, anxiety, spiritual and financial burdens.   The lives of families and friends are diminished along with the person who has pain.

In the future, as time permits, I’ll be adding publications and articles to the site and occasionally posting with a frequency yet to be determined, hopefully twice a month.

Goals:

• This website is dedicated to providing educational resources to patients and healthcare professionals regarding the current understanding of pain medicine, an interdisciplinary field
• The intention is to discuss evidence-based information to improve the lives of patients who choose to use these therapies under the direction of informed physicians
• To distinguish between harmful treatments, beneficial treatments, and treatments that can be safely integrated with conventional treatment
• To encourage communication between patients, families and providers
• To educate both patients and health care providers who need a more comprehensive knowledge base with current and accurate information
• To promote ongoing professional growth through networking in a setting where treatments can be examined together to enhance lives

Please bear in mind, no information in this blog is intended to diagnose or treat any condition.

The opinions expressed here are my own, and are subject to change as new research becomes available.

I hope you enjoy this beautiful music:

Show Me

by John Legend

Oh God of love, peace, and mercy, why so much suffering?

Join me on this journey……