Haunted by the dirty work of managed care & that deadly piece of paper: “Denied”

06/17/2009 — Nancy Sajben MD

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“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 The law has not been repealed, but — here’s the clincher — the law has “collapsed into unenforcibility.”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

("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

Condor

Posted in Controversy, Insurance, Liability, Medications, Politics of Pain. Tags: , . 1 Comment »

Opioids Create Pain via Molecular and Genetic Changes

06/16/2009 — Nancy Sajben MD

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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.

Mt Rainier & Wildflowers

Posted in Hyperalgesia, Medications, Opioids, Research. Tags: , . 1 Comment »

FDA Restricting Opioids, Patients Lose – NIH Does Not Fund Pain Research – No Access to Nonopioid Treatment

06/13/2009 — Nancy Sajben MD

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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

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 Aurora Borealis greenneuropathic 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!

Cloud

Posted in Chronic Pain, Controversy, Epidural Injections, Hospice, Medications, NSAIDs, Nerve Blocks, Pain Management, medicine, Politics of Pain, Procedures, Research. Tags: , , , , , , , , , , , , , . 4 Comments »

Protected: Ketamine

05/26/2009 — Nancy Sajben MD

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“Heavy NSAID Use Linked to Higher Dementia Risk” – Exercise, Antidepressants Both Help Neurogenesis

04/24/2009 — Nancy Sajben MD

NSAIDs are anti-inflammatory drugs used to treat pain, inflammation, or fever.  The only NSAIDs that are NOT associated with increased risk of heart attack or arrhythmia are naproxen (Aleve) or aspirin.  Taking high doses of aspirin has a greater risk of GI bleed than naproxen, which is why I usually recommend naproxen.

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.


methusala-tree

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!

Posted in Antidepressants, Dementia, Exercise, Medications, Memory Loss, NSAIDs. Tags: , , , . Leave a Comment »

Medical Library

04/22/2009 — Nancy Sajben MD
Desert Fairy Duster

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.

~~~~~~~~~


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

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. Tags: , , , , , , , , , . Leave a Comment »

Vitamins and Herbs – Risks and Benefits

04/17/2009 — Nancy Sajben MD

Rum soaked salmon with apple ginger puree from Dan Atkinson's Salmon House on the Hill Cookbook

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.

Vitamin B

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!

seeds-beans

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

Arnica

Posted in Controversy, Medications, Mortality, Recipes, Toxicity, Vitamins & Herbs. Tags: , , , . 2 Comments »