Be the change you wish to see – or walk away. Money at NIH


 

 

A Turning Point

 

$$$$$ MONEY $$$$$

 

at NIH

 

May not come this way again

 

NIH developing

5-year NIH-wide Strategic Plan

 

 

 

Donate to organizations, below

They can provide feedback to NIH via the

RFI Submission site


 

 

 

John C. Liebeskind, 1935 – 1997, distinguished scholar and researcher, past president of the American Pain Society, had the radical idea that pain can affect your health.

 

Research decades ago by an Israeli team at UCLA and others had shown “that pain can accelerate the growth of tumors and increase mortality after tumor challenge.” Decades ago Professor Liebeskind lectured all over the country: Pain kills.

 

He wrote an editorial in 1991, summarizing a life’s work:

 

“Pain and stress can inhibit immune function.”

 

 

Quoting John Bonica, the father of modern pain management, he wrote:

 

“Bonica has long argued that the term ‘chronic benign pain’ (used in distinction to pain associated with cancer) is seriously misleading.  Chronic pain is never benign, he contends; “it is a ‘malefic force’ that can devastate its victims’ lives and even lead to suicide.”

 

 

Liebeskind continues, “It appears that the dictum ‘pain does not kill,’ sometimes invoked to justify ignoring pain complaints, may be dangerously wrong.”

 

Pain mediates immune function

 

Importantly

 

  Opioids mediate the suppressive effect of stress on natural killer cells,

 

 published in 1984, immune system.

 

Alcohol increases tumor progression, 1992, immune system.

 

It used to be news.

He did not live to see change.

 

People just want to go on doing what they’re doing.

They want business as usual.

 

 

After 1991, we saw the great discoveries of neuroinflammation, pioneered by Linda Watkins, PhD, the early understanding of the innate immune system, its involvement in chronic pain and depression, and a few weeks ago, a British team showed neuroinflammation in teens with early signs of schizophrenia and DNA markers.

 

 

Major Depression has the same neuro-inflammation found in chronic pain, often responding to same medications, in particular glial modulators – immune modulators. Now, perhaps early schizophrenia will respond to glial modulators, reducing inflammation seen on scan in teens, before they become homeless and burned out by antipsychotic drugs

 

Inflammation out of control destroys neurons

 

Fire on the brain

 

 

We must be the change we wish to see

 

It’s not just the Bern. It’s been starting. Forces are finally coming together. We want change. It’s been too much. Too long.

 

We won’t take it anymore.

 

I figure if I tell you about it, you might just mention it to someone to pass it on. That is all. One small action may lead to change. Activate inputs to the NIH strategic plan.

 

 

~ Action needed ~

 

Prices of drugs becoming unaffordable

No new drugs for pain or major depression

Research to repurpose existing drugs

Expose the politics destroying our compounding pharmacies

 

Above all

The #1

Major Priority:

Request NIH to solicit priority call for research on

Glial modulators of the

Innate immune system

 

 

Why?

 

Glia modulate

chronic pain, major depression

and almost every known disease

 

Glia are your innate immune system

 

Inflammation kills

 

 

 

 Stress kills. Inflammation kills.

 

 

Pain kills

 

In the 1970’s, Professor Liebeskind and an Israeli team at UCLA injected cancer cells to two groups of rats that had sham surgery. Cancer spread much faster and killed far sooner in the group with poor treatment of surgical pain.

 

 

~ Pain kills ~

 

He lectured all over the country

 

Forty five years ago

 

 

I’m gonna be dead before I see this country do anything but unaffordable opioids and the magical ineffective trio of gabapentin, Lyrica, Cymbalta to treat chronic pain. The devastating, blind, nationwide emphasis does nothing to address the cause: inflammation, the innate immune system gone wild.


 

 

Innate immune system in action

 

Untreated pain suppresses the hormone systems too.

 

Untreated depression – same inflammation kills lives.

 

Where’s the money?

 

We are the change we wish to see. It’s pitiful I am so lazy. Suddenly, too late, we may need something, but, aha, no new drugs in the pipeline.

 

 

 

~ Make a joyful cry to NIH ~

 

They are soliciting input from professional societies

 

If your condition has failed all known drugs for pain or major depression, then make a joyful cry to NIH, now, before they give away all that nice new $$$$$money$$$$$.

 

 

Follow and join

 

American Pain Society

 

 

International Association for Pain

celebrating 40 years of pain research

 

 

Reflex Sympathetic Dystrophy Syndrome Association

help for CRPS/RSD  

 

 

 

The key to CRPS/RSD pain will apply to all forms of chronic pain, in particular the most difficult form, neuropathic pain. RSDSA funds research into all forms of chronic pain, not only Complex Regional Pain Syndrome (CRPS/RSD). Their scientific board members are not funded by opioid money.

 

 

 

Exactly

what is the annual cost of care

as fraction of GDP

for the growing population of Americans on opioids

for one year, for lifetime?

 

 

People are dying from prescription opioids and those who need them find they don’t work well enough. Prescriptions opioid costs must be a huge fraction of the medical costs in the United States GDP. You are required  to see a doctor every single month each year, often lifelong, just for one opioid, 12 months a year x 30 years x tens of millions of people and increasing – a growth industry. Not even counting $600 a day for the opioid, what the cost of monthly visits for 30 years? Not counting the army of DEA, FDA, CDC agents watching the opioids like a hawk. We all have to be sharp, addiction is growing. Addiction aside, deaths from prescription opioids are shaking up the CDC forcing urgent change this coming month.

 

 

 

Opioids do not work well for chronic pain

We need better

It’s not just the $600/day price

They just don’t work

 

 

donate

 

 

Raise a joyful noise at NIH now or write back at us readers with comments and better suggestions. Tell others what you’d like to see. Which politicians do you know would be most interested in this at national levels and organizations?

 

You may never see this change unless you do it now. Other forces will get this new money.

 

 

Turning point now

May not return

 

 

We are at a turning point and we will fail to catch the sail that’s coming fast to carry all research money in their shiny big stem cell direction. They never look back.

 

 

There is so many medications we can use today, FDA approved drugs that can be re-purposed and applied to recent cutting edge science. Someone must pay to do the work to study this.

 

 

Re-purpose old drugs

 

 

Stanford just showed a popular generic drug improved recovery of stroke paralysis in mice to begin at 3 days rather than 30. Old drug, new purpose, of course more years of testing to confirm in humans. Brilliant team applying new science.

 

 

Request
NIH to solicit a

Special Invitation

for 30 good protocols to

repurpose old drugs

 

 

Hundreds of old drugs, already approved, could be involved in mechanisms we have recently learned about. Speak up or money will go to shiny new stem cells. None for chronic pain or major depression. No company will find this profitable – it must be funded by NIH. A popular generic sleeping pill can bring astonishing return from stroke paralysis.

 

 

Congress has not opened this new money to NIH in many long years. How often will there be extra money?

 

 

donate

 

 

Lawrence A. Tabak, D.D.S., Ph.D.
Principal Deputy Director, NIH, solicits you to

Review the NIH Strategic Initiative Plan and their

Request for Information (RFI) and the NIH website

and provide your feedback via the RFI Submission site

 

 

This is for “stakeholder organizations (e.g., patient advocacy groups, professional societies) to submit a single response reflective of the views of the organization/membership as a whole. We also will be hosting webinars to gather additional input. These webinars will be held in early to mid-August.

 

 

 

Be the change you wish to see

Donate to those organizations

to solicit the change you wish to be

 

 

 

Happy New Year

Rejoice!

There’s money at NIH

 

 

 

 

 

 

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.

Relevant comments are welcome.

If any questions, please schedule an appointment with my office.

This site is not for email.

~~~~~

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

 

 

 

 

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3% of Medical Schools Have a Course on Pain Management


Corrections have been made to my previous post

·

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

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

·

Does Pain Management Have a Place in American Healthcare?

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


·

Symposium on Pain Management Aimed at Medical School Students

·

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

Academic Medicine:
April 2009 – Volume 84 – Issue 4 – p 408
doi: 10.1097/ACM.0b013e31819a8358
Letters to the Editor
·

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.

.

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!

.

.

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


··

The War on Drugs Sold so Well That Persons With Pain

Often Cannot Get Pain Medication or Treatment

·

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.

·

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 M. 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. If not hyperalgesia, the benefit of relief is undercut by the pain they create as shown by recent research on glia. Opioids create pain at the same time they relieve pain.

·

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 help and/or relieve 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.

·

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 or reducing 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.

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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.

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

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Controversy on Medication Coverage – “step therapy” (also known as “fail first”)


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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?

According to data collected in 2006 by the health care analytics company Verispan, the drugs for which step therapy is most commonly used are anti-ulcer medications, with 58 percent of health insurance plans using step therapy for this class. The data also reveal that antidepressants are the fourth most common drugs subject to step therapy, with 45 percent of plans subjecting these to step therapy. Twenty-six percent of plans use step therapy for pain drugs, according to Verispan, and other drugs including heart medications and antipsychotics are also on the list.

Zirkelbach argued that in most cases, patients are allowed to switch drugs if the recommended option is not working for them, and if the drug that the patient is switching to is supported by medical evidence.

“If there is a good medical reason to switch to drug A versus drug B, health plans typically allow that to happen,” he said.

But he noted that how long a patient is required to stay on a given medication before making a switch varies from case to case. Doctors who prescribe a drug that is unapproved by the insurance company risk receiving what Tennant calls a “tantrum letter” from insurance companies.

“The insurance companies hire auditing firms, and they demand to know why I prescribe [patients] certain drugs,” he said.

The net effect, Tennant said, is a grave imposition on the doctor-patient relationship.

“I have to say [to patients], ‘I can’t tell you what you should take. I can only get you to get what your insurance can pay for, and I’ll design a regimen,'” he said. “For the expensive medicine, the doctor no longer chooses what he wants.”

And according to a Thomson Reuters study published in the February issue of The American Journal of Managed Care, step therapy may actually be more expensive for insurance companies, at least when it comes to patients receiving medication for high blood pressure.

Step Therapy May Not Be Cheaper

In the study, which was sponsored by Pfizer, researchers looked at insurance claims for 11,851 people with employer-sponsored health coverage that incorporated a step therapy protocol for high blood pressure drugs. These patients’ claims were compared with those of 30,882 patients on similar medication who did not participate in a step therapy program.

What the researchers found was that the group of patients treated for hypertension under the step therapy program had 3.1 percent lower drug costs. But these savings appear to have been wiped out by the apparent increase in hospital admissions and emergency room visits. Over two years, the step therapy patients incurred $99 more in healthcare costs per quarter, on average, than the control group.

Hope for Step Therapy?

If indeed California passes anti-step therapy legislation, it would not be the first to do so. New Jersey already prohibits such plans. And even the Centers for Medicare and Medicaid Services may be considering regulations to limit step therapy by health plans available to Medicare patients.

But Robert Taketomo, president and CEO of the Glendale, Calif.-based managed care contracting services organization Ventegra, warned that if such legislation passed in the state, patients may find that other parts of their coverage will be cut back to compensate.

“As long as healthcare is a benefit, and not a right, then measures such as step therapy are important means of preserving pharmacy benefits,” he said. “If step therapy were to be prohibited through legislative means, there are other means through which a payor — whether they be government, health insurer or employer — could limit their cost exposure in pharmacy.

“These could include removal from formulary, increases in copayment, addition of deductibles (and increasing them), or ‘carving out’ pharmacy altogether and just cover medical expenses.”

Tennant said he believes the true solution to the problem does not lie with new laws.

“There has to be some goodwill meeting of the minds for the people who practice medicine, those who need the help, and the people who are paying for it,” he said. “Most of the [insurance companies] are trying to develop formularies comprehensive enough to get the job done without compromising patient care too much.”

But Cook said that as long as her insurance adheres to a step therapy policy, she and other pain patients will worry about her medication one day becoming unaffordable.

“We all know that our lives could change at a moment’s notice if the insurance companies say, ‘Change,'” she said.

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!

Vitamins and Herbs – Risks and Benefits


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 andColumbia 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 thebest 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.

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 thePhysicians’ 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.

Medicinal Marijuana is a vast subject. I would be happy to schedule time to discuss its medical use with you. Refer here for some of the known research and patient information.

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.

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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.

To Find My Home Page, click here:  

Welcome to my Weblog on Pain Management!

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Vitamin D – A Steroid Hormone, Anti-inflammatory


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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 - click to enlarge

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.

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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.

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