Monday, August 24, 2009

The Roll of Ballantyne and Mao in the Worldwide Tragedy of Opiophobia

Opiophobia is a Worldwide Tragedy

The majority of (Australian) pain physicians support opioid medication use. The case against its use is largely dependent on a single flawed article (see Ballantyne et al below).

Despite the fact that the majority of pain physicians support the use of opioid medication, some practitioners and some governments have tried to limit its use. This decision is not based on any clinical or relevant research evidence. This decision has been based on prejudice and ignorance of proper opioid (treatment). At the base of this conduct is “opiophobia”.

The majority of reputable pain organizations, including the International Association for the study of pain (IASP) the largest pain organization representative group, and the International Association for Pain and Chemical Dependence ( IAPCD) support opioid medication, and recognize that in a some specific cases large doses of opioid medication are the preferred course of action.

Although there is debate about absolute or arbitrary limits on use of opioids, many conclusions proposed in the case against pain management are flawed (see Hochman below).
1. there is no evidence to support the claim that an upper limit of dosage should be mandated. (From a treatment perspective there is no evidence to show that there is ceiling dose, and as the dose increases, the analgesic benefit will also improve).
2. there is no evidence that these medications impair cognitive and personal function, indeed they frequently improve both.
3. addiction is uncommon.
4. the rationale to opioid use is purely relief of symptoms and improvement of function.

In South Australia there has been a major bureaucratic effort to obstruct and prevent treatment of chronic pain. This has been achieved by numerous measures: -
• improper denial of pain relief to patients.
• inappropriate action against practitioners administering to these patients.
• Treatment decisions made by administrators lacking the appropriate technical skills. (Not one patient has been examined by them).”
– Ian Buttfield MD,
Australia



“HYPERALGESIA”, “OPIOPHOBIA”. AND BALLANTYNE AND MAO: AN ANALYSIS

January 14, 2009

The treatment of Intractable Pain remains a peculiarly unresolved controversy in American medicine. Although, in theory, it is generally accepted that pain must be treated, particularly in cancer patients, the treatment of pain unrelated to malignancy remains a stubborn issue.

Some legal experts assumed that as a consequence of tort actions (Bergman v Chin) physicians would be forced to treat pain effectively in compliance with the community standard of care. In this civil lawsuit in San Francisco, California, a jury found Dr. Chin to be negligent in failing to
adequately treat and relieve the suffering of his cancer patient, Mr. Bergman, and awarded his family $2.5 million (reduced subsequently by the court to $1.5 million).

In fact, the Bergman v Chin case had little impact on the medical community. There has been no subsequent case of its sort. Further, in the entire United States, there has been only a single instance of a physician being disciplined by a State Medical Board for inadequately treating pain. In contrast, “unnecessary prescription of opioids” continues to be one of the most common causes of action taken against physicians daring to treat chronic pain unrelated to cancer.

Indeed, the case against pain management has been intensified.
• Insurance companies, clearly responding to the expense of pain medications, have attempted to deter pain treatment through filing state Medical Board complaints against doctors for “unnecessary prescribing”.
• Insurers have also utilized the device of “peer-reviews” to discourage prescribing (described by some observers as “sham reviews”)
• Physicians (typically “interventionalists”) have been hired by insurers to opine that the prescriptions of opioids were “outside the standard of care”.
o They falsely claim that only interventions conform to the standard of care; that the prescribing of opioids is “unnecessary”, “excessive”, “dangerous”, or “addicting”.
o They recommend detoxification, denying or ignoring the medical necessity for on-going treatment of intractable pain. (Interestingly, when these “peer-reviews” are appealed to independent reviewers, affirmation of opioid treatment has been virtually universal.)

An additional strategy in the campaign to save “opiophobia” from extinction has been a movement to establish arbitrary limits on opioid usage, reaching a recent zenith in the drafting of an arbitrary daily limit of 120 mg of morphine, or its equivalent, in the State of Washington (resulting in a federal lawsuit.)

The opioid limitation campaign has largely depended on a single article, by Ballantyne and Mao, published in the New England Journal of Medicine in 2003 (purportedly the product of peer review.) There is no other “peer-reviewed” article in the medical literature promoting absolute or arbitrary limits on the use of opioids. The article has been frequently cited by anti-opioid activists.

Given the central position of this article in the struggle around pain management, this author decided to revisit the original publication, to examine its content, assumptions and conclusions. The findings were enlightening.

BALLANTYNE AND MAO
Turning to the article, Ballantyne and Mao stated that:

1. Experts on pain recommend that pain patients not be denied opioids.
2. Despite this many physicians remain uncertain about prescribing opioids and do not prescribe.
3. Some physicians (a minority) argue that opioids are only marginally useful in the treatment of chronic pain, have a minimal effect on improving functioning, and may even worsen the outcome.
4. Key organizations strongly support the use of opioids to treat chronic pain and have published consensus statements to guide. Ballantyne and Mao reviewed the common elements in these guidelines, including regular assessment of the achievement of goals, careful monitoring for signs of opioid abuse (including toxicological screening in some cases), the use of adjunctive treatments whenever possible, and a willingness to end opioid treatment if the goals are not met, and full documentation.

Ballantyne and Mao then discussed clinical studies, noting that:

1. Most of the literature on opioid therapy consists of reports of surveys and uncontrolled case series and that patients with chronic pain not associated with a terminal disease can achieve satisfactory analgesia by using a stable (non-escalating) dose of opioids, with a minimal risk of addiction, in up to six years of treatment.
2. In most cases, doses are in a moderate range (up to 195 mg of morphine or morphine equivalent per day.
3. In other reports, higher doses were used (up to 2 g/day)
4. Some studies have also assessed functioning on the basis of patients’ own reports, with most patients reporting improvement.
5. Studies have shown that cognitive function, including the ability to drive and operate machinery, is preserved in patients taking stable, moderate doses of opioids for chronic pain.
6. However they then asserted that cognitive function may be impaired for up to seven days after an increase in the dose, “though the effect of high doses of opioids on cognitive function is unknown. “
7. Several controlled studies involving the use of single doses or short intravenous infusions of opioids confirm the responsiveness of various pain syndromes, including neuropathic pain.
8. Neuropathic pain has traditionally been considered opioid-resistant. However, recent clinical studies have shown opioids to be effective, provided an adequate dose can be reached without excess side effects.
9. Controlled studies have assessed the usefulness of long-term oral opioid therapy for chronic pain, and show significant analgesic efficacy of opioids in the treatment of chronic pain, including neuropathic pain,
10. The evidence of their effect on functioning is mixed, with a few studies reporting that pain relief was achieved without functional improvement.
11. Pain relief is the expected end point of opioid therapy, but there is no consensus on whether pain relief without other benefits is a reasonable outcome
12. A fundamental principle of pain management is that the dose of an opioid should be increased until maximal analgesia is achieved with minimal side effects.

However, despite their recognition of all these findings, Ballantyne and Mao then directed their focus on their view that dosage of opioids must be limited. They stated:

1. Clinical experience suggests that many physicians take a much more liberal approach to dose increases. Some patients with chronic pain receive doses as high as 1 g or more of morphine (or a morphine equivalent) per day, which may be five or more times the doses validated by the literature
2. Anecdotal evidence suggests that patients receiving opioid doses of this magnitude rarely report satisfactory analgesia or improved function.
3. Although the clinical trials carried out to date have not examined the efficacy and safety of prolonged, high-dose opioid therapy, evidence is rapidly accumulating that, in the treatment of patients with chronic pain, opioid doses should be limited in order to maintain both efficacy and safety.
4. Opioid Tolerance is an adaptive process at the cellular level
a. Several mechanisms are linked to the desensitization of opioid receptors
b. In patients receiving prolonged opioid therapy, increased expression of the endogenous opioid dynorphin has been noted in the spinal cord dorsal horn associated with enhanced pain sensitivity.
c. Although the exact mechanisms of NMDA-receptor–mediated opioid tolerance have not yet been elucidated, this line of research has provided insights into several issues related to prolonged opioid therapy.
d. Long-term use of opioids may also be associated with the development of abnormal sensitivity to pain
e. Preclinical and clinical studies suggest that opioid-induced abnormal pain sensitivity has much in common with the cellular mechanisms of neuropathic pain.
f. Animal models have also shown that NMDA-receptor–mediated cellular mechanisms mediate irreversible neurotoxic changes.
g. Repeated administration of opioids not only results in the development of tolerance (a desensitization process) but also leads to a pro-nociceptive (sensitization) process.
h. Together, desensitization and sensitization arising during prolonged opioid therapy may contribute to an apparent decrease in analgesia.
i. Prolonged opioid therapy can lead to cellular and intracellular changes,
j. Such changes may contribute to pharmacologic opioid tolerance, increased sensitivity to pain, or both and the need for dose escalation.
k. Prolonged opioid treatment may also result in hormonal changes and may alter immune function.
l. These effects may be exacerbated by dose escalation in some circumstances.
m. Thus, the need for dose escalation during opioid therapy — that is, the development of “apparent” opioid tolerance — may be the result of pharmacologic opioid tolerance, opioid-induced abnormal pain sensitivity, or disease progression.
n. Exogenous opioids may affect immunity through their neuroendocrine effects, or through direct effects on the immune system.
o. On the basis of studies in animals, prolonged exposure to opioids appears to be more likely to suppress immune function than short-term exposure, and abrupt withdrawal of opioids may also induce immune suppression.
p. Different opioids appear to act differently on the immune system. For example, methadone may be less immunosuppressive than morphine.
q. Studies of immune function in patients receiving long-term opioid therapy for chronic pain are notably lacking, but the direct evidence that opioids impair immune function has aroused concern, particularly in the case of susceptible persons. (However, pain itself can impair immune function)
r. The greatest concern is likely to pertain to patients receiving high doses of opioids who do not obtain satisfactory pain relief.
s. Apparent opioid tolerance does not equal pharmacologic opioid tolerance; and prolonged, high-dose opioid therapy may have serious adverse con-sequences.

5. Clinical tolerance is related to pharmacologic tolerance
a. Pharmacologic tolerance to opioids has defined cellular mechanisms.
b. Tolerance is the need for increasing doses to maintain the same level of analgesia.
c. There is evidence that opioids can induce abnormal pain sensitivity or hyperalgesia,
d. Although sophisticated testing can identify hyperalgesia (to distinguish it from pharmacologic tolerance), it may not distinguish the hyperalgesia due to opioid treatment from the hyperalgesia due to worsening neuropathic pain.
e. In every day clinical practice (without testing), it is impossible to distinguish between pharmacologic tolerance and abnormal pain sensitivity.
f. Whether opioid-induced abnormal pain sensitivity is related to the dose, the particular opioid, the route of administration, the duration of use, or other factors remains unclear.
g. Abnormal pain sensitivity may, at least in part, explain the failure to relieve pain in some patients, despite increases in the opioid dose. Thus, in some instances, treating increasing pain with in-creasing doses of opioids may be futile.

6. High dose opioid, prolonged, therapy opioids may have adverse consequences, including:
a. opioid tolerance with the need for dose escalation, and opioid-induced abnormal pain sensitivity.
b. hormonal effects that result in reduced fertility, libido, and drive.
c. immunosuppression, especially in susceptible persons. (“We do not yet know to what extent these effects are clinically relevant. However, prolonged use of high doses of opioids is likely to be more toxic than short-term use of low doses, so hormonal effects are most likely to occur in patients with chronic pain who receive high-dose opioid therapy”).
d. Paradoxically, opioid treatment may actually increase the burden of care, because the management of opioid therapy in patients with complex problems is time-consuming and difficult.

7. The concept of a ceiling dose of opioids in the treatment of chronic pain is growing, yet it is difficult to define a dose that could be recommended as a ceiling. Daily doses above 180 mg of morphine or a morphine equivalent have not been validated in clinical trials involving patients with chronic pain and might be considered excessive. However, ceiling doses probably vary among patients, given the known differences in patients’ responses to opioids. More important than the dose itself, however, may be the need for frequent dose escalation beyond the time when establishing a stable dose during the dose-adjustment phase (e.g., up to eight weeks) would be reasonable. The goal of these strategies is to maintain opioid efficacy while avoiding an adverse outcome.

8. Whereas it was previously thought that unlimited dose escalation was at least safe, evidence now suggests that prolonged, high-dose opioid therapy may be neither safe nor effective. It is therefore important that physicians make every effort to control indiscriminate prescribing, even when they are under pressure by patients to increase the dose of opioids.
------------------------------------------------------------------------------------------------------------

ANALYSIS
Drs. Ballantyne and Mao created a document which is now used, uncritically, by both individual practitioners and governmental authorities, as a basis for attempting to set arbitrary and absolute limits on the dosage of opioids in managing intractable pain. However, a careful reading of their article reveals it to be largely conjectural, though subtly so.

Initially they establish that the treatment of intractable pain is supported by the contemporary standard of medical practice. They then review the accepted approach to pain management through careful titration. Having established this foundation, they then proceed to attempt to construct their case against opioids.
Their case is based upon:
1. The allegation that opioids may impair cognitive and personal function
2. The allegation that opioids may impair the immune system
3. The allegation that opioids may cause serious hormonal problems
4. The allegation that high dose opioids may induce tolerance
5. The allegation that opioids are ineffective
6. The allegation that high dose opioids may induce allodynia and other pain hypersensitivities
Careful reading reveals that none of these allegations are supported by the medical and scientific literature they cite. Nowhere do they state that they do. Instead, every allegation is qualified with the statement that this hypothetical adverse consequence of high and/or long-term opioid usage may be so. Evidence that “suggests” something does not prove it. Hypotheses are not conclusions. They remain hypotheses until proven. None of these allegations have any basis in proof. Indeed, the vast body of clinical evidence, to date, disproves the allegations, with the single exception noted below.

Their clear objective was to construct an argument against opioids, under the rubric of a review of the medical literature.

“Whereas it was previously thought that unlimited dose escalation was at least safe, evidence now suggests that prolonged, high-dose opioid therapy may be neither safe nor effective. It is therefore important that physicians make every effort to control indiscriminate prescribing, even when they are under pressure by patients to increase the dose of opioids.”

We know of no publication, article or practitioner who has ever called for the indiscriminate prescription of opioids. This is simply a straw man. But, most importantly, the hypotheses of adverse consequences, initially qualified by “may”, “can” and “could”, are suddenly reified, and a leap is made to an ideological absolutism. “Opioids are over-prescribed, high doses are dangerous and must be limited – as they are neither safe nor effective.” No evidence is offered to support any of these claims, and they are, in fact, scientifically indefensible.

The Ballantyne and Mao article in fact does not establish that substantial evidence exists that high dose opioid therapy is neither safe nor effective. In fact, there is no such evidence. Indeed, all clinical evidence points to the opposite conclusion.
Specifically, extensive clinical experience demonstrates that, in the treatment of chronic pain:

1. opioids do not impair cognitive and personal function
1. opioids do not impair the immune system (except in a limited number of instances of suppressed testosterone levels in males)
2. opioids do not cause serious hormonal problems, otherwise
3. high dose opioids do not induce tolerance (in intractable pain patients)
4. opioids are effective in controlling pain and dramatically improving the quality of life of pain patients
5. high dose opioids do not induce hypothetical allodynia or other pain hypersensitivities to any significant extent
6. Opioid overdoses are universally the outcome of addictive misuse or unauthorized polypharmacy frequently including alcohol, and are statistically insignificant among pain patients, when the medication is used as prescribed

CONCLUSIONS
While it is judicious to exercise caution and continuing evaluation of the effects of the long term treatment of pain with opioids, the speculation that one MAY (the word is used at least 26 times in the Ballantyne and Mao article) encounter adverse long-term effects is not a defensible basis for assuming that they do.

What Ballantyne and Mao fail to respect is that their speculations are not supported by any substantial or factual evidence. Indeed, the contrary is true. All actual evidence and every clinical report concludes the opposite. To date, none of the allegations they presented has gained any substantial or reproducible evidence to support them. The sole exception, known for decades, is that continued therapy with opioids may induce suppression of serum testosterone levels in males, which is easily rectified with exogenous testosterone supplementation. Sadly, the Ballantyne and Mao speculations have achieved the status of “Urban Myth”, with many physicians uncritically quoting the hypothesis of hyperalgesia as an accepted fact. In fact, “Hyperalgesia” is a hypothetical theory proposed by a minority group of physicians who seek to explain why their inadequate dosing of pain results in treatment failure. There is not a single citation in the medical literature of a peer-reviewed article, based upon scientifically defensible evidence, supporting this hypothesized theory.

Caution is laudable in the practice of medicine. Ideology, masquerading as a scientifically objective review of the literature, is not.

Joel Simon Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org


3150 words

Sunday, August 23, 2009

Health Care Reform - Propaganda and Fact

PART ONE – THE PROPAGANDA
(A search of the AMA database reveals that Dr.Pollard is neither a member of the AMA nor the Georgia Medical Association. Goggling reveals that this scree has been widely distributed in the last two months, including a posting and discussion thread in Surfing Magazine.)

Eye Consultants of Atlanta
3225 Cumberland Blvd., SE
Suite 900
Atlanta , GA 30339
404-351-2220
By Zane F Pollard, MD
I have been sitting quietly on the sidelines watching all of this national debate on healthcare. It is time for me to bring some clarity to the table by explaining many of the problems from the perspective of a doctor.

First off the government has involved very few of us physicians in the healthcare debate. While the American Medical Association has come out in favor of the plan, it is vital to remember that the AMA only represents 17% of the American physician workforce.
I have taken care of Medicaid patients for 35 years while representing the only pediatric ophthalmology group left in Atlanta, Georgia that accepts Medicaid.
For example, in the past 6 months I have cared for three young children on Medicaid who had corneal ulcers. This is a potentially blinding situation because if the cornea perforates from the infection, almost surely blindness will occur. In all three cases the antibiotic needed for the eradication of the infection was not on the approved Medicaid list.
Each time I was told to fax Medicaid for the approval forms, which I did. Within 48 hours the form came back to me which was sent in immediately via fax, and I was told that I would have my answer in 10 days. Of course by then each child would have been blind in the eye.
Each time the request came back denied. All three times I personally provided the antibiotic for each patient which was not on the Medicaid approved list.
Get the point -- rationing of care.
Over the past 35 years I have cared for over 1000 children born with congenital cataracts. In older children and in adults the vision is rehabilitated with an intraocular lens. In newborns we use contact lenses which are very expensive. It takes Medicaid over one year to approve a contact lens post cataract surgery. By that time a successful anatomical operation is wasted as the child will be close to blind from a lack of focusing for so long a period of time.
Again, extreme rationing. Solution: I have a foundation here in Atlanta supported 100% by private funds which supplies all of these contact lenses for my Medicaid and illegal immigrants children for free. Again, waiting for the government would be disastrous.
Last week I had a lady bring her child to me. They are Americans but live in Sweden, as the father has a job with a big corporation. The child had the onset of double vision 3 months ago and has been unable to function normally because of this. They are people of means but are waiting 8 months to see the ophthalmologist in Sweden. Then if the child needed surgery they would be put on a 6 month waiting list. She called me and I saw her that day. It turned out that the child had accommodative esotropia (crossing of the eyes treated with glasses that correct for farsightedness) and responded to glasses within 4 days, so no surgery was needed. Again, rationing of care.
Last month I operated on a 70 year old lady with double vision present for 3 years. She responded quite nicely to her surgery and now is symptom free. I also operated on a 69 year old judge with vertical double vision. His surgery went very well and now he is happy as a lark. I have been told -- but of course there is no healthcare bill that has been passed yet -- that these 2 people because of their age would have been denied surgery and just told to wear a patch over one eye to alleviate the symptoms of double vision. Obviously cheaper than surgery.
I spent two years in the US Navy during the Viet Nam war and was well treated by the military. There was tremendous rationing of care and we were told specifically what things the military personnel and their dependents could have and which things they could not have. While I was in Viet Nam, my wife Nancy got sick and got essentially no care at the Naval Hospital in Oakland, California. She went home and went to her family's private internist in Beverly Hills. While it was expensive, she received an immediate work up. Again rationing of care.
For those of you who are over 65, this bill in its present form might be lethal for you. People in England over 59 cannot receive stents for their coronary arteries. The government wants to mimic the British plan. For those of you younger, it will still mean restriction of the care that you and your children receive.
While 99% of physicians went into medicine because of the love of medicine and the challenge of helping our fellow man, economics are still important. My rent goes up 2% each year and the salaries of my employees go up 2% each year. Twenty years ago, ophthalmologists were paid $1800 for a cataract surgery and today $500. This is a 73% decrease in our fees. I do not know of many jobs in America that have seen this sort of lowering of fees.
But there is more to the story than just the lower fees. When I came to Atlanta, there was a well known ophthalmologist that charged $2500 for a cataract surgery as he felt the was the best. He had a terrific reputation and in fact I had my mother's bilateral cataracts operated on by him with a wonderful result. She is now 94 and has 20/20 vision in both eyes. People would pay his $2500 fee.
However, then the government came in and said that any doctor that does Medicare work cannot accept more than the going rate ( now $500) or he or she would be severely fined. This put an end to his charging $2500. The government said it was illegal to accept more than the government-allowed rate. What I am driving at is that those of you well off will NOT be able to go to the head of the line under this new healthcare plan, just because you have money, as no physician will be willing to go against the law to treat you.
I am a pediatric ophthalmologist and trained for 10 years post-college to become a pediatric ophthalmologist (add two years of my service in the Navy and that comes to 12 years).A neurosurgeon spends 14 years post -college, and if he or she has to do the military that would be 16 years. I am not entitled to make what a neurosurgeon makes, but the new plan calls for all physicians to make the same amount of payment. I assure you that medical students will not go into neurosurgery and we will have a tremendous shortage of neurosurgeons. Already, the top neurosurgeon at my hospital that is in good health and only 52 years old has just quit because he can't stand working with the government anymore. Forty-nine percent of children under the age of 16 in the state of Georgia are on Medicaid, so he felt he just could not stand working with the bureaucracy anymore. We are being lied to about the uninsured. They are getting care. I operate on at least 2 illegal immigrants each month who pay me nothing, and the children's hospital at which I operate charges them nothing also. This is true not only of Atlanta, but of every community in America.
The bottom line is that I urge all of you to contact your congresswomen and congressmen and senators to defeat this bill. I promise you that you will not like rationing of your own health.
Furthermore, how can you trust a physician that works under these conditions knowing that he is controlled by the state? I certainly could not trust any doctor that would work under these draconian conditions.
One last thing: with this new healthcare plan there will be a tremendous shortage of physicians. It has been estimated that approximately 5% of the current physician work force will quit under this new system. Also it is estimated that another 5% shortage will occur because of the decreased number of men and women wanting to go into medicine. At the present time the US government has mandated gender equity in admissions to medical schools .That means that for the past 15 years somewhere between 49 and 51% of each entering class are females. This is true of private schools also, because all private schools receive federal funding.
The average career of a woman in medicine now is only 8-10 years and the average work week for a female in medicine is only 3-4 days. I have now trained 35 fellows in pediatric ophthalmology. Hands down the best was a female that I trained 4 years ago -- she was head and heels above all others I have trained. She now practices only 3 days a week. 


PART TWO –
THE TRUTH

One sided, doom and gloom, propaganda. It is also filled with distortions, errors and half-truths.

1. "They will retire if Obama's health care plan is adopted"

2. Oh yeah? I guess that means they have done so well financially they have the $5,000,000 in retirement money it would take to maintain their lifestyle (5%/year X $5,000,000 = $250,000)

3. "the AMA only represents 17% of the American physician workforce."

The AMA has 340,000 members. There are 981,000 doctors licensed to prescribe in the US. You do the math.

4. "In newborns we use contact lenses which are very expensive. It takes Medicaid over one year to approve a contact lens post cataract surgery."

It takes me five minutes to obtain approval from Medicaid for pain medication that costs $3,000 per month and will be required indefinitely. Either this is a lie, a distortion, an anomaly in Georgia or he's not doing something right.

5. "in Sweden ....... if the child needed surgery they would be put on a 6 month waiting list."

More nonsense. Waiting lists are primarily for elective procedures. What would you bet that if you research this you'll find it to be a total concoction?

6. "I have been told -- but of course there is no health care bill that has been passed yet -- that these 2 people because of their age would have been denied surgery and just told to wear a patch over one eye to alleviate the symptoms of double vision. Obviously cheaper than surgery."

Who told him this? How would they know? In fact, the proposals currently being considered make absolutely no change in the existing Medicare program which currently covers both a 69 and 70 year old. Where does this "rationing" fear-mongering come from? Guess. As far as rationing is concerned, I have many patients who are now into their second year of waiting to be reimbursed by their very large insurance companies for benefits that the company has already acknowledged are covered by their plan. I currently spend about four hours a week arguing with non-medically trained insurance company employees about "medical necessity" and "formulary requirements", etc., etc. That is rationing in sheep's clothing.

7. "In England people over 59 cannot receive stents for their coronary arteries. The government wants to mimic the British plan. For those of you younger, it will still mean restriction of the care that you and your children receive."

More B.S. Check it out. There's no waiting list or denial of stents where needed in Great Britain. But the English have not adopted the current U.S. fad. The fact is that stents are not a panacea and research data here in the U.S. has recently raised questions about this current U.S. fad of placing them in everyone with a putative coronary artery narrowing.

No one has said anything about "wanting to mimic the British Plan" That's just a typical "swift-boating" buzz word sound bite. Medical care now is not restricted but denied entirely to 54 million Americans. How about that? Based on quality of health care, the United States now ranks 39th in the world, right behind Bulgaria!! Check that fact out.

8. "The government said it was illegal to accept more than the government-allowed rate. What I am driving at is that those of you well off will NOT be able to go to the head of the line under this new health care plan, just because you have money, as no physician will be willing to go against the law to treat you."

Another distortion. There is nothing in the current proposal that would eliminate private care. If you have the money you can see anyone you want (just as in Great Britain and anywhere in the European Union.) Restrictions on charges apply only to people on Medicare. The law does not allow a participating physician to charge more to a Medicare patient than is allowed. If a doctor wants to charge more than the fee schedules allow, all he (or she) has to do is opt out of Medicare. I did it four years ago and have never missed it for one day. It is a perfect solution to inadequate fees. If enough doctors opt out the fees will have to be increased to a level that attracts the doctors back in. The term for this is "the force of the marketplace". Currently insurance companies try to escape the marketplace by forcing doctors into "panels", where they have to eat whatever the insurance company serves them or be excluded from treating the Insurance company's patients.

9. "the new plan calls for all physicians to make the same amount of payment."

Another untruth. There is no such provision in the current proposals. More "swift-boating" buzzwords.

10. "The top neurosurgeon at my hospital who is in good health and only 52 years old has just quit because he can't stand working with the government anymore. Forty-nine percent of children under the age of 16 in the state of Georgia are on Medicaid, so he felt he just could not stand working with the bureaucracy anymore."

See number 1, above. He must have a lot of money if he "quit". Is the truth (if this isn't another complete fiction) something more like he quit accepting Medicaid? (see No.7, above). What about working with the insurance company "bureaucracy"? You can't call your Congressman about them. I currently have to deal with 100 times more insurance company "bureaucrats" than government "bureaucrats".

11. "with this new health care plan there will be a tremendous shortage of physicians. It has been estimated that approximately 5% of the current physician work force will quit under this new system. Also it is estimated that another 5% shortage will occur because of the decreased number of men and women wanting to go into medicine."

Again, apocryphal B.S. WHO estimated it? Want to guess, again?

12. "At the present time the US government has mandated gender equity in admissions to medical schools .That means that for the past 15 years somewhere between 49 and 51% of each entering class are females. This is true of private schools also, because all private schools receive federal funding. "

Just in case you haven't figured out the kind of politics behind this propaganda, they give you another chance to figure it out with this little piece of misogyny. The government doesn't mandate gender equality in medical school classes. It mandates gender, (and race, and creed) equality in the process of admission. You can't set quotas on admissions for any reason. If half the new medical students are women it is because women now want to be doctors and see themselves in that career in equal numbers to men, and have obviously proven that they are intellectually and personally equally qualified by winning admissions to medical school at rates equal to men. As for how long they stay in medicine, I think a little peak at the facts will reveal this argument to be more propaganda, this time of the misogynistic type.


THE REAL FACTS:

Insurance companies currently siphon off from 32 to 70% of every health care dollar spent in the U.S. with their "overhead". The current Medicare "overhead" cost is 5%. If insurance companies have to compete with a governmental alternative this highway robbery will stop overnight. 50% of the $3 trillion dollars spent annually on health care is $1.5 trillion dollars. If the insurance companies had to operate honestly, in the marketplace, even a 15% overhead (three times that of Medicare) would put $1 trillion dollars back into actual health care - enough money to pay for all those people currently uninsured. The insurance companies have spent 130 billion dollars in the last three months trying to kill health care reform, using every slimy device they can find, including this piece of propaganda.

Wake up America. Wake up American medicine. If it looks, like it, smells like it, and tastes like it, it most certainly is, B.S. I don't care how much they spend and how many lies they spread. Use your common sense - it sure as hell isn't honey!

J.S. Hochman MD
In private practice for 39 years
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org

Saturday, August 22, 2009

Hell - Opiophobia Style

People ask me why I continue to beat my head against the wall battling Opiophobia. The experience is precisely the same as getting into an argument with a "Right To Life" crackpot. They are religious fanatics. They believe that snakes can talk (see Bill Maher's movie), they are profoundly committed to the concept of saving baby angels who have fallen off heaven's clouds into the world's miasma, and are totally unconcerned and indifferent to real lives - such as that of women bearing unwanted children or live infants born into squalid poverty (and for damned sure they are NEVER going to adopt one of those babies into their life!) But, they will march around all day outside abortion clinics or shoot doctors who are willing to take the professional and personal risks of helping desperate women.

Arguing with opiophobes is the same experience. Opiophobia is a RELIGION, not a scientific or rational discourse.And Medical Board Members are largely ensorcelled by religious opiophobia. This does not lead to pleasant experiences. Hundreds (if not thousands, I am trying to get the data) of doctors go through it every year. The best way to find oneself before a Medical Board for "injudicious prescription" is to regularly write schedule II prescriptions. It wouldn''t matter if your were Hippocrates himself. You will end up being "reviewed" (bend over..you are going to be reviewed"). And trying to engage in a professional, rational or scientifically sound discussion of the use of opioids to control chronic pain NEVER leads to any intellectually satisfying outcome. As the old Texas cowboys say, "Never try to teach a pig to sing. It only leads to failure - and it irritates the pigs".

So despite all of this - and my 42 "reviews" in the last 24 months (all but the most recent 14 led to nothing after about 500 hours of work and $40,000 in legal fees) - I persist. If you want to know why, read the following letter from Mr. Joel Ford (God love him). I feel like a French partisan blowing up the rails that lead to Auschwitz - I know the authorities are going to do everything they can to kill me. But I just cannot stand around and watch the trains go by while I hide in safety.
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From: Joel Ford [mailto:jford@ktis.net]
Sent: Thursday, August 20, 2009 11:59 AM
To: 'jfshmd@gmail.com
Subject: unbearable pain and 20 years of it

I was hit head on March 8th 1989, my passenger and best friend since our teen years was killed and I suffered mass trauma, compound leg fractures, a right ankle that to this day hurts beyond belief with just minutes of weight bearing! I initially was flown to the University Of Mo Medical Center where emergency surgeries over the next 26 hours got some of the open tibia/fibula fractures connected to an external fixture, the nerves to my right foot were severed completely and agonizing neuropathy was the result, also had an open fracture of the mid femur, skeletal traction for a few days pulled the sharp shards of the bone away from the femoral artery, then a rod with crossing screws at the hip and just above the knee intended to regain the original length, the bone chips were wired into the actual fracture, the patella was nearly severed from the tendons and ligaments that hold it in place, in addition to the lower body fractures, the right hip ball was jarred so hard that all kinds of spurs broke off in the actual ball joint, causing a gradual deterioration of that joint, additionally, both wrists were broken and every knuckle on both hands were hyper extended in an attempt to hold the steering wheel with arms locked out, and right leg extended straight on the brake, I had an 89 mustang 4 cylinder and the young men who strayed over the centerline on a narrow state road on a hill crest were in a 78 Buick LeSabre, easily twice the weight of the mustang, as I said, I was airlifted to the only level 1 ER in the middle of the state, only 12 miles by road, however my golden hour was long gone by the time they pried me out, I also broke all the right side ribs, fractured the collar bone and had massive face and head injuries that broke the jaw in a couple places, and the facial bones that surround the eye sockets and the nose, all shattered, ended up ventilated for a couple weeks, jaws wired tightly shut, feeding tube in one nostril and eyes swollen and blackened, communication was impossible, I was later told that team of Psychiatrists were called in to try and regulate the medications as I was pulling out my iv's and even attempting to use the beds trapeze to get out of the bed, I don't remember much of this, 58 days in NICU then to Rusk Rehab, an Intensive rehab for a month, even as I arrived at Rusk, I was immediately placed on a "Demerol cocktail" taken orally, with decreasing doses of the Demerol, I was 38 years old when this occurred and had never taken an opiate in my life, yet even the residents and the rehab team began to warn me that they feared they had addicted me, and the reducing doses of Demerol quickly brought about intense nerve and orthopedic pain to the degree I finally refused to attend the two a day physical and vocational rehabs, only to be told by the rehab Doctor that failure to attend could risk my bed there, I actually laid awake at night and cried, the pain so severe and jaws still wired, I was at my end and a Senior Attending Orthopedic surgeon came and helped me for the moment, the forth week at my rehab "team" meeting I was told once again I couldn't go home while taking these pain meds, and I just said "There IS NOT an addiction problem here, It's a pain problem!! Can't we deal with that right now, and if this dreaded addiction indeed occurs, we can deal with it then! They all huddled up for a minute, then turned and announced I had convinced them and was released the next day to return home, at 127 pounds, weighed about 200 when the accident occurred, I had other issued like viral pneumonia while in NICU, a collapsed lung, and a brain swelling and creating huge survival issues, so anyway, got to go home and immediately problems occurred, had a total foot drop, then the tibia/fibula fractures just snapped one day as I was getting to a car for my brother to drive me somewhere, ended up being a local ER (I had just spent 8 days at UMC for a pic line infusion of a very powerful antibiotic, for an bone infection that developed just above the right ankle a year or so after they grafted the tissue rupture) and a local Orthopedic surgeon on call showed up, and immediately asked the nurse what the ER Doctor had given me, she replied however much Nubane? The surgeon looked at me and told the nurse to give me lots of morphine and phenergan which she did and he came back in and told me he would really like to take me to surgery and set the fractures while I was under from the anesthesia, and I told him No, I wasn't going to spend yet another night, so he said ok and came in and set the fracture (a whole new pain experience!!) and after an hour or so let my brother bring me home, to see him the next morning, in the interest of time and typing, this local Surgeon wasn't even slightly intimidated by the local DEA Agents that ran from the local pharmacies every day to verify the patient had actually seen a doctor and that the medication being prescribed wasn't over kill (10 mg oxycodone a percocet generic, initially 6 times a day, he told me even then that the DEA was the agency that licensed physicians to be able to write prescriptions and it really PO'd him as he said "There is NOT a Doctor of any kind amongst these agents and their Bureau" and I refuse to be bothered by them, after all, I am an orthopedic surgeon, every day I inflict the most intense pain there is on my patients" and over the next 5 years an
additional 11 surgeries were required, all pretty much orthopedic, the femur fracture was also a non union and he had removed the crossing screws to see if the friction would promote the bone healing, he thought it did, I could only tell him of the intense pain in the mid femur area, he x-rayed and CT scanned but it looked healed to him, acting only on my continuing complaints did he take me to surgery, and was waiting when I woke up in recovery with a smile on his face, he told me the area inside the femur had filled with fiber, which meant it had stopped healing, he had to drill down the center of the femur to promote some new growth and put a larger diameter rod back in it, with all of this and much more, it was a constant either surgery or recovering from over the next five years, me taking percocet level pain meds ultimately having to take two every three hours, 16 as day, and they did
little to help, after the last surgery he did he told my two younger brothers he had given me enough morphine to kill both of them and it wasn't going to help much, and that was a fact, an IV push of every 45 minutes did only provided a small measure of relief for minutes, then the pain returned so horribly that I would lose consciousness and be in and out, and it's now been 20 years since that accident, and I still suffer just terrible pain, something one of the residents at UMC told me I would just "have to learn to deal with" which so angered me that my response was "Like I have a choice"? The story goes on and on and I won't, suffice it that my general practitioner, an Osteopath has given me 3 Darvocet N100's and 3 800 Mg Ibuprofen a day for over 12 years, the pain has gotten much worse, I am 57 now, morbidly obese and diabetic, still unable to weight bear for more than a few minutes and he acts like I'm trying to kill him when I complain that those two just aren't working anymore, I mean the Darvocet N prescription reads "take one table three times a day PRN severe breakthrough pain" I have pretty much given up and fully expect to suffer more and more pain in what few years I may have left, I never did Doctor shop until I found one who would properly treat this gruesome pain, I just accepted it and have been at home for 20 years, losing more and more of my possessions on a SSD income, now the head injury brought its own problems and deficits in the brain which I have adapted too as best I can, it just seems totally ridiculous that Physicians cannot treat this pain in some form of management program? I am at my wits end and have even acknowledged that suicide may one day be my only escape from all this, and that's not even a thought I considered lightly, I don't know what else to do? I will attach a couple pictures of my car and me, just to maybe validate these things, it's been a long, long and painful 20 years, getting only 2 or 3 hours sleep before waking stiff and hurting and have to get up and move around a little to go back and get another 2 or 3 hours, and this "addiction" these Doctors had me scared to death over, I was taking percocet or stronger pain meds for a continuous 5 years, and my local surgeon asked me one day how I wanted to scale it down, taper or cold turkey, I told him if I had them, I would take them, so cold turkey it was, 16 percocet a day to nothing, it was a joke!! Two days of diarrhea, and being in a foul mood then went to see him and very concerned, ask him when this horrible withdrawal was going to start, he looked at me and laughed and announced I had already experienced all there would be, he handed me a time magazine with the front cover a breaking story about how opiates interacted with the body when PAIN was the issue and the JAMA clearly stated that people taking opiates for real pain simply didn't become addicted while "recreational" users seemed to suffer way more serious affects when the opiate was withdrawn, they recommended the aggressive treatment of post op pain that speeded the recovery time tenfold? Yet, the hysteria promoted by the DEA continues to prevent people like myself, not seeking a high from any drug, just some relief of agonizing pain, I just today ran across your website and after reading there, it seems many, too many people are in the same "lack of caring about chronic pain" demonstrated by most physicians, and I understand why, but it seems so very wrong to withhold treatment that could vastly improve the quality of life for myself and thousands of others who suffer much worse than I, it just makes no sense, when taking one's own life seems to be the only option left?
Thank You for reading some of my story, perhaps my own circumstances will help someone left to a similar fate?
Sincerely,
Joel Ford
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Dear Joel: Your case makes you a poster boy for opiophobia. If you will contact Mr. Barletta, (our National Coordinator) at the e-mail address above, and give him your address, we will attempt to find you a pain doctor who is a physician, not an idiot. If we cannot locate one, we will give you the option of coming to Houston for stabilization and long-term care.

Your out-patient pain management has been abysmal. A new intern could have done a better job (unless they were operating in an opiophobic environment). There is no reason that your pain should not be effectively contained, if treated adequately.
Join the Foundation (www.paincare.org). Your annual dues support the web site.

Lastly, I would like to use your case in an Executive Director's message on the web site, and perhaps also in several medical publications I have been asked to write. I will not identify you personally. Would that be OK?
Dr. Hochman (also a Joel)

Thursday, August 20, 2009

Notice to the Prescription "Managers"

NOTICE ON STANDARD OF CARE INQUIRIES
August 20, 2009

The receipt of a number of inquiries from prescription "management" organizations (Medco most prominently) in the last four months would seem to indicate that there is a recent onset of a notable lack of current knowledge about the contemporary standard of care for Intractable Pain. I am writing now to direct Blue Cross, United Health Care, Aetna, Humana and other insurers to the Clinical Guidelines for the Use of Chronic Opioid Therapy in Non-cancer Pain issued by the American Pain Society in February of 2009.

The pain management of all my chronic pain patients conforms to the Clinical Guidelines for the Use of Chronic Opioid Therapy in Non-cancer Pain issued by the American Pain Society in February of 2009. The opioid treatment regimens of all my chronic patients are developed through careful titration and clinical trial. As with any pharmacological treatment, appropriate pain medications are selected, dosage is started low, and titration is upwards until effective pain control is accomplished. During this process the patient is carefully monitored for adverse effects. Opioid medications do not have any absolute maximum dosage, the limit being the induction of respiratory depression.

This treatment is in strict conformity with the guidelines. The treatment consistently results in the effective treatment of chronic pain, without medical complications, adverse effects, aberrant behaviors or evidence of the induction or worsening of any addictive disorder. Effective treatment allows patient to make progress in their quality of life, physical status (frequently with dramatic improvement in their range of motion and social and physical functioning.) They consistently suffer no adverse effects or medical complications. Their progress is consistently documented. Their pain regimen typically becomes stable within 90 days and remains so, without significant variation or change, for periods from 24 to 180 months in my research series.

The treatment is consistently supervised on a timely basis during the entire course of treatment and is unarguably of medical necessity. Patients provide outcome letters which are definitive as to the efficacy and safety of treatment. In most cases, because of the unresolvability of the underlying pathology, their pain management will typically be indefinite.
Sincerely, J.S. Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org

Monday, August 17, 2009

MONEY TALKS, PRINCIPLES WALK

MONEY TALKS, PRINCIPLES WALK

The media now informs us that the Government-sponsored alternative to the corporate health insurance companies is dead. If this is true, it represents a crime against the public that makes the Teapot Dome Scandal look like pilferage of Girl Scout Cookies. If the lobbyists for the Insurance Companies pull this one off, they will:
1. Escape meaningful competition in health care insurance
2. Continue their horrendous abuses of the public and physicians (particularly the elderly and chronic pain patients)
3. Gain another 40 million insured by compelling through federal law that they all acquire their insurance from these mega-corporations
4. Gain another half trillion dollars in annual revenues
5. Preserve their criminal overhead rate which varies from 32% (acknowledged) to 50 to 70% (hidden)
6. Demonstrate that swiftboating works with a credible public susceptible to tabloid mentality and incapable of critical and independent analysis
7. Prove that the Congress is owned by lobbyists, political contributions and cronyism
8. Reveal that the Congress (our purported representatives) doesn't give a damn about the people and arrogantly ignores our rights and the government's obligations
9. Seriously raises the question whether it is time for a political revolution in the Congress, such as we have already had in the Presidency. I say that every member of Congress who votes to fold under to the Insurance Companies needs to be voted out of office, and that only candidates who guarantee to serve the needs of the people, not the Trillionaire Insurance Companies, be returned to Washington.
There is still time. EVERY citizen should call, e-mail and FAX their Senators and Representatives and tell them that this an unacceptable crime against the people.

J.S. Hochman MD
Executive Director
The national Foundation for the Treatment of Pain

Wednesday, August 5, 2009

Opiophobia - Racism in Boards of Medicine

I posted this today as my contribution to the on-going dialogue about the persecution of pain management doctors, on the LIST serve "The Project on Pain and Chemical Dependency" (TPPCD)

I'm afraid that what we are dealing with is a form of sick human behavior. There can be no doubt that there is murderous potential in every human being. The BTK murderer is a dramatic example of this. Scout leader; church-goer; a person everyone liked; a long-term employee of an alarm company; married 30 years; father to a charming, healthy daughter; absolutely likable by all who knew him. Yet he secretly harbored a total monster deep inside. When we look around, we see that the history of humans is really a nightmare of horrors. Genocides everywhere we look. 300 million slaughtered in the last 2000 years (if not more). A madman murdering 10 innocent women in a work-out facility - just today. Religious zealots bombing hundreds of innocent people throughout the Middle East. Apparently normal American kids engaging in sexual sadism in Abu Graib. Blue collar folks turning into heartless assassins when they go to work for Blackwater (or the CIA, or state prisons, etc., etc.)

As one of my Psychiatry Professors at UCLA taught us 40+ years ago - "there should never be any doubt about what is inside human beings. The only question is how well they are handling it". (He also used to say that the only crime in psychiatry was being surprised.)

So, the point I want to make is that most people handle their internal monsters by projection. They defend themselves from the emotional trauma of facing their internal monsters by unconsciously projecting the monsters onto others. Take the example of the corrupt prosecutor - who justifies suborning perjury, sequestering exculpatory evidence, fabricating evidence, routinely perjuring ("testilying" the police officers call it) - in order to win a conviction. He (or she) rationalizes this monstrous behavior by perceiving the victim of their behavior as the monster. ("It doesn't matter what it takes me to do to convict this horrible criminal".) This dynamic plays itself out daily in every form of investigation, prosecution and judgment. This Executive Director of the California State Medical Board clearly sees pain management as a meretricious form of behavior hiding behind a white coat. So it is his "duty" to punish it. He (or she) is clueless that what they are doing is denying the most fundamental achievement of physicians since the dawn of the profession - relieving suffering. Their conviction is so intransigent that they don't WANT to interview the patients whose lives have been spared by effective pain treatment (it only gets in the way of their own disturbed emotional needs.) They simply harbor behaviors and attitudes that underlie every mindless prejudice, most notably "racism".

I am convinced that opiophobia is at the deepest level best understood as "pharmacological racism". Just as with any racist belief, it is irrational, springs from vicious and un-understood prejudice, and serves a deep inner illness in the perpetrator. Arthur is a remarkable exception, in his fair-minded rationality. I would hope that there are many like him in his profession. But I have to say that of all the Board (and other) prosecutors I have met, he appears to be a rare exception.

Historically, it took us over 200 years to shake ourselves loose enough from our melanophobia (fear of people with colored skin) and prejudice, to elect an African American to the presidency of the United States. In fact I think it may be a signal of a tidal change in the world. But I hope that it doesn't take that long to change the opiophobia that condemns millions of innocently suffering people, and thousands of compassionate doctors, to a needless hell.

For myself, I have now spent over $40,000 in legal fees dealing with 45 investigations by the Texas Medical Board, over the last two years. All but 14 have been dismissed. The remaining 14, initiated after the first 31, are excellent examples of successful pain treatment (as every patient attests in writing.) But the now Executive Director of the now regressive Texas Medical Board continues to mindlessly and shamelessly seek my destruction (Until eight years ago Texas was a leader in progressive pain managemnt policy. Mr. Bush and his doppelganger, Mr. Perry, changed all that with their appointments to the Texas Board. As Stratton Hill observes, "the opiophobes are winning.").

The pursuit and prosecution of pain management as "injudicious prescription" is simply a smokescreen for the opiophobia that motivates it. And this pursuit is one of the most common activities of State Medical Boards throughout the nation. In many states one simply cannot now find a doctor willing to treat intractable pain. Dr. Robert Kales, a consummate gentleman, an excellent physician, a wise and educated man, has now been persecuted out of Arkansas and now Oklahoma. In New Mexico, where I practiced for 25 years and served two years as the Clinical Director of all the in-patient and community based health programs in the state, a religious cult nut case spent eight years hounding me out of my home and practice, even though I referred the last 142 cases I accepted, to the Pain Clinic at the University of New Mexico School of Medicine for a second opinion and got 100% concurrence and support for my care. Joan Lewis MD, has suffered a similar fate. She now must practice cosmetic medicine because the Board of Medicine stripped her right to prescribe pain medication! How many other cases can we name? Just thinking about it makes me nauseous and disgusted. The State Boards of Medicine give lip service to their Model for the Treatment of Intractable Pain when they are in Washington, at the Federation of State Medical Boards meetings. But when they get back home it's business as usual - lynching pain management doctors. ("Some of my best friends are pain management doctors" I am sure they would say.)

I know that President Obama is aware of this calamity (one of my patients, a victim of intractable pain, the son of a prominent newsman, spent half an hour with him during the campaign, smoking cigarettes, and told him his whole story - for which the then Mr. Obama thanked him - "I had no idea that this was happening, Mr. Obama told him. "But I know about it now".). It is on his list of priorities for change in America. But, unfortunately, it is a ways down the list, under the economy, Iran's nuclear development, reform of Health Care, reforming Drug Policy, congressional corruption by lobbying and special interests, etc., etc.

So, I don't know what more we can do except what we have been doing. Talk about it, write about it. Give interviews, write articles, do research (Craig - where is that damned, history-changing manuscript?), share our knowledge and experience at every opportunity, defend the truth, uphold reality and factuality, defend rationality and science to the death. For myself, if the epithet on my tombstone reads, "they may have destroyed his career, but they didn't touch his convictions, his integrity, or the scientific truth" I will smile proudly for eternity.

JSH

Monday, August 3, 2009

Opioids and Depression

The following is from the LIST serve TPPCD (The Project on Pain and Chemical Dependency)

On Mon, Aug 3, 2009 at 1:28 PM, wrote:

a separate musing thread

recently-I have been seeing sales reps trying to get me to use various psych meds for resistant depression. I hear the same thing- 1/3 get total relief of depression and up to 50% get total relief with a combo of drugs. That leaves 50% of patient with little or partial relief of depression with traditional therapies. Why is that??

The simple answer is that traditional therapies do not treat the neuro-physiologic abnormalities in these patients.

Now , I know we dont have a good grasp on the etiologies of most affective disorders but the effectiveness and mechanisms of traditional therapies have led to a belief that imbalances in seratonin, norepinephrine and/or dopamine are some how contributory. All the patients have a "chemical imbalance"

So can we conclude that in the 50% poorly treated that the "chemical imbalance" occurs in an area separate from these neurotransmitters??

15 years ago a study was published looking at a small number of resistant depressives with no history of opiate abuse. They were given buprenorphine with a significant reduction in symptoms. Could an endogenous endorphin deficiency have been at play here??? If so, how frequent does it occur in clinical practice??

I think that attempting to treat patients for depression with opiates is scary because of the stigma and risk for physical dependency. . And it should be a lesser used treatment. I wonder if that is why no one ever thought of doing the experiment. However, with buprenorphine we have a safer alternative- should it be looked at.???

Stu
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The history of psychiatry reveals that prior to the age of anti-depressant medications, the treatment of choice for depression was opiates!!

Intractable pain patients suffer depression far more frequently than the general population. Clearly this has to be related to the consequences of being disabled, but depletion of endogenous opioid substances must be a major factor.

Opiate addiction is another major clue to the connection of endogenous opioids to addiction. Of the hundreds of heroin addicts with whom I have worked over the decades, parenteral opiates were obviously self-treatment for major depression. All required an anti-depressant as a component of their treatment. Also, the efficacy of methadone suggested the role of opioids and pleasure (the opposite of depression.)

The demonization of opioids is a fascinating historical oddity. I see it as exactly analogous to the history of racism. Recall the Roman Empire. Recall Shakespeare and Othello. Black skin was not always associated with negative prejudices.

It has taken a century to make a dent in melanophobia. Probably it will require the same for opioids. Buprenorphine? Seems like a rational inquiry to me.
JSH

Saturday, August 1, 2009

The Essential Requirements of Reformed Health Care

Although I am a member of AAPS, I have not been happy with their input into the reform of Health Care. For the first time today AAPS issued a POSITIVE statement for the dialogue. I can support this 100% as an addition to my letter to President Obama.

* improve the quality of care by encouraging innovation;
* decrease systems-gaming and nonproductive work related to justifying price-
controlled fees;
* allow physicians to concentrate on healing rather than constantly changing
administrative rules;
* restore the patient/physician relationship and the joy of practicing medicine;
* increase supply, availability, and competition, and thus decrease costs and make
it easier to serve those who are most in need of help; and
* discourage frivolous or predatory litigation.

http://www.aapsonline.org/newsoftheday/00406

The Data from the Drug Czar don't support his Claims

June 9, 2009

The statisticians at the Adverse Events Reporting System clearly state that the system does not report incidence but occurrence, and is unreliable. Is there any data other than from AERS that substantiates an imminent risk from prescribed opioids?

“Reports contain only those reactions voluntarily submitted either directly to the FDA or to the drug manufacturer by consumers and /or members of the health profession and which have been entered into the AERS computerized filing system since November 1, 2007.

The information contained in the reports has not been scientifically or otherwise verified. For any given report there is no certainty that the suspected drug caused the reaction. This is because physicians are encouraged to report suspected reactions. The event may have been related to the underlying disease for which the drug was given to concurrent drugs being taken or may have occurred by chance at the same time the suspected drug was taken.

Accumulated case reports cannot be used to calculate incidence or estimates of drug risk Numbers from these data must be carefully interpreted as reporting rates and not occurrence rates. True incidence rates cannot be determined from this database. Comparisons of drugs cannot be made from these data.

The “National Prescriptive Drug Threatö is based upon “synthesized dataö. The data quoted by the DEA (National Drug Threat Assessment 2009), available at:

* HYPERLINK "http://www.usdoj.gov/ndic/pubs31/31379/index.htm" *http://www.usdoj.gov/ndic/pubs31/31379/index.htm#Contents*

* HYPERLINK "http://www.usdoj.gov/ndic/pubs31/31379/appendb.htm" *http://www.usdoj.gov/ndic/pubs31/31379/appendb.htm#Top*

simply does not support the claim of an “epidemic of diversion and abuse”. What data substantiates an “epidemic”?

In the data cited above, from 2001 to 2005, opioid deaths are said to have increased 113.8% (from 3994 to 8451). However, the survey “drug use in the past month” reports that the use of opioids has increased only 5% from 2003 to 2007 û from 2% of the population to 2.1%. During the same period the population grew 6%. How can this be called an “epidemic”?

In the DEA cited data from the survey “the use of psychotherapeutic drugs in the previous month”, the use of pain medications decreased 12.5% from 2003 to 2007. How was this data considered in arriving at a conclusion that an epidemic is occurring?

From 2003 to 2007, the DEA reports that the annual opioid production rose 51% - from 25,607 kg to 38,680 kg. Despite this increase, the “use of pain medication in the previous month” decreased 12.5% . Based on this data, how can DEA or FDA claim an “epidemic”?

Again, using the DEAÆs own data, the incidence of deaths per grams produced, per 100,000 population, decreased 11.6% from 2003 to 2007, while the amount manufactured increased 51.5%. DoesnÆt this data disprove any form of “epidemic” of drug use?

Based upon the federal government’s survey data, drug use of every drug, by all age groups, declined slightly from 2003 to 2008, and occurred amongst no more than 6.9% of adults for the use of cocaine, 1% for the use of crack, 0.5% for the use of Heroin, 1.9% for the use of metamphetamine, 12.4% of adults between the ages of 18 and 25, and 3.6% of adults 26 and over, for the use of prescription drugs. The use of “Prescription Narcotics” (presumably referring to opioids, benzodiazepines, barbiturates and other central nervous system affecting pharmaceuticals) has occurred in no more than 5.1% of all people over the age of 12, and has actually increased no more than 0.1% over the last five years. Doesn’t this data argue against an “epidemic” of prescription drug abuse?

Based upon the DEA’s data from “Monitoring the Future”, the use of “prescription narcotics” reached a maximum of 9.5% of 12th graders in 2004 and decreased to 9.2% in 2007. The use of sedative/barbiturates reached a high of 7.2% of 12th graders in 2005 and decreased to 6.2% in 2007. The use of tranquilizers dropped from 6.7% in 2003 to 6.2 % in 2007. Where is the “epidemic” in this data?

The incidence of hospitalizations primarily for substance abuse from 2002 to 2006 declined dramatically for heroin, barbiturates and tranquilizers. Hospitalizations for barbiturates declined 36.1% from 2002. However, hospitalizations for opiates and synthetics increased 62.0% for the period, from 46,138 to 74,750.

Given that there were 150,000,000 opioid doses legitimately prescribed in that year, will FDA and the DEA acknowledge that the incidence of hospitalization could have been no more than 74,750/150,000,000 (0.41%)?

Will FDA and the DEA acknowledge that the incidence of fatal overdoses from opioids diverted or illegally obtained could have been no more than 8,450/150,000,000? (0.0053%)?

Given that use of opioids has not increased dramatically in the last five years, will the FDA and the DEA acknowledge that the most logical conclusion is not that there is an “epidemic” of opioid usage, but that usage has become more frequent and reckless among a numerically tiny group of abusers and diverters?

Lastly, can the FDA and the DEA acknowledge that reducing the availability of life-saving pain medication for 50,000,000 legitimate and innocent chronic pain patients is an indefensible and inappropriate approach to reducing the abuse and diversion of opioids by, comparatively speaking, an extremely small number of reckless non-pain patients?

How will the FDA guarantee that any opioid-related REMS will not increase the current unavailability and unwillingness of physicians to prescribe effective pain control for legitimate, innocent and deserving chronic pain patients?

The National Foundation for the Treatment of Pain

J.S. Hochman, M.D.

Executive Director

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Anyone wishing to obtain a copy of the PowerPoint presentation specifically reviewing the data, please email jfshmd@gmail.com

The Drug War Inquisition

The following is part of a current dialogue on the LISTserve "The Project on Pain and Chemical Dependency" (TPPCD) which, founded by Russell Portenoy MD, is now over 30 years old and until four years ago was supported by Beth Israel Hospital (until it got too politically hot for them.
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On Fri, Jul 31, 2009 at 11:01 PM, Sara wrote:

To all,
While sitting and watching "Cops" and other such shows on TV, I am struck by how much more frequently drug busts these days seem to feature psychostimulants (cocaine and methamphetamine, mainly) and potential anti-anxiety drugs (benzos and pot), with a corresponding decrease in frequency of opioids. You still see plenty of IV heroin and other opioid users, but not many that pop opioid pills. This leads me to wonder about something. We have always speculated about how many opioid users wouldn't use if they just had an adequate amount of opioid for their somatic pain. (Pseudo-addiction) Along that same line, I am wondering how often the illegal use of these two classes of drugs reflects a legitimate medical need for them.

The huge frequency of the anxiety disorders has been well documented for the past 30 years. And still is grossly undertreated, with useless drugs like BuSpar, or inferior ones like the antidepressants, being foisted on the patients for much the same reason that gabapentin, tricyclics, antiseizure drugs and tramadol are dumped onto the pain patients. The safest, surest, most effective drugs --- the benzodiazepines --- are denied due to addiction myths and hysteria.

And even more, I wonder how many people on illegal pschostimulants or cocaine have some form of ADD, narcolepsy, or resistant depression that these drugs actually help. The numbers of such people are far less documented than are the anxiety patients, but their numbers may be just as large.

My wife has a severe anxiety disorder that would leave her in a constant and absolute hell were it not for a combination of SSRI, atypical antipsychotic, and Xanax. (Thank God her metabolism is such that only a tiny dab of Xanax will do the job, enough for her panic-stricken doc to prescribe!) Numerous attempts to wean down any of the three are met with prompt dysfunction, but she functions OK with them. But it has often occurred to me: For all I know, a couple of joints a day might eliminate the need for two of the three. Not that we would dare, but I have to wonder how many other people functioin well for just that reason, as long as their employer doesn't do drug screens.

I would welcome anyone's opinion on this. Joel's perspective as a psychiatrist and Stu's as an addiction specialist would be especially valued, but I'd like to hear from anyone. What percentage of people currently labeled as abusing psychostimulants or pot are actually "pseudo-addicts" just like with pain treatment?
Joe Talley, M. D.

OK. Let me reflect a bit. I have been a psychiatrist for 39 years. I have over 100,000 hours of clinical experience. I have treated approximately 10,000 patients (in and out-patient) and 4,000 intractable pain patients. So, how many patients have I seen with:

1. opioid (for pain treatment) induced addictions
2. benzodiazepine addiction
3. cannabis addiction

The answers are:

1. 0 I have seen hundreds of patients who came to me for opioid addiction (mainly heroin) who were not pain patients (methadone candidates in the 70's, 80's and 90's, now Suboxone candidates). But I have NEVER seen a patient who developed an addictive disorder from taking opioids for pain. I understand this because the pain perception mechanism lies in the periaqueductal grey area of the brain and pleasure is mediated in the nucleus accumens. Apparently the neurophysiology is very different. Stimulating pleasure by exogenous opioids requires dose escalation at the nucleus accumens. Controlling pain at the P.A.G. does not. Once you reach containment the patients remain stable in dose and schedule for decades (unless the underlying pathology becomes significantly worse or the patient does things that aggravate the pain).I have followed 204 cases now for over a decade whose data absolutely demonstrates this.

Footnote: If Mr. Craig Dietrich will ever finish his commitment to
analyze the data and complete our manuscript I will have a ground-
breaking,peer-reviewable article to establish this once and forever.Craig
works at a major hospital here in Houston. His employment contract
states that he cannot do research or analytical work for anyone else.
They insisted on reading the manuscript and then told him if he published
it he would be fired. He has repeatedly promised to bring me the finished
m.s.and all the data and reference material I have sent him. To date
he has not done this. I am having a fit.

2. 1 When I was doing in-patient psychiatric medicine I once got a patient
through an emergency commitment who was strung out on benzos (Xanax 6 to 8 mg/day). It took about a week to resolve the case by officially diagnosing his Anxiety and Panic disorder, migrating him to a longer-acting drug, Klonopin, and initiating an effective anti-depressant treatment. I followed him for four years afterward and he never had another problem.

3. 0 I have seen hundreds (if not thousands now) of patients who experimented
with cannabis, smoked it regularly when they were younger, or continued to use it for decades. The results of a five year study I ran at UCLA were published in my book, "Marijuana and Social Evolution" (Prentice-Hall, which is still available on Amazon.com) reviews the extensive data developed in this multi-million dollar NIMH sponsored study at UCLA.) It destroyed my academic career, for which I have been eternally grateful.

As my data analysis of the Drug Czar's (and the FDAS's) own data on the "epidemic of drug diversion and abuse" demonstrates beyond any rational doubt, all this current brouhaha about "drugs" is a pile of you know what. It serves the vested interests of politicians, law enforcement, right-wing ideologues, troglydyte Board of Medicine members, judicial-correctional-legislature entrepeneurs. Michael Jackson was, statistically speaking, about four standard deviations outside the norm in the bell-shaped curve of human behavior. But, of course, all the above will attempt to use his sad life as evidence to support their cynical and/or self-deluded hysteria. All we can do is sit patiently in the middle of the riot and keep repeating our mantra - "two plus two is four. It is not six or 104. It is four." Of course we run the risk of being burned at the stake, because truth, rationality and reason are not popular in Inquisitions (ask Gallileo).
JSH