Bombing the Arkansas Medical Board

Bombing the Arkansas Medical Board

Arkansas: Doctor Found Guilty in Bomb Attack
By ROBBIE BROWN
Published: August 9, 2010
NY Times

A federal jury on Monday convicted a physician of conspiring to detonate a car bomb that badly injured the state medical board chairman. Dr. Randeep Mann faces the possibility of life in prison in the February 2009 bombing in West Memphis, Ark., which left the board chairman, Dr. Trent P. Pierce, badly scarred and partly blind. Prosecutors said the bombing was in retaliation after the board twice sanctioned Dr. Mann for overprescribing pain medication. Dr. Mann’s wife, Sangeeta, was convicted of conspiring to conceal evidence. Prosecutors say that they do not believe the Manns planted the bomb, but that Dr. Mann ordered an unknown person to do so.
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I cannot condone bombing anyone or anything, but I can certainly understand the depth of anger and frustration Dr. Mann must have experienced.

The Arkansas Medical Board is a leading terrorist organization, in my opinion, in the opiophobic campaign against opioid prescribing doctors. This same Board, under the generation-long reign of a Dr.Juette, persecuted Dr.Robert Kales (a fine physician)right out of the state, and personally tyrannized the state's medical community. Perhaps it was no coincidence that Juette was also the medical director for Walmart, which certainly didn't want to pay for pain medications for injured employees. Juette made sure they didn't. Apparently his successor shares the same mission. Now he has to pursue it from a wheelchair, with one eye.

When the People wake up to the venality, cruelty, selfish self-interest, opiophobic "racism" and plain stupidity that supports this denial of legitimate pain care, they will rise in revolt. It can't come a day too soon for me. We don't need to use actual bombs. We just need to set a political bomb under our chicken-hearted and/or misguided lawmakers. They either need to do the job right, and intelligently, or they need to find another job.
Dr. Hochman

Prescriptive Drug "Abuse"- the REAL facts

Emergency Department Visits Involving Non-medical Use of Selected Prescriptions - Unites States 2004-2008 MMWR 2010;59:705-509
JAMA, August4, 2010 -Vol.304, No.5, p 515

"In contrast to the results of this study, NSDUH (National Survey of Drug Use and Health) results have shown no increase in self-reported rates of non-medical use of selected pharmaceuticals since 2004. Increasing ED visit rates in the context of stable self-reported nonmedical use rates might indicate that persons seen in EDs are different from typical respondents to NSDUH; a shift towards riskier types of pain relievers and benzodiazepines, riskier modes of use, more frequent or heavier use; and/or an increased tendency to seek emergency care because of greater awareness of the serious consequences of nonmedical use of such drugs."

I have repeatedly pointed out in responses to the FDA's proposed REMs on opioids, on the web site of the National Foundation for the treatment of Pain, on the blog: jfshmd.blogspot.com, and in e-mail to journalists, attorneys, federal and state representatives, precisely what is reported above - that government sponsored research has shown no increase in self-reported rates of non-medical use of selected pharmaceuticals since 2004.

This stunning fact has been ignored, obscured, or un-reported, in the latest media frenzy to create fear and hysteria in the public, about prescription drugs. The reason is clear - it undercuts the propaganda about the "epidemic" of prescription drug overdoses in America.

In fact, of the 1.6 million ED visits for the abuse and misuse of drugs in 2004, and the 2.0 million such visits in 2008, illicit drugs such as cocaine and heroin were involved in 1 million visits in both 2004 and 2008. The estimated number of ED visits involving the non-medical use of opioid analgesics increased from 144,000 in 2004 to 305,000 in 2008, an increase in rate from 49.4/100,000 to 100.6/100,000 in 2008. The number of overdoses, even increased from 2004 to 2008, represent a statistically tiny and insignificant number, compared to the hundreds of millions of doses of prescriptive medications ingested annually, and safely.

The essential fact is that the abuse of prescriptive drugs has NOT increased in the general population. Rather, what has increased is the abuse and overdose of prescriptive medications by an aberrant and atypical cohort amongst the general public, and the extensive and flamboyant coverage in the media this group has gotten. The media, encouraged by selected federal agencies, has then falsely extrapolated the aberrant phenomenon to the general population. The plain truth is that, despite the large increase in prescribing of analgesic medications over the last four years, there has been NO increase in the rates of non-medical use of selected pharmaceuticals.

The governmental campaign to reduce the availability of prescriptive pharmaceuticals is without validity or value. If implanted, it will simply make it more difficult for patients to obtain the medications for which they have a medical necessity, it will only further deter physicians from prescribing "unpopular" and "demonized" medications, it will further confuse and mislead the public about prescriptive medicines, and it will have no impact, whatever, on the core group of atypical and aberrant abusers of prescriptive and illicit drugs.

In sharp contrast to "Drug War" propaganda, it would be far more valuable to focus attention, funding and resources on identifying the aberrant group who present a mortal risk to themselves, educating the public on the need to provide them effective intervention and medical help, and reduce the pathology that underlies their increased rates of harm to themselves. In that regard, it is not clear to what extent this group is increasing as psychologically damaged military veterans return to civilian life, bringing their substance abuse symptoms and suicidality with them.

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

J. S. Hochman MD

to Jared, Barry, Barbara, bettina, billy.neel, Brett, batlas, Brian, Brigette, Donny, Taylor, capthill, Carey, Cathy, Don, Bob, edye, paul, Gene, Gina, iand14, Jeffrey, joseph, Joyce, karen, Kelly

In response to the link, below, to a video Jared circulated of a really "pissed off" guy:

https://mail.google.com/mail/?ui=2&ik=c7e3742ffb&view=att&th=12a25c8dec6d8467&attid=0.1&disp=attd&zw

Jared:

I am convinced that this kind of scree fits right into the "smoke and mirrors" that keep us all from focusing on the real issues. The real problem is that the United States has become a nightmare of political corruption that involves virtually every politician, state and federal, and the labels "Democrat" and "Republican" are just red herring distractions. Likewise, the labels "liberal" and "conservative" are meaningless distractions.

* What is "liberal" about a tax code that is 80,000 pages long now, in order to accommodate the special privileges that individuals and corporations have bought from politicians since the 22nd amendment eliminated the Constitutional restriction that allowed a federal tax on individuals only "if based on a census" (i.e. divide the cost of government by the total number of citizens).

* On the other hand, what is "conservative" about a two-term president who spent the nation into bankruptcy on a Middle Eastern war that has now lasted longer than Vietnam, killed a million people, and is unwinable?(What is "conservative" about who got all the money we've thrown away on it?)

* What is "conservative" about bailing out banks and insurance companies that had cheated and swindled their way to profits in the hundreds of billions, and allowing them to PROFIT by the hundreds of billions in the bailout?

* What is "conservative" about jailing a million and a half people in federal prisons for non-violent drug crimes (at a cost of $68,000 a year per inmate at privatized prisons owned by politicians and their fellow-travelers) when the infrastructure of the nation is falling apart, most importantly public education, and highways, bridges, power grids, water systems, etc.?

* What is "conservative" about the fact that 1 out of 51 people were on federal probation or parole in 1985 and the figure is now 1 out of 12? What is "conservative" about the fact that America is the only developed nation in the world that murders its citizens and calls it legal because 500 pounds of legal paper sanitize the act?

* What is "conservative" about a nation that permits a true tax rate of almost 51% (Holland's is 50%) (including income tax, sales tax, state income taxes, inheritance taxes, property taxes, etc, etc) and unlike Holland, which provides every conceivable kind of assistance to its citizens from birth to death, gives its citizens NOTHING?

It is not an issue of right or left, black, Hispanic or white, it is an issue of criminal exploitation of every person in the country by the less than 3% of the population who own 98% of the wealth and control a totally corrupted Congress and Executive branch through political "contributions".

* On that subject, when we were trying to legislate reform in our health care (ranked number 46 in the world, right behind Albania) insurance and pharmaceutical corporations spent $500,000 a DAY, that's $1000 a day on every member of Congress, controlling the outcome of the Health Care Reform Act. (The Act states that 80% of premium income must be spent on health care. Now the insurance company lobbyists are fighting to control how that is defined - so that their corporate aircraft, $100,000,000 a year CEO salaries, Board junkets to Monaco, etc., can be defined as "part of health care". Part of how they want to define health care is also the hundreds of millions they spend controlling what doctors can prescribe and how they can treat, their patients.


As long as the mega rich and the media they own can keep the American public "pissed off" about everything EXCEPT the REAL issues, nothing will change in this country for the average person who pays ALL the taxes. The founders of the American republic are spinning in their graves like gas turbines. For God's sake we had a revolution over a tax on tea! What would they think about America now? The Oligarchs of Wall Street and all their moneyed co-conspirators make King George the III look like Mother Theresa.

It is NOT about how many illegal Mexicans have smuggled their way into the United States to escape the drug war in Mexico and the grinding poverty the Mexican Oligarchs have kept them in since the Maya farmed them for food. It is NOT about how many guns you can own. It is NOT about corrupting the whole focus of education into passing meaningless tests that are supposed to create "accountability". It is NOT about piling laws and regulations on top of laws and regulations to keep 8,000 whacked out people from killing themselves every year with illicitly obtained prescriptive drugs. It is NOT about whether white people are threatened by the growth of minorities in this country. It is about everyone, white, black, brown, yellow, red, any color, being degraded into serfs as powerless as those of the middle ages.

The history of Mankind is a nightmare of exploitation of our own. What we have now is that same nightmare souped up by the information age, megabucks, instant communication, the ability to track every individual in the world constantly, and the complete distraction and bamboozlement of the American people from this reality.

Your friend in the video is definitely pissed of. But he hasn't a clue about what he is REALLY pissed off about. He's too busy listening to Rush Limbaugh and the other phonies and hucksters who have made themselves millionaires pandering to the big boys, and exploiting the rage of the little guys, as they distract their listeners from reality.

If you want to really get something done, tell everyone you know to wake up.
All this conservative-liberal, Democrat-Republican stuff is gossamer bullshit.
Joel

"When Pain Drugs Hurt" - According to Whom?

August 2, 2010

To The Editor
The New York Times
Re: “When Drugs Hurt”

It is roundly accepted that approximately 26% of the population suffers from chronic pain. Inadequately treated pain commonly results in the destruction of lives – bed-ridden, unable to function, cut off from family, friends and society. It is a living nightmare for the victims. Virtually every chronic illness will result in chronic pain. And virtually every person will confront this during his or her lifetime.

Chronic pain, when adequately treated, can virtually always be controlled. Tragically, however, few physicians have the experience, training or confidence to prescribe adequately. Paradoxically, when confronted with the failure of their inadequate treatment, pain “specialists” (most often anesthesia-trained “interventionalists” who prefer remunerative procedures over cost-efficient prescribing) rationalize their inadequate dosing with various chimera. They hypothesize patient non-responsiveness, or hyperalgesia (a mythical syndrome in which the patients develop increased pain in response to the pain medications), or demonize the patients as non-compliant, drug-seeking or addicted, when the simple truth is that they have failed to prescribe adequately.

Adequately treated pain patients blossom – they regain the quality of their lives and consider their treatment to be “miraculous”. They suffer no complications, adverse effects, impairment of cognition, or the induction of any form of addictive disorder. They do become physiologically dependent, just as a diabetic would upon insulin or a cardiac patient upon digitalis – sudden discontinuation of their medication will result in definite withdrawal symptoms. Compliant and legitimate pain patients virtually never suffer overdoses. But pain patients must often travel hundreds, if not thousands, of miles to find a physician with the expertise and training to treat them adequately, and most state medical boards, although paying lip service to supporting pain care, intimidate physicians so consistently that few doctors are willing to undertake pain treatment (just ask your private medical doctor if he is willing to write a schedule II prescription.)

The current campaign to reverse the progress of pain management in the last decade (a 30% increase in prescribing) is driven by a resurgence of “opiophobia” (see the original article in 1984 by John P. Morgan MD); by the attempt of interventionalists to corner and control the pain treatment market; by the attempt of insurers to escape or extremely limit the costs of treatment; by addiction treatment mavens who want to label all opioid using patients as candidates for their services; and by “drug warriors”, who having totally failed to solve any illicit-drug related problems after a trillion dollars of income, now seek to continue their gravy-train by redirecting the tabloid-driven hysteria about drugs to the prescriptive side. The drug war is a total scam and the perpetrators can be simply identified by noting where the trillion dollars went.

The current media-supported propaganda is based upon the “epidemic of overdoses” over the last five years. Two facts are neglected in these breathless articles. First, federal surveys over the last four years show that drug us in America has actually decreased . Second, although Emergency Room visits doubled and there were 8,000 deaths in the last three years from drug overdoses, none of the deceased were pain patients. or "little old ladies" from the general public There were over 50 million doses of OxyContin consumed last year. How do 8,000 crazy abusers killing themselves compare to the good done for the majority millions? It is not ‘little old ladies with arthritis” as claimed by Dr. Cahana, but reckless drug-abusers, most often combining illicitly obtained opioids with alcohol, benzodiazepines and many other drugs. The millions of little old ladies with arthritis cannot even FIND a doctor willing to prescribe, so they remain crippled and denied.

Analysis of the actual data cited by the hystericals and the political fellow-travelers reveals that the use of opioids has increased significantly without statistically significant harm. The harm cited in your article is not to legitimate patients, but to abusers who, apparently driven by “natural selection”, relentlessly find ways to take themselves out of the genetic pool.

What is needed is to require every physician to become expert in the ADEQUATE treatment of pain, compel them to treat ALL legitimate pain sufferers, and to provide adequately funded treatment for every person (a tiny percentage of the whole) who suffers an addictive disorder, or who reveals their compulsion to abuse prescriptive or illicitly obtained drugs by overdosing.

The current tabloid campaign is simply an attempt to resuscitate Opiophobia – throwing the baby out with the bathwater – by a conspiracy of the misguided, the self-interested, insurers, the ideologues and the trillion-dollar enriched scam artists behind the war on drugs - now trying to morph into the war on doctors and legitimate pain patients.

J.S. Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org
1714 Whoite Oak Drive
Houston, Texas 77009
713 982-9332

Dr. Petersohn of Philadelphia

Sirs:

If you are the idealists you aspire to be, GIVE the software to your colleagues for a single nominal fee which reflects the cost of developing the product. Charging a monthly fee is a scummy ploy to regularly extract money playing on the fears of physicians who keep poor records, maintain a dubious standard of opiate prescribing, and routinely use industrial strength controlled substances because they are not fully trained pain docs or because they have realized how much money they can make writing controlled substance medications with little or no medical basis as opposed to the hard work that is legitimate medical practice. These practices are no better than the epidural injection or trigger point patient mills favored by ambulance chasing attorneys. If we succumb to these poor practices, we are little better than used car salespeople or politicians.

Offering single-modality treatment with opiates by prescription to the majority of patients in any practice, even a pain practice, is the modern version of "Tea and sympathy," and a highly suspect strategy employed in desperation to provide a simple (but ineffective and inappropriate) solution to a complex problem because the physician, however well-intentioned, lacks the skills and knowledge to evaluate and resolve the underlying problem. Yes, perfect interventional and rehab solutions do not exist for all problems, but most patients who benefit from erudite professional care.

We all know that opiate outcomes are mediocre overall, seldom resulting in improved patient function over years or allowing return to work, etc. The data simply do not support opiophile practice, yet the opiate industry supports groups, like the American Pain Society and the American Academy of Pain Management, yes, and also the throw-away "journals" which espouse opiate medications and oppose interventional treatment. Hard to trust these organizations, in that interventional treatment is based on clearly defined principles of anatomy, neurology, physiology, neurosurgery and orthopedics which have superior outcomes with robust literature support.

As an organization, you will likely go broke defending the practices of the many physicians who charge $100-120 per patient office visit for writing Rx opiates without REAL medical indications. I have seen at least three physicians taken out of practice in my county in the past year and all of them truly deserved to be forcibly retired from their suspect practices, yet more of these fellows remain in their offices, writing Rx's and watching their cash registers ring. These docs should be closed down and the DEA and State Police should be watching these practices closely. While you espouse a noble cause, we must see how noble you are by your standards and your actions or disappointingly, if you are just another group of get-rich-quick schemers. I hope you are the former.

Jeffrey D. Petersohn, M.D
Adjunct Associate Professor
Department of Anesthesiology
Drexel University School of Medicine
Philadelphia, PA
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Dear Dr. Petersohn:

I have practiced the medical management of chronic pain for almost 20 years now. I have a paper in draft for submission for peer review that reports the results of following a universal sample of 204 patients (every consecutive pain patient enrolled in treatment) for ten years. The paper reports the regimen, the doses and schedules, the pain levels, the functionality, adverse consequences (including aberrant behaviors), range of motion and patient and family reports on outcome.

The medical management of pain is bi-phasic. The first phase, after review of history, initial evaluation, affirmation or determination of diagnoses and construction of a plan of treatment, is titration to effective pain control. In conformity with all Standards of Care, dosage and schedule of opioids is entirely individualized, with no restrictions by pre-conceived notions of "maximum" doses.

The second phase is long-term , almost totally stable (pathology does increase in some cases, requiring occasional [but relatively few] adjustments in medication. Virtually every patient in the study achieved remarkable improvements in pain levels, functionality, range of motion (often more than 20"), family confirmation of improvement, with VERY few incidents of aberrance. No overdoses occurred. A few patients were terminated for non-compliance, often determined by urine testing for compliance or obvious "red-flag" events.

If you believe that long-term opiate management is rarely successful it is most likely the consequence opiophobic
under-treatment.
Regarding the PPLA, the offer of electronic medical record keeping is not an activity owned by PPLA. It is an outside source through Medical Office Online. I myself pay the monthly fee (from which PPLA receives NO benefit), which I find to be not only very helpful in maintaining my medical records in compliance with the looming EMR requirements under the Health care Reform Act, but also very inexpensive in comparison with on site hardware and software alternatives.

We share with you your disdain for "Pill Mill" pain treatment. But we do not demonize these operations. They are obviously a free-market response to the millions of blue-collar pain patients who are un or under-insured, and for whom $100 a month is a lot of money. The "War" on these clinics is actually a "War" on blue-collar pain patients (see my blog entry on this subject at www.jfshmd.blogspot.com). Relatively few of the hundreds of patients who attend these clinics are criminals. But the authorities, seeking to maintain the anti-drug hysteria that has directed a trillion dollars of funding into their pockets over the last 20 years, have shifted from anti-illicit drugs (a total failure) to prescription drugs, as a self-serving propaganda campaign to continue their gravy train.

I personally also decry the Intervention-mills, where, as Perry Fine mentioned to me recently, "the only requirement for utilizing procedures is an insurance policy." Interventionalism" has become just another money-making scheme, unimpeded by any scientifically defensible outcome data, which strongly requires the construction of Standards of Care and decision-tree criteria, with robust outcome studies.

We have spent five years bringing PPLA to the medical profession, to encourage the legitimate and effective treatment of millions of unnecessarily crippled patients. Opiophobia, and the fear of regulatory catastrophe, stand in the way of that goal. PPLA provides a state of the art Standard of Care and Record-keeping, the services of a panel of pain-management "luminaries" to provide expert consultation and legal defense expertise, highly accomplished legal consultants to guide legal defenses where necessary, inexpensive EMR, and up to $500,000 of legal defense (to prevent the bankrupting of legitimate doctors.) No practitioner-member of PPLA who practices below the Standard of Care will meet the criteria for being defended.

We urge that you join, and if you are so inclined, join our Professional Advisory and Review committee (along with Perry, Sharon Weinstein, Stratton Hill, Steven Simons, Joe Pergolizzi, and ten others.) And I urge you, before you go off on something about which you clearly had done little exploration, to do your homework first.

J.S. Hochman MD

Phony statistics, Fear-mongering and the Drug War Swindle

See the article from Time Magazine, below.

Experts in the field have known for a long time that claims that deaths were caused by opioids are supported by blood level data that is unreliable. Opioid blood levels in chronic pain patients are not in any way comparable to those in opioid naive patients. Toxicological "standards" typically used by coroners are inappropriately based on naive patients. Clearly prosecutors have no interest in science, except to distort it to win convictions.

Further, the media fails to distinguish the difference between "occurrence" and "incidence".The claim that opioid overdoses have "tripled" in the last decade disregard the fact that the prescription of opioids for pain has increased by approximately the same proportion. Further, when one compares the number of overdose deaths claimed for OxyContin - 8,000 in 2009 - to the total number of doses of OxyContin prescribed - about 50 million - the INCIDENCE of overdose deaths is statistically insignificant (in fact, trivial.) Further, most of these deaths occurred in the presence of alcohol and many other drugs, ingested by crazies, not patients.

The War on Drugs, and it's subsidiary, the War on Pain Patients and Doctors, is not only a catastrophic failure, at the cost of almost a Trillion dollars, but is also a gigantic swindle. Playing upon the fears of a naive public, and the lack of rational and critical thinking, a whole "Drug War" industry has profited enormously. A simple analysis of where all this money has gone will reveal who the swindlers are.

Hopefully that data will be emerging in due course, as the nation wakes up to the crimes of the "Drug War"
J.S.Hochman MD
Executive Director
NFTP
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In a case in Wichita, Kansas which has garnered national attention, Dr. Stephen Schneider and his wife, Linda, the local doctor-and-nurse team are accused of running a large-scale "pill mill" and dispensing prescriptions that led to the drug-related deaths of 68 patients. Prosecutors allege that the Schneiders illegally prescribed large amounts of powerful painkillers for profit, with little regard for patients' safety. The defense, along with some former patients, argue the Schneiders provided sound and compassionate care, and that the deaths were due to underlying conditions or dangerous choices by addicted patients.

The couple's trial, which has been ongoing since April, has once again shed light on the increasingly sensitive issue of prescribing high doses of opioid medications for pain. Opioids (drugs such as fentanyl, oxycodone and hydrocodone, which the Schneiders prescribed), which are crucial for the welfare of pain patients, especially at the end of life, are unfortunately better recognized as addictive drugs associated with overdose death.(See Ledger, Heath.) And although the popular perception of these substances is in many ways misguided, cases like the Schneiders' highlight the dangers of prescription-drug misuse.(See the top 10 medical breakthroughs of 2009.)

But the case has also highlighted the difficulty of accurately determining if a cause of death is indeed a drug overdose. With the rate of prescription-drug-related overdose deaths more than tripling in the U.S. since 1999, according to the Centers for Disease Control and Prevention — and with physicians sometimes being prosecuted for contributing to these deaths — it is the courts, not physicians, that are increasingly forced to make judgments about drug-users' real cause of death.

Unfortunately, the mechanics of that determination are poorly understood — sometimes even by the toxicologists, pathologists and medical examiners who make the call. Circumstances of death surrounding drug use are also often difficult to untangle: In the Schneider case, virtually all the patients who died were found to have multiple drugs in their bloodstream, often including illegal drugs; in addition, many of the patients were known sufferers of chronic pain with chronic, life-threatening diseases such as heart disease and high blood pressure — conditions that can cause death on their own, without drugs.
Much of what scientists do know about drug-related death comes from the 25 years of research by Dr. Steven Karch, a cardiac pathologist based in Berkeley, Calif., who has written two widely respected texts on the topic. On June 7, he testified for the defense in the Wichita case, stating that in most instances of drug overdose, the currently available medical technology cannot accurately determine whether or which drugs caused death.(See how people get addicted.)

Several scientific factors conspire to complicate the issue: First is the widely acknowledged question of tolerance. Patients who take pain medications over the long-term will necessarily build up some amount of tolerance to the drugs. That means that a dosage of a painkilling opioid such as methadone or fentanyl that would be therapeutically appropriate for a pain patient could be enough to kill a person who has never taken them before; in a methadone patient, an extremely high dose might not even be enough to address withdrawal symptoms.

In other words, Karch says, the "lethal dose" of these drugs is impossible to standardize, even for patients who are taking a single drug rather than a combination of many. A 2000 study by Karch compared methadone patients who had died from clear causes, such as car accidents, with those who had died of a suspected overdose. Karch found that there was no predictable difference in the postmortem blood levels of methadone between the two groups. In fact some of the patients who died of other causes had higher levels of methadone in their bodies than those thought to have overdosed. "You can die from a drug and you can die with a drug," says Karch. "When you have four orders of magnitude separating either end of the curve, many of these deaths may not have to do with drugs at all."

At least one forensic tool helps clarify the question in some cases, according to Karch. In 1999, Karch testified on behalf of the prosecution in a case against a British physician who was convicted of killing 15 patients by injecting them with heroin (a legal painkiller in the U.K.) and is suspected of having killed hundreds of others. By analyzing hair samples, which can record an individual's history of drug use, Karch was able to show that the patients were not prior drug users and were, therefore, almost certainly killed by the drugs the doctor administered. This technology, which can cost thousands of dollars per analysis, was not used in the Schneider case, during which the medical examiner testified that a person's drug history is "not something that I usually consider or go into" when drugs are detected in the body and no other cause of death is apparent.

A second complication in cause-of-death findings is what medical examiners call "postmortem redistribution," the shift in detectable drug levels that occurs after a person dies, according to Fred Apple, medical director of clinical laboratories for the Hennepin County Medical Center in Minnesota. Many drugs that may be contained in fatty tissue in a living body are released into bodily fluids after death, which confuses the analysis of substance samples taken postmortem.

In a study published in March in the American Journal of Clinical Pathology, Apple and colleagues measured fentanyl levels in bodies immediately after death and again several hours later at autopsy. The researchers found that some bodies had no detectable levels of the drug at the first measurement but showed significant levels at the second — and that these levels varied widely depending on which part of the body was sampled. Since it is not always clear when exactly a person died, or how long redistribution takes, the variance could make a therapeutic level of a drug appear toxic, or vice versa.

What is clear, however, is that juries across the country are in some cases hearing evidence based on shaky forensic science or from forensics professionals who lack the necessary expertise. According to a 2009 report by the National Research Council of the National Academy of Sciences: "Rigorous and mandatory certification programs for forensic scientists are currently lacking...as are strong standards and protocols for analyzing and reporting on evidence. And there is a dearth of peer-reviewed, published studies establishing the scientific bases and reliability of many forensic methods. Moreover, many forensic science labs are underfunded, understaffed, and have no effective oversight."

Given the state of the science, then, should it be used in court? Ed Cheng, a professor of law at Brooklyn Law School and expert on scientific testimony, says, yes, noting that more research is still needed. "If we were to require studies and statistical assessment on every assertion, almost nothing would be able to be used in court. My view on this is that the question here is not throwing the baby out with the bathwater," says Cheng. "It's clear that the forensic sciences do not have as much of an empirical basis as we would like them to have. The question becomes how do we motivate them sufficiently to come up with the empirical basis that we want?"

Some experts do agree with Cheng. "The evidence base is improving," says Apple, who is currently conducting a study of blood and tissue samples taken postmortem, in order to build up a usable database of drug information. "So when people have to make death determinations from smaller jurisdictions where they don't have [an expert on staff] like me, they can make them with some assurance."

But Karch is less sanguine about the reliability of such data and thinks that as long as the reliability of forensic evidence is still evolving, it has no place in court. "It's a giant miscarriage of justice," he says. He recalls the malpractice and murder convictions that were won many years ago against doctors who were thought to have killed patients by administering digoxin, a drug for arrhythmia and other heart problems. It turned out that the drug collected in the heart muscle in live patients and was released into the body after death, making safe doses of the drug look deceptively high — a result similar to those seen in current studies of fentanyl and methadone.

In the Schneider case, which entered jury deliberations on Wednesday, the defense team sought and failed to prevent the jury from hearing testimony that it believed did not have sufficient scientific foundations. But according to Cheng, it may be preferable to let the jury hear both sides of the scientific dispute and make up their own minds. "I myself have floated between the poles on this," he says. "I'm currently more on the 'Let the jury hear it' side. I'm not convinced that good science and bad science is always cut and dried."

Read more: http://www.time.com/time/health/article/0,8599,1996831,00.html?xid=rss-%20topstories#ixzz0tqsBnxR5
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The Schneiders were convicted - two more casualties in the Phony War. Of course, it isn't phony to them, as their lives have been destroyed. Hopefully in time the wheels of Justice, grinding exceedingly fine (but horrendously slowly) will undo this travesty.

The Intertventionalists' Fraud (Florida, Texas, Louisiana)

Contact: Paul Sloan
pas401@gmail.com

PAIN CLINICS: GRAND JURY REPORT DECEPTIVE

Special Report Uncovers Omissions, Misrepresentations, and Deception in the
Interim Report of the Broward County Grand Jury (Venice, Florida: July 15, 2010)—

A thirty one page research report released today by the Florida Society of Pain Management Providers, available online at www.FLPainNews.com, challenges many of the purported factual findings of the Broward County Florida Grand Jury Report on Pain Clinics (released on November 19, 2009). The result is a document which is factually deceptive and what is left contains far more innuendo than fact.

The Grand Jury, convened in the spring of 2009 by Michael J. Satz, State Attorney for the Seventeenth Judicial Circuit, to study the “proliferation of pain clinics in South Florida” was substantially influenced by special interest groups. The purpose of these groups appears to have been to influence legislation and governmental agencies in the development of rules that would regulate their field. The testimony by these special interests groups went un-researched and unchallenged by the State Attorney.

The research report details how the “The Grand Jury Report is ultimately an embarrassment of monumental proportions because of the slanted, biased, and misleading testimony by “pain medicine specialists” and the complete lack of any law enforcement data or statistics,” says Paul Sloan, Director, of Florida Society of Pain Management Providers and author of a special report, entitled, The Omissions, Misrepresentations, and Deceptions as Reported in the Interim Report of the Broward County Grand Jury, says, “In many cases, what the report states as facts, are in most cases anything but. This Grand Jury reports becomes just another example of why most jurisdictions in the United State have abolished this medieval process.”

The special report, compiled and submitted by Paul Sloan began as research for a series of submissions to the Florida Board of Medicine and Osteopathic Medicine when those boards were conducting rules workshops for pain clinics. Mr. Sloan noticed that the assertions being cited by two professional medical societies with mutual members and interests were not based on any known facts. A review of the testimony and the assertions that found their way into the grand jury report evidenced a well organized and orchestrated scheme to influence both the workshops and legislation. The desired effect: create a monopoly in their specialty field. It is Mr. Sloan’s belief that what was most dishonorable is that this was all done under a guise of concern over the accidental death rate related to the diversion of pharmaceutical medications.

Members of the Florida Society of Anesthesiologists (FSA) and the Florida Society of Interventional Pain Physicians (FSIPP) have attended the joint medical board’s workshops in great numbers and have spoken directly to their desire to eliminate non board certified pain medicine physicians from the specialty field. As evidenced in the special report, it was recently revealed that these societies’ members (some in public positions) have also been manipulating county zoning ordinances to drive out non board certified physicians.

These actions are concerning on both ethical and legal grounds. One of the findings, which was recently uncovered by Mr. Sloan, contrary to nearly all testimony on the subject, is that there are only 204 board certified pain physicians currently practicing in the State of Florida.

The societies desire to drive out all others from this field, if successful, will be at the expense and detriment to the 18,500,000 citizens especially the uninsured and under insured (Medicaid) whose access to pain care will be severely restricted. There are no board certified pain physicians in 31of the 67 counties in Florida and in fact there is just 1 boarded certified pain physician for every 91,765 residents. This puts Florida into the same category as some 3rd world countries. According to Mr. Sloan, currently in South Florida, alone, there are 13 contiguous counties covering 12,000 sq miles with a population in excess of 5,000,000 without a board certified “pain specialist” to treat Medicaid patients.

It is unfortunate that many well educated and respected individuals believe that Grand Juries are a legitimate and ethical institution and in return accept their reports as the unquestionable fact when in fact they are easily manipulated in order to reach a predetermined outcome.

The Special Report is available online as www.FLPainNews.com For more information e-mail Mr. Sloan at pas401@gmail.com
--------------------------------------------
NFTP previously commented on the current assault on "Pill Mills",

http://www.blogger.com/post-edit.g?blogID=4271454310269129358&postID=6364312137204145508

pointing out that it is actually an assault on blue-collar pain patients. With this news release the REAL source of this unconscionable campaign is revealed.

I am ashamed of any physician who would participate in such craven self-interest. But, this is what is happening. Drug "warriors", of course, are happy to go along, as it serves their self-interests (perpetuation of the fruitless and counter-productive waste of a trillion dollars in the last two decades, from which they have profited extraordinarily.)

When will the American public wake up to this swindle?
J.S. Hochman MD

The Invisible Victims

The Invisible Victims

 

Many official sources, including the National Institute of Health and the American Medical Association, estimate that 26% of the population suffers from chronic pain. The causes are as many as the number of chronic illnesses. This amounts to over 75 million people. Yet no one seems concerned that the vast majority of those who suffer, often bed-ridden from pain, cannot find a doctor who is willing to provide medical management for them. Tens of thousands of doctors are glad to try invasive procedures -- blocks, epidural steroid injections, trigger point injections, nerve ablations, even implanted opioid pumps and spinal cord stimulators, but few are willing to consistently prescribe the pain medications that can give quality of life back to these patients - and even fewer doctors are willing to titrate those pain medications high enough to be effective.

These millions of patients are invisible victims. They do not have a distinctive ethnic appearance. They have no loud voice in the media defending them. No Congressional investigation has recognized them. Instead they are lumped into the pejorative "drug-seekers" and treated as criminals when they seek help.

Physicians ignore them either because they, themselves, suffer from "opiophobia" - a kind of pharmacological racism, in which opioid medications are perceived as evil, bad, addictive, inducing abuse, diversion and cognitive impairment. While none of these things are true (in fact opioids are probably the safest medications doctors can prescribe), like racial prejudices, these beliefs stem from irrational beliefs, and defy factual education.

Doctors who are not blinded by Opiophobia, still avoid prescribing for pain patients. They fear condemnation, or the impairment or loss of their medical licenses (state medical boards continue to be the prime source of perpetuating Opiophobia). They also fear criminal prosecution in the on-going War on Drugs War on Doctors. Even though the evidence reveals that the vast majority of illicitly used drugs are diverted from manufacturers by theft or pilfering from shipping, the media promotes the myth that doctors are the prime source. Drug Warriors, in turn, use this myth to promote the propaganda that today's crisis is "the abuse of prescription medication" and the villains are the doctors who write the prescriptions!

All this lacks an iota of common sense. Common sense would tell us that there are a billion prescriptions written, filled and safely used, each year, and only 8,000 overdose deaths from half-witted kids consuming their parent's medications (with alcohol, cocaine, marijuana, benzos, and anything else they can get their hands on.) Common sense would tell us that demonizing doctors and legitimate prescription is insane and mindless. What doctor writes prescriptions that aren't medically indicated? Further, since when does limiting the number of prescriptions written deter adolescent and adult craziness? They simply turn to alcohol instead, (the most dangerous and toxic of ALL drugs) just increasing the volume? Is that going to reduce the number of alcohol-related deaths in teens and young adults? Sure it will.

So what about all the invisible victims? All of us will someday be one of them. So what about us? It's time to stop being stupid. The way we treat the invisible victims is the way we will be treated when the pain is ours. Throw out the pharmacological racism behind Opiophobia. Replace it with common sense and traditional pharmacological principles. Titrate to effectiveness and restore millions to a reasonable quality of life. Cease the demonization of the invisible victims. Teach the kids about drugs, so that ignorance doesn't kill them. Cease sticking our heads in the sand with the wishful thinking that drugs can be made unavailable. Hasn't the trillion dollars wasted on the "War On Drugs" for the last 30 years taught us anything? Wake up. We don't have to be stupid and gullible forever. Where did that trillion dollars go? And who wants it to keep flowing?

 

J.S. Hochman MD

 

Executive Director

The National Foundation for the Treatment of Pain

www.paincare.org

Relentless Follies - Chapter 999 - Urine Drug Testing

The following is my response to a professional group's discussion about the fact there is no scientifically reliable or defensible algorithm for accurately testing for drug metabolites in urine. The current testing simply cannot adequately control for the wide variances in individual pharmacokinetics and pharmacodynamics. Scientifically speaking , drug testing is based on "junk" science in its current state.
---------------------------------------------------------
I think that we have established that virtually any algorithm employed by a urinalysis service is going to be inadequate to meet the requirements of strict professional science.

However, that said, let us return to clinical medicine. In employing the services of Ameritox to examine the urine of my patients, I have found, with about 100 cases in my database, that the reports have come back reading either "consistent" or "inconsistent", I provide the lab with the regimen I am prescribing and the urine, and they provide me their report.

In virtually every instance they have reported back "consistent. In a few cases they have reported "inconsistent". In those relatively few instances the inconsistency has been the presence of prescribed medications I didn't prescribe, or "street" drugs.

I cannot say that the analyses in all the other cases accurately determined that the urinary metabolites were consistent with the doses of ingested drugs prescribed. But I certainly can argue with the Gestapo that I did the urinalysis and no one can bust ME for failing to test them! In a few instances I have been forced to confront a patient with the fact that the Gestapo compels me to not prescribe opioids for people who ingest street drugs. Although I am not personally committed to policing the inner psyche of others - I do enjoy the privilege of practicing medicine; and if I persist in breaking the rules that have been shoved up my colon I won't be much able to help anyone without a medical license.

We live in a world of relentless follies.
JSH

The Current Hysteria

RAIDING PAIN CLINICS

December 4, 2007
Published at www.paincare.org
The National Foundation for the Treatment of Pain

The latest media blitz from law enforcement concerns the closing of “pill mills”. Great fanfare accompanies the news releases about clinics being shut down that “hand out hundreds of prescriptions for hydrocodone, Xanax and Soma.” The assertion is that “the streets are awash in these drugs and it’s the result of medically unnecessary prescribing by unprincipled doctors.”

Wait just a second, please.

The fact is that these clinics are supported by thousands of patients who simply cannot afford more extensive or sophisticated medical care. These patients are largely from the blue collar workforce. Because of the often brutally physical nature of their employments and long work histories from an early age, blue collar people are prone to very high incidences of structural damage, traumatic osteoarthritis, rheumatoid arthritis, late complications of injuries, spinal degeneration, and other stress-related somatic disorders.

They are often uninsured or under-insured. If they are workman comp patients they are typically abandoned by their insurers or so hassled by “case managers” that they have given up on trying to get comprehensive care with continuity of care-givers. All they can afford, typically, is the five minutes of attention, for $50 per month, that high volume, low-cost clinics provide.

These clinics must be high volume, in order to maintain fiscal viability. If they see 60 or 100 patients a day, at $50 each, they will gross $3,000 to $5,000 per day. By the standards of any sophisticated medical out-patient facility, this is “chump-change”. Such a clinic will have to employ a receptionist, a doctor, a physician’s assistant (or two), a nurse, a book-keeper and someone to do maintenance. With $3000 a month in rent, and insurance and utilities on top of salaries (plus unemployment security payments) such a clinic might net $20,000 a month, /before/ taxes. This is not high-dollar crime. This is low-income subsistence for a medical facility.

But, clinics like these are easy targets. Because of their necessary patient volume there are often substantial numbers of patients milling around waiting to be seen. Their cars are in the parking lot. The clinics’ names are boldly identified for the public to see. Often the medical personnel are foreign medical graduates, adding another element - racial profiling and prejudice - to their vulnerability to being targeted. The monotonous sameness of the minimal medical care they can afford to provide their blue-collar clientele (hydrocodone, Xanax and Soma) further dooms them to stereotypy. So, low

cost, high-volume clinics for the pain management of the blue-collar workforce easily become “pill mills” in the eyes of the authorities who really could care less about the poor people who frequent them.

The goal is to “get the drugs off the streets”. But what is actually accomplished is to drive all the blue collar patients into the streets, seeking relief from their suffering. Their choices become:

1. Score hydrocodone off the street
2. Score heroin off the street
3. Try to drown their pain with alcohol.

No one can tolerate unrelieved pain. It is simply not possible. So as long as there is a large profit to be made by supplying drugs to people who can’t get them legally, there will be a huge and flourishing black market on the streets. Closing the low cost pain clinics does not make the problem better; it makes it worse. Drug prohibition IS the engine that drives and supports the black market in drugs.

Only a VERY, VERY small percentage of all the people who buy illicit pain medications do so because they suffer an addictive disorder. At least 90 % are actually people in pain who in fact hate to have to use medication at all.

So where can they go after the police shut down their clinics? We all know where they have to go. So, whose side is law-enforcement actually on? We know what side L.E. "wants" to be on. But where does it actually end up? You know the answer.

The solution is to end opiophobia and fantasy-driven public policy. Establish publicly supported clinics so that every person who needs relief from suffering can get the same quality of care as those who have the financial means to see legitimate and skilled doctors. Demythologize medications and substance abuse. Treat the actually small numbers of people who have addictions with proper, effective medical care. Terminate the assignment of law enforcement to policing drugs (they can’t anyway, isn’t that abundantly obvious from fifty years of trying?) Confront the obvious fact that law enforcement, adjudication, prison and parole, are now totally strung out on the drug prohibition laws and need to be brought back to reality. Over half the 1 out of 21 people in America who are currently on federal parole or probation (that incidence was 1 out 51 in 1985) are in that situation because of non-violent, drug-related crimes.

We can no longer afford this historical folly. It is destroying the nation and creating a disaffected, crime-wise, cynical underclass of disenfranchised ex-felons whose numbers will soon inundate what is left of our society (if one includes those on state probation or parole, nearly every sixth person walking down the street is in trouble with the law and can’t vote.)

So wake up America. Time is running out and the dope lords are making billions. (the little “pain clinics” in the strip shopping centers sure aren’t.)

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


AFTERWORD
May 27, 2010

Three years later - and the current news is that we have spent 1 trillion dollars on the "War on Drugs" (almost 20% of our total current federal indebtedness). And the big news is that the push to "close down the pill mils" (Louisiana, Texas and Florida) is now hysterical.) why?

• Illicit drugs are more common, more abused, cheaper and purer than ever. Kids are over-dosing more often or greater combinations of drugs. Abuse of prescriptive medications has increased. Legitimate Pain is less frequently medically treated. Fewer doctors are willing to risk prescribing for pain. Even terminal cancer patients are more often dying in uncontrolled suffering. State Medical Boards have ramped up licensure and disciplinary actions related to opioids more than ever. The DEA budget is higher than ever. The incidence of imprisonment for non-violent, drug-related offenses is at an apogee.
• Unemployment remains double-digit as the current recession continues. The viability of the Gulf of Mexico is at imminent risk from a calamitous oil spill - caused by incompetence, greed and corner-cutting. Big money in the world markets continues to roil as the economic viability of Europe and perhaps the rest of the world hangs on a thin edge. Iran continues to develop its nuclear potential for weaponry. North Korea has just provoked South Korea in the worst incident in 55 years. Iraq continues to be an endless political and military morass exceeded only by Afghanistan. The U.S. Congress is a hopeless political stalemate - in which right-wing extremists threaten to take over the Republican party and accelerate its descent into a Whig-like demise. President Obama is demonized for not having solved the mess he inherited from eight years of Republican follies aided and abetted by lobbyist controlled Democratic congress people - wars, insolvency, illegal immigration, a catastrophically failed War on Drugs and its bizarre public policy hand-maiden, driven by hysteria and irrationality.
• The illegal drug market is now estimated to produce between 500 billion and a trillion dollars a year. There is a full blown war in Mexico over the control of drug money, which killed more people in 2009 than the entire total of U.S. soldiers killed in Iraq, from 2002 to the present. Mexican hit squads have invaded the United States and operate with impunity in every major city.
• The frustrations of the completely failed War on Drugs has created an unacknowledged strategy of turning on the helpless, and those who try to treat them, who are easy targets. Impotent to confront the Narco-tafficantes, and their superbly-funded and equipped armies, the Drug-warriors and their legislative sycophants, think they can conceal their emasculation behind this. And given the mindless gullibility of (to steal a phrase from H.L.Mencken) the "Boobus Americanus", it might just work for a couple more years of brain-dead Prohibition.

Given all this, is there any need to wonder why drugs have become such an integral part of the 21st century experience?

What is desperately needed is rationality, in every arena. What is right, rational and appropriate, must be given priority over what is most profitable. Money doesn't matter when the world has become lifeless and/or moribund.

In Florida, every single person who has had to go to a "pill mill" should join together to march on the legislature and DEMAND public funding of the legitimate care they need and threaten mayhem if the treatment of their pain is turned over to the Black Market.

One million people should march on Congress to demand the immediate repeal of Drug Prohibition and the War on Drugs. ALL the non-violent drug offenders should be immediately released and either pardoned or placed on probation, with the stipulation that if they descend into addiction again they are going into treatment for as many times and as long as it takes, to get their addictive disorders into remission. Hundreds of thousands must march on every state legislature to demand the same. The trillions being exsanguinated on policing, prosecution and incarceration of people with addictions must be redirected toward education, treatment, job-training, and the creation of vital economic development and growth. The billions being shoveled into the pockets of Mexican drug king-pins must be immediately terminated by eliminating their markets. Legalize domestic marijuana production, regulate and tax it (see Holland). Provide heroin at addiction clinics until the addicts can be effectively transitioned into treatment. Use whatever other drugs people want to abuse as inducements into the clinics that will treat them. (Want to sniff cocaine, drop downers, eat your Grandfather's OxyContin smoke a joint and drink Bacardi? Come on down to the clinic, We are eager to meet you and figure out what you really need. Hurry. It's free.)

JSH

Commentary in British Medical Journal

Cohort study finds nine times increased overdose risk (fatal plus non-fatal) in patients receiving 100 mg/day for 90 days compared with 1–20 mg/day opioids for chronic non-cancer pain, but wide CI and possibility of unmeasured confounders
Joel Simon Hochman1, Joe Pergolizzi
British Medical Journal, Evid Based Nurs 2010;13:55-56 doi:10.1136/ebn1062

+ Author Affiliations
National Foundation for the Treatment of Pain, Houston, Texas, USA
Department of Anesthesiology, Georgetown University School of Medicine, Washington, District of Columbia, USA
Naples Anesthesia and Pain Associates, Naples, Florida, USA
Correspondence to: Joel Simon Hochman
Executive Director, National Foundation for the Treatment of Pain, 1714 White Oak Drive, Houston, TX 770099, USA; jfshmd@gmail.com

Commentary on:
Dunn KM, Saunders KW, Rutter CM, et al
Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152:85–92.

Dunn and colleagues are employed at Group Health Research Institute, the Arthritis Research Campaign National Primary Care Centre and Kaiser Permanent, with affiliations at the University of Washington and the University of California in San Francisco, and with funding from the National Institute of Drug Abuse. From their website (http://www.grouphealthresearch.org/aboutus/aboutghri.html) we note that “Group Health Research Institute (GHRI) is a non-proprietary, public-domain research institution within Group Health, a health care system based in Seattle, Washington. Group Health Cooperative is a consumer-governed, nonprofit health care system that coordinates care and coverage. Based in Seattle, Group Health and its subsidiary health carriers, Group Health Options, Inc. and KPS Health Plans, serve nearly 600,000 residents of Washington State and Idaho. More than 70% of members receive care in Group Health-owned medical facilities.”

This study addressed the increasing frequency of long-term opioid treatment for chronic pain and the doubling of hospitalisations for overdose in Washington, DC. The authors noted a study in West Virginia which found that fewer than 44% of people who died of unintentional prescription drug overdose had received opioids from a physician, which suggests that overdose typically resulted from drug diversion. They then explained that “the overdose risk in patients receiving medically prescribed opioids has not been studied.” This is the focus of their research and report.
Their objectives were to estimate the overall overdose rates (non-fatal and fatal) among people receiving long-term opioid therapy for chronic non-cancer pain from medical sources and to compare the risks for opioid overdoses of long-term opioid therapy.

Their study was based on data obtained from the Consortium to Study Opioid Risks and Trends, which was conducted within the Group Health Cooperative. The cohort they studied consisted of 9940 people from the 600 000 insured by Group Health Incorporated who had received opioid therapy for non-cancer pain, followed for a mean of 42 months (range <1 to 119 months). Two-thirds of the cohort had received a diagnosis of back or extremity pain. The mean daily dosage of opioids prescribed was 13.3 mg (morphine equivalents). Among 46% of the cohort, hydrocodone was the most commonly prescribed opioid, and 10% of the cohort had received predominantly long-acting opioids. During the observation period 51.2% were using opioids, 40.1% at the lowest dosage (1 to <20 mg/day of morphine equivalents), 6.7% at 20–49 mg/day, 6% at 50–99 mg/day and 1.8% at ≥100 mg/day.

During the study the authors identified 6 fatal and 74 non-fatal overdoses. Of the 74 non-fatal overdoses, 2 were identified as definitely not opioid overdoses, 17 as probably not and 10 as uncertain. So, a total of 45 non-fatal opioid overdoses were studied. Of the 51 cases studied in total, 40 (78%) were fatal or serious overdoses, and 11 (21.6%) were non-serious overdose events. Accidental excess ingestion of opioids occurred in eight patients, suicide attempts were made by six people, three people had obtained additional opioid from non-medical sources, and drug abuse was noted for four patients. Four patients had overdosed by applying extra fentanyl patches without medical authorisation or by sucking a patch.
The authors concluded that the annual rate of overdose for the total sample was 148 per 100 000 person years, and 116 per 100 000 person years for serious overdose. The rate for patients who had only recently been prescribed opioid therapy was 256 per 100 000 person years. Overdose rates were somewhat higher for patients older than 65 years and among patients with a history of depression and substance abuse. The overall rate of fatal overdose (6 patients of 9940 studied) was 17 per 100 000 person years.

The authors reported that people receiving <20 mg/day of opioids had an annual overdose rate of 160 per 100 000 person years, whereas patients receiving >100 mg/day had a rate of 1791 per 100 000 person years (“a ninefold increase compared to people receiving the lowest dose”). Also, “persons receiving the highest doses were more often men, smokers, had a history of depression treatment and had a history of substance abuse treatment”.

The authors concluded that, “in our study, patients receiving higher doses of medically prescribed opioids for chronic non-cancer pain were at increased risk for overdose relative to patients receiving lower doses.” However, they added, “because few events were observed in the sample, we could not assess overdose risk for specific opioids or risk differences for long-acting versus short-acting opioids.”

Conclusions

The use of statistics sometimes clouds understanding rather than improves it. The simplest conclusion from this study should have been that the rate of fatal overdose is 6/9940 (1 out of every 1656 patients over a 42-month period, or 1 per 5796 patients per year). The non-fatal overdose rate was 45/9940 (1 out of 148 patients over a 42-month period, or 1 out of 516 per year). Calculations of rates per 100 000 person years are not clarifying or particularly useful.

The reported statistical associations between dosage and overdose rates are also not clarifying. Less than 20 mg/day of morphine equivalents is an insignificant dosage for most chronic opioid patients, particularly in the form of hydrocodone. A dosage of >100 mg/day of morphine equivalents is fivefold greater and obviously associated with more profound pain and therefore an increased likelihood of substance abuse, depression and suicide (all of which were reported by the authors).
If one calculates that chronic pain patients take four doses of opioid per day, and that 9940 patients were studied, the annual number of doses of opioid consumed would be 14 512 000. On the basis of this calculation, the rate of fatal overdose would be 1.71 per 14 512 000 doses, or 1.2e−7%; the rate of non-fatal overdose would be 45 per 14 512 000 doses, or 3.1−6%.

Finally, the significance of the statistical association between dosage and overdose rates is questionable. One would ordinarily assume that patients suffering from the greatest pain, and thus requiring the highest dosages of opioid, would also be at much higher risk for depression, suicide and substance abuse. Therefore, any attempt to associate overdose rates and dosage statistically would likely be an artefact of a post hoc error in logic. The causes of an overdose are far more likely to be the extent and duration of pain, depression and suicidality, the extent to which the pain is relieved or naiveté about the use of opioids, rather than the milligram dosage consumed.
Previous Section

Footnotes
Competing interests None.

Response to the FDA Opiods REMS

Response to Docket No. FDA - 2009-N-0143
May 6, 2010


The National Foundation for the Treatment of Pain has responded previously to this REMS proposal . The previous submission provided extensive analysis of the data proposed by FDA in support of the claimed need for REMS activity regarding oxycodone and other opioids, both sustained and immediate release. This analysis clearly established that there is no defensible statistical basis for restricting the already inadequate treatment of pain in America because of the statistically insignificant incidence of overdoses from the abuse of illicitly obtained prescriptive medications.

NFTP urges FDA to revisit this analysis of the data we have previously submitted. It is plainly obvious to any individual trained in statistics and statistical analysis that the occurrence of overdoses and abuse of prescriptive medications, particularly the opioids, has increased over the last few years, as drug abusers have redirected their activities toward prescribed medications in addition to illicitly drugs of abuse. However, simply stated, there is a profound difference between the concept of "occurrence" and that of "incidence".

A recent article by the editor of Science News
http://www.sciencenews.org/view/feature/id/57091/title/Odds_Are%2C_Its_Wrong
brilliantly addresses the short-comings and pitfalls of statistical arguments in support of conclusions, policies and egulation. The burdens upon the health care system of any proposed REMS must be minimized. y objectives and beliefs. It is strongly recommended that FDA consider it carefully.

While the unfortunate and sometimes tragic consequences of misuse of prescribed medications has increased, the incidence of such events is statistically insignificant when calculated against the total number of prescriptions and legitimate ingestions of these drugs is considered. For example, while almost 8,000 overdose deaths in 2009 from the illicit diversion and ingestion of opioids is a tragedy to the families and friends of the individuals involved, compared to the hundreds of millions of doses safely ingested out of medical necessity, these fatalities are not statistically significant. Simply stated, while NFTP recognizes the political pressure directed at the FDA by the sensationalized media focus on overdose deaths, a Draconian REMS response by FDA would be a clear example of throwing the baby out with the bathwater.


Related to this issue, NFTP strongly supports the views of other interested parties who have responded to this docket matter. Specifically: The burden of any proposed REMS upon the health care system must be minimized. Opiophobia is already a cancer upon the body of American medicine. Adding any additional barriers and burdens upon medical practitioners will only further increase the shameful lack of willingness of physicians to accept responsibility for the adequate treatment of pain. There are 40 million chronic pain patients in America, the vast majority of whom suffer needlessly and endlessly from lack of pain medication. The deaths of even 8,000 drug abusers hardly justifies giving physicians an additional incentive to avoid them.

1. Any proposed REMS elements should be proven to reduce the risk of abuse, misuse or diversion. The concept of the "cost/benefit ratio" for these elements must be carefully examined and researched, prior to their imposition upon the health care system.

2. The REMS should not impose a patient registry upon intractable pain patients. They are already demonized, stereotyped, abused, avoided and abandoned by their families, society, the medical community and policy-makers. Requiring them to register will impose burdens, vulnerabilities and opprobrium upon them far beyond their current suffering, which is already a national disgrace. State and national data systems to track schedule II prescriptions are more than adequate to contain diversion and abuse. Pain patients are not sexual offenders and should not be treated as though they are.

3. Existing DEA registration mechanisms should be used to track and confirm prescriber competency. The skillful and competent management of pain should be an absolutely essential component of every physician's medical skills. Doctors who refuse to treat, and who avoid pain patients, should be identified and re-educated as to their professional, moral and ethical responsibilities. Additional burdens and barriers to prescribing will only worsen the already catastrophic unavailability of effective pain treatment.

4. Any proposed REMS must include all classes and types of opioids, so that regulatory forces don't distort the practice of medicine. The vast majority of abuse of opioids, including fatal overdoses, occur from the abuse of hydrocodone and oxycodone products combined with acetaminophen, ibuprofen or aspirin. REMS directed only at sustained release opioids will drive physicians to prescribe precisely the medications that already cause the vast majority of abuse and overdose problems. Again, however, when one contrasts the hundreds of millions of doses of short and sustained acting opioids that are safely and appropriately ingested each year, to the few thousand instances of overdose from illicit use, there is no reasonable basis for any such change in public policy other than a chimerical need generated by tabloid-driven hysteria.

In summary, NFTP supports the position of every pain advocacy organization that:

1. The problems FDA is seeking to solve with a class-wide opioid REMS, as well as obvious potential consequences (such as, fewer prescribers and reduced access to care) need to have clear definitions and baseline measurements to adequately assess the effectiveness of any REMS.

2. The REMS elements should be proven to reduce the defined problems before finalizing them as regulations, including the use of phased-in testing if no such evidence exists.

3. Any opioid REMS should include ALL classes of opioids, not just extended release opioids.

4. The REMS should not include a patient registry.

5. The REMS should include comprehensive, interoperable State Prescription Drug Monitoring Programs and FDA should appeal to Congress and the Administration for expansion of these programs, through greater funding of the NASPER law or other means.

6. Appropriate opioid education, developed by professional associations, should be voluntary for all prescribers of controlled substances until a system can be put in place that can verify education without disrupting the access to these important medicines and without disrupting the delivery of care. Any system should have minimal administrative burdens on both prescribers and dispensers. DEA should utilize its existing registration procedures to track and confirm the completion of such education. Any such system should make it absolutely clear that the effective management of pain is the ethical duty of every physician, and that Opiophobia is a form of pharmacological racism - irrational, unacceptable and contemptible.




PREVIOUS NFTP RESPONSE TO PROPOSED REMS:

The potential harm that is the object of these concerns actually presents an extremely low risk to pain patients who utilize opioids to contain their suffering sufficiently to give them a reasonable quality of life. Even 8,000 opioid deaths in a single year is a minuscule number, compared with the 150 million doses of opioid safely prescribed in the same year. Further, when these deaths are examined objectively, most occurred as a consequence of what doctors call "polypharmacy" - the combining of alcohol, sedatives, illicit stimulants and often many other drugs, with the opioid. These deaths are the consequence of the abuse of drugs - out of ignorance, peer pressure, compulsive behavior and addictive disorders. They are never the result of use as prescribed. Therefore, the supposition that reducing the availability of opioids will effect a reduction in this kind of overdose death is either naive, or a cynical strategy for generating support for a new extension of the "War on Drugs".

Indeed, as with the lessons learned from the Prohibition of alcohol, the consequences are only greater harm. Restricting the legitimate provision of opioids drives patients to illicit sources. Illicit drugs are not only potentially contaminated and of unpredictable potency, but they also support crime and international criminality. Addicts have never had their disease mitigated by the restriction of supply. Criminal suppliers always find means to meet their demands.

Finally, the current proposal, to restrict the prescribing of opioids by imposing more requirements on physician prescribers, is a dreadful folly.
1. The real crisis regarding opioids is the unavailability of medical management of pain - there are almost 4,500 untreated pain patients for every abuser dead of polypharmacy involving an opioid.
2. Physicians are already dysfunctionally opiophobic - imposing further requirements upon them would catastrophically further reduce the number available for the medical management of pain.
3. EVERY physician's training should make them completely competent to treat pain - acute and chronic. Establishing a special category and training requirements for opioid prescribing would defeat this essential goal.
4. Instead, medical schools should be required to adequately train EVERY physician in pain management as a requisite for obtaining a license to prescribe.
5. The mythologies of opiophobia must be eliminated by competent clinical training in pharmacology. Any physician who practices opiophobia is de facto pharmacologically incompetent.
So, in summary, practicing evidence-based medicine unavoidably leads us to the conclusions that:
1. The need for the proposed REMS is unproven and factually unprovable.
2. The imposition of what is proposed would not only be a national folly, but have horrendous negative consequences for both pain patients and the general public.
3. Criminals would be the primary constituency to benefit from the proposals.
4. What is proposed would have no impact, whatever, upon the incidence of accidental overdose deaths involving opioids of substance abusers.
5. The resources wasted on the proposal would be far more wisely invested in the education of ALL physicians, and ALL young people, and in providing medical treatment for the addictive disorders as an alternative to the criminal justice system..
J.S.Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org

Opiophobia and Incompetent Pain Management in America

By J.S. Hochman MD



Chronic Pain-causing Conditions
» Failed back syndrome
» Degenerative disc disease of the spine
» Late complications of surgery, particularly orthopedic
procedures involving the insertion of hardware
» Osteoarthritis
» Rheumatoid arthritis
» Post-traumatic arthropathies
» Chronic daily migraine
» Classic migraine
» Peripheral neuropathies, including diabetic neuropathy
» Post-herpetic neuropathy
» Complex Regional Pain Syndrome
» Chronic hepatitis
» Coronary artery disease
» Interstitial cystitis
» Fibromyalgia
» Chronic pancreatitis
» Ulcerative colitis
» GERD
» Ehlers-Danlos syndrome
» Temporomandibular joint disease
» Late complications of TMJ surgery
» Chronic renal lithiasis
» Chronic endometriosis

It is estimated that 17 to 30 million Americans suffer significant chronic pain. The American Medical Association has editorialized that inadequately treated pain, both acute and chronic, is one of the most important issues in contemporary American medicine. Eleven years ago, the AMA specifically described this situation in a press release as a “crisis in American medicine.” The situation has not improved.

In the United States, almost 1,000,000 practitioners hold licenses from the federal Drug Enforcement Administration (DEA) to prescribe controlled substances. There is ample evidence in the medical literature that both acute and chronic pain can be contained by the appropriate use of opioid medications (if physicians were willing to prescribe them). The problem is so significant that the Veterans Administration has required pain assessment and management for every patient, and the Joint Commission on Accreditation of Health Care Organizations has made improving assessment and treatment of pain in hospitals and nursing homes a performance standard for the facilities they accredit. Major medical societies have issued standards and guidelines that make it clear that opioids can be safely and effectively used to treat acute and chronic pain.

Despite the medical and organizational consensus, American doctors remain unwilling to prescribe opioids. The following case story paints the perfect picture of the situation.

A case story
A 57-year-old woman fell while trekking after lowland gorillas in Gabon, western Africa. A physician in the travel group preliminarily diagnosed a fracture of the upper left humerus, with possible rotator cuff injury to that arm. The woman was located 7.5 kilometers into the jungle, at a gorilla research station that was unavailable except by a strenuous hike through daunting terrain. Her pain was severe and agonizing.

The research station had only Ibuprofen 400mg available in its emergency medical kit. The leader of the expedition had 20 hydrocodone in his emergency kit and complained that 10 years previously he always traveled with several doses of injectable morphine for emergencies. Now, however, “because of the war on drugs, he could no longer find a physician willing to prescribe morphine for his emergency kit.” The hydrocodone, taken two or three at a time, every four to six hours, provided sufficient pain relief to reduce the patient’s agony to a severe level of pain.

No helicopter was available in Gabon to provide evacuation. Oil company helicopters were “not available for personal medical situations.” The national independence holiday in that country made both military and the Presidential helicopter unavailable for 48 hours. The patient had no option except to hike out of the jungle, which took three hours.

After an additional 90-minute drive over a primitive logging road, she was air evacuated from a jungle airstrip to the capital at Liberville. There, she was competently examined at a hospital and received an X-ray that revealed a complex fracture of the proximal head of the left humerus, with 5mm of displacement in two axes. This took an additional five hours, as the only working X-ray in the capital was at a private clinic on the other side of the capital city.

The patient was then transported by commercial airliner to Paris (the only direct flight to Europe from Gabon). She boarded the plane, with only five minutes to spare, for the six-hour flight. In Paris, she transferred to another direct flight back to the United States, taking nine additional hours.

Back in the United States, she was taken to an orthopedist who specializes in injuries to the upper arm and shoulder. After additional X-rays, he confirmed the fracture. He gave the patient the choice of a surgical intervention for the placement of a plate, or conservative management with immobilization. He noted that the choice was “50-50” and provided a brace.

When queried about pain management, he offered hydrocodone, or Tylenol with codeine. The patient reported that three 10mg hydrocodone and acetaminophen taken every four hours gave her only minimal relief and that on the one previous occasion that she had taken codeine, it made her violently ill. The doctor replied that he could offer her nothing stronger, as he did not have a narcotics license for schedule II medications. “Not having a schedule II license saved him a lot of complications and potential problems,” he explained. “I leave pain management up to pain doctors,” he said.

The patient subsequently obtained 5mg oxycodone, without acetaminophen, from a pain management specialist, a day later. It finally gave her effective control of the pain. She was then able to sleep—after three days of uncontrolled pain.

The orthopedist’s explanation is not uncommon. Very few surgeons are currently willing to prescribe schedule II pain medications outside of an in-patient environment. And even within the hospital, they now most often defer pain management to anesthesiologists. It is fair to assert that few surgeons currently have any competence in pain management. Similarly, few physicians seeing patients in outpatient status are competent (and/or willing) to manage either acute or chronic pain.

Fear
There are many complex reasons for this failure, but more than half of the doctors who have responded to surveys about under-treatment of pain list fear of the DEA and medical board sanctions as a major factor that makes them unwilling to prescribe opioids. They emphasize that if an investigation is begun, whether or not it turns out to be baseless, they have lost time, money, and reputation in defending their practices. Although most state medical boards, some state statutes, and the DEA officially approve opioid use in appropriate cases, the burden is on the doctor to prove that his or her prescriptions have a “legitimate medical purpose.” Doctors are often blamed when their prescriptions are diverted and abused, even when the original prescription was reasonable and medically necessary. Legal defense is not covered by malpractice insurance, and the cost coming out of their pockets can run from $25,000 in the simplest matter, to $1,000,000+ in criminal charges. Further, few attorneys understand the medical issues involved in pain management, and doctors rarely get fully effective, informed defense teams. Given this situation, the unwillingness of most doctors to treat pain is no mystery.

In the United States, the “war on drugs” has put at risk physicians who prescribe controlled substances to treat pain and its related symptoms. This risk is far from insignificant.

Opiophobia
The medical management of intractable pain remains controversial. As recently as 2008, Washington state established guidelines limiting the total daily amount of opioid to 120mg of morphine sulfate for chronic, noncancer pain (or its equivalent). These guidelines are scientifically indefensible, and a lawsuit has been brought to set them aside.

A substantial percentage of cases handled by state medical boards continue to involve the prescription of opioids. The exact number of the cases they annually pursue remains elusive. However, the DEA annually investigates more than 500 physicians, causes the surrender of more than 400 narcotic licenses, and prosecutes approximately 60 physicians. There are now almost 100 instances a year of SWAT team assaults on physician offices—pursuing evidence of “opioid prescription abuses.”

The chilling effect of these activities has reduced the number of physicians who are willing to sub-specialize in the treatment of intractable pain from more than 35,000 in 1985 to approximately 5,000 today. Among the general medical community, opioids are still viewed with fear, discomfort, and anxiety. Addiction, tolerance, abuse, and diversion remain significant causes of anxiety and disapproval among physicians.

The medical literature on these causes of concern remains sparse. The single, recent, “peer reviewed” publication on the subject concluded that the maximum daily dose of morphine sulfate should be 120mg. No scientifically defensible basis for this absolute conclusion was provided. Yet this “peer-reviewed” article appeared in a prestigious medical journal.

These fears doggedly remain part of the opiophobic mythology that persists in American medicine. Major medical organizations and professional associations concur that addiction, tolerance, abuse, and diversion are statistically insignificant complications of the treatment of legitimate pain, both acute and chronic. In the example of methadone, 558 million doses were legitimately prescribed in the United States in 2006. Yet, 3,800 overdose deaths from methadone occurred in the same period, all from illicit use and none from the prescribed use of the drug. Similarly, in the last four years, there has not been a single instance of a death caused by the use of oxycodone as prescribed.

With complete disregard of the statistical insignificance of overdose or addiction in the legitimate use of opioids, media exploitation, self-perpetuating drug enforcement propaganda, and political opportunism have all combined to promote and sustain opiophobia. Even highly intelligent and intensively trained physicians are susceptible to this cynical hysteria. The consequence is the crisis in pain care. The solution to this crisis will not be simple. A number of elements are essential, including:
1. Establishing clear and understandable guidelines for patient evaluation and treatment and for maintaining excellent records by treating physicians. Experience demonstrates that many physicians get into trouble because they fail to document their evaluations and treatments involving opioids and do little to document patient compliance and functional improvement. Documenting medical necessity and treatment outcomes are essential.
2. Providing physicians with clear standards of care for intractable pain that meet all requirements of regulatory and licensing bodies.
3. Training every physician involved in clinical care in competent pain management and ceasing tolerance for any form of opiophobia within the medical profession.
4. Utilizing inexpensive, efficient, electronic medical record keeping and prescribing to improve the quality of pain-patient care and maintain a comprehensive electronic record of care.
5. Providing expert proactive consultation and guidance in the medical management of pain by physicians with impeccable reputation and credentials in intractable pain management.
6. Providing unimpeachable expertise to assist in the defense of those physicians who do follow the treatment and documentation standards and are nonetheless subjected to investigation and allegations of improper prescribing.
7. Making available affordable insurance to pay for the legal defense of legitimate physicians by highly qualified and experienced attorneys with established excellence in the legal area of administrative and criminal defense related to opioid prescription (www. pplaonline.com).
8. Legislating federal law compelling adequate pain management in the United States, requiring pain management competence by all physicians, and eliminating any tolerance of opiophobia.
The compelling truth is that there is no person in the world who is more than a single accident or illness away from acute and/or chronic pain. Further, with age and illness, every person ultimately must face suffering. As the situation now exists, virtually no one can currently expect effective, legitimate, unbiased, and unfearful pain treatment, a national folly and tragedy of historical proportions. Such a situation did not exist prior to the Harrison Narcotics Act, which has accomplished nothing useful in decreasing the abuse of drugs. Substance abuse is a medical issue involving addictive disorders. Law enforcement has failed spectacularly as a societal response to the abuse of or addiction to drugs. Physicians must lead in the fight to restore the role of the medical profession in the control and use of pain medications. For, when it comes to pain: “Ask not for whom the bell tolls; it tolls for thee.”

Dr. Hochman is the executive director of the National Foundation for the Treatment of Pain.

Insurers' Profits

Insurers and Pain Care

Feb 11 2010 12:00AM
For reasons that a good investigative reporter could ferret out, as of January 1st all the major insurers began to deny paying for pain medications and started requiring burdensome and tortuous "prior authorizations" (even though many patients had long ago obtained these authorizations. It is clear that some form of collusion has occurred (recall that insurance companies are uniquely exempt from anti-trust prosecution)in which all insurers agreed to do this simultaneously. Meanwhile, today's news reports that the top 10 insurers enjoyed record profits in 2009.

This collusion is one example of probably why. Meanwhile, their profitability is well established (see below). As I have written extensively, there is an irresolvable conflict of interest between insurance companies and health care. Insurance companies are all about making money. Health care is about taking care of people. Insurance companies pursue their profits by seeking ways to NOT take care of people.

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Health Insurance Profits Soar as Industry Mergers Create Near-Monopoly
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by Mike Hall, May 27, 2009

Profits at 10 of the country's largest publicly traded health insurance companies rose 428 percent from 2000 to 2007, while consumers paid more for less coverage. One of the major reasons, according to a new study, is the growing lack of competition in the private health insurance industry that has led to near monopoly conditions in many markets.

The report says such conditions warrant a Justice Department investigation and, says Sen. Charles Schumer (D-N.Y.), provide compelling evidence of the need for a public health insurance plan option as part of the health care reform initiative President Obama and Congress are developing.

Schumer says the report from Health Care for America Now! (HCAN)

is the starkest evidence yet that the private health care insurance market is in bad need of some healthy competition. A public health insurance option is critical to ensure the greatest amount of choice possible for consumers.

According to the recently released HCAN report, Premiums Soaring in Consolidated Health Insurance Market:

In the past 13 years, more than 400 corporate mergers have involved health insurers, and a small number of companies now dominate local markets but haven't delivered on promises of increased efficiency. According to the American Medical Association, 94 percent of insurance markets in the United States are now highly concentrated, and insurers are thriving in the anti-competitive marketplace, raking in enormous profits and paying out huge CEO salaries.

These mergers and consolidations have created a marketplace where a small number of larger companies use their power to raise premiums an average of 87 percent over the past six years restrict and reduce benefit packages and control and cut provider payments.

In a letter to the Department of Justice's Anti-Trust Division, Richard Kirsch, HCAN national campaign manager, and David Balto, former policy director of the Federal Trade Commission and now senior fellow at the Center for American Progress, write:

Simply put, the private insurance companies have secured monopolies or tight oligopolies and exercised that power to put profits ahead of patients. There were no actions taken against anticompetitive conduct by health insurers in the last administration, in spite of the fact that cases by state attorneys general have secured massive fines against these insurers. A lack of antitrust enforcement has enabled insurers to acquire dominant positions in almost every metropolitan market.

They ask for an investigation of the already consummated mergers that harm competition or create an anticompetitive market structure. They also urge the Justice Department to conduct investigations of anticompetitive conduct by dominant insurance companies and challenge that conduct where appropriate.

Many dominant insurers limit the ability of providers to choose rival insurers or inform patients about more efficient and comprehensive coverage.

Obama budget aned th e"War on Drugs"

The Obama administration released its Fiscal Year 2011 budget proposal this week, including the federal drug control budget. On the drug budget, the Obama administration is generally following the same course as the Bush administration and appears to be flying on autopilot
.http://stopthedrugwar.org/chronicle/619/2011_federal_drug_budget