In Reference To:
Source of Pain Pills Dries Up - Blackford, 2008-08-06
Kentucky Herald Leader (link to source broken, full text below)

All I can say about this article is to echo Malcolm X: the chickens have come home to roost, America. The article (below) well describes the public health chaos that is the predictable consequence of clinical and public health authorities abandoning their real mission to uphold the medical standard of care for their citizenry, and instead focusing exclusively on the policeman’s agenda which prioritizes ‘catching a few addicts’ over providing adequate pain management for legions of innocent patients.

You wanted a drug war? You’ve got a worsening pain crisis as the direct result. If you think catching one substance abuser is worth the medical abandonment of a hundred or more innocent chronic pain patients, then your team is winning.

This country has no coherent strategy to deal with the ongoing, very well documented crisis of routine undertreatment and denial of treatment for chronic pain. And instead of solving the law enforcement problem of massive theft at the pharmacy and wholesale levels (in fact a Freedom of Information Act has to be filed to force DEA to disclose these databases they had been hiding) - instead of going after real interstate organized crime - the govt promoted the idea, through ONDCP announcements and attendant propaganda blitz, that physicians treating pain patients were the primary cause of what they have hyped as this years moral panic, prescription drug abuse.

So they prioritized going after the docs instead of the criminals, and for every doc they take out, entire communities of patients have their lives turned upside down, terrified that the medications they need to function and survive in the world have been suddenly and brutally taken from them by agents of their government. Meanwhile most other primary care docs in the community, now understandably scared that what happened to their colleagues for treating these patients could happen to them, do everything they can to shun these now dangerous patients, patients who need pain medication.

The article promotes the usual inaccuracies about substance abuse and pain treatment:

“Most people who abuse pain medication start out with a legitimate problem and seek appropriate help.”

In fact overwhelmingly chronic pain patients on properly prescribed opioids in adequate dosage rarely develop addiction (DSM ’substance dependence’) and most substance abusers in chronic pain treatment had pre-existing drug and alcohol problems.

The article and also provides an example of how ‘the new academic opiophobia’ (see pages 34-37 of PRN’s State Tort Claim vs WA State), which is mostly a misinterpretation of the medical literature, is used here, obliquely, to suggest that it is perhaps a good thing that chronic pain patients be abruptly cleaved from their treating physicians -sheesh!-:

“New research is showing that long-term use of controlled pain medication might actually increase pain sensitivity over time, and non-steroidal, anti-inflammatory drugs could be more useful.” [and will for sure be far, far more toxic - the great leap backward ..alex..]

These entire communities of patients who have and will predictably suffer terribly are not offered some rational public health policy to establish safe harbors and assist abandoned patients find needed medical care. No, instead these patients have their medical records seized and are left to fend for themselves against medical and insurance whose interests are aligned in not providing care - the docs are afraid, and the insurers smell profit in patients off meds. All eyes remain entranced on the policeman’s movie of doctor-shopping patients and doctors who should have know. The abandoned legitimate pain patients just get sicker and sicker, become invisible, easy to forget about.

You reap what you sow, and we are reaping the whirlwind of a drug war increasingly focused against sick people and their physicians.

..alex…

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Source of Pain Pill Dries Up
Blackford, Kentucky Herald-Leader, 2008-068-06

Patients are flooding into doctors’ offices and emergency rooms around Lexington, seeking a replacement for two local doctors suspended for overprescribing pain medications.

The state’s disciplinary action against Dr. Charles Grigsby and Dr. James Heaphy appears to have dried up an important source of prescription drugs for those who need them — and for those who might simply be addicted.

”I’ve got people going through withdrawal in my waiting room,“ said Dr. Ben Huneycutt, who recently opened a family practice on Third Street.

In the past two weeks, he’s gone from seeing four to five patients a day to two an hour, most of them looking for new prescriptions, he said.

Local emergency rooms are also affected

St. Joseph Hospital’s emergency room has seen a ”significant“ increase in patients with chronic pain problems in the past few weeks, said spokesman Jeff Murphy. Good Samaritan Hospital, now owned by the University of Kentucky hospital system, has been seeing several patients a day with withdrawal symptoms, said spokeswoman Mary Margaret Colliver. Central Baptist Hospital is also referring people to treatment centers.

The Fayette County Health Department has received ”numerous calls from people wanting appointments because their regular doctor cannot practice medicine,“ said spokesman Kevin Hall. However, the health department doesn’t offer pain management services, nor does it manage patients requiring withdrawal from controlled substances.

Late last month, the Kentucky Medical Licensure Board suspended Grigsby from prescribing and suspended Heaphy’s medical license. Both doctors were sanctioned for repeatedly prescribing drugs meant for short-term use for pain, prescriptions for combinations of drugs favored by people who abuse or divert such substances. Investigators concluded that both doctors constituted a danger to the welfare of their patients.

They will appear in formal hearings before the licensure board later in the year.

Kentucky has some of the worst prescription drug problems in the country. Between 2002 and 2004, the state had the highest percentage of people using prescription drugs for non-medical reasons, about 8 percent.

Between 12 and 15 percent of all grievances filed with the licensure board are prescription issues.

Robert Walker, a professor and researcher at UK’s Center for Drug and Alcohol Abuse, says the recent reports of patients seeking prescriptions ”make sense. Any time you have people who have established a pattern of obtaining opiate medications from sources like that and the source dries up, you’re going to find people desperate to find a prescription.“

Lexington police Detective William Goldey, of the prescription fraud unit, says he expects to see an increase in doctor-shopping in the region. More desperate patients might try to steal prescription pads or get pain medication, and in the worst-case scenario, resort to robbery.

”It’s inevitable,“ Goldey said. ”Prescription drugs are becoming the No. 1 drug of choice.“

The two cases in Lexington show just how complicated the issue is, said Van Ingram, branch manager of compliance at the Office of Drug Control Policy in Frankfort. ”We want patients to get the things they need, but we don’t want them to abuse it,“ he said.

Most people who abuse pain medication start out with a legitimate problem and seek appropriate help. That’s why it often takes so long to investigate doctors.

Grigsby and Heaphy were investigated by the licensure board after grievances were reported to the Cabinet of Health and Family Services. Neither doctor returned phone calls from the Herald-Leader.

”It’s important to recognize the board wants doctors giving appropriate pain medications to patients who need them,“ said Lloyd Vest, the licensure board’s general counsel. ”Each case is different and each case warrants a different response.“

Prescriptions only

Grigsby and Heaphy are both longtime internal medicine specialists in the area. The charges against Heaphy were more severe, including altering patients’ charts and a lack of basic care to his patients outside of pain prescriptions.

Debra Milton of Lexington was one of his patients. In 21/2 years, she said, ”he never checked my blood pressure, he never took my temperature, never weighed me, nothing. All he did was give me medicine for my back and neck and anxiety.“

Heaphy prescribed Lortab and Xanax for Milton for injuries received in a 2000 car wreck. ”I have chronic pain, and I need the medications,“ she said.

She’s now looking for another doctor, and said she tried Grigsby’s office, but was told she would have to pay $348 just to come in. She does not have health insurance.

Heaphy — who, according to Fayette County property records, owns a 102-acre horse farm on Old Frankfort Pike assessed at $3.4 million — also practiced in Frankfort. That’s where Louise Schraeder saw him for the past 10 years. ”He’s been a good doctor to me and never been one to push medication,“ she said, although he did prescribe some controlled substances to her. ”There had been some concerns I’d voiced to him about some of the people I’d seen his office.“

Schraeder said Heaphy worked with her to pay for her treatment and would give her free samples of things such as blood pressure medication. Because of that, she said, ”I’m sure there will be physicians reluctant to take his patients.“

Pain specialists needed

UK’s Robert Walker said one of the complications to the prescription drug puzzle is that in Kentucky, there aren’t many doctors trained in the field of pain management. New research is showing that long-term use of controlled pain medication might actually increase pain sensitivity over time, and non-steroidal, anti-inflammatory drugs could be more useful.

”You want a well-trained pain specialist prescribing these things, not necessarily a primary care doctor who has 10 minutes to spend with a patient,“ Walker said. ”There’s a lot of personal history you need to collect before prescribing an opiate, like a history of addiction or alcohol problems. There are people who are partly addicted, partly in chronic pain ­— and making that discrimination takes time.“

Meanwhile, back on Third Street, Huneycutt says he’s still seeing a portion of Grigsby and Heaphy’s former patients, trying to tell them he won’t just prescribe medications, while he tries to diagnose some of the underlying problems they have. ”It’s good these guys were busted,“ he said, ”but when you yank both their licenses at the same time, you create a big problem.“

[END]

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Should Alcohol Abusers Not be Treated for Pain?; Alexander DeLuca, M.D., MPH; War on Doctors/Pain Crisis blog of the Pain Relief Network; 2008-07-14. (Discuss on PRN’s Pain Forums)

It seems to me an uncivilized and insane notion that just because someone in current moderate to severe pain had a history of an alcohol or drug problem, or even a current substance abuse problem, that you would deny them opioid therapy if that was the best medication to relieve their suffering. But this seems to be a point of confusion that increasingly comes up from patients, doctors, and regulators alike. So, in this post, let me make the medical standard of care in this situation perfectly clear.

One way to become an “addiction medicine” specialist is to become American Society of Addiction Medicine (ASAM) certified. Usually this is accomplished by attending a three day Certification Review Course, and then passing a written examination. Since the 1990’s, the ASAM Certification Review Course has included a lecture on the Management of Chronic Pain in the Patient with a History of Addiction, and in the 2000 course (I chaired the Review Course in 1998 and 2000) I selected Dr. Howard Heit ¹, who has a national reputation as a medical educator and expert in addiction medicine and pain medicine, to give this important talk.

In his slide entitled: Patient Characteristics for Opioid Use in Chronic Nonmalignant Pain he emphasizes, “Active, or past history of, substance abuse is not a contraindiction to opioid pain management.” ² Compare that to this statement from Washington state’s Agency Medical Directors Group (AMDG): “With active substance or alcohol abuse, providers should not prescribe opioids.” ³

Huh!? So a person with alcohol abuse (like, 5-10 percent of the population by the usual criteria), who suffers severe chronic pain for which no other treatment has worked, should be left to writhe in preventable pain (and very likely drink more) by his physicians? Madness. Unbelievable. And very NOT the medical standard of care. Which is part of the reason the Pain Relief Network is suing WA.

Medical Society Consensus Statements:
The American Society of Addiction Medicine (ASAM), the American Academy of Pain Medicine (AAPM) and the American Pain Society (APS) have issued two Consensus Policy Statements that make very clear the position of the expert professional medical community on the use of opioid analgesics for the treatment of pain in a patient with a history of addiction or current behaviors perhaps indicative of current substance use disorder (DSM terminology). In Definitions Related to the Use of Opioids for the Treatment of Pain, 2001, they emphasize the very important concept of pseudoaddiction:

“Pseudoaddiction is a term which has been used to describe patient behaviors that may occur when pain is undertreated. Patients with unrelieved pain may become focused on obtaining medications, may “clock watch,” and may otherwise seem inappropriately “drug seeking.” Even such behaviors as illicit drug use and deception can occur in the patient’s efforts to obtain relief. Pseudoaddiction can be distinguished from true addiction in that the behaviors resolve when pain is effectively treated.” [See also: "Opioid Pseudoaddiction: An Iatrogenic Syndrome" ⁴]

The second of these consensus statements is entitled, Public Policy Statement on Rights and Responsibilities of Healthcare Professionals in the use of Opioids for the Treatment of Pain, and was approved in 2005 and updated in 2006. First they review the core ethical obligation of physicians to relieve pain, employing opioids as medically necessary. Second they very clearly state that despite the risks and difficulty and time required to care for often complicated patients, this caring is a MEDICAL act and, ultimately and properly, is the responsibility of the individual physician upholding the individual patients best interests:

“Healthcare professional (HCP) concerns regarding the potential for harm to patients, as well as possible legal, regulatory, licensing or other third party sanctions related to the prescription of opioids, contribute significantly to the mistreatment of pain. HCPs are obligated to act in the best interest of their patients. This action may include the addition of opioid medication to the treatment plan of patients whose symptoms include pain [and] opioids are often indicated as a component of effective pain treatment. It is sometimes a difficult medical judgment as to whether opioid therapy is indicated in patients complaining of pain because objective signs are not always present.

“A decision whether to prescribe opioids may be particularly difficult in patients with concurrent addictive disorders, or with risk factors for addiction, such as a personal or family history of addictive disorder. For such persons, exposure to potentially rewarding substances may reinforce drug taking behavior and therefore present special risks. It is, nonetheless, a medical judgment that must be made by a HCP in the context of the provider-patient relationship based on knowledge of the patient, awareness of the patient’s medical and psychiatric conditions and on observation of the patient’s response to treatment.”

Other Consensus Documents:
There is one Consensus Statement that achieved national attention, notoriety, and indeed infamy in medical circles in the first half of this decade. In 2004,the DEA itself, in collaboration with Last Acts Partnership, and the academically prestigious Wisconsin Pain & Policy Studies Group released, with great public fanfare, a document entitled, Prescription Pain Medications: Frequently Asked Question and Answers for Health Care Professional, and Law Enforcement Personnel ⁵ (aka The DEA FAQ). I will not review throughly here the history of what has been called, “The Amazing, Vanishing DEA FAQ.” ⁶ Several of those thirty Questions and Answers relate directly to the issue of prescribing opioid analgesics for the treatment of pain in patients with current or past substances use disorders:

“Question 22. Is it legal and acceptable medical practice to prescribe long-term opioid therapy for pain to a patient with a history of drug abuse or addiction, including heroin addiction?

“It is within the scope of current federal law to prescribe opioids for pain to patients with a history of substance abuse or addiction.”

 

“Question 21. If a patient receiving opioid therapy engages in an episode of drug abuse, is the physician required by law to discontinue therapy or to report the patient to law enforcement authorities?

“Federal drug laws do not require physicians to report to law enforcement authorities patients who have engaged in drug abuse. The controlling federal legal standard is that the physician must issue prescriptions for controlled substances only for legitimate medical purposes and in the usual course of medical practice.” … In states with no specific legal requirement on this subject, if continued opioid therapy makes medical sense, then the therapy may be continued, even if drug abuse has occurred.”

 

“Question 26. Can methadone be used for pain control, and, if so, is a clinician required to have a special license to prescribe it?

“Methadone is approved by the Food and Drug Administration as safe and effective for medical use as an analgesic… State and federal regulations do not restrict the use of methadone to treat pain.

Footnotes:

APS Symposium: Opiate Dosing Guidelines - Outrage or Imperative?; Alex DeLuca; War on Doctors/Pain Crisis blog of the Pain Relief Network; 2008-07-10. Broken link to Opioid Therapy for Chronic Pain fixed: 2008-08-08. (Comments/Discussion on PRN’s Chronic Pain Forums)

See also:
Opiate Dosing Guidelines: Outrage or Imperative¹
PRN State Tort Claim vs WA State
PRN Complaint for Declaratory/Injunctive Relief, Damages

On May 8-10 of this year, about 2 months before PRN filed its historic class action lawsuits on behalf of disabled, chronic pain patients against the WA State Dosing Guidelines, the American Pain Society (APS) held it’s 27th Annual Scientific Meeting. A Symposium entitled, Opiate Dosing Guidelines: Outrage or Imperative has been made available online, and includes links to PDFs of the handouts and audio of the talks and discussion. [See also: Dr. Quinn's report on the APS meeting for the Pallimed blog]

The speakers include Dr. Gary Franklin, probably the primary individual behind the WA Interagency Guideline on Opioid Dosing for Non-Cancer Pain, published in 2007, which is the main object of PRN’s lawsuits (links above), Dr. Jane Ballantyne, author of the widely misunderstood 2003 review, Opioid Therapy for Chronic Pain, and Dr. Scott Fishman who does an excellent job defending the standard of care for pain management, criticizing the research basis for the WA Guidelines, and generally reminding everyone of the realities of the pain crisis, the war on docs, the (mostly failed) history of regulatory efforts, and of the chilling effect he feels certain has been worsened by promulgation of the WA Guidelines.

So I highly recommend listening to Dr. Fishman’s talk. But even more interesting is the discussion after the talks were given. For example, a doc in Atlanta tells how he is getting letters from insurance companies informing him that it has been determined that doses over 120 mg are no longer considered safe; and a lawyer informs the audience that the 120 mg number is showing up in criminal indictments of physicians, and physician “experts” are using the WA Guidelines as evidence for the prosecution in both criminal and licensure cases; and other testimony regarding the harm already done by the WA Guidelines. The audio for this Discussion part of the symposium can be found (confusingly) after the “Introduction” by Gregory Terman - in the second part of the Terman Introduction Recording. So the Discussion is also very worth listening to, and the other talks are professionally done and informative.²

As usual, the academics ignore the elephant in the living room. Regarding review articles that wring their hands about the lack of long term evidence of the safety and efficacy of opioid analgesic therapy, they never discuss the impossibility of measuring the efficacy and safety of a therapy that almost no physician is comfortable doing properly. For an excellent analysis of what we might call the “new academic opiophobia,” see the Pain Relief Network’s 2008 WA State Tort Claim (PDF), pages 34 - 37.

I think this APS symposium, Dosing Guidelines: Outrage or Imperative, occurring as it did on the eve of PRN’s lawsuit against that misguided effort, may end up being a historical marker of the end of the era in which “The Central Principle of Balance” reigned uncontested.

The pursuit of what I believe is an impossible balance - the apples of pain relief against the lemons of the drug war - has pretty much consumed the efforts of the public health, academic medical, medical ethics communities for decades, culminating in the Amazing, Vanishing DEA FAQ³. I have long believed that “law enforcement does not deserve a place at the table where scientists and clinicians and politicians of good faith should meet to honestly assess the harm that has been done to criminalized drug users, pain patients and physicians and earnestly seek ways to undue the public health crisis stemming from our disastrous drug war juggernaut.”⁴

So, hurray for the beginning of the end for the principle of balance as the only way to frame our issue! June 2008 marks a new era, in which the patients themselves enter the fray as primary actors re-framing the debate to one in which we see an opiobhopic culture, backed by governmental force, denying a vulnerable segment of the citizenry their civil liberties and access to the FDA approved medications they need to survive.

The new framework focuses on the rule of law, a matter for the courts - discriminated-against citizens vs the Govt, not ad-hoc working groups of cops and docs. This framework puts academic research and researchers back in their proper roles, as we no longer need them so much as lead-negotiators, researchers can do their research, the standard of care for pain evolves, and the patients and their lawyers will refer to it.

Very nice historical markers! This APS Symposium on the one hand, and the WA Complaint and WA State Tort lawsuits on the other. Enjoy the links!

Footnotes:

See also:
Schneider Pretrial Motions in Judge’s Hands - DeLuca, 2008-06-25
Fed Seeks to Gag Schneiders/PRN - AP, 2008-04-05

WICHITA | A federal judge on Thursday denied the government’s efforts to gag defense attorneys, family and supporters of a Kansas doctor accused of unlawfully prescribing medication.

In his ruling, U.S. District Judge Monti Belot said the government had not shown a compelling government interest in restraining speech. He said an impartial jury can be seated in the case of Dr. Stephen Schneider and his wife, Linda, by questioning potential jurors about their exposure to pretrial publicity.

“The parties should not misinterpret this ruling as an endorsement of statements to the media by their counsel or their surrogates,” the judge wrote. “This court firmly believes that cases should be tried in the courtroom, not on the courthouse steps.”

Belot also denied the prosecution’s request to order the defense to turn over a recorded statement the doctor made in jail for The Associated Press during an attorney visit. The judge said the matter was moot because defense attorneys contend only AP has the recording.

Prosecutors had sought a court order restraining the defendants, their family and Siobhan Reynolds, president of the patient advocacy group Pain Relief Network, from talking to the media. The government also sought an order keeping Reynolds and Pat Hatcher, the sister of Linda Schneider, from contacting victims and witnesses.

“We will abide by the court’s order,” said Jim Cross, spokesman for the U.S. attorney’s office. He declined further comment.

Reynolds said in a phone interview that the judge made a good call.

“The government was trying to restrain my speech and the speech of the defendants and their family members — and that is constitutionally protected speech,” Reynolds said. “I was a little disappointed to see Judge Belot didn’t distinguish the family’s protected speech and my speech as a political leader, but you can’t always get what you want. I got what I need.”

Hatcher said she will continue to try to get the truth out about the case.

“I am happy that the judge ruled in our favor on that so I can keep supporting my sister and showing my love for my family. That is basically what I am doing,” Hatcher said. “I am not an attorney, I am not putting any information out there that is nothing but support. It makes me feel good. I have faith in the system when a ruling comes down like this.”

A 34-count federal indictment against the Schneiders alleges they directly caused four deaths and contributed to the deaths of 11 other patients. In all, it links their clinic to 56 overdose deaths. Prosecutors charged the couple with conspiracy, unlawful distribution of a controlled substance resulting in death, health care fraud, illegal money transactions and money laundering.

The Schneiders have proclaimed their innocence.

Belot said he reviewed news articles the government submitted as exhibits and failed to see how the news coverage will taint the jury pool. He also said he failed to understand how recorded phone calls from the jail to family members about media coverage submitted as evidence by the government will affect any potential jurors.

Prosecutors had also asked the court to remind defense counsel of their ethical duties. But in his ruling, Belot said he assumes all counsel are aware of their ethical duties. He said if counsel has any information regarding an ethics violation it may be reported to the Kansas Disciplinary Administrator’s Office, noting that his court is not a disciplinary review board.

Belot said he expected counsel to know and follow their ethical responsibilities. For those persons not bound by any code of ethics, the judge cited the words of former Vice President Hubert H. Humphrey: “The right to be heard does not automatically include the right to be taken seriously.”

“I’m relieved, but slightly insulted,” Reynolds said laughingly of the judge’s quote of Humphrey in his ruling. “It’s fine. I want to be funny back. [Funny] is good.”

[END]

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As always, we ask that you help PRN fight to protect the rights of patients and the doctors who treat them. Thank you for clicking the link below.



www.painreliefnetwork.org
info@painreliefnetwork.org

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See also:
PRN Complaint for Declaratory and Injunctive Relief, and Damages - 2008
WA’s Interagency Guideline on Opioid Dosing for Non-Cancer Pain - 2007

SUMMARY:
Nature of Relief Sought: This lawsuit is the result of grossly misinformed prejudices about opioid(1) pain medications held by high-level Washington public health officials. Those prejudices are identified in medical literature as opiophobia.(2) As a direct result of public health policies based on opiophobia, chronic pain patients in Washington are now unable reliably to secure necessary and appropriate treatment for their severe pain anywhere within the State of Washington. The dilemma of the chronic pain patients arises out of overreaching actions on behalf of senior public health officials, as well as that opiophobia - which has now permeated the entire Washington State health culture and also unlawfully influences medical licensing decisions.

This claim is asserted by three individuals as representatives of a larger Class, as well as a physician acting in the capacity of patient representative for the Class. The physician specializes in the treatment of pain. The care of two of the individual pain patients is currently threatened; an additional individual pain patient represents those patients whose treatment options have collapsed so completely that they have been forced to seek care outside the State. All three of the individual pain patients share a common legal problem: specific actions taken by the named Washington public health officials have impaired their necessary medical care.

In addition to the stark incivility of this situation, the challenged state actions constitute violations of both federal and state law. Federal claims have already been asserted in the Federal District Court for the Eastern District of Washington, and are docketed as case No. 2:08-cv-200. The state claims asserted here will be added as amendments to that federal case after the expiration of 60 days from their submission herein unless these state claims have been fully settled.

The state actions responsible for the incomprehensible deprivation of medically-necessary pain treatment for these patients arise out of two separate but legally-related state actions:

1) publication by the Agency Medical Directors Group of the Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain; and,

2) a nonstatutory licensure enforcement regime applied by the Washington Medical Quality Assurance Commission [hereinafter MQAC] against physicians(3) who treat chronic pain patients with opioid medications, as exemplified in its own decisions(4) as well as by conduct of MQAC agents during enforcement actions.(5)

While both types of regulatory actions have targeted medical professionals, they are in reality aimed squarely at the patients, who are now official medical pariahs as a direct result of those state actions. Both state actions challenged herein arise out of a public health culture in Washington that is defiant of the rule of law, principles of science, and basic decency.

[END]

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As always, we ask that you help PRN fight to protect the rights of patients and the doctors who treat them. Thank you for clicking the link below.



www.painreliefnetwork.org
info@painreliefnetwork.org

---

Shop online using iGive, and Support the Pain Relief Network!

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Why Untreated Chronic Pain is a Medical Emergency; Alexander DeLuca, M.D., MPH; Senior Consultant, Pain Relief Network; 2008-02-28; Revised: 2008-07-08. Submitted testimony to the Senate Subcommittee on Crime and Drugs, “Gen Rx: Abuse of Prescription and OTC Drugs“; 2008-03-08. (PDF version)

See also:
Pain Patients Excluded from Prescription Drug Abuse Hearings
Testimony of Siobhan Reynolds, President PRN, to “Generation Rx” hearings. (PDF version)

Contents:
Untreated Chronic Pain is Acute Pain / Fight or Flight, Thwarted, Leads to Illness / Consequences of Unrelieved Pain / Discrimination Against Pain Sufferers / Chronic Pain is a Legitimate Disease / Appendices

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Untreated Chronic Pain is Acute Pain
The physiological changes associated with acute pain, and their intimate neurological relationship with brain centers controlling emotion, and the evolutionary purpose of these normal bodily responses, are classically understood as the “Fight or Flight” reaction, which was elegantly explained by W.B. Cannon in “The Emergency Function of the Adrenal Medulla in Pain and the Major Emotions”, published in 1914.¹

Cannon describes how adrenalin, “Liberated Normally in Fear, Rage, Asphyxia and Pain,” a reflex response to pain and major emotion, leads to hyperglycemia necessary “for putting forth supreme muscular efforts,” and to vascular changes that shunt blood away from vital organs in the gastrointestinal and urinary system in order that “the ‘tripod of life’ - the heart, lungs and brain (as well as the skeletal muscles) - are, in times of excitement… abundantly supplied with blood…” Cannon concludes this most basic and well known medical tract with these words:

“These changes in the the body are, each one of them, directly serviceable in making the organism more efficient in the struggle which fear or rage or pain may involve; for fear and rage are organic preparations for action, and pain is the most powerful known stimulus to supreme exertion.“² (bold emphasis added)

“Fight or Flight”, Chronically Thwarted, Leads to Pathophysiological Changes
When these adaptive physiologic responses outlive their usefulness, as when access to effective dosage of analgesic medications is denied, then the fight or flight response becomes pathological, leading to chronic cardiovascular stress, hyperglycemia which both predisposes to and worsens diabetes, splanchnic vasoconstriction leading to impaired digestive function and potentially to catastrophic consequences such as mesenteric insufficiency, etc.

Unrelieved pain can be accurately thought of as the “universal complicator” which worsens all co-existing medical or psychiatric problems through the stress mechanisms reviewed above, and by inducing cognitive and behavioral changes in the sufferer that can interfere with obtaining needed medical care.³ In a New York Times Magazine article in 2001, Dr. Daniel Carr, director of the New England Medical Center, put it this way:

“Some of my patients are on the border of human life. Chronic pain is like water damage to a house - if it goes on long enough, the house collapses,” [sighs Dr. Carr] “By the time most patients make their way to a pain clinic, it’s very late. What the majority of doctors see in a chronic-pain patient is an overwhelming, off-putting ruin: a ruined body and a ruined life.“⁴ (emphasis mine)

Specific Consequences of Untreated and Inadequately-treated Pain
Following our discussion in the preceding section, the medical consequences of untreated pain are legion. In addition to the direct morbidity of pain induced physiologic stress, including chronic hypertension, ischemic cardiac disease, renal insufficiency, stroke, and gastrointestinal bleeding, we must also consider often profound decrements in family and occupational functioning, and iatrogenic morbidity consequent to the very common mis-identification of pain patient as drug seeker. The overall deleterious effect of chronic pain on an individual’s existence and outlook is so overwhelming that it cannot be overstated. For example, the risk of death by suicide is more than doubled in chronic pain patients.⁵

What happens to patients denied needed pharmacological pain relief is well documented. For example, morbidity and mortality resulting from the high incidence of moderate to severe postoperative pain continues to be a major problem despite an array of available advanced analgesic technology.⁶ In a study of pain following hip fracture, undertreated pain was demonstrated to significantly increase the risk of delirium:

Patients who received less than 10 mg of parenteral morphine sulfate equivalents per day were more likely to develop delirium than patients who received more analgesia (RR 5.4, 95% CI 2.4–12.3)… Avoiding opioids or using very low doses of opioids increased the risk of delirium. Cognitively intact patients with undertreated pain were nine times more likely to develop delirium than patients whose pain was adequately treated. Undertreated pain and inadequate analgesia appear to be risk factors for delirium in frail older adults.⁷ (emphasis added)

Pain Sufferers are Medically Discriminated Against
One very important reason that untreated pain is a medical emergency, particularly in the United States, has nothing to do with neuropathology or cardiovascular complications or even the current state of the medical art. It is that chronic pain patients are routinely treated as a special class of patient, often with severely restricted liberties - prevented from consulting multiple physicians and using multiple pharmacies as they please, for example - that are unquestioned in a free society for every other class of sufferer.

In effect, chronic pain patients are often seen by medical professionals primarily as prescription or medication problems, rather than as whole individuals who very often present an array of complex comorbid medical, psychological, and social problems, all of which demand expert medical assessment and stabilization in the untreated or undertreated pain patient. This phenomenon is painfully on display in Wichita, Kansas in the early months of 2008, as the entire country watches droves of ordinary Kansans unable to access basic primary care services, basic medical assessment and stabilization; instead these complex general medical patients are ‘cared for’ as if their primary and only medical problem was taking prescribed analgesic medication. Obviously the major medical problem of these patients is that they have been forcibly cleaved from their physician, and their obvious primary medical need is for medical stabilization, not knee-jerk detoxification. (See Appendices: 1 - The Distortion of Medical Practice, and, 2 - The Ethical Obligation to Relieve Suffering)

Finally it is well known and documented that special groups of pain sufferers have even higher rates of unrelieved pain. These include the elderly or those with neurological conditions, children, minorities, and those with more severe pain, and pain patients accessing emergency room services.^{8 9 10}

Chronic Pain is a Legitimate Medical Disease
Chronic pain was established as a legitimate, progressive, neurodegenerative disease state in exhaustive research in the 1990’s¹¹ and reported in very widely read academic review articles in 2000.¹² Chronic pain is probably the most disabling, and most preventable, sequelae to untreated, and inadequately treated, severe pain.

The etiology and pathophysiology of chronic pain are very well understood and have been widely published in the medical literature, and have stood the test of time. This understanding is the literal basis of the current legally relevant “reasonable physician” standard of care.¹³ Following a painful trauma or disease, chronicity of pain may develop in the absence of effective relief. A continuous flow of pain signals into the pain mediating pathways of the dorsal horn of the spinal cord alters those pathways through physiological processes known as central sensitization¹⁴, and neuroplasticity.^{15 16} The end result is the disease of chronic pain in which a damaged nervous system becomes the pain source generator separated from whatever the initial pain source was. (See Appendix 3 - A Modern Understanding of Chronic Pain and Opioid Therapy)

Aggressive treatment of severe pain, capable of protecting these critical spinal pain tracts, is the standard care recommended in order to achieve satisfactory relief and prevention of intractable chronic pain. For example, Pappagallo, in an authoritative monograph of the Rheumatic Disease Clinics of North America thoroughly reviewing the pharmacology of nociception as well as the classes of drugs used for pain control, and concluding:

[M]edications represent the mainstay therapeutic approach to patients with acute or chronic pain syndromes… aimed at controlling the mechanisms of nociception, [the] complex biochemical activity [occurring] along and within the pain pathways of the peripheral and central nervous system (CNS)… Aggressive treatment of severe pain is recommended in order to achieve satisfactory relief and prevention of intractable chronic pain.¹⁷

More recently, we are seeing ominous scientific evidence in modern imaging studies of a maladaptive and abnormal persistence of brain activity associated with loss of brain mass in the chronic pain, especially in the areas of the brain that process pain and emotions. In a 2006 news article, a researcher into the pathophysiological effects of chronic pain on brain anatomy and cognitive/emotional functioning.

This constant firing of neurons in these regions of the brain could cause permanent damage, Chialvo said. “We know when neurons fire too much they may change their connections with other neurons or even die because they can’t sustain high activity for so long,” he explained.¹⁸

It is well known that chronic pain can result in anxiety, depression and reduced quality of life. Recent evidence indicates that chronic pain is associated with a specific cognitive deficit, which may impact everyday behavior especially in risky, emotionally laden, situations.¹⁹ The areas involved include the prefrontal cortex and the thalamus, the part of the brain especially involved with cognition and emotions, and it is these same areas that were found in 2004 to undergo striking atrophy in chronic back pain patients, compared to normal controls:

Patients with CBP showed 5-11% less neocortical gray matter volume than control subjects. The magnitude of this decrease is equivalent to the gray matter volume lost in 10-20 years of normal aging. The decreased volume was related to pain duration, indicating a 1.3 cm3 loss of gray matter for every year of chronic pain… Gray matter density was reduced in bilateral dorsolateral prefrontal cortex and right thalamus…²⁰

Medical science is not conflicted on this very important point. That chronic pain is a disease whose etiology and basic pathophysiology are quite well understood in the published literature since the 1990’s. That medical science has had a firm grip on the pathophysiological mechanisms and consequences of untreated or undertreated pain since the 1914 publication of Dr. Cannon’s seminal and classic research. Further, there can be no question but that Dr. Schneider’s patients in Kansas 2008, many with multiple chronic medical problems, or any pain patient maintained on opioid analgesic medication with good result, will be at high risk of serious medical harm if withdrawn from these medications in any precipitous manner.

Appendices
1) The Distortion of Medical Practice
2) The Ethical Obligation of Physicians to Relieve Suffering
3) A Modern Understanding of Chronic Pain and Opioid Therapy

Appendix 1 - A Brief Discussion of the Distortion of Medical Practice, the Standard of Care, and Medical Community Norms
In fields of medicine involving controlled substances, especially addiction medicine and pain medicine, the doctor-patient relationship has become grossly distorted.

This distortion is profound and significant. One manifestation is the ‘chilling effect’ - the ‘chilling effect’ is the withdrawal, for fear of litigation or loss of livelihood, by physicians from the appropriate treatment of pain.²¹ It is important to note that much of the public health damage here is caused not by the doctors accused of wrongdoing, rather it is caused by doctors-in-good-standing who, faced with a patient in pain and therefore at risk of triggering an investigation, modify their treatment in an attempt to avoid regulatory attention. The chilling effect on appropriate pain management leads inexorably to the national problems of the undertreatment of pain and the shortage of physicians knowledgeable and experienced in opioid therapy for chronic pain, and willing to provide this legitimate professional service.

This distortion of the doctor-patient relationship is complex and can be gross or subtle. Examples include a blanket refusal to prescribe controlled substances even when clearly indicated, or selecting less effective and more toxic non-controlled medications when a trial of opioid analgesics would be in the best interests of a particular patient. At the very least, some degree of suspicion and mistrust will surely arise in any medical relationship involving controlled substances.

For most common medical conditions (not involving controlled substances) the quality of care most physicians provide is fairly close to the medical standard of care which is what the textbooks say one should do, and which is generally in line with core medical ethical obligations such as holding the interests of the individual patient before you above all other interests, patient confidentiality, etc. For example, the care a person would receive for an acute asthma attack is pretty much the same no matter what ER he walked into, and that care would be pretty much by-the-book. So, in most medical fields we could say: “How most reputable physicians practice approaches the (textbook) standard of care.”

This is NOT true in the fields of addiction and pain medicine. For example, modern pain management textbooks universally recommend ‘titration to effect’ (simplistically: gradually increasing the opioid dose until the pain is relieved or until untreatable side effects prevent further dosage increase) as the procedure by which one properly treats chronic pain with opioid medications. Yet the overwhelmingly physicians in America do not practice titration to effect, or anything even vaguely resembling it, for fear of becoming ‘high dose prescriber’ targets of federal or state law enforcement.

In pain medicine we have the deeply disturbing situation that what most doctors do (medical community norm) is at odds with the medical standard of care. Literally, in the treatment of chronic pain, an ethical physician attempting to practice in good faith, according to the clinical literature, is an outlier, deviating from how most reputable physicians would practice.²²

Appendix 2 - The Ethical Obligation of Physicians to Relieve Suffering
It is a foundation of medicine back to ancient times that a primary obligation of a physician is to relieve suffering. A physician also has a fiduciary duty to act in the best interests of the individual patient at all times, and that the interests of the patient are to be held above all others, including those of family or the state.²³ These ethical obligations incumbent on all individual physicians extend to state licensing and regulatory boards which are composed of physicians monitoring and regulating themselves.²⁴

Many studies have shown the practice and custom of physicians in managing pain, even in terminal cancer cases, is extremely conservative and below the (textbook) standard of care.^{25 26} In the literature analyzing this discrepancy a number of barriers to effective pain relief have been identified and include:

1. The failure of clinicians to identify pain relief as a priority in patient care;
2. Fear of regulatory scrutiny of prescribing practices for opioid analgesics;
3. The persistence of irrational beliefs and unsubstantiated fears about addiction, tolerance, dependence, and adverse side effects of opioid analgesics.²⁷

Regardless of the particular barriers impacting any particular case, in fields of medicine involving the use of controlled substances a rift has developed between the usual custom and practice standard of care (the medical community norm - what most reputable physicians do) and the reasonable physician standard of care (what the textbooks say to do - the medical standard of care), and this raises very serious and difficult dilemma for both individual physicians and medical boards. From an ethical perspective, and on the basis of precedent in criminal law:

“When credible evidence has been presented that not just a particular physician, or an isolated, retrograde group of them, but a majority of the profession has failed to adopt practices that would materially reduce patient suffering, courts may properly conclude, in the tradition of great justices like Holmes and Hand, that a reasonable physician would not practice in this way and those who do should be called to account for the adverse consequences such practice has on the well-being of patients.”²⁸

Appendix 3 - A Modern Understanding of Chronic Pain and Opioid Therapy
Research into pathophysiology and natural history of chronic pain have dramatically altered our understanding of what chronic pain is, what causes it, and the changes in spinal cord and brain structure and function that mediate the disease process of chronic pain, which is generally progressive and neurodegenerative.²⁹ Simply put, a continuous flow of pain signals into the pain mediating pathways of the dorsal horn of the spinal cord alters those pathways through physiological processes described as central sensitization, and neuroplasticity.^{30 31 32} The end result is the disease of chronic pain in which a damaged nervous system becomes the pain source generator separated from whatever the initial pain source was.

The end result is the disease of chronic pain in which a damaged nervous system becomes the pain source generator separated from whatever the initial pain source was. This understanding explains many clinical observations in chronic pain patients, such as phantom limb syndrome, that the pain spreads to new areas of the body not involved in the initiating injury, and that it generally worsens if not aggressively treated. The progressive, neurodegenerational nature of chronic pain was recently shown in several imaging studies showing significant losses of neocortical grey matter in the prefrontal lobes and thalamus.^{33 34}

The implications for how acute and early chronic pain should be treated, the medical standard of care, are very serious. The analgesic effects of opioids are primarily mediated in the dorsal horn of spinal cord where they bind with receptors blocking pain transmission and thereby protecting the dorsal horn from being bombarded with pain signals which is believed to be the pathophysiological mechanism underlying the development of chronic pain, as just discussed. NSAIDs, antidepressants, and other commonly used non-opioid analgesics do not have this protective property. Therefore, regarding the standard of care for pain management:

1) Delaying aggressive opioid therapy in favor of trying everything else first is not rational based on a modern, scientific understanding of the pathophysiology of chronic pain, and is therefore not the standard of care. Delaying opioid therapy could result in continuous pain signals overwhelming the dorsal horn, would be expected to promote the development of chronic pain and making the patient’s illness progressively more difficult to treat. Opioids in adequate doses can prevent the development of the disease of chronic pain.

2) Opioid titration to analgesic effect represents near ideal treatment for persistent pain, providing both quick relief of acute suffering and possible prevention of neurological damage known to underlie chronic pain.

Footnotes

See also:
Complaint for Declaratory and Injunctive Relief, Damages
a class action lawsuit by Laura Cooper (lead attorney) et al., Filed: 2008-06-24

Exhibit 1: The WA state Opioid Dosing “Guidelines”
by Agency Medical Directors Group (AMDG); Mar. 2007; Filed 2008-06-24

Exhibit 2: Findings of Fact
Laura Cooper, Esq.; Filed 2008-06-24

The nonprofit Pain Relief Network says the guidelines for prescribing narcotics, written by the Washington state Department of Health and published in March 2007, have influenced pain treatment across the country and have made doctors afraid to give opiate prescriptions.

Siobhan Reynolds, president of the Pain Relief Network, says the group decided to target Washington because the state has been a leader both in pain treatment and in restricting doctors’ prescriptions of pain relief medication.

The guidelines, which apply only to treatment of chronic pain, not acute pain, cancer pain or hospice care, recommend a total daily dose of opioids should not exceed 120 milligrams of morphine or its equivalent if both pain and physical function are not improving.

Reynolds said such guidelines do not take into account the needs of individuals and make doctors afraid to give larger doses when necessary.

Laura D. Cooper, a Eugene, Ore., attorney representing Dr. Merle Janes, a board-certified pain specialist, and a (class action) group of Washington residents being treated for pain, compared the prescription guidelines to setting a limit on how much insulin a diabetic could be prescribed.

Although the guidelines apply only to Washington state, they have been used by insurance companies, prisons, worker’s compensation boards and other agencies all over the country as a starting point for their own rules, Cooper said, claiming that Washington’s guidelines have become defacto regulations across the nation.

The lawsuit offers several legal arguments, based on civil rights laws, the Americans With Disabilities Act, and other federal and state laws. It contends Washington’s guidelines violate both state and federal law and should be changed or discarded.

The Washington state attorney general’s office was unable to comment on the lawsuit Wednesday because the lawyers on staff had yet reviewed the case, spokeswoman Janelle Guthrie said.

The medical directors from six state agencies wrote the guidelines as the Agency Medical Directors Group. They are all named in the lawsuit as representatives of their agencies.

Dr. Gary Franklin, chairman of the group and medical director of the state Department of Labor and Industries, explained at the time the guidelines were issued that they were the state’s effort to improve patient care and safety.

Franklin, who is one of the doctors named in the suit, said in a news release there were 32 deaths among injured workers where an accidental overdose of prescription opioids was confirmed between 1996 and 2002.

“Because prolonged, high-dose opioid therapy can be unsafe or can become less effective, we want to provide clear guidance in this area for primary-care providers,” Franklin said.

Reynolds said the guidelines set the interests of ill people against the self-preservation interests of doctors.

“The ramifications are enormous,” Reynolds said. “You never see on a death certificate that people died of pain, but people die of pain all the time.”

This is the Pain Relief Network’s first lawsuit against a state; previous efforts have focused on defending doctors in criminal cases, Reynolds said. The network considers itself Internet-based, and its lawyers are from various states, she added.

[END]

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Related Documents:

American Pain Society - Letter to AMDG Re: WA Guidelines

American Association of Pain Management - Position: WA Guidelines

American Pain Foundation - Position: WA Guidelines

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