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 The Pain Relief Promotion Act, Eric Chevlen, M.D.

Doctor attacks pain, defends pain treatment

Researcher attempt to fight painkiller abuse "For millions, pain is severe enough to be disabling; up to 6 million patients are on long-term opioid therapy. It's not just a question of suffering: Serious pain can actually worsen recovery from various ailments."

Prisoners of Pain Why are millions of suffering Americans being denied the prescription drug relief they need?

Drug maker admits misleading public
 

 




 

Eric Chevlen, M.D.
Testimony Before the Senate Judiciary Committee
Concerning The Pain Relief Promotion Act
April 25, 2000




 
Mr. Chairman, members of the Senate Judiciary committee:

Thank you for inviting me to address you this morning to explain why the Pain Relief Promotion Act (PRPA) should be adopted as law.

Introduction

Allow me to introduce myself and explain my interest in this bill. My name is Eric Chevlen, M.D. I am a physician practicing in Youngstown, Ohio. I am the director of palliative care at St. Elizabeth hospital, and medical director of two hospices. I am certified by the American Board of Medical Oncology, the American Board of Pain Medicine, and the American Board of Hospice and Palliative Medicine. Every day in my practice I face the challenge of relieving the suffering of my patients. One of my best tools in this humane task is the class of drugs we physicians call opioids, and which this legislation refers to as narcotics. I unhesitatingly prescribe them to patients for whom they are the best analgesic, in doses that best balance side effects and benefit, no matter what the number of milligrams may be. Given the nature of my practice, it is not a surprise that I am one of the largest prescribers of opioids in Ohio. To borrow a phrase from the world of business, I am the “end-user” of this proposed legislation.

There is one other thing you ought to know about me. I am opposed to legalized euthanasia and physician assisted-suicide. The reason is this: In over twenty years of practicing medicine, more than a few of my patients have asked me to kill them. In every case—every case!—the request stemmed from depression, or anguish, or desperation, or fear of abandonment. In other words, my terminally ill patients sought euthanasia or assisted suicide for the same reasons that healthy people seek it. And, as in the case of healthy people, their suffering could be palliated, and their longing for death quelled, by proper use of medicine, lovingkindness, and what some have called the ministry of presence. The answer to anguish and desperation is not to coldly dispatch the anguished and desperate, but rather to enfold them within the bonds of a community that sees in them intrinsic, rather than merely utilitarian, value.

I am opposed to euthanasia. Nonetheless, Senators, if the PRPA were somehow to diminish the capability of physicians to relieve the suffering of the dying, if it were to increase the risk of harassment by overweening bureaucrats, or even if it were to chill the ardor of physicians to relieve suffering because they misunderstood the bill—if any of these were the case, then I would not be here speaking in support of the bill. Indeed, I would likely be here speaking against it.

Such, however, is not the case. The PRPA would not diminish the ability of doctors to relieve the suffering of the dying or others in pain. It is likely, frankly, that it would improve their ability to do so.

History of the Controversy

For some thirty years, the Controlled Substances Act (CSA) has regulated the therapeutic use of opioids and other substances. For thirty years, the federal law has recognized that, if misused, controlled substances present a significant potential harm to the public. For thirty years the law has also recognized that, when used properly, they also offer a unique and wonderful relief of suffering.

To minimize the potential harm and to maximize the potential benefit of controlled substances, Congress mandated that they be prescribed only by practitioners who were licensed by the Drug Enforcement Agency. Congress also demanded—and who could argue with this?—that the prescribing of the controlled substances be done only for legitimate medical purposes.

"Legitimate medical purposes." That is a phrase you will hear often today, and whose interpretation—and misinterpretation—is the crux of the issue before us today.

Until quite recently, there was never any argument over the meaning of the term. Every doctor knew that he could not simply sell prescriptions for cash. Every doctor knew that he could not swap prescriptions for sexual favors. Every doctor knew that he could not use prescribed drugs to commit homicide, even if the victim consented or participated in that act.

There was never any question about all this. The meaning of the law was plain, and it was buttressed by numerous uncontroversial court decisions.

This clarity and integrity of the federal law came to an end, however, after the passage of Oregon's notorious physician-assisted suicide law. The question arose: if an Oregon practitioner is in compliance with the admittedly loose requirements of that state law, may he prescribe a controlled substance to kill his patient? The head of the DEA said no: a state law cannot change the fact recognized by federal law, that killing people is simply not a legitimate medical purpose. The Attorney General overruled him. She said, in effect, that in forty-nine states, killing patients was not a legitimate medical purpose, punishable under the Controlled Substances Act. In Oregon, however, it was to be considered a legitimate medical purpose—unless the practitioner failed to fill out the requisite state paperwork. Then, it would again be deemed not legitimate.

Usurping Congressional Authority

Although that decision certainly generated a lot of discussion, I am surprised at how little has been said concerning what a sweeping Executive branch usurpation of Congressional authority was thereby accomplished. The Attorney General's decision effectively eliminated the Controlled Substances Act. If the impact of the law is to be determined, as she says, by state standards, then there is in effect no longer any enforceable federal standard. Oregon has now empowered its physicians to prescribe lethal doses of controlled substances, and the Attorney General says that if the state permits it, so too does the federal government. In effect, she has created a federal license to kill, if only state law be permitting. There is nothing in her ruling that prevents other states from allowing physicians—or pharmacists or podiatrists for that matter—from prescribing a panoply of controlled substances according to any criteria that state may choose. According to the Attorney General's Alice-in-Wonderland ruling, the federal government must recognize the "legitimate medical purpose" of this, simply because such action would be compliant with that state's law.

This point has been argued, and will surely be argued again if the PRPA does not become law. In 1996, two years before the Attorney General’s decision in this case, California passed a law considerably liberalizing the use and distribution of marijuana. In that case, the Justice Department argued the opposite of its point in the Oregon matter, saying, “A state initiative cannot supplant the will of the people of the United States."1 Later, however, in the Oregon matter, the Attorney General argued that Congress never intended the Controlled Substances Act to apply to such a duly passed state law. Rather, claimed the Attorney General, Congress intended the scope of the CSA to be somewhat limited, and authorized the DEA to prevent the "particular drug abuse" deriving from a drug's "stimulant, depressant, or hallucinogenic effect on the central nervous system."2

Set aside, for a moment, the fact that her theory of the law is completely unsupported by its legislative history, wording, and case law interpretation. Even if one grants the Attorney General’s theory, that only drug abuse of this class is interdicted by the CSA, then use of controlled substances to cause death is surely forbidden by the CSA. After all, the very mechanism by which controlled substances in overdose cause death is by depressing the central nervous system, in particular the respiratory center.

Is there to be a uniform federal standard of "legitimate medical purpose" or is there not? If the Senate feels there should not be any standard meaning to a federal law, if it feels that the CSA should be eradicated by bureaucratic legerdemain, then it should not pass the Pain Relief Promotion Act. If, on the other hand, it feels as I do that the very purpose of federal law is to protect the common good by establishing clear and uniform application of the law, then it very much should pass the PRPA. This act has as its main purpose the restoration of a uniform national standard in the Controlled Substances Act, but in fact it would do more: it would prevent the effective elimination of the CSA by the Executive branch without the advice or consent of the Congress.

The PRPA Restores Proper Balance Between State and Federal Laws

Much mischief has been made of the fact that the PRPA puts into statute the law as it has been uniformly and unarguably enforced for many years. The act makes explicit that it is only purposeful killing of patients that is a violation of the CSA. Gentlemen, that is the law today. Even if the PRPA is not passed, the purposeful killing of a patient by use of a controlled substance will remain a violation of the CSA in forty-nine states. This act does not change the law for the doctors of those forty-nine states. It simply restores the effect of federal law to the one state that has abrogated its duty to extend state interest in the preservation of life to an apparently expendable segment of its population, namely those who are severely ill and despairing of life.

It is also important to note that the PRPA would not overturn the Oregon law allowing physician-assisted suicide. It would still be legal for a practitioner to prescribe a lethal potion there; only it must not contain a federally controlled substance. Sadly, there are a number of other drugs that can accomplish this wicked purpose, and there is no end to the inventiveness of people in whom are mixed the traits of cleverness and contempt for the innate value of every human being. While I believe that passage of the PRPA would diminish the number of victims of medical killing, I do not expect the practice to come to an end in Oregon. The states will retain the right to regulate medical practice within their borders. Passage of the PRPA simply ends federal collusion in the nasty business of doctors killing their patients.

Objections to the PRPA, and Their Refutation

As noted above, there are reasons of both law and justice to pass the PRPA. Now let us review the four possible reasons for opposing it.

First logically, and not last in some opponents’ motivation, it would be reasonable to oppose the PRPA if one feels that euthanasia is a public good to be promoted by federal policy. That would be contrary to the unanimous vote in the Senate in denying public funding for euthanasia and assisted-suicide, and contrary to the long history of government protection of vulnerable classes of citizens. But such opposition would be consistent with the effect of the Attorney General's ukase.

The second argument raised against the PRPA is that it diminishes a state's right to regulate the practice of medicine. Even before the inclusion of the amendments introduced by Senator Hatch, this argument held no water, for the bill does not overturn the Oregon act allowing physician-assisted suicide. After the inclusion of the amendments, which specifically declare that “nothing in this subsection shall be construed to alter the roles of the Federal and State governments in regulating the practice of medicine,” such an argument is not even worthy of consideration. Unfortunately, physician-assisted suicide will remain legal in Oregon even if this bill is passed. The federal government, however, will no longer play the role of enabler. Actually, if this bill is not passed, the states will gain new and unconstitutional power to limit the right of Congress to control interstate commerce of drugs. Without passage of the PRPA, it is the states that have power of nullification over a federal law. This country has already experienced considerable unhappiness as a result of nullification theory, and the Congress would be ill-advised to resurrect it now.

The third argument against the PRPA is that its language will have a chilling effect on the willingness of doctors to prescribe adequate doses of opioids to relieve the pain of dying patients, that they will fear a meddlesome DEA bureaucracy eager to swoop down on them and throw them in jail for 20 years when poor Grandma dies of cancer after her final comforting dose of morphine. Since the language of the bill does not adversely affect the license to prescribe opioids in 49 states, this cannot be so. Quite the contrary, this bill puts into statute what has heretofore been only administrative guideline, namely, that it is legitimate medical purpose to use a controlled substance to relieve pain even if that use increases the risk of death. This doctrine of double effect will be the law whether the PRPA passes or not. Making it explicit by statute should increase, not decrease, physician comfort in prescribing opioids.

Opponents of the bill speak as if prosecutors distinguish between homicide and natural death by using a Ouija board, rattles, and feathers. Those of you who have served as prosecutors know how far from reality this is. The circumstances of a death, not the dose of the drug, are determinative. By comparison, in this town of Washington today, two men may die from having a knife stuck in their chests. One case will be an unintended and tragic outcome from a failure to save a patient during a coronary artery bypass operation. The other will be a mugging occurring in an alley near the hospital. Just as it is easy to see that the first death was unintentional and due to a procedure which unavoidably increased the risk of death, so it is easy to see that the second is purposeful and criminal. Deaths associated with opioid use are just as easy to distinguish.

Much mischief is made by the euthanasiasts of the alleged respiratory suppression effect of morphine. Like so much else they promulgate, this is a gross distortion. Experienced clinicians understand that there is an enormous difference between the effect of morphine during its first days of use as compared with its effect in the chronic setting. During the first few days of use, morphine may cause sedation; if used recklessly it may even cause respiratory suppression. But the respiratory system quickly acclimates to morphine therapy. With continued use, morphine—even in high doses—relieves pain, but does not make the patient stop breathing.3

Another source of confusion is the fact that several different pharmacologic classes of drugs are lumped together in the category of controlled substances. Most of our discussion has been about opioids. But opioids are virtually never used to intentionally induce death for the very reason cited above. The recently published data from Oregon shows that 100% of patients who died as a result of prescribed lethal drugs took an overdose of a barbiturate.4,5 Only one of the patients was even prescribed an opioid to accompany the barbiturate; in that case the barbiturate alone would clearly have been fatal. With the exception of the antiepileptic phenobarbital, barbiturates have very little legitimate medical use these days. There are much safer drugs available to treat anxiety and insomnia. Indeed, it is this very lack of safety that makes barbiturates attractive to the doctor intent on killing his patient. My point is that this bill should not lead to reduced use of opioids, because opioids are not the drugs used to kill people; barbiturates are.

The opponents of the PRPA may counter that the doctors will refrain from prescribing opioids for fear that DEA or state regulatory officials will misinterpret their use of opioids as intentionally causing death, when in fact the patient died either of natural causes or as an inadvertent effect of the drug. But the law already forbids use of controlled substances to intentionally cause death in forty-nine states. Failure to pass the PRPA will not eliminate this law. The increased comfort concerning overweening regulation that physicians crave will not come from defeating the PRPA, but from passing it. This bill, for the first time, calls for federal dollars to be spent in the training and education of both federal and local officials, so that they will be more knowledgeable about proper palliative care, and less likely to mistake good care for a violation of law. If the PRPA is not passed, then there is nothing to improve the situation as it now stands, nothing to reduce the regulatory fear that inhibits doctors from prescribing drugs properly.

Fourth and finally, we need to address the possible objection to this bill that it will be misinterpreted by doctors, and that their misunderstanding of the bill will lead them to refrain from treating pain adequately. In particular, opponents argue that this misunderstanding will lead to a lower rate of prescribing opioids such as morphine. That opponents of the bill make this argument is actually a stunning concession that the language of the bill itself cannot justify such fears. Let us set aside for a moment the other implication of this argument, that men and women who have spent years mastering the intricacies of anatomy, physiology, pharmacology, and therapeutics are somehow too knuckle-headed to understand the plain meaning of a simple law. This argument of a chilling effect via physician misunderstanding is testable. In fact it has already been tested. Several states have passed laws similar in impact to the PRPA. If the legislation were to have a chilling impact on a doctor’s willingness to prescribe opioids, we should see a drop in, for example, morphine consumption in those states subsequent to the passage of the laws.

In fact, the opposite is observed. For example, in the spring of 1996, Louisiana passed a law banning assisted suicide, while allowing pain control that might unintentionally increase the risk of death. Per capita morphine consumption in that state rose 80% that year, and had nearly tripled by two years later. Similar results were seen when Iowa, Rhode Island, Virginia, and Kansas passed similar laws. In fact, of the top ten states in per capita morphine consumption in 1999, seven have specific statutes against assisted suicide.6 Now this rise in morphine consumption after passage of state laws resembling the PRPA does not prove that such laws improve pain control. But the data certainly disprove the contention that such passage will worsen pain control by reducing opioid prescribing.

Conclusion: Eliminate the Federal License to Kill

Gentlemen, when I first earned my federal license to prescribe controlled substances, I was proud that my country had recognized my competence to relieve the suffering of my fellow citizens, and had entrusted to me the privilege to prescribe these medications for their benefit. It is deeply offensive to contemplate how this license of which I was so proud, a license to palliate the misery of my patients and fellow creatures, has been degraded to be a federal license to kill them, state law permitting. Senators, remove this stain; erase this blot. Vote to improve pain treatment and to protect the vulnerable citizens of the country. Vote to allow honest physicians to relieve pain without the stigma of a federal license to kill. Please pass the Pain Relief Promotion Act.

ENDNOTES
  1. Justice Department attorney Mark Quinlivan, arguing before U.S. District Court Judge Charles Breyer, quoted by Reuters newservice, March 25, 1998.

     
  2. Attorney General Janet Reno, Letter to Congressman Henry Hyde, June 5, 1998.

     
  3. P.D. Wall, "The Generation of Yet Another Myth on the Use of Narcotics [Editorial]," Pain 73, no. 2 (Nov 1997): 121-2.

     
  4. Arthur E. Chin, and others, "Legalized Physician-Assisted Suicide in Oregon--the First Year's Experience," New England Journal of Medicine 340 (1999): 577-83.

     
  5. A.D. Sullivan, K. Hedberg, and D.W. Fleming, "Legalized Physician-Assisted Suicide in Oregon--the Second Year," New England Journal of Medicine 342, no. 8 (Feb 24 2000): 598-604.

     
  6. Drug Enforcement Administration, U.S. Department of Justice, Statistics on Individual State Consumption of Morphine.

     




 

Source The Pain Relief Promotion Act Eric Chevlen, M.D.


 



By MARC KAUFMAN
The Washington Post


WASHINGTON – Howard Heit knows pain.

He lives it, he studies it, he works to reduce it. His own pain used to get so bad that he wore patches of hair off the back of his head by rubbing it hard against walls in a desperate effort to get some relief.

“What I was feeling was like a cramp in my leg, but multiply that by 100 times and make it continuous,” he now says. He no longer hurts like that, but he still wears a brace with a head attachment he can push against for acupressure when a pain spasm hits.

Heit is a doctor. Today he’s a pain and addiction specialist in Fairfax, Va., but once he was an up-and-coming gastroenterologist, a football player, a jock. That was before his auto accident, the one that changed his life and taught him about pain problems the very hard way – as a patient who often didn’t get the help he so badly needed.

The doctor still spends a lot of time in his wheelchair, but that hasn’t stopped him from becoming a prominent practitioner and lecturer over the past decade. More recently, his profession and personal history have propelled him to the center of a contentious national dispute that he virtually personifies.

On one side, the Drug Enforcement Administration and Justice Department – alarmed by the seemingly widespread diversion of opium-based prescription drugs such as OxyContin and Dilaudid to addicts and abusers – have investigated, arrested and prosecuted as “drug dealers” scores of pain doctors who allegedly misused their authority to write prescriptions for narcotic painkillers. On the other side, many pain doctors and patients have protested the DEA’s approach as overly aggressive and punitive, saying that it’s unfairly penalizing pain patients.

Heit, 61, doesn’t use prescription opioids for his own pain now, but he does prescribe them in high doses to many of his patients, and he’s seen the drugs (in conjunction with proper monitoring) provide remarkable relief – the kind he still wishes had been available when he really needed it. As the showdown between pain doctors and prosecutors stiffened several years ago, he felt obliged to get more actively involved in defense of opioid treatment despite the potential risk to his practice.

So he joined a team of 18 pain and addiction specialists, hospice and cancer-care workers and DEA officials to write and review guidelines for the proper prescribing of narcotics. He was delighted when, after more than two years of work, their Frequently Asked Questions presentation was posted on the DEA Web site in the summer of 2004. But several weeks later the FAQs disappeared from the site and was soon essentially repudiated by the agency, leading 30 state attorneys general to write to the agency in protest. The chill in the world of pain management has grown worse ever since.

“It now is apparent to me that the spirit of cooperation that existed between the DEA and the pain community to achieve the goal of balance has broken down,” Heit wrote in a much-discussed commentary in the journal Pain Medicine earlier this year. “The DEA seems to have ignored the input and needs of the healthcare professionals and pain patients who actually prescribe, dispense and use” prescription opioids.

Heit shares some of the DEA’s concern over drug diversion, but he clearly cares most passionately about making sure that pain sufferers get the relief they need.

“Our government is letting the misbehavior of a relatively small number of people too often trump the needs of many, many good people with complex medical problems and lots of pain,” he said recently, seating behind his office desk where a chart of pain levels is prominently displayed. (1-2 is mild pain, 5-6 is distressing pain, 9-10 is excruciating pain.) “Many doctors won’t prescribe for pain now. And believe me, that’s not where we as a society want to be.”Pendulum swings
Pain is the most common symptom that brings patients to a doctor’s office, but it remains one of the least understood. There’s no CAT scan, no blood test to objectively measure the level of a person’s pain and years of research have determined that different people experience pain very differently. So pain patients are an inherently challenging group for doctors, their ailments difficult to assess and their suffering often difficult to treat.

The strongest and most effective pain relievers are opioids, derived from the opium poppy or synthetic versions of its active compounds. Opioids have been associated with addiction, moral weakness and crime. That the same compounds are a godsend to millions of suffering but otherwise unexceptional and law-abiding people is far less widely understood.

The nation’s qualms about narcotic pain relief seemed to lessen in the 1990s, when many researchers concluded that the drugs were less likely to cause addiction in pain sufferers than earlier believed. While many patients will become physically dependent on opioids – just as other patients become dependent on insulin, calcium channel blockers or anti-depressants – the overwhelming majority can and will be weaned off if their pain subsides. The advent of OxyContin, a time-released, partly synthetic opioid that provides unique pain relief, added to the sense that a new day had arrived in the nation’s thinking about opium-based pain relief.

But that was before OxyContin abuse and overdoses became a widespread problem in places like Appalachia and rural New England, and before local leaders and politicians began calling for stronger action to keep these prescription products from turning into a street drug of choice. It has proved very difficult to stop the criminal diversion of prescription narcotics from the nation’s drug supply chain, but relatively easy to identify doctors who write large numbers of Percocet or Vicodin or OxyContin prescriptions that – through carelessness, bad luck or, as prosecutors charge, criminal intent – sometimes fall into the wrong hands.

Using sometimes novel legal theories, prosecutors have charged many pain doctors with prescribing opioids “outside the normal practice of medicine,” and dozens are now in, or facing, jail. One of the most prominent is William Hurwitz, a nationally known pain doctor also based in Fairfax. After a trial last year, Hurwitz was convicted of 50 counts of drug trafficking, and was found responsible for the overdose death of a patient and serious injuries to two other patients. He was sentenced to 25 years in federal prison.

At the time of his sentencing, DEA Administrator Karen Tandy held up a plastic bag with 1,600 pills and said they were prescribed by Hurwitz to one patient on one day. “Dr. Hurwitz was no different from a cocaine or heroin dealer peddling poison on the street corner,” she said. “Indeed he was worse, because unlike the street dealer, he had and abused the trust and authority to treat people in pain.”

(Regarding the prescription for 1,600 pills, Hurwitz said it was a clerical error that was corrected by a pharmacist before it was filled.)

That case is now on appeal and has become – along with several other prosecutions – a cause celebre for advocates including those in the Pain Relief Network, who are helping Hurwitz and a number of other arrested and convicted doctors to fight the charges against them. While acknowledging that Hurwitz could have been more careful in some of his prescribing, his supporters cast him as a dedicated and courageous professional who has been railroaded by the government.

The new era in pain relief anticipated and promoted by pain doctors and drug manufacturers seems increasingly far off.Quality of life
Wendy Shugol is a nationally recognized special-education teacher at Falls Church (Va.) High School, a French horn player in the Fairfax City Band, a horseback rider and avid woodcarver. She also has cerebral palsy and a host of other serious conditions, and doubts she could even get out of bed were it not for the massive doses of opioids she takes daily. She says her referral to Howard Heit in 1998 marked a fundamental transformation in her life. “I’m a different person now,” she says. “My life was miserable, and I was basically miserable to be around.”

Shugol, 54, wheeled herself into Heit’s office recently for a monthly appointment, smiling broadly and filled with an energy seldom seen in people who don’t carry her many physical burdens. The first order of business was, as always, to hand Heit her vials of drugs, so he could see exactly how many pills she had used since the last visit. Heit took out a pill counter and went to work, first on the OxyContin, and then the Dilaudid. He was puzzled to find more than 100 extra pills.

“Have you been taking everything you need?” he asked.

“Yep, but I think you made a mistake last time,” she replied. Rather than writing a prescription for 230 pills, Heit had written one for 330 pills, and that’s what the pharmacist filled.

Heit went through the detailed paperwork he keeps on all patients. He found a photocopy of his last prescription for her and, to his chagrin, he had indeed overprescribed by 100 pills.

“What you’re seeing here is that we’re all human and make mistakes,” Heit said, somewhat sheepishly. “But Wendy returned them, as she should, and I can see from my records exactly what happened. These are powerful and valuable drugs, and so we should take great care.”

Without intending to, Heit had demonstrated an issue at the heart of the doctor-DEA debate: What constitutes a medical error in prescribing, and what constitutes criminal behavior? Many doctors who have been prosecuted argue that they were aggressively treating pain as the literature now recommends, and that sometimes they made mistakes by trusting a patient who said he or she was in great pain and needed opioid painkillers.

Shugol had followed Kathryn Brock, of Reston, Va. – another woman in a wheelchair with an easy smile and a strong desire to remain active – into Heit’s office. Brock suffers from rheumatoid arthritis in virtually every joint in her body, and she, too, is subject to constant pain. She says that her regimen of six OxyContin and eight Dilaudid pills a day has kept her marriage going, and gives her the ability to continue painting, which she does regularly.

Like Shugol and most other chronic pain sufferers, she says the opioids don’t make her feel euphoric or “high” at all. (Researchers believe that the pain essentially soaks up the drugs’ active ingredients for most legitimate users.) Another Heit patient the same afternoon was an administrator in a healthcare business, a man in his mid-forties who developed a condition 10 years ago that caused him to pass frequent kidney stones. The pain was so excruciating he would collapse on the floor. He was going to a nearby emergency room regularly.

The man, who requested anonymity because of the continuing stigma associated with opioid use, began pain treatment with Heit three years ago. He hasn’t been to the emergency room since.
 

Source:  Doctor attacks pain, defends pain treatment


  • Scientists work on new medicines, treatments to help pain sufferers, discourage addictionBy Lauran Neergaard

    ASSOCIATED PRESS
    Contra Costa Times

    Article Launched:03/13/2007 05:31:17 AM PDTWASHINGTON -- Scientists are hunting for new ways to help millions of pain sufferers -- from addiction-resistant narcotics to using brain scanners for biofeedback -- amid a worrisome rise in abuse of today's top prescription painkillers.

    The good news: Only a tiny fraction of patients who are appropriately prescribed the most powerful painkillers -- drugs known as opioids, including morphine, Vicodin, fentanyl and Oxycontin -- ever will become dependent on them.

    And scientists told the National Institutes of Health last week that those few who are vulnerable tend also to suffer such psychiatric disorders as depression and anxiety, giving doctors a clue about which patients need closer monitoring.

    Opioids "are not dangerous if you know how to use them properly," stressed Dr. Nora Volkow, chief of NIH's National Institute on Drug Abuse. "We need to develop the knowledge that maximizes our ability to use them properly."

    Amid fears that rising painkiller abuse will spark a backlash against pain sufferers, Volkow organized a two-day meeting involving several hundred scientists and primary care physicians to bring the latest science on pain and addiction to doctors struggling to balance the drugs' clear benefits and potential harm.

    Some form of chronic pain affects one of every three or four adults worldwide. The government says one in 10 Americans suffers pain that lasts a year or more.

    For millions, pain is severe enough to be disabling; up to 6 million patients are on long-term opioid therapy. It's not just a question of suffering: Serious pain can actually worsen recovery from various ailments.

    How many need opioids but don't get them? Those numbers are hard to come by, but "pain is really under-treated in our society," UCLA opioid specialist Dr. Christopher Evans told the NIH meeting.

    By some estimates, as many as 40 percent of cancer patients and the terminally ill don't even get those medications.

    At the same time, prescription drug abuse, particularly of opioid painkillers, is on the rise.

    One in 10 high school seniors admits to popping Vicodin for nonmedical purposes, and recent studies suggest about 2.2 million people age 12 and older first abused painkillers in the past year, outpacing new marijuana users.

    Some 415,000 people received treatment for painkiller abuse last year, Evans said.

    So the hunt is on for pain relief that minimizes the abuse risk -- not just for the 2 percent of pain patients who might become dependent, but to discourage theft or other diversion of the drugs.

    "We really need to get smarter," said Dr. Pamela Palmer, director of pain research at UC San Francisco, who laments that the only way now to tell how patients are using painkillers is "making people pee in a bottle to see if the drug I prescribed is in there."

    Under research now:

     

  • Pain Therapeutics Inc.'s Remoxy is in late-stage clinical trials to see if it offers an abuse-resistant version of oxycodone, the ingredient in Oxycontin.

    Oxycontin tablets are supposed to slowly dissolve for long-term pain relief, but abusers crush them and snort or inject the powder for a fast high. Remoxy is a thick gelatin version of oxycodone -- crushing it just yields goo.

     

  • Another approach now in early trials pairs technology with tiny tablets of a hospital-strength opioid, sufentanil, redesigned to dissolve almost instantly under the tongue.

    A computerized dispenser, the size of a remote control, is programmed with the patient's dose of Nanotabs and records how much is used and how often, information the doctor would require before allowing refills or adjusting doses, says Palmer, who is working with manufacturer AcelRx Pharmaceuticals.

    Then there's the nondrug approach: Omneuron Inc. and Stanford University researchers are trying to teach patients to control how much pain they feel by scanning their brains and showing them the real-time MRI images as they try out different techniques.

    "The brain is built to be able to modulate its pain-control processes," says Omneuron chief executive Christopher deCharms. "We're teaching people to gain conscious control."


  • Source for this and similar reports from ContraCosta Times:  http://www.contracostatimes.com/search?sortBy=mngi&similarTo=&similarType=find&runSearch=true&type=any&aff=3&query=Painkiller+OxyContin+a+factor+in+120+deaths+The+drug%27s+producer+did+not+adequately+inform+physicians+about+potential+for+abuse%2C+critics+say&searchbutton.x=40&searchbutton.y=17&searchbutton=Search


    By Barry Yeoman, September & October 2005

    Why are millions of suffering Americans being denied the prescription drug relief they need?
     

    Deborah Hamalainen was feeling more and more agitated by the minute. Waiting to see her neurologist, she was silently rehearsing a confrontation that had been building for months. She planned to look the doctor directly in the eyes and demand that he treat the chronic pain that had invaded her life.

    In the two decades since doctors diagnosed her with multiple sclerosis, Hamalainen learned to tolerate numb extremities, tingling sensations, even the weakness that causes her left foot to drag. And it wasn't like her to be confrontational. "I'm much happier in denial," admits the soft-spoken 52-year-old sculptor.

    Some physicians fear that if they deliver humane pain care, they’ll face prosecution by the DEA.

    The symptoms she couldn't ignore, though, were the intense shooting pains that raced across her shoulder blades and down her limbs. By the time she arrived for this doctor's appointment, they were a 24-hour presence. Hamalainen barely slept anymore. Rolling over was an ordeal. When the Medford, New Jersey, resident awoke, stiff and exhausted, she braced her shoulders so they wouldn't move as she rose. Sometimes, her husband had to pull her upright from the bed.

    Every three months for three years, Hamalainen saw this neurologist. Each time, she mentioned the pain. Each time, the doctor deftly changed the subject. Each time, she left in pain.

    But this time would be different.

    Hamalainen waited quietly as nurses wandered in and out of the examination room, taking her vital signs. Finally, she lost it. "My pain is real," she said frantically to one of the nurses. "I need relief. Why does he keep refusing to talk to me about it? What do I have to do?"

    The nurse turned to her conspiratorially and lowered her voice. "I should not tell you this," she said. "But he doesn't want to treat your pain because the treatment that works is opioids, and he's afraid to prescribe them."

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    With that conversation, Hamalainen joined legions of patients who are the victims of a troubling and all-too-common medical practice: the undertreatment of significant and debilitating pain. An estimated 75 million Americans suffer from chronic pain, according to the American Medical Association, and numerous studies have shown that patients often don't receive the medication that could provide relief. Undertreatment runs as high as 50 percent among advanced-stage cancer patients and 85 percent among older Americans living in long-term care facilities.

    Much of this suffering is preventable. Experts do know how to reduce pain safely. In particular, physicians now know that opioid analgesics—medicines such as morphine and oxycodone—provide relief for a wide spectrum of pain problems, with relatively few side effects when taken as prescribed. "We can't cure everybody who is in pain, but we can make almost everyone feel better," says Scott Fishman, chief of the division of pain medicine at the University of California, Davis, and president of the American Academy of Pain Medicine. "Becoming a prisoner of pain is not an inevitability."

    Additional Resources
    For more on pain-management issues, visit the website of the Pain Relief Network.

    The problem is that the most effective medications cause skittishness among many physicians. Poor medical-school training has left them unaware of the tools at their disposal and even the importance of treating pain. Many harbor the false impression that opioids frequently lead to addiction or unmanageable side effects, even when used correctly for a legitimate medical need.

    'Becoming a prisoner of pain is not an inevitability.'

    Worse, some physicians fear that if they deliver humane pain care, they'll face prosecution by the federal Drug Enforcement Administration (DEA) or state medical boards. In recent years, a number of respected doctors have been investigated and even prosecuted after prescribing large amounts of opioids. The result, according to experts, is an environment that scares doctors away from practicing good medicine.

    "I've had prominent physicians call me up and say, 'I have patients doing well, taking opioids for otherwise treatable pain, but I'm going to stop writing prescriptions because I don't want the DEA coming into my office and putting handcuffs on me,' " says James Campbell, a neurosurgeon at Johns Hopkins University. "Five years ago, we were actually doing a better job at handling pain patients. Now we've seen a backslide, and patients are definitely the victims. They're suffering."


     

     

    On his first day as a licensed physician, Russell Portenoy had a troubling experience that would influence the course of his career. At the New York City hospital where he was interning, a nurse summoned him to a room where a cancer patient was moaning with abdominal pain. Portenoy knew the woman would benefit from opioids, but he was new at doctoring, so he first phoned the resident in charge to clear his decision.

    "I have a patient here. She's 60 years old, she's got metastatic ovarian cancer, and she's in bad pain," Portenoy told his supervisor.

    "What do you want to do?" the resident asked.

    "Well, I thought we should give her some pain medicine."

    "What do you want to give her?"

    "Morphine."

    There was silence on the other end of the line. It was 1980: even physicians who endorsed opioids for terminally ill patients believed that morphine was too potent and too dangerous. Finally, the resident said, "Look, you're the doctor. You want to give her morphine, give her morphine." After further consultation, Portenoy wrote an order for a 3 mg injection, less than one third of what he would likely give her today. He never checked back to see if the medication worked.

    The patient was still on Portenoy's mind the following year when he decided to specialize in pain medicine. "I'd given somebody with severe cancer pain a dose that didn't have a prayer of providing any benefit," he says. "My hope is that there was such a profound placebo effect that she didn't scream the rest of the night."

    Portenoy joined a coterie of pioneers who encouraged their colleagues to become bolder in treating patients' suffering. They argued that pain is more than a symptom; it's a disease by itself that can trigger a cascade of other health problems—from a weakened immune system to obesity—if left untended.

    At Memorial Sloan-Kettering Cancer Center, where he launched his career as a researcher and pain physician, Portenoy initially concentrated on cancer pain. Eventually he discovered that opioid medicines—routinely prescribed in advanced-cancer cases—also worked for patients without terminal illnesses. They relieved the symptoms without fogging patients' brains or turning them into addicts. The only major ongoing side effect, constipation, was manageable with other drugs. But when Portenoy shared the news in a 1986 journal article, he received excoriating criticism from his colleagues.

    Slowly, time has proven Portenoy correct. In 1996 two leading professional groups declared opioids "an essential part of a pain-management plan." Five years later, the DEA and 21 health organizations agreed that opioids are often "the most effective way to treat pain and often the only treatment option that provides significant relief."

    Across the United States, hospitals are starting to take the issue seriously, creating programs specializing in pain management. Portenoy's own department, at New York City's Beth Israel Medical Center, has 14 physicians, a team of researchers, and training programs for doctors and others. Using opioids and other therapies, these programs have restored normalcy to many lives.

    "It's a miracle," says 55-year-old Michele Ferreri, a Staten Island, New York, woman who suffers from a painful nerve condition that appeared in the aftermath of shingles. Once unable to get out of bed because of her burning headaches, she started taking extended-release morphine and other medications after seeing Portenoy at Beth Israel. Now she lives an active life, taking her mother shopping, doing laundry, and attending social functions with her husband, a hospital CEO. "I can smile now," she says. "I can smile and greet people."


     

     

    Until recently, there was no legal incentive for doctors to take pain seriously. That's starting to change. In 2001 a California jury awarded $1.5 million to the family of a lung-cancer patient who lay undermedicated and dying in a hospital near San Francisco. (The award was later reduced in keeping with state law.) Two years later, the California Medical Board reprimanded a physician in a similar case involving a nursing home. These decisions "sound a resounding wake-up call to all health care providers that failure to treat pain attentively will result in accountability," says Kathryn Tucker, attorney for Compassion & Choices, which litigated the cases.

    But the wake-up call hasn't stirred everyone. Millions of Americans still don't receive the therapy they need. "The odds of your getting good pain management are, at best, 50-50," says UC Davis bioethicist Ben Rich.

    Studies bear Rich out. One survey of Oregon families, published in 2004, showed that almost half of terminally ill patients were in significant pain or distress during the last week of their lives. In a study of nursing homes in 11 states, Brown University researchers found that two thirds of the residents initially found to be in daily pain were still suffering two to six months later.

    But even when treatment is available, patients often reject it because of widely held misconceptions. Popular media play up addiction—be it on the TV series ER, where Noah Wyle portrayed a young physician addicted to prescription painkillers, or in tabloid newspapers, which devoted voluminous ink to Rush Limbaugh's struggle with pain pills in late 2003. Indeed, Limbaugh's alleged drug of choice, OxyContin (a form of oxycodone), has become popular among rural drug abusers, who chew the pills to destroy their time-release mechanism and get a heroinlike rush.

    In reality, for those using opioids as prescribed, the likelihood of addiction is extremely low, according to research. "It's really an unwarranted fear," says Christine Miaskowski, former president of the American Pain Society. Many patients do become physiologically dependent—meaning they'd go through withdrawal syndrome if they quit cold turkey—but this is a normal condition that can be managed by tapering down the dosage. It's not the same as addiction, which requires psychological dependence. Experts say patients with a history of drug abuse can safely use opioids too, as long as they are carefully monitored by their physicians to avoid a recurrence of their abusive behaviors.

    These reassurances don't convince everyone. "There is a just-say-no-to-drugs attitude in the United States," says Diane Meier, a geriatric and palliative-care specialist at New York City's Mount Sinai Medical Center. "Even my own family will say, 'I don't want to be doped up on those drugs.' "

    Patients aren't alone in their misinformation. Physicians, trained to suspect there's an abuser lurking behind every painkiller request—and, to be fair, there sometimes is—still confuse addiction with physical dependence. The facts don't dissuade them: although Ferreri has become functional on morphine, her family doctor still "talks to my husband all the time about the amount of medication I'm on, how dangerous it is. He really makes me feel that I'm a drug addict."

    Worse, some physicians simply don't understand the importance of treating pain at all. Miaskowski, a professor in the physiological nursing department at the University of California, San Francisco, recently completed a study of cancer patients. "We had one patient whose primary care physician told her, 'Don't take your pain medicine. Let the pain kill the cancer.' " Was this advice offered years before recent advances in pain management? No, she says. "This was 2001."


     

     

    There's another, more ominous reason some doctors don't treat pain aggressively: they don't want to end up like Arizona physician Jeri Hassman.

    Hassman, a physical medicine and rehabilitation specialist licensed in 1986, opened a solo practice in 1999 to focus on nonsurgical treatments for injured patients. Working with physical therapists and chiropractors, she developed a comprehensive program that includes massage, electrical stimulation, muscle injections, and even posture lessons. She also prescribed painkillers. "Medications are important," she says. "If you decrease pain, you get better compliance with exercise and other rehabilitation." Until 2002, she says, "I wasn't afraid of prescribing strong pain medicines alongside the available therapies."

    Then, in May of that year, federal agents stormed her Tucson office in full view of her patients. They spent eight hours questioning her staff, seizing patient files and appointment logs, and copying the hard drives off her computers. According to a government brief, the DEA had been contacted by pharmacists "concerned about the large amounts of narcotic drugs that were being prescribed for Dr. Hassman's patients, plus the frequency with which they were returning for refills." The druggists were also concerned that some medicines had fallen into the hands of nonpatients, the brief said. Hassman was arrested and charged with 320 counts of illegally distributing narcotics and 41 counts of health care fraud.

    Just before the case was scheduled for trial, federal prosecutors offered Hassman a plea agreement, allowing her to plead guilty to four counts of failing to report prescription abuse. Unwilling to risk a jury trial, Hassman accepted the offer. She was sentenced to two years' probation and agreed to surrender her DEA license to prescribe controlled substances.

    Hassman was relatively lucky. This April, Virginia pain specialist William Hurwitz was sentenced to 25 years in prison for drug trafficking after prescribing large doses of painkillers such as OxyContin, morphine, and methadone to his patients. One of his patients died after taking a very high dose of morphine. DEA officials likened Hurwitz to a heroin dealer. Others, though, testified that Hurwitz provided them with the only effective relief they had ever received for debilitating pain.

    Though the DEA wouldn't comment for this article, it has previously insisted that it only goes after bad apples. "Our focus is not on pain doctors. Our focus is on people who divert drugs," agency official Patricia Good said during a 2004 teleconference. But physician groups and patient advocates point to a growing list of respected pain doctors who have been prosecuted by the DEA and by state medical boards. They say that while the DEA has a legitimate interest in preventing the diversion of harmful drugs, the agency's adversarial zeal has grown in the past four or five years.

    For its part, the DEA notes that it arrests fewer than 100 doctors a year on drug-diversion charges—hardly a full-scale attack on the profession. The numbers hardly matter, though, because the arrests, and the publicity surrounding them, have created a chilling effect. "Every time a physician picks up a newspaper or hears an account of some physician who has been accused of inappropriately prescribing controlled substances, it reinforces the proposition bad things can happen to you when you attempt to manage patients' pain aggressively but appropriately," says bioethicist Ben Rich. "Doctors don't say, 'I'll be more judicious and that won't happen to me.' Their reaction is, 'I don't need this.' "


     

     

    It took Deborah Hamalainen another year, plus the encouragement of a friend, to find effective treatment for her pain. Early one morning, the two women took an 80-mile bus trip to New York City, then took a taxi downtown to Beth Israel Medical Center. There, Hamalainen met with pain specialist Russell Portenoy, who found her story credible. Portenoy explained to Hamalainen that he couldn't cure her multiple sclerosis, but he could control her symptoms. "The goal is to focus on the pain itself, to get you comfortable, and to help you function," he told her.

    After monitoring several medications for side effects, Portenoy and Hamalainen settled on fentanyl, a synthetic opioid delivered through an adhesive patch worn on her lower back. She uses oxycodone as a "rescue" drug when the fentanyl isn't effective.

    As Portenoy predicted, the medicine hasn't eliminated the source of Hamalainen's pain. In fact, the multiple sclerosis has progressed. She's been losing feeling in her hands and feet, dropping objects, and tripping. She relies on a pair of canes to get around. Still, with the pain under control, Hamalainen has been able to return to her art. She recently had a mixed-media exhibition at the gallery where she used to work. In one sculpture, she took old canes—including the ones her father used after he lost a leg to diabetes—and smashed them with an ax, then enclosed them in a clear plastic exhibition box.

    When the pain was at its worst, Hamalainen contemplated suicide. Now, with opioids to relieve the symptoms, Hamalainen can envision a productive artistic future. "Being able to be creative again has been thrilling," she says. "It's like having a new life."

    Barry Yeoman last wrote for AARP The Magazine about eminent domain ("Whose House Is It Anyway?" (May & June 2005).

    SOURCE Prisoners of Pain Why are millions of suffering Americans being denied the prescription drug relief they need?
     
    PHARMACEUTICALS
    Purdue Pharma and three executives will pay $634.5 million over OxyContin claims.
    By Martin Zimmerman, Times Staff Writer
    May 11, 2007

     
    The maker of the painkiller OxyContin and three of the company's top current and former executives will pay $634.5 million in fines after pleading guilty Thursday to charges that they misled the public about the drug.

    A Justice Department spokeswoman said it was one of the largest financial penalties ever assessed against a drug maker.

    Stamford, Conn.-based Purdue Pharma was accused of making claims that OxyContin was less addictive and less subject to abuse than other pain medications and continued to do so despite warnings to the contrary from doctors, the media and members of its own sales force.

    "In the process, scores died as a result of OxyContin abuse and an even greater number became addicted to OxyContin," U.S. Atty. John Brownlee of the Western District of Virginia, whose office brought the case, said in a statement.

    The charges stemmed from sales practices used from 1996 to mid-2001.

    It was the latest black eye for OxyContin, a drug that has been linked to hundreds of overdose deaths and is a favorite of drugstore thieves and illicit online drug buyers. Called by such street names as hillbilly heroin and oxy, the drug has been linked to celebrities including conservative radio commentator Rush Limbaugh and singer/actress Courtney Love.

    Perdue Pharma pleaded guilty to one felony count of fraudulently misbranding a drug. Chief Executive Michael Friedman, general counsel Howard Udell and former Chief Scientific Officer Paul D. Goldenheim each pleaded guilty to one misdemeanor count of misbranding a pharmaceutical.

    Under the agreement, Perdue Pharma will pay $600 million in penalties, including $160 million to reimburse state and federal healthcare programs and $130 million to resolve private lawsuits that are pending.

    The three executives will pay $34.5 million in fines to Virginia.

    Perdue Pharma, which sold $1.3 billion worth of OxyContin in 2004, accepted responsibility for its actions and said it had taken steps to prevent a recurrence of the problems.

    The guilty pleas came two days after the company agreed to pay $19.5 million to 26 states, including California, to settle complaints that it encouraged doctors to over-prescribe the drug.

    OxyContin is a trade name for oxycodone, a powerful opiate also marketed under such brand names as Percocet and Percodan. It is prescribed as a time-release pill designed to be swallowed whole and digested over a 12-hour period.

    Oxycodone is a staple in the management of chronic pain, especially for cancer patients. When crushed and injected, snorted or swallowed, however, the medication's time-release effects are short-circuited, producing a heroin-like high.

    The federal government estimates that of the almost 500,000 emergency room visits attributed to abuse of pharmaceuticals in 2004, more than 36,000 involved oxycodone.

    Stolen from medicine cabinets or ordered illegally online, prescription drugs have become a favorite of high school and college students, ranking second only to marijuana among abused drugs, according to the U.S. Drug Enforcement Administration.

    "They don't have the stigma of heroin or cocaine," DEA spokesman Garrison Courtney said. "They think because it's something doctors use, it doesn't have the same risks associated with those other drugs."

    Last month, a robber cleaned out a Costa Mesa drugstore's entire stock of OxyContin. A few weeks earlier, a man was arrested in connection with a string of Orange County pharmacy burglaries in which OxyContin was among the targeted drugs.

    Last spring, Limbaugh settled a drug fraud charge related to whether he had illegally obtained OxyContin. Love pleaded guilty to possessing the drug without a proper prescription.

    Also Thursday, the U.S. Food and Drug Administration warned consumers not to use True Man or Energy Max dietary supplements, which are touted as treatments for erectile dysfunction. The agency said the products, which it said were distributed by America True Man Health Inc. of West Covina, contained ingredients that could lower blood pressure to dangerous levels in some users.

    The company could not be reached for comment.

     
    martin.zimmerman@latimes.com

    Source Drug maker admits misleading public


     

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