From the FMS Global News Desk of Jeanne Hambleton
Courtesy of Fibromyalgia Network – February 2009
While patients are rightfully concerned about not receiving adequate pain relief, physicians harbor fears about drug abuse, safety issues, and government oversight. New clinical guidelines for the use of chronic opioid therapy in chronic non-cancer pain patients, developed by consensus of the American Pain Society and the American Academy of Pain Medicine, may ease both patient and physician concerns.
The guidelines, published in the February issue of the Journal of Pain, offer a roadmap for physicians on how to safely prescribe opioids to patients with moderate to severe pain.* The authors specifically state that their report applies to patients with “chronic non-cancer pain conditions, including common conditions such as back pain, osteoarthritis, fibromyalgia, and headache.”
Throughout the guidelines, physicians are urged to evaluate their patients’ pain and function on a regular basis. And, if doctors are worried that a patient is abusing or misusing the prescribed opioid, they may need to reduce the time between scheduled office visits. In addition, physicians are encouraged to look at all of the available options for treating patients’ chronic pain, including the use of opioids, and it is emphasized that this class of medications will seldom provide sufficient pain control. This means that patients placed on opioids will likely need to be prescribed medications from other drug classes as well as non-drug therapies. And, physicians who do not have the skill-set to prescribe opioids need to coordinate their patients’ care with another doctor who is experienced in providing this therapy.
The American Pain Society emphasized the following three points to all its members this month:
The guidelines are comprehensive and evidenced-based to assist physicians in managing chronic opioid therapy, according to the American Pain Society President Charles Inturrisi, Ph.D
“Regular monitoring of chronic opioid therapy patients is warranted because the therapeutic benefits of these medications are not static and can be affected by changes in the underlying pain condition, coexisting disease, or in psychological or social circumstances,” said Gilbert J. Fanciullo, M.D., director of the division of pain and palliative care at Dartmouth Hitchcock Medical Center.
Cochair Perry Fine, M.D., professor of anesthesiology at the University of Utah Medical Center, added that doctors do not have to solely rely upon patient self reports. Pill counts, urine drug screening, family member or caregiver interviews, and prescription monitoring data may all be used to check for possible abuse or other opioid-related problems.
The message is clear that under most circumstances, there are reasonable ways for physicians to prescribe chronic opioid therapy for their patients in pain while emphasizing safety issues and minimizing side effects or the potential for drug misuse. The guidelines offer physicians 25 recommendations with detailed explanations on how to follow them—all to help doctors prescribe opioids to their chronic pain patients in a responsible fashion. In addition to the key points already made, here are other highlights from the published guidelines:
Clinicians may consider a trial of chronic opioid therapy (COT) for moderate to severe pain that is having an adverse impact on a patient’s function or quality of life as long as the therapeutic benefits outweigh the risks (abuse, misuse and addiction). Three different patient screening tools (questionnaires that are easy to administer) are included with the guidelines to help doctors assess potential risks associated with COT for a given patient (the SOAPP, the ORT, and the DIRE).
Before initiating a trial of COT, physicians should provide their patients with informed consent, which alerts patients to all of the potential risks associated with taking opioids. After informed consent, doctors should discuss with their patients a COT management plan that outlines the goals of therapy, expectations, monitoring requirements, etc. A sample consent form and management plan are included in the guideline.
Initial treatment with an opioid should be regarded as a therapeutic trial to determine if COT is effective. If the first opioid does not work or produces adverse side effects, other types of opioids may be tried, but patients need to keep in mind that opioids are prescribed on a trial basis.
Physicians should anticipate, identify, and track common opioid-associated side effects. Constipation is the most frequent problem, and unfortunately it does not go away or get better with continued use of the medication. With this in mind, doctors should recommend stool softeners or increased fiber intake when issuing patients an opioid prescription. Nausea or vomiting may occur but tends to diminish over a few days. If it lasts longer, doctors can prescribe a medication to treat this side effect. Sedation and clouded thinking usually goes away with continued opioid use, while reduction in sex hormones may appear down the road with COT. If a patient begins to experience a decrease in libido, sex hormones can be checked and supplemented if necessary. Other side effects may also occur, so patients and physicians need to be on the lookout for them.
Chronic pain is often a complex condition and physicians who prescribe COT should routinely promote other therapies, such as psychotherapy (pain can be awful to cope with), physical and occupational therapies for restoring function, and other non-drug approaches in addition to prescribing other non-opioid medications. The purpose of this recommendation is to treat the whole person and improve the odds that a patient with chronic pain will achieve a more fulfilling life.
Doctors need to counsel patients prior to starting COT and continue until a stable dose is reached or if the dose is later increased as the patients’ cognitive skills may be impaired for a short period of time. If clouded thought processes do occur, driving should temporarily be avoided … so patients might want to start an opioid on a weekend when they do not have to drive. After a stable dose is reached, there is no evidence to suggest that patients on COT should be restricted from driving or engaging in most work activities.
The opioid guidelines give your doctor the “how to” advice for prescribing opioids, including sample copies of patient screening questionnaires, a consent form, management plan, and full details on how to responsibly prescribe opioids. However, they also assume that the prescribing physician is already knowledgeable about issues concerning this class of medications (i.e., the guidelines cannot possibly convert a novice into an expert on COT). Neither the patient nor physician should feel awkward about the consent and management forms, or random urine tests. Doctors who follow these guidelines should be better equipped to implement opioid therapies for their chronic pain patients (such as fibromyalgia) in a safe manner.
* Chou R, Fanciullo GJ, Fine PG, et al. J Pain 10(2):113-130, 2009.
Calling the Kettle Black
… editorial comment
By Kristin Thorson, Editor, Fibromyalgia Network
Posted: February 27, 2009
If your newspaper ran the February 8th Associated Press article “Drugmakers’ push boosts ‘murky’ ailment,” implying that the drug industry has fabricated fibromyalgia in an effort to churn a profit, you have every right to be furious!1 Controversy sells, and that was what the reporter, Matthew Perrone banked on. Perrone sought out Fred Wolfe, M.D., of Wichita, KS, because he knew from the January 14, 2008 front-page article in the New York Times that Wolfe had a track record for trashing patients with fibromyalgia and big, bad pharma as well. It is ironic, however, that Wolfe would make derogatory statements about the drug industry when he is heavily funded by six drug companies himself.
Wolfe is the director (and paid employee) of the National Data Bank for Rheumatic Diseases, a nonprofit registered as The Arthritis Research Center Foundation, Inc. Its mission is “conducting ongoing research to improve conditions for people with arthritis, fibromyalgia, lupus and other conditions.” He openly declares in his research papers, in which he is testing the effectiveness and safety of drugs for rheumatoid arthritis, that he is funded by Centocor, Aventis, Pfizer, Bristol-Myers Squibb, Amgen, and Abbott. So perhaps Wolfe’s dislike is not so much for the drug industry as it seems for fibromyalgia.
Prompted by mixed reports on increased cancer rates in people with rheumatoid arthritis (RA), Wolfe conducted an observational study on the incidence of cancer in RA patients who took the tumor necrosis factor (TNF) blocking agents Enbrel (etanercept) or Remicade (infliximab).2 His findings were derived from information in the National Data Bank (NDB) and per the NDB’s agreement with Centocor, the maker of Remicade, the drug company was allowed to review Wolfe’s manuscript prior to publication. But Wolfe does not just cater to Centocor. His NDB organization has similar contractual agreements with Bristol-Myers Squibb and Sanofi-Aventis.
Wolfe’s study contradicted earlier reports of increased cancer risks for RA patients taking Enbrel or Remicade. It also confirmed that TNF blocking drugs are linked to skin cancers, including potentially deadly melanomas. Instead of using his findings to alert the medical community that these drugs may pose a health hazard, Wolfe went on record with WebMD as stating: “The drugs, at this moment, do not seem to add any risk except for skin cancer and melanoma. This is a small overall risk and I do not think people should be concerned.” He also added that the risks did not outweigh the benefit for patients who truly need the new drugs.3
While there is no argument that people with RA deserve effective therapies, do you not think it is odd that Wolfe is the one pushing drugs on RA patients while in the recent AP article he bashes the drug industry for fabricating fibromyalgia to boost their sales? Yet he is quoted in the AP article as saying, “I think the purpose of most pharmaceutical company efforts is to do a little disease-mongering and to have people use their drugs.” Further in the article he says, “The underlying purpose here is really marketing, and they do that by sponsoring symposia and hiring physicians to give lectures and prepare materials.” Wolfe’s negative sentiments about fibromyalgia appear clear in a February 2009 report in which he writes, “Recently, regulatory authorities have approved treatments for fibromyalgia, offering some de facto support, although no proof, for fibromyalgia as a distinct disorder.”4 However, there was a time when RA had no “proof,” but that does not mean that the patients who suffered with it years ago did not have a real disease.
It is true that Wolfe was the lead author for the 1990 American College of Rheumatology criteria for fibromyalgia, but that was 18 years ago and much has changed.5 In 1990, the number of rheumatologists who were skeptical about the realness of fibromyalgia far outnumbered the believers. I should know, because I hosted an information booth on fibromyalgia at the annual rheumatology meetings throughout the 1990s, and in the early years I can attest to the ugly controversies surrounding this disease.
In 1994, Wolfe orchestrated a consensus conference (paid by the insurance industry) whose primary goal was to trivialize fibromyalgia and restrict patient care.6 Why he wanted to turn his back on fibromyalgia is still unknown, but his efforts failed. During the past eight years, the rheumatologists have rallied to increase the legitimacy of fibromyalgia by developing guidelines for improving the quality of research and for testing therapies to treat this patient population. Today, Wolfe and many of his colleagues do not see eye to eye when it comes to issues concerning fibromyalgia. At age 74, he appears to get his jollies by trash-talking fibromyalgia to headline-mongering reporters.
For all of you who were subjected to the AP story, I hope my comments help you understand the nonsensical nature of the article and that you can ignore any future reports that happen to quote Wolfe. I also want to make three additional points about the AP article:
Although Wolfe’s own nonprofit takes money from the drug companies, this does not mean that all nonprofits and organizations that help patients must do the same to stay afloat. Fibromyalgia Network and its sister organization, the American Fibromyalgia Syndrome Association (AFSA), have never received money from the pharmaceutical industry or other companies that could bias the way these two organizations operate.
Daniel Clauw, M.D., of the University of Michigan, did receive a small grant award from the National Fibromyalgia Research Association (NFRA) in Salem, OR, but the NFRA should not be confused with the National Fibromyalgia Association (NFA). NFRA does not receive money from the drugmakers.
The article implies that Clauw’s brain imaging research, which has documented many brain processing abnormalities over the past ten years, was tainted by drug money. That simply is not true because the funding for these studies came from government grants based on the merits of his proposals. “Most of us conducting research in the field of fibromyalgia were here ten years before the drug industry even took notice of this disease,” Clauw points out.
Perrone M. Associated Press © hosted by Google, Feb 8, 2009; (AP article).
Wolfe F, Michaud K. Arthritis Rheum 56(9):2886-2895, 2007.
DeNoon DJ. WebMD Health News Aug. 29, 2007; (WebMD article).
Wolfe F, Michaud K. J Rheumatol First Release Feb. 15, 2009; doi:10.3899/jrheum.080897.
Wolfe F, et al. Arthritis Rheum 33(2):160-72, 1990.
Wolfe F. J Rheumatol 23(3):534-9, 1996.
Kaufmann I, et al. Rheumatol Int [epub ahead of print] December 4, 2008.
Kaufmann I, et al. Clin Immunol 125:103-111, 2007.
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