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The Impact of the “Business” of Pain Medicine on Patient Care

Mary Lou Taylor PhD
DOI: http://dx.doi.org/10.1111/j.1526-4637.2011.01114.x 763-772 First published online: 1 May 2011

Abstract

Objective. The objective of this article was to examine the impact on patient care of the growing economic forces in pain medicine.

Discussion. Chronic pain is a growing problem in the United States, as more people seek treatment than ever before. The practice of pain medicine is influenced by many market forces, including industry relationships with pain providers, lawmakers and insurance companies, direct-to-consumer advertising, insurance reimbursement patterns, and competition among health care systems and pain management providers. These economic factors can encourage innovation and efficiency and may increase access to pain treatment. However, they have also resulted in unrealistic expectations for pain relief, increased reliance on medications, widespread use of inadequately tested or unnecessary pain management diagnostic and treatment techniques, decreased use of some effective treatments, and lack of adequate pain education. Patients are undergoing more treatments, but there is little evidence of overall improved function.

Conclusions. Following guidelines set out by the industry and pain medicine organizations, safeguarding against false or incomplete advertising, establishing easier methods for questioning advertising content, increasing the practice of evidence-based medicine, increasing government-sponsored research of definitive studies, and improving communication of efficacious treatment will facilitate the practice of ethical pain medicine and improve patient care.

  • Bioethics
  • Chronic Pain
  • Ethics
  • Pain Management
  • Pain Medicine
  • Advertising
  • Pharmaceuticals

Introduction

Pain management is a big business in the United States. On the demand side, the number of available patients seems endless. On the supply side, new technologies and new drugs have provided a cornucopia of treatment choices for chronic pain. It appears that more patients are getting more treatments than at any other time in history.

Recent data on the prevalence of arthritis, for example, illustrate the growth in the number of pain patients. The Centers for Disease Control and Prevention (CDC) reports on National Health Interview Survey data from 2007–09, finding that approximately one in five (49.9 million) adults in the United States report doctor-diagnosed arthritis, with 21.1 million reporting arthritis-attributable activity limitations. These numbers represent an increase of approximately 1 million patients per year since the previous 2003–05 study. The CDC suggests that, given the aging population and the current rates of obesity, the prevalence of arthritis for which patients seek physician care will continue to increase [1]. Recent projections suggest an increase in doctor-diagnosed arthritis to 67 million by 2030, with at least 25 million people experiencing activity limitations due to the condition. Working-age adults, 45–64 years old, will account for almost one-third of the cases [2].

It is difficult to get a firm estimate of the cost of chronic pain in the United States. Martin et al., reporting data from the Medical Expenditure Panel Survey, estimate total expenditures for spine problems among U.S. adults to be $85.9 billion in 2005 dollar rates—a 65% increase from 1997—while the population rose only 10.59%. Direct costs (expenditures directly linked to a relevant International Classification of Diseases, Ninth Revision, Clinical Modification code) were $32.7 billion, a 60% increase from the 1997 figures [3]. Katz estimates the total costs of low-back pain to exceed $100 billion [4]. But those estimates are only for the spine—they do not include headaches, rheumatoid and osteoarthritis, bursitis, torn rotator cuffs, diabetic neuropathy or any of the other conditions causing chronic pain.

But are more patients getting better? Here the statistics are difficult to interpret. More people are receiving treatment than ever before, yet disability rates are climbing. Social Security Disability applications for all causes reached 2,816,244 in 2009, up 47.5% from 1995. Slightly over 35% of applicants were awarded disability benefits. In 2009, 25,371 people per 100,000 population received Social Security Disability, compared with 15,928 in 1995 [5]. However, this indicator includes disability from all causes, not just chronic pain, and is affected by other factors, such as the aging population, the current economic recession, and a shift in attitudes toward being on Social Security. Few recent studies reporting incidence and prevalence of chronic pain are available, and again, these may not reflect chronicity of pain or failure of treatment as much as factors such as the aging of the population and the effect of obesity increases. One recent cross-sectional telephone survey of a stratified sample of North Carolina households indicates that the prevalence of chronic, impairing low-back pain has increased over a 14-year period from 3.9% in 1992 to 10.2% in 2006 [6]. Yet, CDC statistics published in 2009 indicate that the percentage of people over 17 years of age in the United States reporting low-back pain in the past 3 months (which includes acute and chronic pain) has dropped from 26.1% in 1997 to 22.2% in 2007 [7]. It is difficult to draw conclusions based on such sparse data. Certainly, many people with pain have experienced good outcomes from their pain treatment. However, Martin et al. report that though there has been a dramatic rise in expenditures for spine pain, “age- and sex-adjusted self-report measures of mental health, physical functioning, work or school limitations, and social limitations among adults with spine problems were worse in 2005 than in 1997”[3].

Given the statistics on the enormity of the chronic pain problem, it is not surprising that there has been a rise in chronic pain treatments and pain physicians. A patient deciding to seek treatment for pain faces a dizzying array of options. A person typing “pain management” into the Internet site http://www.yellowpages.superpages.com will find 640 listings for Los Angeles, 468 for San Diego, 628 for Dallas, 534 for Chicago, and 396 for Baltimore [8]. Listings range from university-based pain management centers to day spas. There are physiatrists, anesthesiologists, orthopedic surgeons, neurosurgeons, osteopaths, psychologists, chiropractors, massage therapists, acupuncturists, herbalists, physical therapists, and podiatrists, among others. Seeking treatment can be a bewildering journey.

For the overwhelming majority of health care professionals, relieving suffering and providing the best treatments for their patients are primary goals of their practices. However, it is unrealistic to believe that medical practice is not also influenced by secondary, and sometimes conflicting interests, such as the need to make an adequate living, pay for expensive equipment, get promoted or become a practice partner, simplify paperwork, manage workload, etc. Conflicts of interest can create self-serving biases that are unconscious and unintentional [9], and that do influence patient care. As a big business, many market forces influence pain treatment. Industry relationships with pain providers, lawmakers and insurance companies, direct-to-consumer advertising (DTCA), insurance reimbursement patterns, and competition among providers have all led to changes in the practice of pain management. While some of these changes are quite positive—greater access to pain specialists, better end-of-life care, etc.—there have also been negative effects. Greater and often unrealistic expectations for pain relief, reliance on medication, widespread use of inadequately tested or unnecessary pain management diagnostic and treatment techniques, decreased use of some treatments with well-documented effectiveness, and lack of adequate pain education are major concerns.

Industry/Health Care Relationships

Pharmaceutical and medical products and equipment industries have influenced the practice of pain management in many ways. These industries were ranked number 3 and 4, respectively, in the 2009 Fortune 500 list of most profitable industries, based on 2008 return on revenues figures. Pharmaceuticals posted profits as 19.3% of revenues, while the medical products and equipment industry posted 16.3% [10]. These industries have a strong lobbying component and have been very active in legislative issues. From January 2005 to June 2006, for example, pharmaceutical manufacturers and their trade groups spent a reported $155 million lobbying to prevent Congress from acting on legislation that would allow Medicare to negotiate drug prices [11,12]. The lobbying efforts increased during the 2009 Health Care Reform legislative process, with Pharmaceutical and Health Products industries spending over $267 million in lobbying [13]. These lobbying efforts influence the design of health care in the United States, with direct effects on patient care.

The relationship between the pharmaceutical and medical products industries and health care providers and researchers has been shown to affect patient care, although this influence is currently being mitigated by new regulations at most major medical schools and university hospitals and by voluntary changes within the industry itself. As discussed below, industry gifts, samples, support for travel and continuing medical education (CME), honoraria, consulting payments, and research funding are all areas that have been found to affect the practice of pain medicine.

For many years, in pain management, as in almost every other aspect of medical education and practice, it was routine for pharmaceutical or medical device manufacturers to host meals at medical schools, clinics and doctors' offices, sponsor grand rounds, supply pens and notepads, and frequently offer much larger gifts or entertainment, in exchange for the opportunity to discuss the superiority of their product. Both physicians and industry representatives defended these practices as means of providing up-to-date information on new medications and argued that industry interactions with physicians increased accuracy in prescribing, guided management of side effects, etc. While physicians consistently deny that such favors influence their decision-making, social science research and research on prescribing practices indicate that even small gifts may create unintentional and unconscious biases for physicians, resulting in increased prescribing of the company's medication or use of the company's medical products [9,14,15].

Physicians are not alone; the research demonstrating that financial motives distort judgment has put into question the ethics of judges' and lawmakers' junkets paid for by corporations, and most companies now have policies restricting acceptance of gifts and entertainment for purchasing or procurement agents.

Many medical schools and major medical centers have banned industry representatives from sponsoring grand rounds, providing meals, and from giving even small gifts. In 2009, the Pharmaceutical Research and Manufacturers of America (PhRMA) revised their Code on Interactions with Healthcare Professionals. The code states that meals for physicians and their staffs may be offered, “so long as the presentations provide scientific or educational value and the meals 1) are modest as judged by local standards; 2) are not part of an entertainment or recreational event; and 3) are provided in a manner conducive to informational communication,” prohibiting spouses or other guests and prohibiting recreational or entertainment events. Additionally, the code acknowledges that gifts of even minimal value, such as pens and mugs, “may foster misperceptions that company interactions with health care professionals are not based on informing them about medical and scientific issues,” and should not be offered [16].

The standard practice of pharmaceutical representatives supplying samples to physicians has also come under scrutiny. Samples allow patients to try a medication to be sure it is well-tolerated before filling an expensive prescription. They also allow access to medications that a patient might otherwise be unable to afford. However, research indicating the influence on prescribing practice has caused concern, as accepting samples has been associated with increased awareness, preference, rapid prescription of a new drug, and a positive attitude toward the pharmaceutical representative [14]. While noting that “it is rare that the newer medications are significantly better than the less-expensive alternatives,” the American Academy of Pain Medicine Ethics Council concludes that the decision to accept samples is complex and must be individualized [17].

The pharmaceutical and medical device industry have had an influence on patient care through their sponsorship of CME activities, supporting travel to meetings, and the common practice of providing honoraria, lecture fees, and consulting fees to physicians. While sponsorship of CME activities has been defended as providing convenient, inexpensive ways to fulfill continuing educational requirements, the content of many industry-sponsored CME programs has come under public criticism for failing to adequately describe side effects of the medications, highlighting drug therapies, and highlighting newer drugs [18]. The PhRMA Code of Interactions revisions state that financial support now needs to come by underwriting independent CME programs, with responsibility for and control over content given to the CME organizers or creators [16]. However, medical specialty organizations have traditionally relied on money from pharmaceutical and medical product companies as a substantial source of financing for their programs. If a pharmaceutical company underwrites a CME event, it would not be logical for the organization to use the money to host a program on acupuncture or functional restoration or a competing medication, for example, assuming that they are hoping for an equal level of funding the following year. The conflict of interest remains. Code of Interaction revisions on consultants seek to eliminate the former practices of paying consulting fees, travel expenses, etc. for very little work or work of questionable importance [16]. One University of Wisconsin physician, disclosing consulting fees under the university's newer requirements that they disclose actual income, reported $150,000 for 8 days of consulting to a medical device company [19]. While tighter restrictions on disclosure have made abuses more transparent, research does not indicate that disclosure mitigates conflict of interest [17].

Industry-funded research is another area that has been problematic for the practice of pain management, and has directly impacted patient care. As government research funding has dwindled, industry has funded a greater proportion of medical research [20]. While it is recognized that this funding is important for the advancement of science, abuses such as research designs that are influenced by the industry to favor positive outcomes for their product, inability of physicians participating in multicenter studies to have direct access to the data, ghost writers, the number of negative studies that are not submitted for publication, and research conducted by physicians who have a financial stake in the company have all been documented. Shah et al. surveying articles published in Spine from January 2002 to July 2003, found the odds ratio of industry-funded studies reporting positive results was 3.3 times that of research funded by any other sources [21], while a systematic review of Medline studies from 1980 to 2002 found a similar association between industry sponsorship and pro-industry conclusions [20]. The problem is compounded by the fact that journals have been found to be more likely to publish positive results, leading to an unbalanced view of the efficacy of a treatment. Looking at publications of antidepressant clinical trials is a clear example. Of 74 US Food and Drug Administration (FDA)-registered clinical trials between 1987 and 2004, 31% were not published. The FDA deemed 51% of the studies to show positive outcomes, and all but one of the positive studies was published. The other 49% (36 studies) were either negative or questionable: of those, 3 were published as negative findings, 22 were unpublished, and 11 were published to appear positive. When the data from the unpublished studies were included in the analysis of efficacy, the effect size of the published literature ranged from 11% to 69% higher for individual drugs than the FDA data [22]. Reading the published literature leads to the general impression that antidepressant medications are more effective than they actually are, leading in turn to more prescriptions and to an emphasis on medication as a front-line treatment.

The impacts of industry-physician relationships on patient care are numerous. Prescribing practices do change with exposure to industry representatives, impacting prescribing cost, nonrational prescribing, awareness, preference and rapid prescribing of new drugs and decreased prescribing of generic drugs [14]. Given the social science data indicating that even small gifts can and do influence behavior and attitudes, it is likely to assume that practices such as consulting fees for minimal product, meals and research funding also influence physician behavior, however unconsciously or well-intentioned.

Physicians with strong industry relationships are more likely to get information about newer drugs, not older medications with similar efficacy. Industry-sponsored CMEs tend to stress interventional techniques or medications, and may contain only brief descriptions of nonproduct-related treatment options (physical therapies, psychosocial interventions, etc.). Training programs offered by device manufacturers logically promote use of their own products, without an objective study of competitors' products. And industry-sponsored research projects are much more likely to be single-medication or single-intervention studies. While clinical trials are vitally important in the development of medications and devices, especially to establish dosage and test safety, they do little to inform the day-to-day treatment of chronic pain—few patients are ever successfully treated with a single medicine or a single intervention.

The relationships between insurance companies and pharmaceutical and medical device companies also impact pain patients, as companies negotiate to get their medications on formularies or their devices authorized. Insurance company personnel are no less susceptible to the subtle (and sometimes not so subtle) influence of gifts and personal relationships with industry representatives. One major problem has been the increasing difficulty for patients to get insurance authorization for treatments that are equally or more efficacious (such as functional restoration or intensive pain rehabilitation) [23], but are not effectively marketed. Each pain program is independent and not patented, and most do not have budgets to effectively negotiate contracts with more than a few insurance providers. The result is that, despite the cost-effectiveness of comprehensive pain programs [24], patients may have an easier time getting authorization for individual specialized treatments, newer treatments that may have less effectiveness and treatments and diagnostic procedures that in some cases may have harmful effects in the long run, such as discography [25].

DTCA

Pain patient care has also been influenced by the rise in DTCA, both for prescription medications and for pain clinics. A 1997 FDA decision relaxed the requirements for the amount of information on adverse effects that must be included in broadcast advertisements [26]. Overall, DTCA spending increased from approximately $1 billion in 1996 to $2.7 billion in 2001 [27], and has increased to $4.51 billion in 2009 [28]. In one study, patients with higher exposure to DTCA were shown to request more prescriptions, and patients who requested DTCA drugs were more likely to receive one or more prescriptions, either for the requested drugs or an alternative, even when the physician rated the prescription as only a “possible” or “unlikely” choice for similar patients [29]. Most DTCA medications are for chronic, non-life-threatening problems, such as acid reflux and erectile dysfunction, or for problems with high rates in the population, such as depression and high cholesterol. The prevalence of pain and the aging of the population make pain medications a good choice for DTCA. Critics of DTCA argue that such advertising increases the belief that medications can cure pain, increases patient expectations and increases the likelihood that patients will get newer, more expensive medications that do not have long-term safety records. The problem of rapid adoption of medications was highlighted by the aggressive marketing of Vioxx, which was approved by the FDA in May 1999 and posted sales of more than $1.5 billion by 2000. Vioxx was taken off the market in 2004 due to evidence that long-term use increased risk of heart attack and stroke [26].

DTCA for pain providers is also affecting patient care. Patients hear and see advertisements for pain specialists or pain clinics on the radio and TV, on billboards, in newspapers and magazines, and on the Internet. Many of these sources provide little information on the risks and benefits of specific treatments. Many suggest outcomes that, while they may be accurate for a select group of patients, may be overly optimistic for a person with longstanding chronic pain. An ad for AccuraScope Discectomy and Neural Decompression, for example, touts, “Many patients can resume normal activities the following day, and most can return to work in under a week [30].” Unless the treatment is done only on patients who are currently working, this is unlikely, given the statistics on return to work after 6 months or more of sick leave/disability [31]. Another treatment reports that “most may return to normal activity within 1–6 weeks,” suggesting that patients with years of disability may go back to the functioning they experienced years ago. The websites stress procedures. They are dotted with testimonials, but rarely include statistics on efficacy. Unless a patient knows the right words to enter on an Internet search (“pain rehabilitation,”“functional restoration”), it is difficult to find a pain clinic with integrated psychological services. DTCA advertising for pain clinics in general gives patients the impression that there are cures for their pain if they just get the right doctor, the right diagnosis, and the newest technology.

Insurance Reimbursement

Pain treatment is also influenced by insurance coverage. A recent Pain Medicine Position Paper states that, “although the benefits of a multidisciplinary approach to treating pain are now much more widely accepted, pain treatment in practice remains far too fragmented,” citing the rise of managed care as one reason [32]. Though the prevailing biopsychosocial model of pain stresses an integrated approach, coverage for mental health is often “carved out,” requiring patients to see only therapists on the managed care panel. These therapists may or may not have expertise in pain management, and most often are not connected with a pain management program.

Insurance policies that reimburse time spent on procedures at a higher rate than time spent in counseling or medication management also may affect practice. One Internet survey of physicians who implant intrathecal pumps found that 90.5% of respondents felt that reimbursement for pump refills and follow-up were not adequate to cover costs, and 56.6% now use fewer pumps secondary to reimbursement issues [33], despite research indicating long-term reduction in pain scores and decreased oral opioid consumption in a 3-year follow-up period [34].

Competition

Competition among pain management practitioners is happening in the larger context of competition in health care overall. As the number of hospitals in a market rises, competition tends to drive down individual prices [35], but increases overall health care expenditure by treating more patients and providing more services and treatments, without necessarily improving health care in the population. Studies on spinal surgeries on older populations, for example, have found that higher rates of surgeries have not led to better outcomes overall [36].

As an example of competitive forces, specialty surgery centers entered markets by offering newer facilities, newer technologies, plusher surroundings and better food, while keeping profit margins healthy by taking privately insured patients who are less ill and have fewer comorbidities. General hospitals are left with sicker, less well-insured patients [37]. Many of these hospitals compete by offering similar services (Internet access, restaurant-type menus, Jacuzzis in the birthing rooms, etc.), and keep their costs down in part by reducing or eliminating less well-paying services. Hospital space is limited: the spoils go to the high-profit departments. Many hospitals, including university-based medical centers, have closed their intensive pain rehabilitation programs due to these cost/space/reimbursement issues.

This trend can be seen in the number of independent pain clinics. Many clinics offer only high-tech procedures or diagnostics. A patient may be referred to an outside physical therapist or, less frequently, psychologist, but there is no coordinated interdisciplinary treatment, and the intensive, daily pain management program that has been proven to be more useful [23,24,38] is not available. Over time, hospital pain centers have tended to keep up by putting more resources into the higher-paying interventional pain services.

The Impact on Patient Care

Population-adjusted figures suggest that pain patients today are likely to receive more surgeries [39], more invasive surgeries [40] and more medications per user [41]. They are more likely to have expensive diagnostic tests (discograms, medial branch blocks, computed tomographies, magnetic resonance imagings). They are receiving more epidural injections [42], and more facet joint injections [43]. Certainly, many people are being helped by proper diagnosis and treatment of pain. Yet, there are no indicators to show consistent reduction in pain and disability in the population overall. The number of people reporting chronic low-back pain in North Carolina, for instance, has continued to rise despite increasing health care use [44]. In general, patients are less likely to be offered intensive pain rehabilitation, or to even be aware that it is an option. Barriers to rehabilitation programs include unavailability in some areas, limited insurance coverage [45], and a higher initial (though not long-term) cost [24].

Advertising has given pain patients unrealistic expectations for the treatment of their pain. One result is that patients take less responsibility for their pain management, expecting surgery, procedures or medications to do more for their pain relief than do exercise, losing weight, and developing healthy social supports. They may make decisions without understanding all of the risks and benefits [40]. One study found 22% fewer patient chose spine surgery after viewing a video decision aid compared with a control of standard informed consent information. One year later, the groups were equivalent in pain and functional outcome [46]. Without adequate information, patients may fall prey to unscrupulous practitioners in their search for pain relief and the belief that pain cure is just a procedure or a surgery away.

A recent patient illustrates this point. A 60-year-old male has a life-long history of anxiety and depression, with panic attacks and agoraphobia. He has a long history of alcoholism, resulting in peripheral neuropathy, but he is currently abstinent. He also has a long history of poly-substance abuse. He last worked in 1990 and receives Social Security Disability for his mental health issues. He states he has had low-back pain for 10 years, a dull ache with no radiation to the lower extremities. He reports previous treatment at four pain clinics, at least one of which he chose because of the clinic's radio and television advertising. Despite his abuse history, he has been on opioid doses as high as 100 mcg Fentanyl patches or 60 mg long-acting morphine twice a day, with hydrocodone or oxycodone for breakthrough pain; however, he has been discharged from at least two clinics for noncompliance with medications, and has been hospitalized for at least one overdose. Since then, his primary care physician has prescribed two 7.5-mg hydrocodone per day. He has undergone multiple spinal injections and a disc decompression, with no improvement in function. He has had two courses of physical therapy, but does not do the home exercise program. He sees a psychiatrist and a therapist, who is not trained in pain management. He has never had a coordinated pain management program. While it is unlikely that he would be motivated or compliant with an intensive functional restoration program, the piecemeal treatment he has received in the past has been costly, has subjected him to adverse effects and has not been of any overall benefit. Given his reliance on narcotic medications and his continual pursuit of the right pain doctor, he is likely to be offered more invasive procedures in the future. What is the likelihood that they will help [47,48]? What would ethical treatment look like?

Certainly, every pain physician reading this can recall similar cases. And certainly the pull of a patient who is suffering is to do something to help. But when a clinic cannot offer the coordinated care that complex patients such as this truly need, the most ethical course of action would be to help get him that care in another facility—a time-consuming and often frustrating endeavor. When one's clinic contract includes significant billing expectations ($750,000–1 million per year is not unheard of), those expectations can influence treatment decisions. In a case such as this, the patient has been getting bandaids for a gaping wound.

Suggestions for Change

Finding reasonable solutions to the problems inherent in the business of pain management are difficult, but improving adherence to industry/medicine boundary guidelines, improving accountability for false or misleading advertising of pain treatments, adhering to the practice of evidence-based medicine and improving communication of efficacious treatments to insurance companies, patients, and the public may all help to improve patient care.

The problems posed by the business aspect of pain medicine have come under scrutiny by many organizations, and recent changes may reduce some of the negative effects. The 2009 revision of the PhRMA Code on Interactions with Healthcare Professionals provides stricter voluntary guidelines for the relationships between the pharmaceutical industry and health care providers [16]. In 2010, the American Academy of Pain Medicine Ethics Council published a Statement on Conflicts of Interest: Interaction between Physicians and Industry in Pain Medicine. The statement defines a conflict of interest as “a situation in which someone in a position of trust, such as a physician or a medical research scientist, has competing professional or personal interests that has the potential to influence patient care or other professional primary obligations such as research and education,” noting that “if a reasonable observer finds it plausible that the average person could be, but not necessarily would be, swayed by secondary interests,” a conflict of interest exists.

The statement includes the following recommendations:

  • Disclosure needs to include exact dollar amounts and value of materials, and needs to be strictly enforced.

  • Physicians should recuse themselves where any conflict exists.

  • Consultants and advisory boards should be recognized thought leaders with extensive clinical expertise.

  • Written consulting contracts should detail deliverable work products and timelines; payments should be reasonable and commensurate with the value of the work.

  • CME programs should be conducted independently of any industry input.

  • Speakers must adhere to the Accreditation Council for CME guidelines.

  • With rare exceptions, audiovisuals should be created by the speaker without industry editing.

  • Neither speakers nor attendees at conferences should be funded by industry directly.

  • Physicians should eliminate visits from industry representatives and should not accept any gifts, including meals. While recognizing that free samples create a bias to prescribe the medication, the Council notes benefit to indigent patients and concludes that the role of samples must be individualized.

  • Safeguards for reducing conflicts of interest in industry-funded research include registering prospective randomized controlled studies; review by an Institutional Review Board (IRB); claiming authorship only when a significant intellectual contribution has been made; accepting responsibility for the study, having access to the data; and controlling publication decisions.

  • “Ghost writers” are not acceptable.

  • IRBs should have written disclosure and recusal policies.

  • Physicians should not invest privately and directly in a company if they will be doing research for that company or will be speaking or writing for any of the company's products, unless it is unreasonable that someone else could be trained instead [17].

The American Academy of Pain Medicine Ethics Charter, published in 2008, broadly echoes the Council's guidelines, and later added the Statement of Conflicts of Interest as an addendum. However, while stating, “it is strongly recommended that incompetent or unethical professionals undergo corrective action such as mandatory education and/or peer counseling,” the charter suggests reporting concerns to state medical societies, peer review organizations, or licensing boards [49]. There are currently no guidelines for addressing potential conflicts of interest that do not break laws or cross the boundary from questionable to clearly unethical.

Data to gauge the effect of the stricter guidelines on overall pain care is not yet available. Research looking at changes in prescribing or treatment patterns would be useful, as would research on content of CMEs and changes in industry-funded research design, execution, and publication.

Decreasing false or incomplete advertising of pain treatments is difficult, in some cases taking years before the issues are resolved through the court system. In the meantime, patients may have been misled and may have undergone ineffective or inappropriate treatments. The Mill Valley Patch reports that 11 California counties are suing a chiropractor and marketing consultant for false marketing of a spinal traction device, the DRX-9000, quoting a press release about the lawsuit that states, “All claims about the efficacy of the DRX-9000 can be traced to (the defendant's) marketing plans and were either false or not scientifically substantiated”[50]. The device is no longer available for sale in the United States or Canada by the manufacturer [51], but it took quite a long time to halt the device's marketing and sale. Despite multiple lawsuits in other states as well, there are still used units available on the Internet. Enforcing existing restrictions on advertisements or tightening restrictions as necessary is recommended. Requiring more balanced disclosure of risks and efficacy data would help patients seek more appropriate treatment. Establishing easy and well-publicized methods for questioning advertising content or reporting abuses would also be useful. A centralized government or pain-medicine sponsored hotline and website where patients and health care workers could voice complaints and have these complaints investigated is one possible solution.

However, it is also important that physicians take seriously their responsibility to protect patients from fellow physicians who may be providing incompetent, unethical, or questionable treatment. How many pain physicians have seen patients who have had multiple unnecessary or questionable treatments? How many of them have gone to the treating provider to voice their concerns, or in egregious cases, reported the provider to the hospital board or state licensing bureau?

Increased government sponsorship and support for pain research would reduce pain medicine's current reliance on industry as a major funding source. In 2007, the percentage of the total National Institutes of Health (NIH) budget spent on pain research fell to 0.61% [52]. The Pain Medicine Position Paper cites increased government support of research in pain as a major need [32]. Important components of the 2009 National Pain Care Policy Act, which was enacted as part of the Patient Protection and Affordable Care Act in 2010, may help to improve the situation. The bill calls for the establishment of a Pain Consortium at the NIH, and encourages the NIH to expand an aggressive program of pain research [53]. NIH funding for chronic pain conditions was $279 million in 2008. The estimate for spending in 2012 is $366 million, a 31% increase [54].

Another important recent development is the formation of the Analgesic Clinical Trials Innovation, Opportunities, and Networks (ACTION) Initiative. ACTION is a public/private partnership between the U.S. FDA, the University of Rochester, the University of Pennsylvania, and several major scientific societies with the aim of streamlining the discovery and development process for new analgesic drug products [55]. Ideally, increased government funding of research will foster more collaborative and multidisciplinary research and promote research with study designs that meaningfully compare treatments. High quality, well-designed prospective treatment comparisons may better inform insurance coverage decisions and provide more reasoned choices for evidence-based medicine. Continued increases in government funding of research will depend in large part on individual and collective political action and education of stakeholders to demonstrate the importance of pain research to the health of the American public.

The growing body of meta-analyses and practice guidelines based on research evidence will be useful in reducing potential negative effects of market forces. Review articles on interventional therapies, surgeries, interdisciplinary rehabilitation [45], physical therapies and complementary therapies synthesize years of data and weigh evidence based on study quality. Evidence-based medicine needs to become the standard of care in pain medicine, reducing the use of unproven or ineffective treatments. One obvious pitfall is the relative lack of high-quality, prospective, randomized studies for many treatments. Carefully designed studies that select meaningful outcomes, provide long-term follow-up data and compare treatments with meaningful alternative treatments are vitally necessary.

What would be the best treatment for the previously discussed 60-year-old man with anxiety disorders, alcohol and substance use disorders, and chronic low-back pain? Continuing piecemeal treatments is not in his best interest [56]. However, traditional multidisciplinary pain treatment in his case may also fail [47]. Perhaps it is time for a paradigm shift, toward providing patients with complex needs and high pain-care utilization with intensive health care management. Programs such as the Camden Coalition and the Special Care Center in Atlantic City, NJ, are demonstrating improved patient health and significant cost savings by enrolling the highest health care users in intensive management programs. In addition to regular physician contact, these programs may include health coaches, frequent phone calls, social services, health education, yoga, and exercise, with tightly coordinated care [57]. It is not cheap, but it has been shown to be much more economical than the usual care for the most complicated medical patients. Most importantly, it has a high rate of success in improving patient function.

Improving communication of efficacious treatments for chronic pain problems to physicians, insurers, lawmakers, and the public in general may also help patients get appropriate and effective pain treatments. While pharmaceutical and medical device makers have marketing and lobbying strategies to communicate regarding their own products, other effective treatments, although well documented, do not have marketing or lobbying champions. Professional organizations such as American Pain Society, American Academy of Pain Medicine, and the American Academy of Pain Management may be able to impact patient care by providing the communications with insurers and lawmakers and the public that better informs policies and treatment opportunities. Esteemed organizations strongly stating the minimum standards of care can and have been very influential.

Conclusions

Pain management is an art. It is a science. And it is a business. The business of pain management influences patients' attitudes toward pain, their expectation for pain relief and cure, and their choices of treatments. It has increased the use of surgeries, implantable devices, invasive interventions, chiropractic interventions, and complementary and alternative medicines and therapies. Yet, there is little evidence that these interventions have reduced pain and disability overall.

Industry relationships with physicians, insurers, and lawmakers have affected pain management profoundly, influencing policy and insurance coverage, changing prescribing patterns, and increasing use of medical devices and instrumentation. Advertising for pain medication and pain treatments has changed the expectations of patients and decreased emphasis on the patient role in pain management. Insurance reimbursement patterns have decreased the availability of multidisciplinary pain treatment and increased the economic attractiveness of invasive procedures. Competition among pain medicine practitioners has often resulted in a stress on new technologies and high-paying procedures, with a reduction in less profitable treatment options.

In some ways, the profit motive in pain medicine may improve patient care by promoting innovation, efficiency, and safety. However, providing excellent patient care in a profit-driven environment necessitates awareness of secondary and conflicting interests and scrutiny of our practices to safeguard against abuses. As Weiner and Levi, discussing the profit motive in spine surgery, conclude, “This does not mean that we must reject the profit motive. However, it does mean that we must resist the temptation to rush unproven products to market. It means that we must have the discipline to conduct prospective, randomized, controlled trials with appropriate control groups and await the results before adopting new products and/or techniques. It means that we must have the strength and resolve to publish negative results. It means that we must police ourselves by only rewarding those within our profession who engage in the practice of spine surgery and its research with integrity and compassion. Conscientiousness lies at the heart of professionalism. Without it, the profit motive is sure to lead us astray”[58].

Raising awareness of the conflicts of interest inherent in the business of pain medicine and improving adherence to newer, stricter industry/medicine boundary guidelines are positive steps to insuring the ethical practice of pain medicine. Improving accountability for false or misleading advertising of pain treatments and establishing methods of dealing with misleading advertisers will quickly and efficiently help reduce unrealistic expectations and minimize negative patient experiences with ineffective or harmful treatments. Stressing the importance of evidence-based medicine—and funding the prospective, randomized, controlled trials to adequately demonstrate efficacy—is vital. And actively communicating and educating all parties, including physicians, patients, insurers, and lawmakers, about pain and efficacious pain treatment will help to insure that the business of pain medicine does not interfere with the ethical practice of pain medicine.

References

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