Tag Archives: pain

Real World Full of Medical Ethics Challenges

There’s the ideal world, and then there’s the real world. Humans have a wonderful hubris in forever trying to get the twain to meet, and a necessary humility in examining ways that they don’t. That’s as true in medicine as anywhere else.

The Charter on Medical Professionalism, endorsed by the U.S. Accreditation Council on Graduate Medical Education and more than 130 professional groups worldwide, contains three fundamental principles: the primacy of patient welfare; respect for patient autonomy, and promotion of social justice. Who wouldn’t want that? A physician’s professional responsibility as spelled out in the charter entails honesty (including disclosure of medical error), patient confidentiality, maintaining trust by managing conflicts of interest, and much more.

Ben A. Rich, J.D., Ph.D. (SHERRY BOSCHERT/IMNG Medical Media)

Yet, more than 10% of 1,891 practicing U.S. physicians surveyed recently in seven specialities said that they had told adult patients or a minor’s parent or guardian something that was not true, Ben A. Rich, J.D., Ph.D. noted during a session on ethics at the annual meeting of the American Academy of Pain Medicine.

Results of the survey of physicians in internal medicine, family practice, pediatrics, cardiology, general surgery, psychiatry, and anesthesiology also showed that 20% of physicians had not fully disclosed mistakes to patients out of fear of malpractice litigation.

More than 33% said they do not agree that physicians necessarily must disclose all serious medical errors to affected patients, or that it’s important to disclose to patients any financial relationships with drug and device manufacturers (Health Affairs 2012;31:383-391).

More than 25% of the physicians said they had revealed unauthorized information about a patient. More than 50% had described a prognosis to a patient more positively than the clinical facts warranted.

Women were more likely than men to practice consistently within the Charter on Medical Professionalism, as were physicians from racial and ethnic minorities, the survey found.

It’s comforting to note that a majority of physicians seem to adhere to the professional principles, and perhaps we shouldn’t be too hard on those who admit their actions sometimes diverge from the ideals, said Dr. Rich, professor of medicine and director of the Bioethics Program at the University of California, Davis. The “messy facts” of real cases show the challenges that physicians face in trying to help patients while also respecting their autonomy while also being honest, etc.

One example: A published case of a 45-year-old licensed practical nurse whose license had been suspended due to her medical problems. She was being treated for migraine headaches by a psychiatric neurologist and was on gabapentin, topirimate, propranolol for prophylaxis, oxycodone for breakthrough headaches, and IM injections of meperidine and hydroxyzine for breakthrough pain. She signed a contract with her physician saying she would only take narcotic medications that he prescribed and would not seek painkillers from emergency departments (Nursing Journal 2007;29:35-40).

“She violated that contract repeatedly and with impunity and was becoming a `frequent flyer’ in the local E.D.s.,” Dr. Rich said. Her physician persuaded her to get inpatient treatment, but afterward she relapsed and continued E.D.-hopping in pursuit of pain meds. One local E.D. suggested to her physician that he be notified whenever she turned up in an E.D. Her physician suggested instead that the E.D. do what he had resorted to doing — injecting her with saline and telling her it’s meperidine.

Some E.D. physicians gave her medications just to get her out the door. Others refused to give her any narcotics for her pain because of her addiction and violations of her contract. All the healthcare providers in the medical group of one emergency department signed a letter to the patient telling her that if she came there for treatment, she would be evaluated and treated with non-narcotic medications recommended by her treating neurologist but she would no longer be given narcotics.

Which, if any, of these approaches pass ethical scrutiny? What would you do if you were her neurologist or saw her in pain in the emergency department?

The group that sent her a joint letter was “at least trying a collaborative approach and putting her on notice about how she would be treated if she continued to present there,” Dr. Rich said.

The lengthy Ethics Charter of the American Academy of Pain Medicine lists many physician duties, including this “intriguing” one, he noted: Any reports to law enforcement of attempts to acquire pain medications illegally should be based on confirmed firsthand information.

“Some of my colleagues at UC Davis are working on a manuscript right now where we’re finding it’s not as clear as one might hope” when deciding whether you have a duty to report a patient to law enforcement or a duty not to report to law enforcement because reporting the patient may infringe upon patient confidentially, not to mention potentially violating the Health Insurance Portability and Accountability Act (HIPAA), he said.

The messiness of real life doesn’t diminish the importance of standards, it just reinforces the need for ideals to guide us as we muddle our way through the real world.

Dr. Rich has been a consultant to KOL, L.L.C.

–Sherry Boschert (@sherryboschert on Twitter)

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Pain Medicine Rocked by Perception of Conflicts

Controversy around payments to physicians from companies that make pharmaceuticals and medical devices has been much in the news lately, especially related to pain medicine.

ProPublica reported on deep ties between two physician leaders in pain treatment and the pharmaceutical industry. A nifty page created by ProPublica lets viewers search for their physician’s name in the database of payments reported by industry.

The Milwaukee-Wisconsin Journal Sentinel reported that the steep increase in use of pain medications in recent years is paralleled – and their headline says “fueled” – by a network of physicians, researchers and organizations pushing for greater access to narcotics while taking money from drug companies. They published a nifty graphic and a case study to help make the case.

Most recently, the New Haven (Conn.) Independent reported that a dozen doctors in the state continued to receive money or gifts from drug companies while being sanctioned by the state for prescription-related offenses.

Dr. Jerome Schofferman (SHERRY BOSCHERT/IMNG Medical Media)

At the annual meeting of the American Academy of Pain Medicine, I asked one of the speakers at a session on ethics to comment on all this. Dr. Jerome Schofferman said he is not a trained bioethicist but he follows ethics with a passion. How passionate is he? Dr. Schofferman refused to wear the lanyard that all attendees received in their registration package because it had a company’s name on it. (A lanyard is the ribbon that clips onto the name badge, to be worn around the neck.) He brought his own lanyard.

Part of the problem, he said, is that drug companies develop a lot of “me-too” drugs that work like other available drugs, then avoid doing head-to-head comparisons so that no one can say their drug isn’t as good as another, and pour their resources into marketing their drug to boost sales.

“There’s no doubt that these drugs are overmarketed and probably overprescribed, but they work for a lot of people,” so we need to keep the potential benefits in mind in all of this too, he said.

Relationships between industry and physicians or patient advocacy organizations can be a mutually beneficial thing and aren’t inherently bad, but the lack of full and up-front disclosure of the relationships gives the impression that something’s not right and prevents people from making informed judgements, he said.

In the articles on industry and pain medicine, “No one has ever really shown in this context that this is bad. It’s just the perception is that it can’t be good. It can be good if the American Pain Foundation accomplishes a lot of good things,” Dr. Schofferman said. Too many groups and physicians hide their industry connections instead of making them easy to find. “If there had always been disclosure at the top of their Web site or their publications, a lot of this wouldn’t come up. It wouldn’t be a story, and it wouldn’t have that oomph factor,” he added.

In his talk at the meeting, though, Dr. Schofferman was a bit stricter than in our interview, arguing that disclosures alone are not enough.

He cited an article by social scientists suggesting that 61% of physicians say that conflicts of interest do not influence their decisions, but 84% of physicians admit that conflicts of interest might compromise other physicians (JAMA 2003;290:252-255). Bias and influence are neurobiological social processes that can alter behavior in unconscious ways, he explained. People may want and choose to behave ethically but still be influenced by economic factors because human nature inherently reverts to reciprocity and self-interest, functional MRI studies suggest.

Dr. Schofferman suggested several ways to personally minimize industry influence:

Dr. Jerome Schofferman (SHERRY BOSCHERT/IMNG Medical Media)

1) Don’t be in a company’s speakers bureau. These are “marketing by proxy,” he said.

2) Don’t attend industry-sponsored satellite sessions or marketing dinners at meetings. Get your medical education from accredited sources.

3) If you’re an educator, divorce yourself from industry, or at least provide full disclosure including dollar amounts of anything you receive.

4) Don’t be an industry “advisor” or “consultant” unless you truly are a thought leader and innovator with specialized skills, knowledge, or experience that you bring to the relationship. Spell out that relationship in a written contract describing details of the work product to be delivered and a timeline for delivery. Charge only fair market value for your time and expertise.

5) If you are an industry speaker, advisor or consultant, do not seek leadership positions in professional medical associations.

6) Professional medical organizations and conferences should limit industry participation to ads in journals and to exhibit halls (“But don’t put food in there!”), and stop splashing corporate logos on everything, such as lanyards. “We’re like NASCAR drivers” at these meetings, Dr. Schofferman complained.

Starting in September 2013, industry payments and gifts to physicians will be posted online under the Physician Payment Sunshine Act.

–Sherry Boschert (@sherryboschert on Twitter)

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Recycle to Reduce Drug Overdoses

Recycling and prescription drug overdoses have something in common.

Recycling has become second nature in many parts of America. Bins and containers to collect excess paper, bottles and cans are ubiquitous. Yet, only a few a few decades ago, recycling seemed foreign, was not convenient, and took some effort and resolve on an individual’s part.

Keith N. Humphreys, Ph.D. (Sherry Boschert/Elsevier Global Medical News)

That same evolution has to happen in the way that we handle leftover medications, Keith N. Humphreys, Ph.D., told physicians at the American Academy of Pain Medicine annual meeting. There’s an epidemic of opioid overdose deaths in the United States, and the most common source of misused opioids is leftover medications obtained from friends and family.

He’s talking about a huge cultural shift – with consumers going from saving and sharing costly medications that can be hard to come by in the current health system to recognizing their potential for harm and routinely returning leftover drugs on “take-back days” organized by law enforcement or even depositing them in specialized “recycling” bins.

The number of opioid prescriptions dispensed by U.S. retail pharmacies increased from 76 million in 1991 to 210 million in 2010, according to a report by the National Institute on Drug Abuse. And since 1990, the rate of drug overdoses has tripled, increasing approximately from 4 per 100,000 people to 12 per 100,000 people, the Centers for Disease Control and Prevention report.

As someone who worked in hospices for a decade, Dr. Humphries knows the valuable role that opioids can play in relieving pain. So, how do we make opioids available but reduce the risk of addiction, abuse and accidental overdose?

There is no policy framework that will eliminate the tension between these two goals, but some policies will help avoid it, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He recently served as senior policy adviser at the White House Office of National Drug Control Policy, and  reports having no financial conflicts of interest on this issue.

Here, he said, are five emerging public policies, codes of practice, and cultural norms that “most people can agree on” while working toward harder-to-implement options like expanding addiction treatment programs:

1) Build prescription monitoring programs (PMPs). The idea is that physicians could check to see if a patient has received another opioid prescription recently before handing over a new prescription, to prevent drug-seeking patients from “doctor-shopping” to get more opioids. Thirty-six states have PMPs, though most are early versions that are slow, clunky and virtually worthless. Fourteen states and the District of Columbia have enacted legislation to create PMPs, and two states have no PMP plans.

PMPs “may be resisted and resented by many professionals, but they’re inevitable” and deserve support to quickly improve, Dr. Humphreys said. Plus, there’s a bonus for prescribers: In some states, checking with the PMP before prescribing an opioid gives physicians presumptive immunity from legal liability.

2) Lock doctor shoppers into one prescriber. Every week, a West Virginian dies of a drug overdose while holding prescriptions from five or more health care providers. Public and private insurers could tell patients who have opioid prescriptions from multiple providers that they must get all prescriptions from a single provider if they want their insurance to cover costs.

Recycling bins at the Palm Springs (Calif.) Convention Center, where the AAPM met. (Sherry Boschert/Elsevier Global Medical News)

3) Make prescription “recycling” a cultural norm. Legally, opioid narcotics can be returned to any Drug Enforcement Agency law enforcer, though some states also allow pharmacies to take back leftover drugs. When sheriffs in one small Arkansas town (population 20,000) organized a drug take-back day, residents brought in 25,000 pills, Dr. Humphreys said. A physician at the meeting from Santa Maria, Calif., said a drug take-back day organized by sheriffs there was so successful that they installed a permanent drop-off box outside the sheriff’s office. Dr. Humphreys urged physicians to promote drug take-back days in their communities.

4) Make abuse-resistant medication approvals easier. Currently, developing an abuse-resistant version of an addictive medication requires a new drug application, engendering a lengthy approval process and potentially hundreds of millions of dollars in costs. Government regulators should find a way to ease this massive disincentive for pharmaceutical companies to develop safer pain medicines, he said.

5) Change opioid-related medical practice. A potpourri of short- and long-term strategies could improve practice, he suggested. Patients should be told that sharing opioids is dangerous and illegal. Both patients and physicians need to learn that opioids are not the only response to pain. Emergency physicians should break their habit of automatically writing prescriptions for 30 days’ worth of a drug, and write for shorter time lengths when appropriate. Health care workers need to get better at recognizing addiction, and more attention should go toward ways of preventing “iatrogenic” addiction caused by the health care system itself.

Physicians need to lead the way in these efforts. “Who else?” he asked.

–Sherry Boschert (@sherryboschert on Twitter)

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Now tell me where ELSE it hurts…

When it comes to managing chronic pain, have physicians been looking in the wrong places? Physical findings in peripheral tissues rarely match up with patients’ reports of pain, or vice versa. Yet, clinicians typically examine only the area where the patient reports the pain, rather than looking at the whole body and considering that the patient’s perception of persistent pain may have a more central origin, according to pain expert Dr. Daniel J. Clauw.

Image by Kira.Belle via Flickr Creative Commons

“There is no chronic pain state where degree of damage or inflammation in the periphery correlates well with level of pain. Yet, the diagnostic algorithms or paradigms that everyone uses for treating chronic pain still assume that all pain is nociceptive. What we see in the peripheral tissues is not necessarily what our patients are experiencing,” Dr. Clauw said at last week at a 2-day scientific workshop on pain and musculoskeletal disorders, sponsored by the University of Michigan and held on the Bethesda, Md., campus of the National Institutes of Health.

That narrow focus has led many medical professionals to assume that when there is a disparity between peripheral findings and pain, the pain must be caused primarily by psychological factors. A prime example is fibromyalgia, still a somewhat controversial diagnosis. But as the first chronic pain syndrome identified as NOT being caused by peripheral inflammation or damage, fibromyalgia is “a metaphor for the centrality of chronic pain,” Dr. Clauw said.

So what should clinicians do differently? First, look beyond the immediate area the patient is complaining about. Has the patient had pain in other parts of the body? Experience frequent headaches? Have irritable bowel? Previous chronic neck pain, and now pain in the hip? “To me as a pain researcher, this is a blinking neon light that the person has a problem with pain processing. It may be that the particular symptom they’re coming in with is due to increased volume control setting rather than a pathologic problem in that part of the body,” Dr. Clauw told me.

And treatment? Ensuring adequate exercise and sleep and reducing stress are important yet underemphasized. Cognitive behavior therapy also has been shown to help. Pharmacologic therapy that acts centrally, rather than peripherally, may also be effective. The antidepressant duloxetine (Cymbalta), for example, is a serotonin/norepinephrine reuptake inhibitor that has been recently approved to treat osteoarthritis of the hip and low back pain, in addition to fibromyalgia and diabetic peripheral nerve pain.

A major challenge, Dr. Clauw believes, might be in getting clinicians to change their approach to pain. “It takes a long time for people trained in one way of thinking to think differently. This isn’t just a new drug or a new device. It’s a major paradigm shift.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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Osteoarthritis Pain Assessment Poses Challenges

  What is pain, and how much is too much?

Patients with painful hip or knee osteoarthritis say they know how much pain they should have to make joint replacement surgery necessary, and that their physicians are largely in the dark about their pain. Patients use the Supreme Court’s famous approach to identifying pain that warrants knee surgery: I know it when I feel it.

courtesy Flickr user GlobinMedChiro

To get the perspective of osteoarthritis patients, Dr. Gillian Hawker, a Toronto rheumatologist, and her associates put 58 local patients with moderately severe hip or knee osteoarthritis in focus groups, including 36 veterans of total joint replacement surgery. They discussed joint surgery appropriateness, and the point when appropriateness and their willingness to have the surgery intersect. The major determinant was their pain: their ability to cope with it, and its impact on their quality of life.

Patients “evaluated their pain against some invisible marker,” and despite having what they called high levels of pain they often said it was not bad enough to justify surgery, Dr. Hawker reported last month at the World Congress on Osteoarthritis. As one focus-group patient put it, “I don’t feel I’m ready.” But when their pain became bad enough, they said it trumped all other considerations of whether or not to have joint surgery. Most patients in the focus groups also said their pain had been “inadequately evaluated” by their physicians.

Other study results reported at the Congress also highlighted the highly subjective and variable nature of knee pain. Dr. Tuhina Neogi from Boston University measured central sensitization in knee osteoarthritis patients, and saw that both increased disease severity and duration significantly boosted the incidence of central sensitization, a neurologic process that alters the nervous system and potentially increases pain sensitivity.

Dr. Neogi and her associates found the only way to reliably measure central sensitization was by comparing pain in a patient’s knee affected by osteoarthritis and in the patient’s second, unaffected knee. Comparisons between different patients involved too much variable noise to show a significant link between osteoarthritis and central sensitization. Comparing knees within individual patients cut away the effects of genetics, and psychosocial and cultural factors, allowing each patient to apply their own unique, personal criteria for judging pain severity. 

—Mitchel Zoler (on Twitter @mitchelzoler)

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Handling Money: An Antidote to Pain?

Image via Flickr user Gnerk by Creative Commons License

 

Yesterday afternoon I heard American Public Media’s Tess Vigeland interview Kathleen D. Vohs, an associate professor of marketing at the University of Minnesota Carlson School of Management in Minneapolis. 

Ms. Vohs helped to lead a study which found that the simple act of handling money can ease both physical and mental pain. Seriously! In one of the experiments, human subjects were asked to put their hands in hot, scalding water. The people who had touched money prior to this experiment felt less bad about their pain, compared with those who hadn’t.  

No word on how to counsel patients with chronic pain about this phenomenon, or whether handling Monopoly money counts, but you can read a transcript of the interview or listen to it here

 –Doug Brunk (on Twitter@dougbrunk)

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Sex Differences Poorly Understood

From a workshop on sex differences and their implications for translational neuroscience research, sponsored by the Institute of Medicine.

Sex, sex, sex. That’s all they talked about at this day-long workshop in San Francisco, and it was more interesting than you might think. (Or maybe not, depending on what you’re expecting…)

Researchers from basic scientists to clinicians decried how too few studies look at sex — as in the differences between males and females (not sexuality or sex behaviors). The terminology is important, and they clarified up front that the topic of the day was sex, not gender.

Surprisingly, that clarification prompted one of the speakers to change her terminology on the fly. (She had been planning to refer to sex differences as gender differences.) That, as much as anything I heard that day, showed me how far the scientific and medical communities have to go to get the topic of sex differences front and center. In fact, the Institute of Medicine convened the workshop to assess progress since it called for more research on sex differences in its 2001 report, “Exploring the Biological Contributions to Human Health: Does Sex Matter?” (National Academies Press).

Why is this important? Although the impetus for better understanding of sex differences largely has come from proponents of improving the health of women (who long have been under-represented as research subjects), the lack of attention to biological differences between the sexes hurts both men and women.

Just one example: After more than 100 rodent studies showed that dextromethorphan (a common ingredient in cough syrups) potentiated the analgesic effects of morphine, a drug company launched a clinical trial in humans on treating chronic pain with the drug combination. It bombed. The company abandoned the formulation.

But a review of rodent studies in general found that 87% used only male rodents, didn’t specify the rodent sex, or didn’t assess sex differences in the few studies that included female mice or rats. Jeffrey S. Mogil, Ph.D. of McGill University’s Centre for Research on Pain, Montreal and his associates discovered that the potentiating effects of dextromethorphan on morphine work only in male rodents. Because the drug company’s clinical trial of the combination didn’t assess differences in response by sex, it may have abandoned a drug that might have effectively treated chronic pain in men, if not women.

At the workshop, fascinating talks described some of the progress made in studying sex differences in stroke, depression, pain and pain perception, sleep medicine, multiple sclerosis and neuroinflammation, and more. It was clear we’ve only uncovered the tip of the iceberg.

From the start, participants acknowledge an elephant in the room — politics. Ever since 2005, when then-president of Harvard University Lawrence H. Summers drew intense public criticism for what one workshop participant called “unfortunate wording” about sex differences, researchers have felt a chilling effect on public discussion about sex differences. The workshop attendees (many — perhaps even most — of whom were women) see it as just one more obstacle that must be overcome.

Physicians who may wonder what they can do to stay up to speed on consideration of sex differences can take an online course (for Continuing Medical Education credits) created by the National Institutes of Health and the Food and Drug Administration: The Science of Sex and Gender in Human Health.”

— Sherry Boschert (@sherryboschert on Twitter)
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