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Recent Project News
- Dr. Fugh-Berman was quoted in STAT News on how Sackler gifts to Tuft's School of Medicine influenced curriculum.
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Reminder: The PharmedOut conference, "Opioids: Conflicts and Controversies" is coming up on June 13-14; prices will go up on May 15, so make sure you register now!
- A limited number of discounted hotel accommodations are available at The Darcy. More information here or contact Vi Nguyen at vnn3@georgetown.edu
- Our final abstract slam deadline is Wednesday, May 15—graduate and health professional students who submit will be considered to present original research at the PharmedOut conference (with free registration included).
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Our spring semester Masters in Physiology research interns (Wesley Jimenez, Vivienne Edwards, Addy Tham, and Roshan Sharma) presented their research on international and domestic regulations on payment transparency and bans on gifts from pharmaceutical companies.
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Preventing a new generation of opioid “legacy patients”
By Judy Butler, Research Fellow
April was a big month for communications from the federal government about long-term opioid treatment.
First, the FDA announced it would update opioid prescribing information to warn about the risks of rapid discontinuation and provide guidance on tapering.
Then, two letters from the CDC addressed concerns raised by its 2016 Guideline for Prescribing Opioids for Chronic Pain. One answered a letter written by three cancer groups (the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and the American Society of Hematology) that complained that although the Guideline was not written for cancer patients, it was being applied to some cancer patients. The CDC clarified that opioids could be effective for successfully treated cancer patients who continue to have chronic pain and directed prescribers to relevant guidelines. The other, a response to a letter signed by a group of health professionals, related to patients who may be unintentionally harmed by misinterpretation of the Guideline.
Each of these responses address “legacy patients”, or chronic pain patients who have been on opioids for years, perhaps receiving their initial prescriptions at the height of opioid overprescription. Additionally, many legacy patients receive opioid dosages that exceed the CDC Guideline’s upper limit recommendation for initiating high-dose prescribing.
A new generation of legacy patients is exactly what the CDC Guideline seeks to prevent from occurring again. Aimed at primary care physicians, the CDC Guideline raises cautions about the initial prescription of opioids for chronic pain, and recommends regular assessment of benefits and risks when opioids are prescribed.
No one wants to see legacy patients abruptly withdrawn from opioids; anyone going off of opioids should be appropriately tapered. That doesn’t mean, however, that maintaining patients on high doses of opioids forever is appropriate.
Yet this is the solution consistently proposed by chronic pain patients and opioid industry allies, which not only impacts current patients but future patients as well. If legacy patients need to stay on opioids, that must mean opioids are an effective treatment for their chronic pain. Therefore, long term opioid treatment must also be effective for new chronic pain patients.
Perpetuating the use of opioids for chronic pain maintains the opioid industry’s profitable user base. A study of trends in opioid use through 2016 found that the bulk of opioids were dispensed for long term use: “62% of opioids dispensed to commercial beneficiaries were part of a long term episode, 70% for aged Medicare beneficiaries, and 89% for disabled Medicare beneficiaries.”
Providing compassionate, effective medical treatment to legacy patients is not simple. Oregon, a leader in addressing opioid overprescribing, offers resources for treating legacy patients. The overview explains why these resources are necessary: “Prescribers are also asking whether or not tapering is necessary if the patient is stable and compliant on their current dose. Yet, overdose rates continue to be high compared to historical standard and it is well established that patients on high doses of opioids are at increased risk for a variety of side effects, serious morbidities, and death. Quality of life may be adversely affected, despite the fact that the patient perceives benefit in terms of pain relief.”
The CDC Guideline states that “in some cases, where the risks are minimal and the patient appears to be doing well, continued opioid therapy may be justified,” but recommends a systematic assessment of the risks and benefits of continued opioid treatment and provides tools for both assessment and tapering.
Continued prescribing of opioids to all legacy patients may be the easy answer, but it isn’t the right answer, and arguments in support of continued prescribing are misleading. As with so many problems, it’s much harder to correct them than it was to create them. Unless we take this more difficult path, however, both the health of current legacy patients and the health of a new generation of legacy patients is at stake.
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Joy's Favorite Article of the Month
This month I bring you a study by Fleischman et al. Association of Pharmaceutical Manufacturer Payments to Physicians and Prescribing Dosage of Opioids in the Journal of General Internal Medicine, which presents compelling evidence on the relationship between payments to prescribers from opioid manufacturers and rates of opioid prescribing.
The authors used data from the CMS Open Payments system and Medicare Part D prescription claims to examine whether or not prescribers who accepted opioid-related payments from pharmaceutical manufacturers were more likely to prescribe opioids at higher doses using thresholds from the CDC Guideline for their outcomes.
They found that 63,941 physicians accepted more than 416,678 payments, with a median value of $13. The authors also found that opioid-related payments were associated with a higher likelihood of exceeding dosages of 90 MME/day (OR = 1.27, 95% CI, 1.25–1.30, p < 0.001).
This study builds on results from Hadland et al., and once again shows that payments to prescribers can impact patients and public health in potentially harmful ways.
Joy Eckert, MPH is passionate about peer-reviewed literature about pharmaceutical marketing and conflicts of interest. She tweets about health policy at @joyonarant.
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May News Round-Up
(For more, follow @Pharmed_Out on Twitter!)
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Adriane Fugh-Berman, a pharmaceutical marketing researcher at Georgetown University who has been a paid expert witness in opioid lawsuits, is less convinced of the American Pain Society's value. "They do no good at all," she says. Pain scientists should start over, she thinks, and "put together a meeting or a group that does not take industry money." Without the subtle influence of industry funding at meetings, researchers might more readily come up with low-cost, non-drug treatments for pain, she believes.
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As the opioid crisis continues unabated, a federal task force meets next week to review a draft report on managing pain, but dozens of attorneys general worry the final version may be used to unravel prescribing guidelines already issued by the Centers for Disease Control and Prevention...
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Support our work!
PharmedOut is funded primarily by individual gifts. 100% of your gift goes towards investigating corporate misdeeds, promoting rational prescribing, providing resources to healthcare professionals, and feeding our wonderful group of volunteers. PharmedOut would not be possible without your support. All donations are tax deductible.
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