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April 2019 Newsletter


 

Recent Project News

 
  • PharmedOut's study on marketing messages in continuing medical education on fentanyl products was published in World Medical and Health Policy this month. Check out the article, or scroll down to read Joy's take on it for Joy's Favorite Article of the Month
  • Our project manager Sophie Krensky and research intern Olivia Shannon penned the first critical article brexanolone, the first FDA-approved drug for postpartum depression, in the Women's Health Activist. Their article was also quoted in the New York Times.
  • Dr. Fugh-Berman was quoted in PBS NewsHour on Purdue Pharmaceuticals paying a $270 million settlement to the state of Oklahoma, and what that means for the opioid epidemic.
  • Dr. Fugh-Berman was also profiled on Slate's podcast Working, discussing her career trajectory from writer/activist to academic physician-slash-activist.
  • Plus: The PharmedOut conference, "Opioids: Conflicts and Controversies" is coming up on June 13-14 and we're thrilled to roll out our agenda. It's going to be a great conference you don't want to miss! Please register early; we need to count how many cookies to bake.
    • A limited number of discounted hotel accommodations are available at The Darcy. More information here or contact Vi Nguyen at vnn3@georgetown.edu.
During a long day of moving offices Roshan, Sophie, Ben, Addy, and Vivienne enjoyed lunch under the flowering cherry blossoms and magnolias on the Georgetown campus. 

Who's Really Advocating for Pain Patients?

By Judy Butler, Research Fellow

Last month we looked at the testimony of the U.S. Pain Foundation’s Cindy Steinberg before a Senate health committee. She asserted that there was no overlap between two sets of opioid users: those with chronic pain and those with opioid use disorder. This is a consistent, long-standing industry message confirmed by internal documents; not only is it untrue, but documents disclosed in litigation confirm that the industry knew it to be untrue.

Based on the marketing message that chronic pain patients are somehow exempt from opioid risks, there is no reason to restrict or reduce opioid treatment for these patients. Instead, the only relevant “risk” is the undertreatment of pain and lack of access to opioids.

Ms. Steinberg used this argument to malign the CDC Guideline for Prescribing Opioids for Chronic Pain saying that the guidelines should be rewritten and adding "people think that those [guidelines] are based on strong science and they're not."
 
In contrast, she endorsed the Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations issued by the Congressionally-mandated Pain Management Best Practices Inter-Agency Task Force of which she is a member. 

It’s easy to see why one document aligns with an industry message while the other does not. First, compare their methodologies (emphases mine):

  • The CDC guideline is based on “a clinical systematic review of the scientific evidence to identify the effectiveness, benefits, and harms of long-term opioid therapy for chronic pain, consistent with the GRADE approach.” 
  • The draft report of the Task Force “reviewed extensive public comments, patient testimonials, and existing best practices; considered relevant medical and scientific literature; and requested information from government and nongovernment experts in pain management and related disciplines.” 

Then compare the authors (emphases mine):

  • The CDC guideline involved experts without “conflicts that might have a direct and predictable effect on the recommendations. CDC excluded experts who had a financial or promotional relationship with a company that makes a product that might be affected by the guideline.”
  • The Task Force membership was defined by the Comprehensive Addiction and Recovery Act of 2016 (CARA) with no consideration of possible conflict of interest. Members were appointed by the Health and Human Services Department.

See the difference?

Many of the 29 Task Force members had financial conflicts. Of the 15 Task Force members subject to Open Payments reporting, 10 have received payments from pharmaceutical companies and medical device manufacturers, according to Senator Wyden. Other Task Force members may have undisclosed conflicts of interest. In addition, Ms. Steinberg’s organization receives industry funding.

It is no coincidence that the documents differ dramatically.

The CDC’s rigorous, evidence-based approach, purposefully conducted without conflicts of interest, resulted in a guideline with recommendations to treat chronic pain with “nonpharmacological therapy and nonopioid pharmacological therapy” and to limit opioid doses to decrease harms. These highly reasonable guidelines state:

“When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day.”

The draft report of the Task Force rejects the CDC’s rational prescribing recommendations, arguing that “[clinical practice guidelines] that only promote and prioritize minimizing opioid administration run the risk of undertreating pain, especially when the cause of the pain is uncertain or cannot be reduced by nonopioid approaches.”

And it’s not only the Task Force and Ms. Steinberg who are raising the rallying cry of undertreatment of pain: This message is a favorite when it comes to countering evidence-based efforts to address the opioid-crisis. Yet this argument only makes sense if opioid risks are reduced when used for chronic pain (they aren’t) and if opioids were actually effective for treating chronic pain (no evidence supports that).

We do know that there are effective non-opioid treatments for chronic pain that are offered to children (see February newsletter). Why not offer those treatments to adults?

Chronic pain sufferers on high doses of opioids are being done a double disservice by the industry and its allies. Not only were these patients given increasing doses of opioid drugs that have no evidence of efficacy for their condition, but they are getting no support in getting access to safer alternatives with more evidence of efficacy. Maintaining chronic pain patients on high-dose opioids benefits opioid manufacturers. Any benefits to patients are far less clear.

Joy's Favorite Article of the Month

This month I am pleased to recommend PharmedOut’s latest publication titled Continuing Medical Education and the Marketing of Fentanyl for Breakthrough Pain: Marketing Messages in an Industry‐Funded CME Module on Breakthrough Pain.

Infeld et. al examined the differences in messaging between an industry-funded CME and a non-industry-funded practice guideline on opioids. Notably, they found that the non‐industry‐funded article mentioned “death” 26 times, while the industry‐funded article never mentioned “death.” Overall, the authors found that readers of industry‐funded article viewed opioids more positively. 

This serves yet another example of how marketing messages can masquerade as education for practitioners. Continuing education should be evidence-based and free from industry influence, like courses from the DC Center for Rational Prescribing (DCRx).

Joy Eckert, MPH is passionate about peer-reviewed literature about pharmaceutical marketing and conflicts of interest. She tweets about health policy at @joyonarant.

April News Round-Up

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