According to a recent article from Anesthesiology News, “The U.S. Senate Finance Committee is set to complete their investigation into the extent and implications of financial ties between the manufacturers of pain-relieving opioid drugs and professional pain societies, including the American Academy of Pain Medicine (AAPM).” As we noted back in May of this year, the Senate sent letters to several pharmaceutical companies and professional medical associations regarding their relationships.
According to the article, written by Lynn Webster, MD, incoming president of the AAPM, the Committee will be investigating “the amount of money provided to professional societies to create and deliver educational content on how to prescribe and consume opioid medications.” The two senators leading the probe, Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa), “seek to establish if industry support for educational content has led to misleading information that minimizes opioid harm.”
Consequently, as president-elect of the AAPM, the principal U.S. organization for the specialty of pain medicine, Dr. Webster welcomed “the opportunity to shed light on these issues and fear the potential for distortion.”
Dr. Webster maintained that, “Pain professionals absolutely have a responsibility to ensure pharmaceutical companies do not push marketing messages into educational programs.” He acknowledged the potential for problems in the creation of educational content that is underwritten by industry, such as the required education that manufacturers must fund under the Food and Drug Administration’s (FDA) recently released Risk Evaluation and Mitigation Strategy (REMS) for long-acting and extended release opioids. Problems could include:
- allowing marketing priorities to direct educational content
- exaggerating benefits of a medication or medical device while downplaying its risks;
- omitting mention of significant but inconvenient data; or
- failing to cite head-to-head comparisons of competing products, particularly conventional treatments.
Consequently, Dr. Webster asserted that, “Established firewalls, already in place, must be used to prevent undue influence.” He then explained several firewalls that are used by AAPM. First, is unrestricted grants. While educational content at AAPM meetings may be supported in part by unrestricted grants from pharmaceutical or medical device companies, these grants specify that the grantor have no control over the content of the presentation.
A second firewall is the AAPM disclosure policy. Speakers and session leaders must fully disclose relevant financial relationships, including research grants; honoraria or other payments; and advisory board or speakers’ bureau commitments. These relationships are published openly and are available for scrutiny by session attendees. The nationally recognized Accreditation Council for Continuing Medical Education (ACCME), which regulates continuing medical education (CME), has set these standards. In 2011, the ACCME reaccredited the Academy with its highest distinction: “accreditation with commendation.”
Dr. Webster asked that the Senate Finance Committee investigate “whether and to what extent the educational content has been influenced by dollars” from industry. He explained that the senators should not only examine the dollar amounts, but “also the educational content itself for evidence of bias or misinformation.” To do so, he noted that the senators must seek counsel from “unbiased professionals with appropriate credentials in the field of pain medicine—not by parties with a history of bias for or against a particular form of therapy, nor by individuals without ‘real-life’ clinical experience caring for patients with intractable pain.”
The AAPM president-elect affirmed that medical professionals must never direct CME content based on corporate marketing priorities. However, he correctly recognized that “not all industry involvement is harmful.” He explained that while “good journalistic form to ‘follow the money,’ taint does not naturally and inevitably follow.” Instead, journalists need to realize that “new and existing drugs need lots of complicated research to answer important questions. Questions like:
- Who should get the drug and at what dosage and time points?
- What are the risks and how do they change for different study populations?
- How effective is the medication when compared with placebo or other available therapies?
Given that industry supports all facets of American health care delivery, Dr. Webster proposed the following question: “If industry does not pay for the necessary research and education for medical professionals and patients, who will?” He noted that while company’s have funded research “on newer pain therapies created with the goal of having less potential for harm than currently available opioid formulations,” “no such support” has come from government or other sources.
For example, he noted how the National Institutes of Health (NIH) devotes only around 1% of its budget to pain research, despite the overwhelming need of 100 million Americans in chronic pain, as reported by the Institute of Medicine and supported by a recent Gallup poll. Given that the government and industry are the only two viable funding sources available, he encouraged NIH and concerned senators to dig into government coffers to facilitate the pain research that is so desperately needed.
Interestingly, Dr. Webster also pointed out that other sources of funding could also cause conflicts. For example, he noted how a rise in overdose deaths among Medicaid enrollees in Washington state, as reported by The Seattle Times, “accompanied a government foray into medical decision making in which methadone was pushed as the preferred analgesic. Methadone is cheaper than other opioids, but at what cost did this cost cutting take place?” Accordingly, he noted that journalists should also follow the money to these sources that can cause harm.
Ultimately, Dr. Webster correctly recognized that the educational initiatives that industry supports “spread information about appropriate and safe use of its products.” Given that other companies use support from companies to educate doctors about diabetes or cancer, why should pain be any different? And if this is what Congress and journals want, then where should the information come from?