The U.S. Senate Finance Committee is set to investigate 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). At issue is 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. As president-elect of the AAPM, the principal U.S. organization for the specialty of pain medicine, I both welcome the opportunity to shed light on these issues and fear the potential for distortion.
|‘If industry does not pay for the necessary research and education for medical professionals and patients, who will? I would welcome governmental and other sources of funding for this vital research. Unfortunately, no such support is forthcoming.’|
Although profit seeking drives much of American society, as specialists in pain medicine our primary responsibility is to the welfare of our patients. Therefore, we cannot deny the potential for problems in the creation of educational content that is underwritten by industry. 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. Pain professionals absolutely have a responsibility to ensure pharmaceutical companies do not push marketing messages into educational programs. Established firewalls, already in place, must be used to prevent undue influence.
Several such firewalls are used by AAPM. One firewall is unrestricted grants. Educational content at AAPM meetings is 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 directs continuing medical education (CME), has set these standards. In 2011, the ACCME reaccredited the Academy with its highest distinction: “accreditation with commendation.”
The Senate Finance Committee has begun a process of inquiry into industry funding sources and amounts. Respectfully, I would ask that the committee complete the process by investigating whether and to what extent the educational content has been influenced by dollars. To know the answer, senators should examine not only the dollar amounts or percentages of budgets but also the educational content itself for evidence of bias or misinformation. They can only do this by seeking 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. Counsel should come from those who can understand the need for measured thought, critical thinking and modulated judgment in clinical decision making, given the paucity of high-quality effectiveness research and evidence-based outcomes in this burgeoning field.
As medical professionals, we affirm that corporate marketing priorities must never direct CME content. However, not all industry involvement is harmful. Although it is good journalistic form to “follow the money,” taint does not naturally and inevitably follow. 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? The best science takes time and it takes significant resources. A frank approach to these questions would acknowledge that industry supports all facets of American health care delivery. The pain medicine field is not unique in this regard.
If industry does not pay for the necessary research and education for medical professionals and patients, who will? We cannot, as physicians, abandon people with pain—that is unethical. I conduct research on newer pain therapies created with the goal of having less potential for harm than currently available opioid formulations. My former company took money from industry to conduct this research as a precursor to the company’s possible marketing of a new product. I would welcome governmental and other sources of funding for this vital research. Unfortunately, no such support is forthcoming.
Currently, 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, I encourage the NIH and concerned senators to dig into government coffers to facilitate the pain research that is so desperately needed.
Furthermore, we should not pretend that other sources of funding bring no possible conflicts. As reported in The Seattle Times, a rise in overdose deaths among Medicaid enrollees in Washington State 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? If following the money is good journalistic and legislative practice—and, in general, it is—let us keep our eyes open to other sources of influence that could cause harm.
The reality is, at present, that industry supports the educational initiatives that spread information about appropriate and safe use of its products. Indeed, the FDA mandates that it do so as part of Risk Evaluation and Mitigation Strategies for opioids. Other companies that manufacture and market drugs to treat all types of diseases and conditions do the same. Would producers of drugs to treat diabetes or cancer be forbidden to compile and disseminate information on the risks and benefits of their products? Again, from where, instead, should that information come?
Dr. Webster is the medical director, CRILifetree Research,
Salt Lake City, Utah, as well as the incoming president of the
American Academy of Pain Medicine.