Mallinckrodt has a diverse portfolio of branded and generic medicines used in the treatment of pain. Millions of patients face acute and chronic pain every day, and we are proud that our products can help ease this pain and allow many of these patients to keep their jobs, be a part of the lives of their families and friends, and remain productive members of society.
Today, we face two distinct pain-related healthcare issues:
1. Effective Pain Treatment
Even as we work with law enforcement, policymakers and others to address the disturbing problem of opioid misuse and abuse, it is critical to remember that, sadly, even today, pain frequently remains undiagnosed and either untreated or undertreated.1
The scope of the problem is overwhelming. According to a 2011 Institute of Medicine (IOM) report, more than 100 million adults in the United States live with chronic pain, costing the economy an estimated $560 to $635 billion annually.2
Pain affects more individuals than diabetes, coronary heart disease and cancer combined,3 with more than one-quarter of Americans over age 20 reporting a pain condition.4
Against this backdrop, it is clear that patients experiencing chronic or acute pain must have access to affordable, effective medications.
The IOM report called for a cultural shift in recognizing and treating pain and stated that a transformation in how pain is addressed is "a moral and national imperative."5
The report concludes that "the majority of people with pain use their prescription drugs properly, are not a source of misuse, and should not be stigmatized or denied access because of the misdeeds or carelessness of others."6
We should not lose sight of these facts. If we do, we will do a tremendous disservice to the millions of Americans who struggle with pain every day.
The IOM report also acknowledged that many Americans with pain are not receiving adequate pain prevention, assessment or treatment.7 Accordingly, the IOM called for more research in order to better understand the nature and extent of pain in America — specifically to "document rates of treatment or undertreatment of pain."8
We agree that this research is desperately needed.
Provider and patient groups have also expressed concerns about the adequacy of pain management and treatment, particularly in the case of chronic conditions like neuropathic pain. Neuropathy results from nerve damage and is associated with a wide range of underlying diseases and conditions, including diabetes, trauma, autoimmune diseases (such as lupus, rheumatoid arthritis and Guillain-Barré syndrome), tumors, kidney disease, liver disease, Lyme disease and HIV/AIDS. Concerned about adequate chronic pain management in the patients they represent, The Neuropathy Association has stated that "[t]oo often, patients are told there is nothing that can be done for them, [that] they will just have to live with it."9
Sadly, pain is associated with many other diseases and conditions. Sickle cell disease or sickle cell anemia is a genetic blood disorder characterized by red blood cells that assume an abnormal, rigid, sickle shape. Sickling decreases the cells' flexibility and involves various complications, including severe pain. As one sickle cell anemia patient said in a The New York Times article by Anne Underwood profiling the disease, "there's a lot of pain, unbelievable pain. It's like a jackhammer on your back, basically. I wish people in the medical field would take the disease more seriously."10
Sickle cell disease is most common among people of African or South American descent, but is also frequently found in individuals with ancestry from Central America, India, the Mediterranean and the Middle East.
Fibromyalgia is another common disorder that results in chronic pain, affecting about seven to 10 million Americans, the disproportion of whom are women.11 The pain is a result of differences in how the individual processes pain, and proper diagnosis and treatment are uncommon.12
Organizations such as the National Fibromyalgia Association collect patient stories to help other patients, as well as the wider public, understand the pain that patients experience. As one patient writes, "I have fibromyalgia. It causes me to endure days of unrelenting muscle pain and fatigue. My symptoms occur in unpredictable periodic bouts of two to three days of generalized pain, which makes even lying down a slow torture."13
In addition to advocacy groups that focus on disease-specific causes of pain, other organizations, such as the American Chronic Pain Association, address pain conditions more generally and serve as advocates for all pain patients, acknowledging that "[f]or many people, living with pain is a way of life."14
However, underdiagnosis and undertreatment of these patients with pain is finally beginning to be noticed. In the United States, the Interagency Pain Research Coordinating Committee has been created. The committee includes members from the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs. The committee's mission includes a charge to identify critical gaps in basic and clinical research regarding the symptoms and causes of pain and to make recommendations as to how best to disseminate information on pain care.15
It is our hope that initiatives such as these can assist in identifying the undertreatment of pain and helping those in need.
Given the two pain-related public health issues our society now faces, we at Mallinckrodt will continue to work aggressively and support programs and technologies that help address opioid abuse while still providing prescribers with affordable, effective treatment options for their patients with chronic and acute pain.
2. Opioid Abuse and Diversion
For Mallinckrodt, dedication to providing solutions for patients with pain is paired with an equal commitment to working with law enforcement officials, healthcare providers, industry representatives and policymakers to address the complex issue of opioid abuse and diversion. As reports on this abuse and other analyses have repeatedly made clear, opioid abuse is a complicated problem with multiple components. Recognizing the need to combat the issue from all angles and with the involvement of all stakeholders, in April 2011, the White House Office of National Drug Control Policy outlined a four-pronged approach of education, tracking and monitoring, disposal, and enforcement.17
Mallinckrodt agrees and believes there must be an integrated approach, because no one party or one solution can solve the opioid abuse problem. To be successful, state and federal legislators and regulators, patients and patient advocacy groups, physicians and provider groups, healthcare facilities, pharmacies, law enforcement, wholesalers, and manufacturers must all work together.
Currently, federal and state policy efforts seem to focus largely on abuse-deterrent technologies that make it more difficult to manipulate or adulterate opioid medicines for consumption/abuse. An important development was the January 2013 FDA draft guidance publication on the evaluation and labeling of abuse-deterrent opioids.18
Although abuse-deterrent technologies assuredly may raise roadblocks to complicate, and therefore limit, abuse, it is clear that these technologies alone cannot solve the problem.
As noted in the FDA draft guidance, abuse-deterrent "technologies have not yet proven successful at deterring the most common form of abuse — swallowing a number of intact pills or tablets to achieve a feeling of euphoria."19
This is a critical point. Mallinckrodt fully supports the FDA's efforts to establish standards for abuse-deterrent technologies, but we must acknowledge that these technologies alone are not the solution to the incredibly complicated problem posed by opioid abuse.
We at Mallinckrodt support the issuance of clear, fair and consistent FDA guidance for abuse-deterrent technology standards for both branded and generic products. Our long-term vision is for standards that will facilitate a broad range of approaches to collectively and individually reduce an abuser's liking of opioids — going beyond simply affecting the ease of product manipulation or adulteration to using technology that addresses the intensity and immediacy of the addict's high.
An integral part of Mallinckrodt's long-term vision is to invest in and expand the use of abuse-deterrent technology in its product line. By employing products with these technologies with other efforts that target the multidimensional nature of this complex problem, we can help ensure cost-effective access to appropriate pain treatment for the millions of patients suffering from acute and chronic pain, while substantially reducing opioid misuse and abuse. Other critical elements of a comprehensive effort to address opioid abuse and misuse include:
- Improving the integration of federal and state prescription drug monitoring programs and efforts
- Developing and sharing best practices both at the manufacturing and supply chain stage (an area in which Mallinckrodt is an industry leader)
- Improving stakeholder education for patients, providers and the public at large, including redesigned Risk Evaluation and Mitigation Strategy (REMS) programs and education initiatives validated by measurable outcomes
- Enhancing drug take-back and addiction rehabilitation programs
Because it is clear that technology alone cannot solve opioid abuse, this policy statement targets a number of initiatives aimed at addressing this complicated societal problem. We must work to ensure that patients with chronic and acute pain have access to the medications they need on an affordable basis while substantially reducing opioid abuse. We believe that, to truly make an impact on opioid abuse, we must better understand the various interrelated causes and contributors to the problem and address all of them in a comprehensive, thoughtful manner.