Steve Gelfand, MD, secretary of Physicians for Responsible Opioid Prescribing (PROP) responds to recent comments by Drs. Cole and Webster in Pain Management.
In the most recent issue of Pain Management, pain management physicians B. Eliot Cole, MD, (“Just How Responsible is PROP?”) and Lynn Webster, MD, (“Balancing Risks and Benefits When Treating Chronic Pain with Opioids”) made several negative comments about PROP and the FDA Citizen Petition. Below, I address several points raised by each and rebut some of their claims.
The FDA Petition was co-signed by a broad group of medical experts and government healthcare officials both within and outside of PROP and is intended to prevent opioid drug companies from marketing prescription opioids to physicians under the false assumption that they have been proven safe and effective for long-term use in patients with chronic noncancer pain (CNCP), particularly at higher dosages. This type of marketing by companies like Purdue Pharma (convicted in Federal Court in 2007 for lying about a low addiction rate of OxyContin) has played a large part in creating and maintaining the opioid epidemic, costing well over 100,000 lives since 1999 and addicting many multiples of this. For Dr. Cole to state that this is a “radical” proposal is untrue, especially when one considers that this type of marketing to primary care physicians, who are documented to be uneducated about both opioids and CNCP, has led to massive overprescribing and the direct or indirect outcomes of addiction, overdose and death.
Preventing drug companies from aggressively marketing opioids for the broad indication and range of moderate pain will help curtail overprescribing by providing a clear message that these potent brain-active drugs should only be considered in suitable patients with the most severe types of CNCP unresponsive to other therapies. Furthermore, this does not inhibit opioid prescribing by providers according to their clinical judgment under an “off-label” prescribing category, but instead, under Federal law, prohibits dangerous advertising by drug companies for moderate pain, which has already cost so many lives, especially when we consider how often these drugs have been prescribed for chronic pain disorders such as fibromyalgia and nonstructural low back pain (which I noted in my interview article in the June 2012 issue of Pain Management). A label is mandated to indicate that a drug or class of drugs has been proven safe and effective for an indication, but fails to meet this standard in regard to opioid use for moderate pain.
For Dr. Cole to state that this would be a “drastic action [by the FDA] denying patients with CNCP the opportunity to use opioid therapy before we implement REMS education in 2013,” is another misrepresentation of the facts, since he is ignoring the importance of protecting patients from false drug company advertising and withholding important side effect information about opioids, especially since they are often prescribed inappropriately for a wide range of moderate chronic pain indications. Does he not think that patients have a right to be informed about all the facts of drugs which have not been proven safe and effective for CNCP and could potentially addict or kill them, and should they not have the same information about all drug adverse effects like the drugs which are advertised directly to the public on TV?
Furthermore, the success of REMS is questionable given the absence of a mandatory physician education requirement and education unbiased by industry, and its reactive rather than proactive [preventative] approach, while it does not mandate that patients must be told of all the potential adverse effects up front, including addiction and death, before opioids are prescribed.
Dr. Webster acknowledges the lack of physician education and some of the harms caused by opioids, but mistakenly states that most of this has not occurred in patients being treated for pain. He includes patients with mental health disorders in this category, but fails to acknowledge the intimate relationship between depression and pain and that many patients with depression first present with chronic pain for which they have been inappropriately prescribed opioids, and then may use them for mood elevation predisposing to addiction.
He states it would be a travesty for the FDA to eliminate CNCP as an indication for opioids which is what the Petition is asking, which is certainly not the case, since we are requesting label limitation of opioids for only severe types of CNCP; this will prevent false marketing by drug companies for a broad range of 'moderate' chronic pain [with their primary goal of maintaining prescription volume, sales and profits]. He states that “there could be a large number of people harmed if the FDA and others were to adopt what PROP has recommended,” with no examples to support this statement.
As noted above, no one is suggesting that patients with CNCP, whom their physician deems is stable on chronic opioid therapy, should be required to have their drug reduced or discontinued, but only that false marketing needs to stop through limiting the indication label for opioids. This may cause doctors to think twice before prescribing these drugs for patients with CNCP and reduce the unacceptable volume of addiction, overdose, and death in the next opioid-naive population of CNCP patients. To acknowledge that most primary care physicians are uneducated about opioids and CNCP (while being misled about them for years), and yet reject any idea intended to limit the prescribing and availability of these drugs, only supports the industry objective of doing nothing to limit their sales and supply.
The non-industry-influenced PROP physician educational material, including slides created by leading pain management expert, Jane Ballantyne, MD, (taken from the CDC website), can be accessed at the PROP website. Dr. Ballantyne has also summarized the value of the Petition, which represents “a form of constraint that controls overuse while preserving opioids for patients in need [which] can only be a positive step toward more rational and safer prescribing.”
Steve Gelfand, MD, is secretary of Physicians for Responsible Opioid Prescribing (PROP).