The nation continues to suffer through a widespread epidemic to prescription opioids and their illegal cousin, heroin. The CDC estimated that 20 percent of patients who complain about acute or chronic pain that is not from cancer are prescribed opioids. Health-care providers wrote 259 million prescriptions for the medications in 2012, 'enough for every adult in the United States to have a bottle of pills,' the CDC wrote.
Last week, the National Center for Health Statistics reported that the number of overdose deaths from legal opioid drugs surged by 16.3 percent in 2014, to 18,893, while overdose fatalities from heroin climbed by 28 percent, to 10,574. Authorities have said that previous efforts to restrict prescription drug abuse have forced some people with addictions to the medications onto heroin, which is cheaper and widely available.
This rising tide of death and morbidity seems to have been fueled by reckless, sometimes deceptive, sometimes illegal marketing by the pharmaceutical companies that produced narcotics other than heroin.
Background - Legal Drug Pushing
As I wrote in 2013,
the realization began to dawn that patients, doctors and society were being victimized by a new type of pusher man, this time dressed in a suit and working for an 'ethical' drug company. In the earlier days of Health Care Renewal, we first posted (in 2006) about allegations of deceptive and unethical promotion of fentanyl by Cephalon that lead to its overuse by patients beyond those with cancer who were its ostensible target population. Then in 2007 came the spectacular case of guilty pleas by a subsidiary of Purdue Pharma and several of its executives for 'misbranding' Oxycontin, that is, promoting it far beyond any medically legitimate use in severe chronic pain. Following that various investigations, well chronicled in the Milwaukee Journal Sentinel, showed how pharmaceutical companies employed deceptive marketing techniques, subverting medical education and research, and creating conflicted key opinion leaders and institutionally conflicted disease advocacy groups, to push more 'legal' narcotics For example, see the Journal Sentinel reports the subversion of : medical schools and their faculty; .medical societies, disease advocacy groups, and foundations; and guideline writing panels. In 2012, we posted about how a drug company paid key opinion leader admitted to second thoughts about his role promoting narcotics.
As I described in that 2012 post, the new narcotic pushers relied on only the most sketchy evidence about the safety of prescription narcotics. In the 1990s, they taught that the rate of addiction caused by prescribing legal narcotics was only 1%, but this was based on a tiny flawed case series of a mere 38 patients. In 1996, a consensus statement from the American Academy of Pain Medicine and the American Pain Society, entitled "The Use of Opioids for the Treatment of Chronic Pain," included the following statements,
Pain is often managed inadequately, despite the ready availability of safe and effective treatments.
Studies indicate that the de novo development of addiction when opioids are used for the relief of pain is low.
Yet one of the primary proponents of profligate use of narcotics to treat chronic pain later admitted he
erred by overstating the drugs' benefits and glossing over risks. 'Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did,' Dr. Portenoy said in an interview with The Wall Street Journal. 'We didn't know then what we know now.'
'I gave innumerable lectures in the late 1980s and '90s about addiction that weren't true,' Dr. Portenoy said in a 2010 videotaped interview with a fellow doctor. The Journal reviewed the conversation, much of which is previously unpublished.
In it, Dr. Portenoy said it was 'quite scary' to think how the growth in opioid prescribing driven by people like him had contributed to soaring rates of addiction and overdose deaths. 'Clearly, if I had an inkling of what I know now then, I wouldn't have spoken in the way that I spoke. It was clearly the wrong thing to do,' Dr. Portenoy said in the recording.
The CDC Attempts to Moderate the Use of Opioids for Chronic Pain
So to me it seems quite reasonable the US Center for Disease Control and Prevention (CDC), being cognizant of the rising toll of narcotic addiction, would attempt to do something about it. As reported by the Washington Post,
The government on Monday urged primary-care physicians who prescribe opioids for pain relief to rein in their use of the drugs, proposing new guidelines that call for a more conservative approach than the one that has led to a crippling epidemic of addiction to the powerful narcotics.
Just a few days after a new report showed a surge of drug-related overdoses in 2014, the Centers for Disease Control and Prevention suggested in draft recommendations that physicians tackle chronic pain with other methods, such as physical therapy and non-opioid analgesics, before turning to the powerful medications. If opioids, such as OxyContin and Percocet, are necessary, the agency recommended short-acting versions over extended release formulations, the lowest possible dose and short-term prescriptions.
It also suggested that doctors ask patients to take urine tests before prescribing opioids and additional urine tests at least once a year if they continue on the drugs, to ensure that they aren't secretly taking other opioids or illegal drugs.
'What we want to just make sure is that doctors understand that starting a patient on an opiate is a momentous decision,' said CDC director Tom Frieden. 'The risks are addiction and death, and the benefits are unproven.'
Based on the events since they 1990s, the lack of clear data from well performed randomized controlled trials of the effectiveness of opioids in chronic pain, and their obvious, known risks, that seems like common sense to me.
The Strong but Obscure Opposition to the CDC Guidelines
However,others disagreed. The guidelines attracted immediate opposition, for reasons that were not immediately obvious. Four days after the Post article, the Associated Press reported that the guidelines were in big trouble,
A bold federal effort to curb prescribing of painkillers may be faltering amid stiff resistance from drugmakers, industry-funded groups and, now, even other public health officials.
Critics complained the CDC guidelines went too far and had mostly been written behind closed doors. One group threatened to sue. Then earlier this month, officials from the FDA and other health agencies at a meeting of pain experts bashed the guidelines as 'shortsighted,' relying on 'low-quality evidence.' They said they planned to file a formal complaint.
The CDC a week later abandoned its January target date, instead opening the guidelines to public comment for 30 days and additional changes.
Anti-addiction activists worry the delay could scuttle the guidelines entirely.
This, however, did not make much sense. I repeat, the evidence that narcotics are effective for chronic pain other than that due to terminal cancer is very weak. The evidence that opioids have multiple side effects, some fatal, and can cause addiction, which has more side effects, and bad societal consequences, is strong. So the evidence that narcotics have benefits that are worth their harms, both to individuals and society, in this setting is essentially non-existent. So why did these guidelines go too far? Why invoke low quality evidence, when the evidence that is low quality is about the benefits of the drugs? Who should be sued? Furthermore, why did the CDC cave in so readily to these critics?
The AP noted,
But industry-funded groups like the U.S. Pain Foundation and the American Academy of Pain Management warn that the CDC guidelines could block patient access to medications if adopted by state health systems, insurers and hospitals.
Of course they could reduce access. The whole point of the guidelines is to reduce access. But who would want more access to medicines that do more harm than good?
Then there was the issue of just who it was who opposed the guidelines. Much of the opposition seemed to come from rather obscure organizations with authoritative names. Some of the opposition was chronicled by equally obscure, apparently journalistic organizations. (From now on, I will highlight these mysterious organizations by using bold, italic text in this color.) For example, according to the Washington Post,
Many of the patient and physician groups opposing the CDC guidelines are part of a larger coalition called the Pain Care Forum, which meets monthly in Washington to strategize on pain issues. Officials from the White House, the FDA, NIH and other agencies have met with the group over the years, according to documents obtained by The Associated Press under the Freedom of Information Act.
The Pain Care Forum presents itself as a leaderless collective that does not take formal positions. But most members receive funding from drugmakers, including OxyContin-maker Purdue, whose chief lobbyist helped found the group and remains at its center.
The mission of the Pain Care Forum, its organizational nature (informal group, membership society, non-profit advocacy group, etc), its leadership, and its sources of funding were not entirely obvious from this article. But certainly the drift of the article was that the organization maybe represents pharmaceutical manufacturers, particularly the previously discredited Purdue Pharma (see above) more than others. So why not take what it says with many grains of salt.
But who threatened to sue? Which FDA officials chimed in, and why, given that the FDA does not have a mission that includes writing guidelines? That was not clear from the AP story.
My attempts to gain further clarity produced more mystification. A Medscape article also claimed that the opposition to the CDC guidelines included Dr James Madara, the Executive Vice-President and CEO of the American Medical Association, and "some members of the Interagency Pain Research Coordinating Committee [who] criticized the process, according to the Pain News Network." It was not clear whether Dr Madara's viewpoint had broad support in the AMA, which members of the Interagency Pain Research Coordinating Committee opposed the CDC guidelines, and whether this opposition was personal, or reflected the considered viewpoint of the committee. Furthermore, that committee's purview does not obviously include clinical guideline development or public health, so why it was commenting on this issue was also unclear.
The Pain News Network story which apparently was the source used by the Medscape in turn referred to a Politico story, but one which is only available to subscribers. The Pain News Network also credited a survey by "the Pain News Network and the Power of Pain Foundation."
The Medscape article said nothing more about the Pain News Network.which is not exactly a household word in health care journalism. The Pain News Network story did not give more detail about the Power of Pain Foundation, whose mission, nature, leadership, funding etc was not obvious.
The Pain News Network story also quoted the Washington Legal Foundation's chief counsel.
The overly secretive manner in which CDC has been developing the Guideline serves the interests of neither the healthcare community nor consumers.
Similarly, the Washington Post article also credited the Washington Legal Foundation's opposition to the CDC guidelines,
The Washington Legal Foundation, a public interest law firm dedicated to protecting the free enterprise system, accused the CDC of trying to formulate them secretly by failing to make public the work of its original advisory committee, the Core Expert Group. The CDC disputes that accusation, but issued the recommendations in draft form Monday and will have them reviewed by another advisory panel after receiving more comment over the next 30 days, Frieden said.
Yet, neither the Pain News Network nor the Post explained why a group supporting "free enterprise" was so concerned about this issue, or what expertise it might have in this area. It is ironic that a group that proclaims opposition to secrecy seems less than transparent about its involvement in this issue.
Finally, the nature of the Pain News Network, which claims to be a "non-profit, independent news source," is also obscure. It appears to be one of those non-profits that has no physical address per its web page of contact information, does not disclose its sources of funding, and if it files US Internal Revenue Service 990 forms, I cannot find them.
The most detailed article I could find about the substance of the complaints about the CDC guidelines was in another obscure source, the Legal News Line. The article mostly described the concerns of
Peter Pitts, a former associate commissioner of external affairs at the U.S. Food and Drug Administration and now president and co-founder of the Center for Medicine in the Public Interest, can be counted among those critical of how the panel was put together.
Pitts' main issue was that a member of the group that developed the CDC guidelines was biased. He said,
'So you have to have as open of a mind as possible.'
And that’s exactly where the CDC went wrong, Pitts said, pointing to Jane Ballantyne. Ballantyne served as a member of the CDC’s “Core Expert Group,” which played a key role in developing the agency’s opioid guidelines.
Ballantyne, a retired professor of anesthesiology and pain medicine at the University of Washington, is a member of the International Association for the Study of Pain, or IASP, and last year was named president of the Physicians for Responsible Opioid Prescribing, or PROP.
PROP’s mission, according to its website, is to 'reduce opioid-related morbidity and mortality by promoting cautious and responsible prescribing practices.'
'Not only does she have strong opinions, but extra strong opinions -- almost on the lunatic fringe -- on pain medicine issues,' Pitts said.
'For the CDC to say, we’re going to put someone who comes to the discussion with such preconceived notions on such a committee, you have to ask yourself, why? And then why was it hidden from the public?'
The Legal New Line's example of supposed journalism did not apparently ask Pitts what was "lunatic" about wanting to promote cautious and responsible prescribing of opioids. That seems to me like common clinical sense, the opposite of insanity.
Also, Pitts complained that beyond this alleged bias, Dr Ballantyne had a conflict of interest,
Pitts noted Ballantyne’s connection to law firm Cohen Milstein Sellers & Toll PLLC -- a plaintiffs law firm that is known for its class action lawsuits and has been hired by a number of state attorneys general in recent years, including some of those to whom it donated.
Ballantyne reportedly disclosed her services as a paid consultant for Cohen Milstein to the CDC. The firm currently is helping to represent the City of Chicago in a lawsuit filed against a group of pharmaceutical companies over the marketing of opioid painkillers.
Note that in the first paragraph above, the writer apparently meant that the law firm donated to the campaigns of the attorney generals.
More importantly, why the apparent conflict of interest affecting a single member of a large group - the core expert group of which Dr Ballantyne sat included 17 people - was so important was not apparent from Mr Pitts' argument. Mr Pitts did not explain how any sort of advisory group that included experts in the field could avoid people who already had strong opinions about that field. The Legal News Line article did not discuss Mr Pitts' own background, or provide any information about the Center for Medicine in the Public Interest, which he leads.
I could not find reporting in major news outlets or medical/ health care scholarly publications about the opposition to the CDC guidelines beyond the stories in the Washington Post, AP, and Medscape, and a brief report in Modern Healthcare. I did find numerous articles on yet another little known website called the National Pain Report, (e.g. see this one).
So to summarize so far, the opposition to the new CDC opioid guidelines was apparently strong enough to delay, if not derail them. Yet who was in the opposition, their funding, and their interests remains obscure. The arguments of the opposition remain unclear. Even some of the purported journalists reporting on the opposition remain mysterious. There seems to be a tremendous amount of fog surrounding the opposition to more conservative prescribing of narcotics for non-cancerous chronic pain.
The Common Thread - Stealth Health Policy Advocacy
It was striking that much of the opposition seemed to come from rather mysterious organizations, the Pain Care Forum, Power of Pain Foundation, Washington Legal Foundation, and Center for Medicine in the Public Interest. However, the reporting on these organizations was minimal. Furthermore, some of the news sources reporting on the opposition to the CDC guidelines also were rather mysterious, such as the Pain News Network, National Pain Report, and Legal News Line.
One recent media article, and some of our previous blogging, though suggest that the opposition organizations all have ties to the pharmaceutical industry, and in several cases, directly to one of the major producers of legal opioids. On December 23, 2015, Lee Fang wrote in the Intercept by way of an introduction,
The pharmaceutical companies that manufacture and market OxyContin, Vicodin, and other highly addictive opioid painkillers — drugs that have fueled the epidemic of overdoses and heroin addiction — are funding nonprofit groups fighting furiously against efforts to reform how these drugs are prescribed.
An investigation by The Intercept has found that the pharmaceutical companies that dominate the $9 billion a year opioid painkiller market have funded organizations attacking reform of the prescribing guidelines:
The Washington Legal Foundation, a nonprofit that litigates to defend 'free-market principles,' threatened the CDC with legal action if the agency moved forward with the proposed opioid guidelines. The WLG claimed the CDC’s advisory panel for the guidelines lacked 'fair ideological balance,' because it included a doctor who is part of an advocacy effort against opioid addiction. The WLF does not disclose donor information, but has filed friend-of-the-court briefs on behalf of Purdue Pharma, the makers of OxyContin. In a recent article with Pain News Network, a spokesperson for Purdue Pharma conceded: 'We’re long-standing supporters of WLF, in addition to several other business and legal organizations. We’ve provided them with unrestricted grants.'
The Pain Care Forum organized opposition to the CDC prescribing guidelines, mobilizing regular meetings among stakeholders opposed to the idea, according to an investigation by AP reporter Matthew Perrone. A recently re-filed complaint by the City of Chicago found that Burt Rosen, the chief in-house lobbyist for Purdue Pharma, controls the Pain Care Forum. A former drug company employee allegedly told investigators that Rosen tells the Pain Care Forum 'what to do and how we do it.' The Pain Care Forum is funded through contributions by Purdue Pharma, as well as major opioid manufacturers Cephalon, Endo, and Janssen, a subsidiary of Johnson & Johnson.
The Power of Pain Foundation, a group funded by Purdue Pharma, asked supporters to contact the CDC in opposition to the guidelines, claiming that 'taking away pain medication and making providers afraid to prescribe due to your guidelines is only going to make more abusers, increase suicides, and tear apart the lives of millions.'
Fang also noted that the Legal News Line, the source of the story documenting Peter Pitts' problems with the CDC guidelines, also is tied to the pharmaceutical industry:
The U.S. Chamber of Commerce, a corporate lobbying group that represents opioid manufacturers, including Johnson & Johnson, issued a press release masquerading as a news story [published by the Legal News Line] criticizing the CDC guidelines. (The U.S. Chamber operates a public relations effort dressed up as a bona fide media outlet called Legal Newsline, which it uses to disseminate stories that support the political priorities of its member companies.)
In addition, on Health Care Renewal we have previously discussed the Center for Medicine in the Public Interest. Back in 2008, we noted that when writing for the New York Times, Mr Pitts had to disclose that the Center for Medicine in the Public Interest receives pharmaceutical industry funding, including from Pfizer and the PhRMA. At that time, Mr Pitts' day job was Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee had many big pharmaceutical accounts Since then, he moved on to become director for global healthcare at Porter Novelli, also a public relations/ communications company with many health care corporate clients, including pharmaceutical companies, and now appears to be a consultant in the life sciences area for YourEncore. I cannot find any updated information on current Center for Medicine in the Public Interest funding, but there is no reason to think that it is not still funded by the pharmaceutical industry.
Mr Pitts' published objections to the CDC guidelines had to do with the supposed bias and conflicts of interests of a single member of the guideline expert panel, and the alleged lack of transparency of the guideline project. Yet Mr Pitts was not very transparent about his own background, and his and his organizations' financial interests. For Mr Pitts to condemn the guideline panel member's conflict while hiding his own conflict amounts to a garish example of the logical fallacy of special pleading. Similarly, the Washington Legal Foundation's objections to the alleged biases of the guideline panel, given that foundation is apparently funded by Purdue Pharma, is another garish example of the same logical fallacy.
On the other hand, the Pain News Network and the National Pain Report remain obscure. The former claims to be a non-profit organization, but I cannot find its federal 990 filing, identify its board of trustees, or even determine its physical address. It does claim an affiliation with the Power of Pain Foundation. The National Pain Report at least has a physical address, which it shares with the equally obscure American News Report. Other details, like its ownership, remain obscure. The failure of supposedly journalistic organizations to publicly reveal basic information about their nature and operations does raise suspicions that they are not really so journalistic.
In summary, the organizations most widely mentioned as opposing the new CDC guidelines that recommend more conservative use of opioids for chronic pain seem to be heavily involved with the pharmaceutical companies that make such opioids. Thus, the opposition to the guidelines seems to be arising from a stealth public relations campaign leading to stealth health policy advocacy. Furthermore, at least so far, the objections to the guidelines do not seem clearly based on logic and good evidence from clinical research, again suggesting they are more about financial interests than improving patient outcomes and reducing risks.
Overuse and misuse of opioids, which may lead to all the individual and social consequences of opioid addiction, are clearly major, worsening medical and public health issues. We need earnest effort to address these problems, which should be informed by a logical, evidence-based discussion of the clinical and social realities. Such a discussion is only hindered by the growing fog of objections launched by mysterious organizations funded by the companies who have made the most money selling narcotics. So we also need some societal response to the growing domination of the public debate by marketing and public relations, often based on emotional manipulation, logical fallacies, and outright deception.
We cannot address our worsening health care dysfunction when public discussion and policy making blunders about in the fog of stealth health policy advocacy, stealth lobbying, and stealth marketing. If the leaders of big health care corporations really believe they are making good products and providing good services that add value and improve patients' and the public's health, they ought to be able to rely on honest and open communications. If they cannot disavow stealth public relations and stealth marketing, we ought to disavow the companies that practice them.
Not So Cheerful Musical Interlude
Unfortunately, given the topic of this post, here is Lou Reed singing Heroin
ADDENDUM (4 January, 2016) - This post was republished on the Naked Capitalism blog, sadly without Lou Reed. See the interesting comments appended to that version.
Also, this post was republished in its entirety on OpEdNews.