Dysfunction, Lobbying, and Conflict of Interest in the Debate Over Opioids | October 15, 2015 by Shawn McCoy
This excellent article attempts to be fair to both sides, but there is no excuse for how the CDC created these guidelines with support and direction from PROP. (the anti-opioid activists, or “the opioid lunatic fringe”)
Discussion of opioid use has become so heated that some sources for this article (not all sources are quoted) feared death threats from activists as a result of their comments to InsideSources.
You’re kidding, right? Those of us fighting for the right to medical access of opioids have been using our names everywhere, yet it’s becoming clear that PROP would use tactics like this to imply their detractors are violent nuts.
Specifically in regards to opioids, Purdue Pharma, the maker of OxyContin, was fined $600 million in 2007 for its misbranding of the drug and its risk of addiction. Additionally, three top Purdue executives pled guilty to criminal charges in relation to deceptive marketing.
If only Purdue hadn’t pushed its luck, had not trumpeted everywhere that OxyContin wasn’t addictive….
Doctors have a limited arsenal for the management of chronic pain. For patients with severe pain, opioids are often the only way to provide patients with the relief to get through their day and fall asleep at night.
Concerns over abuse have led some advocates to call for tighter guidelines for doctors to follow, but with few effective alternatives, that could leave many doctors unable to relieve patients’ chronic pain for everything ranging from back problems to fibromyalgia to cancer.
Dr. Daniel Clauw, of the University of Michigan, is considered one of the world’s leading experts in the treatment of fibromyalgia. “I think the CDC guidelines are very reasonable going forward to say this is how opioids should be prescribed, but the problem is there are a whole bunch of people with chronic pain that didn’t have opioids prescribed in this manner,” Clauw told InsideSources. “If you apply those same rules or policies to them, it’s going to cause a tremendous problem, and then people will be left without a class of drugs that is improving their pain.”
Clauw believes there needs to be a two-pronged approach so that those who are benefiting from opioid therapy do not have it taken away. Additionally, part of his research focuses on determining when opioids are useful for the management of chronic pain.
Referring to the Drug Enforcement Administration’s rescheduling of the opioid hydrocodone as a Schedule II narcotic and to the pending CDC guidelines, Clauw says there has been a “trickle-down effect” on the people who had been on the drug and benefiting from it. As the rules grow more onerous, more doctors are choosing not to prescribe opioids or not refill prescriptions even when they may be helpful.
As other doctors and patient advocacy groups review the guidelines, they’re speaking out against the document that they argue has little scientific grounding.
In today’s politics, being scientific can be a detriment – people would rather believe the fanatics who are passionate (and wrong).
The process of writing the guidelines, they say, was tainted by decisions made behind closed doors in consultation with anti-opioid activists and a paid consultant for a law firm, which stands to make substantial gains from pending suits
Why ‘Guidelines’ Carry the Force of Law
CDC has declined to release full documentation of expert recommendations and research. All public comments have been anonymized. While the federal government requires by law that regulatory agencies provide 30-90 day public comment periods on proposed rules, the CDC offered only 48 hours and did not provide much notice to stakeholders.
In total, CDC states that it has received 1,200 comments from patients, practitioners, and organizations.
As to why the comments were all anonymous, the agency explains: “CDC redacted all personally identifiable information from comments received to preserve the anonymity of the individual submitting feedback. CDC wanted individuals to feel comfortable and free to share whatever thoughts and opinions they wished. Since we provided comments to peer reviewers and plan to post a summary of comments online, we did not include names or affiliations of persons making comments.”
And the secretiveness continues. By hiding the identity of the commentators, they could be computer “bots” or people hired by special interest groups to create an vast number of comments.
Peter Pitts of the Center for Medicine in the Public Interest has been one of the most-outspoken critics of the CDC action. Pitts previously served as the Food and Drug Administration’s associate commissioner for external relations.
“The complete, 180-degree different approach that CDC took is inexcusable,” says Pitts. “CDC is a government agency. They exist within the same department as FDA. They must play by the same rules.”
CDC has no legal obligation to open the draft guidelines for public comment or fully disclose the research that went into writing the rules. This is part of what has critics so angry.
“By legal definition the guideline is not a proposed regulation subject to the Administrative Procedures Act, but clearly the intent of CDC is that the guideline be distributed to and adopted by state public health entities and certifying organizations as if it had the legal authority of a regulation.”
In medicine, there is no central authority that regulates most patient care.
The FDA is responsible for approving new drugs, but once it finishes that rigorous and costly process, doctors are not required to follow any specific regulations for prescribing a drug.
when they are not followed, doctors and hospitals could be confronted with legal action. Additionally,insurance companies may use guidelines to determine what coverage to provide.
Charles E. Argoff, Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Center at Albany Medical Center in New York, tells InsideSources that the guidelines threaten to cut patients off from the treatment they need that should be left to the doctor’s judgement
insurance companies have already begun to place limits on quantity and duration of treatment for opioids, taking that decision away from medical professionals
Another health care provider noted the fear that many pain clinics have of being investigated and shut down.
While the CDC guidelines may not carry the force of law, they are likely to be central to lawsuits involving opioids because of the, perhaps perceived, authoritative backing of a government agency.
In the California case, the judge argues that the courts are not experts in the medical field, and for an issue with so much disagreement over evolving research, it is challenging to reach a decision. “The court does not shrink from its responsibilities to handle complex, convoluted litigation; it handles such matters every day of the week. It does, however, take pause at involving itself in an area which is best left to agencies such as the FDA who are designed to address such issues.”
At least this is one group admitting it doesn’t have the medical expertise to make judgements.
Indeed, FDA has chosen to avoid action specifically because there is a lack of data.
This is the first time I’ve seen an unbiased statement about the fact that there is NO data on long term opioid use, pro or con (such studies would be unethical)
In 2013, responding to a public petition from Physicians for Responsible Opioid Prescribing (PROP), a lobbying group that works to limit opioid use, the FDA denied the petition’s request to distinguish between cancer and non-cancer pain because of a lack of evidence. It denied a request to list a maximum daily dose or duration of use, both of which are part of the CDC guidelines.
FDA allowed for significant public comment. It looked at the same evidence as the CDC, and it chose to not change its labelling of opioids. Nonetheless, the CDC is a government agency, and its guidelines will likely carry significant weight in a court of law.
The Debate Within the Debate: Who Has a Conflict of Interest?
The CDC guidelines raise questions over why the agency has taken its own action when the FDA has more direct authority on opioid use.
Anti-opioid activists, rather than an independent panel representing both sides of the debate, were the driving force behind the CDC guidelines. Additionally, a member of the “Core Expert Group” that helped to author the CDC guidelines had been a paid consultant to the law firm responsible for both the California and Chicago court cases.
CDC has been secretive throughout the drafting of the guidelines, going so far as to refuse to disclose its outside advisors. Those advisors became public from a leaked confidential draft. Critics say the panel is compromised because of its ideological composition and conflicts of interest.
According to critics, chief among those with potential conflicts is Jane Ballantyne, President of PROP.
Ballantyne has served as a paid consultant to the law firm Cohen Milstein, which was profiled by the New York Times late last year for its coaxing of state attorneys general to sign contingency agreements allowing the firm to file suit against potential targets it has identified by scouring the news media and public records. In what the Times suggests is a quid pro quo arrangement, the attorneys general receive substantial campaign contributions either right before or after they sign the contingency agreements.
When Kolodny was pressed on why Ballantyne working for a law firm with a financial interest in the guidelines is different than input from doctors with financial ties to pharmaceuticals, he said: “I’m not sure how I would understand that to be a conflict if somebody is an expert and they’re asked for their expertise.”
*Pleading ignorance in a matter so obvious would seem to be a confession of stupidity.
Kolodny thinks differently about doctors who receive money from pharmaceutical companies. Out of 970,000 doctors in the United States, 606,000 received payments from pharmaceutical companies in 2014, according to data analyzed by ProPublica. During the 17-month period studied, pharmaceutical companies paid about $9.9 billion to doctors, to include research payments, speaking and consulting fees, and licensing.
Kolodny sees such financial ties as a fundamental conflict of interest.
*Notice that the $9.9billion is from the WHOLE pharmaceutical industry, NOT JUST OPIODS
Asked whether those on the other side of the debate receive consulting fees because they’re also experts, Kolodny responded, “No. They receive fees because they say the things drug companies like them to say.”
*It’s hard to understand why his experts wouldn’t be likewise influenced – they say what PROP wants them to say.
PROP exists under Phoenix House, a nonprofit drug & alcohol rehabilitation organization with over 120 programs in ten states, serving 18,000 individuals each year.
*This is one of the most corrupt “recovery” Industries. See my previous posts:
Who Shaped the Guidelines?
The greatest concern for critics is not a specific conflict of interest but that the panel itself is heavily biased toward implementing overbearing rules.
There were three contributing authors to the guidelines, two of whom were CDC staff members, plus the 17-member Core Expert Group. According the documentation for the draft guidelines, that group served to “assist in interpreting the evidence and translating the evidence into recommendations.”
The Core Expert Group, according to critics, lacks a true representation of scientific opinion on opioids. PROP holds close ties to the Core Expert Group. Ballantyne and PROP vice president Dr. Gary Franklin were both part of the 17-member advisory panel.
“I’m sure everyone on the committee is an expert, but you need to have a variety of opinions, otherwise why even bother having the meeting in the first place,” said Pitts
Referring to PROP’s role in creating the guidelines, Pitts said, “When you basically take one group that is considered the opioid lunatic fringe and allow them to create the basis of your policy almost verbatim is inexcusable. It’s bad policy. It’s bad science. It’s poorly serving the public health.”
InsideSources asked PROP whether it had actively pursued involvement in the Core Expert Group and Kolodny called such accusations a “conspiracy theory.” what role the organization played in encouraging the CDC to write its own guidelines.
*Even though most of the people involved just happen to be PROP memebers; and not just the rank and file, but many of the leading executives
While he’s pleased CDC acted, any claims that PROP lobbied for this are “completely, totally false.”
CDC told InsideSources, “No organization external to CDC or to the Department of Health and Human Services influenced CDC’s decision to develop these guidelines.
PROP and the CDC do have close connections among staff. PROP’s Kolodny worked under CDC director Tom Frieden when Frieden was commissioner of the New York City Health Department. Perhaps more noteworthy is that CDC’s Division of Unintentional Injury Prevention oversaw the writing of the guidelines.
Dr. Leonard Paulozzi, who is the medical epidemiologist for that division of the CDC, appears on PROP letterhead as a board member in its 2012 petition to the FDA. Paulozzi no longer serves on the board, but he did work at the CDC at the time of the petition through the present.
CDC claims “our Core Expert Group comprises a diverse group of subject matter experts – with substantial knowledge on several aspects of opioid prescribing,”
*It’s puzzling how they could possibly believe that this is a diverse group when they so many of them are anit-opioid activists
but critics believe the choices for the Core Expert Group suggest that CDC set out with the goal of writing tough guidelines.
- PROP’s Franklin was responsible for writing very similar opioid guidelines in Washington State.
- In addition to the PROP members, several others have been outspoken about the need to control opioids.
- Psychiatrist Judith Turner rounds out a strong contingent, along with Ballantyne and Franklin, from the University of Washington.
- Several panel members treat addiction and emergency room visits resulting from overdoses.
What is distinctly missing from the panel, says Argoff, are any medical professionals actually responsible for treating patients suffering from chronic pain.
The most affected stakeholders are not included!!!!! comment by Zyp Czyk
There are several more moderate members of the Core Expert Group, but Harvard’s Stossel, a resident scholar at the American Enterprise Institute, recognizes potential problems with the panel based on research in behavioral economics.
But in the case of the CDC panel, he says there may be a “conformity cascade.” The CDC placed a number of outspoken anti-opioid activists on a panel with only a few moderate members and no pain experts. While vigorous debate can lead to good policy decisions, the Core Expert Group lacked opposing arguments, and a drive to conformity can lead all members to reach conclusions inconsistent with the evidence.
“I don’t think there are two sides to this, and in terms of what medical and pain professionals believe, there is only really one side here,” claims Kolodny. “There’s the medical experts and the leaders in the field, and then there’s the industry and the groups and individuals who take money from them.”
*This is the ultimate arrogance. Kolodny simply doesn’t acknowledge any disagreement and thereby writes off all protests as “irrelevant”
Do Only Corporate Ties Bind?
Sally Satel, a lecturer at the Yale School of Medicine who has treated many opioid addicts, says that in selecting a panel to advise guidelines like the CDC’s, you want a team of rivals and representation from all viewpoints, no matter who pays them.
She also notes that ideological commitments are often more influential than financial conflicts. “Why do people think only corporate ties are the ones that bind?”
The Annals of Internal Medicine, in its October 6, 2015 issue, presents guidance from an international board on the disclosure and management of conflicts of interest. While “direct financial” interests are easily defined, the article outlines “indirect” conflicts in the areas of academic advancement, clinical revenue streams, community standing, and scientific interest.
While excluding those with conflicts of interest may be the ideal, we live in the real world. As the report notes: “Pluralism of stakeholders is a desirable feature of guideline panels and may reduce the risk of bias resulting from [conflicts] and lead to balanced final decisions.”
Much remains unknown about when the CDC plans to finalize its guidelines or whether it may work to find more moderate ground than it has currently staked.
But without question, the guidelines will be the subject of debate in billion-dollar court cases, will set standards for coverage by insurance companies, and will change how opioids are prescribed in the United States for both those already treating chronic pain and others who are yet to suffer from it.
About the Author:
Shawn McCoy is the Publisher of InsideSources. Previously, he served as Iowa Communications Director for the Romney Campaign and has advised other campaigns nationwide. Shawn has an MBA, concentrated in econometrics and statistics, from the University of Chicago Booth School of Business, and he completed his undergraduate work at the University of Notre Dame. He has a dog named Milton, after his favorite economist.