I Lost a Good Doctor Because of CDC Guidelines

By Roger Bigelow, Guest Columnist

My doctor responded quickly to the CDC opioid prescribing guidelines by sending a letter to all his patients informing them he would no longer prescribe any opiates to patients in his practice. He gave patients about 4 months’ notice to either find alternative treatment or a doctor who would prescribe opiates.

He had been my general practitioner for about 15 years and had even taken opiates himself when he battled a rare form of cancer recently. He is now in remission.

My doctor and I were friends. In fact, we were members at the same country club. He confided in me. He is by all accounts an outstanding provider. You would be hard pressed to find a better practitioner. Skilled and caring.

He told me the sole reason for changing his opiate policy was fear of the CDC. He demonstrated a "What do you want me to do?" kind of attitude that I suspect is common.

I had expected him to align with his patients, as he has taken an oath to do so. I didn't expect him to cave in so easily. He made no exceptions. I was even more taken aback, given he was a cancer survivor.

As a result, I have had to change doctors, as he left little option. The only pain doctor near where I reside in southern Vermont does not write maintenance prescriptions. I've lost a very good doctor and am now under greater scrutiny.

It's pretty sad when you lose a doctor you had been with for so long. I feel somewhat fortunate to have found another doctor, but it's not a positive change. Not at all.

It's a pretty sad situation we have, where political powers push a false agenda upon the public. If you listen to our "media," you would soon come to the belief that the heroin abuse crisis is solely caused by careless doctors overprescribing. And of course it’s Big Pharma’s fault for developing such effective medications. All it takes is young Jimmy taking two leftover Percocet tablets from the medicine cabinet -- and next thing you know, young Jimmy is plunging a needle into his vein.

Never mind the open borders, drug cartels, counterfeit medications, internet transactions and problems with wholesale distribution. And, of course, young Jimmy (and his divorced parents) are not accountable because addiction is a disease, not a conscious act. So addicts get Suboxone and free needles, while patients with documented medical conditions get cut off -- ironically driving many to street drugs like heroin.

They don't seem to care about the 11 million chronic pain patients who use opioid medication daily.

It's clearly about the money. It always is. With the government paying more and more people (Medicare, Medicaid, Obamacare) and facing an aging population, this is really all about saving our social health programs from destruction.

Prior to accident driven disability, Roger Bigelow worked for nearly 20 years with the New York State Bureau of Narcotics Enforcement, where he helped develop the world’s first prescription drug program designed to curb diversion and fraud. Roger is a national expert on the subject of drug diversion, as well as a chronic pain patient who has endured 17 surgeries.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

CDC Guidelines Study: The Devil Is in the Details

By Stephen Ziegler, PhD, Guest Columnist

JAMA Internal Medicine has published a research letter that purports to be an examination of the relationship between funding from opioid manufacturers and opposition to the prescribing guidelines issued by the Centers for Disease Control and Prevention (CDC) in March of 2016.

The authors examined the written comments made to the CDC during the open comment period, asserted that those who had received funding were more likely to oppose the CDC guidelines, and concluded that their “findings demonstrate that greater transparency is required about the financial relationship between opioid manufacturers and patient and professional groups.”

The following commentary, while critical of information contained in the article written by Caleb Alexander, Andrew Kolodny and others, nevertheless concludes with some positive suggestions for the future.

Illicit Opioids: The Harms Associated With Conflation of Data

The research letter, like many articles authored by those who are rightly concerned about addiction and overdose, begins by asserting that an association exists between increases in opioid prescribing and “large increases in addiction and overdose deaths in the United States.”

However, there are several problems with such a statement. First, association is not causation. For example, while a positive association exists between the size of a fire and the number of fire engines on the scene, fire engines for the most part do not cause fires -- they are only associated with it. Further, it is misleading and harmful to lump all opioids, prescription and illicit, together.

While conflating the two may help create better headlines and fuel the hysteria, such conflation is misleading because studies continue to indicate that two opioids, illicit fentanyl and heroin, are major drivers in the alarming increase in addiction and overdose, not prescription opioids.

Moreover, lumping all opioids together can be harmful because it ignores the size and complexity of the problems associated with the use and abuse of illicit and licit drugs. Because drug abuse remains a moving target, it is important to draw distinctions between a variety of factors and sources so that solutions can be tailored and refined. One size does not fit all.

Unclear Methodology Used to Classify Comments

Another problem with the JAMA article was the lack of measurement clarity regarding content analysis and how the authors categorized (coded) the comments that were submitted to the CDC during the open comment period.

According to the authors, the comments were classified as belonging in one of four mutually exclusive categories: “supportive, generally supportive with recommendations, generally not supported with recommendations, and not supportive.”

While it is unclear whether the coding occurred before or after the comments were reviewed, one section of the paper the authors pointed out that about 6% of the comments “were coded as supportive by 1 reviewer and not supportive by the other; a third reviewer adjudicated these cases.”

The first question that comes to mind is: who was the reviewer? Since it is likely that the authors were not randomly selected, it remains unclear what criteria was used to adjudicate disputes related to coding, especially when we know that two reviewers were at opposite ends of the spectrum and the coding scheme was central to the study.

Along these same lines, what constitutes opposition to the CDC guidelines? Was opposition binary (yes/no), was it mixed (and if so, where was the line), or did opposition exist along a range (strong or weak)?

When dealing with qualitative data (words as opposed to numbers), there are tendencies in terms of direction, but the devil is in the details. This is notable because there were likely many different reasons commentators and organizations were not supportive of the CDC prescribing guidelines, such as, but not limited to:

1. The secretive nature of the entire process
2. The short time frame the CDC allotted for public comments (initially less than 24 hours)
3. Allegations that the process violated the Federal Advisory Committee Act
4. Strong recommendations based on weak evidence
5. Committee membership that lacked balance and broad stakeholder involvement
6. An anti-prescription opioid agenda or bias by some committee members
7. The fixation on dosing limits ignored the problems associated with converting dosage from one opioid to another, the differences in patients, and the potential for unintentional overdose at any dosage level
8. The lack of balance and selective nature of the literature cited in the guidelines
9. The failure to recognize that non-pharmacologic therapy and alternatives to opioids may not be effective or covered by insurance
10. An ironic lack of transparency and full disclosure concerning potential conflicts of interest among those involved in the guidelines at various levels from start to finish

Conclusion

While the reduction of harms associated with the use of prescription drugs and illicit opioids such as heroin remains essential to improving the public health, it serves no laudable purpose to continually lump all opioids together.

Drug abuse is a highly complex bio-psycho-social phenomenon that requires recognition that not all people, nor problems, are the same. We must also not lose sight of the fact that millions of Americans are suffering from chronic pain, alternatives to opioids may not be as effective or covered by insurance, and the overwhelming majority who take prescription opioids use them responsibly.

In regards to the conflicts of interest issue, while the authors eventually admitted that the “CDC did not prompt or require organizations to disclose their financial associations as part of their comments,” I agree that disclosing real or potential conflicts of interest in the future is good for all involved. However, such disclosure should not be limited to just the pharmaceutical industry. It should also include government agencies and those in the substance abuse community.

I have and continue to provide consultation to government and the pharmaceutical industry about the need for balanced solutions that help ensure appropriate access, while at the same time prevent abuse. I care about the under-treatment of pain, as I am sure that those in the substance abuse community care about those suffering from addiction.

Consequently, what both the pain community and the substance abuse community need to focus on is finding common ground and forging balanced solutions, since finger pointing, bullying or taking a zero-sum game approach only impedes progress.

Stephen J. Ziegler, PhD, is a Professor Emeritus of Public Policy at Indiana University-Purdue University in Fort Wayne, Indiana.

Dr. Ziegler conducts research, provides continuing medical education, and consults on the topics of opioid risk management and the impact of drug regulation and enforcement on the treatment of pain. He has been published in several peer reviewed journals and serves as a reviewer for several journals such as the Journal of Opioid Management, Pain Medicine, Cancer, and the Journal of Medical Ethics. Prior to obtaining his law degree, Dr. Ziegler worked as a police detective and as a Task Force Officer for the U.S. Drug Enforcement Administration.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Bias and Conflict of Interest in Opioid Guidelines Study

By Pat Anson, Editor

A new study published in JAMA Internal Medicine is claiming that some patient advocacy groups and medical organizations that opposed the Centers for Disease Control and Prevention’s opioid prescribing guidelines had a conflict of interest.

Ironically, the two main authors of the study appear to have a conflict of interest themselves, as well as a bias against opioid pain medication.

In their review of 158 organizations that made public comments on the CDC guidelines – which discourage doctors from prescribing opioids from chronic pain – researchers found that about one third (38%) of those that accepted funding from opioid manufacturers opposed the guidelines. This alleged conflict of interest should have been disclosed, they say.

“A major concern is that opposition to regulatory, payment, or clinical policies to reduce opioid use may originate from groups that stand to lose financially if sales of opioids decline,” wrote senior author G. Caleb Alexander, MD, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health.

“Our findings demonstrate that greater transparency is required about the financial relationships between opioid manufacturers and patient and professional groups.”

One of the co-authors who designed the study is Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid group that helped draft the CDC guidelines and was itself accused of numerous conflicts of interest. Kolodny is the former chief medical officer of Phoenix House, which runs a chain of addiction treatment centers and was PROP’s chief source of financial support until recently.

Alexander, who is a widely published researcher who has collaborated several times with Kolodny on other opioid-related studies, failed to disclose in the JAMA study that he has accepted funding from Otsuka Pharmaceuticals. The Japanese drug company makes Abilify, an anti-psychotic medication prescribed off-label to treat chronic pain. The amount paid to Alexander in 2015 was relatively small, a $668 fee for consulting, but according to the criteria used in his own study, it represents a conflict of interest.

Any amount of money accepted from an opioid manufacturer was considered a conflict of interest in Alexander and Kolodny’s study, whether it was a grant, gift, advertising or some other material support. No evidence was required to prove the money swayed an organization one way or another. In fact, nearly two-thirds (62%) of the organizations that accepted funding from opioid makers supported the CDC guidelines, disproving their own theory.   

“I’ll be the first to say that our method of assessing financial relationships is somewhat imprecise,” Alexander told Pain News Network. “This study was not designed for causal inference. This study doesn’t permit us to say what the effect of these funding relationships has been. But one has to wonder, when this amount of money is being spent, what the effects are.”

PROP and the “Opioid Lobby”

The claim that many medical organizations and patient advocacy groups have come under the influence of the “opioid lobby” has long been used by Kolodny.

“CDC’s plan was effectively blocked by intense pressure from the opioid lobby, which sees more cautious opioid use as a financial threat,” wrote Kolodny in a newsletter sent to PROP supporters in December 2015, after the CDC guidelines were temporarily delayed after a public outcry and threats of a lawsuit.

Kolodny’s smear campaign was widely covered uncritically by the news media, even though there was no evidence cited to support it.

“This is a big win for the opioid lobby,” Koldony told the Associated Press.

“The story here is how the opioid lobby is using the Cancer Action Network to discredit a public health effort to limit opioid prescribing,” Kolodny told The Hill.

“Here’s background on shady organization now attacking CDC’s draft opioid guideline,” Kolodny posted on Twitter.

Kolodny did not respond to a request for comment for this story.

Like his co-author, Alexander also is convinced there is a quid-pro quo between opioid manufacturers and groups that they fund.   

“The biggest myth out there is that there’s a conflict between reducing our dependence on opioids and improving care for patients in pain,” Alexander told the AP last year. “It’s an artificial conflict, but there are lots of vested interests behind it.”

Does the opioid lobby even exist? Are patient advocacy groups so easily swayed by their funding sources? Kolodny and Alexander’s study presented little evidence of either, yet they still managed to get it published in an influential journal published by the American Medical Association.

“No one in the pharmaceutical industry has ever asked me or anyone that is on our voting board to publicly state a specific stance on any issue regarding treatment options. Not one pharmaceutical representative has ever asked anyone from iPain to comment on the CDC guidelines,” said Barby Ingle, a PNN columnist who is President of the International Pain Foundation (iPain), a patient advocacy group.

Ingle, who did submit her own personal comments on the CDC guidelines, says it is very difficult to get funding from drug makers.

“We have gotten to the point of not even applying for funding unless we are contacted,” said Ingle. “Even when notified of funds available, iPain did not receive the funding requested and it turned out to be a waste of time on our part.”

What is a Conflict of Interest?

“These people perhaps don’t quite understand what is the definition of a conflict of interest,” said Richard Samp, chief counsel of the Washington Legal Foundation, which threatened to sue the CDC for violating federal law when it drafted the opioid guidelines.

“As I understand conflict of interest under federal law, that generally means that somebody has been appointed to serve in one position, but they have some other financial or ideological interest that conflicts with the interests that they’re supposed to have,” Samp told PNN.

“That was the focus of our criticism of the process that CDC went through in adopting its draft guidelines, which were written with the assistance of an advisory group that included people who had very severe conflicts of interest. For example, one particular member of the group, Jane Ballantyne, was a paid consultant for a plaintiffs’ law firm that had a vested interest in suing opioid manufacturers.”

Dr. Ballantyne is the President of PROP, the organization founded by Kolodny. At least four other board members of PROP, including Kolodny himself, served on various CDC panels that advised the agency during the drafting of the guidelines, a matter that the agency refused to disclose for several months.   

“What they are talking about (in the JAMA study) is not a conflict of interest. They’re just talking about the fact that some people who file comments with federal agencies have a particular point of view,” said Samp. “Every citizen regardless of his or her point of view and regardless of his or her background has a right to comment on what our government is doing.”

Another way to look at whether there is a conflict of interest is offered by Stephen Ziegler, PhD, in a commentary for Pain News Network (see "CDC Guidelines Study: The Devil Is in the Details").

“Association is not causation. For example, while a positive association exists between the size of a fire and the number of fire engines on the scene, fire engines for the most part do not cause fires -- they are only associated with it,” Ziegler wrote.

Ziegler says it’s time for the pain community and the addiction treatment community to end the finger pointing and bullying over opioids, and start finding common ground.

“It is misleading and harmful to lump all opioids, prescription and illicit, together. While conflating the two may help create better headlines and fuel the hysteria, such conflation is misleading because studies continue to indicate that two opioids, illicit fentanyl and heroin, are major drivers in the alarming increase in addiction and overdose, not prescription opioids,” Ziegler wrote.

The American Academy of Pain Medicine (AAPM), an association of pain management physicians, also released a statement about the JAMA study, saying it agreed that “disclosure is one means of managing conflicts of interest.” 

While the AAPM cautiously supported the CDC guidelines, it also warned that their widespread implementation could lead to problems.

“It is incumbent upon us all to monitor the deployment of the guideline to ensure that it does not inadvertently encourage under-treatment, marginalization, and stigmatization of the many patients with chronic pain that are using opioids appropriately,” the AAPM said.

Since the guidelines were released in March 2016, many pain patients have complained to PNN that their opioid doses have been reduced or eliminated, and that it’s become difficult to find a doctor willing to treat chronic pain. Others have said they are contemplating suicide because their pain is going untreated.

Pain Community Reacts to ‘Big Brother’ Medicare Policy

By Pat Anson, Editor

Here we go again.

That’s seems to be the reaction from many in the pain community to plans by the federal government to have pharmacists report suspicious activity by doctors who prescribe opioids to Medicare and Medicaid patients. (See “Medicare Takes Big Brother Approach to Opioid Abuse”)

The Centers for Medicare & Medicaid Services (CMS) says its new strategy to fight opioid abuse is aimed at “incentivizing prescribing behavior” by having pharmacists identify and report doctors who may be overprescribing opioids and patients who may be abusing them. 

“It is a terrible idea to pit pharmacist against physicians. It is an unbelievably perverse way to solve a serious healthcare problem that requires trust and collaboration among all the stakeholders,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “Many, many people with pain and addiction are going to be harmed by this decision.”

“This will only serve to further increase stigma and increase distrust between patients, their prescribers, and pharmacists,” says Anne Fuqua, a former nurse, chronic pain sufferer and patient advocate.

“Just the words ‘incentivized prescribing’ makes me shudder.  It may well help root out a limited number of substance abusers and decrease pharmacy claims for Medicare Part D and Medicaid, but this is neither an effective manner to intervene when substance abuse does exist nor an ethical way to decrease prescription drug benefit claims.”

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in state-run Medicaid programs. Under the new policy, information about doctors and patients who’ve been red flagged by pharmacists would be shared through a database with all insurers. The companies would be empowered to “investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.” Violators could be dropped from insurance networks or lose their coverage.    

“A policy like this, that encourages pharmacists to report the prescriber or patient to the insurer for investigation, is dubious enough.  It's even more serious that the allegations would be entered in a database whether or not they are proven,” said Fuqua. “This would be like your doctor saying they think it's possible a patient is misusing medication and then emailing this to all the doctors in your state.  Every element of this reeks of big brother and directly contradicts treating addiction as a health issue.”

“It appears that CMS is dictating that pharmacists perform activities that are both outside of their training and the legal authority granted to them under the state's practice act,” said Steve Ariens, a retired pharmacist and patient advocate. “Pharmacists don't have access to the patient's entire medical records. They are being told by CMS to both diagnose and prescribe what is right for a patient.”

“Many of the pharmacists I know are already overworked with other regulations to the point of PDMP’s not being updated in a timely manner. I know of patients who have been affected by this personally,” said Barby Ingle, president of the International Pain Foundation and a PNN columnist.   

“What a pharmacist believes about a medication’s appropriateness should not come into play when they are not trained on the medical aspects of chronic conditions. Pharmacists know about medication, but not in-depth information on diseases we are living with and therefore should not be making the call on what they deem suspicious on behalf of a prescriber.”

Medicare Policy Based on CDC Guidelines

CMS is basing many of its policy decisions on opioid prescribing guidelines released last year by the Centers for Disease Control and Prevention. The guidelines, which discourage doctors from prescribing opioids for chronic pain, are voluntary and meant only for primary care physicians. But they are being widely adopted by insurers and doctors throughout the country as a “standard of care,” even though the scientific evidence supporting many of the guidelines is weak.

CMS seems unconcerned by that lack of evidence.

“Where sufficient evidence was not available, the CDC guidelines are based on expert opinion, as noted by the CDC,” the agency said in a 30-page briefing paper on its Opioid Misuse Strategy.

“The guidelines were formed by consensus of mostly people with agendas, biased against opioids, and totally insensitive to the needs of people in pain. The dose limits suggested by the CDC guidelines are arbitrary, not evidence based,” said Dr. Webster. “

“Let's be clear about the CDC guidelines.  A major reason the guidelines were developed was to reduce cost of drugs for payers.  If Medicare and Medicaid patients have an increasing incidence of opioid use disorder it is because these people do not have any alternative treatments for their pain other than an opioid. 

“If CMS is going to endorse the guidelines that have little to no science basis, then they should mandate all of the alternative therapies to opioids have unlimited coverage and that payers be mandated to provide adequate coverage for the underlying reasons that lead to opioid use and mental health disorders.  This would more likely reduce the incidence of an opioid use disorder.”

CMS is not requiring insurers to cover alternative pain therapies, such as massage and acupuncture, but says it is a prioritizing efforts to develop more evidence to support their use.

Public Not Informed

CMS convened a “cross-agency working group” to develop its opioid misuse strategy, and says it is “working closely” with other federal agencies such as the CDC, Food and Drug Administration, National Institutes of Health, and the White House Office of National Drug Control Policy. Members of the working group were not identified.

“CMS sought representatives from every component of the agency to ensure a broad range of expertise and perspectives. This diverse group assessed the benefits, limitations, and improvement opportunities within CMS’s current policies and programs. The group then defined desired outcomes from the perspective of CMS’s unique role as a leading payer of health care and identified key actions to achieve those outcomes,” the agency said in a statement on its website.

But CMS never held a public hearing or sought public comment prior to the strategy’s release last week. Several medical organizations and patient advocacy groups contacted by Pain News Network were unaware the policies were even being developed. 

“I was not even aware that these new CMS policies were being created and as a patient on Medicare, I think that we should have been notified at minimum,” said Barby Ingle. “Our opinion as patients in the program should have been a part of the voice of something that will affect proper and timely access to care.”

“Society would never tolerate any other patient group being treated in this manner,” said Anne Fuqua. “It's no accident that this provision has been given so little attention.”

On its website, CMS says it now welcomes “input from clinicians, patients, consumers, caregivers, manufacturers, researchers and others.” But it never makes clear how interested parties can comment or participate, such as a notice or public comment period published in the Federal Register.

The secretive actions of the agency – so far – are similar to those used by the CDC in developing its opioid prescribing guidelines. For several months, the CDC refused to identify members of a “core expert group” that helped draft the guidelines, which were released in September 2015 to a small and mostly selected online audience.

Initially, the public was given only 48 hours to comment on the CDC guidelines -- a decision that was reversed after a public outcry and threats of a lawsuit. Over 4,300 public comments were later received online, most of them in opposition to the guidelines, which were released virtually unchanged in March 2016.

CMS has not responded to repeated requests for an interview about its opioid misuse policies. It is not clear when the policies will be initiated, who was involved in drafting them, or where the idea came from.

CMS caved into political pressure last year when it agreed to drop pain related questions from patient satisfaction surveys. Politicians, hospitals, the American Medical Association, and other health organizations all claimed the questions encouraged the overprescribing of opioids. CMS officials said there was no evidence that was true, but agreed to eliminate the questions in 2017 patient surveys. The agency is still working on a future set of questions to replace them.

Medicare Takes 'Big Brother' Approach to Opioid Abuse

By Pat Anson, Editor

A new strategy being developed by Medicare to combat the abuse of opioid pain medication will encourage pharmacists to report physicians who may be prescribing opioids inappropriately. Patients that a pharmacist believes are abusing opioids could also be referred for investigation.

The strategy, which has yet to be finalized, was outlined by the Centers for Medicare & Medicaid Services (CMS) last week in a 30-page report on the agency’s “Opioid Misuse Strategy.”  It has not been widely publicized by CMS or reported in the news media.

“Many Medicare and Medicaid beneficiaries and their families have experienced opioid use disorder, commonly referred to as addiction,” the agency says in the report’s executive summary.

“Given the growing body of evidence on the risks of misuse… CMS is outlining our agency’s strategy and the array of actions underway to address the national opioid misuse epidemic.”

One strategy CMS will explore is “incentivizing prescribing behavior” by encouraging physicians and pharmacists to consult with prescription drug monitoring programs (PDMPs) to review each patient’s prescription drug history. The use of PDMPs is fairly widespread already, but CMS would take it a step further by encouraging pharmacists to report suspicious activity by prescribers and patients.

“Pharmacies would be able to identify prescribers with potentially illicit prescribing practices or beneficiaries (patients) who may be overusing opioids. This information can be referred to health plans to investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.”

Investigations of abuse or inappropriate prescribing would be shared with insurers enrolled in the giant Medicare/Medicaid system, even if the allegations are never proven. CMS contracts with dozens of private insurance companies to provide health insurance to about 54 million Americans through Medicare and nearly 70 million in Medicaid.

“Part D plans can use CMS’s information sharing platform to identify leads for their own internal investigations and can report actions they have taken. For example, if one plan sponsor suspects a provider of inappropriate prescribing behavior, it can alert other plans to that possibility so that those plans can conduct their own evaluations and take coordinated action if warranted.

“The results of these projects are provided to plan sponsors so that additional actions can be taken, including initiating new investigations, conducting audits, or terminating physicians and pharmacies from their network.”

“It looks like ‘Big Brother’ is going to watch everyone,” says Rick Martin, a retired Las Vegas pharmacist who suffers from chronic back pain.

“Pharmacists are going to be even more paranoid than they already are," Martin wrote in an email. “Retail pharmacists don't have time for this. They aren't the police. Nevada has a PDMP. It already shows a significant decrease in prescribing patterns over the last several years, so it is working.  With the CMS, just who decides what are appropriate quantities and proper prescribing habits?”

CMS Using CDC’s Prescribing Guidelines

In developing its strategy, CMS is relying heavily on prescribing guidelines released in 2016 by the Centers for Disease Control and Prevention, which discourage doctors from prescribing opioids for chronic pain. CMS says it will use the “evidence-based guidelines” to determine what constitutes inappropriate prescribing. The guidelines include a recommendation that opioids be limited to no more than 90 mg of morphine equivalent milligrams a day, a dose that many patients in severe chronic pain consider inadequate. 

The CDC maintains the guidelines are “voluntary” and intended only for primary care physicians. However, under the CMS strategy, the guidelines would apply to all prescribers, except those treating cancer or patients in palliative care.

“I just hate to see something that CDC itself said was voluntary, was a recommendation, and really isn’t all that specific if you really read it, get turned into something that creates bright red lines. And if you step across the line, you’re going to get yourself in trouble. I don’t think that’s right,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, the nation's largest pain management organization.

CMS says the additional scrutiny of doctors and patients is needed because “the Medicare population has among the highest and fastest-growing rates of diagnosed opioid use disorder,” which the agency estimates at 6 out of every 1,000 beneficiaries. Addiction rates are higher among Medicaid beneficiaries, at 8.7 patients for every 1,000, a figure 10 times higher than patients covered by private insurance plans.

“Because there is no systematic policy of screening for opioid use disorder and patients are unlikely to volunteer that they are misusing their medication or are using opioids like heroin because of discrimination and stigma, these rates are likely underestimates,” CMS says.

Rick Martin believes the Medicare policies will make physicians even less likely to prescribe opioids and pharmacists less likely to fill legitimate prescriptions.

“Pharmacists, like the docs, are just plain scared. If they don't know you, many are reluctant to fill,” said Martin, who is enrolled in Medicare's Part D prescription drug plan.

“One pharmacy I went to refused to fill my bona fide legitimate prescription because it exceeded an arbitrary amount. The manager didn't want any extra scrutiny from DEA, the home office, the PDMP, the board of pharmacy, or the (drug) wholesaler. Even though I was in the system for over 2 years and had previously had even higher amounts filled.

“One of the pain docs I am working with told me he has gotten numerous letters from Humana and one other (insurer) because he is in the upper 1% of dispensing opioids. Well, duh!  He is an exclusive pain management doctor. They didn't compare him with other pain doctors, just ALL doctors. Stupid. What will the CMS do on top of what goes on already?”

Bob Twillman worries the CMS strategy will create distrust between physicians and pharmacists.

“We’ve been trying to make efforts over the last few years to get pharmacists and physicians to work more closely together. I’m concerned this could increase suspicion between the two and be counter to that effort,” said Twillman. “Getting prescribers and pharmacists to work together is an important thing in enhancing patient safety and if we do something like this and short circuit that effort we’re doing more harm than we are good.”

CMS did not say when it planned to implement its Opioid Misuse Strategy or if public hearings would ever be held on them. The agency only said in coming weeks it would release “statements reflecting the agency’s Medicare and Medicaid goals.”

Also unclear is why CMS and the Department of Health and Human Services would take a major step affecting the healthcare of tens of millions of patients and their doctors in the final days of the Obama administration.

“The fact that this is coming out a couple of weeks before the new administration comes in does make it a little bit odd. It makes me wonder how many legs it has or whether it will carry over into the next administration,” said Twillman.

FDA Approves New Long Acting Painkiller

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new extended release opioid pain medication with abuse deterrent properties.

Egalet Corporation announced Monday that the FDA has approved Arymo ER – a long-acting version of morphine -- for the management of pain severe enough to require daily, around-the-clock opioid treatment. It comes in the form of a pill that is very difficult to crush or liquefy, methods used by abusers to speed the release of an opioid into the bloodstream.

"With the majority of ER opioids in easy to abuse forms, it is important that healthcare professionals have additional treatment options like Arymo ER that are resistant to different methods of manipulation using a variety of tools," Bob Radie, president and CEO of Egalet said in a news release.

“Arymo ER has physical and chemical properties expected to make abuse by injection difficult which is important given it is the most common non-oral route of morphine abuse and the most dangerous.”

An FDA advisory panel recommended in a 18-1 vote last August that Arymo be approved. It is is the 7th opioid with abuse deterrent properties approved by the FDA. The other medications are OxyContin, Targiniq, Embeda, Hysingla, Morphabond, and Xtampza.

Arymo has been approved in three dosage strengths: 15 mg, 30 mg and 60 mg. Egalet plans to make the drug available in the first quarter of 2017.

Arymo is the first commercial product developed with Egalet’s Guardian technology, which incorporates the medication into a polymer matrix tablet to make it difficult to misuse or abuse.

“Guardian Technology results in tablets that are extremely hard, very difficult to chew, resistant to particle size reduction, and inhibit/block attempts at chemical extraction of the active pharmaceutical ingredient,” the company says in a statement on its website.

“In addition, the technology results in a viscous hydrogel on contact with liquid, making syringe-ability very difficult. These features are important to address the risk of accidental misuse (e.g., chewing) in patients with chronic pain, as well as intentional abuse using more rigorous methods of manipulation. “

The approval of abuse-deterrent medications is still somewhat controversial. Some medical professionals and anti-opioid activists say the technology does not completely prevent abuse and the drugs are still being misused by addicts.

Few Pain Patients Become Long-Term Opioid Users

By Pat Anson, Editor

Less than two percent of patients with prescriptions for opioid pain medication become long-term opioid users, according to a large new study published online in the journal Pain.

Researchers at Indiana University studied a nationwide database of over 10 million patients who filed insurance claims for opioid prescriptions between 2004 and 2013. The study was designed to look at opioid use by patients with psychiatric and behavioral problems, but in the process uncovered data indicating that the overall risk of long term opioid use for six months or more was relatively rare for most patients.

“Of the 10,311,961 incident opioid recipients, only 1.7% received long-term opioids during follow-up,” wrote lead author Patrick Quinn, PhD, of Indiana University, Bloomington.

“The probability of transitioning from first fill to long-term opioids was 1.3% by 1.5 years after the first prescription fill, 2.1% by 3 years, 3.7% by 6 years, and 5.3% by 9 years. Fewer than half of long-term recipients met a stricter long-term definition (at least 183 days supply) during follow-up. The likelihood of receiving long-term opioids by this stricter definition was 1.0% by 3 years.”

Addiction treatment specialists and public health officials have long claimed that even short-term use of opioid medication quickly raises the risk of addiction and death.

“The bottom line here is that prescription opiates are as addictive as heroin. They’re dangerous drugs,” CDC Director Thomas Frieden recently told the Washington Post. “You take a few pills, you can be addicted for life. You take a few too many and you can die.”

The Indiana University researchers did find a “relatively modest” increase in long term opioid use by patients with depression, anxiety and other mental health conditions, and those taking psychoactive drugs. Rates of long-term use were 1.5 times higher for patients taking medications for attention-deficit disorder (ADHD); three times higher for those with previous substance use disorders other than opioids; and nearly nine times higher for those with previous opioid use disorders.

Ironically, the strongest risk for long-term opioid use was in patients being treated with buprenorphine (Suboxone), an addiction treatment drug.

“Patients with OUDs (opioid use disorders) and buprenorphine or naltrexone prescription fills were at substantially greater risk of transitioning to long-term opioids earlier in follow-up than were patients without these conditions or medications,” Quinn wrote.

The researchers also found that patients with a history of suicidal or self-injuring behavior were at greater risk of using prescription opioids long-term.

 “It is likely that patients with psychiatric problems are more likely to experience more severe pain symptoms or greater pain-related functional impairment, perhaps leading providers to prescribe more aggressively to address pain-related concerns,” Quinn said. “It is also possible that patients with comorbid pain and psychiatric conditions may be more likely to seek care repeatedly or from multiple treatment providers because of their greater symptom severity or perceived need for care, resulting in a higher rate of opioid receipt in aggregate.”

Quinn and his colleagues do not rule out opioid therapy for pain sufferers with psychiatric problems, but recommend that they be given mental health counseling “in conjunction with the use of long-term opioid therapy.”

Frieden to Resign as CDC Director

By Pat Anson, Editor

Dr. Thomas Frieden, who has headed the Centers for Disease Control and Prevention for nearly eight years and played a pivotal role in the agency’s opioid prescribing guidelines, plans to submit his resignation on January 20, the day of President-elect Donald Trump’s inauguration.   

Frieden disclosed his plans in a year-end interview with Reuters. The former New York City health commissioner did not say what he planned to do next.

Frieden’s resignation is not surprising, as incoming administrations usually do not retain the heads of federal agencies, most of whom are political appointees.  Food and Drug Commissioner Robert Califf, MD, who has only been in office for 10 months, has not been contacted by the Trump transition team and is also expected to be replaced, according to The Washington Post.

President-elect Trump has not yet said who his nominee will be to succeed Califf or who he will appoint to replace Frieden.

Frieden has an extensive background in epidemiology and infectious diseases, and his tenure at the CDC was marked by major efforts to combat outbreaks of the Ebola virus, fungal meningitis, influenza and the Zika virus. He also doggedly pursued a controversial campaign to put prescribing limits on opioid pain medication, an area traditionally overseen by the FDA.

“One of the most heartbreaking problems I’ve faced as CDC director is our nation’s opioid crisis,” Frieden recently wrote in a commentary published by Fox News. 

“This crisis was caused, in large part, by decades of prescribing too many opioids for too many conditions where they provide minimal benefit and is now made worse by wide availability of cheap, potent, and easily available illegal opioids: heroin, illicitly made fentanyl, and other, newer illicit synthetic opioids. These deadly drugs have found a ready market in people primed for addiction by misuse of prescription opioids.”

thomas frieden, md

But Frieden’s campaign to rein in opioid prescribing has failed to slow the soaring number of overdose deaths, which continued to rise throughout his tenure at CDC, killing 52,000 Americans last year alone.

His repeated claim that the use of prescription opioids by legitimate patients is “intertwined” with the overdose epidemic is also not supported by facts. Only a small percentage of pain patients become addicted to opioid medication or graduate to heroin and other illegal street drugs.

Yet Frieden remains a staunch supporter of the CDC guidelines, calling them an “excellent starting point” to prevent opioid abuse, even though the guidelines themselves state they are based on scientific evidence that is "low in quality."

“There are safer drugs and treatment approaches that can control pain as well or better than opioids for the vast majority of patients. We must reduce the number of Americans exposed to opioids for the first time, especially for conditions where the risks of opioids outweigh the benefits,” Frieden wrote.

“We must not forget what got us here in the first place. Doctors’ prudent use of the prescription pad and renewed commitment to treat pain more safely and effectively based on what we know now about opioids—as well as healthy awareness of the risks and benefits among patients prescribed these drugs—can change the path of the opioid epidemic.”

Frieden undoubtedly had good intentions, but his agency repeatedly showed a penchant for arrogance and contempt for the public while drafting the guidelines.  The CDC held no public hearings, and secretly consulted with addiction treatment specialists and special interest groups, but few pain patients or pain physicians.

The CDC finally unveiled the guidelines publicly in September 2015 to a select online audience. The agency didn’t make the guidelines available on its website or in any public form outside of the webinar, and allowed for only a 48-hour comment period. Only when faced with the threat of lawsuits and growing ridicule from patients, physicians and other federal agencies, did the agency reverse course and delay the guidelines for several months. They were released virtually unchanged in March 2016.

Although “voluntary” and meant only for primary care physicians, the guidelines have been widely adopted by pain specialists and other prescribers, and have even become law in several states. This was always the goal of the CDC.

Within a few months of their release, an online survey of nearly 2,000 pain patients found that over two-thirds had their opioid medication reduced or stopped by their doctors. Over half said they had contemplated suicide.

There have been anecdotal reports of suicides increasing in the pain community. A recent story we did about the suicide of a Vermont man who was cut off from opioids and abandoned by his doctor provoked quite a response from readers.

“This situation has got to be stopped before any more people commit suicide to escape the pain. I also suffer from chronic pain and my medications have been cut back so far they no longer work worth a damn,” Michael wrote to us.

“I'm facing the very same thing right now. I'm in utter agony,” said LadyV. “In my doctor’s office I was told I have to reduce you, wean you off. I through no fault of my own suffered a horrible spinal injury and now no one cares.”

“When I was forcibly weaned off my pain meds last spring, due to the push by the DEA and CDC, I wrote a letter to the White House,” wrote Judith Metzger. “I mentioned a need for them to be watching suicide statistics related to uncontrolled chronic pain. There was never any mention that I was suicidal. Still, I got several calls from a suicide crisis team in DC! Reading this tragic story makes it clear that my prediction was sadly correct. When will they ever listen?”

In his commentary for Fox News, Frieden said it was “important that we look upstream and prevent opioid use disorder in the first place.”

In his final weeks at the CDC, now may be a good time for Frieden to look downstream at the havoc his prescribing guidelines have created.

NSAIDs Raise Risk of Dying From Endometrial Cancer

By Pat Anson, Editor

Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) have long been thought to reduce the risk of some cancers. But a surprising new study suggests that regular use of the pain relievers may actually raise the risk of dying for women with endometrial cancer.

Researchers at Ohio State University studied over 4,300 women with endometrial cancer, 550 of whom died during the five-year study. Those who used NSAIDs regularly and had Type 1 endometrial cancer had a 66 percent higher risk of death.

The research findings are published in the Journal of the National Cancer Institute.

"This study identifies a clear association that merits additional research to help us fully understand the biologic mechanisms behind this phenomenon. Our finding was surprising because it goes against previous studies that suggest NSAIDs can be used to reduce inflammation and reduce the risk of developing or dying from certain cancers," said co-author Theodore Brasky, PhD, a cancer epidemiologist at The Ohio State University Comprehensive Cancer Center.

Over 60,000 women are diagnosed with endometrial cancer in the U.S. annually, making it the fourth most common cancer in women and the sixth leading cause of cancer death.

Endometrial cancer begins in the lining of the uterus and grows outward to surrounding organs. Type 1 tumors are less aggressive and are typically confined to the uterus, while Type 2 tumors tend to be aggressive and are at greater risk of spreading.

In the OSU study, the risk of dying was statistically significant in women who reported past or current NSAID use, but it was strongest among patients who used NSAIDs for more than 10 years and had ceased using them prior to their cancer diagnosis.

Interestingly, the use of NSAIDs was not associated with mortality from more aggressive Type 2 cancers.

"These results are intriguing and worthy of further investigation," said co-author David Cohn, MD, director of the gynecologic oncology division at the OSU cancer center. “While these data are interesting, there is not yet enough data to make a public recommendation for or against taking NSAIDS to reduce the risk of cancer-related death."

Aspirin, ibuprofen and other NSAIDs are believed to lower the risk of some cancers by reducing inflammation, which slows the development of blood vessels that support the growth of cancer tumors. Inhibition of inflammation may have the opposite effect in endometrial cancer, but the reasons why are unclear.

Previous studies have shown that NSAIDs have a preventive effect on colorectal cancer and several other cancer types.

“Observational evidence of a chemopreventive effect of aspirin and other NSAIDs has been reported for esophageal, gastric, lung, breast, prostate, and colorectal cancer. Most of these cancers develop after age 60 years,”  researchers at the University of California Irvine reported in The Lancet.

“Given the apparent delay in the chemopreventive effect of NSAIDs (about 10 years), optimum treatment might start at age 40–50 years. Most individuals who develop premalignant lesions do so in their 50s and 60s, several years before the appearance of cancer, so this age range might be the best time for cancer prevention.”

Low-dose aspirin is also believed to have cardiovascular benefits. For that reason, the OSU researchers recommend that women keep taking the pain relievers.  

"It is important to remember that endometrial cancer patients are far more likely to die of cardiovascular disease than their cancer so women who take NSAIDs to reduce their risk of heart attack -- under the guidance of their physicians -- should continue doing so,” said Cohn.

New CDC Overdose Study Reduces Role of Pain Meds

By Pat Anson, Editor

The Centers for Disease Control and Prevention has quietly released a new report showing that illegal drugs like heroin, cocaine and fentanyl are responsible for more drug overdose deaths in the United States than opioid pain medication.

The report not only underscores the changing nature of the nation’s overdose epidemic, but undermines some of the rationale behind federal efforts to limit the prescribing of pain medication and public statements used to justify them.

In 2010, for example, the study found that oxycodone was the top drug involved in overdose deaths. But by 2014, the painkiller was ranked third, behind heroin and cocaine.

The anti-anxiety drug alprazolam, more widely known by the brand name Xanax, was ranked as the nation’s fourth deadliest drug; while the synthetic opioid fentanyl -- most of it probably illicit -- was ranked fifth and fast gaining ground.

Deaths linked to oxycodone and other prescription pain medications – although still significant, at about 16,000 a year -- remained relatively stable, even as the total number of drug overdoses increased by 23 percent, from 38,329 deaths in 2010 to 47,055 in 2014.

One of the CDC’s stated reasons for releasing its opioid prescribing guidelines earlier this year was that “the death rate associated with opioid pain medication has increased markedly,” a statement that now appears to be factually wrong, in light of the new study.

This online statement in a CDC analysis of overdoses also appears incorrect: "Prescription opioids continue to be involved in more overdose deaths than any other drug."

Both statements came from the CDC's National Center for Injury Prevention and Control. It was a different part of the agency, the CDC’s National Center for Health Statistics that arrived at this new evidence, after collaborating with the FDA in developing an enhanced method to study overdose deaths that allowed them to identify specific drugs.

The old method used by the CDC relies on death certificate codes, known as ICD codes, which can broadly categorize an overdose as “opioid related” without ever determining what the drug was, if it was legal, or even if it was the cause of death.

Using new software, researchers scanned the actual text in hundreds of thousands of death certificates, including notes written by coroners about the cause of death and other significant factors involved in an overdose.

“The literal text analysis method… leverages existing information on the death certificates for statistical monitoring of drug-involved mortality deaths. Assessments conducted during the methods development process demonstrate that these methods have high accuracy in identifying the drugs mentioned and involved in mortality as well as the corresponding deaths,” the researchers said in an analysis of the new method.

2014 OVERDOSE DEATHS BY DRUG

Source: CDC and FDA

The study, which covered overdoses from 2010 to 2014, found that many deaths involved multiple drugs or alcohol. Over three-quarters of the deaths involving oxycodone and hydrocodone, for example, involved other substances. Alcohol was involved in 15 percent of all drug overdoses. 

Anti-anxiety drugs like alprazolam (Xanax) and diazepam (Valium) were also involved in many deaths. Alprazolam was involved in about a quarter of the overdoses involving hydrocodone (26%), oxycodone (23%) and methadone (18%). The FDA recently expanded warning labels on all opioids and benzodiazepines, including alprazolam and diazepam, to discourage doctors from prescribing them together.

“The combinations of drugs in drug overdose deaths are important to consider when interpreting the study findings. Importantly, the most frequently mentioned drugs involved in drug overdose deaths were often mentioned with each other. For example, heroin and cocaine were involved concomitantly in more than 2,000 deaths. Another pair, oxycodone and alprazolam, were involved concomitantly in more than 1,000 deaths,” the report found. 

While the textual analysis of death certificates is an improvement over previous methods, researchers admit it still has flaws. It cannot distinguish between prescription fentanyl and illicit fentanyl; some deaths that refer to morphine may actually involve heroin; and some deaths classified as “unintentional” may have actually been suicides.  

It also cannot distinguish between the recreational use of a medication obtained illicitly and the medical use of a prescription by a legitimate patient.

Many pain sufferers believe they have been unfairly penalized by the CDC’s opioid prescribing guidelines as part of an effort to keep pain medication away from addicts and recreational users. Since the guidelines were released, many physicians have stopped prescribing opioids or sharply reduced the dosage, even if a patient has safely used the medication for years. 

Oddly, the CDC released this new study just a week after releasing its annual report on drug overdose deaths, which used the older, flawed method of analyzing overdoses.  Further adding to the confusion and questionable use of statistics, the White House Office of National Drug Control Policy and the CDC released three different estimates of the number of Americans that died of drug overdoses in 2015 (see “Opioid Overdose Statistics: As Clear as Mud”).  

Chronic Pain Patient Abandoned by Doctor Dies

By Pat Anson, Editor

This will be the first Christmas that Tammi Hale spends without her husband Doug in over 30 years.

The 53-year old Vermont man, who suffered chronic pain from interstitial cystitis, committed suicide in October after his doctor abruptly cut him off from opioid pain medication.

“His primary care provider kept trying to wean him off his opioid therapy, which worked at higher doses,” says Tammi. “My husband ran out (of medication) early a few times, so the doctor cut him off completely one day. Six weeks later he took his life as no medical establishment would treat his chronic pain.”

We’re telling Doug Hale’s story, as we have those of other pain patients who’ve committed suicide, because their deaths have been ignored or lost in the public debate over the nation’s so-called opioid epidemic.  Patients who were safely taking high doses of opioids for years are suddenly being cutoff or tapered to lower doses. Some are being abandoned by their doctors.

“I believe it will get worse with time. The docs are simply more interested in not risking their licenses than in treating chronic pain,” Tammi wrote to Pain News Network in a series of emails about her husband’s death.

Depression and suicidal thoughts are common for many people living with chronic pain and illness. According to a recent survey of over a thousand pain patients, nearly half have contemplated suicide.

DOUG HALE

But the problem appears to have grown worse as physicians comply with the “voluntary” prescribing guidelines released in March by the Centers for Disease Control and Prevention, which have been adopted as law in several states. Many doctors now fear prosecution and loss of their medical licenses if they overprescribe opioids. Some have chosen not to prescribe them at all.

While federal and state authorities track the number of drug overdose deaths, no one seems to be following the number of patients who are dying by suicide or from cascading medical problems caused by untreated chronic pain. Some in the pain community call this “passive genocide.” Tammi Hale compares it to the Holocaust.

“The Nazis eliminated the sick and the weak first, right? Makes you wonder,” she says. “I realize my comments are harsh, but I believe the public needs to be aware of the dangers any one of us could be facing with this silent epidemic.”  

Doctor Insisted on Weaning

Doug Hale began facing a life with intractable chronic pain in 1999, after a surgery left him with interstitial cystitis, a painful inflammation of the bladder. According to his wife, Doug tried physical therapy, antidepressants, epidurals, nerve blocks, TENS, cognitive behavioral therapy, and several different medications before finally turning to opioids for pain relief. High doses of methadone and oxycodone for breakthrough pain were found to be effective.

But a few years ago, Doug’s primary care provider (PCP) started urging him to wean to a lower dose.

“The PCP insisted on weaning. Although Doug clearly had documented malabsorption issues, the PCP persisted on weaning. The pressure to wean was unbelievable,” says Tammi.

“It came to a head in May of 2016. The PCP gave Doug one month to wean completely from 120mg/day of methadone and 20 mg/day of oxy. We knew this was impossible.”

Tammi says Doug checked himself into a 7 day detox program, where he was weaned to 40 mg of methadone a day. The doctor agreed to prescribe that amount, but it was not enough to relieve Doug’s pain. He started taking extra doses. 

“He ran out a week early in late August. The PCP abandoned Doug, stating ‘I'm not going to risk my license for you. The methadone clinic can deal with you.’” 

But the methadone clinic refused to treat Doug because they saw him as a chronic pain patient, not as an addict. “Had he turned to street drugs they could have treated him, but because he didn't break the rules they couldn't help,” Tammi explained.

Doug tried to detox at home, which Tammi calls a “brutal” experience. On October 10th, after being turned down by other healthcare providers, Doug went to his former doctor one last time to beg for help and was refused. The doctor said again that he didn’t want to risk his license.

“Doug left the office still thrashing in pain and despondent,” Tammi recalls. “The next day, my dear, sweet thoughtful husband of 32 years; a father, son, brother, uncle, and friend, well loved by many, dragged a chair to a remote spot in our back yard. A spot we could not see from the house, the road, or by the neighbors. 

“He shot himself in the head to escape his pain. He made sure we could still live in our home and not be plagued by gruesome memories. I just wish the medical establishment had an ounce of the compassion that he did.” 

“Can’t take the chronic pain anymore. No one except my wife has helped me. The doctors are mostly puppets trying to lower expenses.”

— Doug Hale

“Can’t take the chronic pain anymore. No one except my wife has helped me,” Doug wrote in a suicide note. “The doctors are mostly puppets trying to lower expenses, and (do not accept) any responsibility. Besides people will die and doctors have seen it all. So why help me.”

Tammi says she has been comforted by an outpouring of love and support from her family, friends and community. Doug’s suicide surprised many.

“Doug did make vague references about suicide during the summer due to the desperation and pain. He was just such a tough guy, he survived so much that my reaction, and others after the fact, was no. Not Doug. He's like the bionic man. Too much of a warrior to give up,” said Tammi.

“At his memorial so many people commented on what an inspiration he was to them. To graciously bear the path of pain and his never-give-up attitude made them reevaluate their own daily issues. I guess you could say his legacy was love and to never quit.”

Tammi consulted with a medical malpractice attorney after Doug's death, who told her the chances of winning a lawsuit against the doctor were slim. The cost of legal action would have also been prohibitive, after so many years of dealing with Doug’s medical expenses.

Tammi and Doug may never get their day in court, but she is determined to share his story in the hope that patients, doctors and regulators learn from it.

“My promise to him was to share with others. He was thrown away like a piece of trash, but his life and the life of all humans is precious.  All patients deserve to be treated respectfully,” she wrote. “Hopefully some changes will come in time before the holocaust grows too much larger.”  

An Open Letter to President-Elect Trump

By Percy Menzies, Guest Columnist

Dear President-Elect Trump,

You will soon have an extraordinary opportunity to save thousands of lives with one stroke of the pen! I am talking about reducing overdose deaths from opioid overdoses. How is this possible?

We have three highly effective medications for the treatment of opioid addiction, but they are grossly under-utilized, largely due to accessibility. Two of the three drugs used to treat opioid use disorder have restrictions that have no place when overdose deaths exceed 30,000 per year. These restrictions made sense at a different time, but these barriers are now inadvertently contributing to overdose deaths.

I am specifically talking about buprenorphine, the most widely used medication in the battle against the opioid epidemic. This medication, better known by its brand name Suboxone, is an opioid with a very safe profile. Its unique pharmacology makes it almost impossible to overdose.

There are barriers to the use of this medication which made sense 14 years ago, when heroin was not a public health issue, but today they are a hindrance to saving lives.

Buprenorphine is the only drug that requires physicians to complete eight hours of training and then apply to the Drug Enforcement Administration to obtain a special exemption to prescribe it. It gets worse. Physicians can only treat 30 patients with this medication in the first year, and then they must obtain permission from the DEA to increase the limit to 100 patients. The physician also has to keep clear records and can expect a visit from a DEA agent to look at the records. 

This is a major deterrent and way too few physicians have bothered to obtain the required exemption. Any physician who has a DEA license can prescribe an FDA-approved controlled substance without restriction, but they have to deal with this barrier to prescribe buprenorphine. 

These restrictions were put in place to prevent buprenorphine from joining the opioid “pill mills” when few anticipated heroin sweeping our cities and towns. At the present time, there is no strategy in place to cut off or curtail the supply of heroin, or heroin that is laced with super potent opioids like fentanyl. Deaths from prescription opioids are declining, while deaths from heroin and fentanyl are climbing. Indeed, prescriptions for opioids drugs have fallen between 12 -25%, but the overdoses deaths have not declined. 

Yes, buprenorphine is being diverted, but most experts believe that is due to the lack of treatment. Patients desperately seeking treatment are purchasing the drug on the streets. Many experts believe that if patients have expanded and easier access to buprenorphine, the diversion will drastically reduce and more patients will be in treatment and get away from heroin.

Several steps have been taken to address this catastrophic problem, but these steps are woefully inadequate. Expansion of the needle-exchange programs and the widespread distribution of the opioid overdose drug naloxone (better known by the brand name Narcan) are welcome and should be expanded, but they are at best palliative in nature. These measures do little to address the underlying addiction.

The federal government is increasing the patient limits for buprenorphine for selected specialists from 100 to 275, and will also allow nurse practitioners and physician assistants to complete the required training and obtain the DEA exemption to prescribe buprenorphine. These are welcome steps, but fall far short of the response required to expand treatment and reduce deaths. 

You got elected on a law-and-order platform and a promise to reduce the flow of heroin coming in from Mexico. Almost 50 years ago, Richard Nixon got elected on a similar platform.  He too faced an unprecedented public health epidemic of heroin addiction – one that is nowhere close to what we are facing today.  

President Nixon is remembered for taking a bold measure, which at that time was controversial. He initiated the opening of methadone clinics, which for the first time provided evidence-based treatment for heroin addicts. This measure reduced overdose deaths, protected society from criminal activity, and allowed these patients to become productive members of society.  For the first time in the dark and checkered history of our nation, addiction was treated as a chronic healthcare issue and not a criminal activity. 

Nixon went a step further to curb the supply of heroin coming into this country. He put political pressure on France to shut down the illegal labs processing Turkish-grown opium into heroin. Turkey also complied with the strong U.S. demand to curb the illegal cultivation of opium. Who can forget The French Connection, the thriller movie about this operation.

Mr. Trump, you have an extraordinary opportunity to lift the present restrictions on buprenorphine through executive order, to lure patients away from heroin and drastically reduce overdose deaths. Your action would provide increased treatment and not just palliative care.

Furthermore, you are in the best position to bring pressure on Mexico to eliminate the opium processing labs and drastically reduce heroin coming into this country.  An epidemic is best treated when effective treatment is combined with eliminating factors contributing to the spread of the epidemic. In this case, it is the supply of heroin.

This one single action will earn you the gratitude of tens of thousands of families terrified at hearing a knock on the door informing them of the death of a loved one. You will also earn the gratitude of millions of patients suffering from chronic pain, who have been needlessly cut off from prescription opioids because of the overreaction of regulators and many physicians.

You will be remembered in history for a bold action that saved a generation from succumbing to a man-made epidemic.

Percy Menzies, M. Pharm, is the president of the Assisted Recovery Centers of America, a treatment center based in St Louis, Missouri.

He can be reached at: percymenzies@arcamidwest.com

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Opioid Overdose Statistics: As Clear as Mud

By Pat Anson, Editor

We’ve written before about how confusing and muddied the statistics can be for overdose deaths from opioid pain medication. (see “Lies, Damned Lies, and Overdose Statistics”). Now the White House and the Centers for Disease Control and Prevention are adding to the confusion.

Last week a news release from the White House Office of National Drug Control Policy stated that 17,536 Americans died in 2015 from overdoses involving prescription opioids, a 4% increase from the year before.

This week the CDC reported in its Morbidity and Mortality Weekly Report that the number of overdoses involving painkillers was actually smaller.

“Natural opioids (including morphine and codeine) and semi-synthetic opioids (including commonly prescribed pain medications such as oxycodone and hydrocodone) were involved in more than 12,700 deaths in 2015,” a CDC news release said. The agency said that was a 2.6% increase from the year before.

We asked the CDC to explain the discrepancy and were given a third number

“Given the recent surge in illegally-made fentanyl, the CDC Injury Center is analyzing synthetic opioids (other than methadone) separately from other prescription opioids (natural, semi-synthetic, and methadone). Using this approach, the number of deaths involving prescription opioids was… 15,281 in 2015,” CDC spokesperson Courtney Leland said in an email.

“This number better reflects the deaths associated with prescription opioids given the changing nature of the epidemic and increasing surge of illicit opioids.”

And what about the White House estimate?

“Their analysis of 17,536 deaths in 2015 was calculated by including any death that involved: opium; natural and semi-synthetic opioids; methadone; and unspecified narcotics (opioids). You would need to check with them about their rationale/methodology,” Leland explained.

In other words, the White House Office of National Drug Control Policy knowingly counted a number of overdoses caused by illicit opioids as prescription drug deaths.

All of these numbers may make your eyes glaze over, but they demonstrate an important point about the nation’s so-called opioid epidemic: No one really knows how bad it is.  Which is startling, because it’s an important national issue and Congress just voted to spend another $1 billion to fight it.

They may want to get their numbers straight first.

One thing the White House and the CDC do agree on is that overdoses from illegal opioids such as heroin and fentanyl are soaring, and deaths involving opioid pain medication appear to be leveling off.

The CDC reported many troubling statistics about opioid overdoses, which claimed over 33,000 lives last year:  

• Death rates nationwide from synthetic opioids such as fentanyl increased by over 72%
• Death rates from synthetic opioids more than doubled in New York (136%), Connecticut (126%) and Illinois (120%).
• Heroin death rates nationwide increased by nearly 21%
• Deaths rates from heroin jumped even more in South Carolina (57%), North Carolina (46%), and Tennessee (44%).

Perhaps the only bright spot was that deaths associated with methadone dropped by 9 percent, which the CDC attributed to lower methadone doses and less prescribing.

The agency still believes there is an “ongoing problem with prescription opioids” and that the number of overdoses may be undercounted.  

“Regardless of the analysis strategy used, prescription opioids continue to be involved in more overdose deaths than any other drug, and all the numbers are likely to underestimate the true burden given the large proportion of overdose deaths where the type of drug is not listed on the death certificate,” the CDC explains in a separate report.

Questionable Data

The CDC continues to rely on death certificate codes for much of its data, which many experts find troubling because the codes do not reflect the cause of death --- only the conditions that exist at the time of death.  In other words, somebody could die from lung cancer, but if a doctor used morphine to help ease the dying patient’s cancer pain, a box could be checked on their death certificate indicating opioids were present at the time of death. The CDC would consider that an “opioid involved” death.

Other factors that raise questions about the reliability of the CDC’s data:

• Overdose deaths were based on data from only 28 states “with high quality reporting”
• Wide variability in the expertise and training of local medical examiners and coroners who complete death certificates
• Nearly 1 out of 5 death certificates nationwide do not include any drug data
• Some heroin deaths may have been misclassified as prescription drug deaths
• Some overdose deaths may have been counted twice.

Critics also say there is a disturbing tendency by the CDC to “cherry pick” data to dramatize the harm caused by prescription opioids, without ever discussing their benefits. For example, the agency referred to a recent report from the DEA this way:

“The Drug Enforcement Administration referred to prescription drugs, heroin, and fentanyl as the most significant drug-related threats to the United States. The misuse of prescription opioids is intertwined with that of illicit opioids; data have demonstrated that nonmedical use of prescription opioids is a significant risk factor for heroin use, underscoring the need for continued prevention efforts around prescription opioids.”

The CDC does not mention that the DEA also found that the prescribing and abuse of opioid pain medication is actually in decline, that the number of admissions to treatment centers for painkiller addiction is falling, and that less than 1% of prescription opioids are diverted. Nor does the CDC mention that the DEA found a “massive surge” in the production of counterfeit pain medication made with illicit fentanyl, which is probably killing quite a few patients seeking pain relief.  

The CDC cites its own research to make the claim that it “did not find evidence that efforts to reduce opioid prescribing were leading to heroin overdoses.” But the DEA report said just the opposite: Some prescription opioid users are switching to heroin when they are no longer able to obtain medication:

“Some abusers, when unable to obtain or afford CPDs (controlled prescription drugs), begin using heroin, a cheaper alternative that offers similar physiological effects. With the successful reduction in availability of controlled prescription drugs, more users may shift to abusing heroin.”

This isn’t the first time the CDC has been accused of cherry picking data for public consumption. The same complaint arose when the agency released its opioid prescribing guidelines, many of which relied on “weak” or “very weak” evidence to support the contention that opioids should not be prescribed for chronic pain.

Recent research published in the journal Pain Medicine also took the agency to task for dismissing evidence that opioids could be used safely long term, while making no mention of the significant risks posed by non-opioid pain medication.

“No common nonopioid treatment for chronic pain has been studied in aggregate over longer intervals of active treatment than opioids. To dismiss trials as ‘inadequate’ if their observation period is a year or less is inconsistent with current regulatory standards,” wrote lead author Daniel Carr, MD, President of the American Academy of Pain Medicine and Program Director of Pain, Research, Education & Policy at Tufts University School of Medicine.  

“Basing therapeutic decision-making upon durations of published clinical efficacy or effectiveness trials does not support choosing any drug or nondrug therapy over another. In fact, the opening words of the first recommendation of the CDC… make no mention of the overwhelmingly strong evidence for significant morbidity and mortality risk from the most likely nonopioid alternatives to opioid therapy for chronic pain: NSAIDs, coxibs (cox-2 inhibitors), and acetaminophen.”

Although the CDC guidelines are “voluntary” and only intended for primary care physicians, many patients have reported that their chronic pain is going untreated or under-treated because they are no longer able to obtain opioids or their doses have been drastically lowered by their physicians. Other patients have been abruptly “fired” by doctors who no longer want to treat chronic pain because they fear prosecution for overprescribing opioids. Still other patients are contemplating or have committed suicide.

Where are the statistics about that?

FDA Designates CRPS Drug as ‘Breakthrough Therapy’

By Pat Anson, Editor

The U.S. Food and Drug Administration has designated an experimental drug as a potential breakthrough therapy for Complex Regional Pain Syndrome (CRPS), a chronic and disabling neurological disease for which there is no cure or treatment.

Neridronic acid was discovered by Abiogen Pharma, an Italian drug maker, and is jointly being developed with Grünenthal, a German pharmaceutical company.

The Breakthrough Therapy designation by the FDA came after the companies reported the results of a Phase II clinical trial showing a significant reduction in pain and symptoms of CRPS with neridronic acid treatment. The drug has already received fast track and orphan drug designations from the FDA.

The agency considers a new drug as a breakthrough therapy if it is intended to treat a serious condition and if preliminary clinical evidence demonstrates substantial improvement over current treatments. There are no current FDA approved treatments for CRPS, which is also known as Reflex Sympathetic Dystrophy (RSD).

"It is very encouraging to see that the FDA recognizes the urgent need for new treatments for patients with CRPS and has granted neridronic acid the status of a Breakthrough Therapy. This supports our efforts to develop an efficacious treatment option to these patients,” said Klaus-Dieter Langner, MD, Chief Scientific Officer of Grünenthal. “We are committed to working closely with the FDA to bring neridronic acid to patients with CRPS as fast as possible.”

In the Phase II study, neridronic acid or a placebo was administered intravenously to 464 patients with CRPS type 1, when the disease is in its early stages. The study ended in November.  

A previous study of 82 CRPS patients in Italy found that those who were treated with infusions of neridronic acid experienced significant and persistent reductions in pain.

Neridronic acid is currently being evaluated in a Phase III clinical trial. If successful, the drug could be the first FDA-approved treatment for CRPS, which is characterized by severe, burning pain that usually begins in the arms or legs after an injury or surgery. The pain often spreads throughout the body.

"Grünenthal is highly dedicated to improving the lives of patients with pain as well as rare diseases with limited treatment options. This is an area of high unmet medical need,” Gabriel Baertschi, CEO of the Grünenthal.

The company recently purchased Thar Pharmaceuticals, which is developing an oral form of zoledronic acid for the treatment of CRPS. That drug is also undergoing a Phase III study.

Neridronic acid is an investigational aminobisphosphonate. According to the Reflex Sympathetic Dystrophy Syndrome Association (RSDSA), bisphosphonates have been used for years overseas to treat CRPS.

“We need options and if this can help patients and encourage other medications and treatment options to come onto the market for CRPS’ers, it’s a great thing,” said Barby Ingle, who suffers from CRPS/RSD and is President of the International Pain Foundation.

“We saw with fibromyalgia and Lyrica that once it (fibromyalgia) had a medication designated it gained more awareness and acceptance in society, leading to better access to care. The same could happen with a CRPS designation for a medication, leading to greater treatments and a cure in the future.”

Pain Relievers Linked to Hearing Loss in Women

By Pat Anson, Editor

Long-term use of acetaminophen and ibuprofen raises the risk of hearing loss in older women, according to a new study published in the American Journal of Epidemiology.

Researchers at Brigham and Women’s Hospital in Boston analyzed data from over 55,000 women between the ages of 48 and 73 enrolled in the Nurses’ Health Study, a long-term study that began in 1976.

They found that about 1 in 6 women who used ibuprofen or acetaminophen for at least six years suffered some degree of hearing loss. No such link was found in the women who used regular doses of aspirin.

“Although the magnitude of higher risk of hearing loss with analgesic use was modest, given how commonly these medications are used, even a small increase in risk could have important health implications,” said senior author Gary Curhan, MD, a physician in the Channing Division of Network Medicine at Brigham and Women’s Hospital.

“Assuming causality, this would mean that approximately 16.2 percent of hearing loss occurring in these women could be due to ibuprofen or acetaminophen use.”

Curhan noted the study was limited to mostly older, white women participating in the Nurses’ Health Study and that further investigation with larger and more diverse populations would be needed to better understand the connection between hearing loss and pain reliever use.

The researchers have previously published findings that indicate high frequency use of non-steroidal anti-inflammatory drugs (NSAIDS) and acetaminophen is associated with hearing loss in men and younger women. High doses of aspirin have also been associated with hearing loss.

The new study did not look at why the medications affect hearing, but previous research suggests the pain relievers affect blood and oxygen flow to sensitive parts of the ear that may compromise hearing.

About two- thirds of women in the U.S. over the age of 60 report some degree of hearing loss.

“Hearing loss is extremely common in the United States and can have a profound impact on quality of life,” said Curhan. “Finding modifiable risk factors could help us identify ways to lower risk before hearing loss begins and slow progression in those with hearing loss.”

Many people wrongly believe that over-the-counter pain relievers are relatively safe because they are available without a prescription. But studies have linked NSAIDs and acetaminophen to cardiovascular disease, hypertension, kidney problems and liver failure.

“I worry that people think NSAIDs and acetaminophen are completely safe, and that they don’t need to think about their potential (side effects),” Curhan told Time.  “But particularly for people who are taking them for chronic pain, I try to encourage them to look at why they are having the pain, not what they can take to try to treat the pain.”