Drug Tests Scare Off Some Chronic Pain Patients

By Pat Anson, Editor

Urine drug testing has become standard protocol for many patients who are prescribed opioid pain medication. But a new study suggests the practice may be counterproductive, because it increases the odds a patient won’t come back for further treatment.

In a study involving 723 chronic pain patients being treated at a pain clinic, researchers at the University of Houston and the University of Texas Medical Branch at Galveston found that nearly a quarter (23.75%) who were given a urine drug screen on their first visit failed to show up for the next appointment. 

The odds were even higher for those who tested positive for an illicit drug, but the “no show” trend also applied to patients whose drug tests were negative.

“Even those who tested negative for illicit substances in the UDS (urine drug screen) were more likely to be no-shows compared to those who did not get tested. This raises concerns that the UDS administered early in the doctor-patient relationship might have an inadvertent impact on injuring patient expectations of trust,” the researchers reported in the journal Pain Physician.

Only about 10% of those who weren’t tested skipped their follow-up appointment.

“It is a balancing act,” said Partha Krishnamurthy, director of the Institute for Health Care Marketing at the University of Houston’s Bauer College of Business. “On one hand, concerns about patient safety and public health necessitate the monitoring of patients on opioid medications. On the other hand, aggressive monitoring may interfere with the therapeutic alliance.”

Routine use of urine drug tests is one of the main recommendations in the CDC’s draft guidance for opioid prescribing, which calls for primary care physicians to “use urine drug testing before starting opioid therapy and consider urine drug testing at least annually.”

The scientific research behind that recommendation is considered weak, as is much of the evidence that standard “point of care” urine drug tests are reliable or accurate.

“I've only been saying that UDT (urine drug tests) harms patients and the patient/provider relationship for the past seven years and not a single physician, researcher, or healthcare provider of any kind supported my position.  I guess common sense wasn't enough but now we have evidence,” said Mark Collen, an independent scholar and patient advocate. 

“As I've stated previously in regards to UDT, the entire pain community will end up on the wrong side of history and it looks like that's beginning to occur.”     

Researchers say one possible solution to the high-rate of patient “no shows” is for doctors to delay drug screening of new patients until they’ve had a chance to develop rapport and trust with them.

“Not testing is not an option,” the researchers said, while at the same time warning that routine testing may only make prescription drug abuse worse.

“If the patients are disengaging from the clinic, where are they going? Is the illicit market place their next stop? Thus, while UDS may induce the problematic patients to go away from the clinic, the problem of opioid misuse may continue to persist.”

FDA Endorses CDC Opioid Guidelines

By Pat Anson, Editor

In a move that may have more to do with politics than healthcare, the U.S. Food and Drug Administration has set aside the advice of its own experts by endorsing the CDC’s controversial guidelines for opioid prescribing.

The move is part of several sweeping changes the FDA is making in its opioid policies, including some that the agency has resisted in the past. The most significant change is support for the CDC’s proposed opioid guidelines, which are designed to combat the so-called epidemic of opioid addiction and overdoses.

“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” said Dr. Robert Califf, FDA Deputy Commissioner for Medical Products and Tobacco.

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse, and dependence. It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”

Califf’s nomination to be the next Commissioner of the FDA has been held up in the U.S. Senate, in large part by senators who want the FDA to go much further than it has in restricting access to opioid pain medication.  

ROBERT CALIFF, MD

“We need to change the culture of the FDA, and that will not happen if the person at the helm is not a champion who is committed to pushing back against the pressure to continually approve new opioid medications given the significant risks to public health,” said West Virginia Sen. Joe Manchin (D), who has criticized Califf for his ties to the pharmaceutical industry and threatened to filibuster his nomination.

In a news release issued late Thursday, Califf said FDA would “re-examine the risk-benefit paradigm for opioids,” use tougher language in warning labels on extended release opioids, and prioritize development of non-opioid alternatives for pain.  The FDA also promised to convene an expert advisory committee before approving any new drug applications for opioids that do not have abuse deterrent properties, one of Manchin's key demands.   

“I was very disappointed that Califf would release a statement like this as talk of blocking his nomination for FDA Commissioner grows in the Senate amid concerns that he was ‘soft’ on a range of issues, including genetically modified salmon, e-cigarettes, and regulation of opioids,” said Anne Fuqua, a chronic pain sufferer and patient advocate.

“I am concerned his desire for career advancement is interfering with the oath he took to ‘first do no harm’ when he became a physician.  This statement is heavily focused on the potential harms of opioids. Though it says they will seek to balance individual and societal risks, it seems that the need to prevent people from making poor choices will be given priority over providing care to individual pain sufferers for whom opioid therapy has proven to be an essential element of care. “

The FDA’s opioid policy changes are further outlined in a “special report” in the New England Journal of Medicine that was co-authored by Califf.

“We will start by launching a broad reexamination of our approach, considering how best to apply existing policies to this problem, which policies need to be improved and updated, and whether new policies must be developed,” Califf wrote.

“Accordingly, we are supporting the CDC’s Guideline for Prescribing Opioids for Chronic Pain. The draft guideline received extensive public comment, and we look forward to participating in the process when the CDC finalizes it soon. We are also supporting the Surgeon General’s efforts to engage the clinical community in a concerted approach to curbing inappropriate prescribing and proactively treating opioid addiction, while reinforcing evidence-based approaches to treating pain in a manner that spares the use of opioids. Until clinicians stop prescribing opioids far in excess of clinical need, this crisis will continue unabated.”

Some of the FDA’s own experts have been highly critical of the CDC’s proposed guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. As many as 11 million Americans use opioids daily for chronic pain and many fear losing access to them if the guidelines are adopted.

“I think we need to recognize that CDC wants to substantially limit opioid prescribing. Period,” said Sharon Hertz, director of the FDA’s Division of Anesthesia, Analgesia and Addiction Products, at a December meeting of a federal pain research panel. Hertz said the evidence cited to support the guidelines was “low to very low and that’s a problem.” Other panel members said they were “appalled” by the guidelines, calling them an “embarrassment to the government.”

The CDC planned to implement the guidelines last month, but delayed doing so after widespread complaints about its secrecy and lack of transparency during the guidelines' development. The CDC is now reviewing changes to the guidelines recommended by an advisory committee.

“I guess it shouldn't surprise me that the FDA is selling out by endorsing the CDC guidelines,” said Kim Miller, a pain sufferer and patient activist. “Could it be the FDA was not wanting to be made to look irrelevant in light of the CDC taking care of what many see as the FDA’s territory? Either way, it's an extremely gloomy looking horizon if you're a pain patient. Just when you think it can't get any worse, it always does.”

"It is a sad day for chronic pain patients in this country. The unintended consequences of these guidelines will bring about a true epidemic; not the media manufactured so-called epidemic of overdoses from opioids," said Chrystal Weaver, a Florida woman who suffers from Complex Regional Pain Syndrome. "The last figure I heard quoted for veterans taking their life is around 42 per day. When you take away the only tool we have to help lessen the pain from war injuries you'll see that number skyrocket from 42 per day to perhaps 500 per day. It will be the same story for non-veterans as well."

Earlier this week, the Obama administration said it would ask Congress for $1.1 billion in extra funding to help fight the opioid abuse epidemic. Most of the money would be used on expanding addiction treatment programs.

Will ‘Secret Deliberations’ Lead to Lawsuit Against CDC?

By Pat Anson, Editor

The Washington Legal Foundation is “keeping its options open” on a potential lawsuit to block the Centers for Disease Control and Prevention (CDC) from implementing its controversial guidelines for opioid prescribing. At issue is whether the CDC violated the Federal Advisory Committee Act (FACA) by developing the guidelines in secret and with little public input.

The CDC contends the guidelines are urgently needed to stop the so-called epidemic of opioid addiction and overdoses, while millions of chronic pain patients fear they will lose access to opioids if the guidelines are adopted.

Last week a “workgroup” appointed by the CDC recommended to the agency’s Board of Scientific Counselors (BSC) that the guidelines by adopted with few changes. The 10-member workgroup spent only three weeks reviewing a dozen complex guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. The panel met four times during that period and all of its meetings were closed to the public.

“Why is CDC so afraid of transparency here? That’s my question,” asked Mark Chenoweth, general counsel to the Washington Legal Foundation (WLF), a pro-business group that has threatened to sue the agency for its “culture of secrecy” and “blatant violations” of FACA.

FACA clearly states that “each advisory committee meeting shall be open to the public,” as well as any records, reports, minutes or other documents provided to or created by the committee.

The CDC has taken the position that the BSC is an advisory committee, but the workgroup is not.

“The BSC charged the workgroup with developing a report of its observations on the draft guideline and its underlying evidence,” said CDC spokesperson Courtney Leland. “Under FACA, the time for public input is when the BSC meets to deliberate on the work prepared by the workgroup.  This meeting, held on January 28, was a public meeting announced in the Federal Register, and included a public comment period.“

But the WLF’s legal team disputes that interpretation of the law.

“I don’t see why you can provide input to the government through secret deliberations simply because you’re providing your advice to an advisory committee rather than to the government itself. The whole point of the law is to make sure that advice that comes to the government and is relied on by government is a product of open deliberations,” said WLF chief counsel Richard Samp, who believes the guidelines were quickly reviewed to prevent any further delays in their implementation.  

The CDC planned to adopt the guidelines in January, but was forced to delay them after widespread criticism about its secrecy and lack of transparency during the guidelines' development.

“They want this to go on quickly. Obviously their existing advisory committee doesn’t have the expertise on its own, so it had to go outside of its ranks to do it,” said Samp. “But it realized that if the group was going to meet four or five times, it was going to drag on for months. And so the only way to do it quickly was to do what they have done.”

“If one wanted to test the legality of this sort of working group workaround on FACA, this is an excellent fact pattern on which to test it,” said Chenowith.

Asked by Pain News Network if the WLF would go to court before or after the guidelines are implemented, Chenowith and Samp were non-committal, but hinted they were prepared to take action in federal court in Atlanta, where the CDC is based.

“It never does any good to wait until final agency action. By that time people have really suffered some severe damage,” said Samp. “I assume one’s interest in these sort of cases is to prevent the agency from adopting guidelines and that’s why you sue early to try to prevent them from taking into account the recommendations before they make their final decision. One could easily file that in federal district court in Atlanta if one wanted to.”

WLF has a lengthy history of taking the government to court for regulations and laws effecting free speech, the environment, health care, and drugs. WLF describes itself as a public interest law firm “that regularly litigates to ensure that federal administrative agencies comply with statutes designed to ensure procedural fairness.” It often supports business groups and companies in litigation against  government agencies, and has represented or acted in behalf of pharmaceutical companies such as Johnson & Johnson and Purdue Pharma, the maker of OxyContin. 

"We’re long-standing supporters of WLF, in addition to several other business and legal organizations. We’ve provided them with unrestricted grants," a spokesman for Purdue Pharma told Pain News Network.

That connection to a major opioid producer has led to insinuations that WLF and other organizations that accept funding from the so-called “opioid lobby” are somehow tainted. That charge is often made by Physicians for Responsible Opioid Prescribing (PROP), which supports the guidelines and had some of its board members on CDC committees that helped draft them.

A recent story by the Associated Press pointed out that nearly a third of the members of the Interagency Pain Research Coordinating Committee have financial connections to opioid makers. That same committee criticized the CDC for developing the opioid guidelines with little scientific evidence to support them.

“The apparent conflicts of interest on the panel underscore the pervasive reach of pharmaceutical-industry dollars, even among federal advisers who are supposed to be carefully vetted for such connections before serving,” the AP story said.

The article failed to point out that some of the committee members most critical of the CDC are federal employees of the Food and Drug Administration and the Agency for Healthcare Research and Quality (AHRQ), who as government workers are not allowed to accept financial contributions.

“I would be remiss and I’m certain so would many of my government colleagues if I didn’t go back to my director and say there’s a report coming out of the CDC that has very low quality of evidence,” said Richard Ricciardi, AHRQ, during a December meeting. “That’s an embarrassment to the government.”

The AP story also didn’t mention that the CDC itself has a foundation that accepts funding from healthcare companies such as Abbott Laboratories, Amgen, Medtronic, Johnson & Johnson, Merck, Quest Diagnostics and Pfizer, some of which stand to benefit from stricter opioid guidelines because they offer non-opioid treatments for chronic pain. The CDC Foundation accepted over $157 million from donors last year.  

Lyrica and Neurontin Face UK Restrictions

By Pat Anson, Editor

Two drugs often recommended as safer alternatives to opioid pain medication could face new restrictions in the UK because of increasing reports they are being abused.  

British health officials say the prescription drugs pregabalin and gabapentin, which are sold by Pfizer under the brand names Lyrica and Neurontin, are being used by drug abusers to get high, resulting in dozens of overdose deaths.

Since 2012, at least 38 deaths involving pregabalin and 26 involving gabapentin have been reported in the UK.

The prescribing of pregabalin and gabapentin in the UK has soared by 350% and 150%, respectively, in the last five years.  Both medications are anti-seizure drugs widely prescribed to treat epilepsy, neuropathy, fibromyalgia and anxiety.

The UK Advisory Council on the Misuse of Drugs (ACMD) is recommending that gabapentin (Neurontin) and pregabalin (Lyrica) be reclassified as Class C controlled substances – which would mean prescriptions would only be valid for one month and there can be no refills.

“Both pregabalin and gabapentin are increasingly being reported as possessing a potential for misuse. When used in combination with other depressants, they can cause drowsiness, sedation, respiratory failure and death,” said Professor Les Iverson, ACMD chairman, in a letter to Home Office ministers.

“Pregabalin may have a higher abuse potential than gabapentin due to its rapid absorption and faster onset of action and higher potency. Pregabalin causes a ‘high’ or elevated mood in users; the side effects may include chest pain, wheezing, vision changes and less commonly, hallucinations. Gabapentin can produce feelings of relaxation, calmness and euphoria. Some users have reported that the ‘high’ from snorted gabapentin can be similar to taking a stimulant.”

The letter warns there is a risk of addiction for both drugs, as well as misuse and diversion.

“The use of gabapentin and pregabalin by the opioid abusing population either together or when opioids are unavailable reinforces the behavior patterns of this high-risk population. There is a high risk of criminal behavior stimulated by the wish to obtain gabapentin and pregabalin,” said Iverson.

Lyrica is Pfizer’s top selling drug and generates worldwide sales of over $5 billion annually. Pfizer said the recommendation to reclassify the drugs and limit their prescribing could be harmful to patients.

“We are concerned that the advice contains a number of inaccuracies and some potentially misleading information, and is contrary to the totality of the safety data available for pregabalin and gabapentin,” the company said in a statement reported on the Pulse website. “Controlling the supply of these products across the whole UK, would be a disproportionate measure that would impact on patients and their quality of life, and could also result in additional economic and operational burden on an already strained healthcare system.”

Earlier this month a study of 440 drug abusers in Ireland found that 39 tested positive for pregabalin in their urine. Only ten of them had been prescribed the drug. Other drugs detected in pregabalin positive patients were opiates, cocaine, benzodiazepine and cannabis, according to the Irish Examiner.

The study called the abuse of pregabalin a “serious emerging issue.” Recreational users of pregabalin in Belfast call the drug “Budweisers” because it induces a state similar to drunkenness.

Neurontin (gabapentin) is approved by the FDA to treat epilepsy and neuropathic pain, but is widely prescribed “off-label” for a variety of other conditions, including depression, migraines, fibromyalgia and bipolar disorder. In 1999 a Pfizer executive was so mystified by Neurontin’s growing use he called it the “snake oil of the twentieth century.”  

Committees Support CDC Opioid Guidelines

By Pat Anson, Editor

Two advisory committees expressed broad support Thursday for the controversial guidelines for opioid prescribing being developed by the Centers for Disease Control and Prevention (CDC). Those guidelines discourage primary care physicians from prescribing opioids for chronic non-cancer pain and recommend other therapies such as over-the-counter pain relievers, acupuncture, and cognitive behavioral therapy.

One newly formed committee --- which the CDC calls a “workgroup” --- did express “significant concern” about the cost of those alternative pain therapies and whether they are covered by insurance. The workgroup's report to the CDC’s Board of Scientific Counselors (BSC) also suggested that the guidelines be “framed with positive rather than negative language” that supports “integrated care for people with chronic pain.” It also recommends the impact of the guidelines be monitored for “unintended consequences” after they are implemented. 

The BSC voted to support the workgroup’s report, which can be found here.

“The BSC voted unanimously: to support the observations made by the BSC Opioid Guideline Workgroup; that CDC adopt the guideline recommendations that, according to the workgroup’s observations, had unanimous or majority support; and that CDC further consider the guideline recommendations for which the workgroup had mixed opinions,” said CDC spokesperson Courtney Leland in an email to Pain News Network.

“CDC is taking the BSC’s recommendations, as well as comments received from the public, into consideration in revising the guideline. The guideline is a priority for our agency. Given the lives lost and impacted every day, we have an acute sense of urgency to issue guidance quickly.”

The CDC planned to implement the guidelines this month with little public input, but was forced to change course after widespread criticism about its secrecy and lack of transparency during the drafting of the guidelines. In response to critics, the 10-member workgroup was formed three weeks ago and met four times by teleconference to review the guidelines. A potential legal problem for the CDC is that none of the workgroup’s meetings were open to the public. The workgroup also reviewed the guidelines with outside consultants without publicly disclosing who they were.

The Washington Legal Foundation (WLF) has threatened to sue the agency for its “culture of secrecy” and “blatant violations” of the Federal Advisory Committee Act (FACA), which requires meetings to be open to the public.

Over 4,300 online comments were received by CDC during a public comment period that ended earlier this month. Many opposed the guidelines as being too restrictive, while others wished the guidelines were stronger to combat the so-called epidemic of opioid abuse and overdoses.  There were passionate arguments on both sides, but in the end the workgroup decided that the case for the guidelines was stronger.

“Comments from patients and family members, in particular, expressed the desire that patient-centered care is enhanced rather reduced by these Guidelines. Members felt that the guidelines could be implemented in a manner consistent with patient centered care,” the workgroup said in its report.

As many as 11 million Americans use opioids for long-term chronic pain and many fear losing access to the drugs if the guidelines are adopted.

“The purpose of the guideline is to help to primary care providers offer safer, more effective care for patients with chronic pain and to help reduce opioid abuse disorder and overdose from these drugs,” said Debra Houry, MD, director of the CDC’s National Center for Injury Prevention and Control, which is overseeing development of the guidelines.

"The guideline itself is not a rule, regulation or law. It is not intended to deny access to opioid pain medication as an option in pain management. It is not intended to take away physician discretion and decision making.”

“Pain specialists and their patients fear the Guidelines will not be used that way though and adoption by boards, professional organizations, and insurers will pressure even specialty pain providers to taper patients,” said Anne Fuqua, a chronic pain sufferer and patient advocate. “Pain patients nationwide have been experiencing dose reductions and losing access to care altogether for several years, with the situation becoming more acute in the past year.  In an environment where physicians are tapering patient doses or ceasing opioid prescribing altogether, I feel these guidelines will serve like an accelerant in a growing fire.”

Although the CDC has said it doesn’t want the guidelines implemented until they are finalized, Fuqua said many doctors are already doing just that. She said her faith in democracy “took a swift kick in the teeth” as she listened to the workgroup’s presentation during a conference call. Fuqua was not given an opportunity to speak, although the president and founder of Physicians for Responsible Opioids Prescribing (PROP) were given time to address the BSC in support of the guidelines they helped draft.

“There were 28 comments supporting the Guidelines and 4 dissenters. One physician made statements partially supportive of our needs. CDC will no doubt use this ‘overwhelming support’ to justify adoption of the guidelines. I fear they see us as simply a casualty of war, much like those with tuberculosis who were quarantined to prevent disease spread. The only difference is that harming us doesn't save other lives,” she said.

CDC has not released a timetable on when it plans to finalize or implement the guidelines.

#PatientsNotAddicts Campaign Launched on Twitter

By Ken McKim, Guest Columnist

There’s a hashtag coming to a screen near you: #PatientsNotAddicts. Its importance to the millions of people who suffer from chronic illness cannot be overstated.

Words matter. Words are powerful. They can educate, but they can also blind. They can sway the opinions of millions of otherwise thoughtful and intelligent people through nothing more than simple repetition, even if the information they repeat is patently false.

In a 1992 study by McMaster University researchers, it was shown that people give more weight to something they hear repeated over and over again, than something they have only heard once. People will do this even if the person repeating the information has proven untrustworthy in the past on multiple occasions. Repeat it often enough, and a lie becomes the truth.

We see this all the time in life. It’s why advertising exists, and why politicians will never completely stop using negative campaign ads. Its how one discredited doctor was able to scare the daylights out of millions of Americans about the so-called dangers of vaccines, thus leading to a resurgence of diseases that had previously been all but eradicated, like measles and whooping cough.

This same tactic is now being used against medications that give relief to millions of people who are fighting cancer and chronic illness: opioid-based painkillers.

There’s no better way to ascertain public opinion on a subject than by Googling it. In this modern century of seemingly unlimited information, Google serves as society's mirror, reflecting back to us the truth of how we feel about any given subject. It’s not hyperbole to say that as Google goes so does the world, and this is especially true when it comes to the subject of opioids.

A recent search of Google using just the word “opioids” found that 50% of the search results had to do with addiction and abuse. Only 4% of the results dealt solely with the proper use of opioid pain medication.

It’s plain to see that media coverage on the subject of opioids skews overwhelmingly negative, and the average person researching the topic will come away with an equally negative (and unknowingly distorted) opinion of them.

It’s this negative societal view that the CDC was probably counting on to divert attention from their covert attempt to issue new prescribing guidelines to severely limit the prescribing of opioids. The webinar they held on the subject last September was an invitation only affair. No press releases were issued, and the period of time allotted for public comment was a paltry 48 hours (which was laughable considering most of the public had no idea this was taking place). 

If not for the vocal pushback from the chronic illness community and organizations like the Washington Legal Foundation, these new guidelines would already be a fact of life for all United States citizens. Sadly, these guidelines are now the law of the land for our wounded veterans, as part of the $1.1 trillion spending bill passed and signed into law by President Obama last December.

Taking opioids for pain does not automatically turn you into an addict, any more than eating M&Ms turns you into chocolate.

Chronic illness may be invisible, but the chronically ill can no longer afford to be. That’s why #PatientsNotAddicts is important. Words are powerful and repetition can be a tool for the truth as well as for lies.

Using this hashtag can help remind everyone that pain patients are ordinary people. They are your loved ones, friends, neighbors and co-workers. What they want more than anything (except for a cure, of course) is to recapture just a small piece of the life they had before their illness took hold, before the never-ending pain of their condition destroyed the lives they had built for themselves -- lives that included careers, birthday parties, graduations, playing with their kids and being intimate with their spouses or significant others.

For hundreds of millions of people, opioids help them do just that. To deprive them of that small ray of hope in the name of “protecting them” is nothing short of inhumane.  I believe we are better than that, America. Prove me right.

Ken McKim is an advocate for anyone with a chronic illness, and has made more than 43 videos on topics such as Crohn’s disease, lupus, depression, Ehlers-Danlos Syndrome, Complex Regional Pain Syndrome and much more. You can see his videos at Don’t Punish Pain and on his YouTube channel.

Ken began advocating for pain patients when his wife was diagnosed with Crohn’s – and he came to realize that the chronically ill were often stigmatized by society. That realization led him to make a 32-minute video called "The Slow Death of Compassion for the Chronically Ill."

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

Major Decline in Hydrocodone Prescribing

By Pat Anson, Editor

Prescriptions for Vicodin and other hydrocodone products declined dramatically in the United States after the opioid pain medication was rescheduled by the Drug Enforcement Administration to make it harder to obtain. But there may have been unintended consequences for cancer patients, according to a new study published in JAMA Internal Medicine.

In October 2014 the DEA rescheduled hydrocodone from a Schedule III controlled substance to a more restrictive Schedule II medication because of its “high abuse potential.”

The rescheduling limits patients taking Vicodin, Lortab, Lorcet and other hydrocodone combination products to an initial 90-day supply and requires them to see a doctor for a new prescription each time they need a refill.

In the first year after rescheduling, the number of hydrocodone prescriptions in the U.S. plunged by 22 percent, from nearly 120 million to 93.5 million.

“Dispensed hydrocodone combination product prescriptions decreased substantially after rescheduling by the US Drug Enforcement Administration, with 26.3 million fewer hydrocodone combination product prescriptions and 1.1 billion fewer hydrocodone combination product tablets dispensed in the year after rescheduling,” wrote lead author Christopher Jones, PharmD, U.S. Department of Health and Human Services. “Most of this decline was due to the elimination of hydrocodone combination product prescription refills, consistent with the prohibition on prescription refills for schedule II medications.”

The decline in prescribing was seen in almost all healthcare specialties, including primary care, surgery, dentistry, emergency medicine and oncology. Nearly 187,000 fewer prescriptions for hydrocodone were written for cancer patients in the first year after rescheduling, a decline of nearly 21 percent.

“It appears that up-scheduling of hydrocodone accomplished the goal of the DEA,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and author of The Painful Truth. “The more important question is what impact this has had on the rate of abuse and patient access to the medication. It may be too early to know whether rescheduling has affected the rate of people abusing opioids or if it just forced some abusers to seek alternatives like heroin.

“The JAMA report suggests that even cancer patients found it more difficult to obtain hydrocodone. That should be alarming to the medical community and illustrate to policy makers and law enforcement there are consequences to every action and in this case some people have been subjected to more cost, inconveniences and abandonment without any data to suggest an improvement in abuse or overdoses.”

Interestingly, the number of hydrocodone prescriptions written by pain management specialists after rescheduling increased by 7 percent. And there was a modest 4.9% increase in the number of prescriptions for opioids other than hydrocodone, as some patients apparently switched to opioids that were easier to obtain.

"The uptick from pain specialists most likely reflects a transfer of narcotic provision from non-specialists to specialists. That is, a decrease in prescribing from those who have less training in prescribing opioid pain relievers offset to some extent by an increase from those who have more such training," said Stuart Gitlow, MD, Executive Director of the Annenberg Physician Training Program in Addictive Disease and past president of the American Society of Addiction Medicine.

Gitlow believes the large overall decline in hydrocodone prescribing was a sign that many of the refills being ordered before rescheduling "were ultimately determined to be unnecessary."

"This was not meant to address the overall opioid prescribing problem, but was rather filling one hole in the dike," Gitlow wrote in an email to Pain News Network. "There remains much left to do, such as removal of the cap for treatment of opioid use disorders in office settings, and availability of tapering to avoid having patients move to heroin when their supply of prescription narcotics is suddenly cut off."

Hydrocodone was once the most widely prescribed medication in the United States, with over 137 million prescriptions annually. Prescribing of hydrocodone was already in decline before rescheduling, because of growing concern the drug was being abused and diverted.

CDC Guideline: A Good Start that Needs Improvement

By Stefan Kertesz, MD, Guest Columnist

President Obama began his 2016 State of the Union address by referencing an American epidemic of opioid overdoses. He was right to do so. The Centers for Disease Control report that 2014 saw a record of 18,893 deaths related to opioid overdose, a category that includes both medications and heroin. Given a rising tide of deaths, it is only sensible to look closely at how opioids come into distribution. There is more than one path. Doctors write prescriptions, and the pills may be consumed properly or improperly. Or they can be sold, given to friends, or stolen. Heroin is incredibly cheap and potent these days. It’s often laced with other drugs and can cause overdose in ways that users can’t predict.

A major portion of the public health response has focused on doctors and their prescriptions (disclosure: I’m a primary care doctor trained in internal medicine and addictions). Most public health authorities believe a major contributor to the rising tide of overdoses has something to do with the prescriptions for opioids we write. Our tendency to write prescriptions for pills like hydrocodone or morphine rose precipitously from 2000 to 2011.

Everyone knows a story of someone who wheedles pills out of credulous physicians. Barring a few so-called pill mills (which alone cannot account for the rise in prescriptions), most doctors writing prescriptions for opioid pills do so in response to a patient with severe chronic pain. There are an estimated 100 million Americans with chronic pain, and between 5 and 8 million take opioids for that pain.

It stands to reason that among the patients who have received opioid prescriptions, surely some (or many) should not have received them. Many doctors have decided to prescribe less, starting in 2012, according to national data.

If prescribing went down while overdoses went up these past few years, it’s fair to say that there is room for argument about precisely how doctor’s prescriptions relate to overdoses. But few would argue there is no relationship at all. Thus, great hopes are pinned on the notion that getting doctors to prescribe differently (and less) for their patients with pain will be key.

Last year the Centers for Disease Control, after consulting an extensive array of experts and interest groups, prepared a draft guideline for doctors on prescribing opioids. In December they placed notice in the Federal Register seeking public commentary. By deadline on January 13, over 4,300 comments were received.

There is a reason this document excites so much passion. In part, organizations such as the American Cancer Society project this guideline will not be voluntary, but will carry force of law.

The hope is to prevent development of addiction and overdose that devastates countless families. Yet, there are those 5 to 8 million patients who receive opioids, some of whom believe that they are at risk of losing access to a crucial medication that is helping manage their pain, improve their quality of life and overall function. As medical boards, insurers and government agencies enforce this guideline, prescribing differently from the topline recommendations is likely to become onerous, leaving many patients in the lurch.

If you listen to this conversation between this 70-year old coal miner who suffered 18 major injuries, and a chief advocate (addiction specialist Dr. Andrew Kolodny) for the reduction of opioid prescribing, you feel the tension. You will hear the distress of a man who fears being confined to bed from his pain, and the concern of an addiction doctor who believes opioid pills have done harm, not good, even perhaps to the man to whom he is speaking.

The experts convened by the CDC include many I know and respect. They have taken a fairly strong stand. They conclude that the literature shows no evidence of enduring benefit from opioids, and that measurable harms are tied closely to dose. They urge careful assessment of risk and benefit. They urge aggressive use of urine drug testing to identify patients who take opioid medication differently from intended or use illicit drugs.

In 56 pages, they say a lot more. My primary care patients include several with chronic pain, and my practice lines up pretty closely with precisely what the guideline recommends. And despite that, I feel this guideline is not yet ready, not given the power we project it to have.

For reasons I shared with the CDC, I think it reaches a bit beyond the available science in some places, neglects it in others, and misconstrues how best to translate it in the care of our patients. It risks making opioids less available to patients who are benefiting from them. It is not far from where it needs to be, but it needs improvement.

Friends, some of them national leaders in primary care, addiction and pain medicine, have urged me to publish this concern broadly.

For people interested in learning more about these concerns, I offer them in linked piece at Medium.com. I offer it to show that one can take a different stand without rejecting the science or the underlying public health commitment that I fully share with the honorable drafters of the CDC’s draft Guideline. For the readers who believe I am right, or perhaps have also misconstrued the science, I welcome your thoughts.

Stefan Kertesz, MD, is an Associate Professor at the University of Alabama at Birmingham School of Medicine. Opinions expressed are solely his own and do not represent positions of any agency of the U.S. Federal Government or the State of Alabama.

This column is republished with permission by the author. It originally appeared in Medium.com, along with the comments submitted by Dr. Kertesz to the CDC about the guideline.

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.

Montana Doctor’s License to Be Suspended

By Pat Anson, Editor

The Montana Board of Medical Examiners voted unanimously Thursday to suspend the medical license of Dr. Mark Ibsen for unprofessional conduct, the latest chapter in a three year investigation into Ibsen’s opioid prescribing practices. A final order on the board’s ruling still needs to be drafted and voted on again. Ibsen has said he will appeal the decision.

The medical board accepted almost all of the recommendations made in a proposed order by Michael Fanning, Special Assistant Attorney General to the Montana Department of Labor and Industry, but it refused to consider lengthy allegations that Ibsen has “destructive psychological and behavioral issues.”

Ibsen was one of the last doctors in Montana willing to prescribe opioid pain medication to new patients, including many who drove hundreds of miles to see him. While that made Ibsen a folk hero of sorts in the pain community, it also attracted the attention of investigators who thought he was overprescribing opioids, and raising the risk of addiction and overdose.

“Opioid deaths are frighteningly common with one source estimating one death for every 500 opioid prescriptions written in America,” Fanning wrote in his 62-page proposed order, without citing a single case where Ibsen’s prescribing practices led to someone’s death or injury.

The case against Ibsen largely centered on nine pain patients and the incomplete records he kept on their treatment.

MARK IBSEN, MD

“Dr. Ibsen’s charts did not contain satisfactory evidence that he attempted more conservative care short of chronic opioid therapy,” Fanning wrote. “While the charts include occasional references to mental or behavioral health and rare references to interventional services, there was no consistent evidence that the more conservative option had been attempted and failed before continuing opioid therapy.”

Ibsen’s charts also did not include records of a written or oral contract with patients about their opioid use, which is a common requirement in pain management. Fanning said Ibsen also overlooked “red flags” in a patient’s behavior that could indicate signs of opioid abuse or diversion.

Last year a hearing officer recommended that Ibsen be put on probation for 180 days, but Fanning went much further, asking the board to suspend Ibsen’s medical license indefinitely. The board spent over seven hours reviewing the case and over 6,000 documents admitted as evidence before making its decision.  

“I just want to say that nothing has made me feel more ashamed to say that I am a Montanan born and raised than this kangaroo court in action,” said Gary Snook, who suffers from Arachnoiditis, a painful and disabling spinal cord disorder caused by botched spinal injections. He now gets medical treatment in California.   

“I am appalled by the total lack of understanding of the treatment of pain by these doctors. No wonder Montana has one of the highest disability rates in the nation,” Snook said in an email to Pain News Network.

“Overreaching is far too gentle a term for what occurred here. It felt like a witch hunt,” said Terri Lewis, PhD, a rehabilitation specialist and patient advocate.  “No doubt Dr. Ibsen, like many, has flaws, but holding this physician to a standard of perfection which exists in neither law nor practice makes no sense.  Maybe they will assign him a scarlet ‘O’ to wear on his chest.

“This is signal in the noise of our public confusion about the management of chronic pain.  This hearing process provides a good deal of insight into the conditions of care, or lack thereof, that both clinicians and patients find so challenging and threatening.”

One board member – who voted to suspend Ibsen’s license -- praised Ibsen for his compassion toward patients and said she hoped he would apply to have his license reinstated if he submits to professional oversight..

Publicity about the case and financial problems forced Ibsen last month to close his Urgent Care Plus clinic in Helena. Ibsen was arrested in November, not for opioid prescribing, but for a misdemeanor domestic assault charge. He has pleaded not guilty.

CDC Still Holding Secret Meetings on Opioid Guidelines

By Pat Anson, Editor

A newly appointed advisory committee to the Centers for Disease Control and Prevention (CDC) has met twice in recent meetings that were not open to the public, Pain News Network has learned, a possible violation of federal open meetings law.

The committee of outside advisors – which the CDC calls a “Workgroup” – was appointed to review the agency’s controversial opioid guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.

“Workgroup meetings are not open to the public,” said CDC spokesperson Courtney Leland in an email to PNN. “CDC anticipates the workgroup will meet four times. Two meetings have been held to date and two are scheduled in the coming weeks.”

Ironically, the opioid guidelines were put on hold and the new workgroup was appointed after widespread complaints about the CDC’s lack of transparency and secrecy in developing the guidelines. None of the agency’s prior meetings about the guidelines were open to the public either.

“It sounds like the CDC hasn’t learned what a federal advisory committee is,” said Mark Chenoweth, general counsel to the Washington Legal Foundation (WLF), a pro-business group that threatened to sue the agency for its “culture of secrecy” and “blatant violations” of the Federal Advisory Committee Act (FACA).

In November, the WLF sent a letter to CDC Director Tom Frieden warning that the agency “was required to comply with each of the numerous obligations that FACA imposes on such committees – including open all meetings to the public,” as well as publicly releasing minutes of the meetings and documents provided to advisory committees.

The new 10-member workgroup was appointed by the agency’s Board of Scientific Counselors (BSC) last week. Critics say a previous workgroup called the “Core Expert Group” had too many members biased against opioids, including one who had a financial conflict of interest. None of its meetings were open to the public.

“CDC developed its Draft Guideline with considerable input from an improperly established federal advisory committee,” said WLF chief counsel Richard Samp. “Any new, properly constituted committee should be directed to take a fresh look, rather than simply being asked to judge the existing proposal. In the absence of such a fresh look, any final guidance document issued by CDC will be tainted inescapably by the major role played in its formation by an illegally constituted federal advisory committee.”

Unlike the previous workgroup, the new advisory committee has broader experience in pain management, pharmacy, and primary care practice. One member is a longtime advocate for pain patients. Two were members of the original Core Expert Group, and two others were part of a "Stakeholder Review Group" that also advised the CDC. A complete list of members for the new workgroup can be found here.

The workgroup’s two meetings were held via conference call and an online meeting platform, according to Leland. The group’s chair is expected to present a report to the BSC on January 28. That short schedule suggests the new panel is only reviewing the work of the old one and is not initiating guidelines of its own.

Further information about the January 28 conference call, which is open to the public, can be found here. Ninety minutes have been set aside for public comments, with a maximum of two minutes per speaker.

Online Public Comment Period Ends

Meanwhile, today was the deadline for the public to submit online comments about the CDC’s draft guidelines. Over 4,000 comments have been received, many opposing the guidelines as being too restrictive, while others wish they were stronger.

The passionate and sometimes painful stories shared by commenters demonstrate the toll opioids can take, both when they are denied patients who need them and when they are abused.

“My son Luke was polite, popular, multi-sport, all-star athlete,” wrote Stacy Watson, who said her teenage son started taking opioids for a sports injury, but became addicted to painkillers and then heroin.  “Seemingly overnight, he became one of the hundreds of thousands of teens in our country addicted to prescription (Rx) painkillers. His life CHANGED & SO DID OUR FAMILIES. He went from being the person I described above to a stranger; the addiction devoured him and our family. It has been heartbreaking. He is 28 years old and now sits in a prison cell.”  

“My wife suffered from chronic pain. It was so heartless that you tied the hands of her doctors to prescribe the pain medication that she needed,” wrote Charles Martens. “You were not the ones that watched her suffer day in and day out until the day she died. Have some mercy and knock this restrictions crap off. Let the Doctors be Doctors for gosh sake.”

You can read more comments here.

Although the CDC’s voluntary guidelines are meant for primary care physicians, many experts say they will quickly be adopted by many prescribing doctors, medical societies and regulatory agencies. As Pain News Network has reported, under a recently enacted federal spending bill the Veterans Administration will be required to adopt them.

As many as 11 million American take opioids daily for chronic pain. Many pain patients report they already have trouble obtaining opioids or getting their prescriptions filled by pharmacies.

FDA Committee Approves New Drug Implant

By Pat Anson, Editor

An advisory committee to the U.S. Food and Drug Administration has approved a new drug delivery system to treat opioid addiction – an implant that could potentially be used to treat chronic pain and other diseases that require steady doses of medication.

The FDA’s Psychopharmacologic Drugs Advisory Committee voted 12 to 5 in favor of the new drug application for Probuphine, a tiny implant about the size of a matchstick that contains buprenorphine, a drug already used to treat addiction that currently only comes in pills and oral film strips. The FDA is expected to make a final decision on Probuphine next month.

“You can never be 100 percent sure of anything,” said Sunil Bhonsle, CEO and president of Titan Pharmaceuticals (NASDAQ: TTNP), which partnered with Braeburn Pharmaceuticals in developing the implant. “The data clearly shows that this product can be of benefit to this patient population. And we hope the FDA will approve it.”

COURTESY BRAEBURN PHARMACEUTICALS

Once implanted under the skin, Probuphine is designed to deliver a steady dose of buprenorphine for six months. Buprenorphine is a weaker opioid that’s long been used as an addiction treatment drug sold under the brand name Suboxone. While it reduces cravings for opioids, buprenorphoine can also be abused and is prized by addicts as a street drug that can ease withdrawals pains from heroin.

The advantages of an implant are many. The dosage is controlled and there’s hardly any risk of abuse, diversion, or accidental overdose. Users also never have to remember to take a pill.

Probuphine’s path to the marketplace hasn’t been a smooth one. Braeburn and Titan were stunned in 2013 when the FDA denied approval of the implant and asked for a new clinical study proving Probuphine’s effectiveness in treating opioid addiction.

The results of a six month, double-blind clinical trial on 177 patients, found that the implant was more effective than buprenorphine film strips in treating addiction. The implant’s insertion and removal were "generally well tolerated," although nearly one in four patients had a "mild" adverse event at the implant site.

Several members of the FDA's advisory committee, including its chairwoman, voted against approval, saying there was not enough evidence of Probuphine’s effectiveness after six months.   

"New treatment options for the millions of patients and their families suffering from opioid addiction are desperately needed, and we appreciate the Committee's comprehensive review of Probuphine," said Bhonsle. “There are many applications for this technology and I think the medical community is now more in tune with looking at long-term delivery technology in the chronic disease setting. So I think it’s probably accurate to say the time is right to expand the use of these technologies to different settings.”

Bhonsle says Titan is already looking at ways the implant can be used to treat Parkinson’s disease and hypothyroidism, adding that chronic pain could also be treated with an implant.

“Clinical studies will need to be done to establish the ability, but the drug levels can certainly be delivered that are going to be beneficial for treating chronic pain,” he told Pain News Network.    

Survey Finds Most Doctors Favor CDC Guidelines

By Pat Anson, Editor

Chronic pain patients and their doctors appear to be on opposite sides of the fence when it comes to controversial guidelines for opioid prescribing being drafted by the Centers for Disease Control and Prevention (CDC).

An email survey of over 1,600 doctors found that 87 percent of them “would welcome and use” the CDC guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. The survey was conducted by SERMO, a social network for healthcare providers.

Less than six out of ten doctors (59%) believe opioids should be used to treat chronic non-cancer pain. About half said they knew someone personally who has suffered from addiction to opioids.  

In personal comments, several doctors said they believed some patients were “doctor shopping” for opioids.

“It is often impossible to know whether a patient is drug seeking, and it's hard to deny them pain meds simply because my gut tells me so,” wrote one oncologist.

“I am frequently approached by patients with ‘acute’ complaints of pain. Since these patients are usually unknown to me, it is difficult to tell if these are truly ‘acute’ issues versus drug seeking,” said an urgent care physician.

“While there are some patients that need pain medications there are several that have now become addicted and I think physicians need more training in not only how to prescribe pain meds properly but also how to cut back appropriately as well,” wrote an internal medicine specialist.

“Physicians are the gateways to drugs. They have the prescription pad and ultimately they are the ones who make the call. They should be at the frontline of this epidemic and adequate education is required,” said a neurologist.

Asked what they thought was the “most important tactic" to curb opioid abuse, this is how doctors voted:

• 43% of doctors support broader use of prescription drug monitoring programs (PDMPs)
• 20% support more education for physicians on proper opioid prescribing
• 14% support increased access to addiction treatment programs
• 14% support more education for patients at risk of addiction
• 7% support increased access to Naloxone, a drug used to reverse the effects of an opioid overdose
• 2% support needle exchange programs

A large majority of doctors (82%) favor PDMP’s, but only 63% said they were registered with their state’s PDMP.

A survey of over 2,000 patients by Pain News Network and the Power of Pain Foundation found very different attitudes about the CDC’s opioid guidelines. Nearly 90% are worried they won’t be able to get opioid pain medication if the guidelines are adopted. A similar number believe the guidelines discriminate against pain patients and will be harmful to them.

How the CDC Misclassifies Opioid Overdoses

By Denise Molohon, Guest Columnist

I think the minute anyone without bias or personal agenda began reading through the CDC's proposed guidelines for opioid prescribing, they must seriously question many things.

Chief among them, the highly suspect "low to very low quality" evidence being presented to support their "strong recommendations," but also their dangerously skewed data; which ultimately could leave millions of chronic pain sufferers critically ill, without sound medical treatments, and with little to no quality of life.

In a recent CDC Morbidity and Mortality Weekly Report (MMWR) on drug and opioid overdose deaths, I found myself doing the exact same thing -- seriously questioning the data. In 2014, the report found that 28,647 people died of drug overdoses involving opioids, including heroin, a 14 percent increase over the previous year. 

However, the CDC admits in the MMWR, that "some overdose deaths may have been misclassified and the data has limitations.” I wondered how much was misclassified? Exactly what data has limitations and why?

I believe the American people have a right to transparency and full disclosure, not flawed data that is often presented in a confusing manner, such as the following qualifiers in the MMWR:

“At autopsy, toxicological laboratory tests might be performed to determine the type of drugs present; however, the substances tested for and circumstances under which the tests are performed vary by jurisdiction.”

“The percent of overdose deaths with specific drugs identified on the death certificate varies widely by state.”

"Approximately one fifth of drug overdose deaths lack information on the specific drugs involved. Some of these deaths might involve opioids."

 “Heroin deaths might be misclassified as morphine because morphine and heroin are metabolized similarly, which might result in an underreporting of heroin overdose deaths.”

 If heroin deaths are being misclassified as morphine, which results in the "underreporting" of heroin overdose deaths, then wouldn't the opposite also hold true? That there is "over-reporting" of morphine deaths, which are then misclassified as prescription opioid deaths? 

According to the Washington Post, CDC Director Tom Frieden admitted some heroin overdose deaths were counted twice!

Another egregious misclassification, which I find grossly unjustified, is the following:

"Historically, CDC has programmatically characterized all opioid pain reliever deaths (natural and semisynthetic opioids, methadone, and other synthetic opioids) as ‘prescription’ opioid overdoses."

On the surface this statement doesn't appear too concerning. Until you begin to take a closer look at what has been happening over the last 3-5 years with heroin and illicit fentanyl overdose deaths, and how both illegal and legal opioids have been lumped together into one category.

All opioid pain reliever deaths are counted as “prescription” opioid overdoses. Why?

“Natural opioids” includes those heroin deaths that were misclassified as morphine related overdose deaths, which no doubt contributed in some degree to that 14% increase in opioid overdose deaths in 2014.

But how many of these heroin deaths were misclassified? We may never know. The DEA reported last year in its National Heroin Threat Assessment Summary that, “Many medical examiners are reluctant to characterize a death as heroin-related without the presence of 6-monoaceytlmorphine (6-MAM), a metabolite unique to heroin, but which quickly metabolizes into morphine.  Thus many heroin deaths are reported as morphine-related deaths."

illicit fentanyl seized in ohio

“Synthetic opioids” includes not only prescribed fentanyl, which is a potent pain reliever, but illicit fentanyl overdoses,  which have skyrocketed over the last two years. Because most medical examiners and coroners did not routinely test for fentanyl in 2014, many illicit fentanyl/heroin overdose deaths were also probably counted as prescription opioid overdoses. 

Medical examiners and coroners are just now beginning to test for fentanyl because of the sharp rise in overdose deaths in the U.S. and Canada. Both the CDC and the DEA issued advisories about illicit fentanyl overdoses last year, but we don’t know exactly how many deaths there were.

Why is the data about opioid overdoses so flawed and what is the government doing about it?

A federal agency called the Substance Abuse and Medical Health Services Administration (SAMHSA) brought together groups of experts four times in 2003, 2007, 2010, and again in 2013. All agreed uniform standards and definitions were needed for classifying opioid-related deaths. Guidelines were developed in July 2013 by SAMHSA to provide uniform standard procedures for medical examiners, coroners and other practitioners.

The CDC is not only aware of these guidelines, but it recently recommended medical examiners and coroners in all states implement them “to ensure death reports are complete and accurate.”

“It is especially important to include the word ‘fentanyl’ on the death certificate when the drug is a contributing cause of death,” the CDC said in a Health Advisory distributed on October 26, 2015.

Why fentanyl? Based on reports from states and drug seizure data, a substantial portion of the increase in synthetic opioid deaths appears to be related to increased availability of illicit fentanyl, which is often combined with heroin or even sold as heroin.

David J. Hickton, U.S. attorney for western Pennsylvania and co-chair of the Justice Department's National Heroin Task Force, told the Washington Post that "fentanyl and more potent heroin appear to have contributed to the 2014 spike in fatal overdoses."

According to the DEA's National Heroin Threat Assessment Summary, the overwhelming number of fentanyl overdose deaths are not attributable to pharmaceutical fentanyl but rather illicit fentanyl.

“There have been over 700 overdose deaths reported, and the true number is most likely higher because many coroners’ offices and state crime laboratories do not test for fentanyl or its analogs unless given a specific reason to do so,” the report warns. "While pharmaceutical fentanyl (from transdermal patches or lozenges) is diverted for abuse in the United States at small levels, this latest rash of overdose deaths is largely due to clandestinely-produced fentanyl, not diverted pharmaceutical fentanyl."

Note that the DEA is making a critical distinction between an illegal drug and a legal prescription drug. Why isn’t the CDC doing this?

In my opinion, for the CDC to lump all opioids together as "prescription" opioids or as "pain relievers" shows a highly dangerous bias, an unwillingness to address the soaring number of heroin and fentanyl overdoses, and a lack of competence in taking a responsible leadership role.

If the CDC can’t be counted on to clearly report on the data, sources and causes of overdose deaths, how can we trust their opioid prescribing guidelines?

Denise Molohon was disabled with Adhesive Arachnoiditis after multiple spinal surgeries.

Denise is a strong supporter and patient advocate for ASAP, the Arachnoiditis Society for Awareness & Prevention. She and her family live in Indiana.

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 Holds First Public Hearing on Opioid Guidelines

By Pat Anson, Editor

After months of controversy over its guidelines for opioid prescribing, the Centers for Disease Control and Prevention (CDC) held its first true public hearing today on the proposed guidelines – which many pain patients fear will make opioid pain medication much harder for them to obtain.

The CDC planned to implement the guidelines this month with little public input, but was forced to change course after widespread criticism about its secrecy and lack of transparency during the drafting of the guidelines, which would discourage primary care physicians from prescribing opioids for chronic pain. As many as 11 million Americans use opioids for long-term chronic pain.

“We have heard some concerns about the process. We’ve done a lot, but want to be sure there will be no concern about the final guidelines when released,” said Debra Houry, MD, director of the CDC's National Center for Injury Prevention and Control, which is overseeing development of the guidelines.

“As a part of our response, we are proposing the establishment of a workgroup under the BSC (Board of Scientific Counselors) to review the guidelines and the feedback we have received from stakeholders, peer reviewers, and importantly the public. We want to ensure that this workgroup includes diverse perspectives of experts, stakeholders and consumers invested in reversing this epidemic, while cognizant of the need for safe and effective pain management.”

The CDC nominated a workgroup of ten health care experts to review the guidelines and advise its Board of Scientific Counselors, most of whom have expertise in workplace injuries, but little experience in pain management. Unlike a previous workgroup known as the “Core Expert Group,” the new workgroup has broader experience in pain management, pharmacy, primary care practice and patient advocacy:

• Erin Krebs, MD, MPH
• Mitchell H. Katz, MD
• Mark Wallace, MD
• Gregory Terman, MD, PhD
• Katherine Galluzzi, DO
• Christina Porucznik, PhD, MSPH
• Penney Cowan, American Chronic Pain Association
• Chinazo Cunningham, MD, MS
• Anne Burns, RPh
• Traci Green, PhD, MSC

Krebs and Porucznik were members of the original Core Expert Group, while Cowan and Terman were part of a "Stakeholder Review Group" that also advised the CDC.

The BSC approved the CDC's nominees with little discussion, although it encouraged the workgroup to add additional members, if needed. Only one member of the BSC voted against the nominations.

No members of Physicians for Responsible Prescribing (PROP) were nominated by the CDC to be part of the new workgroup. As Pain News Network has reported, five PROP board members advised the CDC during the initial drafting of the guidelines. PROP is funded by Phoenix House, which runs a chain of addiction treatment centers, and critics had complained the PROP members were biased and had conflicts of interest against the use of opioids.

Several pain patients said they wanted to see more patients in the workgroup. Penney Cowan of the American Chronic Pain Association was the only one nominated by the CDC.

“I want this panel and this group to have patients. You need to hear our side,” said Diane Gracely, who said she has been a chronic pain patient for 46 years. “The goal of the CDC is to reverse the prescription drug epidemic. I think this is inhumane to us chronic pain patients. The voices of chronic pain patients need to be heard by the CDC and the DEA. We need you to listen to us. You’re pushing more patients to the street for drugs and causing more suicides.”

The new workgroup is expected to meet at least four times to review the guidelines, a process that could delay finalizing the guidelines for several months.

“The guidelines will be an important and essential step in reversing the prescription drug epidemic, said Houry. “Given the lives lost and impacted every day, we have an acute sense of urgency to issue guidance quickly.”

That urgency was also stressed by CDC director Thomas Frieden, MD, who spoke briefly by telephone during the hearing.

“We know we don’t have ideal evidence, but we also know that we can’t wait,” said Frieden, who claimed prescription opioids were “fueling an increase in heroin use” and that their benefits were “largely unproven and uncertain.”

“Addressing the prescription drug overdose epidemic is one of CDC’s top priorities. Overprescription of opiates for pain is the key driver of this epidemic and we believe the epidemic can be reversed. Key areas will be to improve prescribing for both pain and for addiction. There are definite, often fatal risks, including both addiction and death with prescription opiates.”

The public can still comment on the CDC's prescribing guideline until January 13th. You can make a comment online by clicking here. 

The draft guidelines and the reasoning behind them can be found in a 56-page report you can see by clicking here.

CDC ‘Not Aware’ of Website Issues

By Pat Anson, Editor

The start of the New Year means the deadline is fast approaching for people to submit their comments about the opioid prescribing guidelines proposed by the Centers for Disease Control and Prevention (CDC). The deadline is January 13th to comment on the draft guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.

So far, nearly 1,500 comments have been received at the regulations.gov website, and while the process appears to have gone smoothly for most users, some have complained to Pain News Network about the website loading slowly, not accepting comments, "internal errors" and other “technical difficulties.”

One couple even sent us a series of screen shots showing some of the problems the website was having around Christmas.

“I have multiple screen shots for days of being told the site was experiencing technical difficulties and to send an email. Another saying due to internal error they were unable to retrieve docket info, etc.,” wrote Jerry and his wife Sharon, who asked that we not use their last name.

The CDC says the website was undergoing maintenance the weekend of December 19-20, but the agency is unaware of any other period when the website was down.

“CDC is not aware of issues with submitting comments via Regulations.gov. People should be able to submit a comment through the docket without any issues. Once submitted, they should receive a receipt confirming the submission. There might be a slight delay in comments appearing online given the holiday,” said CDC spokesperson Courtney Leland in an email to PNN. She urged anyone experiencing a problem to call the Regulations.gov help desk (1-877-378-5457).

The delay in posting comments has contributed to the frustration of some posters, especially those who were already suspicious of the CDC, given the agency’s secrecy and lack of transparency when the guidelines were first drafted.

“My comment wasn't posted on the CDC opioid issue – I’m not surprised,” said David Becker, who submitted a lengthy comment accusing the agency of trying to “subjugate people in pain to forces beyond their control.”

Becker complained to the CDC and his comment appeared on the website the next day.

The CDC says it is not trying to censor or silence anyone – but is reviewing all comments for personal information, inappropriate language and other issues before posting them. That delay causes a discrepancy between the numbers of comments received and the number posted on the website.

 “There were comments pending posting while CDC contacted individuals who had included personal, private information in their comments. CDC contacted the commenters to ensure that they agreed to have their personal information publicly posted. CDC has completed contacting those commenters and their comments have been posted. The only comments currently waiting to post are those that the docket managers need to review and catalog before public posting,” said Leland, adding that no comments had been rejected as inappropriate for posting.

Another issue that has led to frustration is the limit on characters, not words, used in comments. The limit is 5,000 characters, including spaces, something the CDC says it is unable to change, and posters say is too limiting and confusing.

“The site certainly isn’t very (user) friendly is it?” asked Janice Reynolds, a retire nurse and pain sufferer. “I read ‘words’ when it actually said characters.  So even though it looked like I was under the ‘word’ limit it would say I had too many characters.  I finally recognized what it was saying and divided the paper in two (pain patient and pain management nurse) and did them separately.  That worked however it still wouldn’t let me download a file.  It was frustrating.  So it was really operator error with a poor instruction manual.”

Still another issue that has raised concern is efforts by some organizations to get their followers to submit form letters as comments. Physicians for Responsible Opioid Prescribing (PROP), for example, sent a newsletter last week to supporters urging them to submit comments in favor of the guidelines. In his “urgent request” to supporters, PROP founder Andrew Kolodny, MD, even had several suggestions on what to write.

But in its “Tips for Submitting Effective Comments,” the government says that tactic won’t work. It’s not the number of comments that come in, pro or con, but the quality.

“Many in the public mistakenly believe that their submitted form letter constitutes a ‘vote’ regarding the issues concerning them. Although public support or opposition may help guide important public policies, agencies make determinations for a proposed action based on sound reasoning and scientific evidence rather than a majority of votes. A single, well-supported comment may carry more weight than a thousand form letters,” the regulations.gov website states.

The public comment period on the CDC's prescribing guideline continues until January 13th. You can make a comment by clicking here. 

The draft guidelines and the reasoning behind them can be found in a 56-page report you can see by clicking here.