CDC Maintains Secrecy Over Opioid Guidelines

By Pat Anson, Editor

The Centers for Disease Control and Prevention (CDC) is refusing to disclose what outside advisors it consulted with during the drafting of its controversial opioid prescribing guidelines for physicians. The proposed guidelines, which were released this week, have angered many pain patients who think they could lead to sharp reductions in the prescribing of opioids for both acute and chronic pain.

“The anonymity of the reviewers engaged in this process is important during the ongoing development of these guidelines, as it allows reviewers to provide honest and independent comment and feedback,” said Courtney Lenard, a health communication specialist in the CDC’s National Center for Injury Prevention and Control. The panel of advisors is known within the CDC as the Core Expert Group.

“The Core Expert Group includes a limited number of CDC scientific staff, primary care professional society representatives, state agency representatives, experts in guideline development methodology, and other subject experts,” said Lenard.

Pain News Network has learned through a reliable source that about 15 people are in the Core Expert Group, only one of which is a physician with expertise in pain management.

The other members were “physicians and non-physicians, many of whom have been involved in efforts to rein in (opioid) prescribing.”

“Input from the pain management community in developing the guideline was, essentially, non-existent,” said the source, who identified Jane Ballantyne, MD, a professor of Anesthesiology and Pain Medicine at the University of Washington as the sole member with pain management expertise.

“As a member of the Core Expert Group, I have been asked not to comment on the (final) guideline until it is released,” said Ballantyne in an email to Pain News Network.

Ballantyne last year was named President of Physicians for Responsible Opioid Prescribing (PROP), a controversial organization that has lobbied Congress and criticized the Food and Drug Administration for not doing more to limit opioid prescribing.

The CDC and PROP appear to have a close working relationship -- a link to PROP literature recommending “cautious, evidence-based opioid prescribing” can be found -- unedited -- on the CDC’s website.

Asked if he was also a member of the CDC’s Core Expert Group that drafted the guidelines, PROP founder Andrew Kolodny said that he had no comment. Kolodny, who is chief medical officer for Phoenix House, which operates a chain of addiction treatment clinics, also said he would have no comment on the guidelines themselves.

Phoenix House was recently the subject of a highly critical report by Reuters, which claimed that in recent years the publicly funded institution “has consistently failed to provide the quality of care necessary to help addicts kick the habit.”

CDC Guidelines for Prescribing

Now that the draft guidelines have been released, the CDC plans to consult with a “Stakeholder Review Group” that includes over a dozen professional organizations involved in the field of pain management. Only two “stakeholders” – the American Chronic Pain Association and the American Cancer Society – represents pain patients.  A full list of the Stakeholder Review Group will be listed at the end of this article.

Secrecy has surrounded the development of the CDC's guidelines from their inception and continues today. The CDC refused to provide an advance copy of the guidelines before they were released Wednesday during an online “webinar.” Even after their release, only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on the guidelines after a 48-hour window of opportunity.

“Given the public health need to respond to the prescription overdose epidemic, it was critical to identify a public participation method and comment period that was rapid and efficient so that comments could be immediately provided to peer reviewers for their consideration,” explained the CDC’s Lenard in an email.

The first prescribing guideline recommends “non-pharmacological therapy” as the “preferred” treatment for chronic non-cancer pain, and states that opioids should only be prescribed if the benefits of reducing pain outweigh the risk of addiction and overdose.

Other guidelines recommend urine drug testing of all patients who are prescribed opioids, both for illicit drugs and prescribed medications. Smaller doses and quantities of opioids are also recommended – including a “three or fewer days” supply of opioids for most types of acute pain. The guidelines also recommend that benzodiazepines not be prescribed concurrently with opioids. A complete list of the guidelines can be found here.

“We’re concerned about some of the provisions in here, and by the fact that such guidelines issued by CDC are often accepted, sometimes rather uncritically, by state health departments and licensing boards, and thus quickly become standards of practice,” said Bob Twillman, Executive Director of the American Academy of Pain Management, which is one of the stakeholder groups that will be consulted by the CDC.

“I was generally satisfied with the proposed guidelines,” said Pete Jackson, president of Advocates for the Reform of Prescription Opioids, who lost his teenage daughter to a single dose of OxyContin in 2006.

“My main concern at this stage is how the federal government will reconcile these guidelines with the FDA REMS guidelines for long-acting opioids, which were voluntary guidelines issued a few years ago by FDA and have not been effective at deterring the overprescribing,” Jackson told Pain News Network. “Hopefully the CDC's guidelines will supersede the wholly inadequate FDA guidelines.  I would also like to see the CDC implement a very intensive training program to support the implementation of their new guidelines."

Pain Patients Worried

Pain patients – including many who already find it difficult to get opioids for pain relief – are angered and worried by the CDC’s recommendations.

“This terrifies me. I take two Norco per day, it barely keeps my pain at tolerable levels so I can do fun things like shower and get out of bed. I already jump through hoops to get my prescriptions every month.” said Cynthia Mittel. “To arbitrarily take away my only chance to have a life halfway worth living is evil and very short-sighted! Government at its finest. Guess we'll all be getting our drugs off the street now!”

“This is such a slap in the face to the millions of pain sufferers in this country," wrote Sue B. "We are not addicted to opioids! We need them in order to live. Would you think of putting these strict guidelines on insulin? It is not our fault drug abusers use our meds, our lifelines, to sell and get high, yet we are constantly punished.”

“We are not treated properly now. We get drug tested and insulted now. I cannot believe this is even coming up after the last change in guidelines,” wrote Kryste Southwick.  “Why do junkies have more meaning than chronic pain patients? Why are you stripping us of what little lives we can have? Do your research people. If this happens there will be A LOT of suicidal blood on YOUR hands.”

“This is wrong of the CDC to try and force their guidelines in people who live with chronic pain. I am monitored by my rheumatologist for my pain medication. I do not abuse my medication nor am I addicted to them,” said Suzanne Stevenson. “These guidelines the CDC want to impose are wrong and unfair to so many people. What right does the CDC have in this matter? None!”

Many have wondered why the CDC is acting as the lead agency in creating the prescribing guidelines – a role traditionally played by the Food and Drug Administration. The FDA has yet to release a statement about the CDC guidelines or say what role – if any – it had in drafting them.

"CDC and FDA are federal partners and collaborate on many different issues and at many different levels, prescription drug overdose being one of them. FDA has been involved in the review process of the guidelines and we will continue to work with them on this prescription drug overdose epidemic," said the CDC's Lenard.

CDC officials have long been critical of opioid overprescribing and have repeatedly cited a study that claims over 16,000 Americans are killed annual by overdoses linked to pain medications.

"CDC’s top focus in developing these guidelines is improving patient safety and reducing the risk that any more patients will die from an overdose related to mixing medications, using alcohol while on treatment, or taking a dangerous dose of opioids," said Lenard.

"We want to provide tools that primary care physicians can use to help determine when and how to safely initiate, maintain, and discontinue use of opioid therapy for chronic pain outside the setting of end-of-life care.  We understand that pain is a complex problem and that some patients will require treatment with a pain specialist. These guidelines are not intended to guide that care. We want patients currently on opioid therapies to work with their doctors to stay safe while managing their pain."

According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

The CDC said it will now consult with the “stakeholders” group --and will then submit the guidelines to a peer review panel  -- before releasing a final version in January, 2016.

Members of the stakeholders group include the following: American Academy of Neurology; American Academy of Pain Management; American Academy of Pain Medicine; American Academy of Pediatrics; American Academy of Physical Medicine and Rehabilitation; American Cancer Society; American Chronic Pain Association; American College of Medical Toxicology; American College of Obstetrics and Gynecology; American Geriatrics Society; American Hospital Association; American Medical Association; American Pain Society; American Society of Addiction Medicine; American Society of Anesthesiologists; American Society of Hematology; American Society of Interventional Pain Physicians; and Physicians for Responsible Opioid Prescribing.

CDC: Opioids ‘Not Preferred’ Treatment for Chronic Pain

By Pat Anson, Editor

New draft guidelines by the Centers for Disease Control and Prevention (CDC) would – if adopted -- sharply reduce the prescribing of opioids for both chronic and acute pain in the U.S. The proposed guidelines may also trigger a turf battle between the CDC and the Food and Drug Administration over which agency has primary responsibility for the safe prescribing of medication.

In an unusual online “webinar” held by the CDC, the agency today unveiled a dozen draft guidelines for physicians to follow when prescribing opioids. The first recommends “non-pharmacological therapy” as the preferred treatment for chronic non-cancer pain, and states that opioids should only be prescribed if the benefits of reducing pain outweigh the risk of addiction and overdose.

Other guidelines recommend urine drug testing of patients both before and during opioid use, and that smaller doses and quantities be prescribed. Only “three or fewer days” supply of opioids is recommended for most types of acute pain. The guidelines also recommend that benzodiazepines not be prescribed concurrently with opioids.

Pain patients listening to the webinar expressed alarm over some of the recommendations.

“I would caution the CDC that putting these dosage limits in here would cause problems for patients,” said Marjorie. “These recommendations have severe ramifications.”

“I have been on and off opiates for a few years. I do not have cravings for opiates. I am not addicted to opiates. I do think there has been a demonization of opiates among the medical community, as well as the CDC possibly and definitely the DEA,” said Chardonnay. “How do you decide which patients to continue, that really get benefits from this, and how do you decide which patients take them to get high?”

The CDC took comments about the guidelines during the webinar, but refused to answer any questions about them. The agency said it would finalize its guidelines in early November to submit to the Department of Health and Human Services, with the goal of publishing them in January, 2016.

The CDC’s guidelines were not publicly available before the webinar, there was little advance notice about it, and there were numerous technical problems for some people who tried to participate online. There were so many complaints about lack of access to the webinar, the CDC said it would hold a second one tomorrow.

While the CDC recorded the webinar, it is not making it available for people to watch or listen to afterwards. The draft guidelines, outlined below, will also not be available on the CDC’s website.

(Update: PNN has obtained a transcript of the webinar through the Freedom of Information Act. You can see the transcript by clicking here.)

CDC Draft Guidelines for Opioid Prescribing

1. Non-pharmacological therapy and non-opioid pharmacological therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks.

2. Before starting long term opioid therapy, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.

3. Before starting and periodically during opioid therapy, providers should discuss with patients risks and realistic benefits of opioid therapy and patient and provider responsibilities for managing therapy.

4. When starting opioid therapy, providers should prescribe short-acting opioids instead of extended-release/long acting opioids.

5. When opioids are started, providers should prescribe the lowest possible effective dosage. Providers should implement additional precautions when increasing dosage to 50 or greater milligrams per day in morphine equivalents and should avoid increasing dosages to 90 or greater milligrams per day in morphine equivalents.

6. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, providers should prescribe the lowest effective dose of short-acting opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three or fewer days will usually be sufficient for non-traumatic pain not related to major surgery.

7. Providers should evaluate patients within 1 to 4 weeks of starting long-term opioid therapy or of dose escalation to assess benefits and harms of continued opioid therapy. Providers should evaluate patients receiving long-term opioid therapy every 3 months or more frequently for benefits and harms of continued opioid therapy. If benefits do not outweigh harms of continued opioid therapy, providers should work with patients to reduce opioid dosage and to discontinue opioids when possible.

8. Before starting and periodically during continuation of opioid therapy, providers should evaluate risk factors for opioid-related harms. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid-related harms are present.

9. Providers should review the patient’s history of controlled substance prescriptions using state Prescription Drug Monitoring Program data to determine whether the patient is receiving excessive opioid dosages or dangerous combinations that put him/her at high risk for overdose. Providers should review Prescription Monitoring Program data when starting opioid therapy and periodically during long-term opioid therapy (ranging from every prescription to every 3 months).

10. Providers should use urine drug testing before starting opioids for chronic pain and consider urine drug testing at least annually for all patients on long-term opioid therapy to assess for prescribed medications as well as other controlled substances and illicit drugs.

11. Providers should avoid prescribing of opioid pain medication and benzodiazepines concurrently whenever possible.

12. Providers should offer or arrange evidence-based treatment (usually opioid agonist treatment in combination with behavioral therapies) for patients with opioid use disorder.

The CDC said the guidelines were developed after a series of meetings with a “core expert group” and “independent peer reviewers” that the agency did not identify by name.

CDC officials have long been critical of opioid prescribing practices and have repeatedly cited a study that claims over 16,000 Americans are killed annual by overdoses linked to pain medications.

"If the evidence of their guidelines are of the quality of their research on opioid overdoses, then we are in big trouble. They claim they will be using evidenced based material in forming these guidelines, however they have never shown any desire to correctly evaluate evidence for its strength and value,” said Janice Reynolds, a retired nurse and longtime activist in the pain community.

“I am sure their information came from addiction disease doctors who have an arrogance based model of practice and many don’t care about pain management.  Much of their information comes from PROP."

PROP (Physicians for Responsible Opioid Prescribing) is a controversial organization that has lobbied Congress and criticized the FDA for not doing more to limit access to opioids. A link to PROP literature recommending “cautious, evidence-based opioid prescribing” can be found -- unedited -- on the CDC’s website.

“The CDC knows nothing about pain management and possibly less about pharmacology, so why should anyone listen to them?” asked Reynolds. “Their complaints against opioids only increases the misery of people with pain and does little to prevent deaths as most people with an addiction to prescription medications obtain their meds not by legitimate prescriptions.”

According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

The CDC does not normally get involved in setting guidelines for prescription drugs, a responsibility that falls on the FDA – which regulates drugs and determines which ones can be used to treat medical conditions. A spokesman for the FDA who handles opioid issues told Pain New Network he was unaware the CDC was drafting its own opioid guidelines.

Zohydro 'Not a Public Health Risk'

By Pat Anson, Editor

Eighteen months after the introduction of Zohydro, there is little evidence the controversial painkiller is being abused or diverted, according to a new report from a nationwide drug monitoring program.

"Zohydro is not a public health risk and has shown little tendency to increase over the time it has been available," stated the report by the Researched Abuse, Diversion and Addiction-Related Surveillance System (RADARS). "The drug is either not desirable or unavailable for abuse."

The report covered the first quarter of 2015. RADARS monitors hundreds of hospitals, poison control centers and addiction treatment clinics in the U.S. to track the abuse, misuse and diversion of prescription drugs.

"Everyone thought this was going to be some horrible, horrible thing. And it didn't materialize that way," said Errol Gould, PhD, Director of Medical Affairs for Pernix Therapeutics, which bought the rights to Zohydro from Zogenix Inc. earlier this year.

"There have been very few reports of people checking into treatment centers and reporting Zohydro ER as the drug they were abusing. In the past 18 months I can tell you there have been less than 40."

There was a storm of controversy surrounding Zohydro when it was introduced in March 2014. The first single ingredient  hydrocodone painkiller sold in the U.S. was approved by the Food and Drug Administration over the objections of its staff and an advisory committee -- which warned there was a potential for Zohydro to be abused even more than other hydrocodone products.

Addiction treatment experts also predicted Zohydro would fuel a new wave of painkiller addiction and overdoses. The Governor of Massachusetts even declared a state of emergency and tried unsuccessfully to ban Zohydro sales in his state.

"All the media attention sort of scared people, so there weren't a lot of prescriptions written in the beginning," said Gould. "But now over time the prescription rate has picked up. But we're still not seeing diversion. The abusers already know what hydrocodone is like and they're not going out and looking for Zohydro when they can get other things that are more readily available to them."

Only about 1,600 prescriptions are being written for Zohydro each week, a tiny fraction of the 130 million hydrocodone prescriptions that are filled each year in the U.S. Prescribing of Zohydro is also closely monitored to keep it away from pain patients who might misuse or abuse it.

"I think the growth has been slow. Most of that has been because of the prior perceptions. We fully expect that to change over time. It just takes time to change people's views and minds. We've had a bit of an uphill battle," said Doug Drysdale, President and CEO of Pernix. "The good news here from RADARS is that the product is not being abused. And I think that's very encouraging."

The biggest problem faced by Pernix going forward may not be the hysteria over Zohydro's introduction -- but competition from rival drug makers.

Purdue Pharma has introduced its own "pure" hydrocodone product -- sold under the brand name Hysingla ER. Hysingla is designed to be taken once a day, while Zohydro is meant to be taken twice daily for chronic pain. Both products are sold in abuse deterrent formulas that make them harder for drug abusers to snort or inject.

Until the introduction of Zohydro, most hydrocodone products on the market were combined with acetaminophen, which at high doses can cause liver damage. Hydrocodone combination drugs such as Vicodin, Lortab and Lorcet are the most commonly prescribed and abused painkillers in the U.S. In 2014 hydrocodone was reclassified by the Drug Enforcement Administration as a Schedule II medication to make it harder to obtain.

Montana Clinic to Reopen Without Doctor

By Pat Anson, Editor

A Montana health clinic that closed its doors last week will reopen on Monday, but without its owner -- who says he will not write opioid prescriptions for chronic pain patients because he is "paralyzed with fear" of being arrested.

"I don't think it's safe for me to continue seeing these patients until I get some reassurance that I can do it. I'm risking my well being by going in there.," said Mark Ibsen, MD, owner of the Urgent Care Plus clinic in Helena.

Ibsen says he left behind "tapering" prescriptions for opioids at lower doses to help wean patients off the drugs and prevent them from going into withdrawal.

"I have a couple who are upset and feel abandoned. And I have a lot of them who are upset and understanding," he said. "They've seen what I am going through. They've been watching me kind of deteriorate emotionally over the last few months. And I tell my patients I can't continue to do this, you've got to find someone else. This is dangerous for me."

image courtesy of mark ibsen

Ibsen fears being arrested like Dr. Chris Christensen, another Montana doctor who was recently charged with 400 felonies, including two counts of negligent homicide, in connection with the overprescribing of opioids. Ibsen himself was the target of a lengthy investigation by the Montana Board of Medical Examiners after he started treating some of Dr. Christensen’s former pain patients.

If he keeps writing prescriptions for opioids, Ibsen worries he'll be next.

"The DEA agents that met with me five different times will not meet with me again unless my lawyer is present. My only inference from that is that they have an open investigation. I haven't been able to confirm that , but you don't know that until they walk through the door and cuff you.  I have no idea, so I am paralyzed with fear," he said.

dr. mark ibsen

Pain News Network caught up with Ibsen in Las Vegas, where he is attending PAINWeek, the nation's largest conference for frontline practitioners in pain management. Ibsen hoped going to the conference would re-energize him, but found that many of the lectures focused on opioid abuse and diversion.--. the very subjects he's grown weary of.

"All I've seen is more evidence of hysteria," he said. "Prescription drug overdose is number 22 on the list of causes of death in America. And this so-called epidemic, I mean calling it an epidemic is insane."

Like Ibsen, other doctors around the country have also stopped writing prescriptions for opioids.

"Many of them with much less provocation than he's had," said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management. "You worry you're going to lose your practice and lose your livelihood by doing something you don't intend to do. And the easiest way to do that is don't go there, don't prescribe."

Ibsen says he was prescribing opioids to about200 patients when he stopped. Some have gone to hospital emergency rooms seeking more medication, while others are in search of new doctors in a state where very few are willing to prescribe to new patients.

"My patients are now being shunned by other doctors and judged by the fact that they've seen me," Ibsen said. 

Your Friendly Neighborhood DEA Snitch

By Steve Meister, Guest Columnist

A recent story out of the Southeast caught my eye. A local pain management doctor has been cut off by local pharmacies, or more precisely, the patients of that doctor have been cut off because local pharmacies are refusing to fill pain scrips written by that doctor.

In these instances, which I’ve seen some of my own doctor-clients’ experience, the pharmacies’ actions range from altruistic and concerned, to cowardly and hasty disassociation from a provider who may or may not have done anything wrong.

The doctor who was the subject of the news story does, admittedly, write many, many pain prescriptions, and perhaps he does deserve a close second look by pharmacists. Pharmacists, after all, have a very important job, not only to fill a prescription correctly and consider drug interactions, appropriate dosage, and medical necessity, but they also have a responsibility under federal law to double-check the legitimacy of the prescription to begin with.

This is especially true when it comes to pain prescriptions, and so says the DEA. Loudly, in fact. So loudly does the DEA make this pronouncement to pharmacists, that many times I have seen pharmacists inform on doctors just to get the DEA off the pharmacy’s back.

While a pharmacist can always say, perhaps legitimately, that he or she was righteously concerned about the sheer volume of pain scrips coming out of a certain doctor’s office, that same pharmacist might be getting visits from DEA agents.

The pharmacist knows from the get-go that “naming names” is often a good way to get the DEA to redirect its focus. So pharmacists name names. And then other pharmacists in the area get word, and cut off the same doctor or the doctor’s patients. A type of local hysteria takes over, and pretty soon, there are a lot of pain patients finding pharmacy counters off limits to them.

What happens to these patients? An excerpt from the recent news story gives you an idea:

“I didn’t have a real good feeling about cutting people off cold turkey, but in some cases it was warranted,” a local pharmacist said.

The pharmacist interviewed is admitting that an abrupt cut-off of one’s prescription drug dosage can force people to go “cold turkey,” without tapering off of powerful medication on which the patient may have become physically dependent or developed a tolerance. What does it mean when there’s no tapering off? It means a patient risks going into withdrawal, which can be very dangerous and which subjects innocent people to great physical and psychological agony.

According to prescribing and pharmacy practice guidelines, doctors and pharmacists SHOULD NOT subject patients to abrupt, 100% cut-off from opioid dosage, even if a patient is exhibiting signs of misuse. Medication is to be titrated down, patients provided with enough medication for a reasonable time to allow them to find another provider, or be referred to substance abuse treatment programs if necessary, and patients are NOT to be placed at unnecessary risk of going into withdrawal.

And when the DEA is breathing down your neck, Mr. Pharmacist? It’s OK to kick patients to the curb then? No, it’s not. The pharmacist interviewed in the story is actually violating prescribing guidelines and probably running afoul of rules of professional conduct. He is certainly not placing patient safety ahead of his own survival. And without doubt, he is not alone in his self-serving behavior.

Unfortunately, as is often the case, people who otherwise act with dignity and compassion in their professional lives fail to show courage in the face of government intimidation. It’s easier to name names.

Steve Meister is a criminal defense attorney and former prosecutor in Los Angeles.  He advises prescribers on how to comply with prescription criminal laws, and defends people accused of overprescribing narcotics.  

This column is republished with permission from Steve’s blog, Painkiller Law.

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.

The Dangerous Game of Forced Opioid Reduction

By Forest Tennant, MD, Guest Columnist

A colleague who I highly respect just informed me of a woman with intractable angina who had multiple, inserted coronary splints and required a high daily dose of morphine. Without warning, her insurance company arbitrarily decided she did not need opioids. As one might expect, the forced cessation of opioids led to her death.

The forced reduction and/or cessation of daily opioids in stabilized patients have, in some corners of our country, reached the point of unscientific and inhumane hysteria. The craze to fight opioid abuse and force opioid dosages below 100 to 120 mg of morphine equivalents a day (MEQ) is now harming some patients who have been doing quite well on stable, daily opioid dosages. Some of the rhetoric and tac­tics being used to force opioid reduction are farcical if they weren’t so tragic in their consequences.

First, who is doing the forcing? There are multiple culprits: insurance companies, state legislators, regulators, and suppli­ers. Some of the tactics to force opioid reduction are indirect, such as limiting the amount of opioids a pharmacy can stock. Others are blatant, such as states that require physicians to seek a pain consultation if they continue to prescribe over a threshold MEQ level, even to patients who have been well maintained for a considerable time period. For example, in Washington State, a 120 mg/d MEQ threshold will trigger the prescribing physician to conduct, or refer the patient for, a pain consultation (exceptions and exemptions do exist). As noted by Stephen J. Ziegler, PhD, JD, “in some states, these thresholds appear in regulations, making the actions required actions, while in other states the thresholds appear in guidelines, making the actions merely recommended.”

Insurance companies are currently the most dangerous “forcers.” Neither patient, pharmacist, nor physician is pre­pared when a stable, opioid-maintained patient goes to fill a long-standing opioid prescription only to be told their insurance company has suddenly decided the patient should immediately cut their opioid daily dose by 30% to 70%, or even stop it altogether. The saddest aspect of this dan­gerous practice is that the motive is clearly greed, although the reduction may be accompanied by an “out-of-the-blue” statement that the forced reduction is for the patient’s safety. For example, insurance companies have recently informed long-standing, opioid-maintained patients that they have suddenly and capriciously decided they will no longer cover brand name opioids, injections, patches, compounded for­mulations, or a daily dosage above a specific level.

Insurance companies and some state guidelines are spitting out two illogical excuses for the forced reduction of opioids. One is that opioids dosages above 120 mg or so of MEQ are unsafe. Show me a study that indicates tissue toxicity of opioids at dosages over 120 mg in patients who have been maintained at a stable dosage for over 1 year. Patients who have been titrated up to dosages above 120 mg of morphine and periodically monitored by competent physicians almost always experience improved health and function, not the reverse. I have several patients who have been safely main­tained on high opioid dosages and led quality lives for over 20 years!! Why force these folks into sickness, suffering, and possibly death by suddenly and capriciously claiming their life-saving medication is dangerous?

The other straw-dog is “hyperalgesia.” Would someone please tell me how I’m to define and diagnose hyperalge­sia in a patient who has been well maintained on a stable opioid dosage—high or low—for over a year? Hyperalgesia has become a label and excuse to force down opioid dos­ages. Reputable and credible pain practitioners are not even sure it exists in a human who is well maintained on opioids. Whenever I see a patient who is on opioids and claims their opioids aren’t working as well as they used to, I take a hor­mone profile. Once I replace any deficient hormones, the patients’ opioids resume working.

My demand is for someone to send me the consensus doc­ument that tells me how to objectively diagnose hyperalge­sia in patients who have been well maintained on opioids over 90 days. What’s more, if hyperalgesia exists, what harm does it do? If we really believe that hyperalgesia is a problem with high-dose opioids, we must remove all intrathecal opi­oid pumps because these devices deliver a MEQ directly to the CNS receptors that is far in excess of any dosage we can achieve by peripheral administration!!

Readers of Practical Pain Management well know that severe, constant pain has far more risks than any stable, daily opioid dosage. Severe pain adversely affects the cardiovas­cular, endocrine, immune, and neurologic systems. It sends patients to bed in agony to lead a short, suffering life. There is no need to take these risks in a caring, concerned soci­ety, as a minute extract from the opium plant can prevent these complications and the pathetic, miserable death that a forced opioid reduction can bring.

So what do we do at this point? First, physician’s need to correct any false comments about the imagined dan­gers of stable, on-going opioid dosages. Whenever possible, pain practitioners should attempt to prescribe non-opioid pharmaceuticals that have come forward in recent years. In the latter category, I place ketamine, anti-epileptic agents (gabapentin, pregabalin, etc), and neurohormones (oxyto­cin, human chorionic gonadotropin, and progesterone). I’ve cut my patients’ opioid use by about 50% over the past 5 years by use of these new agents. I also recommend obtain­ing an opioid serum level in patients who take over 100 mg of MEQ. The presence of a reasonable opioid serum level indicates that the patient is ingesting opioids and is func­tioning well with a high opioid dosage.

Lastly, and most important, families of patients who must take a high daily opioid dosage need to become publicly active as advocates for their loved one. Unfortunately, but realistically, patients who must take a high opioid dosage always have a debilitating condition such as arachnoiditis, CRPS, traumatic brain injury, post-encephalitis headache, or facial neuropathy, and are too ill to fend for themselves. But their family can. Its time families demand the right of their suffering loved ones to obtain opioids, and their direct and blunt communication should go to State Medical Boards, insurance companies, wholesale suppliers, and their elected representatives.

Also, pain patients and family members should start joining the emerging nationwide organizations that are now forming to fight back. While we physicians have little public voice left, families of pain patients can, should, and will be heard.

Dr. Forest Tennant is pain management specialist in West Covina, California who has treated chronic pain patients for over 40 years. He has authored over 300 scientific articles and books, and is Editor Emeritus of Practical Pain Management.

This column is republished with permission from Practical Pain Management.

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.

Controversial Montana Doctor Suspends Practice

By Pat Anson, Editor

A Montana doctor who has been at the forefront of the debate over opioid prescribing is closing his urgent care clinic and will no longer prescribe medication to pain patients. Dr. Mark Ibsen said he didn't do anything wrong, but was tired of facing regulatory scrutiny over his opioid prescribing practices.

“The clinic is closing today. I’m going to disappear for awhile,” said Ibsen, who owns and operates the Urgent Care Plus clinic in Helena.

Ibsen said he would stop practicing medicine “in solidarity” with Dr. Chris Christensen, another Montana doctor who was arrested last week and charged with 400 felony counts, including two negligent homicide charges, in connection with the overprescribing of opioids.

Ibsen himself was the target of a lengthy investigation by the Montana Board of Medical Examiners after he started treating many of Dr. Christensen’s former patients after Christensen’s Ravalli county clinic was shutdown. Many of the patients were in opioid withdrawal and went to Ibsen because he was one of the few doctors in the state still willing to prescribe pain medication.

“I’m the last man standing in Montana, I think. I don’t know if there is anyone else who will do it. I think not. Because they were all coming to me because they were abandoned by their doctors,” said Ibsen.

Although a state hearing examiner ruled this summer the medical board “did not meet its burden of proof” in the overprescribing case against Ibsen, he has not yet been formally cleared of charges.  The examiner recommended that Ibsen be put on probation for 180 days for poor record keeping.

Ibsen told Pain News Network he was under a lot of stress and was deeply in debt from the legal cost of defending himself and treating Medicaid patients at low reimbursement rates.

“This is not a protest. This is me saying I can’t do this. I’m working in a hostile regulatory environment. And I’m stopping,” Ibsen said.

dr. mark ibsen

“I’m frightened. They’ve got me scared. The DEA said to me two years ago, ‘Dr. Ibsen you are not only risking your license, you’re risking your freedom by prescribing to patients like these.’ And I said patients like what? And they said patients who might divert their pills. And I said might? And they said yes. I said that’s a law enforcement job. My job is to treat the patient in front of me and do what I think is best for them based on what they tell me and what my testing shows.”

Ibsen said his urgent care clinic treated about 30 to 60 patients a day for a variety of conditions and he regularly prescribed opioids to a “couple hundred” patients. He said he didn’t know where they would get their pain medication now.

“I have also deeply considered whether stopping prescribing opiates sends a message that I'm afraid I've done something wrong. Let me assure you I have done nothing wrong. I have upheld my oath as long as I can. The pressure is just too much and today in particular I cannot concentrate on these complex cases. Therefore my clinic is closed and I'm going home,” he said.

"Dr. Ibsen was unfairly targeted and helped Christensen's patients wean from high doses.  Who is going to wean Ibsen's patients now?" asked Terri Anderson, a chronic pain sufferer and patient advocate who lives in Hamilton, MT.

"Pain patients are ultimately the ones who suffer.  I try to look at it from all sides and if it were my brother who overdosed then I would be upset. However it is easy to judge and my first thought is that pain patients come with risk to the prescriber, because they often suffer many other health issues besides just pain, including anxiety, depression and PTSD (post traumatic stress disorder)."  

In the last month, Ibsen said three staff members had resigned from his clinic, which he likened to a “war zone” because of the stress of treating patients who had nowhere else to go.

“Maybe I will come back. But I’m rattled. I’m too rattled to think of the right blood pressure medication to give to a patient. I can’t concentrate. I don’t want any patient injured today because my concentration is so poor,” Ibsen said. “When I am well enough, and I feel safe to practice in the way I know how, I will return.”

Reader Calls for Pain Patient 'Bill of Rights'

By Pat Anson, Editor

A North Carolina woman who suffers from Reflex Sympathetic Dystrophy and several other chronic pain issues wrote to us recently about a serious problem she had with a urine drug test (UDT) performed in her doctor’s office.

Her urine tested positive for oxycodone and hydrocodone, two opioid pain medications she did not have prescriptions for. So the doctor dropped Paulette Waters from his practice, informing her by registered letter that she would no longer be his patient after 12 years without any other issues.

“This is where my horror story starts and has as of yet to end. The letter stated that I had broken the pain agreement and my doctor would not be seeing me anymore. The letter being generic and not including any details or UDT results,” wrote Paulette, who asked that Pain News Network not use her real name because she’s afraid of being blackballed by more doctors.

We’ve written before about these “point of care” (POC) urine tests. The immunoassay tests are often used by doctors to screen pain patients for the misuse or abuse of drugs – but they’re wrong about half the time. One study, for example, found that POC tests give false positives 41% of the time for oxycodone. Sometimes even a simple over-the-counter medication like ibuprofen can trigger a false positive for marijuana.

A more complex laboratory test that uses chromatography-mass-spectrometry to identify individual molecules is far more accurate than POC tests, but they cost thousands of dollars -- something many insurers and patients are unwilling or unable to pay for.

Instead of conducting additional tests or giving a patient the benefit of the doubt, some doctors take the easy way out by dropping patients like Paulette.

“The problem now has become that since this test, no pain clinic will see me, let alone let me tell my side of the story,” says Paulette, who has been struggling for the past year to clear her name and get the pain medication she needs.

“Knowing I have a legitimate chronic disease there is no cure for, why would I jeopardize myself by doing something that would put me in a position to not have the medicine I needed to help me live somewhat of a normal life?” she asks.

Paulette has called different lawyers and even the ACLU, but no one has taken her case. She’s also written to the state medical board, believing her doctor didn’t follow proper protocol before dismissing her.

“As of now a patient who legitimately suffers from chronic pain has no voice, recourse or method to keep them from being falsely accused of failing a urinary drug test,” she adds.

Patient Bill of Rights

Paulette thinks it’s long past time for a “Patient Bill of Rights” – one that spells out exactly what’s expected of doctors andpatients before, during and after a drug test, including:

1. Make patients aware that UDT’s can have false positives and false negatives.
2. Inform patients what kind of test they are taking.
3. Make sure the patient and doctor have a list of all prescription drugs the patient is taking, including over-the-counter meds, vitamins and supplements that could affect the test results.
4. Make patients aware what consequences they could face if a test result is abnormal.
5. Make sure the patient has a signed copy of their pain contract or drug agreement.
6. Allow the patient to observe the urine sample being sealed in front of them.
7. Make patients aware that insurance companies do not always pay for drug tests.
8. Make doctors follow guidelines if there is an abnormal test result. Have them tell the patient in person, instead of a generic letter dismissing them.
9. Allow at least one more reliable drug screen to be sure false positives or negatives did not occur.

Paulette says pain patients have paid a price for too long in the “War on Drugs” – becoming casualties of misguided policies they have no voice in. 

“All of these battles are between the DEA, insurance companies and doctors,” she says. “The one person that is left out is the patient who is the one suffering. that only has the option of seeing a doctor for their chronic pain. This leads them to such things as buying street drugs, depression, committing suicide, and other health problems because their legitimate chronic pain is not under control.”

Pain Education Improves Opioid Prescribing

By Pat Anson, Editor

A safe opioid prescribing course --- aimed at filling in gaps in pain education at many medical schools -- can help reduce the abuse and misuse of opioids, according to a new study published in the journal Pain Medicine.

Boston University School of Medicine launched its Safe and Competent Opioid Prescribing Education (SCOPE) program in 2013, offering live or online courses in chronic pain and safe opioid prescribing practices.

A survey of over 10,000 doctors who took the SCOPE program found that two months after the training about two-thirds of participants reported greater confidence in their prescribing practices, and 86 percent improved how they prescribed opioids and monitored patients.

"Our program improved knowledge, attitudes, confidence and clinical practice in safe opioid prescribing," said corresponding author Daniel Alford, MD, associate professor of medicine at Boston University School of Medicine and course director of the SCOPE of Pain program.

SCOPE was the first program to receive funding from the Food and Drug Administration’s Risk Evaluation and Mitigation Strategy (REMS), which requires opioid manufacturers to fund continuing education programs in pain management.

"While education cannot be the only strategy to combat this national crisis, it can help improve clinician behaviors and be a major part of the solution,” said Alford.

An earlier survey of physicians by Boston University found that many lacked confidence in managing patients on opioids. Over a quarter (28%) said they had not completed certified medical education (CME) in safe opioid prescribing. Many also said they lacked the time or staff to implement an opioid monitoring system for patients, such as drug testing and pill counts.

Only a quarter of the doctors surveyed said they were very confident about their ability to safely manage chronic pain with opioids.

Pain education for doctors – or the lack of it – is such a concern that the National Pain Strategy considers it a top priority.

“Many health professionals, especially physicians, are not adequately prepared and require greater knowledge and skills to contribute to the cultural transformation in the perception and treatment of people with pain,” a draft version of the report states. “Core competencies in pain care are not fully developed and generally do not inform undergraduate curricula in health professions schools or graduate training programs, even those in pain medicine.”

A 2012 study published in the Journal of Pain  called pain education in the U.S. and Canada “lackluster” and warned that unless steps were taken to improve the training of pain physicians, “the crisis in pain care and resultant deaths from opioid abuse will only spiral upwards.”

The study of 117 U.S. and Canadian medical schools found that less than 4% required a course in pain education and only one in six schools offered a pain elective. A large number of U.S. medical schools do not have any pain courses and many of those that do have less than five hours of classes.

The Painful Truth: How Patients Are Treated Shamefully

Lynn Webster, MD, is past President of the American Academy of Pain Medicine, vice president of scientific affairs at PRA Health Sciences, and one the world’s leading experts on pain management. He treated people with chronic pain for more than 30 years in the Salt Lake City, Utah area.

Dr. Webster’s new book, “The Painful Truth,” is a collection of stories involving several of his former patients, who struggled with the physical, emotional and financial toll that many chronic pain sufferers experience.  

Pain News Network editor Pat Anson recently spoke with Dr. Webster about his book.

The interview has been edited for content and clarity.

Dr. Lynn webster

Anson: Dr. Webster, you’re no longer practicing medicine, but you’re still very involved in the pain community and in research. Why write this book now at this stage of your career?

Webster: It takes a lot of time to write a book, as you can imagine, and it’s taken me four years to get to this point.  I think that at this stage in my career I can look back and put together a story about the people who I’ve taken care of for most of my career that I’m not sure I could’ve done in the middle of it. I think that’s given me the ability to look back and reflect and feel the heartache that patients have, and my inability to deliver to them everything that I wanted to deliver to them, because of all of the barriers and obstacles in healthcare.

I’m hoping that my book is going to be a seed that will contribute to a cultural change, a social movement that will bring some dignity and humanity to a large population of our country.

Anson: In your book you said the painful truth is that people in pain are treated shamefully. What did you mean by that?

Webster: When I was growing up on a farm I observed something as a young boy that always puzzled me and that was watching the injured or sick animals. We had all sorts of animals; cows, pigs, sheep, and chickens, and I could see that the injured somehow were always separated from the healthy ones. It wasn’t that the sick separated themselves from the healthy, but the healthy separated themselves from the injured or the ill.

I see that to some degree in people and I wonder if this hasn’t been a biological aspect of survival for man from the beginning. We as humans are better than that; we’re better than we may have been thousands of years ago.

Today, I think that it is shameful that people are stigmatized because they have pain, they’re isolated, and they’re denigrated often. Because of our healthcare system, at least in this country, they’re viewed as addicts, lowlife’s, and druggies. That’s rarely true and it absolutely prevents, it really contributes to the harm that pain sufferers feel towards themselves and their inability to get the type of care they need. I think that it hurts our society in so many different ways, but most importantly the people in pain.

Anson: A lot of your book is dedicated to telling the stories of some of the pain patients that you treated. Virtually every one went through what you just described, where they had trouble getting proper treatment, they had trouble with their jobs, with their families, and with their friends. Is that why you write the book in this way, so that their stories get across the point you’re trying to make?

Webster: Absolutely. It’s less important that a physician tells a story than a patient tells their story. I wanted this book to be felt by the readers, to understand what people in pain experience and the struggles they have.

Anson: You wrote that, “People in pain need to be both treated by medical professionals and supported by all the important people in their lives.” Is that happening?

Webster: No, of course not. There are some patients that have pain who have great support structures in their personal life. For example Alison, she is an individual who had what I thought was the quintessential family support. Were it not for her mother, father and sister, she could’ve gone down the path that too many others take, which would be resignation rather than resilience. It’s one where drugs are used to cope and to escape the pain, physical but also the emotional.

Too many people are separated and too few have the structure of the support system that Alison had.  Our healthcare system is abominable. It shamelessly abandons them with limited resources, limited access and actually a labeling of the individual as if they’re a leper; they have a disease that is contagious.

Anson: Is the average physician in U.S. prepared to treat chronic pain?

Webster: No. I think it’s been reported that medical schools average less than 10 hours of education on pain and even less for addiction. Yet this is the number one public health problem in America and it’s not recognized by the CDC like many other disease states have been.

And so very few physicians understand what pain is. In fact, many think that it’s just a symptom and you never die from pain which is categorically wrong. As I write in my book, pain can be as malignant as any cancer and it can be just as devastating. It can take the soul but it also takes the life of some individuals when we ignore it and when we’re unable to provide them the relief that they deserve.

Anson: If you were a young man again in medical school and trying to decide what specialty to go into, knowing what you know today, would you go into pain medicine?

Webster: Without a doubt, there is no hesitancy in this response; I love the field that I’ve been in. As an anesthesiologist I could’ve stayed in the operating room and honestly the compensation of doing that would have been far better than the path that I chose. But the rewards I’ve received from trying to make a difference and the thank you’s that I’ve received will never be matched by any kind of financial or professional recognition in any other areas.

The most rewarding part of life is really to be able to make a difference in someone else’s life. And I think I’ve been able to do that with hundreds, if not thousands of individuals. That actually is the reason for the book. I’m hoping the book is going to make a difference for more people than I could physically touch in my clinic.

Most of the people that I saw as patients were already experiencing a large amount of pain, they’ve been through the mill and many had their chronic pain for years before they came to see me. We are basically going to be taking care of them the rest of their life. We do get to know them, much like a primary care person does to a family they’ve been caring for, and so we get to know them well. They get to know us. We also begin to see the struggles that they have in the system and with the rejection of their families sometimes, their friends, the isolation. And we become the only source that’s grounded, that gives them potential hope. I took that very seriously and I think that’s why it was so rewarding for me.

Anson: You wrote that you’re neither pro-opioid or anti-opioid. What do you mean by that?

Webster: My focus has never been about making opioids available or that they should be used. In fact ten years ago I started the first national campaign about the risk of opioids. My campaign was called Zero Unintentional Overdose Deaths and you can still find that on the Internet. I did a lot of work at trying to understand the potential risks and mitigate those risks so we can prevent people from harm because I knew one day that if we couldn’t prevent people from being harmed from opioids that there would be political response to this that could be very harmful to a large number of people who are not harmed by opioids.

I think the focus should always be about what’s best for a patient and not about whether a drug or a certain treatment is good or bad. All treatments have potential risks and complications, and we need to evaluate whether or not the potential benefit outweighs the potential risk or harm and it has to be patient centered. So my focus has never been about really any treatment, but it’s always been about what’s best for the patient. I’m more anti-pain than I am pro or anti-opioid.

Anson: You prefer a multi-disciplinary approach to pain treatment?

Webster: Yes, it’s been demonstrated that for people with moderate to severe chronic pain, the type that’s not likely to be resolved, it is best managed in a multi-disciplinary, integrative approach. I see the need for more cognitive behavioral therapy. We should always tap into the different treatments that have low risk associated with them before we ever tap into something that has more risk, for example opioids or even interventional treatments we as anesthesiologists and some of the other pain specialists can provide.

Much about pain is really learning how to cope, how to deal with it from day to day and how to manage the stress that’s associated with it because stress augments all pain. And so it’s really important that we use all of the resources that we have to manage the pain and not just a single modality, certainly not opioids or spinal cord stimulators, but look at how we can manage this in a more mindful way, even as clinicians. I use that word intentionally because mindfulness is really what the doctor needs to use as much as the patient in order to optimize the treatment with the lowest risk.

Anson: Has the pendulum swung too far against use of opioids?

Webster: I think there’s too much focus on opioids by almost everyone. And what it has done is it’s forgotten about people. Opioids can cause a great deal of harm, we see way too many people harmed from opioids. But certainly a vast majority of people who have been exposed to opioids are not harmed by them and there are countless number of people, a huge number of individuals who have been on opioids for decades, that believe very strongly that they’ve improved their lives and they could not live without them.

I think the focus is in the wrong place. Our focus should not be on opioids and whether they should or should not be prescribed, but what is the best treatment for the patient? And if opioids are inappropriate as a pain treatment, then I say all of the anti-opioid people as well as the individuals who are interested in helping people with pain should come together and demand that we have more money invested in research so we can replace opioids entirely.

We cannot always know who’s going to have an addiction triggered by exposure. As I pointed out in my book, Rachel just went in for an appendectomy and that initial opioid that she received lead her down a serious, dreadful path because she didn’t have the social support to keep her from taking that path.

I think that the anti-opioid people and those of us who are interested in bringing some dignity and humanity to a large population of people in pain need to come together and insist that we have a Manhattan Project basically and to discover safer and more effective therapies that are not addictive.

Anson: The final version of National Pain Strategy will soon be released, with the goal of advancing pain research, healthcare and education in the U.S.  From what you’ve seen and heard so far about it, are they on the right track?

Webster: Yes, I think it’s an important step forward. I think that it brings most importantly the government into the picture, recognizing the need that we do something on a national scale and that alone is a big step forward.

It’s kind of like in my book there are three important words, “I believe you.” This is really the way the government can say, “I believe you.”  There is a problem in this country with the way in which we treat pain and the National Pain Strategy is about how they’re going to address that. Having the federal government say I believe you, there is a problem, let’s see if we can change the way pain is treated in this country is a huge step forward.

Anson: Thank you, Doctor Webster.

You can follow Dr. Webster on his blog, and on Twitter @LynnRWebsterMD, Facebook and LinkedIn.

Purdue Pharma's 'Misleading' Websites

By Pat Anson, Editor

Days after launching a new website promoting abuse deterrent technology, drug maker Purdue Pharma has reached a settlement with New York’s Attorney General in which the company agreed to be more transparent about how it promotes itself in “unbranded” websites.

The maker of OxyContin also admitted its sales representatives contacted doctors who were on a “No Call List” -- even after they were red flagged for possible abuse and diversion of opioids.

“Over the past two decades, New York has experienced a sharp increase in opioid addiction,” said Attorney General Eric Scheiderman.  “My office will work to ensure that prescription drugs are marketed and prescribed responsibly.”

The Attorney General’s investigation found that one of Purdue’s websites, In the Face of Pain, could “mislead consumers” by suggesting that its content was neutral and unbiased, when in fact nearly a dozen “advocates” who appeared on the site and in YouTube videos were paid nearly a quarter of a million dollars by Purdue.

“The website failed to disclose that from 2008 to 2013, Purdue made payments totaling almost $231,000, for speaker programs, advisory meetings and travel costs, to 11 of the Advocates whose testimonials appeared on the site. The videos on YouTube also fail to disclose Purdue’s payments to the Advocates. Purdue’s failure to disclose its financial connections with certain Advocates has the potential to mislead consumers by failing to disclose the potential bias of these individuals,” the settlement states.

The agreement calls on Purdue to disclose financial relationships with any individuals, including doctors and other healthcare professionals, that endorse the benefits of pain treatment.

Purdue removed the profiles of the paid “Advocates” from In the Face of Pain in April 2015, after the attorney general’s investigation was well underway.

The settlement also takes Purdue to task for its sales practices. Purdue admits that its sales representatives on at least three occasions contacted doctors on a “No Call List” of 103 physicians in New York state who the company suspected may have been involved in the abuse and diversion of opioids. The calls were made to promote OxyContin.

Purdue sales representatives, who amazingly were not required to check the company's No Call List, made about 1,800 sales calls to doctors on the list over a six year period, “some quite extensively,” even buying meals for about a third of them.  It's not clear if the sales calls were made before or after the doctors were added to the list. Some of those doctors were later arrested or convicted for illegal prescribing of opioids.

A company spokesman told Pain News Network that sales calls could have also been made to doctors on No Call Lists outside of New York.

Under the terms of the settlement, Purdue agreed to adopt more “red flags” to identify doctors who may be prescribing opioids inappropriately or illegally. Sales representatives will also be required to check the No Call List before contacting a provider and will be disciplined if they don’t

As part of the settlement, Purdue Pharma will also pay $75,000 in fines and costs.

“Rather than pursuing an expensive, lengthy and uncertain litigation-based approach, the Attorney General’s initiatives will yield immediate and improved efforts to address issues designed to enhance public health,” said Robin Abrams, Vice President and Associate General Counsel for Purdue Pharma.

“For more than a decade we’ve implemented industry-leading programs designed to reduce the abuse and diversion of prescription medicine. We’ve relied on the input and encouragement of law enforcement officials, like the Attorney General, to continually upgrade and improve our programs.”

Purdue’s New Website

Early this week, Purdue introduced Team Against Opioid Abuse, a new website designed to help healthcare providers and laypeople learn about different abuse-deterrent technologies that make opioid medications harder to misuse and abuse.

Like In the Face of Pain, Team Against Opioid Abuse is not clearly identified as a Purdue Pharma website, except by a small copyright notice at the bottom.

“Using clear graphics and easy to understand language, the website features sections about why it's critical to deter abuse and how all the members on the healthcare team can make a difference,” Purdue said in a press release announcing its newest website.

In the wake of the New York settlement, the company said it would review the website, listen to feedback and incorporate any necessary modifications. 

Purdue was also in the news recently after the U.S. Food and Drug Administration quietly approved OxyContin for use by children aged 11 to 16 who suffer from chronic pain and who are already being treated with opioids.

The FDA’s move angered many anti-addiction advocates because the agency did not consult with an outside advisory panel or hold any public hearings before making its decision.

“We've known for a long time how immoral this company is.  As far as Purdue's role, this comes as no surprise; they have had this idea for some time now, as it represents a very lucrative market for them.  We've also known for a long time how unethical the FDA is.  This brings both truths out in the open,” said Pete Jackson, president of Advocates for the Reform of Prescription Opioids, who lost his 18-year-old daughter Emily to a single dose of OxyContin in 2006.

OxyContin was introduced to the U.S. in 1996 and soon became a blockbuster drug for Purdue,  reportedly generating profits in excess of $10 billion. Many believe it also helped fuel an “epidemic” of opioid addiction and overdoses, leading to the deaths of thousands of people.

In 2007, a class action lawsuit against Purdue for deceptive marketing ended when several company executives pleaded guilty to a felony count of misbranding OxyContin, by playing down its addictive and abusive side effects. The company and its executives were fined $634 million.

Florida’s ‘Modest’ Reduction in Opioid Prescribing

By Pat Anson, Editor

Florida was one the first states in the country to get serious about fighting the “epidemic” of prescription drug abuse.

In 2010, a year when eight Floridians were dying every day from drug overdoses, the state started cracking down on rogue pain clinics – “pill mills” -- and began to closely monitor the number of opioid prescriptions written and filled by physicians and pharmacies.

By most accounts, the crackdown has been a success – overdose deaths dropped and over 250 pain clinics were closed. But legitimate pain patients also began to complain that they couldn’t get their prescriptions filled. Their search for a pharmacy willing to dispense opioids – a search that could take hours or days – even got a name: Florida’s “Pharmacy Crawl.”

Which makes a new study in JAMA Internal Medicine all the more surprising.

Researchers analyzed an extensive database of prescription claims and found that there was only a “modest” decline of 1.4 percent in the number of opioid prescriptions in Florida from 2010 to 2012.

The reductions were generally limited to prescribers and patients with the highest rates of opioid prescribing and use – meaning the average pain patient shouldn’t have been affected at all.

That 1.4% reduction, researchers say, was a “statistically significant” decline by some measures. But they also acknowledge that Florida’s crackdown on opioids “had no apparent effect on days’ supply per transaction or on total number of opioid prescriptions dispensed.”

That less than overwhelming finding raises questions about the effectiveness of the crackdown and, in particular, prescription drug monitoring programs (PDMPs). Almost every state has implemented a PDMP in the last few years, spending millions of dollars to track patients with electronic databases that have yet to be proven effective. 

“Our findings highlight the need for more evidence demonstrating the effect of PDMP and pill mill laws,” wrote lead author Caleb Alexander, MD, of the Johns Hopkins Bloomberg School of Public Health.

Effect on Pain Patients

So if the number of opioid prescriptions in Florida barely budged, what about all those pain patients who claim they couldn’t get a prescription filled?

"The opioid lobby and media they've influenced portray Florida's efforts as draconian. We keep hearing that pain patients in Florida have lost access to opioids.  The study's findings refute these claims," said Andrew Kolodny, MD, a prominent critic of opioid prescribing practices who is President of Physicians for Responsible Opioid Prescribing.

“Dr. Kolodny can't see the whole picture just by looking at this short term study,” says Donna Ratliff, a chronic pain patient who founded the Fight for Pain Care Action Network, a non-profit group lobbying for adequate pain care in Florida.

“Things did get draconian after the DEA fined the distributors and chain pharmacies. The media headlines stigmatized the pharmacies and doctors early on into not treating legitimate pain patients out of fear.” 

It was in 2012 that Cardinal Health, one of the nation’s largest drug wholesalers, was fined $34 million by the DEA after it failed to report suspicious orders for hydrocodone at a distribution facility in Lakeland, Florida. Shipments of controlled substances from that facility were suspended for two years.

Walgreens and CVS Pharmacy were also fined tens of millions of dollars for violating rules and regulations for dispensing controlled substances. Afterwards, both pharmacy chains began to screen patients with opioid prescriptions more carefully, and told their pharmacists not to fill them if anything appeared suspicious.

Those developments, according to Ratliff, were not fully covered during the opioid prescription study, which ended in September 2012.

“This induced the pharmacy crawl, that got worse as time went by,” she told Pain News Network.

In a recent survey of hundreds of pharmacies, drug wholesalers and physicians by the General Accounting Office (GAO), over half said DEA enforcement actions had limited their ability to supply drugs to patients. Many said they were fearful of being fined or having their licenses revoked by the DEA.

“Some pharmacies may be inappropriately delaying or denying filling prescriptions for patients with legitimate medical needs,” the GAO report states.  

FDA Approves OxyContin for Kids

By Pat Anson, Editor

In a controversial move, the U.S. Food and Drug Administration has approved OxyContin for use by children aged 11 to 16 who suffer from severe, long-term pain.

OxyContin is a potent, extended release opioid painkiller that has been blamed for fueling an “epidemic” of prescription drug abuse and addiction in the U.S.

One critic, whose teenage daughter died after a single dose of OxyContin, called the FDA’s decision “beyond disgusting.”

The agency did not make a formal announcement about its decision, issue a news release, or consult with an outside advisory panel about the risks and benefits of making OxyContin available to pediatric patients.

Instead, the news was revealed in an FDA blog posting, an interview with Sharon Hertz, MD, a Director in the FDA’s Center for Drug Evaluation and Research.

“OxyContin is not intended to be the first opioid drug used in pediatric patients, but the data show that changing from another opioid drug to OxyContin is safe if done properly,” Hertz said.

“In pediatric patients who require opioid treatment to manage pain, extended-release opioids may be a useful alternative because they are taken only once or twice per day rather than every 4 to 6 hours. Fewer daily doses may free patients for physical therapy appointments, allow them to go home from the hospital sooner, and may help them to sleep through the night without waking up from pain. So from that perspective it's very useful.”

Hertz said the FDA decision was a "team effort" involving physicians, pediatricians, clinical pharmacologists, statisticians, ethicists and opioid experts. It came after the safety and efficacy of OxyContin was studied in children who were prescribed the drug after extensive trauma or major surgery. 

“Prior to this action, doctors had to rely on adult clinical data to shape their decision-making in treating pediatric patients. This program was intended to fill a knowledge gap and provide experienced health care practitioners with the specific information they need to use OxyContin safely in pediatric patients,” said Hertz.

She said OxyContin should only be prescribed to pediatric patients when they have shown they can tolerate a 20 mg daily dose of oxycodone, an immediate release opioid.  

The Duragesic patch, which contains fentanyl, is the only other extended release opioid product approved for use by children.

Hertz hinted the FDA would be approving more opioids for pediatric patients in the future.

“Quite a few of the newer opioid drugs have pediatric studies underway to gather the data that will help prescribers use them safely. I expect that our teams will be working together a lot more in future to make sure that new pediatric pain management options continue to be safe for children in the U.S.,” Hertz said.

OxyContin has a controversial history. It was introduced to the U.S. in 1996 and soon became a blockbuster drug for Purdue Pharma, reportedly generating profits in excess of $10 billion.

In 2007, Purdue and three of its top executives pleaded guilty to felony criminal charges for the off-label marketing of OxyContin – falsely telling doctors it had low potential for addiction.

Critics, who blame Purdue for thousands of fatal OxyContin overdoses, are angry about the FDA's decision to approve the drug for children.

“We've known for a long time how immoral this company is.  As far as Purdue's role, this comes as no surprise; they have had this idea for some time now, as it represents a very lucrative market for them,” said Pete Jackson, president of Advocates for the Reform of Prescription Opioids.

Jackson lost his 18-year-old daughter Emily to a single dose of OxyContin in 2006.

“We've also known for a long time how unethical the FDA is,” Jackson said in an email to Pain News Network.  “This brings both truths out in the open.  This is the pinnacle of dysfunction in our federal government: that a federal agency would openly sanction the use of a deadly narcotic on kids without even an advisory committee meeting to hear from the experts and the public is beyond disgusting.”

By 2010, nearly half the patients entering drug treatment facilities for opioid abuse said they had used OxyContin to get high at least once in the previous 30 days. That same year Purdue introduced a reformulated version of OxyContin to discourage patients from crushing the tablets for snorting or injection.

As a condition of its approval for use in pediatric patients, Purdue is required to conduct a follow-up study examining rates of injury, overdose, accidents and medication errors involving OxyContin in pediatric patients.

Sedatives or Opioids: Which is the Bigger Problem?

By Pat Anson, Editor

New research shows that the prescribing of opioid pain medications is declining in United States, but the co-prescribing of sedatives with opioids remains a serious problem that raises the risk of an overdose.

In a study of over 35,000 patient visits for acute and chronic pain from 2001 to 2010, researchers found that the prescribing of benzodiazepines was three to four times more likely when opioids were prescribed.

Over a third of the patients prescribed opioids for chronic musculoskeletal pain were given a sedative. And patients with a history of psychiatric and substance abuse disorders were even more likely to be co-prescribed opioids and sedatives.

"Multidrug use is the trailing edge of the opioid epidemic," said Mark Sullivan, MD, a professor of psychiatry and behavioral sciences at the University of Washington School of Medicine. "We are making progress on decreasing opioid prescribing, but co-prescribing of opioids and sedatives has not decreased."

The study, published in the journal Pharmacoepidemiology and Drug Safety, estimates that opioid prescribing peaked in 2007. It’s the latest indication there has been a reversal in the growth of opioid prescribing – which has long been blamed for the so-called “epidemic” of prescription drug abuse.

In April, another study was released showing that the painkiller hydrocodone was no longer the most-widely prescribed drug in the U.S.

While opioid prescribing is in decline, researchers found no evidence that the co-prescribing of opioids and sedatives is also dropping. Opioids, benzodiazepines and muscle relaxants are all central nervous system depressants. Mixing the drugs is potentially dangerous because their interaction can slow breathing and raise the risk of an overdose death.

"Patients who are on long-term combined opioid and benzodiazepine therapy are often on a treadmill," said Sullivan. "They feel relief when they take their medications and withdrawal when they stop, so they continue this combined therapy, even though many function poorly and some will die as a result."

A study by the Centers for Disease Control and Prevention found that as much as 80 percent of unintentional overdose deaths associated with opioids may also involve benzodiazepines. Nearly 6,500 people died from overdoses involving benzodiazepines in 2010.

“We are seeing a disturbing increase in the use of benzodiazepines, mostly Xanax and Klonopin and Adderall. I call this the evil trifecta,” said Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis, Missouri area. “To make matters worse, the use of heroin continues to grow as Mexican farmers are switching to growing the opium poppy.”

While fewer opioids are being prescribed for pain, Menzies says there has been explosion in the use of buprenorphine – a weaker opioid – to treat addiction. For many years, buprenorphine was only available under the brand name Suboxone, but now there are several other buprenorphine brands competing in the lucrative addiction treatment market. 

“We have reduced the number of prescriptions for opioids but the use of opioids (primarily buprenorphine) are growing. Never in the history of drug treatment, has the sale of a medication exceeded $2 billion,” said Menzies in an email to Pain News Network.

Recent studies by the Substance Abuse and Mental Health Services Administration (SAMHSA)  found a ten-fold increase in the number of emergency room visits involving buprenorphine. Over half of the hospitalizations were for non-medical use of buprenorphine – meaning  many users took the drug to get high.

Over 50,000 visits to ER’s in 2011 involved a combination of benzodiazepines and opioids, according to SAMHSA.

Fear of DEA Causing Drug Shortages

By Pat Anson, Editor

Millions of dollars in fines and thousands of investigations by the U.S. Drug Enforcement Agency have had a chilling effect on the nation’s drug supply chain, leading to quotas, shortages and legitimate prescriptions going unfilled, according to a new government report.

Pain patients have complained for years that it was becoming difficult to get opioid prescriptions filled, but the DEA called the evidence of that “anecdotal” and said it was not responsibility for any shortages.

In a survey of hundreds of pharmacies, drug wholesalers and physicians by the General Accounting Office (GAO), over half said DEA enforcement actions had limited their ability to supply drugs to patients. Many said they were fearful of being fined or having their licenses revoked by the DEA. Others blamed the agency for poor communication and unclear rules.

“In the absence of clear guidance from DEA some pharmacies may be inappropriately delaying or denying filling prescriptions for patients with legitimate medical needs,” the GAO report states.  

In recent years the DEA has fined distributors, pharmacies and practitioners over $94 million for violations of the Controlled Substances Act. Over 4,500 criminal investigations were also launched.

The crackdown helped lead to a reduction in prescription drug abuse and diversion, but it has also disrupted the drug supply chain. The GOA estimates that over half the distributors have placed a strict quota system on the amount of controlled substances that pharmacists and physicians can order.

“A distributor reported it refuses to distribute large volumes of controlled substances to prescribers or pharmacies that specialize in pain management, even if it has no evidence that the prescribers or pharmacies are engaged in diversion,” the GAO said.

One pharmacy chain told the GAO they were “afraid of being the target of DEA enforcement action even if they fill a prescription in good faith.”

Another small pharmacy chain said “we take things to the extreme to the point where we have received complaints from providers for turning away legitimate patients.”

“The DEA has NO communication out to pharmacies at all. The DEA is not preventative, it is all reactive,” one pharmacist complained. “The only experience we get with the DEA is hearing when they investigate and levy fines against a pharmacy for common pharmacy practices.”

The GAO recommended that the DEA improve its communication with distributors, pharmacists and practitioners so they would have a better understanding of what’s expected of them.

In response to the GAO report, a top DEA administrator wrote a letter stating there was only “anecdotal data that patient care is being compromised.”  

“The DEA would like to emphasize that it has no authority to control otherwise legitimate business decisions of registrants,” wrote Joseph Rannazzisi, deputy assistant administrator of the DEA’s Office of Diversion Control. “DEA and state partners have repeatedly and emphatically informed distributors that arbitrary thresholds are inappropriate, negatively impact legitimate patients, and are an inadequate substitute for fulfilling their obligations under the CSA (Controlled Substances ACT).”

The GAO report is the second this year to criticize the DEA for its management and policies. In March, we reported the GAO had faulted the DEA for "weak internal controls" and poor management of the system under which controlled substances are produced and distributed. The GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers.

The shortages have grown worse in recent years, according to many pain patients, who say controlled substances such as hydrocodone are increasingly difficult to obtain in some parts of the country.

Under federal rules, the manufacture and distribution of controlled substances is regulated by the DEA, while the Food and Drug Administration regulates what conditions the medications can be taken for. The two agencies are supposed to work together when shortages develop, but according to the GAO they do not have a “sufficiently collaborative relationship” and even “disagree about what constitutes a shortage.”