You’ve probably seen the dramatic photo of the Ohio couple slouched, overdosed, and passed out in the front seats of a car, with a little kid sitting in the back seat.  (View the video here)

Even if you haven’t seen that picture, images and words of America’s opioid overdose epidemic have captured headlines and TV news feeds for the last several years. 

But there’s a different image seared into my mind, a mental picture of a different little kid and two adults. This one never made it into the news, but it’s just as real. I can’t get this “picture” out of my mind ever since I wrote about it for my new book, “The Global Pain Crisis: What Everyone Needs to Know.” 

It took place in India, on June 1, 2014. The little boy in this scene had been suffering unbearable pain for most of his eight years, pain triggered by a severe genetic disorder. The hospital he was in, like most hospitals in India, had no morphine. 

Eventually, the parents did the only thing they could think of to stop his pain. They killed him. Then they committed suicide, leaving behind a note saying they could not stand to watch him suffer any longer. 

In this country, mention the word “opioid” and people think “overdose,” “abuse” or “death.”  But in much of the rest of the world, the problem is quite different: A massive shortage of available morphine for millions of people suffering in pain, people like this Indian boy. 

Morphine costs just three cents a dose. It is safe, when used properly, and effective. Yet tens of millions of people around the world suffer in pain because of the lack of access to controlled medicines, according to the World Health Organization. That’s not just people at the end of life, but people who’ve had accidents or been the victims of violence, people with chronic illnesses, people recovering from surgery, women in labor.

In some countries, according to Treat the Pain, part of the American Cancer Society, the situation is truly desperate. Take Ethiopia, a nation of 90 million people. For that huge population, there is only one ward (with 10 beds) offering morphine in the entire country. 

The problem, which I explore in my book, is excessive regulations governing morphine and other “essential medicines.” Back in 1961, the world community adopted an international agreement called the Single Convention on Narcotic Drugs, which then set up the International Narcotics Control Board. 

The board has two jobs. One is to control drug abuse and diversion. The other is to ensure access to opioid drugs for people in pain. Essentially, it only does the former. Yet failure to treat pain amounts to “torture by omission” in the eyes of some medical ethicists. 

Clearly, as the tragic Ohio photo shows, there is a need to curtail abuse of opioids. But there is also, just as clearly, a need to make morphine and other powerful pain-relievers available to the millions of people who need them. 

With all the other tragedies competing for the world’s attention – war, terrorism, dictators, economic problems – the lack of access to morphine never makes it to the headlines. 

But it should. There is no question that we should try to keep powerful drugs out of the hands of would-be abusers and that we should provide much better treatment for people who become addicted. 

There is also no question that a little boy in India should have had access to morphine. His death, and the deaths of his parents, didn’t make the news. 

I wish it had.

The U.S. Centers for Disease Control and Prevention recently came out with controversial proposed guidelines for opioid prescribing through a process that critics say may harm pain patients and is based on relatively low-grade evidence.

One of those critics is Cindy Steinberg, national director of policy and advocacy for the U.S. Pain Foundation, a patient advocacy group which receives funding from opioid manufacturers. Steinberg said in an interview and in emails that she’s worried the guidelines may negatively impact patients suffering with severe pain. “I am concerned that if these guidelines go forward as they are now written, they will lead to further restrictions on access to opioids for people with unremitting pain who truly need them and take them responsibly,” she said.

Dr. Jane Ballantyne, president of the non-profit Physicians for Responsible Opioid Prescribing (PROP), which is part of a larger group involved in the guidelines process, said in a telephone interview that the worry about limited access to opioids for chronic pain patients is a “very legitimate fear.” But, she added: “We don’t want to reduce access for people already dependent on opioids. The guidelines are designed to not have so many people dependent on opioids in the future…”

Ballantyne said that the new guidelines are similar to previous guidelines with two key exceptions: lower dose limitations and the recommendation that, for acute pain not related to major surgery or trauma, opioids should be prescribed for only three days.

The month-long period for public comment on the proposed guidelines will be over Jan. 13.

A major concern of some critics is the lack of solid evidence backing up the guidelines, which give recommendations on prescribing practices; they include when to start opioids, how to establish treatment goals, how to discuss risks and benefits, recommended limitations on drug doses, duration of treatment and other issues.

For instance, the fifth of the 12 recommendations says that physicians should generally avoid increasing dosage to more than 90 “morphine equivalents” per day. (Opioids differ in potency. One opioid may be three times as potent as another, so doctors use morphine equivalency tables to compare doses.)

But the quality of the evidence backing up this recommendation is rated only “3,” a low rating, acknowledged by the CDC itself. In addition, calibrating morphine equivalents is an inherently tricky process, with multiple, potentially conflicting formulas available. (Moreover, some patients in severe pain may need higher doses.)

The CDC guidelines are aimed at adults with chronic pain “outside of active cancer treatment, palliative care, and end-of-life care.” The guidelines are advisory, not mandatory, but are nonetheless likely to be a powerful influence on physicians, insurers and other government agencies.

The potential problems with the new guidelines are serious enough that on Dec. 18, the U.S. House Committee on Oversight and Government Reform sent a letter to Dr. Thomas Frieden, the CDC director, sharply questioning why the CDC recruited a so-called “core expert group” to write the guidelines instead of complying with standard government (FACA) regulations for establishing advisory groups. (FACA is the Federal Advisory Committee Act.)

On its website, the CDC says it did use a transparent process to create the guidelines.

Among the groups opposing the new guidelines is the American Cancer Society Cancer Action Network, (an advocacy group which lists major drug companies on its corporate member list) which has called for the CDC to withdraw the guidelines, stressing that they were based on “limited” and “low quality” evidence. In a letter to Frieden in October, the cancer group wrote: “We have concerns about the lack of evidence on which the guidelines were based, the methodology used to develop the guidelines and the transparency of the entire process.”

Seven of the 12 recommendations were  “very low quality evidence” and five of the 12 were based on “low quality evidence,” according to the cancer group’s letter, which also noted that the CDC’s attempt to solicit public input on the guidelines was “cursory and did not allow adequate opportunity for thoughtful responses.”

I asked the CDC to respond. In an email, a spokesperson said: “Clinical guidelines are always based on best available evidence, including low quality evidence. This does not mean ‘bad’ evidence, it means that not enough randomized control trials were conducted.”

Ballantyne, PROP’s president, acknowledged the lack of good randomized controlled trials on long-term safety and efficacy. But doing such trials is impractical, she said. From clinical experience, she added, “if you use opioids long term, they don’t give you good enough pain relief to warrant the risk.”

(The non-profit PROP “has received financial support from some of its members and from a few individual donors who have been personally impacted by the opioid crisis. We have never accepted corporate support,” according to its executive director, Dr. Andrew Kolodny.

The American Medical Association, on December 17, stated its concern that the guidelines lack “a patient-centered view and any real acknowledgement of the problems chronic pain patients may face.”

In other letters to the CDC (that I obtained) a number of industry-backed organizations expressed concerns, including the American Academy of Pain Management, the Oncology Nursing Society, the Interstitial Cystitis Association and the U.S. Pain Foundation.

The CDC guidelines note that prescription opioid sales have increased by 300 percent since 1999, but also say that “there has not been an overall change in the amount of pain Americans report.” But in 2011, the Institute of Medicine documented the growing chronic pain problem, noting that more than 100 million American adults now live with chronic pain, an increase over previous estimates. The IOM report said the incidence of chronic pain is growing and is likely to continue to do so.

For more details on the dispute over the proposed guidelines, here’s coverage by the AP and an editorial in The Washington Post. And here’s more on the larger opioid crisis from WBUR’s Tom Ashbrook.

(Originally posted on WBUR’s CommonHealth. To view comments, please visit WBUR.)

Governor Baker’s plan to increase opioid education, which he announced on Nov. 9 with the deans of the state’s four medical schools, gets it only half right.

It’s wonderful to teach future doctors how to prescribe opioids safely to reduce abuse and addiction. But the US is actually caught in the middle of two colliding epidemics, not just one: The well-publicized problem of opioid abuse, and the under-publicized epidemic of chronic pain, which affects 100 million American adults, according to the Institute of Medicine.

Unfortunately, medical schools not only fail to teach students how to prescribe opioids, they do an abysmal job of teaching about chronic pain itself. Chronic pain, which is not just acute pain that doesn’t go away after three to six months, is now known to be a disease of the nervous system in its own right, not just a symptom of something else. It is the main reason Americans go on disability and a leading reason people go to doctors.

Yet over four years of medical school, American med students get a median of only 9 hours of pain education, according to a 2011 study from Johns Hopkins. Even veterinary students get more – 87 hours, other research shows.

In the laboratory, pain researchers have discovered a lot about chronic pain: How the nervous system transforms itself as acute pain shifts to chronic pain. How microglial cells derived from the immune system help with this transformation. How a handful of genes play a major role in how susceptible a person is to chronic pain. How hormones such as testosterone and estrogen influence pain sensitivity.

But doctors on the front lines don’t know this because medical schools don’t teach it.

Doctors themselves are fully aware of how ill-prepared they are to help people in chronic pain. One survey by Harvard Medical School researchers found that half of doctors in primary care positions felt only “somewhat prepared” to counsel patients on pain management. Because they learn so little about pain in medical school, few young doctors have any desire to become pain medicine specialists. When professors at one medical school asked graduating med students what they would do when faced by a pain patient, one student spoke for many, “Run!”

Indeed, chronic pain appears to be an important driver of the rising suicide rate among white, middle-aged Americans, according to a study published last week by Princeton economists.

There are no hard data on how many people with chronic pain die by suicide every year. But it is known that people in chronic pain are significantly more likely then those not in pain to commit suicide. Given that there are 41,149 suicides every year, according to the National Center for Health Statistics, by inference, this suggests by inference that more than 20,000 American a year with chronic pains kill themselves. That would be more than the government’s figure of 16,235 deaths per year involving prescription opioids.

The other tragedy in all this is that because of time and reimbursement pressures, doctors on the front lines get only a few minutes with each patient. That’s not enough time to address the other issues in a person’s life that may be adding to the distress of chronic pain. Nor enough time to advise about non-drug treatments such as acupuncture, massage, exercise, meditation or alternatives such as marijuana.

The governor’s plan pays lip service to teaching med students how to evaluate a patient’s pain. But lip service is not enough. The state government has declared that substance use disorder is a “chronic, progressive, relapsing disease.”

So is chronic pain.

This week’s grim report about rising suicide and overall death rates among white, middle-aged Americans contains a slim silver lining. Here it is:

The new analysis by two Princeton economists, Anne Case and Angus Deaton, suggests that chronic pain — and the opioids used to treat it — may be a key driver of the rising deaths. While the “noisy” opioid epidemic has garnered near-daily headlines across the country for several years now, the equally horrible but silent epidemic of chronic pain has not yet broken through into the nation’s consciousness. Maybe things are beginning to change.

Many people still don’t realize it, but 100 million American adults live with chronic pain, many of them with pain so bad it wrecks their work, their families, their mental health and their lives.

There are no hard data on how many people with chronic pain die by suicide every year. But there are inferences. The suicide rate among people with chronic pain is known to be roughly twice that for people without chronic pain.

Since there are 41,149 suicides every year in the U.S., according to the National Center for Health Statistics,  it’s possible that roughly half of these suicides are driven by pain. Not proven fact, but plausible hypothesis. This would suggest that perhaps up to 20,000 Americans a year with chronic pain kill themselves, which would be more than the government’s tally of 16,235 deaths from prescription opioids every year.  According to a CDC spokeswoman:

In 2013, there were 8,257 deaths that involved heroin and 16,235 deaths that involved prescription opioids. These categories are not mutually exclusive: if a decedent had both a prescription opioid as well as heroin listed on their death certificate, their death is counted in both the heroin as well as the prescription opioid death categories.

The truth, of course, is devilishly difficult to figure out with any certainty. Many people in severe, chronic pain have, and should have, opioids available. But unless they leave a suicide note it’s virtually impossible to tell if they overdose on purpose or accidentally. That’s in stark contrast to a pain patient who ends his or her life using a gun. That’s clearly a suicide, with or without a note.

In the course of researching my 2014 book on chronic pain, I heard many grisly stories. One Salt Lake City truck driver I interviewed would be dead today if his wife hadn’t walked in on him with a gun in his mouth. He had been in severe headache pain and after many visits to the ER, was repeatedly dismissed as a drug seeker, even without a medical workup. (Eventually, he was diagnosed with two brain aneurysms, bulging weak spots in a blood vessel).

I also heard about a surgeon with shingles who could find no relief for his pain and took a scalpel to his back in an attempt to dig out the painful nerves; he wound up in his own ER — as a patient. I heard of another man with ophthalmic shingles who finally shot himself because of unrelieved pain. A Boston surgeon I met was on the verge of suicide due to unrelenting pain from a rare autoimmune disease.

The anecdotes go on and on. Unfortunately, from a statistical point of view, they are just anecdotes. And unlike opioid abuse deaths, the stories of these and other pain patients rarely make the headlines.

Nor do these cases routinely make it into the reports of medical examiners and coroners, according to Utah pain specialist Dr. Lynn Webster, writing in a recent issue of Pain Medicine News.

In this week’s Princeton study, the lead author, Anne Case, was particularly interested in the role poor health might play in suicide because, as she told The New York Times, she herself has suffered for 12 years from disabling and untreatable lower back pain. In her research, Case discovered that middle-aged people, unlike the young and unlike the elderly, were reporting more pain in recent years than in the past. One-third of people in this group had chronic joint pain in recent years and one in seven reported sciatica.

The dismal situation with chronic pain — and the potential link with suicide — is unlikely to improve until the federal government takes the pain epidemic seriously. While the government spends $2,562 on research for every person with HIV/AIDS, it spends only $4 for every person with pain.

Clearly, chronic pain needs more attention and more research dollars. After all, it is the main reason Americans go on disability.

And it appears to be driving growing numbers of Americans to kill themselves.

(Originally posted on WBUR’s CommonHealth)

Using a new brain scanning technology, neuroscientists at Massachusetts General Hospital in Boston have produced dramatic images showing how glial cells – cells derived from the immune system that live in the nervous system – get activated in chronic pain patients. The technology should not only help diagnose pain, but boost research into the novel idea of using an antibiotic and other anti-glial drugs to treat back pain. (Citation: Brain, March, 2015.)

When pain signals from nerve cells land on glial cells, the glia pump out chemical signals that then land on other nerve cells, ramping up transmission of pain signals to the brain. Hundreds of animal studies have shown that blocking glial activation reduces pain, but human studies have lagged behind.

The new technique, a merger of PET (positron emission tomography) and MRI (magnetic resonance imaging) showed clear evidence of glial activation in patients with low back pain. Neuroscientist Marco Loggia’s team compared nine patients with chronic back pain with nine matched controls without pain. In the pain patients but not the controls, the brain scans showed elevated levels of a protein called TSPO, a marker of glial activation. Strikingly, levels of TSPO were higher not just in the thalamus but in the somatosensory cortex, specifically in parts of the “homunculus” (a map-like representation of the body) corresponding to the lumbar spine and the leg, exactly where the pain patients hurt. (Curiously, the more intense the pain reported by the patients, the lower the levels of TSPO, perhaps because the increase in TSPO during the inflammatory response may itself have an anti-inflammatory component.)

The new technique expands the booming field of imaging to study pain. At Boston’s Children’s Hospital, neurobiology and neurologist David Borsook has used imaging to show brain changes in chronic pain patients responding to treatment.

The new study may also spur research into the idea of treating chronic pain with the antibiotic minocycline, which has the side effect of blocking glial activation. “It’s time to be more aggressive in this,” Loggia says. Sean Mackey of Stanford and University of Colorado neuroscientist Linda Watkins are also pursing the use of a form of naltrexone (an opioid blocker) to damp down glial cells.

(Letter to the Editor, published in The Boston Globe, January 1, 2015)

I WAS delighted to see two terrific stories on pain in Monday’s paper — the front-page story by Christopher Rowland (“Groups unite against curbing painkillers”) and the g section cover story by Deborah Kotz on children’s pain (“Pushing past pain”). Far too often in recent years, the press has focused almost exclusively on the problem of opioid, or narcotic, addiction and far too little on the far bigger, silent epidemic of chronic pain in both children and adults.

Both stories were fair, balanced, and realistic about the challenges faced by people in chronic pain — 100 million American adults, according to the Institute of Medicine. Chronic pain is actually a bigger problem than heart disease, cancer, and diabetes combined, yet it is often overlooked.

Judy Foreman

Cambridge

For several years now, pain researchers have been wondering about a question that lay folks, including federal government regulators, might dismiss as absurd: The idea that marijuana, far from creating more problems for people who use opioids (narcotics), might, at least in some cases, help prevent opioid overdoses.

The notion took hold several years ago in California, when oncologist Donald Abrams, chief of hematology and oncology at San Francisco General Hospital and a cancer specialist at the University of California, San Francisco Osher Center for Integrative Medicine at Mount Zion, began testing marijuana in chronic pain patients in a federally funded study. Patients inhaled vaporized marijuana three times a day for five days while taking their regular opioid pain relievers. In 2011, Abrams reported that pain was significantly reduced, by about 27 percent, when inhaled marijuana was added to the opioid regimen.

This finding suggests that marijuana may have a synergistic effect, enabling pain patients to get good pain relief with lower doses of opioids. It’s too small a study to constitute proof, to be sure, but it’s a scientific hypothesis that seems well worth pursuing — except to the feds.

Fast forward to late July 2014, when a different team of researchers, using a different approach, supported the findings. Dr. Marcus Bachhuber, an internal medicine fellow at the Philadelphia VA Medical Center and a Robert Wood Johnson clinical scholar, led a team that simultaneously analyzed opioid overdose deaths from 50 states between 1999 and 2010 and tracked the implementation of medical marijuana laws in the 10 states that had them during that period.

The findings, reported online in The Journal of the American Medical Association Internal Medicine, offer another bit of tantalizing evidence about marijuana’s role in mitigating the potentially lethal effects of opioids.

The team found that states that had legalized medical marijuana had a 24.8 percent lower average annual opioid overdose death rate compared to states that hadn’t. In 2010, that translated to about 1,729 fewer deaths than expected.

The Bachhuber team acknowledged that the finding is an association, not proof of causality, but added that if the relationship between medical cannabis laws and opioid overdose mortality is substantiated in further studies, laws permitting the use of marijuana as part of a comprehensive approach to pain relief might make sense.

Dr. Abrams agrees. In early August, he told me that the new finding “is consistent with the reality” of animal studies and his own work in human pain patients showing that “cannabis potentiates opioids — you can get away with less opioids if you add cannabis.” Particularly for patients in pain at the end of life who wish to communicate with their families and have trouble doing so if on high doses of opioids, doctors can “wean them off [opioids] by using cannabis.”

Abrams suggested to the National Institute on Drug Abuse (NIDA), that the agency consider a study on marijuana as adjunctive (or auxiliary) therapy for people in pain. The agency refused his request. It is longstanding NIDA policy to fund only studies of controlled drugs for their abuse, not their therapeutic potential. Abrams called that policy “unfortunate and short-sighted.”

In an editorial accompanying the JAMA study, Dr. Marie J. Hayes, a psychologist, clinical neuroscientist and addiction specialist at the University of Maine, wrote, “The striking implication is that medical marijuana laws, when implemented, may represent a promising approach for stemming runaway rates of non-intentional opioid analgesic-related deaths. If true, this finding upsets the applecart of conventional wisdom regarding the public health implications of marijuana legalization and medicinal usefulness.” Hayes and her co-author, Dr. Mark S. Brown, caution, however, that if medical marijuana laws afford a protective effect, it is not clear why.

In an interview with ABC News, Dr. Igor Grant, chief of psychiatry at the University of California, San Diego, and director of the Center for Medical Cannabis Research, suggests a synergistic, or “opioid-sparing” effect, much as Abrams believes. “This isn’t a new idea,” he said. “Physicians have used combination drugs for a long time, such as acetaminophen with an opioid. By putting several different pain medications together, they are able to reduce the overall opioid dose, and thus decrease the risk of overdose.”

By extension, changing marijuana laws may help not just individuals, but bring public policy more in line with medical science.

(Originally posted on WBUR’s Cognoscenti)

U.S. District Court Judge Rya W. Zobel today disappointed anyone who expected her to quickly strike down Gov. Deval Patrick’s ban on the sale of the new pain reliever Zohydro. She declined to rule on the drug maker’s request to quickly but temporarily lift the ban, and is continuing to consider whether to lift the ban permanently.

Judge Zobel faces a difficult decision but not because Zohydro, as many media reports have said, is more potent than anything else on the market. It’s not, and we’ll get to that in a minute.

First, the legalities. It should be up to federal health officials, including the U.S. Food and Drug Administration, not governors, to make decisions about the safety (or lack thereof) of drugs. For better or worse, the FDA, after a long 2013 review, and against the vote of its own advisory committee, did approve Zohydro in October of last year.

Legally, and logically, it also made little sense in the first place – except politically — for a governor to focus on one particular drug when the whole class of drugs to which it belongs — opioids, also known as narcotics – is controversial precisely because that whole class of drugs has such a complex mix of risks and benefits.

In truth, Zohydro is probably not the wonder drug that its manufacturer, Zogenix, claims, nor is it the menace that critics assert. The furor over Zohydro is simply the latest example of how difficult it is to balance the legitimate needs of people in chronic pain who need long-acting opioids and the also-legitimate need to protect vulnerable people from getting their hands on drugs they might abuse.

The unique feature of extended-release Zohydro is that it contains the opioid hydrocodone, and only hydrocodone. Other hydrocodone-containing drugs such as Vicodin contain both hydrocodone and acetaminophen (the active ingredient in Tylenol.) Strange as it may seem, it’s the acetaminophen that is often the dose-limiting ingredient because it can cause serious liver toxicity. So, in that sense, a hydrocodone-only pill is a step forward.

Zohydro is likely to lose its unique status soon. Purdue Pharma has just finished Phase 3 trials on its own extended release hydrocodone-only product, which still has to go through the FDA approval process.

A major criticism of Zohydro is that it was approved without having tamper-resistant features built in. Zogenix spokeswoman Catherine O’Connor said in a telephone interview that the company is working on two approaches to tamper-resistance now.

Why the FDA would allow a non-abuse-deterrent form of Zohydro on the market is a mystery to many, among them pharmacologist and neuroscientist June Dahl of the University of Wisconsin.

Dahl, who has studied pain drugs for decades, said in a telephone interview that it’s a good thing to have a hydrocodone-only pain reliever on the market because it gives pain patients another option. But she asks, “Why in the devil did the FDA allow this formulation to get approval? It seems like a disaster waiting to happen.”

On the other hand, it’s not clear how helpful abuse-deterrent forms of opioid pain relievers actually are.

“I would love if we had abuse-deterrent formulations that were actually meaningful and effective at deterring abuse in all instances. We are moving in that direction,” Dr. Margaret Hamburg, the FDA Commissioner, told a senate panel in March. But, she added, “Right now, unfortunately, the technology is poor.”

One problem is that, even when pills are manufactured so that they are harder to chew or crush (which addicts do in order to snort or inject the drug), determined abusers can simply swallow handfuls of the pills to get the high they are looking for.

Another problem is that abuse-deterrent formulations can actually spur some abusers to turn to heroin. That’s what happened when Purdue began marketing an abuse-deterrent form of OxyContin in 2010. It worked — in the narrow sense that, because it turned to a mushy gel when chewed or ground up, it couldn’t be snorted or injected. But an unintended side effect was that frustrated abusers turned to heroin.

In a July, 2012 letter to the New England Journal of Medicine, for instance, researchers from Washington University reported that the percent of drug abusers who chose OxyContin as their primary drug of abuse dropped from 36 percent before the release of the abuse-deterrent form to 13 percent – and their use of heroin almost doubled.

So what are the real risks and benefits of Zohydro? Here’s what FDA spokeswoman Sandy Walsh wrote in answer to that question:

First of all, she stressed that the FDA approved Zohydro because it is a “new option for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatments…are inadequate.”

Unlike the combination hydrocodone products, Zohydro “can be taken without the threat of severe liver damage,” she noted. People who are prescribed Zohydro will probably be those pain patients who are already taking other opioids – in other words, they will be switched to Zohydro. Thus, Walsh wrote, the total number of pain patients taking opioids may not be increased: “We anticipate Zohydro will take a slice of the market away from other opioids, and not expand the opioid market in general.”

As Walsh went on to note in her email, “There are many misperceptions about the potency of Zohydro in the press.” The FDA has been trying to correct those.

In an April 3 interview with TIME magazine, FDA Commissioner Margaret Hamburg, said, “It’s been said that Zohydro is super-potent. That surprises me because the highest dosage unit of Zohydro extended release is lower than the highest dosage unit of all the other available extended release products on a milligram basis…No doubt it’s a powerful drug, and it needs to be used appropriately with the proper oversight. But it’s certainly not the most powerful drug on the marketplace.”

As FDA spokeswoman Walsh explained in her email, “The highest Zohydro strength is five times the highest combination immediate-release hydrocodone strength; whereas the media is reporting 10 times…[the] highest strength of Zohydro is roughly half that of the highest strength OxyContin and extended-release morphines. Media reports have said that hydrocodone is stronger than anything on the market.”

In its own press release, Zogenix notes that a patient taking the 10-milligram Vicodin every four hours will have the same total daily dose of hydrocodone as a person taking the 30-milligram Zohydro every 12 hours. (Zohydro comes in five different doses ranging from 10 to 50 milligrams.)

A bit complicated, isn’t it? But that very complexity is all the more reason to think drug policy questions through carefully and to not rush to panicky, band-aid solutions such as banning certain drugs and not others.

Zohydro is certainly not a perfect pain drug. But it’s probably not the menace it’s portrayed to be, either.

(Originally posted on WBUR’s Common Health)

In an unusual move, a coalition of activists and physicians, concerned about the problem of prescription pain-reliever abuse, yesterday asked the U.S. Food and Drug Administration to revoke its approval of a new type of opioid called Zohydro. The medication is expected to be on the market soon.

“Too many people have already become addicted to similar opioid medications and too many lives have been lost,” said the Feb. 26 letter to the FDA, signed by a coalition of consumer health advocates, addiction treatment and health care providers.

But that request is provoking outrage and anxiety among chronic pain patients who applauded the FDA’s approval of the new medication last fall and would like to see Zohydro added to the list of prescription pain-relievers now on the market.

Zohydro is a type of opioid called hydrocodone and, in its chemical structure, is similar to morphine, said June Dahl, a professor of neuroscience at the University of Wisconsin School of Medicine and Public Health, in a telephone interview and email conversation.

“It’s an advantage to have another pure opioid agonist on the market and to have that agonist in a controlled release formulation,” said Dahl. She questioned, however, whether it is wise to allow the current formulation of Zohydro on the market right away, instead of waiting a few years for an abuse-deterrent, a formulation specifically designed to thwart abusers.

Until recently, the only hydrocodone-containing products on the market were combination medications such as Vicodin which contains both hydrocodone and acetaminophen. The major concern about Vicodin is actually not the opioid it contains but the acetaminophen (which is also the active ingredient in Tylenol), noted Dahl. (Last fall, the FDA took the first steps toward moving medications like Vicodin to a more restrictive category, which would limit the how easily patients could get refills.)

Zohydro is different from Vicodin in that it contains only hydrocodone, with no other ingredients. The company that makes Zohydro argues that this formulation makes the drug safer than the combination products.

Dr. James Cleary, a palliative care specialist at the University of Wisconsin, said in a telephone interview that “it is reasonable to have this product [Zohydro] out there.” Opioids are defined as “essential medications” by the World Health Organization and several other major groups, he added.

“Therefore we need to make sure they are available to appropriate patients and we need to establish a balanced system that also reduces abuse and diversion. We need to understand the opioid crisis much better.”

After a lengthy study, FDA scientists issued a report in October, 2013 saying that Zohydro appears to be safe, effective and should be on the market like other medications that are also long-acting. The FDA report recommended that Zohydro be classified as a Schedule II drug, the second most restrictive class of medications.

Here’s more from the CNN report:

In December, 29 state attorneys general sent a similar letter to the FDA. The month before, members of Congress asked the agency to review its decision to approve the drug.

The concerns echoed by all groups are broadly about the drug’s potency and abuse potential. They say they fear that Zohydro — especially at higher doses — will amplify already-rising overdose numbers.

“This could be the next OxyContin,” says a petition on Change.org asking the FDA to reconsider.