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Opinion: Why Zohydro Ban Is A Tough Call

Update 4/15:

The AP reports that a federal judge blocked Massachusetts from banning the powerful new painkiller Zohydro.

U.S. District Court Judge Rya Zobel on Tuesday issued the preliminary injunction after the maker of the drug, Zogenix, said in a lawsuit that the ban ordered by Gov. Deval Patrick was unconstitutional.

Zobel said in issuing the injunction that Massachusetts appears to have overstepped its authority in banning the drug, which had been approved by the U.S. Food and Drug Administration.

Patrick ordered the ban after declaring a public health emergency in light of widespread prescription drug abuse in the state.

The judge said federal law preempted the state’s order.

By Judy Foreman
Guest contributor

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 drugmaker’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.

(wikimedia commons)

(Wikimedia Commons)

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. Continue reading

Women’s Anal Sex More Common And Still Taboo, Says Researcher

Sexual health researcher Debby Herbenick often says what the rest of us are merely just silently, sheepishly thinking.

A few years back, Herbenick, a researcher at Indiana University, co-director of the Center for Sexual Health Promotion, and a sexual health educator at the Kinsey Institute, raised the issue of pain during sex based on her landmark study of sex in the U.S. And here she is again, discussing the pros, cons and surprising new data on women and anal sex in America.

It’s worth reading her full report at Salon, titled Anal Sex: Science’s Last Taboo, but here’s a snippet:

That anal sex remains taboo may explain why a study about anodyspareunia – that is, pain during anal penetration – received little attention when it was published in the Journal of Sex & Marital Therapy. The study should have turned heads: It was the first research on anodyspareunia among women; it was conducted by a well-respected scientist (Dr. Aleksander Stulhofer from the University of Zagreb); and it was centered on young women and sex. That’s often the kind of research that attracts media attention (Young women sext! They get pregnant! They give oral sex! You get the picture …). However, anal sex remains such a strong taboo that this otherwise important study barely turned a head.

younglove

Except it did turn mine. Here’s why. In an incredibly short period of time, anal sex has become a common part of Americans’ sex lives. As of the 1990s, only about one-quarter to one-third of young women and men in the U.S. had tried anal sex at least once. Less than 20 years later, my research team’s 2009 National Survey of Sexual Health and Behavior found that as many as 40-45 percent of women and men in some age groups had tried anal sex. With its rising prevalence, I felt it was important to devote a chapter of my first book, “Because It Feels Good,” to anal health and pleasure — only to find that a magazine editor wouldn’t review it because the topic of anal sex was “not in the best interest of our readership.” Even though nearly half of American women in some age groups have done it! She added, “In the correct circles, I personally will be suggesting the book to those with whom I can share such a resource.”

Hmm. The correct circles. Which ones would those be? The ones where scores and scores of women openly sit around talking about anal sex between glasses of wine? Continue reading

Fighting Abuse But Hurting Pain Patients: FDA Seeks New Opioid Limits

colorpills

Longtime nationally syndicated health columnist Judy Foreman is the author of the forthcoming book, “A Nation in Pain — Healing Our Biggest Health Problem” coming out in February, 2014 from Oxford University Press. She looks here at the FDA’s latest move to tighten control of painkillers.

By Judy Foreman
Guest contributor

In a move designed to combat drug abuse but likely to put further burdens on pain patients, the US Food and Drug Administration has just announced that it is recommending tighter controls over opioid pain relievers such as Vicodin and Lortab that contain hydrocodone.

The shift in policy –- the subject of a controversial hearing in January –- will limit the number of refills a patient can get before going back to the doctor for a new prescription. It will also mean that a patient must physically take each prescription to a pharmacy, instead of allowing doctors to call the prescription in. For patients in severe, chronic pain and those with physical limitations, these requirements are likely to pose significant difficulties.

In the statement on its Website, the FDA said that opioids (narcotics) do allow people living with chronic pain to “manage their pain as well as significantly improve their quality of life.” But the FDA also said it had become “increasingly concerned” in recent years about the “abuse and misuse of opioid products.”

The FDA said that by early December, it would formally submit its recommended changes to the Health and Human Services Department. It added that the National Institute on Drug Abuse is expected to concur with the new recommendations and that a final decision on the new policy will be made by the Drug Enforcement Administration, which, in 2009, asked for the change. In bureaucratic language, the change involves moving products that contain hydrocodone in combination with another drug such as acetaminophen from classification as a Schedule III drug to classification as a more restricted Schedule II drug.

In practice, said Cindy Steinberg, a chronic pain patient and National Director for Policy and Advocacy at the US Pain Foundation, a nonprofit advocacy group, the change will impose serious hardships on the 47 million Americans who currently take hydrocodone-containing products. Continue reading

Medical Marijuana For Kids? Really?

Here’s the provocative lede of an NBC News report earlier this week:

Zaki Jackson was 6 months old when doctors diagnosed him with a form of epilepsy so severe that it sparked as many as 250 seizures a day.

For years his mom, Heather Jackson, feared for his life. “He would stop breathing,” she told NBC chief medical editor Dr. Nancy Snyderman. “All the air leaves his lungs and he does not take another breath until that seizure is over.”

After 10 years and 17 medications, Zaki wasn’t getting any better. Then, finally, his doctor wrote a prescription for a medication that calmed the electrical storms in Zaki’s brain. The surprise was that it wasn’t for a standard anti-seizure medication — it was a prescription for marijuana.

(“Caveman Chuck” Coker/flickr)

(“Caveman Chuck” Coker/flickr)

Wow, I thought, I’ve never heard of any doctors prescribing medical marijuana for kids. I called around, and none of the pediatricians I contacted knew of any specific cases.

It’s clearly not the norm, though it’s permitted under state regulations approved by the Mass. Department of Health. According to an earlier post here:

…youth under 18 will have access to the use of medical marijuana, but will need two physicians to certify that the risks and benefits have been assessed and the benefits will outweigh the risks, one being a board-certified pediatrician.

But when the state was finalizing the rules earlier this year, the Massachusetts Medical Society raised concerns about use by children in a May 8 statement:

We are concerned that the Department has changed the regulations related to children, by allowing the override of the “life-limiting” provision and by changing the definition of “life-limiting illness” from six months to two years. In the absence of well-designed scientific research data, we are concerned about extending the time from six months to two years. The scientific evidence is clear that marijuana use by children is dangerous, as studies have found toxic effects on the still-developing brains of young people.

Here, Dr. Sharon Levy, of Boston Children’s Hospital and Harvard Medical School, offers her perspective Continue reading

Why Are More Women Overdosing On Painkillers?

By Judy Foreman
Guest Contributor

Overdose deaths linked to prescription pain relievers have increased dramatically among women in recent years, the Centers for Disease Control and Prevention announced yesterday.

And nobody really knows why.

Part of the increase may be due simply to a higher prevalence of chronic pain conditions in women, the CDC said, adding that “some of the most common forms of pain are more prevalent among women,” including abdominal pain, migraine and musculoskeletal pain.

Indeed, one of the more puzzling findings from the latest CDC figures is that the opioid-related overdose death rate was not highest among younger women, but among women aged 45 to 54.

painchartDr. Nora Volkow, director of the National Institute on Drug Abuse, suggested in an interview with The New York Times that this may in part reflect the fact that older women are appropriately prescribed pain relievers because they have more chronic pain. If death rates were driven purely by abuse, she said, then one would expect the death rates to be highest among younger women who are more likely to be abusers.

In addition, women on average weigh less than men – a fact that doctors may not sufficiently take into account – and therefore, at the same dose, may suffer more adverse effects. Continue reading

It’s Not An Opioid, So This Painkiller Is Safe, Right? Not Quite

(ParentingPatch/Wikimedia Commons)

(ParentingPatch/Wikimedia Commons)

By Judy Foreman
Guest contributor

So there I was at midnight, night after night, my neck pain screeching at a 10+++ on a scale of 10, popping ibuprofen by the handful, dutifully worrying about the well-known dangers of a painkiller-induced stomach bleed, but reassuring myself, “At least these pills are safe – not like opioids, the really dangerous stuff.”

Oops. Not quite right. It turns out that I, like many other people with chronic pain, had gotten my worries somewhat backwards: being overly fearful of opioids, which, of course, do have considerable risks, but not worried enough about NSAIDS — non-steroidal anti-inflammatory drugs — such as ibuprofen, Advil, Motrin, Nuprin, Aleve and others.

My mixed-up worries came straight from newspaper headlines, which play up the dangers of opioids (narcotics), and less frequently note the growing evidence for the risks of NSAIDS as well.

But a major new study in the medical journal The Lancet is helping set things straight. In it, British researchers pooled data from an impressive 639 randomized studies involving more than 300,000 patients, comparing various types of NSAIDS to each other and to placebo.

They found that both so-called “coxibs” (anti-inflammatory drugs such as Celebrex) and high doses of traditional NSAIDS such as ibuprofen raise by about one-third the risk of major “vascular events” such as non-fatal heart attacks, strokes and death. These newly-appreciated risks are in addition to the well-documented risks of gastrointestinal bleeding long linked to NSAIDS.

Put differently, the researchers found that for every 1,000 people with a moderate risk of heart disease taking high doses of the NSAIDs ibuprofen (2400 milligrams daily) or diclofenac (150 milligrams daily), about three would suffer a preventable heart attack, one of which would be fatal.

For unclear reasons, Naproxen (Aleve) seems to carry much less risk, a finding that has shown up in a number of previous studies as well.

This is serious, of course, especially for older people who tend to have more cardiac risks as well as more pain. Continue reading

Listening To Medical Marijuana: From Chronic Pain To Fear

WBUR’s Martha Bebinger reports on the state’s efforts to nail down the details of the new medical marijuana law. Here she sits in on a “listening session” in Roxbury where some participants said they desperately need the drugs for long term, debilitating pain, while others are afraid of increased drug abuse and related problems in the community:

Scott Murphy, from Auburndale, shifted nervously in his chair as he began to speak. Murphy was one of more than a dozen patients who came to Roxbury Community College on Thursday for a “listening session” on the state’s new medical marijuana law.

State public health officials are taking input on many parts of the law they must define. The law authorizes the drug’s use for patients with a “debilitating medical condition,” but what does that include?

Eric McCoy (left) and Peter Hayashi (right) urged state regulators to make access to marijuana easy for patients. (Photo: Martha Bebinger)

Eric McCoy (left) and Peter Hayashi (right) urged state regulators to make access to marijuana easy for patients. (Photo: Martha Bebinger)

Murphy uses marijuana and several prescribed medications to manage ongoing back, leg and arm pain from a serious motorcycle accident years ago. Murphy claims marijuana is also effective in helping veterans cope with post-traumatic stress disorder, or PTSD.

“As you might be aware, we’re losing one soldier a day to suicide,” Murphy said, his voice shaking. One of those soldiers was a close friend of Murphy’s, an Army buddy who killed himself last year.

In between sobs, Murphy told state regulators that “if medical marijuana could help one person, I would hope you would consider that.” The panel nodded and smiled. The audience broke into applause.

Murphy won’t be able to get a medical marijuana certificate through the Veterans Administration because doctors there are bound by the federal definition of marijuana as an illegal substance.

More than a dozen patients spoke Thursday morning about medical conditions they do hope the state will certify for treatment with marijuana. Continue reading

One Man’s Sedation-Free Colonoscopy (And Why You Should Try It Too)

By David C. Holzman
Guest Contributor

I’m one of an elite group of American patients. Only about one percent of us undergo colonoscopy without sedation. The big secret: it doesn’t have to be painful. And it’s probably safer than with sedation.

Like most Americans, I was ignorant of all of this until about a month ago. In my imagination, a sedation-free colonoscopy would have been painful indeed, the device snaking up my GI tract, pushing against my insides as it resisted the twists and turns. Then my best friend, Greg, who has made several suggestions that have resulted in distinct improvements in my life, suggested forgoing the drugs, as he had recently done.

Gateway to the author's colon (Courtesy)

Gateway to the author’s colon (Courtesy)

It made sense. I could drive myself to and from the hospital, and I’d be able to work when I got home.

Greg had also told me that there’s a correlation of anesthesia with loss of memory later in life. Some googling revealed that this may be true in some cases. But despite that uncertainty, that made the unmedicated colonoscopy far more compelling.

It helped to learn that Dr. Douglas Horst, who would be doing the colonoscopy, did a number of them unsedated, and even more, that he called me to discuss it, putting my mind even more at ease. (He gets top grades on several different doctor evaluation websites.)

And overall, the discomfort was minimal, hitting maybe 3-max out of 10 on the pain-meter for seconds at a time here and there, and otherwise never going beyond 2 out of 10, comparable, perhaps, to a very mild cramp. I’d much rather have another colonoscopy than an upset stomach.

The Prep: Dystopian Poison

Far worse than the colonoscopy was the “prep.” Continue reading

Overdose Antidote: What The Government Doesn't Do, And What You Can

naloxone

(PunchingJudy/Flickr Creative Commons)

You hear a lot these days about the national epidemic of painkiller overdoses. What you don’t hear so much about is what you can do to respond to those overdoses when they happen, much as we learn about CPR or defibrillators for heart attacks.

In an opinion piece just out in the Journal of the American Medical Association, Northeastern University assistant professor of law and health sciences Leo Beletsky and his co-authors argue that the government should do far more to enable the public to fight overdoses. Why doesn’t it? And what can each of us do? He explains here.

By Leo Beletsky
Guest contributor

Now a true national crisis, overdose from opioid drugs like Oxycontin and heroin kills about 16,000 Americans every year. Outranking car accidents, it is now the leading cause of accidental death in many states, including Massachusetts.

Rural and poor communities are particularly hard-hit, but contrary to popular belief, this epidemic does not discriminate: Overdose victims come from all classes, races, and age groups. Deaths afflict both legitimate and illicit users of prescription medications as well as those using street drugs like heroin.

Many of these deaths could be averted. Long-term prevention efforts are needed, but in the meantime, there are some straightforward things we can all do immediately to stop overdoses from turning fatal.

First: From the onset of the telltale signs of overdose, such as shallow breathing and slow pulse, it typically takes 30 to 90 minutes for the victim to die. This provides a precious window of opportunity to save a life. The tragic reality is that people often don’t recognize the overdose in time and thus don’t quickly call 911.

Second: Most people do not realize that once an ambulance has been called, they can help save the victim’s life. The key is to determine if the person is breathing; if not, rescue breathing and CPR should be performed. And ideally, the drug naloxone should be given to the victim.

Leo Beletsky

Northeastern University’s Leo Beletsky (Courtesy of Northeastern)

What is naloxone? Known by the brand name Narcan, it is an overdose antidote, a drug whose only effect is to reverse an overdose from opioid drugs like Oxycontin, Vicodin or heroin. Given via injection or nasal spray, it blocks the opioid receptors in the brain, typically working within about four minutes to revive the victim.

It seems like a no-brainer, doesn’t it? Shouldn’t anyone who takes opioids, or who is close to someone who does, know what to do in the event of an overdose, and keep this potentially lifesaving drug available?

In fact, however, it is much harder than it should be to get and fill a prescription for naloxone, even though it’s extremely safe and has no potential for abuse.

Why? Continue reading

Foreman: For Adults In Pain, Just Say Yes To Marijuana

(“Caveman Chuck” Coker/flickr)

By Judy Foreman
Guest Contributor

I have just finished writing a book on chronic pain and, although I didn’t initially plan it this way, I ended up devoting an entire chapter to marijuana because, as I did my research, I found considerable evidence that marijuana is both safe and reasonably effective at relieving pain. In fact, if a person taking opioids (narcotics) for pain relief also smokes marijuana, the dose of opioids needed can often be reduced.

For historical and political reasons, the federal government persists in classifying marijuana as a Schedule I drug, which means it is deemed to have a “high potential for abuse” and no recognized medical usefulness. Both parts of this are false.

Although the government has stymied marijuana research in this country, there has been significant research from other countries on the risks and benefits of inhaled marijuana.

Marijuana used alone is actually remarkably safe, in part because, unlike other drugs, including opioids, it does not cause respiratory depression.

In fact, there are simply no deaths – zero – from marijuana alone, according to the federal Centers for Disease Control and Prevention. This is in stark contrast to deaths from alcohol (80,000 a year), tobacco (443,000 a year), even NSAIDS, non-steroidal anti-inflammatory drugs, which kill an estimated 7,000 to 10,000 American adults every year.

Marijuana used alone is actually remarkably safe, in part because, unlike other drugs, including opioids, it does not cause respiratory depression.

Nor does marijuana seem to be the “gateway” drug that opponents claim it to be. A 1999 report from the Institute of Medicine, part of the National Academy of Sciences, found that marijuana is not the substance that gets teenagers on the road to substance abuse – underage tobacco and alcohol use are. Continue reading