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Analysis: Controversy Over CDC’s Proposed Opioid Prescribing Guidelines

OxyContin pills are arranged at a pharmacy in Montpelier, Vt. in this 2013 file photo. Opioid drugs include OxyContin. (Toby Talbot/AP)

OxyContin pills are arranged at a pharmacy in Montpelier, Vt. in this 2013 file photo. Opioid drugs include OxyContin. (Toby Talbot/AP)

Updated at 3 p.m.

By Judy Foreman

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. Continue reading

FDA Reclassifies Vaginal Mesh, Device Used For Prolapse, As ‘High Risk’

The U.S.Food and Drug Administration has moved to strengthen regulations on vaginal mesh, a controversial medical device used to treat pelvic organ prolapse, a condition that can occur after childbirth as a result of weakened pelvic muscles.

Following reports of thousands of injuries related to the devices, FDA issued two orders this week: It reclassified the devices from Class II, generally considered to be a moderate-risk, to Class III, considered high-risk. Additionally, the agency will now require vaginal mesh manufacturers to submit “a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of” pelvic organ prolapse.

From the FDA statement:

The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.

“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias; in the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and there are five manufacturers who are currently marketing this product.Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair, and an advisory panel of experts recommended in 2011 that more data is needed to establish the safety of the device. The FDA has since taken several actions to warn doctors and patients about the use of surgical mesh for transvaginal POP repair.

Manufacturers of surgical mesh to treat POP transvaginally will have 30 months, as required by federal law, to submit a PMA for devices that are already on the market. Manufacturers of new devices must submit a PMA before those devices can be approved for marketing.

Prolapse occurs when pelvic muscles become stretched, torn or weakened, making it difficult to support the bladder, bowel or uterus; these organs can then drop and bulge into the vagina.

“While not a life-threatening condition, women with POP often experience low back pain or pelvic pressure, painful intercourse, constipation or urinary problems such as leakage or a chronic urge to urinate,” according to the FDA.

This week’s move follows a series of actions by the FDA warning of potential dangers of vaginal mesh. Notably, the agency’s latest orders relates specifically to transvaginal surgery for prolapse, and not other conditions, such as stress urinary incontinence, which has also been treated with vaginal mesh.

For reaction, I reached out to several doctors and a woman who suffered from complications related to vaginal mesh.

Amy Gezon, who testified before an FDA advisory panel about her experience back in 2011, sent me this email: “I am disappointed that the FDA did not reclassify mesh kits for the treatment of [stress urinary incontinence]. The apparent disregard of the serious complications experienced by myself and countless other women is truly disheartening.” Continue reading

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Health Analyst Scans New Obesity Options From Drugs To Devices, Heads Back To Gym

Dr. Fiona Clement, an assistant professor in the Department of Community Health Science at the University of Calgary, writes in the journal JAMA Internal Medicine about her own struggle with obesity. (Courtesy)

Dr. Fiona Clement, an assistant professor in the Department of Community Health Science at the University of Calgary, writes in the journal JAMA Internal Medicine about her own struggle with obesity. (Courtesy)

This will not be welcome news for all of us who resolved to eat less and move more this year, but still secretly hoped that maybe medicine would step in. Maybe some novel treatment would reach maturity just as our willpower waned — a drug, a device, some new twist on surgery.

Sigh. The journal JAMA Internal Medicine is just out with an up-to-date analysis of options for treating obesity, accompanied by editor Fiona Clement’s vivid personal account of her own struggles with weight. The conclusion she draws from the latest data: “After much thought and brutal honesty with myself, I would not pursue any of the interventions; the risks outweigh the benefit,” she writes. “I’m off to the gym.”

I spoke with Dr. Clement, an assistant professor in the Department of Community Health Science at the University of Calgary, about her take on the data and her decision to discuss her own obesity — and even reveal her Body Mass Index — in print. “This is by far the bravest thing I’ve ever written, and perhaps ever done,” she says.

“After much thought and brutal honesty with myself, I would not pursue any of the interventions; the risks outweigh the benefit.”

– Dr. Fiona Clement

But first, a distillation of the data from lead author Dr. Dan Ollendorf, chief scientific officer at the Institute for Clinical and Economic Review in Boston. The review is actually geared for doctors, but here’s his summary for the general public:

Surgery: “The evidence is pretty consistent that these procedures do lead to significant weight loss in the short-term, up to about two years of follow-up. The challenge with the evidence available is that after two years, it’s a a bit of a black box. It’s unknown what actually happens. There’s some suggestion that in a pretty significant number of situations, patients actually regain weight. In cases where other conditions related to obesity, like diabetes, have improved or resolved as a result of surgery, that can be reversed in some individuals. And so that is the really big unknown with surgery: What are the longer term outcomes for patients?”

• New drugs: “The bottom line is that this is sort of more of the same. A number of drugs have been used — some FDA-approved and labeled for weight loss, others used off-label for weight loss. The new drugs result in relatively modest reductions in weight, really not very different from the existing medications that have been available for decades. They are very high cost and in some cases have the potential for really significant side effects. So there really is mixed evidence, and the benefit, if any, that appears to be available with the current evidence is pretty modest.”

Devices: “This is kind of a heart-wrenching situation because surgery is a major step for people. Most of the advanced surgical programs in the U.S. have been able to reduce their complication rates, but this is still a risky surgery, and there are some major complications that can occur. And given that medications have produced only modest weight reductions, there’s been a lot of interest in trying to produce something that may be less invasive than surgery but more effective than medication. Continue reading

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Child Psychiatrists Suggest Resolution For 2016: ‘Let’s Parent Ourselves This Year’

The authors propose framing resolutions in an entirely new way. (PROfrankieleon/Flickr)

The authors propose framing resolutions in an entirely new way. (PROfrankieleon/Flickr)

By Drs. Gene Beresin and Steve Schlozman

There’s this guy, Sisyphus.

I feel like he invented the New Year’s resolution.

You know Sisyphus — he’s the guy who works so hard to push that stupid boulder up the hill, only to have it roll down again at the end of his hard work. You’d think he (and we) would have learned after all these years, but there he is, at the bottom of the hill, trying again and again.

It’s a lot like so many of us. “Today,” you may be saying with resolve, “will be different.” “Today I will get that boulder to the top of the hill.” Or: “This year I’ll lose weight. Drink less. Exercise more.” Fill in the blank.

But how many times do we fail in these New Year’s resolutions?

Researchers note that New Year’s resolutions are typically grounded in motivations to change our perceived vices: our addictions, our “bad” behaviors, our so-called “destructive flaws.” We know what’s good for us, we just can’t get it right.

Luckily for us, we do a little better than Sisyphus. It turns out that almost half of us succeed in our goals. We don’t hear about those successes so much but it’s true: We manage to keep about 50 percent of our self-improvement mandates. Of course that means that about 50 percent of the time we lose our momentum before the year is over. Hence, those same darn resolutions return to us each December.

This exercise in at least partial futility begs a fundamental question: Why is “bad” behavior so hard to change? We try to raise our kids to correct misbehavior; why can’t we do it ourselves?

This query is, understandably, the focus of a lot of research. We harbor false or exaggerated predictions. We assume (and we all know the dangers of assumptions) that change will be easier this year, or more predictable this year, or that we’ll somehow have changed enough that the resolution will finally be within our grasp.

Here’s the kicker, though, and it’s an important one: We truly believe that we’ll succeed. We’re not actively lying to ourselves.

Psychologists Janet Polivy and Peter Herman call this a “false-hope syndrome,” an exaggeration of our expectations for change, inevitably followed by the forlorn shutting down of our previously high aspirations. Continue reading

Top CommonHealth Stories Of 2015: From Kale And Sex To Opioids And Suicide

This Jan. 1, 2014, file photo shows fireworks lighting up the sky over Boston Harbor to celebrate First Night in Boston, during New Year’s celebrations. (Elise Amendola/AP)

This Jan. 1, 2014, file photo shows fireworks lighting up the sky over Boston Harbor to celebrate First Night in Boston, during New Year’s celebrations. (Elise Amendola/AP)

In the Radio Boston segment above, Dr. Neel Shah looks back at the year in medicine and highlights several important trends, among them:

  • Obamacare is now here to stay, but health costs — particulaly out-of-pocket costs — continue to rise; Obamacare affected how health care is paid for, but curbing costs requires reform of how health care is delivered.
  • Health care is moving — slowly — toward more transparent consumer information about prices, and hospitals are taking more responsibility for the costs of care.
  • Tracking apps are transforming not just fitness but health care and disease management.

All important. Now, let’s also look back at 2015 through the CommonHealth lens. Of course, we must resist the siren song of easy metrics; if click counts were everything, we’d write about nothing but trendy vegetables and sexual organs. But just in case you missed them, these were our highest click counts of the last year:

Now to get serious, as serious as drug overdoses and suicide.

In this September photo, Joey, who had recently started using methadone to try and kick his heroin addiction, visits his parents grave at Woodlawn Cemetery in Everett. (Jesse Costa/WBUR)

In this September photo, Joey, who had recently started using methadone to try and kick his heroin addiction, visits his parents grave at Woodlawn Cemetery in Everett. (Jesse Costa/WBUR)

Opioids

There’s been a lot of (well-deserved) journalistic self-congratulation around Boston lately, so let’s limit ours to this: At a recent public forum, the dean of Harvard Medical School introduced WBUR’s Martha Bebinger as “a treasure,” and we concur with his diagnosis.

Along with her continuing coverage of health care, Martha has focused particularly this year on medical marijuana and, with WBUR’s Deborah Becker, on the opioid crisis. Three of her many memorable stories:

Suicide

WBUR’s Lynn Jolicoeur performed an important public service this year with her series, “Suicide: A Crisis In The Shadows,” and CommonHealth was honored to help bring the painful topic a bit further out of the shadows.

The opening segment — ‘The Biggest Barrier’ To Preventing Suicide: Not Talking About It — was shared about 30,000 times on Facebook within the first week or so. Lynn received messages from all over the country, from people who were glad to see the issue of suicide reported on, wanted to share their own stories of how suicide had affected them, or wanted to suggest angles to cover. Continue reading

Play Through The Pain? Audition Season Means Injury Risk For Young Musicians

The Emerson String Quartet performs in 2004. Imagine a quartet without its instruments and it becomes more clear how unnatural their positions are, says neurologist Dr. Michael Charness. (AP Photo/Jennifer Szymaszek)

The Emerson String Quartet performs in 2004. Imagine a quartet without its instruments and it becomes more clear how unnatural their positions are, says neurologist Dr. Michael Charness. (Jennifer Szymaszek/AP)

By Ian Coss

Caitlin Cawley was only 15 when she developed tendinitis in both elbows. The condition is commonly known as “tennis elbow,” but Cawley wasn’t practicing her serve. She was studying classical percussion at a pre-college program for aspiring musicians.

She ignored the early signs until the prickling sensation grew to stabbing pain throughout her forearms so excruciating she had to stop playing. It took three months of rest for the inflammation in her tendons to subside, and she has had multiple flareups since then.

Now 21 and a senior at Boston University’s School of Music, Cawley is preparing to audition for graduate programs. So while most college applicants can breathe a sigh of relief now that their Jan. 1 deadline has passed, she and other music students are headed back to the practice rooms. Cawley currently averages six hours of independent practice a day, not including ensemble rehearsals. In her words: “Right now I’m doing as much work as I’ve ever done for music.”

Boston University senior Caitlin Cawley practices on the marimba (Photo: Ian Coss/WBUR)

Boston University senior Caitlin Cawley practices on the marimba. (Ian Coss for WBUR)

That diligence also means risk of injury. For Cawley and other young musicians, the question of this season is: How much practice can my body take before perfection turns to pain?

Their odds are not good. In the mid-2000s, a Chicago-based physician began surveying the incoming music students at a midwestern university, and after four years, the trend in the data was clear: Almost 80 percent of freshman “reported a history of playing-related pain.”

For players of string, keyboard and brass instruments the percentage was even higher. For percussionists like Cawley: 100 percent.

Dr. Michael Charness, who directs the Performing Arts Clinic at Brigham and Women’s Hospital, has treated thousands of musicians who play everything from bagpipes and sitars to violas and trombones.

He describes the crux of the problem: “If you look at a string quartet, it’s the most natural looking sight, but if you simply remove the instruments from their hands and pose them on stage, it’s nothing that we were ever really designed to do for any long period of time.” Continue reading

Opinion: ‘Lactivism’ Has Trump-Like Appeal For Breastfeeding Backlash, But Science Is Off

A baby sleeps in the arms of his mother after breastfeeding. (Nikolas Giakoumidis/AP)

A baby sleeps in the arms of his mother after breastfeeding. (Nikolas Giakoumidis/AP)

By Melissa Bartick, M.D.

Judging from the hype around Courtney Jung’s new book “Lactivism,” breastfeeding backlash is alive and kicking. In fact, if Donald Trump suddenly jumped into the breastfeeding fray, he might sound a bit like Jung: In her world, breastfeeding advocates are nearly always “lactivists,” self-righteous extremists preying on innocent mothers in the name of science and good parenting.

Jung, a professor in the Department of Political Science at University of Toronto, conjures a villain (or villains) everyone can rally against, as evidenced in the book’s subtitle: “How Feminists and Fundamentalists, Hippies and Yuppies, and Physicians and Politicians Made Breastfeeding Big Business and Bad Policy.”

If only some of the glowing book reviews mentioned Jung’s sloppy reading of the scientific literature, her absurd claims about the breastfeeding industrial complex and her misplaced theories of breastfeeding class warfare.

Let’s be clear: There is no place for shaming any mother about how she feeds her infant. There are indeed people out there who deserve our ire, who shame and pressure women instead of listening and educating. But Jung lumps nearly all breastfeeding advocates into this camp, stoking hatred of an entire group where only some are guilty.

Perhaps the book is popular for the same reason Trump is popular. It taps into mothers’ collective anxiety, anger and fears over a highly emotional topic, and then hold up twin “culprits”: breastfeeding zealots and bad science. The only problem is, the actual zealots are few (though offensive), and the science is not as Jung states.

Here are some facts: Breastfeeding mothers still get harassed in public and at work, and formula feeding mothers are subject to shame as well. For decades, formula feeding has been the norm in this country, and for much of our society it’s still the norm. CDC data show low-income women and African-American women have lower breastfeeding rates than middle class white women.

Not everyone can breastfeed and not everyone wants to breastfeed, but data show 68 percent of women who want to exclusively breastfeed do not meet their own goals.

To be fair, Jung does a few things right. For instance, a 2007 report from the Agency for Health Research and Quality (AHRQ) found that exclusively breastfeeding for three months cuts the risk of ear infections in half. To her credit, Jung highlights the same data from a different perspective, illustrating that six babies would need to be exclusively breastfed for three months to prevent one ear infection. And, also to her credit, she highlights fairly recent data showing little if any link between breastfeeding and lower risk of asthma, eczema and type 1 diabetes.

But overall, Jung’s grasp on the medical research is poor. Scientific papers are peer reviewed by other researchers who are experts in the same field and must pass rigorous standards before publication. Jung is not a medical researcher. While I don’t know if Jung’s book was reviewed by any medical authority, as a reviewer myself I can say it never would have made it past the first stage of the peer review process. It was reviewed by editors whose goal is to sell books.

She misstates so much of the medical literature, one wonders if she did more than just skim through these papers. Here are a few examples of inaccuracies:

• The rate of HIV transmission from mothers to their 6-month-old infants via breast milk is 4 percent among those exclusively breastfed, according to a study in The Lancet; Jung wrongly puts that number at 22 percent. Continue reading

Boston Raises Legal Age For Buying Tobacco Products To 21

Cigarette packs are displayed at a convenience store in New York. (Mark Lennihan/AP)

Cigarette packs are displayed at a convenience store in New York. (Mark Lennihan/AP)

You’ll soon have to be 21 to buy cigarettes in Boston.

By a unanimous vote on Thursday, Boston’s Board of Health approved the mayor’s proposal to raise the minimum age for buying tobacco or nicotine products in the city from 18 to 21. The rule, which will go into effect on Feb. 15, 2016, will also cover e-cigarettes.

Eighty-five other Massachusetts communities have already raised their tobacco purchasing age.

“We know the consequences of tobacco use are real and can be devastating,” Boston Mayor Marty Walsh said in a statement. “These changes send a strong message that Boston takes the issue of preventing tobacco addiction seriously, and I hope that message is heard throughout Boston and across the entire country.”

The American Lung Association of the Northeast commended the move, saying it will help prevent youth from becoming addicted to tobacco.

Continue reading

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1 In 6 Mass. Residents Put Off Health Care This Year To Avoid Costs, Survey Finds

A new survey of Massachusetts residents finds that about one in six did not get health care they said they needed in 2015 because of the cost.

The survey from the state’s Center for Health Information and Analysis (CHIA) highlights a trend showing more people have high-deductible plans in which insurance covers less care and patients pay more out of pocket. Continue reading

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When It’s OK To See A Nurse Practitioner, Physician Assistant — And When It’s Not

(Alex E. Proimos/Flickr)

(Alex E. Proimos/Flickr)

By Dr. David Scales

Let’s say you hurt your knee doing your best Tom Brady impression playing flag football.

It hurts like the dickens and you’re not sure if you tore something or just have a really bad case of tendonitis. You go to your local urgent care clinic, or doctor’s office, and you’re seen by a physician assistant  (PA), who examines you, says everything is structurally intact, and you should use ice, elevate your leg and take some ibuprofen for the pain.

What the PA said makes sense, but shouldn’t you see — you know — the doctor?

Well, maybe not. While it seems to make sense to always ask for an expert, there can be some downsides. It can take months to get an appointment with a doctor, or cost more to see them versus a PA or nurse practitioner (NP). Also, with the holidays approaching, it’s prime season for senior physicians to be away, with the rest of the health care team pitching in. So when is it fine to see someone besides the doctor for your medical care? And when should you avoid it?

Well, who else might you see at a medical clinic? In addition to a doctor, you could see a PA or NP. If you haven’t seen one yet, you will. Medicine is increasingly becoming a team sport, requiring well-synchronized “pit crews rather than isolated physicians. In Massachusetts, for instance, there are already close to 8,000 NPs and over 2,000 PAs and those numbers are rising to fill a growing shortage in primary care. A 2013 study estimates that Massachusetts will need 725 more primary care providers by 2030.

I asked a few NPs and PAs — each with at least five years of clinical experience, and some with more than 30 — what they think patients should know about all this. They agreed that it’s best to focus on experience rather than the degree behind the name. An NP with three decades of experience may be more knowledgeable than an MD who just finished their residency — and I say that as someone who is just about to finish residency.

One of those NPs with over 30 years experience is Lynne Crawford, a primary care NP at Cambridge Health Alliance. She phrased it this way: “If you see someone and you’re uncomfortable with the encounter, it might be your rapport with them rather than the degree behind their name.” Continue reading