Author Archives: Denise Fulton

Avastin Anon and On and On

In a move that should surprise no one, the National Comprehensive Cancer Network’s panel of breast cancer experts has voted 24-0-1 to stand by its endorsement of bevacizumab (Avastin) for metastatic breast cancer.

Courtesy flickr user Earls37a

The unanimous vote echoes the position taken by panel at the NCCN’s annual conference earlier this year. “The data observed in the [E2100 trial] really had not changed from its approval previously, and we thought that if the data were compelling 2 years ago, why isn’t it compelling enough today?” panel chair Dr. Robert W. Carlson of Stanford (Calif.) University said at that time.

The new endorsement is not the strongest, with an evidence designation of 2A, but the expert panel called bevacizumab in combination with paclitaxel “an appropriate therapeutic option for metastatic breast cancer.”

The panel conveyed its thinking in the following footnote:

“Randomized clinical trials in metastatic breast cancer document that the addition of bevacizumab to some first- or second-line chemotherapy agents modestly improves time to progression and response rates but does not improve overall survival. The time to progression impact may vary among cytotoxic agents and appears greatest with bevacizumab in combination with weekly paclitaxel.”

The unanimity of NCCN panel’s stance – in direct opposition to the unanimity of the Food and Drug Administration’s Oncologic Drugs Advisory Committee’s 6-0 vote in favor of withdrawing Avastin’s indication for metastatic breast cancer does raise the question of how the proposed withdrawal is viewed by breast cancer experts.

But breast specialists were in short supply on the pared-down advisory committee — a reality noted in a joint comment by Dr. Howard A. Burris III, editor of The Oncology Report, and associate editors Dr. Hope S. Rugo and Dr. William J. Gradishar. In the comment, posted online in advance of print publication, the three oncologists wonder whether “FDA Commissioner [Dr. Margaret] Hamburg is able to hear through the noise and reach a compromise that will be the best for our patients.”

The Pink Sheet, a sister publication of The Oncology Report, tallied 34 speakers in the public portion of last month’s sturm-und-drang hearing — 4 favoring withdrawal, 22 against, 1 defending the pivotal Eastern Cooperative Oncology Group E2100 study, 1 calling for better collaboration on breast biomarker research, and 6 “who generally opposed withdrawing the [metastatic breast cancer] claim but spoke primarily to express concerns about FDA approval standards and the potential impact a withdrawal decision could have on development and approval of oncology treatments in settings beyond breast cancer.”

Public comments on the proposed withdrawal were due to close today, July 28. It will be interesting to see how comments stack up after the mishmash that came in on Medicare’s deliberations over coverage for the prostate cancer drug Provenge.

Meanwhile, the dueling parties — Genentech, Inc. and the FDA’s Center for Drug Evaluation and Research — have been granted an extra week until Aug. 4 for their post-hearing submissions. Considering the current stalemate in Congress, one can only wonder whether there will be anyone at the FDA to read them.

— Jane Salodof MacNeil

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Filed under Health Policy, IMNG, Oncology

Cardiologists Challenged

The opening scientific session at the annual American College of Cardiology meeting kicked off with a glitzy video montage that would have made Hollywood proud. I half expected to see a reminder to visit the concession stand crawl across the big screens. But just as the hype was beginning to overwhelm, Dr. James Orbinski rose to deliver the most scorching presidential lecture in memory.

Image courtesy TheSilentPhotographer at en.wikipedia (CC)

The internationally acclaimed physician and humanitarian challenged the audience to get involved in global heath and to tackle issues that most people write off as hopeless causes. He pointed out that the $13,000 price of antiretroviral drugs to combat AIDS was once a virtual death sentence for all but the wealthy.

With vocal outrage from humanitarian groups including Dignitas International, which he cofounded with James Fraser, however, the price tag has dropped to just $64 per year for generic therapies, and somehow, Big Pharma did not collapse, as was prophesied, he said.

Dr. Orbinski didn’t shy away from politics, which at most medical meetings is politely veiled in talk of pending legislation.

As Chief of Mission to Rwanda with Médecins Sans Frontières during the genocide, he recalled a young girl brought to his care who avoided being hacked to death as her mother had been by hiding in a latrine. He scolded France for supplying arms to the Habyarimana regime, and the global compliancy exhibited by countries including the United States despite overwhelming evidence of genocide.

Dr. Orbinski, who collected the Nobel Prize on behalf of MSF for its work in Rwanda, spoke of the need for ongoing research of neglected tropical illnesses and the growing threat that West Nile virus and Dengue fever pose to even the most well-heeled Americans. He spoke about climate change and the political unrest caused by hunger, now experienced by one in seven persons across the globe.

He reminded us that 43 years ago today when Dr. Martin Luther King Jr. was assassinated in Memphis, no one would have dreamed that it was possible for a black man to become president of the United States.

The lecture was nothing like I’ve ever heard before.

Dr. Ralph Brindis

When he finished, the packed ballroom was silent and still. Many rose to give Dr. Orbinski a standing ovation, but some did not. So when outgoing ACC president Dr. Ralph Brindis rose to speak, there was something of a sense of relief in the air. It was short lived.

Dr. Brindis cited the recent ICD-registry study by Dr. Sana Al-Khatib and colleagues that found that 22.5% of 111,707 patients received nonevidence based ICD implantations for the primary indication of sudden cardiac death between January 2006 and June 2009.

Dr. Brindis said he has been disappointed in physician participation with the National Cardiovascular Data Registry, despite its ability to provide greater understanding of physician practice as well as local and national trends in socioeconomic disparity.

“The NCDR data are your clinical data,” said the mild-mannered Dr. Brindis, while pointing his finger squarely at the audience. “You are responsible for the accuracy of the information, and you should strive to take advantage of these reports to discover opportunities to improve the care of your patients.”

This reporter tips her hat to the ACC for selecting New Orleans for its annual meeting and for being bold enough to challenge its members. Thinking outside the box beats Hollywood any day.

—Patrice Wendling from New Orleans

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Filed under Blognosis, Cardiovascular Medicine, Drug And Device Safety, Health Policy, IMNG, Internal Medicine, Internal Medicine News, Uncategorized

With Diabetes, the Hands Aren’t Free

You’ve got to hand it to diabetes for leaving few parts of the body unscathed, including the hands. While far less common than foot problems, hand complications that are more common in people with diabetes – including tenosynovitis (aka “trigger finger”), Carpal tunnel syndrome, Dupuytren’s contracture, De Quervain syndrome, and limited joint mobility – can be equally crippling.

“Hand problems, although not usually life-threatening, can certainly be livelihood threatening,” according to Dr. Leo Rozmaryn, an orthopedic hand surgeon in Rockville, Md.

Although vascular complications can occur in the hands, diabetes-related hand problems more often involve the tendons, nerves, and/or joints. The exact mechanisms aren’t well understood, and the complications can occur even in diabetes patients who are well-controlled, particularly in those with type 1 diabetes.

The most common is “trigger finger,” which occurs when the sheath surrounding the flexor tendon in the finger becomes inflamed and thickened, causing stiffness and pain and impairing movement. Instead of gliding smoothly when the fingers bends, the tendon gets caught and “snaps” back.

Photo by Miriam E. Tucker

Dr. Rozmaryn says that he sees about 7-8 patients a day with trigger fingers, and of those about a quarter to a third have diabetes. But diabetics make up about 70% of patients who present with multiple trigger fingers, as I did. I’ve had trigger “release” operations – in which the tendon is cut in order to widen the space within the sheath – on 8 fingers, including a thumb.

Cortisone shots are a temporary fix for some cases of trigger finger. But Dr. Rozmaryn says that he doesn’t like to give those to patients with diabetes, because the steroid can drastically raise blood sugar levels. “I’m very hesitant to give diabetics shots of cortisone unless they’re very well controlled and can monitor themselves and adjust their insulin doses.”

Most studies on diabetic hand complications are published in orthopedic and rheumatologic literature, rather than in endocrinology or primary care journals. As a result, diabetic hands aren’t often on the radar screen, Dr. Rozmaryn says.

“With diabetes, you’re worrying about the eyes, kidneys, the heart, and so many other things. But still, if you’re a physician who’s treating diabetics, my advice is don’t ignore the hands.”

—Miriam E. Tucker (@MiriamETucker on Twitter)

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Filed under Endocrinology, Diabetes, and Metabolism, Family Medicine, IMNG, Internal Medicine, Orthopedic Surgery, Primary care, Rheumatology

Repeal? Replace? The Policy & Practice Podcast

Washington’s abuzz this week as Congress returns to begin its lame duck session and Republicans start laying the groundwork for the next Congress — including their much-talked-about promise to repeal or replace the Affordable Care Act.

Via Flickr Creative Commons user Fibonacci Blue

In the meantime, new and returning congressmen might want to take a look at the National Commission on Fiscal Responsibility and Reform’s draft plan to reduce the deficit, issued by the two co-chairmen of the bipartisan commission. Health care is a big reason for runaway government spending, the co-chairmen said; however, they added that health reform might be an important mechanism for reducing those outlays.

Among the proposals was something near and dear to most physicians’ hearts: an overhaul of Medicare’s Sustainable Growth Rate.

But some veteran Congress-watchers said last week that the Commission’s proposals could easily go by the wayside. To hear what they have to say, check out this week’s podcast:

And look for next week’s installment, when we’ll bring you the best and the worst of this week’s Senate Finance Committee grilling of Don Berwick, the recess-appointed head of the Centers for Medicare and Medicaid Services.

— Alicia Ault (on Twitter @aliciaault)

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Filed under Health Policy, health reform, IMNG, Podcast, Practice Trends, Primary care

Health Reform Challenges All Around: The Policy & Practice Podcast

Election Day is less than a week away and health reform is facing challenges from several sides.

Courtesy flickr user Just Us 3 (CC)

Lawsuits addressing the constitutionality of the Affordable Care Act abound in federal court. Congressmen are crying foul over what they view as partisan attacks by the Obama administration against health insurance companies. And even America’s Sheriff, Andy Griffith, is under criticism for some public service announcements he did for Medicare open season.

Want the details? Take a listen to the Policy & Practice Podcast

—Denise Fulton (@denisefulton on Twitter)

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Filed under Health Policy, health reform, IMNG, Podcast, Practice Trends

The Medicine Cabinet of Dr. Caligari

 

In the 1920 horror film “The Cabinet of Dr. Caligari,” the mysterious Dr. Caligari arrives at a carnival with a cabinet whose contents ultimately cause mayhem, madness, and murder.

In our modern-day editorial offices, a series of display cabinets has suddenly arrived in a side corridor—cases whose colorful contents once had much the same effects as the cinematic Dr. Caligari’s cabinet.

Photo by Terry Rudd

The mysterious cabinets contain antique bottles of medicinal magic, including these pre-modern marvels:

  • Who needed biologics when you had Yohn’s Rheumatic Elixir, “An Infallible Cure for Rheumatism, Lumbago and Gout”?
  • The 18th Amendment probably went down easier with Dr. Fenner’s Golden Relief, containing “Alcohol 65%, Ether 22 minims, Chloroform 5 minims, Capsicum, Turpentine, Ammonia,” and several other Prohibition-relieving compounds.
  • Chemoprevention was as simple as a spoonful of Dirigo Bitters and Blood Purifier: “A Preventive of Cancer.”
  • And finally, Parke-Davis & Co. discovered what Ponce de Leon futilely scoured Florida to find: “Life-Everlasting,” featuring the apparently immortality-inducing agent Gnaphalium polycephalum.

These historical artifacts actually belong to our corporate cousins who cover the pharmaceutical industry. But on some level, they belong to us all, a bottled legacy of medicine’s sometimes perilous evolution.

The medicine cabinets offer a rare glimpse back into the Valley of the Shadow of Death and Snake Oil. They’re reminders that we haven’t been climbing the mountain of medicinal progress as long as we might think.

In a time when a routine case of acute otitis media practically autogenerates an amoxicillin script, it’s easy to forget that many of our parents lived their childhoods in the deep shadows of a pre-antibiotic Dark Age. It’s hard to remember that the politically disparaged words “government regulation” once weren’t even in the pharmaceutical vocabulary, with painful results for millions. It wasn’t so long ago that our well-meaning physician ancestors chipped away at disease with the pharmaceutical equivalent of stone tools.

At best, those cabinets’ antique contents did little for their users. At worst, they were products from the closing moments of a millennia-long medical era that spawned the phrase “The cure is worse than the disease.”

Medical practice and the drugs upon which it relies have escaped their Dark Ages. From the antibiotic I’m giving my AOM-afflicted 7-year-old to the antiretroviral revolution in HIV treatment, scientifically tested and government-approved pharmaceuticals have helped create a world of health and longevity inconceivable a century ago.

Certainly, its snake-oil ancestors’ mortal sins don’t excuse the shortcomings of today’s pharmaceutical industry. Or those of the industry’s sometimes fallible regulators. But while we work ourselves into a righteous dudgeon over the influence of pharmaceutical industry funding or clinical trial obfuscation, or point fingers over imperfections in federal government oversight, we might want to take a moment to look back down the medicinal trail.

And remember how far we’ve come from the madness of those Caligari-esque medicine cabinets.

—Terry Rudd

 

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Filed under Drug And Device Safety, Endocrinology, Diabetes, and Metabolism, Family Medicine, Gastroenterology, Health Policy, IMNG, Infectious Diseases, Internal Medicine, Pediatrics

Doctors: Help Them Understand That “It Gets Better”

Any growing tolerance of a person’s right to his or her own sexuality that is evidenced in the mainstream culture has yet to impact the Lord of the Flies scenarios that exist for gay, lesbian, bisexual, transgendered, or questioning students in many schools across the country—something that is comically but bitingly portrayed in the Fox hit series, “Glee.”

Courtesy flickr user VJnet (CC)

Proof that modern student life in America is not a Rainbow coalition comes from several areas, including a 2009 survey of 7,261 middle and high school students that found that nearly 9 out of 10 LGBTQ students experienced harassment at school in the previous year. Almost two-thirds (60%) said that they felt unsafe at school because of their sexual orientation and 40% said they felt unsafe because of how they expressed their gender; 40% were physically harassed at school within the past year and about 20% were physically assaulted.

Further, Dr. Elise D. Berlan of Nationwide Children’s Hospital in Columbus, Ohio, and her colleagues recently found that in a study of more than 7,500 adolescents, gay males were twice as likely to report being bullied and mostly heterosexual males were almost 1.5 times as likely to report being bullied, as compared to straight males (J. Adolescent Health 2010; 46: 366-71). Their findings among LGBTQ young women were similar. Dr. Berlan and colleagues advised doctors who are taking care of gay and bisexual youth to ask about teens’ experiences with violence and bullying, probe how they were doing with those experiences, and try to determine if there is anything that could be done to support them.

Tragically, gay teen suicide and suicidal ideation are nothing new—I should know, I tried my best to find a way out as a gay 17 year old. But a recent spate of highly publicized gay teen suicides, noted even by Secretary of Education Arne Duncan, has catalyzed a remarkable grassroots movement that may provide a new tool for doctors to help at-risk gay teens cope, especially in those bleak hours when no one seems to notice, much less counsel them.

Importantly, the movement speaks the language that they may best accept and understand—the voices of gay men and women, beloved celebrities from their favorite TV shows and movies and iTunes downloads telling them “It Gets Better.” The campaign uses the social media in which these teens are already immersed—YouTube, Twitter, MySpace, Tumblr, SocialVibe—and includes a 24/7 hotline staffed by trained counselors ready to take on the tough questions and sorrows of troubled gay teens when there may be no one else around.

If you are not of a certain (young) age, a hopeless lover of musical theater and schmaltz, gay, or just nostalgic for high-school glee club, or have a child in any of those categories, you may not be aware of one of the movement’s new poster boys, Chris Colfer.

On October 5, Colfer, a 20-year old out gay actor who plays a 16-year old gay teen on “Glee,” released a public service announcement for The Trevor Project, an LGBTQ youth support organization. Although the Project has been around since 1998, their involvement in the “It Gets Better” campaign has struck a chord, making it more relevant than anything going in today’s world for pointing at-risk gay teens to the support they desperately need.

Emmy-nominated Colfer, who plays Kurt Hummel, an effeminate, bullied, yet triumphantly out gay glee-club “loser,” is perhaps the most popular gay youth icon on the planet today. On his Twitter page, which has more than 318,000 followers, he was asked in late September if he would do a video for the Trevor Project; he tweeted back that it was in the works. His PSA hit YouTube on Oct. 5 and rapidly became one of the most tweeted and retweeted PSAs in the project’s history—so much so that it became the face of the project’s website and has a YouTube hit count of nearly 300,000 views (in less than 3 days online), far above that of Daniel (THE Harry Potter) Radcliffe, a Trevor Project supporter who happens to be straight. If you are into comparative battling, the hit count for Radcliffe’s YouTube PSA hovers around 38,000.

Colfer’s own story is well known among his fans—a gay kid bullied throughout his school years, especially for his high-pitched speaking voice, which however wonderful for a juvenile cast member who can hit the high notes of a counter-tenor on a hit musical “dramedy,” is a deadly trait for most teenaged boys.

Heightened by the recent spate of gay teen suicides, The Trevor Project’s “It Gets Better” campaign has gone viral in recent weeks, in part helped when Dan Savage, a syndicated gay columnist, began his own YouTube channel last month. Inspired by Billy Lucas, a 15-year-old high school student in Indiana who committed suicide after being taunted by his classmates for being gay, Savage has asked famous and non-famous alike to record messages of hope to gay teens who are being bullied, and more importantly, thinking about suicide.

The difference between these announcements and the impassioned attacks against gay bullying by the likes of Ellen DeGeneres and straight celebrities such as Joe Jonas, is the fact that they are not ABOUT gay kids, they are messages TO gay kids, saying, “Hang in there. It is wretched now, but if you can make it, things DO get better.” And this from the very people they most respect, fantasize about, and who are living proof of survivorship. Gay celebrities and gay-friendly icons who have made their own “It Gets Better” videos, include such out luminaries as actor Neil Patrick Harris and fashion guru Tim Gunn, who detailed his own suicide attempt as a gay youth.

Perhaps if you don’t know how to help that gay teen in your office who’s bullied, depressed, or withdrawn, or what to tell that kid’s parents who desperately ask what to do about their “strange” son or daughter, you can use your 15-minute slot to let them know about “It Gets Better.” Let them know they are not alone and that there is hope.

“It Gets Better” may be especially important because it is a resource that these kids can turn to when they’re are most alone—in the middle of the night staring at their computer screens, reading the inevitable anti-gay bile being spewed in comments posted on any gay news or entertainment items, or in the early morning, when they wake up, terrified of facing another day of bullying at school. If they can’t access the campaign on a computer at home, tell them to go to the library or their school computer room—but to watch who might be looking over their shoulder and delete their browser history if they feel they’ll be bullied because of it. At the very least, give them The Trevor Project Lifeline number: 866-488-7386.

If the kid isn’t out (at least not to you) or if the parents aren’t willing or able to deal with that kind knowledge or suspicion, perhaps you can slip some links into a generalized list of resources for troubled teens. If the kid is LGBTQ, he or she WILL follow them and likely be grateful for the secret high sign.

October 11 is National Coming Out Day. Many who should be will not be here to see it. Maybe you can help do something about the next batch of gay or questioning youth at risk. They may be shy. They may speak in monosyllables. They may be painfully polite or wryly sarcastic. And you may actually be patching up the physical or mental results of gay bullying or gay self-hate without realizing it, because they probably won’t tell you what really happened to them.

Don’t let them scare you off. Educate yourself as best you can. Help them if you can. And tell them, from me, that it does get better.

—Mark S. Lesney

Other related resources for LBGTQ teens include Matthew’s Place, named in honor of murdered gay teen Matthew Shepard and the Gay, Lesbian and Straight Education Network, which promotes education and lobbying for gender equality in schools.  And for these and other teens being bullied for whatever reason, visit Stomp Out Bullying and the National Center for Bullying Prevention. PFLAG – Parents, Families, and Friends of Lesbians and Gays – is a good place for parents and families of LGBTQ teens to find valuable information. To learn the names and faces of the recent suicides, go here.

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Filed under Family Medicine, IMNG, Internal Medicine, Obstetrics and Gynecology, Pediatrics, Practice Trends, Primary care, Uncategorized