Essure – Bad Marketing. FDA – Pull This Ad.

If ever a medical device company crossed a line with their marketing, this one has.

Essure, which makes a sterilization device for women, is trying to scare men away from vasectomy in order to drive women to use their device.

“We made men watch footage of an actual vasectomy” says the female overvoice – and then they proceed to show men’s reactions to watching a surgical procedure –  “That’s frickin’ gross, man” being the most memorable quote.

The final tagline – “You can only wait so long for him to man up.”

Yeah – and to be sure he doesn’t, we’ve created this ad.

Slimy, harmful, obnoxius and just plain stupid. A couple’s decision as to which sterilization procedure to have should be one informed by real information, not stupid frat boy marketing.

How dare they?

The FDA should pull this ad.  Now.

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Addendum –

I just emailed the FDA at BadAd@fda.hhs.gov.   Feel free to copy my message below and send your own email –

To the FDA –

I find the following ad for Essure both inflammatory and unethical. I am incensed at the impact this ad could have on couple’s informed choices about sterilization.

http://www.youtube.com/watch?v=nPk5mtLMv94

I ask that you mandate that the company who makes Essure immediately pull this ad, both from the web and from any media outlet where it is playing.

Thank you for your attention to this matter.

Blue Hill-Inspired Thoughts on Real Food and a Recipe for Braised Fennel with Apples

If you had a gift certificate for dinner at Blue Hill, when would you go? Summer or winter? Would it be salads, corn, fresh tomatoes, summer vegetables and berries or root vegetables, greenhouse greens and autumn fruits?

I chose winter. Perhaps it’s my Irish/Slav potato-loving roots and my love of cheeses and cured meats. Or the fact that the gift certificate, given to me by a grateful patient over a year ago, was about to expire.

For those of you who may not know Blue Hill, it’s the restaurant the Obamas chose for date night in 2009,  where chef Dan Barber, at the forefront of the farm-to-table movement, serves food the NY times says “you’d almost rather hug than eat”.

We took the girls to Blue Hill for a special family dinner, riding the train to West 4th St one Sunday evening in mid-January, walking through the Village and stopping along the way to browse the vinyl at Bleecker Bobs before taking a late seating at Blue Hill. We’ve never before eaten with the kids at such a high end restaurant, but they’re old enough now to appreciate it, and have a good consciousness of the issues regarding the food supply in this country and the importance of restaurants like Blue Hill in supporting local farmers.

The meal was marvelous, every bite a satisfying surprise. Since the gift certificate went only so far towards what is a very pricey meal, we decided to share the appetizers and skip the bottle of wine so we could enjoy dessert. So no one was more surprised than I to discover that, despite what might have seemed small portions in another restaurant, we were utterly satisfied by the end of our meal and elected to forgo dessert.

But that’s what real food does, doesn’t it? It truly satisfies.

Sometimes I wonder if the reason Americans are so fat is because we just keep looking to satiate our inner craving for real food, a craving that synthetic processed food will never be able to fill. Which suggests that the higher price tag for organic veggies and grass fed meats may actually bely the biggest food bargain we’ll ever get.

Blue Hill-Inspired Braised Fennel and Apples

The Blue Hill appetizer that inspired this dish was braised and roasted fennel, smoked apples and homemade pancetta. They sliced their apples so thin you could almost see through them – without a mandoline, I couldn’t come close, but still I enjoyed my own version almost as much. I based my recipe on one from Simply Recipes (nice pic there of braised fennel), used pistachios instead of pancetta, and drizzled a nice rich balsamic vinegar atop for color and a dash of flavor.

2 small fennel bulbs
Extra-virgin olive oil
Salt and freshly ground black pepper
(optional) a tiny sprig of fresh rosemary or thyme
1/2 cup chicken broth
1 tbsp balsamic vinegar
1 large Gold Rush or other tart crisp apple, thinly sliced
Roasted peeled pistachios – I get mine from a local Middle Eastern Food shop

Trim the fennel, halve each bulb through the core, then cut lengthwise into 1/2-inch-thick slices.

Heat 1 tbsp olive oil  in a large skillet over medium-high heat. Cook the fennel (in batches if ned be) until browned on all sides, turning carefully and seasoning with salt and pepper while browning, about 4-5 mins each.

Add the broth and bring to a boil. Simmer, covered, until tender, about 10 minutes. Using a slotted spoon, transfer to a bowl. Raise the heat to high, add 1 tbsp balsamic vinegar, and reduce the sauce until syrupy.

Arange the apples on a serving plate, then top with fennel and pistachios. Drizzle with balsamic reduction.

Po. Go.

Po is Mario Batali’s first restaurant, except it’s not Batali’s restaurant anymore. The place is owned by Steven Crane, who opened Po with Batali over 20 years ago, but the kitchen is now manned by Lee McGrath. Which is every reason you need to eat there.

Mr TBTAM, my daughter and I had dinner at Po last Sunday evening to celebrate Restaurant Week and Valentine’s Weekend. We had a 5:15 pm reservation, since we had tickets for the 7 pm show at the Angelika theater . Although totally uncool, it was a great time to go – we had first sitting, great service, and by the time we left, the line was just starting to form at the door.

What I loved most about Po is that it is small, intimate and feels nothing like the restaurant empire that I know Batali has built since opening Po. The only scene here is the food. The decor is simple and white, but feels warm and cozy. Steve Crane the owner was there, locals kept stopping by the bar to say hi, and it just felt like what a restaurant should be, on a street that still feels like the Village has always felt. I wanted to move there. Now. After all, Murray’s Cheese shop is right at the end of the block. So is Amys’ Breads. And Faccio’s Pork Shop. And Reafettos Pasta Shop is just around the corner. What more could a person want?

Which brings me to the food (and the usual bad restaurant Iphone food photos)

  • White Bean Crostini. Complimentary. Fresh, garlicky, although I did sprinkle a tad of salt on mine.
  • Mesclun greens with a lemon thyme vinaigrette. Perfect.
  • Orichetti with sausage ragu and broccoli rabe. OMG. Reminiscent actually, of my mother in law Irene’s Bolognese, but with a robust but not overpowering thyme aroma and a butteriness that made it so satisfying, we brought leftovers home and had it the next night – even better.

  • Grilled Guinea Hen  with Pumpkin scallions, fregula & saba. Their signature dish, and I know why. Sweet, savory, light, amazing.

  • Lingiuine Vongole with fresh clams, pancetta, red chile and white wine. Mr TBTAM, someone finally made a clam sauce as good as yours.
  • Wine – I  had the Pino Grigio ’08 “Santi” Sortesele (Vento) by the glass – light, citrusy. I’m back onto a Pinot phase, and am tasting flavors in it I had never tasted before. Not sure why. Maybe my taste buds are maturing…
  • Dessert – Not knowing in advance the reputation of the ricotta cheesecake, we opted for a warm apple tart with ice cream. I think I got one bite away from my companions. Thanks, guys…

My only complaint was that the cushion on the banquette needed some bolstering – we had to fight over who got “the sinking spot”. That should be easily fixed, but we forgot to tell them because we were distracted by the wonderful meal. If someone from Po is reading this, it’s the first table on the right wall as you walk in the door…

Despite the fact that we did not have the restaurant week meal, everything was very reasonably priced.  Not cheap, mind you, but it did not feel like we were being gouged in return for the privilege of eating fresh, local ingredients in an intimate setting. I like the fact that Po has maintained relationships with local food purveyors since it opened, and that they get fresh food from a farm upstate. In a way they’ve been at the vanguard of the local food movement, without being all precious (and pretentious) about it.

Bottom Line

If you’re looking for a really special meal in a really special NYC location, go to Po. I’m definitely going back again. And again.

And in my next life, the one where I can afford to buy an apartment wherever I want in New York City? I’m moving to Cornelia Street.
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Mo’ Po from around the web

The EMR and the Pathologist – A Winning Combo

A pathologist uses the EMR to find out just a little more about the patient whose cerebro-spinal fluid she has under her microscope – and changes her diagnosis.

This patient had a diagnosis of plasma cell myeloma with recent acute mental status changes. So the lone plasma cell or two I was seeing, among the lymphs and monos, could indicate leptomeningeal spread of the patient’s disease process. I reversed the tech diagnosis to atypical and added a lengthy comment – unfortunately there weren’t enough cells to attempt flow cytometry to assess for clonality of the plasma cells to cinch the diagnosis. But with the information in the EMR I was able to get a more holistic picture on a couple of cells and provide better care for the patient. I cringe to wonder if I might have blown them off as lymphs without my crutch.

The much hoped-for improvement in quality due to the adoption of EMRs has been elusive to date, so anecdotal experiences like this will be important evidence to consider in judging the impact of the EMR on health care outcomes.

Kudos to pathologist Gizabeth Shyner, who writes over at Mothers in Medicine and her own blog, Methodical Madness,  for “Thinking Outside the Box”.

Sondheim on Blogging

Actually, I have no idea if the Great One even knows what a blog is. But the preface of his book Finishing the Hat contains what could be the best writing advice this blogger’s ever read.

There are only three principles necessary for a lyric writer (blogger), all of them familiar truisms… In no particular order, and to be written in stone –

Content Dictates Form

Less is More

God is in the Details

all in the service of

Clarity

without which nothing else matters.

Now go forth and write.

(Photo- Jerry Jackson, coutesy Indian U.)

2010 Medblog Awards Winners

Congratulations to the fabulous blogs that have won the coveted Medblog Awards this year! If you don’t read these blogs already, you’re missing out on some great blogging.

  • Best Medical Weblog of 2010 – EMCrit blog. An intense blog from an ER intensivist.
  • 2010’s Best New Medical Weblog – ZDoggMD. Medical rap. Yo.
  • The Best Literary Medical Weblog – StorytellERdoc. This ER doc has a way with words.
  • The Best Clinical Weblog of 2010 – GeriPal. Geriatrics and palliative care, the true angels in healthcare.
  • The Best Health Policies/Ethics Weblog – Covert Rationing Blog. The blog that dares to use the “R” word in healthcare.
  • The Best Medical Technologies/Informatics Weblog – ScienceRoll. Informatics and Genetics.
  • This year’s Best Patient’s Blog – Wheelchair Kamikaze. A go to blog for MS patients and those who love them.

We Must Keep Title X and Planned Parenthood Funding

The House of Representatives will vote this week on continuing resolutions that could end funding for Title X programs and eliminate all Title X Funding going to Planned Parenthood.

Despite the beliefs of their supporters, these resolutions will NOT reduce abortions. In fact, if they pass, abortion rates will surely increase. In addition, vital preventive health services will be cut.

Here are the lies you may have heard about Title X and Planned Parenthood, and the truth you need to know –

Lie #1 : Title X Funding pays for abortion –  FALSE.

It does not, because, by law, it cannot. Here’s what Title X funded for in 2009, straight from the the HHS Website:

  • Contraceptive services for over 5 million family planning users;
  • Over 2 million pap smears, 1% of which had precancerous abnormalities that required treatment;
  • Over 2 million clinical breast exams, 3% of which were abnormal and led to further evaluation or treatment;
  • Over 2 million STD screening tests; and
  • Almost 1 million HIV tests

The majority of Title X funded clinics serve clients with incomes at or below the poverty line, and who have no other funding source for these services. In some states, Planned Parenthood is the only provider of Title X services.

Lie #2 – Planned Parenthood’s Major Business is Abortion – FALSE.

Ninety seven percent of Planned Parenthood’ services are contraception, cancer screening and STD screening and treatment.  Only 3% of the almost 11 million services provided in 2008 were abortions. (Click the pie chart below for detail.)

Lie #3: We can’t afford Title X funding FALSE.

We can’t afford not to pay for these preventive health services, all of which have been shown to be a cost effective use of federal funds. According to the Guttmacher Institute –

The contraceptive services provided at (Title-X funded) centers helped women and couples avoid 973,000 unintended pregnancies, which would have resulted in 433,000 unplanned births and 406,000 abortions.

By helping women avoid unintended pregnancies, Title X–supported family planning centers saved taxpayers $3.4 billion in 2008—or $3.74 for every $1 spent on contraceptive care.

Lie #4 . Taking Title X funds away from Planned Parenthood will prevent abortion – FALSE.

Loss of funding for contraception means more unplanned pregnancies, which means more abortions.  Without restating the above argument, I’ll state the obvious –

If you want to prevent abortion, you’ll contact your representative and tell him/her to vote against any attempt to eliminate Title X funding.

Take action now.  The threat to funding is real, and the need is urgent.

Linguine with Shrimp and Cilantro Lime Pesto

The weeknight warriors have done it again, this time with a delicious pasta recipe.

My role in the whole operation was limited to finding a recipe after Mr. TBTAM and I agreed over the phone on the ingredients we had in mind – shrimp, lime, pasta. I emailed him the recipe, then went back to work, strolling in the door at 7 to younger daughter having a piano lesson and Mr .TBTAM reading in the den, the table set, salad made, pasta water simmering and the ingredients for the meal prepped and waiting for the final cook after the lesson was over. I quickly made a lemon vinaigrette for the salad and started some applesauce cooking for dessert while Mr. TBTAM cooked and assembled the pasta.

But hey, I did the dishes, so it all comes out even.

Linguine with Shrimp & Cilantro-Lime Pesto
Modified from Bon Appetit, July 2010

This recipe uses Cotijo cheese, or Mexican Parmesan, an artisan cheese made from cow’s milk taken during the rainy season when the grass grows on the mountainside. Coteja is sort of a cross between a mild feta and a parmesan – salty, white, softer than parmesan, but easily crumbled – and does not melt when cooked. We found ours at Fairway, where it was very reasonably priced. You can substitute Feta if you can’t find Cotija.

I was taken aback by the final calorie count on this recipe – for 4 servings, it’s a whopping 830 calories each. Of course, one does not have to have an entire 1/4 pound of pasta per serving, but this stuff is so good it’s like crack. Next time, I’ll portion it to serve 6, cut back the olive oil to 1/4 cup, the tequila to 2 tbsp and up the lime juice to 4 tbsp total to lose some calories – I don’t think it will hurt it at all.  Any other suggestions on lightening this dish without losing its oomph would be most appreciated.

Ingredients

  • 1 1/2 cups fresh cilantro leaves, plus 1/4 cup chopped
  • 1/4 cup coarsely chopped scallions
  • 3 tbsp fresh lime juice
  • 2 garlic cloves, sliced
  • 1 tbsp chopped, seeded serrano pepper
  • 1/2 cup plus 1 tbsp olive oil
  • 1 lb linguine
  • 1 lb medium shrimp, peeled, deveined
  • 3 tbsp tequila
  • 1/4 cup crumbled Cotija cheese

Preparation

Blend 1 1/4 cups cilantro leaves and next 4 ingredients in processor until coarse puree forms. With machine running, gradually add 1/2 cup oil. Season with salt.

Cook linguine in large pot of boiling salted water until al dente. Drain. Meanwhile, heat remaining 1 tablespoon oil in heavy large skillet over medium-high heat. Add shrimp and cook until almost opaque in center, about 3 minutes. Remove skillet from heat; add tequila. Return skillet to heat and stir until sauce is syrupy, about 30 seconds. Add pesto; stir to coat. Remove from heat.

Add pasta to sauce in skillet; toss to coat. Season with salt and pepper. To serve, plate and sprinkle with Cotija cheese and chopped cilantro.
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I’m not the only one making this pasta.

  • Michael Beyer does a gorgeous big plating.
  • Mardi suggests a splash of lime juice at serving. Turns out that’s just what my daughter did.
  • Erin made hers with Parmesan and Feta and added some hot pepper flakes.
  • Sally at Bewitching Kitchen notes that it’s unusual to find fish and cheese paired so well.
  • Shea Evans and his cat takes a pretty pic of this pasta.
  • Eye for a Recipe shows you what the pesto looks like before being added to the pasta. Hmmm!!
  • Jennifer makes the pasta while recovering from a belly dancing lesson. That’s one way to work off the calories.
  • Amanda is as excited as I am to have discovered Cotija cheese.

Biologic SuperGlue for Repair of Childbirth Lacerations

Bio-adhesives are a reasonable alternative to sutures for repair of perineal lacerations sustained during childbirth, according to a poster presentation at last week’s annual meeting of the Society for Maternal Fetal Medicine. Researchers at the Hadassah Hebrew University Medical Center in Jerusalem randomized women with first degree perineal tears to either 2-octyl cyanoacrylate (Dermabond) adhesive glue or suture for wound closure. While healing and incisional pain was similar, women who received the adhesive closure were more satisfied than those who were sutured.

In Portugal, bioadhesives have been studied for closure of the top skin layer of an episiotomy repair, and found to shorten the duration of the procedure with similar outcomes to suture in terms of pain, healing and infection.

Biologic adhesives are chemically related to Superglue, which is ethyl-cyanoacrylate. Midwives have been using Superglue for perineal wound repair for some time, according to Anne Frye, who has authored a book on wound closure for midwives, and who gives instructions for its use in repair of perineal lacerations. Apparently Superglue was also used by the military during Vietnam for wound closure.

A Pub Med search on Dermabond finds multiple studies of its use, from plastic surgery to mastectomy, surgical wound closure, retinal surgery, lung and gastric leak closure, and even on esophageal varices. RL Bates mentions Dermabond as an option to repair skin tears in elderly patients. This stuff is turning into the duct tape of the medical profession…

It’s important to remember that adhesives are only for superficial skin closure, as use in deeper layers can cause irritation and burning of tissues. Side effects of their use include irritation and allergic reactions, and of course wound infections and pain can always occur no matter how one closes a wound.

Mrs. Goundo’s Daughter
National broadcast premiere
PBS World’s AfroPop series on February 9, 2011 at 7 pm.
Check local listings for additional dates and times
(The film will be shown multiple times )

Mrs. Goundo’s Daughter follows the tale of a Malian woman protecting her daughter from the harmful tradition of female genital mutilation.

Congrats to my good friend Janet Goldwater and fellow film maker Barbara Attie on this important premiere. I”ll be watching here in NYC on WNET/WLIW.

Abortion does not cause mental illness

Yet another study showing that abortion does NOT lead to future psychiatric problems.

In Denmark, where termination of pregnancy is legal and freely available until the 12th gestational week, we found no significant increase in the incidence rate of psychiatric contact in the 12 months after an induced first-trimester abortion as compared with the 9-month period before the abortion. The incidence rate of psychiatric contact was higher among girls and women who underwent an abortion than among those who underwent delivery, but this relationship was evident before the abortion or childbirth occurred. On the basis of these results, it seems likely that girls and women having induced abortions constitute a population with higher psychiatric morbidity. We interpret this as a selection phenomenon rather than a causal association, since the observed difference in psychiatric morbidity between girls and women having abortions and girls and women delivering antedated the abortion or delivery.

Can we please talk about something else? Like maybe how to help these young women with the issues and unmet contraceptive needs that led to unplanned pregnancy in the first place?

Deepok, Oprah, Jenny, Suzanne – This one’s for you

Comedian Tim Minchin takes on the alternative medicine, pseudo-science, homeopathy crowd as he recounts, in rhyming beat, a dinner party encounter with a beautiful, woo-spouting, tattooed girl called Storm.

The anti-woo rant starts around 2:15. But find nine minutes and listen to the whole frickin’ thing. Especially the end  (starting at about 7:30).

Brilliant.

The Levonorgestrel IUD (Mirena) as an Alternative to Hysterectomy for Treatment of Adenomyosis

Diffuse adenomyosis as seen on transvaginal ultrasound

Adenomyosis is a benign condition in which the glands that normally line the inner cavity of the uterus grow within its muscular walls, causing uterine enlargement, heavy, painful menses and anemia. Adenomyosis can be likened to endometriosis within the uterus and, in fact, often co-exists with pelvic endometriosis.

Not all women with adenomyosis have symptoms, and those with mild symptoms can find relief with oral contraceptives or Depo Provera. But for women with more extensive disease whose quality of life and health are threatened by heavy bleeding and pain, and for whom these hormonal interventions fail, the best treatment until now has been hysterectomy.

Now a new study shows that the levonorgestrel IUD (Mirena) may be just as effective as hysterectomy in treating adenomyosis.

The data

Researchers in Turkey randomly assigned women with strictly-diagnosed adenomyosis to treatment with either hysterectomy or insertion of a levonorgestrel IUD (Mirena). At baseline, all the women had heavy menses for at least 6 months, in addition to other symptoms such as dysmenorrhea and painful intercourse. The mean hemoglobin in the groups was 10 gm/dL, indicating significant anemia.

At one year post treatment, both hysterectomy and IUD groups had normal hemoglobin levels and improved quality of life as measured by the World Health Organizations Quality of Life Questionnaire. The study authors state that the IUD group had a greater improvement in psychological and social measures, but I suspect this was because the IUD group has lower scores in these domains at baseline.

Complications of hysterectomy were limited to post op wound infection in one patient. IUD users experienced headache (11%) , acne (5%) , breast tenderness (7%) and transient mood issues (1 subject), but no woman requested removal of her IUD due to side effects. One woman expelled her IUD and went on to hysterectomy.

The Study Has Important Limitations

The authors do not tell us what treatments women had tried before entering this study, so I am a bit wary that they may not have adequately sampled the group of women with adenomyosis who are most likely to warrant hysterectomy – those women who have tried and failed hormonal treatments such as birth control pills. One would never proceed to hysterectomy without at least trying these interventions. If the group studied here included all comers with adenomyosis, and if Mirena was their first attempt at treating the condition, than of course the IUD would prove to be effective (and hysterectomy potentially unnecessary). In the same way, oral contraceptives could be said to be an effective hysterectomy alternative for adenomyosis.

Bottom Line

Not all adenomyosis needs to be treated. But if adenomyosis is causing significant symptoms, the Mirena IUD can be added to the list of treatment options, and may prevent the need for hysterectomy in women with the more severe forms of the condition. Although this particular study is only one year, previous research on Mirena use in adenomyosis has found that it remains effective for at least 3 years, although side effects reduce satisfaction a bit over time.

For any given women, if Mirena’s benefits don’t persist, or if its side effects become intolerable, hysterectomy is still there as an effective and definitive solution to the problem.

Of note, Mirena has also proven to be effective in treating endometriosis.

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Image from Geneva Foundation for Medical Education and Research (I believe these images are royalty free…)