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Bad Medical Marketing: An Ad The FDA Should Pull

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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 voiceover — and then they proceed to show men’s reactions to watching a surgical procedure, with “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, they’ve created this ad.

The ad is slimy, harmful, obnoxious, and just plain stupid. A couple’s decision as to which sterilization procedure is best for them should be one informed by real information, not frat-boy marketing.

How dare they? The FDA should pull this ad — now.

**********

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

Thank you for your attention to this matter.

*This blog post was originally published at The Blog That Ate Manhattan*

Questioning The Annual Pelvic Exam

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A new article in the Journal of Women’s Health by Westhoff, Jones, and Guiahi asks “Do New Guidelines and Technology Make the Routine Pelvic Examination Obsolete?”

The pelvic exam consists of two main components: The insertion of a speculum to visualize the cervix and the bimanual exam where the practitioner inserts two fingers into the vagina and puts the other hand on the abdomen to palpate the uterus and ovaries. The rationales for a pelvic exam in asymptomatic women boil down to these:

  • Screening for chlamydia and gonorrhea
  • Evaluation before prescribing hormonal contraceptives
  • Screening for cervical cancer
  • Early detection of ovarian cancer

None of these are supported by the evidence. Eliminating bimanual exams and limiting speculum exams in asymptomatic patients would reduce costs without reducing health benefits, allowing for better use of resources for services of proven benefit. Pelvic exams are necessary only for symptomatic patients and for follow-up of known abnormalities. Read more »

*This blog post was originally published at Science-Based Medicine*

A Helpful Vitamin Chart

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Lately I’ve been worrying about Kevin’s refusal to eat broccoli, and wondering what exactly is so good about those green bunches of roughage. In browsing the Web for more detailed information on the matter, I found a helpful vitamin chart.

The table comes from the HHS–sponsored National Women’s Health Information Center — a good spot to know of if you’re a woman looking online for reliable sources. It’s a bit simple for my taste. In the intro, we’re told there are 13 essential vitamins our bodies need. After some basics on Vitamin A — good for the eyes and skin, as you probably knew already — the chart picks up with a quick review of the essential B vitamins 1, 2 ,3 ,5 ,6 , 9 and 12 (my favorite), followed by a rundown on Vitamins C, D, E, H (that would be biotin) and K:

Vitamins, Some of their Actions, and Good Food Sources
Vitamin Actions Sources
A
  • Needed for vision
  • Helps your body fight infections
  • Helps keep your skin healthy
Kale, broccoli, spinach, carrots, squash, sweet potatoes, liver, eggs, whole milk, cream, and cheese.
B1
  • Helps your body use carbohydrates for energy
  • Good for your nervous system
Yeasts, ham and other types of pork, liver, peanuts, whole-grain and fortified cereals and breads, and milk.
B2
  • Helps your body use proteins, carbohydrates, and fats
  • Helps keep your skin healthy
Liver, eggs, cheese, milk, leafy green vegetables, peas, navy beans, lima beans, and whole-grain breads.
B3
  • Helps your body use proteins, carbohydrates, and fats
  • Good for your nervous system and skin
Liver, yeast, bran, peanuts, lean red meats, fish, and poultry.
B5
  • Helps your body use carbohydrates and fats
  • Helps your body make red blood cells
Beef, chicken, lobster, milk, eggs, peanuts, peas, beans, lentils, broccoli, yeast, and whole grains.
B6
  • Helps your body use proteins and fats
  • Good for your nervous system
  • Helps your blood carry oxygen
Liver, whole grains, egg yolk, peanuts, bananas, carrots, and yeast.
B9 (folic acid or folate)
  • Helps your body make and maintain new cells
  • Prevents some birth defects
Green leafy vegetables, liver, yeast, beans, peas, oranges, and fortified cereals and grain products.
B12
  • Helps your body make red blood cells
  • Good for your nervous system
Milk, eggs, liver, poultry, clams, sardines, flounder, herring, eggs, blue cheese, cereals, nutritional yeast, and foods fortified with vitamin B12, including cereals, soy-based beverages, and veggie burgers.
C
  • Needed for healthy bones, blood vessels, and skin
Broccoli, green and red peppers, spinach, brussels sprouts, oranges, grapefruits, tomatoes, potatoes, papayas, strawberries, and cabbage.
D
  • Needed for healthy bones
Fish liver oil, milk and cereals fortified with vitamin D. Your body may make enough vitamin D if you are exposed to sunlight for about 5 to 30 minutes at least twice a week.
E
  • Helps prevent cell damage
  • Helps blood flow
  • Helps repair body tissues
Wheat germ oil, fortified cereals, egg yolk, beef liver, fish, milk, vegetable oils, nuts, fruits, peas, beans, broccoli, and spinach.
H (biotin)
  • Helps your body use carbohydrates and fats
  • Needed for growth of many cells
Liver, egg yolk, soy flour, cereals, yeast, peas, beans, nuts, tomatoes, nuts, green leafy vegetables, and milk.
K
  • Helps in blood clotting
  • Helps form bones
Alfalfa, spinach, cabbage, cheese, spinach, broccoli, brussels sprouts, kale, cabbage, tomatoes, plant oils. Your body usually makes all the vitamin K you need.

(From womenshealth.gov; table accessed 2/19/2011.)

Overall I’d say the chart is useful — a good place to start if you want to know, say, what’s a good, non-citrus source of Vitamin C. It could be improved by provision of more details, like the precise amount of Vitamin B2 per cupful of Swiss chard, and how preparing foods in distinct ways — like roasting, sautéing, boiling, or serving them raw — affects the nutritional value.

*This blog post was originally published at Medical Lessons*

Managing Patient Uncertainty

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How comfortable are we with uncertainty? I struggle with this question every day. I treat children with abdominal pain. Some of these children suffer with crohns disease, eosinophilic esophagitis, and other serious problems. Some children struggle with abdominal pain from anxiety or social concerns. I see all kinds.

But kids are tricky, and sometimes I can’t pinpoint the problem. Trudging forward with more testing is often the simplest option since it involves little thinking. And some parents perceive endless testing as “thorough.”

The question ultimately becomes: When do we stop? Once we’ve taken a sensible first approach to a child’s problem and judged that the likelihood of serious pathology is slim, when and how do we suggest that we wait before going any further? This requires the most sensitive negotiation. It’s about finding a way to make a family comfortable despite the absence of absolute certainty. This is easier said than done. Parents can unintentionally advocate for themselves and their worries by insisting on the full-court press. Alternatively they may refuse invasive studies when absolutely indicated.

All of this is for good reason: You can’t be objective with your own kids.

Pediatrics is tricky business and managing parental uncertainty is perhaps my biggest preoccupation. As I’ve suggested before, sometimes convincing a family to do less represents the most challenging approach.

*This blog post was originally published at 33 Charts*

Independent Peer-Reviewed Scientific Journals: Just How Independent Are They?

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On September 27, 2010, the peer-reviewed scientific journal Europace published online-before-print a case report entitled “Spontaneous explosion of implantable cardioverter-defibrillator” by Martin Hudec and Gabriela Kaliska. In the pdf of that case report a figure containing a color photo of the affected patient’s chest, chest X-ray, and two pictures of the extracted device (one seen here) were included.

The pictures and case presentation were dramatic and the case very rare. Both were perfect reasons to report such an important case to the medical literature. And so these doctors sent the case to Europace on June 29, 2010, and the article was accepted after revision on August 16, 2010, with the article appearing online September 27, 2010.

The authors must have felt very proud to have an article published relatively quickly, and the editors and reviewers of Europace must have thought the case was unique enough and important enough to have the article revised according to their specifications, then published online — until I reported the case on this blog on October 5, 2010, and included images from a portion of the case report’s figure.

Remarkably, later that same day, Europace removed the case report from its website without comment. The article simply vanished. I attempted to e-mail the editor of Europace to inquire about the reason for the retraction but received no reply, so I contacted the lead author, Martin Hudec, M.D. He kindly responded and I included his email response in the comments to my post two days later. Read more »

*This blog post was originally published at Dr. Wes*

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