Reacting & Adapting to the New Pap Smear Screening Recommendations

Pap Smear (image from Wikipedia)

Cervical cancer screening used to be easy – they came once a year, I did a pap.  High risk patients with abnormal paps stayed at the top of my radar because they came more frequently or had procedures. If they managed to slip under the radar, we caught them at their annual.

Easy.

Now, with new consensus guidelines for pap smear screening, every patient is different. (Of course, they always were, but you get my point).

  • Under age 21 – No pap. No HPV Testing. (That one’s easy…)
  • Age 21-29 – Pap every 3 years. No HPV unless pap abnormal.
  • Ages 30-65 – Pap every 3 years, or Pap + HPV every 5 years.
  • Age 65 and older – If no history cervical pre-cancer, we can stop paps.
  • Cervical pre-cancer at any age – Manage individually.

How I feel About the New Pap Smear Recommendations

Overall, I think we are moving in the right direction, but I must admit that I am not entirely comfortable with every aspect of the new guidelines.

I do like the “no paps before age 21” recommendation. Cervical cancer is exceedingly rare in this age group, and has not declined appreciably with increased screening. And there is nothing less fun for patient or doctor than a colposcopy in a teenager. Which does not mean I won’t slip in an occasional pap a year or two early in a young woman who initiated sexual activity at a very young age (like before age 16). These kids worry me.

I’m not so enamored with jumping right into every 3 year screening (as opposed to having three normal annual paps first) starting at age 21. That recommendation is based mostly on modeling and not real world results, and accepts a small increase in the number of cervical cancers in return for less colposcopies.  I also worry that an every three year pap will turn into every five years, especially as we move towards longer acting contraceptives at the same time. This could increase the rates of cancers further in this group. Finally, I’d also argue that we’ve already made huge strides towards decreasing over-treatment by observing rather than treating low grade lesions in this age group. If it had been up to me I think I would have kept annual paps in this group, at least for three years before heading off to every three year paps.

This stands in contrast to the expected outcomes in women ages 30-65, where adding co-testing for HPV leads to better pre-cancer diagnosis and less cervical cancers – I like that a lot.

I also admit that I am having a bit of a problem thinking about stopping paps in healthy 65 year olds who are having new sexual partners and may be acquiring new HPV infections. The guidelines advise not to take sexual history into consideration in this age group, but I wonder if this is based on data from a world before the baby boomers found Match.com. In having discussions with such women about stopping paps, I find myself ordering an HPV test for reassurance before backing off. And thinking about readdressing the question in 5 years or so based on interval sexual history.

I’m still waiting to see what ACOG comes up with. They wrote in support for the new recommendations, but have yet to publish their own.

Doing less paps sounds simple, but the reality is that it takes more time

Not a lot of time, but in the era of the 15 minute office visit, every minute is precious.

Actually doing the pap takes a few seconds. But deciding whether or not to do the pap takes much longer. In order to determine which screening group a given patient falls into, I now have to go back and look at all her paps, review her history and figure out where we are in a given year on her screening scedule. That takes a few minutes.

Asking women to keep track is not always so helpful. You’d be surprised how many don’t know what their pap results were or how they may have been treated for abnormalities in the past. Getting old records is not always easy. The annual pap was always a great fallback position when there was uncertainty in the history.

At this point in time, my EMR has no ways of flagging the pap screening interval for me. (It still thinks I’m on an annual screening schedule with everyone.) So I’ve come up with little notes to myself in the assessment and plan – thinks like a macro that says “no hx abnormal paps, HPV neg, paps every 3-5 years”.  Next visit I can see this and carry it forward. Or putting a pap flag in the problem list – though it really isn’t a problem, is it? Until I get off schedule because I’ve lost track, that is.

Patients have their own issues with the new recommendations

Some are thrilled to have one less test. Others, not so much. Needless to say, we’re having a lot of conversations during visits about the new guidelines, which takes – let’s say it shall we? – time.

I’m not arguing that we need to to go back to one size fits all annual screening

Every woman is an individual, and deserves to be treated as such.   The new recommendations demand that we consider each woman’s risk of cervical cancer and weigh it against the harms of over-treatment in her age group. Overall, the risk-benefit ratio is favorable, but it does accept a small increase in cervical cancers in the age 21-29 age group, and a very very  small number of expected cancers in the over 65 crowd without allowing for consideration of other risk factors such as sexual activity. I’m not convinced that’s a trade off worth making. Unlike mammograms, which have had a limited impact on breast cancer mortality and none on its incidence, pap smears actually prevent cancer.  I wish we could have moved just a tad more slowly before making such sweeping changes.

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How do you feel about the new pap recommendations?

If you’ve come up with any little tricks for using your EMR to track individualized pap intervals for your patients, let us know in the comments section.

Leek, Spinach and Courgette Kugel (aka Persian Kuku)


I know. You’re wondering what a courgette is. I’ll give you a hint. It’s long, green, has seeds and can grow to enormous sizes. And no, it’s not a male frog’s body part, get your mind out of the gutter, will you?

Courgette is the French word for zucchini.

Courgette = Zucchini (French)

Speaking of words, although this dish, which hails from the Sephardic Jewish Jews of Turkey and Persia, is called a kugel, it is actually almost identical to the Persian egg-vegetable dish called a Kuku.

Remarkably similar words, similar ingredients, but, it seems, completely different etymology. According to the Jewish Encyclopedia, the word “Kugel” is derived from the German/Yiddish for Kugeltopf – a ball shaped ceramic jar in which puddings were cooked on the stove – while the word “Kuku” is believed to stem from  the Farsi word for fowl, which either makes a noise like the word or lays the eggs from which the dish is derived.

LEEK, SPINACH & COURGETTE KUGEL

Another recipe from Martha Spieler’s Jewish Cooking. This is one of the healthiest, most delicious ways to use the spring harvest, and is chock full of veggies, with the egg serving as more of a binder for the veggies than a main player.  Yet another reminder of what makes the Mediterranean cuisine so good for you. 

  • 6 tbsp olive oil
  • 2 large leeks, cleaned and thinly sliced
  • 1 1/2 pounds spinach, washed
  • 1 courgette (zucchini), coarsely grated
  • 1 baking potato, coarsely grated
  • 3 garlic cloves, finely chopped
  • 3 scallions, thinly sliced
  • 2 pinches ground turmeric
  • 3 tbsp matzo meal
  • 2 tbsp chopped fresh dill
  • 3 eggs, lightly beaten
  • salt and ground black pepper to taste
  • Lemon wedges to serve

Preheat oven to 400 degrees F.

Heat half the oil in a large saute pan. Add leeks and saute till just tender. Remove leeks to a large bowl and set aside.

Add the spinach to the pan with just the water that clings to it after washing. Place the cover on (it will seem like a lot of spinach, but don’t worry – it cooks way down) and saute over med high heat till just softened, using tongs to distribute and toss the spinach as it cooks down. (This step only takes a few minutes) Drain really well (use technique below if needed) , and when cool, chop roughly.

Meanwhile, grate the courgette and the potato, then drain and either squeeze in your hands to remove the excess liquid, or wrap in a clear dish towel and wring  to accomplish the same.

Add zucchini, potato and spinach to leeks, along with scallions, garlic, turmeric and salt and pepper to taste. Add the matzo meal. Stir the dill into the eggs and add to the vegetable mixture.

Pour the remaining 3 tbsp olive oil into a lasagna-type baking pan and heat in the oven for about 5 minutes. Carefully and quickly remove the pan to the top of the stove, and spoon the vegetable mixture evenly into the pan, allowing the hot oil to bubble up over the ides and onto the top of the veggie mixture.

Bake for 15 minutes, then reduce the heat to 350 degrees F and bake another 15-20 minutes till firm to the touch, golden brown and fluffy.

Sprinkle with chopped dill for garnish ad serve warm with lemon wedges to squeeze over the kugel.

ADDENDUM 6/24/12 – IRENE’S VERSION

My mother-in-law Irene, the Best Home Cook in the World, modified the recipe as follows –

One leek instead of two. 1/2 chopped red pepper in with the leek. One 10 oz. bag spinach instead of 1-1/2 lbs. 2 tbsps. matzo meal instead of 3. 2 scallions instead of 3. I stirred in about 1/4 cup of crumbled feta cheese to the finished mixture before baking it. Had some home-made spicy tomato sauce in the fridge and smeared about 1/4 cup on top, halfway thru the baking. Thanks, a great recipe and will be wonderful at Passover.

Just tasted her version and it is even better than the one I made.  She made hers in a 7 by 12 by 2.5 inch oval ceramic pan, which gave hers more height.

Moroccan Carrot Salad

Marlena Spieler’s marvelous cookbook Jewish Cooking covers the breadth of traditional Jewish cuisine across Europe, the United States, Africa and the Middle East. Accompanied by gorgeous illustrations, a fascinating historical introduction on the Jewish Diaspora and a very informative (for this Catholic-raised girl at least) chapter on Jewish dietary laws and foodstuffs, the book has become one of my favorite go-to sources for new and foolproof recipes. After all, these are the dishes that have withstood generations of cooks, with adjustments and tweaks along the way. At this point in their evolution, they’re pretty much perfect.

MOROCCAN CARROT SALAD
My only modifications on the original recipe were to lightly saute the garlic in olive oil  (I don’t like garlic too raw), eliminate the vinegar (it gives me migraines), and increase the lemon juice accordingly. ff you like vinegar, use just 1/2 lemon and add 2 tbsp of red wine vinegar.

  • 4 carrots, thinly sliced
  • Pinch of sugar
  • 3 garlic cloves
  • 1/8  tsp ground cumin (you can use up to 1/4 tsp if you prefer a stronger flavor)
  • Juice of 1 lemon
  • 3 tbsp extra virgin olive oil
  • 2 tbsp chopped fresh coriander, parsley or a mix of both
  • salt and ground black pepper to taste

Cook carrots in boiling salted water till just tender but not soft. Drain and let dry a bit, then put into a bowl. Saute the garlic in 1 tbsp olive oil till soft but not browned. Add sugar, herbs, garlic w/ oil, cumin, lemon juice and the remaining 2 tbsp of olive oil and toss. Season with salt and pepper. Serve at room temp or chilled.

Birth Control – Clarifying the (Small) Heart Attack & Stroke Risks

In a detailed analysis of a large national health database including over a million women ages 15-49, Danish researchers have clarified how various hormonal contraceptives might affect the risk for heart attack and stroke.

While these events are exceedingly rare in the young population of women using pills, the age at which women use hormonal contraception has crept up. Some women are using pills well into their 40’s and even up till menopause.  So it’s appropriate to take a gander at these vascular risks a bit more closely to ask just how much risk women are taking by using hormonal contraception.

And the answer is – not very much.

Let’s see if I can break it down for you –

The risk of heart attack and stroke is largely age-related, whether you take hormonal contraception or not. Women in their late 40’s having a risk of 6 per 10,000 compared with less than 1 per 10,000  for women under age 25.

Having diabetes, hypertension, hyperlipidemia, arrhythmias and being a smoker elevate the risk of heart attack and stroke. By about a factor of two in women up to age 49. Remember though, that the risks related to these factors will increase with age, so don’t let this low number make you too comfortable.

Taking estrogen containing birth control increases the risks of heart attack and stroke, but those risks are very, very small. Just how small?  If you are age 20 years old and are on the pill with no additional risk factors, your overall risk of a heart attack or stroke is about 100 times less than 1%.  If you are 45 and on the pill, your risk is increased from about 6 per 10,000 to 12 per 10,000, a risk that is about 10 times less than 1%.

The risk of stroke and heart attack from estrogen-containing hormonal birth control goes away when you stop taking it. That’s good, since the age at which women stop needing birth control is around the time heart disease risks start to rise.

The risks for heart attack and stroke are estrogen-dose related. This means that the higher the estrogen exposure, the higher the risks.

Here is a very simplistic rendering of how the vascular risks compared between methods. This rendering may not be entirely correct statistically, but I have to place the data into clinical context, and this works for me –

Vascular risks of Hormonal Contraception

Patch, Ring & 50 ug pills > 30 ug pills ≥ 20 ug pills > POPs > Mirena & Implanon

(POPs = progestin-only pills. ug = amount of ethinyl estradiol)

Overall, the difference in risk between the highest and lowest risk hormonal methods is still quite small. Within a given estrogen dose class, the differences between brands of pills is negligible. In some cases, the risk of a 30 ug pill may be the same or lower than some 20 ug pills.

Noticeably absent from the analysis were the 20 ug norethindrone and levonogestrel pills, my personal go to pills for new pill starts these days.

There is also a new pill being marketed that contains just 10 ug of estrogen. If you’re willing to put up with a bit of breakthrough bleeding and want what this study suggests will be a lower risk of vascular side effects, that pill is sure to be a good choice for you.  I personally like it in the over 40 crowd.

Finally, it’s worth noting how good Yaz looks in this study – it’s a 20 ug pill, and no heart attacks were noted among Yaz users in this study. Their numbers were small relative to other pills, however, and the researchers caution that differences between different formulations of pills of the same estrogen dose were not statistically significant.

Bottom Line

Nothing in life is risk free, and that includes birth control. The good news is that the risks are low, and we now have data that women and their doctors can use in deciding between methods based on vascular risks. Or, as Diana Pettiti, MD, MPH states in her excellent editorial accompanying the article

Women, their physicians, and the public should be reassured not only by the Danish study but by the vast body of evidence from epidemiologic studies of hormonal contraception that have been done over the past five decades. This body of research documents the small magnitude of the problem of arterial thrombotic events in women using combined estrogen–progestin hormonal contraceptives. The research shows that the small risk could be minimized and perhaps eliminated by abstinence from smoking and by checking blood pressure, with avoidance of hormonal contraceptive use if blood pressure is raised.12 With the addition of the Danish data, evidence is now even stronger that progestin-only formulations of hormonal contraception have vascular risks that are undetectable with modern epidemiologic methods. Although hormonal contraception is not risk-free, the evidence is convincing that the low and very low doses of ethinyl estradiol (<50 μg) in the combined estrogen–progestin contraceptives studied by Lidegaard and colleagues — whatever the progestin and whether delivered orally or by means of the patch or the ring — are safe enough.

How you can use this data in making contraceptive choices

If you don’t want vascular risks, however small, stick with a progestin only method. The price you’ll pay is some degree of menstrual irregularity, whether its unpredictable bleeding (Impanon), breakthrough bleeding (POP’s, Mirena, Depo- Provera) or over time, no periods at all (Mirena, Depo-Provera).  Progestin only methods also may not benefit skin the way estrogen-containing methods do, and some (like Depo-Provera) can lead to weight gain.   POP’s have slightly less efficacy that estrogen-containing methods and the other progestin-only methods.

If you’re willing to accept the small but real vascular risks of estrogen containing contraceptives, you can potentially minimize that risk by starting with a 10ug or 20 ug pill. These pills do have higher rates of breakthrough bleeding than the 30 ug and higher methods.  Some studies have suggested that in obese women, more perfect compliance is needed to maintain efficacy with these pills meaning you have less leeway to miss a pill occasionally than a thinner woman. Other studies have suggested that these ultra low dose pills may not be as good for bone protection in teens, who are building bone they will need for their adult lives.

If remembering to take a pill is your issue, and you’re not willing to accept the menstrual cycles changes associated with the long acting progestin only methods, consider the ring or patch.  You’ll be accepting a slightly higher risk of vascular side effects, but if you’re under age 40, those risks are exceedingly low.

If you are over age 40,  progestin-only  methods and the lower dose estrogen-containing methods are good first line choices. Women without risks for heart disease remain good candidates for estrogen-containing hormonal contraception, and the pill in particular can ease the perimenopausal transition.

The above is just a rough outline of one approach to take. There are as many options and choices to make as there are individual woman. Other considerations, such as cost, availability, previous experience with a given method, other medical and gynecologic conditions,  other side effects and personal preference need to be taken into account in making contraceptive choices.

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Good reporting on this story

The Best Carrot Cake I’ve Ever Eaten

The original Frog Commissary Carrot Cake
The Original Commissary Carrot Cake (embed from visitphilly.com on Flicker)

The best carrot cake I’ve ever eaten was the one they served at Steve Poses’ long-gone Commissary Restaurant in Philadelphia. That carrot cake was insanely over the top – pecans and raisins in the cake, three layers with pecan cream filling between, cream cheese frosting on the outside with baked coconut topping and an icing carrot on top. I’ve made it before, and it’s incredible. (Though mine never looked as good as the one up there…)

But the original Commissary carrot cake is very, very rich. It’s also a lot of work. As Poses says in his cookbook –

This cake is most easily made if you start it at least a day ahead, since the filling, for one thing, is best left to chill overnight. In fact, the different components can all be made even several days in advance and stored separately until you are ready to assemble the cake.

Right. I can barely get started cooking in time for dinner, let alone start a cake a day ahead of time.

So I started making the cake without the make-ahead filling and the coconut topping, and discovered that I much prefer it that way. This simpler version allows the sumptuous cake flavor and texture to shine, and the pecans and raisins become stars instead of just members of an ensemble cast.

I usually make this cake in a tube pan. But this time, planning to serve the cake as dessert at a small pre-theater dinner at our apartment, I decided that I did not want leftovers to tempt me next day.  So I made individual cakes in a large muffin tin to use that night, and with the rest of the batter made cupcakes that I froze to frost and serve at some later date.

If you want to make the original Commissary Carrot Cake,  Steve Poses has posted the recipe on his blog. Better yet, buy the Commissary Cookbook. The cake was not the only amazing thing on that restaurant’s menu.

CARROT CAKE ala THE COMMISSARY

I used canola oil instead of corn oil. Be sure to use high quality golden raisins ( I got mine at Fairway)  I always wondered how this cake would taste using brown sugar, but never had the nerve to change it. Let me know if you do. 

  • 1 1/4 cups canola oil
  • 2 cups sugar
  • 2 cups flour
  • 2 teaspoons cinnamon
  • 2 teaspoons baking powder
  • 1 teaspoon baking soda
  • 1 teaspoon salt
  • 4 eggs
  • 4 cups grated carrots (about a 1-pound bag)
  • 1 cup chopped pecans
  • 1 cup golden raisins

Preheat the oven to 350°.

Grease and flour a 10 inch tube pan (or a large muffin tin and two cupcake tins)

Sift together the flour, cinnamon, baking powder, baking soda and salt.

Whisk oil and sugar together in a large bowl. Stir in half the dry ingredients.Then alternately add in the rest of the dry ingredients while adding the eggs, one by one. Combine well. Add the carrots, raisins, and pecans. Pour into prepared pan and bake (70 mins for tube pan, 30-40 mins for large muffin size and 20-30 mins for cupcakes.)  Cool upright in the pan on a cooling rack.

When completely cooled, remove cake from pan and cut into two layers using a serrated knife. Frost.

Cream cheese fosting

  • 8 ounces soft unsalted butter
  • 8 ounces soft cream cheese
  • 1-pound box of powdered sugar
  • 1 teaspoon vanilla extract
Cream the butter well, then beat in cream cheese. Add sugar and  vanilla. Refrigerate till use.

ACOG to Legislators – Get Out of Our Exam Rooms

In a strongly worded editorial in the NY Times, James T Breeden, MD, President of the American Congress of Obstetricans & Gynecologists (ACOG) has spoken out in support of Planned Parenthood and against recent legislative attempts to limit access to reproductive health care. After boldly pointing out the much-denied obvious – “The onslaught of laws focusing on denying reproductive health care rights is a concerted campaign against women,” Breeden then proceeds to succinctly and unequivocally address the four major fronts in that campaign –

Evidence-based medicine -“These laws are not grounded in science or evidence-based medicine.”

Planned Parenthood -“Efforts to de-fund Planned Parenthood, which provides cervical cancer and mammography screening, contraception and other preventive care to millions of women, are egregious and disproportionately hurt poor women.”

The Legal Practice of Abortion -“Mandating that women be legally forced to undergo transvaginal ultrasound or any other medical procedure against their will and against their physician’s judgment is an outrageous violation of patient autonomy and the confidential doctor-patient relationship.”

The physician-patient relationship and the legal practice of medicine -“Politicians were not elected to, nor should they, legislate the practice of medicine or dictate the parameters of the doctor-patient relationship. Our message to politicians is unequivocal: Get out of our exam rooms.”

Thank you, thank you Dr Breeden and ACOG, for speaking out on behalf of the obstetrician gynecologists who have dedicated their lives to the reproductive health care of women, and who are outraged on this attack on both our patient’s right to reproductive health care and on our right to legally practice medicine.

Roasted Carrot & Ginger Soup with Cheddar Dill Scones

I don’t know about your husband, but mine is out of control when it comes to food shopping.

It’s not his fault, really. He is a victim of his own evolutionary programming, which, in a bizarre maladaptation to modern society, is triggered whenever he enters Costco. At that point it begins to fire off uncontrollable urges that he cannot possibly resist, as co-activation of the male hunter-gatherer gene and the bargain hunting gene drives him to purchases extremely large boxes and bags of foods in quantities that we can’t possibly store in our NYC apartment or eat before they go bad.

Like the 5-pound bag of baby cut carrots be brought home last week. (What on earth was he thinking?… )

Short of setting up a take out salad bar in the dining room or throwing a cocktail party for 100 complete with the world’s largest crudite platter, I was going to have to figure out some way to use those little suckers.

But I love a challenge. And, thankfully, my family loves carrots.

Hopefully, you love carrots too, because that’s about all you’ll be getting on the blog this week. Today, it’ll be carrot soup. Wednesday, Carrot Cake. Then on Saturday, a Moroccan Carrot Salad.

Feel free to post your own favorite carrot recipes in the comments section. I’m starting to run out of ideas, but unfortunately, not carrots – there’s still about a pound left.

ROASTED CARROT & GINGER SOUP

I modified a recipe from the Silver Palate Goodtimes Cookbook, leaving out the wine and using olive oil instead of butter and roasting the carrots first. Serve with Cheddar Dill Scones (recipe below) and garden greens tossed with Lavender Honey Vinaigrette.

  • 4 tbsp olive oil (divided)
  • 1 1/2 pounds baby-cut carrots (or thickly sliced regular carrots)
  • 8 cups chicken stock
  • 1 large onion
  • 3 cloves garlic
  • 3 large pieces of crystallized ginger, finely chopped
  • 1 bay leaf
  • Salt and pepper to taste
  • Fresh dill to garnish

Toss the carrots with 2 tbsp olive oil, salt and pepper in a large bowl, then spread out on a baking sheet and roast at 400 degrees F for about 15-20 minutes till they start to soften and are browned.

In a soup pot saute the onions, ginger and garlic in 2 tbsp olive oil over medium high heat till onions are soft. Add stock, carrots and bay leaf. Heat to boiling, then reduce heat and simmer, uncovered, about 15 minutes.

Remove the bay leaf. Puree in the pot using an immersion blender. Season with salt, pepper and lemon juice if desired. Garnish with fresh dill and serve. Also delicious cold.

CHEDDAR DILL SCONES

Modified from Ina Garten. I cut back the butter from 3 sticks to two and used whole milk instead of cream – it just seemed like an insane amount of fat, especially since I was also adding cheese and eggs.  Ina adds the dill and cheddar at the end – I just added them right in with the wet and dry ingredients so I would not have to work the dough so much. I also added a tad of pepper for a slight kick.  

  • 4 cups flour
  • 2 tbsp baking powder
  • 2 tsp sea salt
  • 1/4 tsp ground black pepper (or a pinch cayenne pepper)
  • 2 sticks cold butter, diced
  • 4  cold large eggs, beaten lightly
  • 1 cup cold whole milk
  • 1/2 pound mild Cheddar, small dice
  • 1 cup minced fresh dill
  • 1 egg beaten with 1 tbsp water for egg wash

Preheat oven to 400 degrees F.

Combine flour, baking powder, and salt into a large bowl. In another bowl, beat milk, eggs and dill.With a pastry blender, cut the butter into the dough until it is the texture of coarse meal. With a wooden spoon, stir in the cheese.Make a well in the center, pour in the egg-milk-dill mixture, and working quickly with the spoon and eventually your hands, make a shaggy loose dough.

Turn out dough onto a well-floured surface and knead lightly for just a minute or less till workable. Pat or roll to 3/4 inch thickness and using a biscuit cutter, cut out your scones. Lay out on baking sheet lined with parchment or waxed paper.

Brush with egg wash and bake till golden, about 20-25 mins.  Serve warm.

TO SERVE THIS MEAL TO COMPANY

This is a very easy meal to serve to company as a lunch or light dinner.

The soup can be made up to a day ahead and reheated. You can also roll, cut out and flash freeze the scones ahead.  You can wash and dry your greens ahead and refrigerate, and make your dressing ahead.

Just before your guests arrive, take out the salad greens and dressing and put the greens in a salad bowl.  Preheat your oven.  Twenty minutes or so before you plan to serve dinner, pop the scones in the oven.  While the scones are baking, reheat the soup and hold it warm. Once the scones are done, call everyone to the table, dress the salad  and enjoy!

If this meal seems too light, add some grilled sausages or Irene’s baked chicken. 

Introvale Recall – The FDA (rightly) plays it safe

A birth control pill packaging error has led to a recall of Introvale, a 3 month birth control pill and generic for Seasonale. The apparent mix-up was that the placebo week was placed in the 9th instead of the 13th row of the pack.

Sandoz notified the public that it issued a voluntary recall of 10 lots of its generic oral contraceptive Introvale in the US, following a recent report of a packaging flaw. A consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled “Week 13”). Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week. While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.

The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the US between January 2011 and May 2012.

RECOMMENDATION: If a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception and contact their healthcare professional.

The FDA is being appropriately cautious, and so should you. Follow their recommendation, especially if you have not been perfectly taking your pills. The pills are not what they should be, and they should be replaced.

But I have to admit, of all the pill packaging errors we’ve had to date, this one worries me the least. Here’s why – Traditional birth control pills have a placebo week once a month without impacting efficacy. So, unless the placebo week in the Introvate pack is one of the first 3 weeks of the pack, its placement elsewhere in the pack should do nothing more than give you an unexpected menstrual period. Certainly a placebo week that occurs after a full 8 weeks of active pills is not something that makes me concerned.

One exception would be a woman who had missed a pills or two just before that placebo week – not you’ve extended the pill free interval beyond 7 days and that’s a pregnancy risk. Which I suspect is one reason why the FDA is being extra cautious with their recommendations. I also suspect they’re making sure they’ve covered the possibility that there could be other issues with these lots.

What’s going on with birth control pill manufacturing these days?

I’ve never seen so many recalls – this is the third one in recent memory for me. All different manufacturers, all different pills. Anyone have any ideas?

The Sense of An Ending – a TBTAM Book Review

The Sense of An Ending, Julian Barnes Man-Booker prize-winning novel, is one of the most beautifully written and engrossing books I’ve ever read. It is also one of the shortest – a mere 160 pages. As Barnes has said “It is a concise novel. I couldn’t make it any shorter, and I don’t think I could make it any longer.”

It is a story, really. A very specific story about a very specific time and place in the life of a man, Tony Webster. Webster’s memories of that time, however erroneous they may be, reverberate beneath his life thereafter, until the day when he learns that he has been bequeathed a diary, a bequest that ultimately will upend his memories and his well-worn sense of who he is and has been. The startling and unexpected truth of what actually happened is revealed in the books last pages. Yet even that truth, while final and irrevocable, is incomplete, as is our memory and our knowledge of those we think we know.

This is a book you can read in one very long sitting, as if Webster were spending a long afternoon and evening with you, telling you a story about a pivotal event in his life. You’ll stop for dinner perhaps, then take up on the porch afterwards and sit till the wee hours until a sense of an ending is achieved.

At some point, you will learn that he has had a wife and a daughter, and even give you glimpses into these relationships. But what he tells you about them will be limited to what you need to know for this story, or as Webster puts it “They are in this story, but this story is not about them”.

In truth, this is the way we tell one another stories, isn’t it? We may glide off track occasionally, or dip into detail when necessary, but our listeners will pull us back on track “What happened next?” or ” Get back to the story”.  Barnes anticipates his reader’s need to move the story forward, while leaving us craving just a bit more detail than he gives us. But we are moving on towards an ending, so onward we go.

It’s a wonderful construct for ADHD readers such as myself who tend to become sucked into a book for long periods of intense time, but then have trouble picking it up again later. The satisfaction of completing the book, without skimming, in just two sittings was for me, enormous.

This was my first introduction to Barnes, and I’m adding his books to my long list of must-reads. I may make Love,etc my next. At 240 pages, it’s a bit heftier, but still manageable for my attention span. Although I may have to start with A Pedant in the Kitchen – at 136 pages, this collection of essays on cooking seems just about right for my plate.
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This is an unsolicited review. 

HRT – Still No Place for Prevention

In a much-needed and thoughtful analysis, the United States Preventive Service Task Force has summarized what we have learned about HRT since the Women’s Health Initiative was published in 2002. (See summary chart above.)

They have also issued draft recommendations on the use of HRT for prevention of disease.

The U.S. Preventive Services Task Force (USPSTF) recommends against the use of combined estrogen and progestin for the prevention of chronic conditions in postmenopausal women.

The USPSTF recommends against the use of estrogen for the prevention of chronic conditions in postmenopausal women who have had a hysterectomy.

I wholeheartedly agree. 

The USPSTF Recommendations do not address the use of HRT for treatment of menopausal symptoms

That’s an important message for women who may want to consider using HRT for a few years around menopause. In that setting, the heart disease risks are probably minimal for an otherwise healthy woman, while the breast cancer risks, while real,  are quite small.

I tell my patients their breast cancer risk is about 1% higher for 20 years of HRT use, so HRT use for a few years conveys far less than even that risk. On balance, using HRT to get through the peri-menopause is not a terribly risky decision, and for women with severe symptoms, it is not an unreasonable choice.

Despite this reassurance, most of my patients with mild to moderate symptoms are choosing to forgo HRT and deal with their symptoms in other ways – exercise, reducing or eliminating alcohol, trying to lower stress. Those with more severe symptoms are still using hrt, but they are aiming for lower dosing and transdermal regimens, or considering non-hormonal alternatives such as SSRI’s instead.

It’s called informed choice. And when given that choice, these days,  more women than not are choosing against using HRT.

And just in case you’re interested, here are my rules for prescribing HRT.

The USPSTF Recommendations do not address premature menopause

Most practitioners agree that women with early menopause benefit from HRT. The risks for osteoporosis in this group is quite high, and symptoms are often quite severe.

In my practice, almost all of these women choose to use HRT until they reach the usual age of menopause, at which they begin to think about it the same way the rest of my patients do and usually wean off over time.

The USPSTF Recommendations do not address vaginal estrogen use

The one symptoms of menopause that does not get better over time is vaginal dryness. Most women, unless they are very frequently sexually active, will need to use something to treat dryness.

One treatment option is low dose vaginal estrogen.  Most practitioners feel comfortable prescribing vaginal estrogen, even in women at risk for blood clots and even in most women with breast cancer.

My patients, however, tend to want to avoid estrogen in any form and so they usually will try non-hormonal treatments first.  I’d say that about half of these women eventually end up using vaginal estrogen.

Those who might disagree with the USPSTF

The window theory believers

The WHI naysayers will argue that no one has properly studied HRT the way in which it is most often used, and in which it is most likely to prevent heart disease – namely, starting at menopause and continuing indefinitely.

They hypothesize that there is a “window of opportunity” during which estrogen will protect against heart disease, and after which starting estrogen will worsen pre-existing heart disease.

Subgroups analysis of WHI findings suggest that they may be correct in this regard. In the WHI, women starting HRT shortly after menopause had a lower risk of cardiovascular disease than those starting 20 years or more later.

Unfortunately, even if HRT were cardio-protective, the risks of breast cancer (and stroke and blood clots) with combination HRT use cannot be ignored, and mitigate against prescribing hormones for reason of heart disease prevention.

The Gap Theory Believers

There are those who argue that the estrogen-only arm of the WHI actually showed less breast cancers, indicating a potential protective effect of estrogen on breast cancer. They theorize something called the “gap theory”, which states that estrogen, when started 10 years of more after menopause, actually acts to inhibit breast cell growth. They are supported in this by in vitro data.

Unfortunately, while the gap time theory may explain the findings of the WHI estrogen-only arm, it is irrelevant to clinical practice, since the way most women use HRT is to start it at menopause. (ie., there is no gap)

They are both right – and both wrong

If both the gap and window theories are correct (and I suspect they are), when considered together they actually support the findings of the WHI and the recommendations of the USPSTF.  Starting estrogen at menopause may prevent heart disease, but it increases breast cancer risk.  Waiting to start HRT may decrease breast cancer risks, but it increases the risks of clotting and stroke and dementia. Or, as my mother used to say, “You’re damned if you do and damned if you don’t.”

The benefits of HRT as they exist in practicality and theory come at a price. That price is high enough to recommend against  the use of hormone replacement for the prevention of chronic disease.

If you have any issues with the USPSTF Recommendations on HRT –

You can submit a comment to the Task Force between now and June 26, 2012.

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Chart above from USPSTF Draft Recommendations on HRT

First Bread of the Season

We’ve only got one day to open up the cottage, having stopped along the way to taking my eldest daughter back to college for her summer research session.

There’s so much to be done. We really should clean out the gutters and scrub down the porch and the outdoor furniture.

The stone patio (and I use the word patio loosely) is overgrown; but the weeds are too pretty to pull right now, and gratefully, I let it be.

The herb garden needs weeding and replanting – only the thyme has survived.

But we’re only here for a day, so we just do the bare minimum while the girls sleep in. Mow the lawn, sweep the porch and put out the furniture, wipe down the refrigerator and the open kitchen shelves, sweep the kitchen and dispose of the two dead animals we found outside in the garbage can. (Somehow, it seems there are always dead animals…)

Then, before the day gets too far along, I head back into the kitchen to do what I love most when I am here – bake bread. We’ll serve it at lunch with egg salad made with thyme from the the garden, and sliced tomato and avocado. They’ll be plenty left to pack sandwiches for the road, and I’ll give the second loaf to my daughter to christen her new apartment at school.

Later this afternoon we’ll all head down to the lake for a cold but glorious first swim of the season. We feel so remarkable afterwards that I decide from here on in, we will shall call it “taking the waters”. The girls will sunbathe on the floating dock and Mr TBTAM and I can catch up with the our neighbors and make plans for the rest of the summer. Tonight after dinner, we’ll have S’Mores on the back deck under a crescent moon, then play Boggle before an early bedtime. After all, we’ve got a long drive ahead of us tomorrow.

In a few weeks, we’ll be back again to properly settle in, but this christening has been exactly what the season needed.

Wheat Bread, No.1

This bread recipe comes from Mrs CH Leonard’s Cookbook, circa 1923, a little gem I picked up at last year’s antique fair. This is my first foray into the book, compiled by a woman who, according to the preface –

…may properly be styled as one of those olden times wives and mothers who personally superintends and much of the time actually selects and prepares the food for her family.

This, of course, stands in contrast to myself, who –

…may be properly styled as one of those modern times wives and mothers whose husband usually cooks weeknights and stocks the larder since he works near Fairway and sees a Saturday morning trip to Costco as sacred as completing a mignon, and who pretends she’s a good mother on weekends, when she cooks and posts recipes on her blog to create the impression that she is one of those olden times wives and mothers who… you get the point.

Mrs GH Leonard’s recipes read like recipes your grandmother might give you – rich with detail, but vague as to exact amounts and cooking times.  The book also contains medicinal recipes and household cleaning formulas scattered amidst the foodstuffs – the “Antidotes for Poisons” chapter, for example, comes just before “Chafing Dish Recipes.”

I’m reprinting Mrs Leonard’s recipe exactly as written –

Take 3 pints of flour to 1 pint of wetting. The ‘wetting” may be either milk or water  or half of each, but must be warmed. It milk is used, scald it and let it cool to a temperature of 75 degrees, or pour boiling water in the milk and let the milk and water cool to the same temperature.  The flour should not be so cold as to cool the wetting below 75 degrees. Dissolve one cake compressed yeast in one cup warm water; add this yeast to the wetting; salt to taste; add 1/2 tbsp lard and 1 of sugar and mix with flour in a large bowl or pan in a stiff batter; place the batter on a moulding  board and knead to a stiff dough; work in all the flour necessary at this kneading. Some breads require more flour than others. Grease a large bowl or pan, put in the dough, and set in a warm place to rise; also grease the top of the dough. When it has risen sufficiently, knead with as little flour as possible to keep from sticking, form into loaves and put into greased tins, pet it rise and bake. To test the oven, throw a little flour in the oven; if it browns quickly the oven is all right ; if the flour burns the oven is too hot. The fire must be hotter after the bread has been in 10 minutes. An ordinary sized loaf requires 45 minutes  for baking. When taken from the oven, brush the loaf over with milk and place where it will cool quickly or near an open window.

I used 1 envelope instant yeast rather than compressed yeast.  For “lard” I used olive oil, used 1.5 tbsp salt “to taste”, assumed “1 of sugar” meant 1 tbsp of sugar, and used about a cup of flour for the kneading. Following Mrs Leonard’s method for determining oven temp, I ended up with 400 degrees fahrenheit, which I raised to 425 degrees after 10 minutes of baking.

The bread was delicious – think homemade Wonder Bread, but a little more dense and without the squishiness, meaning that you can’t roll this bread up into a little ball and pop it in your mouth the way you can with Wonder Bread. Sorry. A very nice sandwich bread that should toast beautifully.

Osteoporosis Drugs – You Got to Know When to Fold ‘Em …

If you are one of the millions of Americans taking a bisphosphonate drug for treatment of bone loss, you’ve most likely worried about what you’ve gotten yourself into.

Earlier this month, the FDA took the highly unusual step of publishing the results of their investigation into reports of atypical fractures of the femur occurring in long term users of drugs like Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate) and Reclast (zoledronic acid).

Now we have yet another investigation confirming the association of these fractures with bisphosphonate use, and correlating the increasing risk with increasing duration of therapy.

When categorized by duration of treatment, compared with no treatment, the odds ratio for an atypical fracture vs. a classic fracture were 35.1 for less than two years of treatment, 46.9 for two to five years of treatment, 117.1 for five to nine years and 175.7 for more than nine years.

What’s Going On Here? 

How do drugs that are supposed to prevent fractures cause new ones? That’s a good question. And the answer is complicated, so let’s see if I can simplify it.

Think of your bones as a road system that is constantly being remodeled depending on where the traffic is. There’s a large well-funded road crew constantly digging up the old road and replacing it with new road. They work in small sections scattered throughout the system, so as not to disrupt the road’s integrity. The members of the crew that digs up the old road are called the osteoclasts –

 and the ones who fill in and re-pave it are called the osteoblasts.

Now suppose over time, for whatever reason – age, bad weather (underlying medical conditions), lack of road material (vitamin D deficiency, menopause) –  you’ve dug up or lost more roads than you’ve replaced (Osteoporosis).  So you start treatment with a bisphosphonate like Fosamax or Actonel or Boniva. These drugs work by cutting back on the digging crew, but keeping the paving and refilling going in the areas that have already been dug up, thus rapidly bringing miles and miles of untravelable road into good use. Not to mention it’s a nice strong road, becoming mineralized over time. (That’s your bone density increasing.)

The whole thing is working so well that you send almost the entire road crew on a prolonged vacation. (Suppression of bone turnover, which is how bisphosponates work) Now you’re left with a skeleton road crew (pun intended), which, for most folks is still enough to deal with the usual cracks and potholes that appear over time, and can keep the road (your bones) in good working condition. But in some of you (perhaps those who are genetically predisposed) the downsized crew just can’t keep up with the repair work. As time goes on, the structural integrity of your bones becomes weakened. And then one day, for no apparent reason, just during the course of usual activity,  a small crack that the crew hasn’t yet repaired becomes a large crack – and you’ve just fractured your femur.

You don’t have to be on a bisphosphonate for these kind of atypical fractures to occur. Some folks just get them. But taking a bisphosponate increased the chances in predisposed individuals, and that chance increases the longer you take the drug, especially if your bone mass is in the osteopenic or normal range.

Exactly What are the Risks?

The chance that you’ll get one of these atypical spiral fractures while taking bisphosphonates is extremely low –  one study estimates the incidence at about 32 per million users per year, compared with over 10 times that many fractures prevented in the same million users.  So overall, the benefits of these drugs still far outweigh the risks.

However, drilling down into the fracture data reveals that we can do better than just accepting a rare risk in return for a common benefit.

Those who develop atypical fractures appear to be  individuals whose bone mass in the femur is in the normal or osteopenic range, as opposed to those whose hips show osteoporosis. This happens to be the very same group that recent studies suggest may safely stop Fosamax after 5 years without losing the benefits of having been on the drug.

So, if continuing the drog for longer than 5 years adds little benefit but increases risks, even if those risks are rare, it becomes pretty darned obvious what we need to do.  Stop the drug.

Which reminds me of that song from Kenny Rogers – “You got to know when to hold ’em / Know when to fold ’em / Know when to walk away /Know when to run… ” Not that treating osteoporosis is a gamble, but the Gambler’s advice rings eerily true for this class of drugs.

 

When to Fold ‘Em

New data suggest that as long as your bone density is above the osteoporotic range, you can stop taking your bone meds after 5 years.  Continuing the drug past that time only brings added risk without any benefit.

When to Hold ‘Em

If you’re at increased risk for fracture and have been taking your meds for less than 5 years, you may still be getting benefit without significant risk. Remember that these drugs decrease the risk of conventional osteoporotic fractures at over 10 times the rate that they increase the risk of atypical fractures, so don’t throw the baby out with the bathwater.  But make sure you are getting adequate vitamin D, calcium and weight bearing exercise to maximize the benefits you’re getting while you’re still on these drugs. And discuss with your doctor whether its worth considering coming off the drug in the future if your bone mass improves into the osteopenic range.

If you’ve been on these drugs for 5 years or more, but your bone mass is still in the osteoporotic range, you also may still be getting benefit from continuing treatment. Ditto if you’re at high risk for vertebral fractures. You are not in the group at highest risk for atypical fractures, but are in the group at highest risk for the more common type of osteoporotic fractures. Talk to your doctor about the comparative risks of continuing vs stopping treatment. It may not be a straightforward decision, as we don’t have exactly clear guidance on when to stop in everyone.  But at least have the conversation.

Should You Even Be in the Bisphosphonate Game?

Not everyone taking bisphosphonates needed to start them in the first place. Aggressive marketing and disease mongering by Big Pharma initially led to overuse of these drugs for treatment of osteopenia, a condition we now know does not necessarily need to be treated.  With the help of the FRAX fracture risk calculator, we’re now able to determine which patients with osteopenia are at significant fracture risk and require treatment (very few, it turns out) and which ones can be adequately managed with lifestyle, calcium and vitamin D (most).  Talk to your doctor about using FRAX before deciding if treatment is warranted. 

Remember too that bisphosphonates are not the only drugs that treat osteoporosis. Other medications to consider include hormone replacement,  Evista (raloxifene) and injectable terapeptide. Each of these drugs has its own set of risks and benefits, and some work better than others depending on your type and location of bone loss, so a reflex switch from bisphosphonates may not necessarily be the best option. As always, its best to talk with your doctor about what is right for you.

Bottom Line

The optimal duration of bisphosphonates for most individuals appears to be between 3-5 years. Beyond that point, unless there is osteoporosis at the hip or a high spinal fracture risk, there appears to be added risk rather than additional benefit to prolonged use of these medications, and it may be time to consider stopping therapy.

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