Yaz and Blood Clots – Two More Studies Point to Higher Risks

Update – the FDA addresses clot risks and Yaz

Two studies published in this weeks’ British Medical Journal, one from the US and the other from the UK, report that users of drosperinone containing oral contraceptives (Yaz, Yasmin and their generics) have increased relative risks for non-fatal blood clots compared with users of pills containing levonorgestrel.

While neither study is perfect, and indeed have some very major limitations, they add to a growing body of evidence that pills containing drosperinone may impart higher risks for blood clots than older pills. Yaz is not alone in this regard – other studies have suggested that pills containing the newer progestins gestodene and desogestrel also impart slightly high clot risks than the so-called first and second generation pills containing the older progestins norethindrone and levonorgestrel.

I won’t go into the studies’ limitations here, but will say that trying to get our hands around comparative data on clot risks between various pills is an extraordinarily difficult process given that the diagnosis of blood clots is not always straightforward (or correct), pill choices are not randomized and fraught with prescribing bias, and confounding risk factors for clotting are numerous and difficult to control for. I wish folks would stop trying to answer these questions on the quick and cheap using claims and pharmacy databases without requiring chart review and strict diagnostic criteria. But that’s the way these studies are being done, and that’s the data I am being forced to contend with in my practice, so let’s talk about it.  Continue Reading

Strawberry Rhubarb Pie

Although I did not actually make this masterpiece*, if it were being published in a journal I would be last author, Mr TBTAM second, and my daughter first author. I initiated the project and sent Mr TBTAM shopping for the ingredients, but when I invited my daughter to join me in making the pie, she stated “I want to make it myself”.

And so she did.

Nice job, honey.

* The recipe is from Bon Appetit via Epicurious, although we substituted a double recipe of pate brisee from the Pleasures of Cooking for the shortening crust. I guess they get authorship too, huh? I’m think a dusting of confectioners sugar and a dollop of vanilla ice cream would be an excellent way to serve it at Easter Dinner later today.

The OBG Why Me Blues

If I ever get enough time and guts to put together a cabaret act, this is totally gonna’ be my opening number…

The WHI – Yet Another Follow up

This is the study that doesn’t end…
The longterm follow up extends…
Some people started studying hormones in menopause,
And they’ll continue publishing more data just because…
(repeat)

In yet another paper in a major journal, we hear once more from the investigators of the Women’s Health Initiative. This time it’s the long term outcomes of women who took estrogen alone, now seven years out from stopping their hormones. What new information can we learn from this extensive analysis of new data?

Nothing.

Really.

The WHI’s been telling us the same thing about ERT (Estrogen replacement therapy) and HRT (Combination estrogen/progestin therapy)  since 2002, and all each subsequent study does is reinforce and expand on that initial data. The data on breast cancer risk and estrogen alone was first published in 2004, but the media ignored it the. It is only now making it news.

Allow me to summarize what we know  –  Continue Reading

FDA Does the Right Thing re Makena

The FDA has announced that it will allow compounding of hydroxyprogesterone caproate, in the wake of Makena manufacturer K-V Pharmaceutical’s plan to bring the previously inexpensive generic product to market at a price 100 times its cost.

FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct.

In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products. As always, FDA may at any time revisit a decision to exercise enforcement discretion.

There will be those who will argue that this will discourage pharmaceutical companies from producing so-called orphan drugs, and somehow try to make this case into something bigger than what it is, which is simply the story of how the new management of one drug manufacturer tried to turn a bad company around by turning a small profit maker into a blockbuster drug.

I happen to agree (for once) with my Pharma-friend Schrugglin’s comment on my prior Makena post that the FDA holds a significant portion of the blame here for not steering this product towards a more reputable manufacturer. I encourage you to read his thoughtful comments if you want Pharma’s side on this issue.

Hopefully the FDA and KV will come to a compromise that will allow Makena to turn a profit for KV without them resorting to price gouging. Stockholders may need to adjust their expectations a bit more in line with reality.

The sad thing is that we have created an industry whose only definition of success is blockbuster.  While that may work for the movie industry, it’s not appropriate for healthcare.  We need to readjust the business model.

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More on Makena –

  • St Louis Dispatch – March of Dines, Am Acad of Peds and ACOG met with KV to persuade KV to lower price
  • Via Pharmalot – KV Stock plummets, and there are parallels to the colchicine story
  • Corante In the Pipeline – Interesting discussion in the comments section on the issue
  • Health Reforms Watch – After Makena – Is there a better business model?
  • Gekkowire outlines KV’s finances and reveals how much it had counted on Makena profits

Loving Doc Martin

No, not the shoes. The British TV series.

Martin is surgeon, whose glittering career comes crashing down around him when he develops a phobia which prevents him conducting operations. He makes a life changing decision to retrain as a GP, and applies for a vacant post in the sleepy Cornish hamlet of Portwenn, where he spent childhood holidays.

Doc Martin is as grumpy, short-tempered and brilliant as House, and while he has no cadre of residents to torture, he does have a town full of varied and wonderful characters to annoy him. And of course, there’s a love interest.

We’ve barely started watching, and already there have been these memorable lines –

Patient – Am I your first official patient?
Doc Martin – You are indeed. Collect a thousand loyalty points and you get a free coffin.

Elderly patient with a cough – Could it be something serious?
Doc Martin (writing a script for medicine) –  Yes. Lung cancer.

Patient: And you reckon these will work, do you?
Doc. Martin: No – I just prescribe them for fun.

Doc Martin – Well, there’s the mystery of medicine. Everyone comes to you for an opinion but when you actually give them that opinion nobody really wants it, do they?

I took a bit of umbrage when the only treatment the good doc offered for osteoporosis was an increase in estrogen dosing, but he has the right attitude when it comes to vaccines.

Thanks to Mr TBTAM for discovering this wonderful series in the DVD section of our local library. You can also watch the grumpy Doc on Hulu.

And though they are spelled differently, I actually do love the shoes too. 

Homemade Croutons

We like to buy nice bread, and always store leftovers in the freezer. When the leftovers begin to infringe on Mr TBTAM’s ice cream space, I make breadcrumbs. But what does Mr TBTAM do when I’ve made breadcrumbs and he still has no room for his ice cream?

He makes croutons! (Did I mention he actually cooks more than I do?…) Then he uses them in our fave everyday salad -Bibb lettuce and mesclun greens with goat cheese, dried cranberries and balsamic or lemon vinaigrette.

We’re storing the croutons in an airtight glass jar in the cabinet. I do keep breadcrumbs in the freezer, but I have a feeling these delicious babies will be gone long before they get stale or rancid in the jar. What do you think?

Homemade Croutons

Use whatever dried spices you like, but be generous with the salt and pepper. If you use fresh garlic, better to fry it up in the oil first, then discard the garlic and use the garlic=flavored oil so you don’t get burnt garlic pieces on your croutons.

  • 4 cups cubed leftover French Baguette (If frozen, thaw it just enough to be able to slice it)
  • 1/4 cup olive oil
  • Salt
  • Pepper
  • Dried spices to your liking (we used some garlic powder and paprika, you could use dried herbs)

Directions: Preheat oven to 350 degrees fahrenheit. Toss the bread with olive oil and the spices in a large bowl being sure to coat well. Spread our in a single layer on baking sheet and bake till golden, about 20 minutes, tossing a few times to be sure they brown evenly.
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Crouton Round-up – If you have a favorite crouton recipe, send me a link and I’ll put it here.

  • Celtic Mommy makes her Croutons w/ sourdough bread and parmesan
  • OurGirlBites uses sourdough, garlic and herbs.
  • Cooks Hideout uses Herbs de Provence and just a tbsp of oil for 4 cups of bread, and they look delish!
  • Dogtipper makes bone-shaped croutons for dogs! I have to admit, I’ve been tossing a few to our pup and she loves them…
  • Underground Caterer uses fresh herbs and has instructional pics

An Emotional Grand Rounds

Dr Val at Get Better Health has organized this week’s Grand Rounds submissions according to the emotions they evoke. (No surprise my post on Mikena pricing is assigned to the “Outrage” group…..)

Head on over for some great reading.

The Doctor’s Wife Has Breast Cancer

If you’ve come here looking for Peter Bach’s recent New Yorker essay on his wife’s death, it’s here. And here are my thoughts on his essay.

A Well Blog post series in the NY Times, written by Peter Bach, MD, an attending physician at Memorial Sloan-Kettering Cancer Center in NYC, chronicle’s his experiences with his wife’s diagnosis and treatment for breast cancer.

As painful as it was to read of Bach’s wife’s breast cancer diagnosis and treatment, I found reading the comments section on the first few posts to be equally difficult. The comments ranged from supportive to downright vitriolic, as patients took the opportunity to vent at doctors and a medical system that they perceive gave Bach’s wife better access to treatment than theirs. The bitterness that comes through these comments is astonishing, but should not be.

Fortunately, as the series has progressed, the bitter comments have subsided. (And Bach has a much better photo…) His most recent post on how his wife’s doc refused to spout recurrence numbers for them was quite thought (and comment) provoking.

So, Doc, why not just tell us our odds?

Ruth’s oncologist elaborated on his refusal, promising he would tell us the number just as soon as we told him what probability of recurrence would cause us to make different choices for our lives.

Neither of us had an answer.

I encourage you to spend some time reading this excellent series and discussion it has prompted. I wish Dr Bach’s wife all the best for a speedy recovery and both of them many years ahead together.

Happy Spring!

The Bluebird
by Charles Villiers Stanford.

The lake lay blue below the hill
The lake lay blue below the hill, below the hill
As I looked, there flew across the waters cold and still
A bird whose wings were palest blue

The sky above was blue at last
The sky beneath me blue in blue, was blue in blue
A moment ere the bird had passed
It called, as if in a trance he flew

The lake lay blue below the hill

Makena – Big Pharma vs Big Insurer Smackdown

The cost of preventing preterm labor with 17 alpha-hydroxy progesterone caproate, a very cheap compounded progestin, is about to skyrocket, according to an editorial in this week’s NEJM.

Why? Because this cheap, generic, compounded drug, proven to prevent preterm birth by well-done research funded by the federal government, is now available in an identical but FDA-approved patented formulation called Makena.

In a move that is pure and shameless profiteering, K-V pharmaceuticals has decided that FDA-approval of Makena means they get to charge $29,000 for a treatment that until now cost at most $300 per pregnancy.

The advantages of an FDA-approved formulation are obvious – consistency of product, reassurance of safe compounding practices and widespread availability. But at this cost?

Aetna takes on K-V

The NEJM editorial highlighting the problem with Makena’s cost was written by Joanne Armstrong, MD, a  physician with the Women’s Health Division of AETNA, who makes well-reasoned case for FDA intervention on the price of Makena.

Rather than representing a good investment of increasingly scarce health care resources, Makena will force patients, physicians, and those responsible for financing care to make hard choices. K-V Pharmaceutical has announced a copayment-assistance program, but no program providing short-term financial assistance to some patients will mitigate the harm that this new cost will cause to publicly funded programs, including Medicaid, and the women who rely on them. Nor will it mitigate the cost to employers and individuals who purchase insurance coverage and therefore directly bear all increases in health care costs. This tremendous cost increase and the likely decrease in access to an effective medicine are sizable unintended consequences of the FDA approval of 17OHP. They demand reconsideration and corrective action.

It’s a Big Insurer vs Big Pharma smackdown.

Kudos to Armstrong and Aetna for publicly taking on Big Pharma. This is one case where the interests of the insurer are clearly aligned with that of women and their families.

I for one feel like David sitting watching two Goliaths fight it out.

And this post is just me joining in the battle with my little slingshot…

 

A Tuscan Vegetarian Repast – Funghi alla toscana


Note – this post went out on the feed before I had finished editing it. Don’t use the feed recipe, it’s got errors. Use this one.

Having friends over for dinner who are both Kosher and vegetarian can be a challenge, and I love a good challenge. What makes it a fun challenge is that these friends are always up for trying something new, and appreciate the efforts we make to accomodate their dietary preferences. Even better is the fact that our kids are older, which means we’ve moved on beyond just pasta.

Mutual college spring breaks for our daughters was last night’s reason for getting together. It was also the first day in weeks when I did not have to be anywhere but home, having been overwhelmed with work, life and family issues. I actually had time to cook!

Turning to one of my favorite cookbooks, Regional Italian Cuisine, for inspiration, I found it on pages 156-157, where there were photos and recipes for four gorgeous Tuscan vegetable dishes.

  • Fagioli all/accelletto (White Beans w/ Sage)
  • Spinach gratinati (Baked Spinach)
  • Funghi alla toscana (Stewed Mushrooms)
  • Finocchi al fortno (Baked Fennel)

“Let’s make them all!” I called to Mr TBTAM, who agreed that they looked so beautiful together in the book, they’d make a perfect dinner.  We figured we’d round out the meal with mesclun salad with a lemon vinaigrette and a warm baguette.

So we rode our bikes to Fairway for provisions, doing a Central Park Loop on the way there and back. (My first ride of the season, I can’t wait for more warm weather!)

Believe it or not, preparing these four dishes was not very difficult, and Mr TBTAM and I only spent a total of about 2 hours in the kitchen, including time for making some fresh breadcrumbs. We started with the beans, which we allowed to stew on the stovetop for about an hour, while we made the rest of the dishes. The breadcrumbs and the Fennel were next, and while that baked, I made the spinach. Last was the most amazing – the mushrooms. All the cooked dishes kept nicely while we sat around drinking wine and munching on appetizers for over an hour, and reheated beautifully just before mealtime.

The best part is that we now have four tried and true side dishes for future dinners, vegetarian or not.

And so do you.

I’m starting with the prettiest first, and will post the others over the next few days. Enjoy!

Funghi alla Toscana

Garlic, tomato paste, lemon and mint combine to give these mushrooms a most wonderful flavor. My recipe uses more mushrooms and a tad less olive oil than the original, (17 ounces and 5 tbsp, respectively, in the original recipe).

  • 1 1/2 lbs small to medium sized fresh mixed mushrooms (I used bella, white and chanterelles)
  • 4 cloves garlic, thinly sliced
  • 4 tbsp olive oil
  • Salt + pepper to taste
  • 2 tbsp tomato paste
  • Juice of 1 lemon
  • 1 tbsp butter
  • 2-4 tbsp chopped fresh mint for garnish

Preheat oven to 400 degrees Fahrenheit. Clean and thinly slice mushrooms, tossing them with 1/2 the lemon juice. Heat olive oil in a cast iron skillet. Add mushrooms and saute over medium high heat – how long? The original recipe does not say. I figured until  they just barely give up their water, or about 5 minutes. While the mushrooms are cooking, melt butter in a sauce pan. Saute garlic in the butter until golden, about 1-2 minutes, then add the rest of lemon juice and the tomato paste and season with salt and pepper. Add to the mushrooms, season again with salt and pepper and pop the skillet into the oven for 10 minutes. Top with mint and serve hot in the skillet.

Tsunami Images – To Look, But Not Too Much

Should you look at a disaster?

Anesthesia Oboist tells us why we must watch the images of the Tsunami in Japan –

What turns my stomach is the image of a bunch of safe, comfortable Americans / British people / Europeans WHINING from their comfy homes about how “tough” it is to look at other’s pain and suffering. THEY WON’T EVEN LOOK, they REFUSE TO SEE the faces of their brothers and sisters suffering across the world – and thus, to my mind, in a way deny or refuse to affirm the reality of that suffering.

At the same time, she offers us a link to an amazing post that contrasts our Western disaster porn with the Japanese media, which has been a beacon of calm.

When news broke of the radiation leakage and the explosion at the Fukushima Daiichi nuclear power plant, I expected the televisions to be splashed with infographics of the potential fallout, showing kill zones and decay zones.  But nothing happened. Instead, a Japanese official held up a diagram of the reactor’s coolant system, explained how it was failing, and what they were doing to allay the damage.

…Creating a national sense of fear and panic won’t make the tsunami stop, and won’t keep the nuclear plant from a meltdown.  So these people have decided their role is to keep Japan moving, to keep the national spirit up, to wait for news rather than manufacture it themselves.

Do follow the links and read both eloquent posts arguing why we must look, but not look too much.

I have to admit that I’ve been a bit addicted to tsunami news – in fact, I was up past 1 am last night trolling the net for Tsunami videos. Call it morbid curiousity, but I just needed to see. To understand the enormity of what had happened. To wrap my head around this horrific reality. Shamefully I have to admit that before this, I really did not understand the power of the tsunami. I thought it just destroyed things near the beach, not miles inland.

But that video up there set me straight. And finally showed me everything I needed to see. So I’m posting it for those, like me, who want/need to look.

But now I’m going to turn off CNN, delete “Tsunami” from my search engine, send a check to Red Cross and get back to living. Because in the end, that’s really all I can do.

Urban Homesteading

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A Pasedena family has created a homestead on 1/5 acre in Los Angeles – complete with a year-round garden producing a 6,000 lb annual harvest, chickens, small farm animals and bees. In addition, they use solar powered, hand-powered kitchen appliances and run their cars using homemade biodiesel.

Their dream? A community of like-minded homesteaders living what they call the Path to Freedom. (That dream,unfortunately, may be on hold, as they’ve raised the ire of their own community by patenting the term “Urban Homestead”…)

I don’t know about you, but I find the idea of urban homesteading inspiring. I wish there were more than 24 hours in a day so I could create a similar existence for my family here in NYC.  (This darned day job just keeps getting in the way…)

I may just make a small start this year and see if I can build me a raised bed on the roof. I’ve not had great success to date growing much other than herbs in containers, and my apple trees are becoming more  and more challenged by their containers every year. But a raised bed might be worth a try. I’m on the lookout for a reasonably priced plan for building a moderate sized bed that won’t leach dirt onto the roof and will drain well. While the subsoil irrigation systems look interesting, I’m afraid I’ll blow it if I try something that complicated on the first go round.

Any and all advice welcome.