The Fine Line Between Blogging and Giving Medical Advice – or Why I Finally Wrote a Disclaimer

Just yesterday, I put up a post about the recent birth control pill recall. This recall is a big deal – millions of women are potentially impacted, and the adverse effect – an unplanned pregnancy – is very significant.

I knew women taking these pills would be very worried, and wanted very much to do more than just spit out the press release from the FDA. I wanted to both reassure women and give them information that they could use other than just a link and a phone number. I also needed to figure out  how I would be handing the recall in my own practice. So I combined the two and posted what I’ll be telling my patients to do if they find that they are taking a recalled pill pack.

As soon as the post went up, I got worried.

What if the advice I was giving my patients was not what other docs might do for their patients? What if patients misconstrued it, or had an individual situation that warranted some other approach ? (I couldn’t figure out what that might be, but that’s why it’s called individual.) What were the pharmacies and the pill manufacturers telling these women to do?

I knew that the advice I would be giving my patients was reasonable. The two weeks I was telling them to use backup contraception was double that recommended for women starting pills more than 3 days after their menses. The additional pregnancy tests I recommended were more than ample for detecting a pregnancy as early as possible, without leaving the chance that it was too early to be detected. This is bread and butter gynecology, folks. It’s what I do every day, and I can do it in my sleep. It’s no different than me telling women what they should do if they miss a pill in  pack. (Repeat after me -Take two the next day.)

But this just felt different. Probably because it is a unique situation for which there is no published consensus or package labeling. And because the whole scenario is ripe for lawsuits. It’s a birth control pill recall, for god’s sake.

I debated taking out the information about what I’ll be doing in my practice. But I’d be damned if this blog was going to turn into nothing more than a newsfeed. Where’s the value added that my readers get from me being a doctor? No. I was going to keep the post as it was. With one small change.

I made it very clear in the post that this was advice I was giving to my patients, not advice I was giving to my readers. And I told the readers to talk to their own doctor about what to do.

Most importantly, I finally did what every medical blogger should do, and what I should have done years ago on this blog. I wrote a disclaimer, and linked to it prominently, both in my navigation bar and on my “About” page.

Suddenly, I feel better.

If you’re a blogger, and don’t yet have a disclaimer, it’s time to write and post one. Here are a few links I found helpful in writing mine –

Birth Control Pill Packaging Error Leads to Recall – Tell Someone

CLICK HERE FOR INFORMATION ON THE FEB 1, 2012 PFIZER BIRTH CONTROL PILL RECALL.

A recall has been issued for certain brands of generic birth control pills. The pills have been recalled because they were packaged incorrectly, which could lead to unplanned pregnancies. Essentially, the pills were packaged upside down. This could lead women to take an extra week of placebos at the beginning, rather than the end of the pack, leaving them unprotected against pregnancy.

Brands affected are –

  • Cyclafem(TM) 7/7/7
  • Cyclafem(TM) 1/35
  • Emoquette(TM)
  • Gildess® FE 1.5/30
  • Gildess® FE 1/20
  • Orsythia(TM)
  • Previfem ®
  • Tri-Previfem®

What should you do if you’re taking a recalled pack?

If you’re taking one of these brands, don’t panic. First check to see if you are taking an affected lot by going to http://www.qualitestrx.com/pdf/OCRecall.pdf. Your pill’s lot number should be on your pill card or pack. A tip off that you have an affected pack is that the seven days of placebos, which are a week of different colored pills than the rest of the pack, are at the beginning of the pack. Pill users can call 1-877-300-6153 between 8 a.m. and 5 p.m. CT for further information. You can also head to your pharmacist for help.

Talk to your doctor about what you should do if you are taking a recalled pack.

Here’s what I’ll be telling my affected patients. (Disclaimer – what follows is information about advice I will be giving my patients. What your doctor may want you to do could differ. Talk to your doctor if you are taking an affected lot of pills )

  • If you’re taking a recalled lot of pills, head immediately to the pharmacy for a new pack.
  • If you’ve been sexually active since your last period, do a pregnancy test. If it’s negative (and it most likely will be negative), start your new pack immediately and use condoms for the next two weeks. Your next period should come at the end of your new pack of pills. If it does not, do another pregnancy test. If you don’t want to wait till then to be sure you’re not pregnant, you can do a second pregnancy test two to three weeks after the first.
  • If you haven’t been sexually active, no harm has been done. Get a new pack and start it right away. Use condoms if you have sex in the next two weeks.
  • If you’re pregnant, contact me. What you decide is up to you, but know that accidental exposure to normal doses of birth control pills in early pregnancy should not impact the pregnancy outcome.

I expect a message from my EMR very soon giving me a list of those patients known to be taking these brands so I can contact them personally. But most of the time, I have no idea which generics my patients have been given until they come back next year for their annual or call for a refill. But the pharmacy and their insurer know which pills my patients are taking. Hopefully their databases are kicking into gear to rapidly identify and contact affected pill users. The lawyers are probably kicking into gear even faster…

Confounding Confounders!

“Let me never be confounded”

Ben Goldacre does a great job explaining why you can’t always take a headline about a research study at face value. Readers need to understand the concept of something called “confounding variables” – not always so obvious factors that can explain away associations that looks causal but in fact are nothing more than coincidence.

Why does he care? Because the media still keeps reporting unadjusted findings in headlines, only to use the last sentence in their article to say “Never mind – there’s a whole ‘nother reason why what we said in the headline really isn’t true”.

Goldacre uses the theoretical example of how drinking is linked to higher rates of lung cancer – until one takes into account the fact that drinkers tend to smoke more. Then – Voila! The association between drinking and cancer disappears and the real troublemaker – nicotine – is unearthed.

Required reading for science writers and lay readers alike.

And that video up there?

It just may probably be the best choral song ever written, and the most fun I have ever sung – In Thee Have I Trusted, from Handel’s Dettingen Te Deum. (If you don’t have time to listen to it all, start around 2:40 – the end is the best part…)

It has just two lines –

Oh Lord in Thee I trusted
Let me never be confounded.

“Let me never be counfounded.” Best song line ever. It is my mantra.

Un-linking Menopause from Heart Disease – A New Paradigm?

The idea that heart disease mortality rises dramatically at menopause has been one of the truisms of medicine that spawned a generation of hormone use by women and led to the rise and subsequent fall of Prempro in the Women’s Health Initiative, the end-all-be-all study that failed to prove the truism. The truism is still so strongly believed that research to prove it right continues, using different hormone formulations and different cohorts of women, in the hopes that the hormonal fountain of youth was just misbranded and given to the wrong aged cohort.

Now comes a landmark study that suggests that what we’ve thought all along about heart disease and menopause may actually be wrong.

Dhananjay Vaidya and colleagues at Johns Hopkins and the University of Alabama have re-analyzed mortality data on men and women in the UK and US and concluded that, contrary to popular belief, heart disease rates and mortality do not increase dramatically with menopause, but rather rise more gradually as a function of age in both men and women.

“Our data show there is no big shift toward higher fatal heart attack rates after menopause,” said study leader Dhananjay Vaidya, an assistant professor of medicine at the Johns Hopkins University School of Medicine. “What we believe is going on is that the cells of the heart and arteries are aging like every other tissue in the body, and that is why we see more and more heart attacks every year as women age. Aging itself is an adequate explanation, and the arrival of menopause with its altered hormonal impact does not seem to play a role.”

Statistical mumbo-jumbo

(I am no statistician, so what follows is my own interpretation of what I read in the paper. )

The researchers  use of logarithmic instead of linear graphing of statistical data, and state that it is a better way to measure associations such as heart disease with age. What I think they are saying is that it is better to describe mortality at a given point in time as a proportion of previous mortality than to graph absolute mortality rates at different points in time.  They state that their way of looking at the data aligns more with heart disease being a function of aging and loss of repair mechanisms with time, as opposed to some dramatic external force changing the curve at a given time. By restricting the analysis to various ageing cohorts over time, they also can compensate somewhat for improvements in prevention(such as statins) that can affect heart disease rates in a younger populations compared to, say, their parents.

A Very Compelling Argument

I have to say after reading the paper that that Vaidya and colleagues make a very compelling argument for rethinking the old truisms that have had us looking to estrogen as the holy grail of heart disease prevention in women.

However compelling, the study does not change anything at the moment in my clinical practice, since I do not prescribe hormones for heart disease prevention. I will continue to offer HRT as one of several treatment options for women suffering from menopausal symptoms, so long as they understand its risks as well as benefits. (See my 10 Rules for Prescribing HRT)

The Breast Cancer Mortality Data is Even More Interesting

Even more interesting was the researchers’ finding that breast cancer mortality, in contrast to breast cancer incidence, decreases dramatically at menopause.

This would argue strongly against the routine use of hormone replacement in menopause. It also would argue that the bang for the buck in mammogram screening may be better spent on younger than older women, something that flies in the face of the recent USPSTF recommendations to back off on one-size fits all routine mammograms in younger women.

Wow.

This is really fascinating stuff. It really turns the so-called window hypothesis on its head. (The window hypothesis says that there is a small window of time around menopause in which to start HRT to get it’s cardiac benefits, and that starting it too late, as was done in the WHI, actually can be harmful.)

The study also  hammers the biggest nail yet into the coffin of HRT as the anti-aging cure for all women.

I can’t wait to hear this study discussed at the upcoming Menopause Society Meetings in Washington.  So glad I am going – this is sure to be one interesting meeting. Stay tuned…

 

NYC Cricket

New York City may be densely populated with people, but the cricket density is pretty darned low – like maybe one cricket in the whole darned city – and guess where it is? Yep – it’s on my rooftop.

This means that while you folks in rural America are being serenaded to sleep by a soft background hum of millions of crickets –

here’s what I have to listen to –

Any suggestions on how I’m supposed to get to sleep tonight? How long do crickets live, anyway?

Book Launch!

It’s not like I and my fellow authors will be heading on a book tour or be invited onto Oprah anytime soon (especially since she’s off the air, but you get my point…), but I am so proud to announce that the American Academy of Pediatrics Textbook of Adolescent Healthcare has finally been published!

I wrote the chapter on contraception, but it’s just a teeny-tiny piece of this amazingly comprehensive text, available either in hardcopy or as an e-book from the AAP Bookstore.

Congratulations and thanks to the hard-working editors, especially Elizabeth Alderman, MD at Montefiore, and to Diane Lundquist at AAP, for their long and hard work on this wonderful project.

I’m honored to be a part of so esteemed an academic community as the physicians who have written and edited this textbook.

IUDs – Are They Really the “Best” Contraception?

That’s the opinion of television’s The Doctors, a syndicated TV Show that appears to be giving Dr Oz a run for his money, in USA Today. In fact, that’s the headline – IUDs: The Best Contraceptive Option.

What you know about birth control: Nearly half of all U.S. pregnancies are unintended; abstinence is the only sure-fire way to prevent pregnancy (and protect you from STDs); smoking while on the Pill may increase your risk of heart attack or stroke; as long as you are still getting a period, you can get pregnant during menopause. But here’s something you may not know:

We think IUDs work best.

This is contraceptive education at its worst.  Highlighting the rare side effects of other methods and dismissing the ones of the method you are touting. (Almost made me wonder if there’s advertising money coming from the IUD manufacturers to the show, but I could find nothing on the show’s website to support this…)

IUDs are a great method, but they’re not for everyone. Pills are also a great method, and they’re not for everyone.  Ditto for condoms, diaphragms, sterilization, Essure, the Ring, the Sponge and the Patch.

All these methods are great, and none is perfect.  They all have benefits.  They all have side effects. And every woman has a unique body, health history and personal concerns that determine what birth control is “best” for her. Which may be entirely different than what’s “best ” for someone else.

Contraceptive choice is not a horse race. There is no “best”. There’s only what’s right for you.

Don’t let a headline drive your choice. Make your own decision with the help of your own doctor.

Not some TV Doctor wearing blue scrubs on a sound stage in Beverly Hills.

No-Knead Bread. Thank You, Irene!

Long time blog TBTAM readers know that many of the great recipes I share on this blog come from my mother-in-law Irene, the world’s greatest home cook. So it should come as no surprise to learn that this weekend’s hurricane, which shares my mother-in-law’s name, brought me the best bread recipe I have ever made, and the best bread I have ever eaten.

I’ve been wanting to try Jim Leahy’s No-Knead Bread ever since Mark Bittman first revealed it to the world in 2006 – a simple yet elegant method of making bread that has found an almost cult-like following on the web and around the world. But the 12-18 hour rise always stopped me dead in my tracks whenever I considered making the bread, since I rarely, if ever, plan anything that far in advance. But once I realized on Saturday morning that Hurricane Irene would essentially confine me to my apartment till at least Sunday afternoon, I knew the time had finally arrived for me to drink the No-Knead Kool Aid.

And am I ever glad I did. This bread will change you life. I mean it. It is the easiest and best bread you will ever make. The crust is hard and golden, while the crumb is porous, soft and almost spongy with a sourdough type taste and consistency that rivals anything from the best bakeries. Hot from the oven it is heaven. Toasted with a little butter and jam it is divine. Use it for sandwiches. Eat it with cheese. Or just eat it plain.

You’ll never want any other bread again.

Thank you, Irene!

No-Knead Bread

From Jim Lahey via Mark Bittman in the NY Times. I strongly encourage you to watch the accompanying video before making this bread. 

As pointed out by baking maven Rose Levy Beranbaum, the water amounts in the recipe (1 5/8 cups) varies from that in the the video (1 1/2 cups), as do the rise times. (The video says nothing about the second 2 hour rise.) I decided to use 1 1/2 cups, and did not realize there was a second rise since I based my recipe on the video. I also used rapid rise instead of instant yeast. (With the MTA shut down, I could not get to a store that carried it.) As a result, my dough had completed its rise by about 4 hours, and by morning it actually had dropped a bit. Next time I will use the right stuff, do the second rise and expect my bread will be even lighter.  I should also point out that I accidentally put my bread in seam side down, so I did not get the nice folds that Leahy got in the video.

  • 3 cups all-purpose or bread flour (I used King Arthur all-purpose)
  • 1/4 tsp instant yeast
  • 1 1/2 cups water
  • 1 1/4 tsp Kosher salt
  • Wheat bran or cornmeal (I used wheat bran)

Combine flour, yeast and salt. Add 1 1/2 cups water, and stir until blended with your hands or a wooden spoon (I used a spoon). The dough will be shaggy and sticky. Cover bowl with plastic wrap and let rise 12  to 18 hours at warm room temp (mine was about 72 degrees). The dough is ready when its surface is dotted with bubbles. Turn dough out onto a lightly floured surface. Sprinkle a bit of flour on it and your hands, and working with a very light touch, press the dough down a bit then fold it over on itself (see video for technique.)  Cover loosely with plastic wrap and let rest about 15 minutes.

Sprinkle a clean smooth cotton towel with wheat bran, flour or cornmeal. Shape the dough into a ball and place seam side down on the towel. Sprinkle more bran on top and wrap the towel loosely around the dough. Let rise another 2 hours.

During the last half hour of the rise, heat a Dutch oven or other heavy baking dish in a 450 degree oven. When dough is ready, remove the pot from the oven and turn the dough into the pot (again, see video for technique – I screwed this part up…) Shake pan to center the dough in the pot .(Careful! It is hot!)  Cover with lid and bake 30 minutes, then remove lid and bake another 15 to 30 minutes, until loaf is beautifully browned. Cool on a rack. Try to wait till it cools before slicing and eating, so the crust can develop a bit more.

No-Knead Links (Share your fave No-Knead links in the comments.)

  • Lahey has a book of his No-Knead bread recipes (I’m adding this one to my wish list.)
  • Lahey’s version of the recipe varies cooking and rise times. Worth reading.
  • La Weekly interviews Lahey on his technique.
  • Breadtopia bakes Cooks Illustrated almost no-knead variation on Lahey’s No-Knead, including a whole wheat version.
  • Garden Fork uses parchment paper to make the transfer of the dough to the hot pot easier.
  • Sofya simplifies the method with a mixer and one bowl technique.
  • Vanilla bean blog has gorgeous pics of the method, and a beautiful final product.
  • Simply So Good makes some wonderful additions to the recipe, which she says she got from Le Creuset, but is the same as Lahey’s.
  • The Cookbook Chronicles uses a sourdough starter and regular yeast to get a gorgeous bread.
  • Leite’s Culinaria has Lahey’s No-Knead olive bread recipe.
  • Penni Wisner has whole grain variations and lots of tips on the no-knead technique.
  • Shutter bean makes Lahey’s walnut raisin No-Knead.
  • Bob Parvin has an excellent post with tips on no-knead that answers almost any questions you may have about the method.

Bring It On, Irene…I Made Jumbles

I’m ready for you.

The terrace is cleared.

The roof is as secure as we can make it.

The windows and doors are closed.

The tub is filled with water.

As are all the pots, the teapot,

bowls and water pitchers.

Even the big trashcan is filled.

(You may think I’m going overboard, but when we lose power, we lose water here on the 12th floor. During the big blackout a few years back we went through every drop in the tub and pots. But we were clean.)

I’ve got two flashlights and loads of batteries.

Laptops are charged and shut off. Cell phones are charged, shut off and forwarded to the home phone. Two back up battery phone chargers are charged and ready to roll. (One even has solar recharging capacity.)

The old phone is out of the closet, hooked up and working. (It doesn’t need electricity. During the blackout, we were the only ones who had a working phone.)

Dog is walked (and not too happy given that the rain had already started when I walked her for the last time this evening…)

We are showered. (sorry,no pic…)

But most importantly…

I made cookies.

Because when a hurricane is on the march up the coast, and the subways, buses and Broadway are shut down, you do what you gotta’ do.

Bake.

Stay safe, and I’ll see you on the other side of the storm.

Jumbles

A sweet little recipe from The Rumford Complete Cookbook (copyright 1908), a little gem I picked up at an antique store upstate. (Google Books actually has the entire book online!) The actual recipe is so old that they don’t give cooking temperatures, just tell you that most baked goods require a “moderately hot oven”. I decided that meant 350 degrees fahrenheit. But on a regular cooking sheet, making the cookies using a melon baller, my first batch were too brown on the bottom and not enough on top. So I used an insulated cookie sheet, pressed the cookies down before baking and extended the cooking time from 10 minutes to 15 minutes. Perfect! If you don’t have an insulated cookie sheet, lower the heat to 325 and let me know how that worked for you. Makes 24 cookies.

  • 1 cup flour
  • 1/2 level tsp salt
  • 1 level tsp baking powder
  • 1/2 cup butter
  • 1/2 cup sugar
  • 1 egg, lightly beaten with a fork
  • Grated rind of half a lemon

Preheat oven to 350 degrees fahrenheit. Grease an insulated cookie sheet. Sift flour, salt and baking powder together in a bowl and set aside. In a large mixing bowl, cream butter and sugar in mixing bowl; add the egg, the lemon rind, and then the dry ingredients, beating slightly after each addition. Drop onto cookie sheets using a melon baller. Flatten cookies slightly with your fingers. Bake 12-15 minutes till edges are browned. Serve immediately.

 

NIH’s Medicine in the Media Course – Time to Go Big

The NIH is doing it’s best to get science writers on the right track when it comes to responsible health reporting by holding an annual course on Medicine in the Media.

The National Institutes of Health’s Office of Medical Applications of Research (OMAR) presents a free annual training opportunity to help develop journalists’ and editors’ ability to evaluate and report on medical research. The course curriculum builds on the best of prior years’ offerings to create an intensive learning experience with hands-on application.

When I read about the course on Gary Schwitzer’s tweet stream, I got really excited and started scouring the NIH course site to listen to some of the fabulous speakers in the 2011 course, which just finished in July. I was disappointed to discover that that the course, while free, is by application only, limited to 50 participants and not broadcast or archived on the web.

While limiting the course this way will certainly serve to create an elite group of science reporters, it won’t help the thousands of local news outlets playing “pass on the press release” health reporting that continues to be the main feeding source for health information for so many Americans.

Here’s a call to the NIH to open up its course content to the public and the media at large, in the same way that so many of its events are broadcast and archived. Imagine if every health editor and reporter were to take the course online. And while we’re at it, how about every medical center and university employee responsible for writing press releases? In a very short time we could have major impact on the quality of health reporting in this country. Which would translate into a better informed public.

Now that’s my tax dollars at work.

Blog Break

Heading off to the Pacific Northwest and California for a two week vacation.  I’m going to see how long I can survive off the grid.

See you when I return!

CNN Does a Nice Job Covering the Aftermath of the Mammogram Controversy

Kudos to CNN’s Lisa O’Neil Hill for a well-balanced and thoughtful article on the mammogram controversy. Absent from the article is hyperbole and stridency that make the medical community sound like a bunch of cats and dogs. Instead of “Them’s fightin’ words” soundbites, O’Neil Hill gives a well-written summary of all the major viewpoints on the issue.  She took the time to understand everyone’s point of view, and chose quotes that illustrate the fact that this is not a fight, but an intelligent discussion about how to maximize the benefits and diminish the harms of a less than perfect screening test for breast cancer.

“The initial recommendation from the task force caused a great deal of confusion, which was unfortunate because what I think they were trying to say is, I think, something very reasonable. The way they said it and the way it came out was very unreasonable,” said Dr. Otis W. Brawley, chief medical officer of the American Cancer Society.

“What the task force was trying to say is mammography is an imperfect screening tool and there are some harms associated with it, but there are also some benefits associated with it,” he said. “They were trying to say the benefits are not nearly as good as we would all like.”

Moyer said Brawley is on target.

“In many, many instances, our recommendation has been interpreted as a ‘don’t do it.’ That is incorrect,” she said. “It’s something that needs to be discussed on an individual basis. For some women, it will be consistent with their values to choose to have a mammogram between 40 and 50. For other women, they will choose not to, and those are both reasonable decisions.”

I strongly encourage you to read and share the article.

Helix – Playing the Hand You’re Dealt

If your DNA determines who you are, and defines both your strengths and limitations, then you could say we all live our lives with a pre-dealt deck of cards.

That’s the premise of a new card game on display as part of the Talk to Me exhibit which opened at MOMA this week.

Players send in swabs of saliva; the designers send it out to be analyzed and then generate a customized 50-card deck from each player’s specific DNA…The deck allows players to become shadow versions of themselves, with all their genetic cards on the table, and in the game, as in reality, life depends on how the cards are played, not on which cards are dealt. The effects of any trait depend on the player; the challenge of the game is how to contend with or take advantage of it. A player with a great deck can still lose if the game is played without strategy, and a skilled player with a weaker deck can win.

Fascinating idea. A life lesson in a card game.

_______________________________________________________

We visited the Talk to Me exhibit Saturday with friends, including Helix’s graphic designer Mike Essl. Congrats Mike on being included in this amazing exhibition!

If you haven’t yet been to Talk to Me, You MUST go.