Genital Photos, HIPAA and the Media

A surgery resident at the Mayo Clinic is under fire for taking a photo of his patient’s genitals during surgery for a gallbladder problem. A concerned surgical staff member took it upon themselves to contact the press about the incident, and so now the entire country knows what this poor guy has tatooed you- know- where.

It seems to me there’s a bigger problem here than the photo – and that’s the violation of this patient’s privacy by the staff member who took the story to the media. Since when is calling the local paper the appropriate way to handle a hospital incident involving a patient?

In fact, I’d argue that the “whistle blower” to the media committed an even bigger violation of the patient’s rights than did the resident who snapped the photo. What could have been a private matter between the patient and the Mayo Clinic (and the lawyers for both sides) has now become national news.

(Hat tip to Kevin, MD for the story, the latest addition to his “Doctors Gone Wild” post series.)

FDA Warnings on Nonoxynol-9 Re-Define Sponge Worthiness

Elaine’s date tries to convince her that he is “Sponge-Worthy”
The FDA has issued a new ruling requiring manufacturers of contraceptive and spermicidal products containing Nonoxynol-9 to warn users that Nonoxynol-9 does not protect against HIV or other STD’s. Labels must also warn that Nonoxynol-9 can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner.

Nonoxyl-9 is the active ingredient in the contraceptive sponge. It’s also found in spermacidal jellies used with diaphragms and cervical caps, and in contraceptive inerts, foam and vaginal film.

Nonoxynol-9 is a surfactant, and acts to disrupt sperm membranes, thus preventing pregnancy. Contraceptive efficacy of N-9 containing spermicides ranges from 70% if used alone to 80-90% when used with a diaphragm. Advantages include absence of hormones and easy reversibility. The disadvantages are that they are less effective than hormonal methods, can cause irritation and can increase HIV transmission if your partner is HIV-infected.

So before you dip into your sponge stock or take out your diaphragm for a guy, better make sure he’s truly worthy and does not carry the HIV virus. If you’re not sure, forget the sponge or diaphragm and use a condom.

TBTAM’s Rules for Spermicide Use

  1. If you are at risk for HIV or if your partner’s HIV status is unknown to you, don’t use Nonoxynol-9 containing contraceptives. Use a non-spermicidal lubricated condom. If you want additional protection against pregnancy beyond that which condoms provide, look towards additional methods that don’t entail spermicide use, like the oral contraceptive.

  2. If you are at low risk for HIV infection, and especially if you know that your partner is HIV negative, go ahead and use whatever contraceptive works best for you, including spermicides, diaphragms and sponges.

  3. The best way to protect yourself against HIV infection is to limit your number of sexual partners, or as TBTAM has said again and again – Save sex for those you love. But since even someone you love could have HIV, both of you should get that HIV test before you stop using a condom or use spermicides.

The Road to the Ruing

We’ve known for some time that Nonoxynol-9 use can increase HIV transmission, from studies of sex-workers in Thailand and Africa, who were found to acquire HIV more often when they used Nonoxynol-9 spermacides along with condoms, compared to their counterparts who used just condoms.

In 2002, the CDC issued a warning against the use of Nonoxynol-9 for HIV or STD prevention, and advised against using spermicidal lubricated condoms for HIV prevention. In response, over a dozen condom manufacturers, including Planned Parenthood, stopped adding spermicides to their products, as did makers of personal lubricants.

But at the FDA, the issue became politicized, since it involved labeling on condoms.

Right-wing advocates of abstinence wanted the label to say that condoms don’t protect against AIDS. AIDS Advocacy Groups wanted to be sure that the labeling did not discourage condom use. Women’s groups were concerned that the warning against spermicides might be applied too broadly, causing women who were at low to no risk of HIV to turn away from effective contraception. Also at the table were the condom manufacturers, some of whom continued to manufacture spermicide-lubricated condoms on the grounds that these condoms are appropriate for couples without HIV. And, I suspect, the instability of the FDA leadership over recent years didn’t help the matter…

In 2003, the GAO, under pressure from the right wing lobbyists, issued a statement against the FDA, urging them to move forward on the labeling change. Four years later, the ruling is finally final.

The FDA warning goes beyond the 2000 CDC message to address the widespread use of Nonoxyl-9 in contraceptives, and to correct any remaining mis-perception that these spermicides protect against HIV.

The ruling also contains wording for condom labels that states that their consistent use greatly reduces, but does not eliminate, the risk of catching or spreading HIV. A nice compromise, I think, on that issue.
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The full FDA Ruling is posted on the FDA Website
Great info on Nonoxynol-9 from IBIS Reproductive Health

XO Laptop – First Impressions

My daughter’s XO Laptop arrived today – just one day late for her birthday, not bad delivery timing.

She called me screaming in excitement, and when I arrived home about a half hour later, she opened the door holding the laptop up, with the words “Hi Mom!” written on the screen. She had already made a video, taken a few pictures and figured out where our wireless network was. All I had to do was explain that our network password was in hexadecimal, and she had her Internet up and running.

User friendly start up – Check.

We’re still exploring it, figuring out the tricks to this new interface. Found a writing program, but haven’t figured out where the files get saved to. Fortunately, there is support info on the web, and a community of users is growing.

The only downside so far is that I don’t think the XO will run I-Tunes. There’s a USB port, so the I-Pod should be able to connect. I think a program called Banshee should do the job, but I’ll have to do little learning about Linux to download it and get it working for her. One more job for IT Support-Mom…

I wish we could find out who the kid was that got the laptop we donated – it would have been fun to connect with him/her wherever they are (?Africa maybe).

Make Sperm, Not War

The Civil War in Lebanon caused a decrease in sperm count, according to a study published this week in Fertility and Sterility.

Researchers at the American Hospital in Beiruit retrospectively reviewed records of couples receiving fertility treatment between 1985 and 1995, and compared the results of semen anlyses performed on samples collected during the war (1985-89) and after the war (1991-95).

Sperm concentrations were significantly lower during the war compared with the post war period, although sperm volume and motility remained the same. Sperm morphology was actually more abnormal after the war. (Whether this latter result was due to toxic exposure during the war or a change in how semen anlayses are reported is unclear, but the latter seems more likely.)

The authors suggest that the stress of war leads to a decline in sperm production, possibily through a depression of testosterone levels via the effect of stress hormones on the hypothalamic-pituitary-gonadal axis.

Although a longitudinal study of men before, during and after war would have made a better case, these results are interesting to say the least, and give us one more reason to make love and not war.

More on Ghostwriting

For a brilliant analysis of the art of ghostwriting by Big Pharma, read this post at Dr Carlat’s blog. And while you’re at it, put him on your blogroll. This is an important blog.

Medicare and the Annual Gyn Exam

This post is for all you baby boomers out there who are enrolling into Medicare after having seen your gyn every year since college for an annual exam, and for all you Medicare veterans coming to my practice for the first time since your previous doctor retired. There’s something you need to know –

Medicare only pays for routine breast and pelvic exams and pap smears every 2 years.

It’s true. Here it is, from Medicare’s web site –

Medicare helps pay for a Pap test, pelvic exam, and clinical breast exam once every 24 months.

Most women don’t need a routine pap smear every year. So I’m happy to have you forgo that testing on an annual basis. In fact, if your paps have always been normal, we can even go 3 years between paps.

But I still recommend you have a breast exam every year, and a pelvic if you still have all those parts.

What if I’m high risk?

If you are high risk for cervical cancer (see below for the definition of high risk), you get a pap every year.

But if your paps have always been normal, and you see me for only a routine check up less than 2 years since your last routine check up, Medicare just won’t pay.

What About Problem Visits?

Now, if you a medical problem, Medicare will almost always pay for your visit. So don’t be afraid to come in if, for example, you have a urinary tract infection. Or a yeast infection. Or have a pessary, osteoporosis, breast cancer, abnormal paps, abnormal bleeding or are on hormone replacement and you need to come in more often than once every two years. We have a diagnosis code to support the medical necessity of those visits, and we’ll all be fine.

In fact, if you come to see me for a “check-up”, but also have other problems that we deal with on that visit, I can “carve out” the portion of the visit that medicare will pay from the preventive part they won’t – so you won’t get stuck with the whole bill.

The ABN (Advance Beneficiary Notice)

If you’re here for preventive services, my staff will ask you to sign a form called an ABN, or Advanced Benificiary Notice. This is to prove to Medicare that we informed you which services were not covered and that you agreed to pay for them if Medicare won’t.

If we don’t have the signed ABN in your chart, we can’t bill you, so please understand when we ask you to fill one out. Every single year.

If, after reading the ABN, you decide to forgo the preventive services, that is absolutely your choice. We’ll happily see you next year for these services.

What about your secondary insurance?

Good question. You may have a secondary insurance that will pick up what Medicare pays. On the other hand, your secondary may not pick up the uncovered portion of your visit. Since everyone’s plan is different, that part is up to you to figure out.

Apologies

I’m really sorry about this, but there is absolutely nothing I can do. I can’t make up a code to get your visit covered if it is not.

And I really don’t know how your last doctor got Medicare to pay for you to see him every 6 months for the past 10 years when you don’t have any gyn problems.

I only know that these are the rules, and I have to play by them.
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Read Medicare’s Information Booklet for Women

High Risk Definition: You are at increased risk for cervical cancer, according to Medicare’s guidelines, if you have not had a pap for 7 years or have not had 3 normal paps in a row. Also, if you started having sex before age 16, have had more than 5 lifetime sexual partners or an STD, or are a DES-daughter, you get a pap every year.

Apple Torte

Thanks for Bureka Boy for a marvelous recipe, and as usual, a great how-to that makes baking gorgeous desserts like this a snap.I brought the torte to a Hanukkah dinner party tonight, and it was a huge hit with all ages. (Hint- keep the sides on the springform pan for risk-free transport.)

Go ahead, try it. It’s not hard to make at all….

European Apple Torte 

I strongly encourage you to read the recipe at Bureka Boy’s site – it’s complete with beautiful prep photos and hand holding instructions. I’m putting an abbreviated version here for easy printing. 

Crust Ingredients

  •  1/2 c butter, soft
  • 1/3 c sugar
  • 1 pkg vanilla sugar, optional
  • 1/2 tsp vanilla
  • 1/8 tsp salt
  • 1 c all purpose flour

Cheese layer ingredients:

  • 1 pkg (8 oz/25o g) cream cheese, room temp.
  • 1 tbsp lemon juice
  • 1 tsp vanilla
  • 1/4 c sugar
  • 1 egg

Apple layer ingredients:

  • 2 large baking apples* (plus 1 extra, just in case)
  • 1/3 c sugar
  • 1/2 – 3/4 tsp cinnamon
  • 1/4 c sliced almonds

Crust: In a large mixing bowel using the paddle, together the butter, vanilla, sugar and salt. Mix until well blended.  Add the flour and mix only until blended. Place the dough in an ungreased 8 1/2″ springform pan. Pat and press the dough evenly across the bottom of the pan and up the sides about 1 1/2 inches. make sure it is even. And not too thick between the bottom of the crust and the walls of it. You will think you don’t have enough dough, but trust me, you do. Just keep working it and thin it out to cover.  Set aside.

Cheese filling : Mix everything together in a medium sized bowl using the paddle for 2 or 3 minutes. It needs to be perfectly smooth and not grainy.  Place the cheese filling in the unbaked crust, smoothing it using a rubber spatula. Set aside.

Preheat the oven to 450F at this point.

Apple layer: Peel and slice the apples 1/8 inch think. Layer the apples around the outer perimeter, carefully overlapping them. When you get to the first apple you layered, lift it to add the last one. Repeat a second layer just inside the first. Arrange the few apple slices in the innermost layer nicely. Mix the sugar and cinnamon together and with a spoon, distribute the mixture evenly all over the apples.. It will look like too much – don’t worry it is not. Finally, sprinkle the almonds evenly over the apples.

Bake for 10 minutes only @ 450 F and then reduce the heat right away to 400 F and cook for another 25 minutes.  Remove from the oven to a baking rack and let cool completely. Gently run a knife around the cooled torte and release the spring siding. Let the torte sit several hours in the fridge for it to firm up properly before eating it. It is best served slightly cold or at room temperature.  Dust with confectioners sugar if you like or serve with whipped cream dollops. I serve mine plain.

A Latke by Any Other Name…

Tonight is the first night of Hanukkah, and of course that means latkes.

Hanukkah is one Jewish holiday where I feel right at home food-wise, since I grew up eating latkes. Of course we didn’t call them latkes – we called them potato pancakes, and they are a standard in the Slovak kitchen. My Grandma used to come up and make them for us in our kitchen sometimes on Saturday nights. We were so anxious to eat them, I don’t think we even waited to all sit down at the table together – we just lined up next to the electric fry pan with our plates and practically grabbed them from the spatula as Grandma was laying them onto paper towels to drain!

My Grandma grated her potatoes by hand using the small holes of the grater and never drained the liquid. This meant she needed a fair amount of flour to sop things up, and ended up with a rather thick, dense, floppy and wonderfully delicious pancake.

The potato pancakes I make now are a bit different than the ones I grew up with. They are based on my mother-in-law Irene’s recipe, and they are pretty perfect if you ask me. Actually, Irene didn’t really give me a recipe, just approximate amounts and a gestalt. But I decided to try and nail down the amounts tonight as I made them.

The trick is to use the large grating blade of the food processor to shred the potatoes and onion, and thento drain away the liquid. Eggs hold the potatoes together and coarse motsa meal fills in the spaces without the heaviness of flour. Cook the latkes in an electric fry pan – it’s really so much easier and safer than doing it over the stove and you get a more consistent pancake as long as you don’t overload the pan. If you do it right, what you end up with is sort of a latke nest, with lots of crevices of crispiness on the outside and a few wonderful soft pockets of old time potato pancake in the middle.

Sour cream and homemade applesauce are the only other things you need. My kids, of course, also like ketchup.

Latkes (or Potato Pancakes)

For this batch, I used Yukon Gold potatoes and Streits Motsa meal that I borrowed from my friend Rachel down the hall. (Without Rachel I would never cook – she never runs out of anything…) I had never used that brand, and I like it – it is a coarser grind than Manichevitz, and so instead of just sopping up the egg and clumping together, the meal sort of stayed aloof on the outside of the shredded potatoes. This made for a less dense pancake. I also used canola oil because it is healthier, and noticed no difference from the traditional vegetable oil. You can vary the amount of onion depending on your tastes. Mr TBTAM likes his on the oniony side.

3 pounds potatoes (I used Yukon gold tonight)
2 eggs, lightly beaten
1 1/2 large onions
A little less than 1/4 cup Motsah Meal
salt
Pepper
Canola oil for frying

Peel potatoes. Shred using the food processor and remove to a large bowl. Shred the onion the same way and add to the bowl. Open out a large clean dishtowel onto the counter and dump the potato onion mixture on it. Top with a second clean towel and lightly roll to mop up the excess liquid (Don’t overdo it, you need a little of the potato starch and liquid for things to stick together.) Dump back into the bowl and add the eggs and the motsah meal. Season with salt and pepper.

Heat about a 1/2 inch of canola oil in electric frying pan at highest heat (mine goes to 400 degrees Fahrenheit). Scoop some of potato mixture into a large spoon, then put into the oil, flattening with the back of the spoon. Cook until the edges start to crisp and the underside is light brown, then gently flip and cook the other side.

Remove from pan to a cookie sheet lined with paper towels or newspaper. Keep warm in a low oven while cooking the rest of the potato pancakes.

Serve with sour cream and warm homemade applesauce.
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This of course, is not the only way to make latkes.

4Bureka Boy has a great round up of recipes and methods on his blog, as does Slashfood, whose latkes look suspiciously like mine.

4Epicurious does a nice job on technique, and uses a mixture of butter and oil to fry in their Classic Potato Pancake recipe.

4For healthier versions, see Got No Milk (no fat) and Diabetes Daily (lo-carb in the comments section).

4And, for a genuine latke making lesson from a genuine Jewish Mother, watch Feed Me Bubbie– Latkes.

Happy Hanukkah!

Cookies from an Angel

I’ve been invited to submit a recipe to Leonard Lopate’s Holiday Cookie Recipe Swap. I love Leonard’s radio program, so it was a thrill to get the email from his staff asking that I submit a recipe and help spread the word about the swap.

Picking a recipe was easy – Angel Fingers. When I was little, my Grandma made Angel Fingers at Christmas, along with shaped sugar cookies and a wonderful, crisp brown cookie she called a “Sand Tart”. I loved them all, but I only have the Angel Fingers recipe, handwritten by Grandma on an index card that is becoming increasingly yellowed with age.

My dad’s mom was a one of a kind. Never afraid to speak her mind, she was famous for such lines as “You have such lovely teeth! Are they your own?” and to her parish priest “If I’d known you when you were younger, you’d never have made it to the Cemetery.”(She of course meant to say Seminary.)

My Grandma loved her garden, her little bird, her crossword puzzles and the Phillies. And she could stand on her head even in her early 60’s, a skill she demonstrated to us during sleepovers at her house after we did her nightly calisthenics with her.

Grandma held a much less strict view on Catholicism than my parents, who insisted we attend church every single Sunday while I was growing up. And so I will never forget that Sunday morning when I came downstairs after spending the night and Grandma told me we were skipping Mass that day.

“God is in the birds, the trees and the flowers”, she said, spreading her arms out toward her garden. “We don’t need to go into a building to be with him.” So we sat on her porch that beautiful sunny morning looking at the garden, listening to the birds and reading the funnies.

I don’t go to church anymore now, having lost organized religion long ago. But I never lost my Grandma’s religion. I still believe that God is in the flowers, the trees and the birds.

And he’s also in these little cookies – cookies from my Grandma, who taught me to see holiness in the world around me.

Angel Fingers

Submit your favorite holiday cookie recipe by December 6, along with the reason why the recipe is special. Then tune in to WNYC on December 11 and listen to Leonard and Ruth Reichl talk cookies.

The Soup that Never Ends….

It started out as Jessie’s turkey soup on Thanskgiving. A family standard and always delicious. Jessie makes a huge pot, so there was enought left over for all of us to take some home.

It was a bit thick after refrigerating it, so we add a couple of cans of chicken stock, a bit of barley and some chopped fresh mushrooms. My God, that was good. The broth was so rich…. It lasted us two dinners plus Emily’s lunch. But there was still some left over, and of course it had thickened up again.

Today I added some water and a chicken buillon cube and some gorgeous raw Kale with sesame seeds that Nellie left behind in our fridge after her stay at our apartment last weekend. We each had a bowl with dinner tonight and there’s still some left over.

Remember that song you sang as a kid? Time to sing it again….

Ghostwriting – Another Winning Strategy from Big Pharma’s Playbook

Since I’m on the topic of Big Pharma, here’s another eye-opener, this time from the WSJ Blog, about a physician who was offered sole authorship of an abstract for research she never even conducted.

In fact, she had never heard of the drug until receiving the email pitch…“We can draft the abstract, offer our editorial support in developing the content of the abstract and help with the submission process on your behalf,” wrote Liz Burtally, who identifies herself in the email as a medical writer “for the nebivolol team working with Forest Laboratories.”

Sealey asked a lot of questions. Would she be the only author? Yes, she says she was told. When Sealey asked if she would have access to the raw data, the phone went dead. Burtally never called or emailed again.

It’s called Ghost-Writing, and it’s much more common than you think. (Via Hooked: Ethics, Medicine and Pharma. A blog by Howard Brody, MD, author of a book with the same title.)

For those interested in the topic, here’s a little primer on Ghost-Writing from Health Care Renewal Blog,

… ghost-writing practice is common, perhaps accounting for as many as 10% of journal articles. Moreover, stealth marketing campaigns that emphasize ghost-writing may create a bolus of articles that may be enough to dominate the literature on particular topics.

According to a recently published scholarly review on the subject –

In the three years that Healy and Cattell examined, approximately 57% (55 of 96) of all published articles on Zoloft in the peer-reviewed medical literature had originated from Current Medical Directions (A Medical Communications Company engaged by Pfizer – TBTAM) . Not only did the articles from Current Medical Directions outnumber the traditionally authored articles, they appeared in higher-impact journals. Perhaps most significantly, the citation rate for athe articles produced by Current Medical Directions was over five times higher than the citation rate for the traditionally authored articles.

And finally, from Plos, a free article on the topic by Sergio Sismondo –

… during key marketing periods as many as 40% of published articles focusing on specific drugs are ghost managed [24]. Even if the more typical figure is half that, ghost management exerts a huge force on the shape of scientific opinion on new drugs, and does so in the service of marketing.

Makes reading the literature a real challenge these days. I’ve personally taken to looking at the conflict statements before I even read an abstract. But it’s almost impossible to know if an article has been ghostwritten. Peer review does not pick it up. We have to rely on the journal editors to get stricter about forcing disclosure of every single person who contributes to a manuscript.

Maybe it’s time to call in the big guns. Let’s sing together, shall we?

If there’s something fishy
In the research study
Who we gonna’ call?
GHOSTBUSTERS!

If the meta analysis
Don’t look quite right
Who we gonna’ call?
GHOSTBUSTERS!

I ain’t afraid of Big Pharma
I ain’t afraid of Big Pharma…

An Insider’s Look at Big Pharma’s Playbook

A must-read for every doctor and patient is an article in this Sunday’s NY Times Magazine called Dr Drug Rep.

It’s a first person account from a psychiatrist who is recruited by Wyeth Pharmaceuticals to speak on Effexor, an anti-depressant, but whose relationship to the company sours as he begins to respond honestly to questions and criticisms of the drug from prescribers.

Several days later, I was visited by the same district manager who first offered me the speaking job. Pleasant as always, he said: “My reps told me that you weren’t as enthusiastic about our product at your last talk. I told them that even Dr. Carlat can’t hit a home run every time. Have you been sick?”

As disturbing as it was to read about how drug reps influence the message, what was most upsetting was learning how peer-reviewed and published meta-analysis was used by industry-paid researchers to help Effexor stand out among its competitors. Analysies in which new measures of outcome were defined, while standard measures were either ignored or never used.

In his study, he emphasized the remission rates and not the response rates. As I listened to his presentation, I wondered why. Was it because he felt that remission was the only really meaningful outcome by which to compare drugs? Or was it because using remission made Effexor look more impressive than response did?

Originally designed as a method for mining much-needed information from multiple studies to answer important medical questions, it appears that meta-analysis is now just another tool for the pharmaceutical industry to market drugs.

Why had I not realized this till now? Have I really been that naive?

I feel like I need to go back to Go, pay my $200 and start all over again. This game is one I really haven’t fully understood until now.