Friday, November 20, 2009

SSRIs in pregnancy associated with 5 days earlier delivery, 2X PICU likelihood

SSRIs in pregnancy associated with 5 days earlier delivery, 2X PICU likelihood.

More evidence emerging raising alarm regarding bad effects on the baby from mom taking antidepressants during pregnancy.

The new study is: Lund N, Pedersen LH, Henriksen TB.Selective serotonin reuptake inhibitorexposure in utero and pregnancy outcomes. Archives of Pediatrics & AdolescentMedicine. 2009 Oct;163(10):949-54.

For moms taking SSRIs, kids were born five days earlier. Kids who ended up inthe NICU were twice as likely to have moms on antidepressant versus not onantidepressants. Etc.
There are plenty of reasons to blog about this.

Discussing the issue repeatedly, from many angles, can possibly, hopefully,lead to some avoidance of these suspected harmful outcomes. As I have blogged before...

There is an awesome alternative to antidepressant medications in pregnancy.Talk therapy. This intervention has decades of empirical support, including ahost of recent-generation (most recent decades) evidence for efficacy. Itwould take an embarrasingly over-extended stretch of the imagination tohypothesize a risk of harm from talk therapy that is equal to the harm thatseems increaasingly evident.

Another great reason to discuss this issue is because of the vested interestspushing FOR the use of antidepressant medications in pregnancy. This is thetwo leading organizations that should be advocating for SAFE care for moms andthe unborn children: the American Psychiatric Association, and the AmericanCollege of Obstetricians and Gynecologists.

At the time when either, or both, ought ot be on the vanguard, comprehendingthe risks and alternatives, these two organizations have jointly combined,WITH FUNDING FRON BIG PHARMA, to advocate for exactly the opposite:medications for depression in pregnancy.
Here is the OFFICIAL, joint APA ACOG statement:

Here is THEIR language where they soft-pedal and downplay talk therapy:

"Pregnant and not currently on medication for depression:Psychotherapy may be beneficial in women who prefer to avoid antidepressantmedication. For women who prefer taking medication, risks and benefits of treatmentchoices should be evaluated and discussed, including factors such as stage ofgestation, symptoms, history of depression, and other conditions andcircumstances (eg, a smoker, difficulty gaining weight)."

---talk therapy, infinitely safer for the baby, is relegated to a condescending "preference," if the little lady insists.

I predict: within two years, this heavily credentialed guideline will be totally up-ended. Totally thrown out.

How can the APA and ACOG make such a glaring mistake?
Follow the money.

"Dr. Yonkers has received a research grant from Eli Lilly this past year. Shehas received study drug from Pfizer for a National Institute of Mental Healthtrial. Dr. Stewart serves on the Advisory Boards of Wyeth and Eli Lilly andBoehringer Ingelheim. Dr. Dell has received research grants from Pfizer hasconsulted to Bayer Schering Pharma AG and Berlex and is on the Speaker'sBureau for Berlex, GlaxoSmithKline, Pfizer and Wyeth. Dr. Wisner serves on theSpeaker's Board of Glaxo Smith Klein. Dr. Oberlander; Dr. Ramin; and Drs.Stotland, Chaudron, and Lockwood have no conflicts to disclose."

That is a brief review of the extensive degree of financial relationshipsbetween some of the authors and the drugs that the authors are advocating. Ibelieve I noted in an earlier post: Dr. Wisner has relationships going back at least a couple decades with Big Pharma.

So, take your pick. Meds vs. Therapy. According to paid shills from APA andACOG, meds wins. Until you account for the efficacy of talk therapy, and the horrible side effects, on developing babies in utero, of these antidepressants.

Friday, November 6, 2009

Tragic Fort Hood Shooting: This fits the pattern where I assume SSRI until proven otherwise.

This sounds like yet another story straight out of SSRI Stories.

If the problem is a rogue, loose-cannon religious fanatic, then we need to be aware of this type of problem, and respond accordingly. Regardless of denomination.

If the problem is that there is a great, growing Muslim conspiracy to overthrow the United States, then we neeed to be aware of this type of problem, and respond accordingly.

If the problem is that this man is one of the approx five percent of the population who get his nitric oxide neurotransmitter affected by SSRI drugs or SNRI drugs, and he has been on an SSRI / SNRI antidepressant, and he loses some second-thought and impulse control capability that is the function of the frontal lobe, then we need to be aware of this type of problem and respond accordingly. There are many psychiatrists who are on psychiatric drugs.

If the problem is any one of these, and we respond in a manner for one of the other ways, then we fail to make any progress, and we entrench the real problem.

In that sense, I don't so much care what the real problem is, but that we have truth as our goal. Not re-election, not PC correctness, not recruitment goals, not Jihad, but truth.

Another problem to figure out:
the military just came out and said most kids are not fit to be soldiers.

A year ago, there was a tragic incident at Fort Lewis, another army base, up near Olympia, Wash. A teen girl was escorted onto the base by one of the enlisted guys, and she died from at least too much alcohol, but possibly alc and other drugs. How did she get in? Security let her in. This revealed a pattern of some - not all - but some -- Ft. Lewis personnel traveling off base and down the road a bit, being approached by teen girls asking to be helped to get on base, then getting on base, and going wherever - not necessarily staying with the guy that brung 'em. Local teens were interviewed, and said, yes, this is what you do to go have fun and drink on the weekends. duPont is not a big town, and so secrets travel.

To get into Fort Lewis, you show ID to a hired / contracted security guy, not an Army guy. That is how it worked when I was hosted at Fort Lewis, and I commented to colleagues at that time: it seems odd that a major military base is protected by hired private security.

The person at Fort Hood who shot Hasan apparently was a hired security guy. In the middle of a crowded army base. At a time when most of our kids are unfit for duty. Sad. It just doesn't sound right. Our army base is protected by a hired security guy, not an army guy.

mediTation or mediCation: Well-Established Mindfulness Meditation Training Helps Kids in Psych Treatment Get Off Meds, Build Esteem

RCT study in JCCP: Well-established Mindfulness Meditation Treatment Helps Kids in Psych Treatment Get Off Meds.

THe study is: Biegel, Brown, Warren, Schubert, authors: Mindfulness-Based Stress Reduction for the treatment of adolescent psychiatric outpatients: A randomized clinical trial. Journal of Consulting and Clinical Psychology, 77, 5, October 2009, pages 855-866.

In short, the researchers took a group of adolescents who were refered to psychiatry specialty care in a large health care provider organization - Kaiser Permanente. The diagnostic problems were, bascailly, whatever came through the door - predominantly cases of depression, some cases of anxiety, some various other complaints.

The kids were randomized to the well-recognized Jon Kabat-Zinn developed MBSR (mindfulness-based stress reduction) or to usual care. This would typically end up being a mix of talk therapy, maybe family talk therapy, and some medication therapy. A hundred kids altogether, about fifity in each group. MBSR is explained and referenced well in the article. I have read the book and done MBSR-based treatment - their intervention is great from what I can tell.

So, the test ends up being: for a group of adolescents that is typical of cases seen in a mental health / psychiatric practice in a large health care organization, can mindfulness-based stress reduction lead to better outcomes than the usual?

The results? In brief, MBSR wins compared to care as usual. In other words, MBSR is a suitable treatment strategy for a general case load in a psychiatric practice. Depression scores improved more for MBSR than the usual care group. Also, MBSR was superior for anxiety, anger, and somatic symptoms. Across the board.

Is this a big deal? Maybe, maybe not. It does serve to expand the robustness of yet another psychosocial intervention. so, it helps me and other proclaim more strongly: you have plenty of options! You don't need to take psych drugs just because a DSM diagnosis fits!!

Here is the biggest deal, in my opinion:

**The MBSR got kids OFF of psych drugs.**

Without even trying. That was not a specific outcome of the study.

Not only did MBSR result in superior benfit across a whole set of outcomes, metioned above, but the kids in that group migrated away from psych drugs AND got even better than the other group. Double Play!

At baseline, about half in each group were taking psych drugs. At the beginning, 25 of those randomized to MBSR were on psych meds, while 20 in the usual-care group were on psych meds.

At completion, eight weeks later, the number of MBSR kids on psych drugs had gone down to 18. A 20% reduction. By the later follow-up assessment, the number of MBSR kids on psych drugs had gone lower, to 15. A 40% drop. From 25 to 15.

In the usual care group? No change. 20 to 22, reflecting increased psych drug use typically happens when you get referred, then to 19 at the follow-up assessment. I guess if you get out your calculator, you will see that there was, technically, a 5% reduction in meds, since one person fewer, out of 20, was on psych meds at the follow-up point.

Five percent or forty percent: you be the judge. Meds vs. therapy. Therapy wins this one.

**Also, another cool outcome**

While symptom change, what changes IN the kids? Sure we measure change, but what is going on?

Well, you think about it: you go for help for depression or anxiety, or whatever. You get given meds, or someone trains you in stress management. Either way, your symptoms get better.

What is your view of your problem and solution? If you get cured with meds, you figure: I have a biologically based brain disorder; without meds I am at risk of not being able to cope with whatever life brings me. For the rest of my life. I used to believe I was half-way OK, but now I know I am diseased, and need meds to be normal.


You learn skills, and you figure: I was lacking some skills to cope with life, and now I have been trained; I am better able to cope with whatever life brings me. For the rest of my life. I did it, and I can do it. There was not something wrong with me, I just lacked a skill set I needed, just like going through Driver's Ed.

Myself, I believe it is preferrerd for a kid to have good outcomes AND believe they are prepared for the future, versus believing, FALSELY, that they are diseased and are dependent on meds for the rest of their life. Hey, call me crazy. I am sure some people are comforted to know they can take a pill and get relief. Me, not so much.

I don't know what the kids are thinking. But I believe this interpretation of the nature of the problem is one dimension that shows us we should generally favor talk therapy if it seems indicated whatsoever, before meds.

In this study, evidence supporting my belief: self-esteem IMPROVED for the MBSR group, where med use dropped 40%, but got slightly worse for the usual care group, where med use was the same.

---It would be interesting to see an after-the-fact analysis: noting the influence of med use upon self-esteem, across the two groups, along with the main finding of MBSR being superior to usual care, which holds status quo with meds.

Thanks for listening. This analysis of the results will probably be found nowhere else, but is probably the result that has the most potential to really suport a change in every day practice for these kids.

Thursday, November 5, 2009

75% unable for military svc: failed to graduate hs, engaged in criminal activity, or are physically or mentally unfit."

"Today (Thursday, Nov. 5) the generals and admirals of Mission: Readiness, along with US Secretary of Education, Arne Duncan, are releasing a new report that details the fact that 75% of young Americans are unable to serve their country because they have either failed to graduate high school, engaged in criminal activity, or are physically or mentally unfit."

How is that permissive, indulgent, negligent parenting working out for ya?

Add this with the Maria Shriver Report: what a pretty picture.

Obviously, we need more se x ed, more Obama songs, more self-esteem curricula, and more "bullying" curricula in our schools. In our homes, we need more food stamps:

On the other hand, if someone comes to invade us, it will be easy, but they will be so disappointed in the populace they have taken over, that they will probably just turn around and leave.

Wednesday, November 4, 2009

If docs will sell out to Coca Cola, do you think they have any problem selling out to Big Pharma? Docs discover "Coke Adds Life!"

If docs will sell out to Coca Cola, do you think they have any problem selling out to Big Pharma? American Academy of Family Physicians discovers miracle cure: “Coke adds life!!”

If docs will sell out to Coca Cola, do you think they have any problem selling out to Big Pharma? American Academy of Family Physicians discovers miracle cure: “Coke adds life!!”

You just can’t make this stuff up. October 6, 2009. This press release has apparently been out for a mnoth, but media are just now running with this story. I believe because Center for Science in the Public Interest has hammered AAFP:

AAFP: Why?

I kid you not: They declare: to diversify support beyond Big Pharma: “The Consumer Alliance program also will create a new source of funding for AAFP, which, in recent years, has broadened its search for funding outside the pharmaceutical industry.”

So, do we now believe that AAFP will no longer be beholden to Big Pharma, will no longer be shills for pills?

Do we think they will decrease their dependence upon Big Pharma?

Only time will tell.

Are they gonna say Coke is healthy? Is it as good, or better, than other family physician type stuff, such as immunizations? Will their new slogan be “Cokes, Not Pokes!” how about “Cola, Not Ebola!”

Ouch. This story is making my stomach hurt. I am getting a case of dys PEPSI a. Maybe a coke would settle my stomach.

Sadly, there is probably not a more deleterious health influence that the AAFP could have chosen. The relations between sodas consumed and poor health outcomes are robust (no pun intended). Coke is omnipresent, including in our public schools, as the child obesity epidemic swings into full force. There have been simple before / after trials of removing coke machines from schools, and corresponding U-turns in the health of the kids. There are many weight-loss success stories where a person’s first step was to cut out cokes.

Cheeto’s would have been better: at least there is nutritional content in a Cheeto.

Coke adds life! Enjoy!

Tuesday, November 3, 2009

Lilly Publishes Study on How to Measure Placebo Effect In An Antidepressant Trial.

Lilly Publishes Study on How to Measure Placebo Effect In An Antidepressant Trial.

Wow. What a cool idea! Measure the placebo effct in a depression study!

I was looking for the HamD, a very commonly used depression scale, to see what the items are. To help me evaluate a study. I did a google scholar search, and came across a study that looked like it might have the actual items.

There are many of these scales. Typically, someone gives one of the provide responses to each of the questions: for the past two weeks, have you felt sad or blue? No, not at all, a little, somewhat, a lot.

You add the score for each question and that is your total depression score. If you score lower, you are less depressed. If you score higher, you are more depressed.

so, total score depends upon the various questions. What are the questions?

So, I pull up the study. PDFs-plus-internet is awesome for these types of things!

The study I look at is:The responsiveness of the Hamilton Depression Rating Scale. Journal of Psychiatric Research, 2000, v 34, pages 3-10. Authored by: Faries, Herrera, Rayamajhi, DeBrota, Demitrack, Potter.

The study notes the HamD scores across several antidepressant studies, comparing the drug to placebo. As is well-established, there will be a placebo effect: people taking the non-active pill get less depressed across a few weeks. As do the people taking the pill.

To declare that the pill has some effect, you simply look to see if the pill group has some degree of improvement beyond the placebo response.

The study does not have the various questions. So, My desired reason for looking at this study is not fulfilled. Bummer.

What it does have is an analysis of recognized subsets of the HamD questons, and how much each subset goes along with the treatment outcome or goes along with placebo effect.

So, here is an obvious depression-study, placebo-effect detail that has never occurred to me:
As well as getting more better, it is possible that the people getting less depressed due to pills versus placebo will have a different pattern of responses across the various questions that add up to the total depression score.

So, by analyzing questions within this scale, you might be able to figure out more specifically whether improvement is due to the med, or due to some other factors.

This study does just that. They report overall result for med- versus placebo, AND subscale results for three recognized sub-groupings of HamD items: "Bech," and "Maier Phillip." [they overlap each other but difer on a couple Qs.]

BOTH subscales were superior at distinguishing between the med and the placebo group than the overall HamD scale.

The authors conclude that, for med versus placebo studies, We depression researchers may be wiser to use the scales that seem to exclude some of the placebo response.

**My mind additionally throws in another idea: We depression researchers should maybe identify and include a few MORE items that are more closely responsive to placebo than med effect.**

This would help answer the question: to what degree is depression improvement due to placebo, and what degree due to the medication?

Add a few items to the HamD, and it goes from 17 to 20 or 21. Not much additional TIME. But a world of increased knowledge.

If it exists, it can be measured. If a placebo response exists, we can use our knowledge on deperssion symptomatology, and psychometrics, and develop a emasure of placebo response. To some degree, this study does just that. It is sub-optimal because the data were not specifically developed to do just that; it is more like: proof-of-concept.

to what extent has our observed improvement been seen with the questions that have been shown to be LESS responsive to placebo effects, in contrast to the items that have been shown to be MORE responsive to placebo effects?

Now, keep in mind: ALL questions measure depression. None alone is perfect. That is why you use several.

If it exists, it can be measured. But it will be measured imperfectly, since no measure is perfect.
It seems intuitive that some meds will have MORE of an antidepressant effect than others. If a med has more antidepressant effect compared to a med with less, you would see a greater response on that subset of questions. you could calculate the ratio between the "core," or less-placebo-influenced items, and the more-placebo-influenced items. A better antidepressant would be one with a greater ratio.

And yet another great idea occurs to me: you could look at this placebo-influece-subscale, and measure the degree that your specific study evoked a placebo, versus a med-based antidepressant effect, if you knew what a typical, desireable, med-based effet was: for example, if typical strong-antidepressant effect on a subscale is a change of 6 points in six weeks, and you get a good outcome OVERALL on the full HamD, and you do get a change of 6 points in your current study, then you know that your study had a normal amount of placebo influence. But if you get a good outcome, but a low response on the "core" subscale, then you know that, somehow, your study has a good amount of placebo effect built into it.

How? Could be any of many ways: very supportive, friendly, optimistic research assistants, clinicians wearing lab coats and ties versus wearing birkestocks and Hawai'ian shirts, Professional appeal of the med packaging, a prestigious institution, who knows.
With all of the drug studies we see, is this ever reported? discussed? No.

Why not? This has not occurred to anyone else? No one else read this 2000 study?

I know who IS aware of this study: Eli Lilly. Cuz 4 of the authors were Lilly employees.