Friday, November 21, 2008

"Middle-aged women drive rise in U.S. suicides." SSRI Rx?

The headline:

"Middle-aged women drive rise in U.S. suicides; Overall rate grew 0.7 percent between 1999 and 2005, researchers report"

Link to the story (if link gets old, just google the headline):

" "The biggest increase that we have seen between 1999 and 2005 was the increase in poisoning suicide in women — that went up by 57 percent," said Susan Baker, a professor in injury prevention with a special expertise in suicide. "

This adds a second prominent group currently with notably high suicide rates, and possibly also with notably high rates of Rx of SSRIs. gulf war vets are the one group with suicidality being well-documented, but with major media and VA researchers as yet unable to put their finger on the connection with SSRI Rx.

Vet stories:
"Soldier suicide rate may set record again" [sept 2008 story]

I would consider whether the prescription rates in these women have had a similar increase. Suicidality problems had been increasing in adolescents, then the 'black box' warnings came out for adol and ssri and sucide risk, and rx of these meds to adol decreased.

Tuesday, November 18, 2008

Conflict of Interest: Resolved? What does that mean?

I just posted on the reently published guidelines for antidepressants in the treatment of depression - carefully phrased to indicate the qualifier IF you are gonna use meds, while not bringing too much attention to the IF issue (successful, as headliens seem to indicate).

The article is: Qaseem et al. Using Second Generation Antidepressants ... Annals of Internal Medicine 2008;149:725-733.

Wondering (OK, actually, "suspecting") a conflict of interest, I looked for a COI statement. One conflict is noted: One author, Snow, has received pharmaceutical funding. Fair enough. Just let us know so we can include a grain of salt when flavoring the findings.

But that statement is followed by the curious statement:
"Any conflict of interest of the group members was declared, discussed, and resolved."


There is no such thing.

One of the challenges of science is to minimize any and all sources of bias, so as to test, as purely as possible, the specific hypothesis at hand.

There are many kinds of bias. One area of bias is "experimenter bias." Simply put: as long as an experimenter has some vested interest in an outcome, SCIENCE itself declares that, whether any bias is involved or not, that the result is to be considered suspect to some degree. The theoretical possibility of experimenter bias is enough to taint the study. That is all that is necessary to have a theoretical conflict of interest: to have any degre of care regarding the outcome. Done. Degree of nobility has nothing to do with it.

If any author has in recent history had any financial relation with any of the involved pharma companies, the taint is there.

It cannot be "resolved." It just is.

So: I have no idea what "resolved" means.

Something is fishy.

Being skeptical, as we scientists should be, I start thinking abt who has bankrolled this endeavor: it has apparently been paid for by the "American College of Physicians' operating budget."

which should seem to put the study "above" the spectre of bias or COI.

But let's think abt thia bit more.

Who bankrolls the ACP?

So, I google.
ACP publishes several journals, including Annals of Internal Medicine, that make money by selling ads for: first on their list of acceptable ads: FDA-approved prescription meds.

OK, so the journal itself, exercising its editorial control, has a vested interest in the livelihood of pharmaceutical companies.

In the words of Thurgood Marshall, "Those companies willing to pay for advertising space got it."

Lead author, Qaseem: google: OK he has been funded by Endo, a company testing SSRIs for pain. As luck would have it, this was one of the sub-topics of the article!

So, now lead author Qaseem, and the Annals itself, have COI / have a vested interest in the results but with no disclosure. Snow has "resolved" conflict, whatever that means.

Well, that's enough for me to see the spectre of conflict and bias, "resolved" or not.

"Therapy Wins: Odds Ratio 2.25." Or "Read Between The Lines."

Meds Versus Therapy for depression, and Therapy Wins!!

Well, ya gotta kind of read between the lines to come up with this result.

First: let me put a confidence interval around that odds ratio of 2.25, and explain what that odds ratio is comparing.

The article I am looking at is the newly published clinical guidelines for treating depression, brought to you by the American College of Physicians, as published in the Annals of Internal Medicine. Nov 18, 2008, v. 149, i 10, pages 725-733.

Well, not quite a guide for treating depression. Here is where the 'read between the lines' part comes in.

Without being all that clear about it, the article states, basically: to paraphrase:

"If you are gonna treat depression with pharmaceuticals at all, here is a guide to the ins and outs of which to use."

That is quite different from: "if you have a depressed patient in front of you, here is an evidence-based guideline for what you should do."

Why not the 2nd question? Isn't that what we want to know? How to treat depression?

I assume that most of us would appreciate a timely, well-done review of how to treat depression. But the article clearly states:

"Various treatment approaches can be used to manage depression, such as pharmacotherapy, psychotherapy, and cognitive behavioral therapy. However, the scope of this guideline is limited to pharmacotherapy with second-generation antidepressants (selective serotonin reuptake inhibitors [SSRIs], serotonin norepinephrine reuptake inhibitors [SNRIs], and selective serotonin norepinephrine reuptake inhibitors [SSNRIs])."

And that is the end of the issue of: how to treat depression.

No statement abt meds versus therapy, or whether combo meds-and-therapy is better, the same, or worse.

Why not?

My guess: if and when someone does a similar comprehensive review of evidence for depression treatment, the conclusion will be: if you only can do one modality, do psychotherapy. If you can do anything additionally, do a combo. If meds are the only thing available - say you are on a deserted island with only a pharmacy and no hairdresser, bartender, or minister, then do meds.

This article is startign to get some news coverage.

The headline message, the take-home message, has not been:

"meds might help, if you are the 40% of patients who are lucky to get some relief, and if you don't mind the risk of suicidality (2.25 times the odds compared to placebo, which happens to be moderately less effective than SSRI)."

The headlines have been:

"SSRIs are equally effective for depression. So, just take your pick."

No headline is gonna say: "Why bother with SSRIs?"

Although that is what I wonder, looking at a range of evidence: placebo response in SSRI trials, efficacy of psychotherapy (numbers bounce around but can be 70%, not 40%).

This article side-steps the issue of: how to treat depression. But I am afraid it will be consumed that way.

I haven't been able to read through everything really closely, but since the issue of SSRIs and suicide is incrasingly being documented [hint: google "SSRI" and "suicide"], I thought I would see what this treatment guideline has to say abt suicide.

First: the review concludes that the risk of suicide is not greater versus placebo. Given existing evidence, I am surprised to see this bold statement. I will have ta look into the strategy for making this findign go away.

BUT - the article does acknowledge that suicide atempts are greater for SSRI vs. antidepressant; odds ratio 2.25.

Curiously, though, they have an untenable confidence interval, so I know something is fishy in Denmark. The confidence interval, the "error band", around the 2.25 odds ratio is:
3.3 to 4.6.

This is either: sloppy editing, i.e., a typo, or it indicates that someone does not understand the statistics they are reporting.

If you don't understand a confidence interval, I am gonna explain by analogy:
A hurricane is approaching New Orleans. Forecasters say they project it will hit New Orleans, but they know the hurricane may stray from this path, one way or the other. So, they give the range where it might hit: from Baton Rouge to the wet of New Orleans, to Mobile which is east of New Orleans. That is the "error band" that "surrounds" the "point estimate."

The best-guess, specific point estimate is New Orleans.

Same deal. So, a point estimate of 2.25 with a best-guess range from 3.3 to 4.6 is like saying the hurricane is going to Baton Rouge, but it might hit anywhere from New Orleans to Mobile. That just doesn't make sense.

They may publish a correction fairly soon. Or, we will just have to dig into the original data to find the source of this statistic.

Either way:

Why not skip the risk of a suicidal act, and go do some talk therapy?

Well, there ya have it. Ask a stupid question, and get a stupid answer.

Here was their primary question:
"Key question 1: For adults with MDD or dysthymia, do commonly used medications for depression differ in efficacy or effectiveness in treating depressive symptoms?"

Now ya have your answer. The article is quite skillfully engineered to stick to this question while side-stepping the question of: why bother with meds at all, considering the side effects?

UPDATE: here come the headlines:
from "HealthDay" and "US News" (actually supplied by "scout news service"):
"2nd Generation Antidepressants Prove Effective."

Thursday, October 9, 2008

Therapy Wins! News Coverage Gets It Totally Wrong. Totally.

Hi! A recent Reuters news story - carried by Yahoo News and some other news sites, reports some animal-model research that truly illustrates how depression can occur from EXPERIENCES, rather than by whatever genetic "illness" model promoted by Big Pharma. Also, smashingly, this animal-model study of depression illustrates how a BEHAVIORAL, rather than a pharmaceutical treatment, can work. Finally, the authors conclude that the pathways involved do NOT notably involve the serotonin pathways that are spoken of in such reverential, hushed tones in the halls of psychiatric academe.

In other words, Big Pharma, and their paid shills, look really wrong on this one.

This is a recent study from the journal Neuron.
Daniela D. Pollak,1 Francisco J. Monje,1 Lee Zuckerman,1 Christine A. Denny,3 Michael R. Drew,1 and Eric R. Kandel. An Animal Model of a Behavioral Intervention for Depression. Neuron 2008; 60: 149-161. October 9, 2008. No PMID identifier yet.

Basically, in short, they use the learned helplessness experimental paradigm that was explicated decades ago: put animals in bad situations, such as put a mouse in a tub of water, with nowhere to swim to, so they are not able to achieve anything for all of their swimming/escape efforts, and they eventually give up swimming when palced in the water yet again.

If, subsequently, you experimentally change the situation so that some effort WOULD result in avoiding the bad situation, such as putting an unseen platform in the water, the animal still does not respond- the animal has learned that effort does not improve things, and therefore stays passive, and depressed.

In this recent study, the authors conditioned a swim respone in the mice - before the mice were ever placed in the water. They classically conditioned the mice to swim at the sound of some tone. Then, they went and kept putting mice in the water until each mouse gave up trying to swim for safety when palced in the water. At that point, the learned helplessness point, the authors THEN rang the tone.

The mice responded as conditioned - they began swimming again.

Thus, experimentally, learned helplessness AKA depression was invoked, and was treated. How? With pills? No - the depression was invoked by circumstances, and was treated by some behavioral training.

Cool! Maybe this success conditioning could work in humans! Maybe successful tehrapy has actually worked in this way, if only we reflect back on successful cases, and reframe the change as some rekindling of hope!


But all of that is not patent-able. Plus, does not fit the American Psychiatric Association / Big Pharma model that depression is an inherited, genetic "brain disorder," more specifically, one affecting the serotonin pathways.

SO: How does Reuters Health sell this news story?

The detection of the involvement of some other pathway means that maybe we can make a new drug! There must be a "natural Prozac" causing all of this, and we can make a drug to do the same!

No kidding. Gurgle "mice natural prozac" and this news story will pop up.

Quote in the news story from the lead author:
"This opens up new pathways that may profitable."

With all of the bad side effects of antidepressants, and the widespread recognition of behavioral theories including learned helplessness, why is this story not heralded as yet more strong evidence that we have a great alternative to antidepressants?

Meds vs. Therapy. Therapy wins this one hands-down. Nonetheless, the story targets in on the meds side of the issue. What a shame!
We get experimental

--I have not gotten hold of the actual study, yet. I may have more comments when I look this over. But the portrayal by the media, a large part of the "translation" from bench to bedside, is the upsetting piece.

Monday, October 6, 2008

Meds loses this one: Nemeroff resigns. Oct 06.

This link to the NYT story looks like it won't work.

Well, Google "nemeroff" and another key word, such as "grassley" or "emory" or "new york times." You will find the line of stories.

With ample funding support from pharmaceutical companies, Nemeroff has been a greatly influential "thought leader" in psychiatry. Part of this role involved fighting the eventual emergence of the recognition of the problem [in the form of black box warnings, etc.] that SSRIs increase likelihood of suicidal thoughts, and also the eventual but less common suicidal actions resulting from these thoughts.

He has also been strongly working on the vagal nerve stimulator as a treatment for depression. Hopefully, that effort will be slowed without his weight behind it. If it is as good as the meds he has been pushing for years, we are all in for a treat with this cute little implant.

While it is emerging that many of these leading psychiatrists were not more than hucksters, and that the meds often don't actually deliver what the ads and the reps say they will deliver, at least there still is good ol' talk therapy to treat depression. Now, if only the American Psychological Association could figure out a way to let the American public understand that psychotherapy treats depression, we might be able to comfortably wave goodbye to the rest of these pill shills.

Wednesday, October 1, 2008

Long-term Therapy Wins for Complex Cases (i.e., borderline etc.)

Wow. JAMA just published a stunning meta-analysis article evaluating the efficacy of long-term psychodynamic psychotherapy. This is gonna get blogged a lot. I was eager to peek at it, and post a note abt it.

Pubmed does not have this sited yet. Here is the ref:

Leichsenring F, Rabung S. Effectiveness of Long-term Psychodynamic Psychotherapy: A Meta-analysis. JAMA 2008; 300 (13): 1551-1565. October 1, 2008.

Long-term psychodynamic psychotherapy seems to have a good effect for patients with this mixed bag of difficult psychological problems. Problems include chronic depression, bipolar disorder, and others.

Especially to the credit of the authors is the section in which they assess the degree that results may have been biased by non-publication of any unknown studies which hypothetically could have, and reasonably would be expected to have, negative results. That is a long sentence, so I will say it another way: the authors reviewed all avalable decently conducted studies; they obviously can only review those published; there could be unpublished studies that failed to get published because they demonstrated no significant beneficial effect for long-term psychodynamic psychotherapy. The authors conducted some processes to add this unknown factor into their conclusions.

This is a conservative, cautious, judicious move. And commendable.

The conclusion, after that adjustment, or reinterpretation for hypothetical non-significant results that might be out there somewhere, in the "file drawer" of some researcher who could not or chose not to get it published, still remained.

I am gonna have to read the article more carefully than the one minute I spent looking this over.

But the bottom-line looks like: meds vs. therapy, and therapy has won this one. Long-term psychodynamic psychotherapy resaerch too often does not have the data to support this type of evaluation. It is commendable for the authors to pull all of this together.

Why all the big deal about this problem of hypothetical missing unpublished studies?

Well, on the other side of the meds vs. therapy issue, many of the unpublished studies CAN be discovered and included. When they ARE included, as was done last year, it greatly influences the result to show that antidepressants have a very modest effect for treating depression (and that is being generous to say 'modest').

Here is one main reference:
Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008 Feb;5(2):e45. PMID: 18303940.

You just won't see this "file drawer" problem addressed in studies from Big Pharma. You won't see CME on this topic. It is likely rare that physician researchers are taught the issue and methods for addressing the file drawer problem. In my training, I was, which helps me appreciate the problem. And to understand how it is one of the ways that Pharma can lie with statistics.

Meds Vs. Therapy. Meds won this one. Good night.

Friday, September 26, 2008

Hypertension: Get Meds or Get Moving?

In August, a “HealthDay News” headline reported that “exercise reduces blood pressure…but too few doctors recommend it to their patients.”

I recently got hold of the article:
Halm J, Amoako E. Physical activity recommendation for hypertension management: does healthcare provider advice make a difference? Ethnicity and Disease, 2008 Summer;18(3):278-82. PMID: 18785439.

The researchers drew upon a big, longitudinal health survey to examine specific aspects of hypertension: for patients with hypertension, what portion reported that their physician had urged them to exercise to treat hypertension.

Only a third of these hypertensive patients reported that their physician had urged them to exercise.

A sad finding. Despite evidence that physical exercise lowers blood pressure, and has a range of other “side effects” that are basically good, such as warding off depression, reducing risk of cancer, lowering bad cholesterol, etc., physicians in the U.S. are not advising hypertension patients to exercise.

Why not? Could it be because the recommendations don’t work? Well, according to further questions, that is not the case. Actually, it seems that, for hypertension patients who reported that their physician did recommend exercise, about 70% reported that they were following the recommendation! A much higher rate of regular exercise compared to those who reported receipt of no such advice.

Well, did the advice-giving work? As well as this data set can indicate, the exercisers had great results: average 3-4 blood pressure points lower (in mmHg): average systolic of 126 versus 129.

Now, this type of study has a host of limits. It is possible that hypertensive patients did receive advice, but did not remember it – totally conceivable: it makes more sense that if you as a patient are receptive and ready to act on advice, you will later remember getting that advice. It is also possible that a healthy user effect is operating: those who are willing to figure out anything to do to improve health may ask for advice, and thus actually get advice. Similarly, if a physician judges that a patient is more likely to act on advice, the physician may be more likely to give the advice.

We don’t know. The nature of this data set does not eliminate these alternatives. But, a host of similar research does support the same story: patients do act upon physician advice, and accordingly do achieve decreases in blood pressure, but physicians often do not ask about exercise or give good advice about exercise.

Why? My suspicion is that Big Pharma, and other forces, are creating the belief that hypertension is a medical disorder that needs to be treated with a real treatment – meaning meds. And if the meds don’t work, try more, or try a different med.

Rarely do you hear of a physician doing the full-court press for their patient to begin and maintain a regular aerobic exercise habit. Sad. Despite benefits from hypertensive meds, including proven efficacy in reducing blood pressure, and also reducing the more important outcomes such as stroke and kidney disease, blood pressure meds have host of annoying side effects. Structured instruments for these side effects range from inquiring about 10 or a dozen recognized side effects (nothing to sneeze at) up to 70 or a few more side effects.

And what kind of "CME" are physicians receiving? Well, it is recognized that Big Pharma is a major provider of CME. And yes, you can give enough blood pressure meds to get blood pressure into the normal range. But at what cost? Who is out there in the physician offices advocating for Asics along with or instead of ACE inhibitors?

All the while, the side effects of exercise are, what, blisters? Decrease in quality of life because you have to do more laundry?

Anyway: the article is a nice read: it reviews the problem of hypertension and presents decent detail on the study data (NHANES). Finally, it is yet another piece of data indicating that too many physicians may not be encouraging an effective treatment for a very treacherous disease.

An update: Reuters has just put this out as a headline story:

Monday, September 22, 2008

Meds Vs. Therapy: Drinking Water Safety

AP news story from September 11, 2008:
"46 million in U.S. have drugs in drinking water.”
“Testing shows traces of meds in water greater than previously reported."

Here is a link:

If the link has expired, just enter the headline above to find the story.

Basically, we are filling prescriptions for medications to such an extent that these meds are showing up in drinking water supplies.

A quote:
"Many cities found the anti-convulsant carbamazepine. Officials in one of those communities, Colorado Springs, say they detected five pharmaceuticals in all, including a tranquilizer and a hormone."

Meds will end up in the water supply. There are legitimate situations for many meds. But also, we have gone greatly overboard with meds – taking meds for a great range of problems and situations where there are, simply put, better alternatives, and also, simply put, situations where the meds just don’t have the “benefits” to justify the “costs.” The degree that any unnecessary meds are contaminating our water is unknown, but – per this story and others – may be a serious problem. This contamination is yet another negative on the side of medications in the cases where therapy is a viable treatment. As I have said in at least one other posting, meds for psychiatric reasons are overprescribed. Meds are also overprescribed for other conditions, but I am just more expert in psychiatric treatment efficacy.

To the degree that carbamazapine, AKA CBZ, is being prescribed for seizures, then that is a clear situation of: meds wins. But CBZ is prescribed for psychiatric disorders as well. If prescribed appropriately, then meds wins again, and the challenge is just to figure out whether the CBZ in the water supply poses any threat to the rest of us, and how to deal with it. But to the extent the CBZ is inappropriately prescribed, that is a downside potentially affecting anyone drinking the water, thus a negative influence far beyond the usual circle of patient, physician, and payer.

Tranquilizers: generally, in my opinion, therapy almost always wins. Technically, the term “tranquilizer” almost always refers just to the “benzodiazepines,” such as Valium and Klonopin. In my opinion, therapy wins this one hands-down: the tranquilizers in any water supply are generally posing an unknown risk with benefits that can be conveyed by therapy. Tranquilizers may also include other “sedative / hypnotics” such as Benadryl and other antihistamines, as well as a range of other soporifics / somnalytics / whatever term-you-like-for-sleeping-pill. There are many.

Therapy wins for sleep, and therapy wins for antianxiety. So, all of those “tranquilizer” meds contaminating the water, at unknown risk, pose a largely avoidable risk.

“Hormone:” my guess is that this is related to birth control pills. The use of estrogen/progesterone type meds (“HRT”) for menopausal symptoms decreased greatly once everyone figured out that, in contrast to the belief that they had the side effect of protecting users from heart disease, they actually are associated with increased risk of heart disease. So, although HRT had been about the most widely prescribed and taken med for the span of several years, the past 6 years has seen that level of use decrease. [BTW: recent headline about menopausal symptoms where therapy beats meds:
"Yoga soothes worst symptoms of menopause"]

So, my guess is that the “hormone” related to birth control pills (widely prescribed, but potentially may be greatly affected if I am correct in my suspicion that they generally cause blood clots despite various specific drugs and doses and dosing schedules).

This AP story also notes that traces of antidepressants can be detected in some water supplies. Again, in my opinion, a great deal of this is not beneficial, so the unknown risk posed is generally unnecessary.

What to do?
Well, obviously, the threats to health needs to be determined. This includes determining the level at which some med in the water can cause problems. This is obvious, but vey challenging to figure out scientifically.

Also, water authorities need to figure out what might be in the water, and test for these. Unlike other water contaminants, this may not be a “local” challenge:

Finally, maybe we just need to start ending our dependence upon meds, like we are talking about ending our dependence on foreign oil. Like the foreign-oil issue, there are just too many workable alternatives.

Wednesday, September 10, 2008

Back pain tx: Great work if ya can get it.

Expenditures increase while improvement is, well, have you looked at the stock market lately?

Expenditures and health status among adults with back and neck problems. Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, SullivanSD. JAMA. 2008 Feb 13;299(6):656-64.

Well, I was looking into another topic, and came across this January JAMA article.

Martin and colleagues use some wide-ranging hospital data to calculate expenses for back pain. Along with this, the cool thing is they are able to look at the benefits of this treatment.
The data set was: the Medical Expenditures Panel Survey. Or, MEPS.

MEPS is carried out year after year. A big federal attempt to describe where you and I spend our health care dollar, and for what problem or symptom. Questions are asked about problems and symptoms, and the researchers also try to figure out what you paid to treat the problem. This is a big study, folks, with many people looking over the shoulder of the design and implementation, as well as sample sizes well beyond 10,000. So, this is no "Dewey Beats Truman" poll. (Although it could be in the future, depending upon how they transition to cell phone recruitment).

Now, either you are a current back pain patient, or you are a "pre-consumer." Either way: ask yourself: for my current or future back pain, as I spend money on my care, what do I want for my dollar? what are the outcomes I am concerned about?

This is what the researchers evaluated. This JAMA-published MEPS study compares results from 1997 to 2005 -- almost a decade.

Here are the outcomes. "Physical functioning:" Can you rake the yard? Load the dishwasher? Reach the top shelf? "Work:" are you able to get back to the same job you had before back pain treatment? "School:" Are you able to get back to scholastic pursuits, if any, that were interrupted by the back pain?

The answer:
Costs (as proper, dollars adjusted for inflation) increased per patient from $4700 in 1997 to $6100 in 2005.
Outcomes: the same. These people spent more to arrive at the same outcome.

Because this is an amazing finding, and because ink is cheap on the internet, let me repeat:
These people spent more to arrive at the same outcome.

So, if practicing back pain treatment, and a patient asks about empirical evidence for outcomes, what do you tell them? "I will carry out the recognized interventions, but chances are that you will not get better"?

To be honest, that seems to be the answer.

This is consistent with an extensive body of knowledge that has indicated that: results for back pain treatment, notably medication and surgery, are not great; and a decent, satisfactory body of evidence indicating that physical therapy and almost-mandatory emphases on activity do achieve results, but the pills and surgery lead to both worse outcomes, and to the sad result of a patient who sees the answer solely in terms of the right pill or the right surgery.

Some day soon I will put together a handful of info for this blog on the lousy outcomes for traditional, recognized, reimbursed back pain interventions, and also share some of the evidence showing the unorthodox but encouraging evidence for appropriate physical therapy, including where this concept parallels Pilates and yoga, and also for the benefits of more psychological-type interventions like social involvement and psychotherapy.

Speaking of pain and orthodoxy, there has even been a small but decent emphasis on evaluating yoga intervention for carpal tunnel syndrome.

Meds Vs Therapy for back pain. Therapy continues to lead on this one.
Frankly, having resolved my own lower back pain, at no expense, and hearing similar successes of others, plus having done training rotations in "pain/aneasthisiology," (and binging on the free lunches as the new meds and devices emerged), and having read a bunch on the topic, including Block specifically but Cochrane as well, this topic just seems ready to declare: stick-a-fork-in-me.

Social Phobia: Pill or Hypoxia?

Social Phobia: Pill or Hypoxia?

Meds Vs. therapy, and it looks like therapy is gonna win this one!

Hypoxia means low oxygen. The mental health world has known, for a long time, that the detection of low oxygen, or even the fear of low oxygen, can start a panic attack. People with panic attacks “know” part of this problem all-too-well, but have to be convinced, by various means, of the other part of this problem: when, for whatever reason, the oxygen that you are breathing gets a bit low, it “triggers” a panic attack. If you start to get scared in some situation, and your body has a typical fear reaction including your chest tightening up AND your heart beating faster, the amount of “air” or oxygen getting in your body will be reduced. It is the same as if you were holding your breathe for a few moments. The feeling is light-headedness, as if you were spinning around a couple times, or dipping your head between your legs then raising back up a couple times, or breathing through a narrow soda straw, like a coffee stirrer.

The mental health world has also known, for a long time, that learning to handle this problem can drastically reduce panic attacks.

SIDEBAR: If you have panic attacks, get a self-help book on the topic, or find a decent therapist who acknowledges this established treatment, or check the youtube videos on panic attack, and get help! You have a strong possibility of greatly reducing panic attacks with modest, little or no professional cost or help, as long as you can grasp hold of the basics and train yourself accordingly, or get this done with the guidance of someone who knows the established science of this, and is skilled in helping you gain some control over panic attacks. And this includes the use of pills ONLY as a reassuring security-blanket backup plan, such as when traveling/flying. Now back to my blog.

A recent study published in the Journal of Psychiatric Research indicates that, along with people suffering from panic attacks, people suffering from social anxiety, but who do NOT have panic attacks, may also be sensitive to reduced oxygen.

The unhelpful thoughts and the body response that is part of social phobia may be triggered by low oxygen in the body.

So, you are about to do a job interview, or attend a work party, or give a public talk. The fearful thoughts - what if this, what if that - make your body tense up - this includes your muscles generally, including chest muscles. You all-of-a-sudden are breathing shallow, and your heart is going a little faster. After a few moments, your brain detects low oxygen. From this, your social phobia symptoms are on a roll. Off on their own, out of your control.

What is new is that the researchers in this new study have discovered that low oxygen in the body is part of this. Social phobia, and the problematic behaviors that follow from it, are not just from the off-base, unproductive thoughts, but also, somehow, low oxygen is part of this.

That’s good news! That is like discovering that Wellbutrin, supposedly effective for depression, might also help people quit smoking!

This suggests that a new avenue of treatment is available for social phobia!!!! And it totally already exists!! It just needs to be borrowed from panic attack treatment!!!!

Or, you could go to your physician, and they can start prescribing pills. Which pills? Antidepressants and or “anxiolytics,” also known as ant-anxiety drugs. Anxiolytics include “valium,” Klonopin, and other similar pills - that have side effects including dependence, withdrawal, and being unable to “operate heavy machinery” such as a job interview, public speaking, work holiday party, or an automobile.

Also, some pills that are primarily used for blood pressure -such as propanolol - will work, and do not have the addictive-type side effects except, possibly, eventually leading you to believe you cannot perform in certain situations without a pill, and the slight increase in risk of fainting from lowered blood pressure.

So, how do you treat this sensitivity to low oxygen? Low “air?” Well, it translates directly from what I said above, about the dizziness and feeling short-of-breath.

One: therapists, or self-help books, will train people to breathe deeply. This is why they always tell ya to breathe deeply.

Two: therapists, or self-help books, will train people to practice coping with slightly low oxygen so you can feel it, but not have it lead to a bunch of calamitous, disastrous thoughts in your head - those thoughts that crowd out what you really want to have in your head - like answering questions, keeping your balance, not dropping food on yourself in a social setting, etc.

The self-help books and the therapists can help anyone learn this, with fancy techniques such as: put your head between your knees, then raise it, then repeat, but keep breathing deeply, and keep telling yourself reassuring thoughts. Or breathe through a coffee stirrer (after managing to breathe through a soda straw). Etc.

There are lots of ways to conquer social phobia. All of this knowledge is widely known and widely available. The reason I am glad to see this study is because it holds the promise of even more strategies for treating social phobia -- these recognized therapies for panic attacks may also benefit people with social phobia but no panic attacks. That is cool.

At the same time, it is worth mentioning because, as this knowledge marches forward, the pharmaceutical companies are marching forward with the idea that pills will solve social phobia.

On the web, the power of cognitive/behavioral therapy, as I have alluded to, is widely recognized. However, some sources delve into the pharmaceutical aspect, such as this site:
It is bothersome that, rather than some in-depth discussion of the types of maladaptive thoughts addressed by cognitive therapy, or the many possibilities for behavioral, cognitive, and social-skill exercises to deal with social phobia, the discussion is centered on the various antidepressants and how one might be different from another.

The erroneous belief that various psychotherapeutic interventions are not “therapy” but are some other kind of help (I don’t know what kind, but my recent Phelps/ADHD post indicates that one term is “tips”) pops up on some websites:
The NIMH website shows this view:

“Stress management techniques and meditation can help people with anxiety disorders calm themselves and may enhance the effects of therapy.”

Uh, what? --Stress management and meditation is therapy, not something that might “help” or “enhance” therapy.

So, to wrap this little discussion up, it is cool to see some decent, organized study investigating social phobia, since it affects so many people. It is cool to see that, if sensitivity to being out-of-breath is part of social phobia as it is for panic attacks, then the treatments for panic attacks might also work for social phobia. Non-pill treatments. In the future, we may see meds vs. therapy for social phobia, and therapy will win this one.

Friday, September 5, 2008

That '65 Mustang in the garage. Parenting. Things I will get around to one day.

Computer working again. Plenty of topics to blog abt right now, but I jacked up my computer and it took me a while to get it running again - I need to have a backup computer.

For a great, recent story: Gurgle this headline to find the AP news story:
"Help-wanted ad for nanny: `My kids are a pain'"

As soon as I see the headline, I know what is coming. The kid is gonna have one of these diagnoses that get given to kids who are not adequately parented.

If you haven't read the story yet, basically, the mom in a busy family posts an ad for a nanny, NY style. Let's cut the crap, yes I am hard to work for deal with it, etc.

And, in the ad, there it is: if you don't believe in Ritalin for kids, don't apply.

I do not know these people. I just have this image in my head. I can see it now. Mom is busy with her social group, and Dad is keeping the rent paid with his business. No one has time to parent. So, hire a nanny.

Sure enough, the kid is gonna fail to please. Neglect your children and they will get your attention one way or another. So, the kid is restless at school, or whatever. So, you take the kid to the head-shrinker, and within 30 minutes, you have your ADHD diagnosis. Now, you can blame any unsatisfactory behavior, performance, mood etc. on the ADHD, not your lack of involvement in your kid's life.

It just bugs me. I see it a lot.

A kid is not like that project car you have in the garage, under the tarp, that you are gonna restore one day. The kid is not and old Mustang. I understand the desire to have good intentions but never get around to some project. I have an old, classic Austrian road bike (Austro-Daimler) waiting to be restored. I will get to it one day.

But kids are different. They require parenting. They are not a hobby, or some project. when you don't parent them the right way, you will end up with trouble. The worst is that there are docs are ready to help you pin the blame on the kid.

Diagnostically, you need to rule out social confounders before diagnosing ADHD. In the research on ADHD (not to mention any names, Dr. Biederman), I never see this assessment as part of the diagnostic process for defining a study group of kids with ADHD. They report that they merely conducted the eval per DSM, then randomized the kids or whatever step was next. In the real world, we all hear of docs providing the ADHD (or bipolar or whatever) dx after only assessing for 30 minutes.

That is not right. Kids are suffering from this disservice in research and in clinical practice.

Wednesday, August 20, 2008

Michael Phelps: Mom gives "tips" for ADHD

A nice story in the popular press. Good Housekeeping has an interview with Michael Phelp’s mom, Deborah Phelps. The focus of the story is on her experience raising a son with ADHD, and her subsequent involvement with (yet another phony citizen’s advocacy group that is merely another front for Big Pharma’a multiprong marketing efforts) “ADHD Moms.”

The story (as long as the link stays active):

Mom’s group:

The man behind the curtain:

The man behind the man behind the curtain:

Well, the story is truly nice. This single mom really took care of her son, despite his high activity level. And no dad in the picture.

The story gets her views on treatment of ADHD. Plus some tips.

But in the article is evidence of our culture’s misguided beliefs regarding treatment of mental disorders: When asked about “treatment,” Ms. Phelps acknowledges the role of Ritalin. Then, secondly, when asked for “tips” on how a parent can cope with ADHD, Ms. Phelps has a handful of hard-won wisdom: “Make a task list….I posted a task list on the refrigerator and gave him stickers when he completed his responsibilities.”

“The pool itself helped, too. ADHD children need parameters.”

“Treatment.” “Tips.” Get it?

Meds Vs. Therapy. Therapy lost this one: demoted to “tip” status.

Where did Ms. Phelps come up with the idea of a behavioral chart with stickers as rewards and recognition? In therapy, we call that “treatment.” Straight out of the handbook on treatment for kids. Sticker chart. Treatment.

But in the common view, the view that Big Pharma wants you to believe, the pill is the treatment, and the behavioral strategies are “tips.” Like: to avoid lint when cleaning windows, use newspapers instead of paper towels. To keep your guacamole from turning brown, squeeze lemon on it. Use ammonia to clean your diamond. Those are tips. Clever ideas, take ‘em or leave ‘em.

The truth is that children need to have rules and expectations. ADHD interferes with this. Pills help. But no pill will get your child to complete chores.

Kids, especially boys, need to burn off energy. And it is better if it is in some kind of activity with rules and parameters, rather than just running the streets or running mom ragged around the house. A pill will never make a kid take the trash out on trash day, or make a kid complete a homework assignment. Or stay in his chair through a whole class period. For someone with ADHD, it will help. It will get a kid in the range for performing the behavior, like a footstool can help Michael’s mom reach for something on the highest pantry shelf. But the footstool won’t get the can or whatever down for you.

Is this a big deal? What’s the big diff? Well, I think it is a big diff. If the doc says to take the meds: it will cure your kid’s ADHD problem, well, you are gonna be sorely disappointed. Cuz the kid is still gonna fail to have follow-through or stick-to-it-iveness or respect or to stay in his chair. The meds can get the kid in range, then you need some more “treatment” to achieve these goals.

But when this component of treatment is never mentioned, or is labeled as a “tip,” versus “treatment,” what degree of adherence do you think you are gonna get?

Well, rant off. What would be nice to hear in the future is: Ms. Phelps: how did you learn all of these behavioral strategies? How did you find the therapist or counselor who guided you to develop your first sticker chart? Did you believe in the chart idea at first? How long before you saw it work its magic? How many target behaviors did you have on it at each time? This is what the single moms raising kids with ADHD really need to hear.

Monday, August 18, 2008

If Meds Don’t Work…Add Another!

I was browsing the new TIME magazine when a bizarre advertisement caught my attention.

This is for Abilify, an antipsychotic from Bristol-Myers Squibb.

Here is the deal: if you are taking an antidepressant, and you still have “unresolved symptoms,” the physician should add Abilify.

Am I missing something here?

If your antidepressants aren’t working, maybe you should start talking to your physician about how to find a decent therapist. As in: talk therapy is an effective treatment for depression. “Behavioral Activation” is also a decent intervention: getting off the duff and getting active. Exercise is an effective intervention for depression. Any of these, with or without an antidepressant, will help improve things.

What people are increasingly figuring out is that the pills just really do not work. Not like we are lead to believe” You have this biological illness called depression. It is caused by some imbalance (or deficit) of serotonin. If you take these pills, the serotonin levels will be restored, and you will no longer be depressed.”

Right. If I had a dollar for every time A psychiatrist played out this tired story, I would be as rich as…as a pharmaceutical company.

So, apparently Bristol-Myers Squibb comes up with a great idea – antidepressants never work that well – so let’s figure out a drug to augment.

To figure out a bit more info, I found the website equivalent of the print ad:

Sure, if it helps some people, I guess that is what we want: less depression. But sad to see the reinforcement of pills as the answer, especially pills as the answer when pills don’t work. Is some pharmaceutical company out there currently studying a third category of pill for augmenting the antidepressant/antipsychotic combo if that leaves you with “unresolved” symptoms?

It doesn’t make sense. The ad, and much of this physician-directed and pharmaceutical-directed message fails to ever suggest: Try therapy when the meds fail ya.

Even scarier – the side effects of Abilify must be wicked. The disclaimers and cautions are very prominent on this ad. Seizures, anxiety, and more. Especially a shockingly clear statement about meds being associated with increased suicide risk, paired up with explicit direction to talk to the doc if you start thinking about hitting the gaspipe. All this, plus, very clear warnings that this pill is off-limits to the youngsters. Quite a scary ad, really.

Now consider the side effects of talk therapy: Increased confidence. Greater insight. Increased interpersonal effectiveness.

Take your pick: meds versus therapy.

Wednesday, August 13, 2008

Meddy-Go-Round: multiple 'trials' of meds cuz they ain't workin

I hate to hear people tell me stories of being lead by some physician to get on psychiatric meds for some behavioral or emotional problem, when the problem truly ought to be addressed with therapy. There are a lot of conditions and problems out there, in my opinion, where therapy should be first line of treatment. Largely due to efficacy, and due to the lack of bad side effects, and the range of good side effects of decent therapy.

But, for a couple reasons, getting started on pills is preferred over doing the good, hard work of therapy. Some other time, I will blog about the three main reasons why, tragically, we end up on pills instead of in the therapist’s office. MedsVsTherapy, and too often, meds wins.

So, what happens when you get put, inappropriately on meds?

Well, you have just jumped on the Meddy-Go-Round. You probably will not enjoy the ride. However, like some merry-go-rounds, this is difficult to get off.

The term “meddy-go-round” popped into my head one day, as I was thinking about this common problem. It seems to fit the problem really well. I remember the days when I was a wee lad. Binghamton, New York was the home of the merry-go-round. As a kid, my family would travel over to this happy land of shoe factories and merry-go-rounds, and spend some time visiting my grandparents. The coolest thing was when we kids could get loose of the adults and head down to a nearby park, where it seems they were always running a classic merry-go-round. We would just wait for the next turn, get on, and ride. When it was done, get on another bejeweled horse, and you are riding again. Over and over.

When you go to the doc’s office for some problem: a kid is noncompliant, you are depressed, you can’t sleep, you have stage fright, whatever – well, the old saying about the hammer and the nail applies. So, the doc provides an answer for you, and writes out the prescription. Maybe you are unsure, but you give it a try.

Well, maybe the meds work for a while. Maybe they don’t work at all. Or maybe the side effects are so bothersome that you would rather go back to your familiar problem. But no. when you go to the doc, you hear one of three things: raise the dose, switch to another med, or “augment” with another med. You have now jumped on for your second go-round on the meddy-go-round.

When this new regimen of pills fails to solve your problems, you go back to the doc. The doc asks: how is your depression? Still glum? Well, let’s try another. You start to wonder, “when are we gonna start talking about my problems?” But the doc is firmly in control, socially speaking. You are on the doc’s meddy-go-round.

And so it goes. The next trip on the meddy-go-round. The doc has you try another prescription. Or raises the dose. Or augments.

Tragically, as this goes on, you get into believing that your problem will be solved by pills, because surely the doc would not keep trying you on one prescription after another unless the doc was really sure. You buy into this idea that multiple trips on the meddy-go-round are necessary to find the right pill, or right combination of pills. Maybe. But, maybe not. However, how often do people hear the 'maybe not' from their doc?

Here is a variation in the trips upon the meddy-go-round. Antidepressants are commonly prescribed for depressive type problems, and a range of other things. Well, the problem here is that for many people, the antidepressants actually do have an effect for a brief, shining moment. The mood lifts. The world again has color. You have found a solution.

But then, it happens: the magic wears off. After about five months, the pills no longer work. Maybe four months. Maybe six. But that fleeting period of normalcy really convinces you that pills are the solution. So, you get on the meddy-go-round for yet another trip.

This happens, in my opinion, because the antideprssants, the SSRIs, do have an effect on your mind, as do other drugs including alcohol. And, like other drugs including alcohol, at first your brain, and body, are naïve to the effects of the SSRI. They have their impact.

But with time, the body adjusts – the body does not like foreign substances upsetting the balance. So, the brain recalibrates itself back, as close as it can, to normalcy in the face of this foreign, upsetting substance. You get tolerance. Just like with alcohol.

No one ever talks about this phenomenon. It is simply noted, and dismissed with the comment that it was close, but not quite the correct pills. Onto the next bottle of pills. The next trip on the meddy-go-round.

Tragically, the change in the brain as it compensates to the influence of this foreign substance causes withdrawal problems in some people when they go to quit the pills. There is a lot of talk on the web now about the difficulties getting off of SSRIs. Especially Paxil, but others also. This is just evidence that, like alcohol, your brain has adjusted itself to get back to normal in the context of constant foreign substance.

Ask yourself: how much BETTER are you on the meds? Are you where you hoped to be when you sought treatment? Like so many people, are you still having your same problems AND taking meds? Does that make sense? Think about it, and start searching the web. Start reading up on non-pharmacological treatments for what ails ya. Maybe you will be able to finally get off the meddy-go-round. You will catch a lot of difficulty from the physician, but it might just be a good move.

Sure, this short-term response is good for getting someone out of a depression. Often, therapists note how it is great for getting someone into the range of functioning where they can get engaged in decent therapy. And, pills work for some people. But all too often, they simply don’t but somehow you get caught on this meddy-go-round, trip after trip.

Same thing for kids and behavior problems. Well, these pills did not make junior start to complete his homework and start to talk to me in a decent tone. So, let’s try some other pills. Folks, let’s get real. There is no pill that makes a kid talk to you respectfully, stop listening to angst-ridden music, stop stealing your smokes, and start completing homework. No pills will achieve that. Maybe it is time to think about getting off the meddy-go-round.

Friday, August 8, 2008


I wrote that other blog, Meducation, and spontaneously came up with that term Meducation. I posted my blog. Then, I went to see if anyone else had applied the label "Meducation" to the Big Pharma role in CME education. I found a zillion web entries for "meducation."

Darn! I really wanted to coin a term today.

I don't think anyone has used the term "pharmeducation" to refer to Pharma-developed or sponsored CME. It is kind of hard to tell how the term was used in one manic post [google "whypsychopsdrugsemfcontrolbad" and give me your opinion).

However, "meducation" has occurred as a clever neologism to many, for many explicative and expository demands.

So, I devoted a couple more brain cells to the effort, and came up with "pharmeducation."

When googled, this basically led me to: someone's email (to mr. pharmeducation: sorry for all the dumb emails you may now receive), and to an online pharmacy site that seems to either be very slow to load, or very slow to load malware onto my computer. No thanks, online drug store: I have great health insurance and docs who will provide me with any samples I need (worthy of another post one day).

So, I am claiming to be the innovator of the term "pharmeducation" as a euphemism for Physician Continuing Medical Education that is tainted by conflict of interst from Big Pharma.

Darn. I still kinda like "meducation."

Meducation: Could CME exist without Big Pharma?

Recently, I had to get some continuing education hours to meet my CEUs (continuing education requirements) for psychologist license renewal. I have a “membership” with Medscape, an organization that reports medical news, features, content, and provides continuing medical education (CME) content for physicians. Since the content areas of psychology and psychiatry overlap, and since free CEU are better than dollar CEUs, I thought I would check out Medscape’s “free” CME offerings in the area of psychiatry.

So, I log in to Medscape. I click on the CME button. I click on the choice for “Psychiatry.” I select the option for CME articles published in the recent 12 months.

After a moment, a long list pops up.

I start to browse for a couple topics to round out my CEU hours.

I notice a pattern. See if you notice a pattern to the curricula offerings:

“Effectiveness of Second Generation Antipsychotics: A Systematic Review of Randomized Trials.”

“New Data in the Recognition and Management of Bipolar Disorder.”

“Augmentation Strategies in Treatment-Resistant Depression.”

“Improving Remission in Depression: Focus on Augmentation Strategies.”

“Improving Mental Health Outcomes: Focus on Atypical Antipsychotics.”

“Optimizing Management of Bipolar Disorder in Children.”

Patterns of Pharmacotherapy and Treatment Response in Elderly Adults with Bipolar Disorder.”

“Improving Remission in the Treatment of Major Depressive Disorder: Assessing the Augmentation of Traditional Antidepressants with Atypical Antipsychotics.”

“Pediatric ADHD: Guidelines for Initiating and Monitoring Treatment.”



In all, across approximately 125 CME course in psychiatry posted to Medscape in the past year, it really looks like the “atypical antipsychotics are good for everything” message is coming through loud and clear in about 75% of the articles offered.

From reading on this topic lately, I knew that Big Pharma was really pushing atypical antipsychotics, and their puppet spokesmen psychiatrists were promoting expansion of the borders of whom to diagnose and/or treat. But a peek into some of these articles shows a very consistent, coordinated campaign.

The term “obvious” comes to mind when thinking of Chik Fila’s EAT MOR CHIKN campaign. The Big Pharma campaign to get everyone diagnosed and hooked up to the antipsychotics is a bit more subtle, but equally consistent, sustained, and coordinated. Multi-pronged: radio, billboard, television, print, etc.


What if the obesity CME was sponsored by Chik Fil A, and breaded, fried chicken sandwiches were recommended as the nucleus of recommended diet for just about every diet-related condition? Wouldn’t we begin to wonder if we were being “sold” a bit strongly? What if your physician was recommending fried chicken sandwiches as a remedy for your obesity, or cholesterol, or hypertension, as he or she wrote out a prescription, with a Chik Fil A pen, for you to eat one Chik Fil A sandwich per day?


This brought home the issue that some other psych med bloggers have been noting: Big Pharma uses Key Thought Leaders (Big Pharma-sponsored psychiatrists) and Continuing Medical Education as marketing tools.

Because of FDA rules, Big Pharma cannot even hint that a med ought to be prescribed for some application, such as depression augmentation, unless the med has been FDA-approved for that application. However, Big Pharma can: 1. sponsor a particular physician’s research and 2. sponsor continuing medical education.

Did you catch that? That is how Big Pharma sponsors off-label use of their products while not violating, but side-stepping, federal law. Well, this is no revelation. Many people have noted this.

It just struck me as I went to get my CEUs. I just was struck by the extent to which Big Pharma has grown to control CME as I hunted for a couple free CEU hours for myself. Well, I guess it is true that you get what you pay for. I clicked away from Medscape and went and found some psychologist-intended CEUs.

There are, currently, many related controversies and emerging issues regarding the role of Big Pharma and COI. One debate is framed this way: Can the continuing medical education system survive without Big Pharma sponsorship?


Folks, here is the source. Of the money made by providing CME, over half is from Big Pharma providers. If you analyze the situation in different ways to get at the portion of CME “sponsored” by Big Pharma, you realize that closer to 90% of CME is supported by Big Pharma, an entity with a clear stake in the game.

The extent, and the tradition of the Big Pharma-sponsored lunch, is so entrenched in the medical system that some people actually wonder if we could still hold the requirement that practicing physicians ought to continue to receive education following licensure.

So, debate is everywhere. However, from my point of view as a licensed psychologist, and from the point of view of all of the other clinical professions where CME (or CEU or whatever it might be called) is required, we just cannot figure out what the issue is.

We all pay for CME that is, generally, free of Big Pharma, and, generally, we all make less than medical doctors. We don’t see any problem whatsoever. Do we like it? Well, generally, people are hesitant to part with their money. Do we manage? Yes.

Of course, you won’t get lunch with your CME.

But seriously: name a profession, outside of “licensed physician,” where the salary levels are so consistently upper middle class that anyone would even think to say that they could not AFFORD CME unless it was provided for free. Who?

Name professions where we DO pay for CME (and lunch is generally not provided). Psychologists. Licensed clinical social workers. Licensed marriage and family counselors. Licensed chemical dependency counselors. Licensed professional counselors. Licensed physical therapists. Licensed occupational therapists. Licensed massage therapist. Licensed Speech/Language Pathologist.

Doc, all of us can manage to scrape up the dollars required for a few CME credits per year. I think that question is now answered.

Tuesday, August 5, 2008

Consumer Reports Sept 08: Meds versus Machine

September 2008 Consumer Reports finds those sound machines are a great alternative to sleep medication.

Big Pharma has been making plenty of money by pushing pills for sleep. Partly this is because we (in general) have gotten into the habit of thinking that we need to run to the physician every time we have some problem. People describe this as the “medicalization” of problems. Take a problem, figure out how it could be a medical problem. Define it that way for others. Provide the medical-style solution (typically pills or surgery). Problem Solved.

So, we all start believing that a problem like insomnia is somehow fundamentally the same as cystic fibrosis. Give it a diagnosis. Give it a diagnosis code. Allow a physician to be “reimbursed” for providing “diagnosis” and “treatment.”

People, let’s get real. If you have sleep problems, you know you have sleep problems. You don’t need a “diagnosis.” Does it make you feel better if a physician tells you that you can’t sleep?”
So, you come home and tell your family:
“Oh, now I know what my problem is. The doctor said I have insomnia 780.52.”
“What is 780.52.”
“It’s the number for my medical condition. It also coincidentally is the cost of getting diagnosed and starting treatment. Thank goodness I have that nice, fat health insurance package.”

[Now, we are all starting to see how we spend so much and get so little for our health care dollar.]

So, Consumer Reports decides to ask a group of everyday people about sleep problems. Things don’t look so good for Big Pharma, because unlike academic researchers, the universities, psychiatrists, other physicians, medical organizations, advocacy organizations, the prominent peer-reviewed journals who accept advertising, the FDA, and other entities, Consumer Reports cannot be “supported” through loads of cash. No conflict of interest.

For those who don’t know, Consumer Reports is the main publication from Consumer’s Union, a magazine-subscription-supported group who evaluate everyday products and services that everyday people are concerned with. Such as sleeping pills, since many of us have problems with sleep. To stay independent, when they test something, they usually go out and buy their own. If they test five different models of toasters, they just send staff out to the store and buy these. Then they run the toasters through tests to see how well the toasters perform. Their criteria are usually the things we everyday people are concerned about: does it burn the toast? Is an inexpensive model as good as an expensive model?

Increasingly, Consumer Reports has branched out from evaluating toasters and lawn mowers. They have gotten more into health care. I think this is awesome.

In April, they conducted a phone interview of almost 1,500 everyday adults in the U.S. to ask about sleep problems, and what people do to address sleep problems, and how well that attempt worked. One weakness of the Consumer Reports strategy is that I can’t readily find details, so I cannot evaluate various potential limits and biases of this study.

Nonetheless, they found that 20% of us are taking these sleeping pills, prescription or OTC, at least once a week to sleep better.

Wow. One in five of us.

The U.S. has 300 million people. One-fourth are under 18. That leaves a guesstimate of 225 million adults. Let’s say the survey failed to be representative of half of that, and that none of that half of us take sleeping pills. That leaves 20% of 110 million people. So, conservatively, well over 20 million people each week are taking at least one pill for sleep. Now, some of them are only paying a nickel for a Benadryl. But some are paying a lot more – for prescription pills. So, there is a lot of money to be made from 20 million or more people per week. A million dollar industry? It sounds like a million dollars-per-week industry.

But, seriously, folks. We know why we can’t sleep. We watch TV too late. We don’t take time to calm down and relax. We are over-committed. We don’t manage our time well. We drink something with caffeine too late in the day. We get allured into surfing the internet, or talking on the phone, too late into the night. We never get active enough in the daytime to be tired enough to really fall asleep at night. We worry a lot – we worry about money problems, job problems, aches and pains, the leaky roof, the noise in our car, about someone breaking into our home, etc.

“Therapy” for sleep involves assessing and addressing these various problems. Look at that list. You are probably on there. Therapy for sleep is obviously going to be individualized, not one-size-fits-all. For me to address my worries, I will need a different conversation to help me discover these, and address these, than you will need for your worries.

[Oh, excuse me – let’s just re-label the worries as “racing thoughts,” and diagnose ourselves with the bipolar 296.80. Then we can simply be cured with Zyprexa.]

You might need to switch to decaf. Or find a non-caffeinated tea. Sure, it will not be as satisfying, but it is the trade-off for solving the sleep problem. Oh, excuse me – I meant to say “curing” your “insomnia 780.52.”

Any of these methods will take work and effort. The pill companies are gonna try to convince you that it is all much easier – just take a pill and you are done.

The advertisements are sooo peaceful!

You might be able to get it covered by your insurance, since you have a legitimate medical disorder: “insomnia 780.52.”

What worked for the people surveyed by Consumer Reports?
For those using prescription medication, 75% said the pills worked “most nights.”
Listen to this: what was in second place?

A sound machine. 70% said this worked “most nights.”

What else worked? OTC meds (57%), making the sleep schedule more routine (50%), and also practicing “muscle relaxation (40%).”

So, why not go with the pill? It is the clear winner. Meds versus therapy, and meds won.

Well, what are the trade-offs?

This problem is so big, I can’t begin to get through it all at once. Sleep-driving. Drug dependence. Rebound insomnia. Tolerance. Oh, don’t worry about these – as Big Pharma says- only use these pills OCCASIONALLY. In other words, people, you are still left with the problem.

The problems with sleep pills rose to a level that the FDA broadcast a special warning last year about them:

The Consumer Reports survey said that for people using pills, half were using strong pills not meant for sleep but meant for other problems: Xanax (anxiety), Darvocet (pain), Neurontin (seizures). Wow. Fifty percent paying big bucks and facing big side effects.

Not to mention the fact that with the pill, you are moving one more step down the path to believing that all of our problems are actually “medical disorders” that need to be treated by a physician, and by a pill or surgery. You are losing the belief that you can use your own abilities, and help from others, to figure out your own problems and solve them. To determine when some are and some are not medical problems.

Insomnia due to some thyroid problem = medical problem. Insomnia because you are wondering if checks are gonna bounce = you need financial therapy. See the difference?

Your physician may or may not. What we do know is that your physician does not have time to diagnose the root cause of your insomnia, and is probably not very good at providing counseling to help you manage your money, and ALSO we know the physician was just visited by his or her best friend, the drug rep. The drug rep just provided a free-lunch talk on the epidemiology, diagnosis, treatment, and third-party reimbursement of insomnia 780.52. Plus, the drug rep left some samples. Mmmm.

Now – how easy is it for the physician to provide you a solution? They just hand you a sample and send you on your way. Oh, and the side-effects issue? Well, uh, that’s up to the pharmacist. Besides, you weren’t gonna use alcohol at the same time, anyway, right?

If you live in a dangerous neighborhood, and can’t sleep because you worry about someone breaking in, the pills will not make the bad guys stay away!! Have you made your home relatively safe? Yes or no. If not, do it, to the best you can. Once it is reasonably safe, then “rest-assured.” We can never be safe. But you can do only what you can do. How safe is it to be intoxicated into somnolence when that burglar or rapist does break in?

So, in Consumer Reports, meds barely squeaked out a victory over behavioral strategies. There is a great body of literature, more “scientific” – ruling out more alternative hypotheses, etc. – defining behavioral interventions as the first choice for most sleep problems. And these are very effective. Plus, with GOOD side effects versus BAD side effects. For example, if you learn Jacobian progressive muscle relaxation (Gurgle that to learn more) to help you sleep, you can then use it to help you with test anxiety, stage fright, etc.

Tuesday, July 22, 2008

ADHD treatment: Placebo versus….placebo?

JAMA just published a study of St. John’s wort for ADHD. Pubmed18544723.

This made a lot of headlines. For example,
“Herbal Remedy No Better Than Placebo in Treating ADHD” [Psychiatric News]
“St. John's Wort No Help for ADHD” [TIME magazine]
“ATTENTION-DEFICIT HYPERACTIVITY DISORDER: St. John's wort may not affect symptoms” [Washington Post]

I spotted this article as I was looking at the recent publishing activities of Dr. Joseph Biederman, who has been investigated lately for either poor memory, or not really knowing how to fill out forms for his employer, Harvard.

This poor performance in filling out forms has drawn the attention of a senate investigating committee, and press in the New York Times, and none-too-soon. We can’t have Harvard researchers out there failing to properly fill out routine forms. It has been quite noble of Dr. Biederman to acknowledge that there were some problems filling out forms, and note that this should all be straightened out tout-suite. His employer has been supportive.

I can understand all of this. Dr. Biederman publishes well over ten peer-reviewed articles per year, and has maintained this steady rate for over a decade. Much of this has focused on ADHD, AKA “hyperactivity” and ADD.

It seems that some people have suspected that an herbal remedy, St. John’s wort, may be useful in treating ADHD. So, Dr. Biederman being a leading authority in ADHD diagnosis and treatment, along with his colleagues, ought to evaluate whether this herbal remedy actually does provide some relief.

Not to mentioned Dr. Biederman’s other interest in ADHD: he profits greatly from his involvement with the pharmaceutical companies who sell the FDA-approved drugs for ADHD. Specifically, ALZA corporation makes Concerta, a sustained-release Ritalin that is under patent for a few more years. ALZA supports Dr. Biederman, per the disclosures at the end of this article on St. John’s wort and ADHD.

OK – segue back to the article: Well, I had not heard of St. John’s wort as a possible treatment for ADHD. So I decided to look at this article.

A bunch of kids were screened for ADHD – not difficult to find nowadays since everyone has ADHD – you just need to exclude the kids that also have bipolar and autism. Then, randomized to receive either “treatment” or “placebo.” “Treatment” was hypericum, a component of St. John’s wort that is believed to be the active ingredient, or at least one of the active ingredients, in St. John’s wort.

So, the kids receive ADHD measurements at “baseline,” then every couple of weeks up to eight weeks. Ideally, if the herb has some effect, average ADHD scores will be lower for the hypericum group compared to the placebo group.

Well, Dr. Biederman, your financial status is safe. Hypericum did no better than placebo. Actually, the placebo group did a bit better than the hypericum group. The herbalists will not be replacing the pharmacists anytime soon.

OK, so I am done looking at the picture that tells me the main result, and I am on to the Discussion. Almost done gathering this bit of knowledge.

Wait. What is that in the discussion?

I have to quote this directly. This literary passage is too good to not share.

“Hyperforin is a very unstable constituent that quickly oxidizes and then becomes inactive, which is likely what happened to the product used in this clinical trial.”


Haven’t I heard that before?

Oh, yes: in the definition of “placebo.” A placebo is an inactive formulation, per Wikipedia and as per the rest of the knowledgeable world.

So, JAMA publishes a study that declares that St. John’s wort is not effective for ADHD, but the active arm of the randomized study received a formulation that was inactive, just as the inactive arm did?

What would the result be if the study was repeated with hypericum which had not gone stale?

We don’t know. The hypothesis is still totally untested.

However, the drug reps that are out there for ALZA are now able to declare, when it is worth mentioning, that “St. John’s wort was not any better than placebo, in a recent JAMA study.”

I am gonna wrap up this part with a couple comments: I believe there is such a thing as ADHD. I belive it exists at a much lower prevalence that Dr. Biederman might believe. But I believe it exists. I also believe that there are medications that can be helpful. I also believe that any child who has ADHD will need top-notch parenting, and will need skilled teachers. ADHD may make a kid distractible, leading to poor school performance, etc. A pill can help some of this. But a kid with ADHD still needs to learn all of the things that any other kid has to learn. To follow through. To figure out how to understand and complete assignments. To cooperate with others. Et cetera. ADHD interferes with the acquisition of these qualities. These learned qualities cannot be delivered by pill. They can only be delivered by people and the right circumstances. Usually, family and school teachers. School teachers get training and experience dealing with this sort of thing. But any given parent does not have some special place to learn how to be a top-notch parent for a kid with a demanding challenge. Whether an herb or some other pill works, it will be the social dimensions of response that will help get the kids with ADHD ready for the real world. The parents will need some training - perhaps from a therapist.

OK: You can return to your regular web-browsing.

If you want to read a bit further, I am gonna throw in a couple more thoughts and observations.

Would it have been that much more difficult to recruit another 60 kids, and run it all again with ACTIVE ingredient?

At least the authors note that the hypericum can easily become inactive. It gets stale, basically. Moisture from the air leads to processes that result in the breakdown of this molecule. They get credit for noting this. Nonetheless, it is sad that a leading medical journal chose to run this story as is. That means that the peer reviewers were OK with this (or that some editor over-rode the objections of peer reviewers).

Another acknowledged weakness is the sample size. Each group had 27 participants. Considering the heterogeneity of ADHD, the variability in ADHD scores generally, and the use of multiple tests (two subscales of RDS and two of CBCL = 4 tests), this study probably was under-powered. If you don’t understand all of that, don’t worry. Bottom line is they probably did not include enough study subjects to detect a clinically significant effect for St. John’s wort if, hypothetically, it actually works (which would apparently require using fresh, not stale, St. John’s wort).

One odd thing I noticed that was not acknowledged was the odd pattern of results on CBCL. The Child Behavior Checklist is a checklist of a bunch of problem behaviors that kids might perform. This is a widely recognized instrument for measuring child behavior, and a decent general measure of ADHD problems, although it is not specific to ADHD.

While the study may have been underpowered to have a real-world meaningful difference also show up as a statistically meaningful difference, the pattern of results on the CBCL show that the placebo worked better than the St. John’s wort. How could that be?

The CBCL scores are “standard scores:” a score is translated into a standard scale that is more easily interpreted and understood: this is the same as saying that the Farenheit scale can be translated in to a standard scale of Celcius, with freezing at zero and boiling at 100. It is just more interpretable. For the CBCL, the standard deviation is 15. The placebo group had their scores, on average, drop about 15 points, or one standard deviation, on both the “internalizing” and the “externalizing” scales of the CBCL, while the scores of the St. John’s wort group dropped only 4 points on each of these two parts of the CBCL.

Why would the placebo group have a consistently decent, even admirable, therapeutic response to placebo, but the herb group does not? The herb group should be benefitting from any placebo effect to about the same degree as the placebo group. The placebo group scores on the ADHD symptom scale also followed this pattern, with the placebo group experiencing lower scores, thus more improvement, than the herb group, although the actual differences are probably far from being at clinically meaningful difference.

Frankly, that pattern makes it plausible that something else was going on.

Here is my guess: as the authors note, the kids were randomized, but the randomization did not succeed, as it typically does, in spreading various factors out equally between the two groups. The authors go no further. However, my eye gets caught on the assignment of gender: for the placebo group, half were males, while for the herb group, three-fourths were males. So, maybe females happened to have more response just to the burst of clinical attention compared to guys. Or maybe females have more sensitivity to hypericum, possibly through some sex-based difference in metabolism. The authors note that they controlled for sex statistically, but this is really a difference that can only be controlled by a greater sample size: first, the study certainly was not powered to determine if my pet hypothesis is supported: that the treatment, whether placebo or herb, had a greater effect on females than males, and second, with a greater sample size, the assignment would increasingly get closer to an even match of boys and girls in each of the two groups.

Again, as I have said already: JAMA published this? The leading medical journal?

Hmmm. Pharmedout reports that a third of JAMA pages are advertisements.

JAMA has been heavy on publishing studies noting the influence of direct-to-consumer drug advertising upon prescribing habits. Maybe it is time that JAMA evaluate the influence of drug advertising in JAMA upon editorial decision-making. Cuz a ‘conflict-of-interest’ type explanation would sure fit this pattern of results.

Saturday, July 19, 2008

License, Please. –or- What Happened to the Third Arm?

“Escitalopram and Problem-Solving Therapy for Prevention of Post-Stroke Depression.” JAMA May 2008.

OK, so I recently got around to looking over a recent JAMA study. Right up my alley. Meds versus therapy. I am so curious! Did therapy prevail? Should the health care system be directing patients to counselors, versus to the pharmacy, for yet another clinical problem?

Well, the short answer seems to be “No.”

Darn. Meds wins this one. But maybe I can call, “FOUL!” So I begin a careful reading. Especially alert for the subtle-yet-profound influence of Big Pharma.

The issue: Given that the prevalence of depressive episodes post-stroke is fairly high, can preventive / prophylactic depression intervention prevent some of this depression incidence? If so, does medication or therapy, or both, work? Better than placebo? If both medication and therapy work, which works better?

The article is Pubmed ID 18505948.

The article tells that this study recruited people who had recently had a stroke, and randomly assigned them to one of three treatment groups, each with a different, competing treatment for prevention of depression in a follow-up treatment surveillance period of one year. Some cases of depression should be expected in each group. The degree that either the medication or therapy group would have a lower portion of depressive episodes compared to the placebo group would be the degree that the intervention worked – that it prevented depression.

Well, it worked. Both meds and therapy worked. Fro the group receiving placebo, 22% had a depressive episode. That can be seen as a base rate. For the group receiving escitalopram, 9% had a depressive episode. For the group receiving therapy, 12% had a depressive episode. So, preventive depression treatment worked to prevent depression, both meds and therapy. And meds worked a bit better than therapy.

That is good news for Forest pharmaceuticals, who sell escitalopram as Lexapro, still under patent. Forest can seek the FDA to approve escitalopram for post-stroke prophylaxis of depression, thus creating a whole new market for this antidepressant – anyone who has had a stroke.

Darn. Meds beat therapy in this one. But let’s dig a little deeper.

For many reasons, it is a challenge to run a therapy study. Therapy is always individualized to some degree, despite efforts to have it be standardized. Also, with a pill, you know the specific dose received. But if a therapy client doesn’t really ‘work’ at therapy, and doesn’t happen to get as much out of therapy, then the dose can really differ. For one person, eight hours of therapy might be life-changing, while for another person, it might just be tedious. In contrast, if you give someone a pill, and they take it, you know they got one dose of the pill.

So, I looked over the training and standardization of the delivery of therapy. Pretty good. Problem-Solving Therapy may not be the most intimate, life-changing brand of psychotherapy, but it can be effective for depression. In this study, it was trained and supervised to be orthodox. Good.

One thing that is missing, however, is information on the therapists. Were they licensed? Were they graduate students? Were they master’s level? Doctoral level? Were they psychiatrists?

No info.


Well, I search and finally find some information. Not in the article. But tucked in the back between the study and the references, is a set of notes. Including a note thanking two people for administering the therapy. One of these people has a bachelor’s degree noted after their name, and the other has a master of arts degree.


180 patients receiving therapy, and some received therapy from a master’s level person, and some from a bachelor’s level person? Are you kidding me? Is there anyone out there looking to pay $100 an hour for psychotherapy from a person with a bachelor’s degree? This was funded by NIH? No info about license on either.

So, medsvstherapy, and meds won. But there is no evidence that therapy was even provided by a counselor or therapist. What if this were a physical therapy intervention, but the person doing the physical therapy was not a physical therapist? What if this was yoga versus surgery for back pain, but the yoga instructor was not a yoga instructor? What if this was a comparison of two surgery techniques, but the person performing the surgery was not a surgeon?

The person with the bachelor’s degree clearly is not in the game. There is some outside chance that they could legitimately be legit to do therapy – if they were a seasoned, trained minister, for example. But that would be some rare kind of exception. So, let’s just figure that at least one therapist is not a therapist. What about the second noted therapist, with the MA?

This could be a master’s level counseling degree, and the person could be credentialed as a master’s level counselor. Or it could be a master’s degree in some other area. The study just does not say.

So, with a few minutes, I decided to figure out if I could find evidence of licensure. Other published literature establish this person as a colleague at Iowa’s psych research shop for years, sometimes as co-author, sometimes as research assistant. Thus, the most likely jurisdiction of licensure would be Iowa.

Iowa has a listing of all licensed professional occupations here:

You can see who is licensed here:

Well, this person is not a licensed marital / family therapist. Not a Mental Health Counselor. Not a Health Service Provider in Psychology. Not a Psychologist.

It is possible that this person, who provided this therapy, was a licensed counselor of some kind. But the topic is avoided in the study, and there is no indication of licensure in Iowa, despite some hunting on the web I was able to do.

In some U of Iowa document on the web, I did find this person listed as a “Research Assistant II” for 2006 – within the time span of recruitment, 2002 – 2007. Doesn’t sound very likely that this person is a counselor or therapist.

So, meds versus therapy, but not therapy provided by an actual counselor. Were they afraid that therapy might win if it were delivered by an actual counselor?

Maybe the original proposal would say. The proposal submitted to NIH for funding. Well, I don’t have the original proposal. However, the article does have the NIH grant number, allowing the original study abstract to be pulled up on the government’s website listing all research grants: CRISP. Just google CRISP and you will find this.

So, I enter the lead author’s name, and quickly locate the study’s abstract from when it was submitted for funding. NIH R01 grant 65134. I discover the grant. And I discover a couple things that don’t quite match up with the publication.

First, the proposal reported that citalopram, not escitalopram, would be used in one arm, and problem-solving therapy in a second arm. But there was also supposed to be a third arm: a group receiving another antidepressant, nortriptyline. Commercial name Pamelor.

What happened to the nortriptyline?
What happened to the citalopram?

First: What happened to the nortriptyline?
Was the nortriptyline given, per the NIH grant? Did it win? Why would it be excluded? Hmmm.

I have a theory. A suspicion. Nortriptyline is no longer under patent, unlike escitalopram, so discovery of a new use for nortriptyline would not be a gold mine of a new clinical population. Maybe the authors chose not to report the nortriptyline arm of the study, so that escitalopram, under patent, could be promoted, without the data out there in the published realm concerning the generic?

Second: What happened to the citalopram?
It turns out that citalopram was about to go generic as this proposal was submitted to NIH. However, at the same time, the developers of citalopram were just developing a similar drug, escitalopram, to replace citalopram as a money-maker. Right around the time when this study proposal was funded. So, escitalopram being very similar to citalapram, the researchers may have switched to the newly developed, newly available drug which would be under patent for a while, thus potentially generating more revenue if the drug worked as suspected for preventing post-stroke depression.

So, after this little review, these are my thoughts:
First: problem-solving therapy conducted by therapists might have had similar or better results, compared with escitalopram, for preventing depression post-stroke.
Second: if the nortriptyline arm of the study was conducted, nortriptyline may have had a similar efficacy when compared with escitalopram, but the strategy of not reporting this would leave open the possibility of spreading the knowledge regarding the under-patent medication, not the now-generic medication. The benefit of this, for the pharmaceutical company, would be: a new market consisting of the post-stroke population in general, barring any contraindications.

Now, I am gonna consider how to follow up on this. Cuz in the battle of meds versus therapy, therapy really might have won this one, if only it had a chance.

Monday, July 14, 2008

Meds Versus Therapy: Opening Salvo

Hello. This is my first blog. So, please excuse the blog-quality while I learn.
However, I know my content. Meds versus therapy. Specifically, in mental health / psychology / counseling / psychiatry, the heavy promotion of medications when psychotherapy, and other therapeutic interventions, may be preferred. I plan to also address the topic of non-medication interventions for other health care problems when there are decent interventions to be considered, and even preferred, over medications.

I am going to review research as it emerges to illuminate how Big Pharma works the marketing campaign to get research developed, executed, shaped, and dispersed to favor increased sales, whether helpful or not. And how psychiatry in general is involved in the ride.

Many people are blogging on this and similar issues. I believe I can contribute to this emerging discussion. Someone has to. The over-promotion of medications, and the pathologizing of phenomena that should not be pathologized, has gone to such an extreme that some sort of counter is needed. So, what occurred to me is the counter: therapy, versus meds.

Sure, there are lots of problems where medications help. And where medications are needed. Are life-saving. Are the best things going, although they may not be optimal. Yes, I believe mental illnesses exist. And should be treated with pharmacotherapy when indicated.

However, Big Pharma, along with the practice of medicine in general, psychiatry in specific, and also medical research as well as other parties, have really gone too far. They have gone too far.

Time after time, medication is provided, is heavily promoted, as the answer, when the answer ought to be therapy. Talk therapy. Psychotherapy. Counseling. Personal Effctiveness Training. Personal Financial Management. Parent Effectiveness Training. Stress Management. Relaxation Skills. Problem-Solving. Assertiveness. There are currently many problems where the evidence is there to indicate that decent therapy is about equal to medication. Yet, in practice, medication is promoted as the first-line treatment, with often no mention of talk therapy as a preferred intervention, a viable alternative, etc. There are circumstances where therapy should be prescribed along with medication. But therapy is never mentioned.

Why? Well, that is what I plan to blog about. I will probably get to sound like a broken record. Heavy marketing by Big Pharma. Pharma's well-planned manipulation of physicians and the educational media to which physicians are exposed. Our society's general desire to have a pill, versus hard work, to cure our problems. The lack of the field of psychology to make psychotherapy understood the way it should be. The misguided belief by people in general and by physicians specifically that physicians are scientists, and thus know how to consume science. The role of third-party payers in health care. The influence of Big Pharma money upon psychiatric research. Shifty, sneaky, misleading research. Lies, Darn Lies, and Statistics. Did I mention Big Pharma? OK. But Big Pharma has not been able to achieve their stunning success alone. Other stakeholders have been complicit.

Well, it comes down to this: sometimes, it is simply meds versus therapy, and sometimes the evidence says therapy wins, even though in practice meds wins. To me, that doesn't sound right. So I am gonna blog about it.