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No one can snatch my sheep out of my hand

My sheep listen to my voice; I know them, and they follow me. I give them eternal life, and they shall never perish; no one can snatch them out of my hand. John 10:27-28

Multi Pronged Pharmaceutical Company Marketing Can Make Evidenced Based Medicine a Joke

The above quote was taken from a talk by Ben Goldacre at the TED conference.

Of course, readers of this blog know that misleading pharmaceutical company marketing strategies and techniques are a recurring theme here. Deep sixing studies that show that their products don't work very well is just the tip of the proverbial iceberg.

One of the more impressive attributes of their marketing strategies is how multi-faceted they are. They target both physicians and the public at every possible turn, and affect every step of the process of generating the accepted “evidence base” for medical treatment in the minds of anyone potentially involved.

In a new article in the European Journal of Clinical Investigation, authors Emmanuel Stamatakis, Richard Weiler, and John P.A. Loannidis point out that just one drug, Lipitor, brought in $130 billion dollars in 14 years - an amount higher than the 2010 gross domestic product of 129 different countries.

They go on to enumerate many of the misleading marketing strategies, and describe the obvious biases that results from them. I will briefly review them here.

1.   Evidence production:

a.     Pharma designs and controls a large portion of the most influential studies.

b.    Industry-sponsored trials are more likely to compare their drug against an inactive or “straw man” comparator.

c.    They almost never compare their drugs to a variety of different possible interventions – including mere life style changes. I would add that when it comes to child psychiatry, they never compare their results to that of Supernanny-style family therapy. (Come to think of it, neither do most of the purveyors of various psychotherapy treatment paradigms).

d.   Their studies often guide the content of subsequent clinical research.

e.    Their studies are more likely to state favorable results and slyly avoid “inconvenient” findings.

f.     They raise the status of studies that they have actually writen up themselves by attaching the names of well-known academically-affiliated investigators (ghost writing) who are then paid off.

2.   Evidence synthesis

a.      Systematic reviews that they sponsor review prior studies that had asked the wrong questions to begin with.

b.     They limit access to the raw data on which their studies are based.

c.      With meta-analysis, or combining statistics from many previous studies, 100% of industry sponsored meta-analyses recommended using their drug, compared to 0% (you heard right) of independent meta-analyses, even though the actual statistics presented in both cases were quite similar. Conflicts of interest are generally not reported in meta-analyses (not that anyone would pay attention if the were).

3.   Understating risks of drugs

a.      Recent withdrawals of previously FDA-approved drugs seem to indicate that manufacturers intentionally distort the presentation of clinical trial safety data.

b.     Companies carefully train their sales representatives to tactfully avoid physician questions about the safety of their products.

4.   Cost-effectiveness evaluation

a.      Studies funded by industry are more than twice as likely to show good cost-effectiveness of their drug than independently financed studies.

b.     This is accomplished through the use of subtly biased assumptions about the intervention and its comparators.

5.   Clinical practice guidelines

     Because many of the authors of treatment guidelines produced by various medical specialty and subspecialty groups have a financial conflict of interest because they are paid by drug companies via consultancies, research support, or stock ownership, these guideline are often heavily focus on new, costly interventions and only loosely follow all of the available evidence.

6.   Healthcare professional education

a.     Gifts to medical students, which lately have been banned by many medical schools, were routinely given for decades. These are often given during “academic” presentations that are sponsored by industry and which are given by influential medical school professors.

b.   Industry-sponsored continuing medical education (CME) for practicing physicians accounted of approximately half of all CME as recently as 2010.

c.    The doctors who present CME usually use slides provided by the drug companies that manufacture the drugs prominently featured during the presentation.  Pharma also pays the presenters hefty fees.

7.    Direct influence on docs

a.    Drug sales representatives frequently visit doctors’ offices to “share” information with both the doctors and their staffs.

b.   Regular interactions with sales reps increases the chances that a company’s drug will be added to a hospital drug formulary (their list of preferred medications) by over 300%.

8.   Direct of consumer advertising

    Industry spending on TV and media adds increased from $11 billion dollars to $30 billion dollars per year over the period of 1996-2005.

Need they say more?

Do we have to Fully Recover from Depression Before we Can Get Back out There

Depression is a debilitating illness, and it is normal for someone suffering from depression to withdraw from life, doing little more than hiding and waiting. This is especially true during depression’s darkest phase.

This is what I wrote while in that phase:

What is this storm that rages within me?
Why won’t it abate, why won’t it subside?
It comes in like a storm, and devours me.
And it won’t go away. It’s near four months now.
Four months of doing nothing, just hiding, hiding, and waiting.

In my previous post I spoke about the foundation for my recovery that had been laid during those dark months. This included going onto anti-depressant medication to dull the pain, counselling from a Christian counsellor to help me to face and find the correct perspectives regarding the deep fears and traumas in my life. Many other things also played their role, such as physical exercise, pursuing hobbies and interests, and so on.

In July ’90, after eight months of despair and hopeless, I read “Self Help for Your Nerves” by Dr Claire Weeks. Everything changed after that, as hope returned to my life, I finally understood what was wrong with me, how I had gotten into such a state, and had a strategy for recovery.

In October ‘90 I went to see my counsellor again. Since reading “Self Help for Your Nerves” three months earlier, many of depression’s symptoms had gone, while most if not all others had reduced in severity and duration.

I was not better, though, not by a long shot – that would take another four years. At this stage I still felt uncomfortable or slightly disturbed most of the time, I was still suffering from fatigue to the extent that I needed a 45 minute rest every day when I got home from work, I still struggled with anxiety, had occasional panic attacks and heart palpitations, and felt pretty gross when I woke in the mornings.

However, in seeing how much I had improved compared to what I had been like earlier in the year, and noticing that a spring had returned to my step, my counsellor told me that her impression of me was that I was hiding behind Jesus like a small child hides behind his father’s legs, watching the world but too cautious or scared to get out there and experience it.

She told me that although I was still suffering from plenty of depression’s symptoms, she said that I was better enough to stop getting counselling and to get back out there.

Had she said this earlier, I would have been terrified, but as she gave me this advice, I knew she was right. I felt the Lord confirming that it was time for me to stop hiding and waiting and get back into life.

It took four more years for me to recover from depression, but I spent those four years living an almost normal life. I accepted the remaining symptoms of depression as being part of my life, and was content to let them be there like background music to my day, and got on with living.

After that final meeting with my counsellor I joined a new home fellowship group and became the group’s pianist. I joined all the social activities this group ran such as jazz and badminton nights – all things I could not have done even a few months previously. A few months later I started teaching Sunday school again. I asked if I could be a helper, but the organiser laughed (he had more confidence in me than I did) and put me in charge of an entire class, a responsibility I was able to handle with ease.

Everyone recovers from depression at their own rate, there is no formula. But it is encouraging to know that we do not have to wait until we have completely recovered before we can get back out there and enjoy life again.

And the good news is that we do not have to do this by our own strength. Jesus is there, ready to help and empower us with His divine strength.

I can do everything through him who gives me strength. Philippians 4:13

I love the way the Amplified Bible says this:

I have strength for all things in Christ Who empowers me [I am ready for anything and equal to anything through Him Who infuses inner strength into me; I am self-sufficient in Christ's sufficiency]. Philippians 4:13 (AMP)

“Remain in me, and I will remain in you. No branch can bear fruit by itself; it must remain in the vine. Neither can you bear fruit unless you remain in me. I am the vine; you are the branches. If a man remains in me and I in him, he will bear much fruit; apart from me you can do nothing.” John 15:4-5

But he [Jesus] said to me, "My grace is sufficient for you, for my power is made perfect in weakness." Therefore I will boast all the more gladly about my weaknesses, so that Christ's power may rest on me. That is why, for Christ's sake, I delight in weaknesses, in insults, in hardships, in persecutions, in difficulties. For when I am weak, then I am strong. 2 Corinthians 12:9-10

Can I Claim a Second Birthday

My birthday was a few days ago. I'm a year older! Hooray! However, today, Halloween, is a different kind of birthday for me.

On October 31st, 2009, I became a writer. Some of you know this about me. I've talked about it a few times. Before 10/31/2009, I'd pretty much never written creatively, apart from assignments in literature courses in high school and college. I didn't write for fun. I'd never journaled or written poetry. I never considered myself an overly creative person.

But quite suddenly, two years ago, I decided to write a book. The idea had been churning in my mind for a little while, both the idea of writing a book and the idea for the story I wanted to tell. I was intrigued by the challenge of writing a novel. And on 10/31/2009, I started doing it.

It was the most all-consuming, startling experience I've ever had. I didn't do it for NaNoWriMo or anything, but by the end of November 2009, I had completed a 98k-word novel.

I was as surprised as everyone else who knew me. My parents were frankly stunned. My husband was entirely perplexed. My friends were quizzically amused. It was so out of character for me.

That's how it all started for me. At first, I was pretty much convinced it was a one-time thing, but the passion for it only grew. I couldn't rid my system of it, and every other part of me--and my life--has been trying to adjust ever since. Now we're two years down the road, and although I supposed my drive to write could die, it doesn't show any signs of doing so. I'm a writer now. It's part of who I am.

Do YOU have a writing birthday, or a moment to which you can connect your "birth" as a writer? Or has your journey been one of gradual evolution rather than a Big Bang?

*note: I'm without power AGAIN, thanks to the freakish October snow storm, and may not be back this week, since they're saying we won't have light or HEAT until 11/3. I'll try to get around to blogs to comment as best I can!*

Can a 700 year old Chinese medicine help treat depression and anxiety

According to this, yes, it can. A recent study cited here points to the efficacy of Kami-shoyo-san in treating depression in rats. And another study (.pdf) linked to here claims this drug and another traditional Chinese medicine, Hange-koboku-to, can help treat panic, anticipatory anxiety, and agoraphobia. According to the first link:

Kami-shoyo-san consists of 10 medicinal herbs, including chai hu (柴胡, Radix Bulpleuri), bai shao (白芍, Radix Paeoniae), dang gui (當歸, Radix Angelicae Sinensis), and gan cao (甘草, Radix Glycyrrhizae), bo he (薄荷, Mentha haplocalyx), fu ling (茯苓, Poria cocos), mou dan pi (牡丹皮, Paeonia suffruticosa), 槴子 (Gardenia jasminoides), and ginger (Zingiber officinale). In Taiwan, its concentrated form was the most popular herbal drug for depression and anxiety and alike disorders. It is also a popular herbal drug to treat insomnia in Japan.

The formula first appeared in Song Dynasty (between 960 and 1279 AD.) in a TCM classic He Ji Ju (太平惠民和劑局). It was said to relieve muscular pain, dizziness, uneasiness, hot flashes, extreme sweating, insomnia, decreasing appetite and abnormal menstrual symptoms. In modern times, it has been used to treat many neuropsychiatric disorders, as well as liver diseases.

Literature shows that the formula has been shown to relieve panic attacks, anticipatory anxiety and agoraphobia. It has been used to treat irregularity of menstruation and anxiety involved with a menstrual cycle.

When used as an adjunct to carbamazepine (carbamazepine is an anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy and bipolar disorder. It is also used to treat schizophrenia and trigeminal neuralgia) in patients with bipolar disorders, the Kamo-shoyo-san combo treatment resulted in significantly greater clinical response rate in depressed patients. Kamo-shoy-san has proved to provide additive beneficial effects in bipolar patients, particularly for those in the depressive phase.

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Starting or stopping anti depressant use can be an unpleasant experience

To many with panic, anxiety, and/or depression, SSRIs are a gift -- a ticket to contentment, to an ease of mind that makes life liveable again. But anti-depressant use can be unpleasant, especially as you're beginning or stopping usage, as one recent article discusses:

Difficulties can develop at any time in the course of antidepressant therapy, but they seem to cluster at the beginning and the end.

Although it usually takes weeks for a therapeutic response, many adverse reactions—nausea, headache, somnolence, and agitation—appear soon after the first dose.

On the other hand, when some of the most widely used agents are discontinued, multiple symptoms across diverse bodily systems are common.

Early and late difficulties may be understood in terms of antidepressant neurobiology, said Dr. Pierre Blier, professor of psychiatry at the University of Ottawa.

“When serotonin reuptake inhibitors [SRIs] are initiated, there's an immediate surge in the neurotransmitter throughout the brain,” Dr. Blier said.

“It appears to be accentuated in certain regions [such as those that regulate nausea], while in areas involved in depression, like the hippocampus and frontal cortex, the surge of serotonin goes down because of negative feedback actions.”

Specifically, autoreceptors on serotonin neurons are activated by elevated levels of the neurotransmitter, inhibiting its release. Over time—the weeks before an effective response—these receptors become desensitized, allowing serotonin to rise in a consistent manner.

Discontinuation phenomena probably involve multiple neurotransmission systems that must adapt to reduced serotonin, Dr. Blier said.

I can speak to the unpleasantness of starting and stopping SSRIs from personal experience. While I've never experienced the heightened anxiety that some report when starting a new SSRI, I've definitely gone through the frustration, discussed in the article, of waiting for an SSRI to start working ("It's like purgatory," as I told my psychiatrist). And when coming off Paxil last year, I was in a constant dizzy-zombie state, punctuated by occasional moments of feeling like there was an electrical storm passing through my brain. (Apparently, this is called "the zaps," and I'm not the only one to have experienced 'em.)

Overall, though, in my experience the good of SSRIs far outweighs the bad; I'm very happy to have the opportunity to use SSRIs as part of my efforts to manage my panic, anxiety, and depression.

Plausibility Check Can a loved one trigger a flashback

Here's another question from Rachael at Writers' Chasm:

My male MC has a mother with PTSD. [Describes traumatic situation, after which mother believes son is dead for a brief period of time] She refuses to get help for her PTSD and never leaves home. She also has a panic attack whenever she sees her son because he reminds her of the terror of that day. Is this realistic? 

Rachael's character would probably be experiencing a flashback when something reminds her of the trauma, and flashbacks vary in their severity. During some, people re-experience the trauma to the point of temporarily losing their connection with reality. During others, it's just a momentary jolt at a reminder of the trauma (commonly called a "trigger"). It sounds like this character is having a pretty severe flashback if she's having panic symptoms.

In this case, the woman's son, someone she's lived with for a long time, is reminding her of the trauma. So the question is: Could someone's own loved one trigger a flashback?

Well ...

Yes.

With some caveats.

First, I'm not talking about whether a loved one's behavior could trigger a flashback. That DEFINITELY happens. For example, I've worked with women who had been battered by their boyfriends or spouses. Usually the reason they come to me is because their son or daughter is aggressive or defiant. And in the cases where the mother has been traumatized, sometimes the child's aggressive behavior toward her triggers a flashback (which, of course, leads to a less-than-effective parenting response to the aggression).

But that's not what I'm talking about here. In this case, just the loved one's presence is causing the flashback. And here's how it could happen for this character: She sees her son, and she re-experiences the horror of thinking he was dead and all the images/memories associated with that period of time. Now, just seeing him could then set off a feeling of relief, like "Oh, thank god, you're here and you're not dead." And that would help her calm down. BUT, if her thoughts spun in another direction: "If you died, I wouldn't survive, I couldn't go on, it would be so terrible, oh no oh no oh no ..." then it's a whole different ballgame.

It's all in the thoughts.

If you read Wednesday's post, you saw me say that treatment for PTSD involves helping the person reframe her thoughts to avoid that kind of panic. But also, treatment involves exposure to the memories of the event until the person is able to tolerate them.

And here's where a loved one as a trauma-trigger gets tricky. IF she was exposed to her son's presence every day, she'd be more likely to get over the trauma. That's because just being around him would trigger the memories, and if she remained in his presence for awhile, her distress would probably wane. BUT if she avoided him diligently, then that habituation (i.e., a reduction in her distress as she got used to his presence) wouldn't happen as quickly, if at all.

So--yes, a loved one could be a trigger for a traumatic reaction. But at the same time, just being around someone a lot would likely help recovery (from that particular trigger, at least). And again, if the thoughts are negative or maladaptive (e.g., "this is so terrible" as opposed to "thank god it wasn't worse"), then the trauma reaction will be stronger and more persistent.

If any of you have questions about mental disorders or the plausibility of psychological symptoms or reactions, please feel free to email me at strangestsituation (at) comcast (dot) net.

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