Worse Than Placebo? Forest Laboratories’s Shameful Marketing


While Forest [Laboratories] applied to the FDA for pediatric use of Celexa [the anti-depressant] and was eventually denied, the company admitted it had marketed the drug to doctors by hiring speakers to tout its benefits for young patients. Forest also admitted it had suppressed the negative results of research in Europe that found Celexa was no more effective in treating depressed children and adolescents than a sugar pill. Fourteen young patients in that study attempted suicide or contemplated suicide, compared with five in the placebo group, court records show.

From this article. Is Forest Laboratories worse than other big drug companies? Probably not. What’s horrible is how this sort of thing — suppression of negative results — keeps happening. It suggests that the evaluation of drugs should be taken entirely out of the hands of drug companies.

Assorted Links

Thanks to Anne Weiss.

Morning Faces Therapy For Bipolar Disorder: A Story (Part 1: Background)

In the mid-1990s I discovered that seeing faces in the morning raised my mood the next day. If I saw faces Monday morning, I felt better on Tuesday — not Monday. This discovery and many other facts suggest that we have an internal oscillator that controls our mood — in particular, how happy we are, how eager we are to do things, and how irritable we are. For this oscillator to work properly, we must see faces in the morning and avoid faces and fluorescent light at night.

In rich countries, almost everyone gets nothing resembling the optimum input. One of the problems this may create is bipolar disorder. A week ago I posted how a friend of mine used my faces/mood discovery to control his bipolar disorder. After that post, a man I’ll call Rex wrote to me thanking me — that post had inspired him to try to control his own bipolar disorder that way. Before knowing anything about whether he would be successful, I decided it would be good to follow and record what happens. Either way — successful or not — it should be revealing.

I am going to post his story in several parts. The first few parts are background.

My first full-blown bipolar episode was at 29 years of age. (I am now 37.)

I was a civil engineer working for the government in an Eastern State. I had self-diagnosed myself as having Seasonal Affective Disorder (SAD), also known as the morning blues. The symptoms are mild to severe depression, lethargy, apathy and weight gain. A form of treatment for SAD is the light box. Mine is an Apollo GoLite Box. As soon as I read about this device, I was excited. It came via UPS. I plugged it in during my lunch break soon after it arrived. By the end of the work day my mind was in overdrive. I was a total motor mouth, with racing racing thoughts and unusual activities such as inventing things, writing songs and books for the first time. Friends knew I was totally not myself. I went without sleep for days at a time. I began drinking heavily and not going to work. My mind could not rest. Alcohol or extreme exercise were the only medicine. I stopped eating, lost about 30 pounds in 30 days. I became paranoid and shut everyone out of my life including my friends, family, and co-workers. I was buying hundreds if books and dozens of bottles of supplements. Overall I was turning into a different person with new interests.

Finally my parents stepped in because of my isolation and irresponsible behavior. This led to a three week outpatient clinic stay in Illinois. Right away I was diagnosed as Bipolar I. I was vaguely familiar with it, but was quite stunned I had it. On the other hand, it was a huge relief to have a name to this craziness I was feeling. I was put on four medications and went through extensive therapy, including talk therapy, group therapy, family talks, and letter writing. It was a wonderful experience that helped me to deal with painful past experiences. It had an excellent scheduled program with early-morning group therapy and prayer. [Note the morning exposure to faces.] This was a Christian-based psychiatric clinic. Then daily small classes on mental health issues, then one-on-one discussions with a licensed therapist and plenty of other group activities and meals on the town. Lots of love, support and scheduled work.

That was an ideal setting. After three weeks I came home. I slowly went back to those sad, frustrated days. The drugs seem to stop working. My moods began turning sad or mad, for no particular reason. [Note that this downturn happened soon after exposure to morning faces — via group therapy — stopped.] The frustrations of an unfulfilled, boring and dead-end career grew worse. Maybe the worst was a lonely life. Silence in the mornings and only late-night television before bed.

The disappointments of my life were bad, but the bipolar manifestations of the highs and lows seemed to magnify all emotions to the nth degree. My medications were replaced by the new ones, without expired patents. Perhaps I have been prescribed ten different anti-depressants overall, sometimes in combinations, but I only found relief in narcotics such as prescription xanax or klonopin.

They truly numbed the pain, but led to regrettable behavior. I took to cutting myself as a sort of punishment for the unwarranted guilt and self-absorption (for feeling depressed and angry) and to ease the pains with the endorphin releasing that was given by cutting with a razor blade. It seems insane now, but at the time it was the quickest release. These cuttings not only led to my first surgery, but led me back into a different psychiatric hospital in Vanderbilt at age 31. I had a tendon transfer surgery from my the top of my wrist to closer to my thumb, where I had severed my tendon. It was very embarrassing to my family and myself. I came clean to my employer and became eligible for FMLA (The Federal Medical Leave Act).

During these last couple of years, my manias have been much rarer and weaker. I faithfully take my medication daily. I still experience mild depression, but to a lessor extent, a more numbing feeling. I still feel sad but not the weepy, nostalgia I felt overwhelmed with previously.

To be continued.

Comment on “Morning Faces Therapy For Bipolar Disorder”

In yesterday’s post, a friend of mine with bipolar disorder told how he used my faces/mood discovery. It allowed him “to enjoy life and relate to others in ways that I never could my entire life,” he wrote. Partly because it allows him to stop taking the usual meds prescribed for bipolar disorder, which have awful side effects.

What do I think about this?

To begin with the obvious, I am very happy that something I discovered has helped someone else. Practically all science has no obvious use. (A tiny fraction is eventually helpful.) In experimental psychology, my field, I can’t think of a single finding that’s helped many people. Because of this background, managing to help someone via science seems like a fairy tale. It’s too soon to say the story has a happy ending — it isn’t over — but it is beginning to have a happy ending.

Thank heaven for blogs. Something like my faces/mood discovery is difficult to publicize, yet without accumulation of evidence it will go nowhere. It wouldn’t be easy to publish in a psychiatric or psychotherapeutic journal because I’m not a psychiatrist or psychotherapist. Even if published, the chances of interesting psychiatrists and psychotherapists are low because it doesn’t involve a treatment you can make money from (gatekeeper syndrome). It should greatly interest persons with bipolar disorder but they are not the typical readers of the scientific literature on mood disorders. However, like all sufferers, they search the Internet.

In my internal calculus, the story provides what I think of as industrial strength” evidence. Industrial-strength evidence is evidence that something works in practice, not just in the lab. In a laboratory setting, which to some extent includes me studying myself, you try to keep things constant. You want to reduce noise. Noise reduction makes signals clearer. An effect you can see easily in a lab experiment, however, may be too small to matter outside the lab, where more powerful forces push people around. Whether your lab experiment — in which you have managed to control Force X — has practical value depends on the size of Force X relative to other forces at work outside the lab. An example is the theory behind the Shangri-La Diet. Does that theory tell us anything useful about why people are fat? Does it explain the obesity epidemic, for example? I knew the theory had plenty of truth because it had led me to several new ways of losing weight and had helped me lose considerable weight and keep it off forever. But that was far from showing (a) it was the only thing that controls weight or even (b) one of the big things. Lab experiments can’t do that. It’s been claimed that obesity is due to a virus. Experiments support the idea. Yet the idea is irrelevant to everyday life, I’m sure. No one has written How to Lie With Laboratory Science but it could be written. The only way to find out if a “true” idea explains enough of reality to be useful is to use that idea in real-world situations. Which is what my friend did.

But that isn’t the biggest thing. The biggest thing, from my point of view, is that what my friend has done helps keep this idea alive. When it comes to ideas, grow or die. My friend’s story keeps the idea alive by expanding it. It gives it a new and personal dimension. It isn’t just about mood measurements, it’s about living a reasonable life. I’ve given talks about this idea, but this story makes it much easier to talk about to a general audience.

 

 

 

 

Morning Faces Therapy for Bipolar Disorder

In 1995, I discovered that seeing faces in the morning improved my mood the next day. If I saw faces Monday morning I felt better on Tuesday — but not Monday. The delay was astonishing; so was the size of the effect. The faces not only made me cheerful, they also made me eager to do things (the opposite of procrastination) and serene. This is the opposite of depression. Depressed people feel unhappy, don’t want to do anything, and are irritable. Eventually I found that the mood improvement was part of a larger effect: morning faces produced an oscillation in mood (below neutral then above neutral) that began about 6 pm on the day I saw the faces and lasted about a day. As strange as this may sound, there was plenty of supporting data — the connection between depression and insomnia, for example.

After I had observed the effect on myself hundreds of time, I urged a friend with bipolar disorder to try it. Recently he wrote me about how it has helped him.

Here is the very short story of my experience with this treatment.

I have used your treatment since 1997. As an indication of its effectiveness, from 1999 to 2003 I was completely off of medications, and now I’ve been off again since August of last year.

I was severely ill when I began the treatment. I was first hospitalized in 1985 for manic psychosis, and I was hospitalized later for suicidal thoughts and then again for psychosis. In 1997 I was 46 years old, taking Prozac, Depakote, and Moban (an anti-psychotic), and I was barely functioning.

The initial reaction, after three days of the treatment, was astonishing. It felt like a giant headache was just lifted off me. But the [new] clarity of mind enabled me to see my awful condition, and I had acute suicidal thoughts for a day or two. After that initial bounce, the improvement in mood was more subtle, but definitely correlated to how early I started looking at faces.

The early years of the treatment were often rocky. You were still working out some of the kinks in the treatment. The biggest surprise came when you found that exposure to fluorescent lights at night cancelled the effect of the faces. Another problem, also having to do with fluorescent lights, arose when I added early-morning bright-light therapy: the start-time and duration had to be adjusted by trial-and-error. At least six times I was one step away from becoming delusional, and then the treatment would pull me back within 48 hours. You were indispensable during those early years because I could call you and you would give me advice and the will to pull through.

By 2003, I had made some good progress. I had moved back to Berkeley, I was living with “normal” roommates instead of with other bipolar guys, and I had even been able to work for short periods. But along the way I had accumulated several minor pains. Back pain and stress made it difficult to get more than 4 hours of sleep. Sleeping pills did not solve the problem. I was scared that I would have to return to the mental health system; I would be a failure at the only thing I ever cared about [using the face treatment to stay out of the mental health system]. I made a pathetic attempt at suicide and wound up back in Herrick Hospital.

It was back to the crappy life—dulling medications, the psychiatrist and the psychotherapist, the support group, a volunteer job. Then, in 2006, the publicity for your diet book motivated me to try the “faces in the morning” treatment again. By that time, you had found that using a mirror was as effective as using videotapes [such as C-SPAN Booknotes recordings], which greatly simplified the process.

By 2009 I had reduced my doses of Prozac and Depakote to only 10 mg and 250 mg, respectively. (I hadn’t needed Moban since 1999.) In August of 2010, dissatisfied with my low energy level, I decided to go off medications completely again. Getting off of Prozac and Depakote gradually was tricky, because Prozac, which can induce mania, has a plasma half-life of about 10 days, while Depakote, which is anti-manic, has a half-life on the order of only 10 hours.

Today, most people would no doubt say that I’m still a loser. No matter, I’m able to enjoy life and relate to others in ways that I never could my entire life. I’m a Total Believer in the treatment. I don’t proselytize, though. People automatically reject the idea, and in any event I don’t want to be (directly) responsible if the treatment doesn’t work for someone. (Example: My nephew has clinical depression; he also has guns. If he tried this treatment, went off of medications, and then for some reason killed himself, my sister would never speak to me.)

The most difficult aspect of the treatment for me has been simply going to bed early. Even though I feel better the earlier I go to sleep, 10:45 pm is the best I can do on a regular basis.

To sum up, I believe you have discovered a powerful anti-depressant treatment that, in my case, has been effective for severe bipolar disorder. As a complete substitute for medications, however, it has entailed serious risks, and it requires substantial discipline to maintain. It is also important to note that “face therapy” is not the only alternative therapy that I use. In addition to the bright-light therapy that I mentioned above, I currently take 3 grams of omega-3 per day in the form of fish oil capsules.

There are a few more details and observations in these blog posts:

https://sethroberts.org/2007/05/06/life-size-faces/#comment-10539

https://sethroberts.org/2007/07/31/more-about-faces-and-mood/

https://sethroberts.org/2009/10/15/more-about-faces-and-mood-2/

Tomorrow I will comment on this.

Cold Showers Raise Mood

Todd Becker pointed me to this post which is negative about the notion that cold showers raise mood (“empty science”) but you can ignore the negativity and go to the comment that gives a long list of studies that support the idea. Todd has blogged about his use of cold showers.

Todd calls this hormesis. About the mood-raising aspect of cold showers, I’m not so sure. There is a broad correlation between being sleepy and being in a bad mood.  So anything that wakes us up is likely to improve our mood. But if cold showers improve one’s response to stress of all sorts — which is less clear — it does seem like hormesis in other contexts. When I think of hormesis I think of two sorts: intra-cellular (e.g., x-ray-like radiation breaks stuff, activating repair systems — radiation hormesis) and extra-cellular (microbes in fermented food activate the immune system). But there are other examples of similar stuff: exercise breaks muscle fibers (which is why you shouldn’t exercise the same muscles two days in a row) and longer-term increases them; bones when broken grow back stronger. If we need a certain amount of thermal or other stress to properly respond to stress that would be another example.

Do Fermented Foods Improve Brain Function?

I’m sure we need to ingest plenty of bacteria for our digestion and immune systems to work properly. What about the brain? When I started eating lots of fermented foods, I didn’t notice any brain-related changes, such as changes in mood or sleep. Suggesting that fermented foods have little effect on the brain. But a new study in the American Journal of Psychiatry suggests I reexamine the question. The researchers followed 160,000 high-school students in Taiwan for eleven years.

The incidence rate of suicide mortality in participants with current asthma at [the start of the study] was more than twice that of those without asthma (11.0 compared with 4.3 per 100,000 person-years), but there was no significant difference in the incidence of natural deaths.

Linking immune-system dysfunction (asthma) with brain dysfunction (suicide). I believe fermented foods will substantially reduce asthma. This finding makes it more plausible they’d also improve brain function.

Two Faces Better Than One?

Here I describe my discovery that seeing faces on TV in the morning improved my mood the next day. The details of the effect suggested that the ideal stimulus is what you’d see during a conversation. For a long time I used the C-Span show Booknotes as the main source of the faces. I watched it on a 25-inch TV. More recently I used my own face in a mirror. It was readily available and perfectly life-size. I listened to a podcast or book at the same time.

A few months ago, Caleb Cooper commented saying that he’d found that looking at two faces every morning seemed to work better than looking at one face. He found that Bloggingheads.tv expanded to full screen on a 24-inch monitor (measured diagonally) produced close-to-life-size faces, which is what he wanted.

This interested me for several reasons: 1. It might make the effect stronger. 2. Bloggingheads.tv has a big selection, offering control over size. 3. I disliked looking at my face for long times. 4. It seems more naturalistic than looking at my own face.

I’ve been trying this with a 22-inch monitor (which I already had). Perhaps 24-inch would be better. The effect does seem stronger, as Caleb said.

I asked Caleb several questions about his experience.

How did you get started doing this?

I think it started when I read your posts about standing and sleeping. This led me to read your paper on self experimentation and sleep. Like you, I often suffered from early awakenings where I would wake up around 2-3 hours early, still feeling tired but having a hard time going back to sleep.

Based on what I learned from you and other sources, I tried out the following; got a pair of blue blocker clip-ons for my glasses which I put on about two hours before bed; ordered an Apollo goLite blue light emitter that I use for about an hour in the morning, I would sometimes take 1/3 mg of melatonin nine hours after waking up, and 3mg half hour before bed, and I started standing on a high difficulty Thera-Band balance pad on one leg while looking into a mirror for 30 minutes in the morning.

What made you think it was worth a try?

Well, why not:) Most self experimentation can be easily done for practically no cost, while the potential upside is significant. There’s also satisfying curiosity, expanding self knowledge, gaining mastery over your mind and body… You had a plausible theory, had collected suggestive data, and I’d already found the appetite suppression effect of the Shagnri-La was very real, so you had a track record of introducing ideas worth paying attention to.

What happened at first?

It felt to me like my sleep modestly improved, sleeping through the night longer and having the energy to get up and go much sooner after waking. This was awhile ago though, I didn’t keep any data, and I was adding and dropping different things, so my experience doesn’t have a high enough confidence interval for drawing any general inferences.

When did you make those changes?

I’d guess around sixteen months ago.

After you made those changes (“got a pair of BlueBlocker glasses…”) did your mood change?

It improved in as much as waking up feeling rested makes you feel a lot better than trying to get up while still tired.

Tell me something about yourself (job, age, etc.).

I got into medicine through Clinical Massage Therapy. Being a high school dropout I wanted something I could get into quickly, then sink or swim on my own. Massage is one of the few fields the university-accreditation complex hasn’t sunk its tentacles deeply into (a mixed blessing; for an autodidact it lets you quickly start a great career, but the field really needs a bifurcated certification track to separate medical massage from relaxational spa massage). I live in the Pacific Northwest, near the site where they developed the atomic bomb dropped on Nagasaki. Despite all the lingering nuclear waste, it’s a nice, mid sized metro area. I’m in my mid twenties.

Assorted Links

  • “ant tribes” near Beijing
  • What exactly is umami?
  • Is omega-3 an antidepressant? “Initial analyses failed to clearly demonstrate the effectiveness of Omega-3 for all patients taking part in the study. Other analyses, however, revealed that Omega-3 improved depression symptoms in patients diagnosed with depression unaccompanied by an anxiety disorder.” Are they fooling themselves? Maybe not. My research suggests that morning faces can reduce only depression but also anxiety disorders. So if you have depression without an anxiety disorder it may indeed have a different cause.

Thanks to Anne Weiss.

What Antidepressants Do

After I complained about lack of outrage in Daniel Carlat’s Unhinged, Bruce Charlton pointed me to this essay (registration required) by Simon Sobo, a psychiatrist. Sobo says something I may end up repeating every time the subject of antidepressants comes up:

Rat pups that are isolated from their mother and littermates produce ultrasonic sounds that are indicative of stress. SSRIs [the most popular type of antidepressants] reduce these sounds (Oliver, 1994). Is a chemical imbalance being corrected? I doubt it.

That’s a nice summing-up. Prozac (an SSRI) really does something, but the notion that it returns to normal something broken is absurd. Sobo also gives an example of how the anti-anxiety effect of such drugs works in practice:

Mrs. L. had originally required 40 mg of Paxil (paroxetine) per day to recover from a postpartum depression. After 12 months on the medication, an incident happened that disturbed her. During her lunchtime, she was visiting her 1-year-old son at his day care center when one of the workers began screaming at another infant instead of picking her up. The next day Mrs. L. went shopping during her lunch break. Later that week a co-worker became tearful during the course of a conversation with Mrs. L. regarding her own child’s day care center. Only then did Mrs. L. wonder about her decision to go shopping the day after she had witnessed the day care worker’s inappropriate reaction. She wondered if her Paxil had made her indifferent when ordinarily she would have reacted and worried about such a thing.

My research about mood suggests that depression is due to defective entrainment of a mood oscillator. It’s caused by something missing from the environment. “Chemical imbalance” has nothing to do with it.