FDA finds new ways to increase Merck’s revenues

FDA approves wider market for schizophrenia drug Saphris.

The drug was first approved in August 2009 for treating acute schizophrenia episodes in adults and acute mania or manic-depressive behavior in adults with bipolar disorder.
 Merck says the FDA now has approved Saphris for ongoing treatment of schizophrenia and for treating acute mania or manic-depressive behavior in adult bipolar patients along with lithium, a mood-stabilizing drug often used to treat mania, or the antiseizure drug valproate.

This raises the perennial, but naive question “Who exactly is the Food and Drug Aministration working for?”

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“Evidence” that does stand up in court

Lately, I have noticed how often the DSM label is used in court in an attempt to either exonerate the person from assuming full responsibility for the crime of which they are accused or else to win sympathy from the court against the person with the label. In the past I have agreed with the general insanity defence, but am not at all convinced that parsing the insanity defence down to the specific “disorder” is a wise idea. In fact, the more I see this happening, the less I am convinced about the insanity defence. I see this being used more and more as an “out” for people who are not at all criminally insane or as a vehicle to convict the person you have a grievance against. Both sides are smart enough to know that the DSM carries the weight of “expert opinion.”

Since the more esoteric labels weren’t in existence much before the 1990s when pharma cemented the idea of the diseased brain in the public consciousness, it is axiomatic that their use in the courtroom has skyrocketed.

Last week-end’s Financial Times has an absolutely pathetic piece of journalism on Narcissistic Personality Disorder. Since the average reader of the Financial Times is supposedly a London investment banker, I feel this article was written more to titillate than to inform. The article begins with an anecdote about an enraged husband who threatens his wife with a gun when she decides to leave him. He backs off when she calls her father and later denied threatening her and the charges were dropped. At the divorce proceedings “a social services report diagnosed Rob with narcissistic personality disorder.” Why am I not surprised that the party seeking the divorce will try to pathologize the spouse’s behavior through “expert” testimony. The DSM is their friend in court.

The FT articles goes on at length about NFP as if it were a clinical disease (classified as a cluster B or “dramatic” disorder, as opposed to a cluster A “odd” disorder (paranoid and schizoid) and cluster C “anxious” disorders such as dependent disorders and OCD). It claims that NPD disorder is “diagnosed” when it it really apparent that there is no diagnosis, only “opinion.” The article demonstrates that even though “there is no laboratory test, no genetic predisposition, no specific types of people more susceptible than others,” a non-existent disease or disorder such as this will still stand up in a court of law. In my opinion, the social services report in the divorce case is tantamount to “hearsay.” Actually, much of the FT article struck me as hearsay evidence. We are supposed to believe the nasty things that someone else says about a husband, parent without our actually knowing them ourselves.

The author of the article writes while keeping a straight face “The disorder, formerly known as megalomania, affects 1 per cent of the population and up to 16 percent of the clinical population. It is not easily discernible to the untrained eye, partly because a degree of self-love is essentially healthy . . . . ” The article claims that this disorder is found frequently in the higher reaches of politics, finance and medicine, and, with no basis, claims that there is no cure!

Should this fuzzy labelling of a disorder that works well for many really have clout in a court of law? Should law abiding people who carry the label of schizophrenia and bipolar disorder object to their label being bandied about in a court of law to excuse someone else’s behavior? If these are phony diseases, as I firmly believe, then their presence should be struck from the court room, or certainly not carry the weight of “expert evidence.” Sensationalistic or lurid court cases where schizophrenia and other so-called disorders are invoked, condemn the vast majority of people with these labels who would no more kill someone, drive drunk or steal than the next person. They are stigmatized with the larger public courtesy of the DSM being allowed in the court of law.

“Expert evidence” in these cases claims to justify  that there is no other motivation for the behavior beyond the “disorder.”

Political correctness just another form of social control

Kris Ulland’s recent post on Scientology involvement with Thomas Szasz’s Citizens Commission on Human Rights has been generating a lot of interest. I made a remark in one of my comments to her post that politics makes strange bedfellows. Organizations and politicians may disagree vehemently with another’s policy planks, but when their interests occasionally coincide they are more than happy to get into bed together to further a common goal.

Szasz’s reputation as an anti-psychiatrist is built on his disagreement with the idea that mental illness is a disease. I have come to the same conclusion myself, based on my observations of my son’s behavior. It walks like a duck, it quacks like a duck, but it is not a duck. It looks in many ways like a physical illness (slow and odd movements, incoherent speech, etc.) but it is not a physical illness. It didn’t really matter if Chris was on drugs or off drugs, the behavior was the same. I am glad to report that this is not the case now.

Wikipedia on Thomas Szasz:

While people behave and think in ways that are very disturbing, and that may resemble a disease process (pain, deterioration, response to various interventions), this does not mean they actually have a disease. To Szasz, disease can only mean something people “have,” while behavior is what people “do”. Diseases are “malfunctions of the human body, of the heart, the liver, the kidney, the brain” while “no behavior or misbehavior is a disease or can be a disease. That’s not what diseases are” Szasz cites drapetomania as an example behavior which many in society did not approve of, being labeled and widely cited as a ‘disease’ and likewise with women who did not bow to men’s will as having “hysteria”[9] Psychiatry actively obscures the difference between (mis)behavior and disease, in its quest to help or harm parties to conflicts. By calling certain people “diseased”, psychiatry attempts to deny them responsibility as moral agents, in order to better control them.

Szasz, in his later book, The Manufacture of Madness (1970) writes:

The best, indeed the only, hope for remedying the problem of “mental illness” lies in weakening – not in strengthening – the power of Institutional Psychiatry. Only when this peculiar institution is abolished will the moral powers of uncoerced psychotherapy be released. Only then will the potentialities of Contractual Psychiatry be able to unfold — as a creative human dialogue unfettered by institutional loyalties and social taboos, pledge to serving the individual in his perpetual struggle to rise, not only above the constraints of instinct, but also above those of truth.

I worked for many years in politics at both the national and state levels and directly for a couple of political parties. I have a certain sympathy for Scientology, not because I am a member, which I am not, but based on the experience of being the brunt of political correctness when the going gets down and dirty in politics. The party in perpetual power where I worked, would float all kinds of accusations against the party I worked for – racism, sexism and religious fundamentalism are the big three that generally make middle of the road people, tempted to shift allegiances, scurry right back to their comfortable center line. Do I want to be a Scientologist? No, but that doesn’t mean that I disagree with everything they have to say. Their stance on psychiatry (anti-drugging and anti-coercion) is one of the things they stand for that strikes me as appropriate.

Thomas Szasz suffers from the same political problem as any person or organization whose opinions are not held by the mainstream. He is politically incorrect by North American standards. I may be stepping on a lot of Hungarians’ toes here (hi, Tibor!), but Hungarian’s (like many of their European counterparts) are more often than not politically incorrect. Europeans have a long history of being at the mercy of the state and of those who enforce state control. Who are Szasz’s critics? Institutional Psychiatry, of course and those who are under its power.

I began to really appreciate Szasz when I was looking for something positive to believe in about my son’s prospects. Institutional Psychiatry was hinting that Chris was a lifer. It is odd that this psychiatrist, who mainstream psychiatry kept insisting was a heretic, was actually a psychiatrist who seemed to put the rights of the individual first. He seemed very much on the patient’s side. From my limited experience with institutional psychiatry at the time, I never got the feeling that it understood (had empathy for) the patient.

Szasz believes that the label of schizophrenia is like being persecuted for being a witch.

A direct line of progresion can be traced from the witch’s marks to the so-called stigmata of the hysteric, and, most recently, to the signs which schizophrenics are made to reveal through projective psychological testing. Each of these “diagnostic” findings is used to incriminate the subject — as witch, hysteric, or schizophrenic; each is then used to punish him — by means of theological, medical, or psychiatric sanctions.

He then goes on to say that “While some witches may have survived dunking, no “madman” survives psychological testing.” (Read Szasz for dark humor, too.)

The figure of the psychotic or schizophrenic person to psychiatric experts and authorities, according to Szasz, is analogous with the figure of the heretic or blasphemer to theological experts and authorities. According to Szasz, to understand the metaphorical nature of the term “disease” in psychiatry, one must first understand its literal meaning in the rest of medicine. To be a true disease, the entity must first, somehow be capable of being approached, measured, or tested in scientific fashion. Second, to be confirmed as a disease, a condition must demonstrate pathology at the cellular or molecular level.

A genuine disease must also be found on the autopsy table (not merely in the living person) and meet pathological definition instead of being voted into existence by members of the American Psychiatric Association.

The above quotes are from taken from Wikipedia and directly from Szasz’s The Manufacture of Madness, Random House, 1970.

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Roughly speaking, institutional psychiatry is imposed on you, perhaps by force of law, while contractual psychiatry is when the individual seeks out a psychiatrist and retains complete control over his participation with the expert.

A question of accountability

Is there an organized effort (lobby?) that pressures the media to disclose the pharmaceutical ties of the people they are interviewing?

The media habit of publishing a story, such as this one, and failing to disclose that some, if not all of  the “experts” quoted have ties to pharma, is just not good journalism.

So, who is forcing the media to be more accountable in this area?

I am doing my bit where I can and so are you, but I would like to know if there are organizations that are doing this more systematically.

Here’s what I object to in the NY Times article

I read the NY Times article Child’s Ordeal Shows Risks of Psychosis Drugs for Young. This is a bit of a rambling discourse because I am still feeling quite jet-lagged. I doubt if I’m making my points clearly.

I suppose I should be grateful if focusing on children to highlight the problem with psychiatric drugs will also benefit adults who feel they are being force medicated and overmedicated. Doctors don’t seem to be making the mental leap, judging by what I read in the article. Actually, the article made me extremely angry because it seems that the focus on children may be diverting attention from the greater flaws in the drug paradigm system. I am very cranky after reading this article.

If you read the comments section that accompanies this article, you will see that a great deal of the criticism is directed against  the doctors who prescribed the drugs, but equally against the mother who allowed this to happen. Everybody has jumped all over this one and readers have offered up all kinds of parenting advice. Show us an innocent child and we all say, oh, it is obvious that the parent didn’t know what she was doing when she medicated this child. All the family needs is counselling, not drugs. True, true, but how does this change when the child is an adult? What seems ridiculously easy to spot in children somehow becomes “a true illness” as soon as they reach the age of psychosis, which is 15 to 25 in men and 25 to 35 in women.

I’ll start with the word “young” in the title of the article “Child’s Ordeal Shows Risks of Psychosis Drugs for Young.” The risks are the same for everybody – weight gain, diabetes, leaking breasts. Why isn’t this point made more forcefully? I guess the answer is found in the quote from Dr. Gleason, below. Apparently, there is mental illness for which antipsychotics can be justified.


Dr. Gleason says Kyle’s current status proves he probably never had bipolar disorder, autism or psychosis. His doctors now say Kyle’s tantrums arose from family turmoil and language delays, not any of the diagnoses used to justify antipsychotics.

So, the myth will continue to be peddled by people who benefit from enforcing these labels that there is something akin to true bipolar, autism or psychosis. Where’s the scientific validation, doctor, for mental illness? Show me! Dr. Gleason’s justifying antipsychotics is opinion based on wishful thinking. It is laughably easy to see that Kyle suffered from poverty, and a medically naive young unwed mother. It is not so easy, but shouldn’t be impossible, to figure out that adults with these labels are just children who have aged a few years.

Here’s the myth being promulgated in one of the comments to this article. Stephen Reidbord, MD, San Francisco writes: Antipsychotics are tremendously helpful for severe conditions such as schizophrenia, where the benefits usually outweigh the considerable risks. For lesser conditions, the risk/benefit ratio swings the other way.

The benefits to whom, exactly? Prove that they are “tremendously helpful.” Where’s the evidence? How patronizing.

…………………
“There are too many children getting on too many of these drugs too soon,” Dr. Mark Olfson, professor of clinical psychiatry and lead researcher in the government-financed study, said.

You mean that it is okay to get on these drugs later?
…………………

The article, which is not remarkable because there are so many of them today, has left me furious because it’s trying to separate obvious innocents from the older victims of this abuse. Since “Kyle” is a bright happy six year old today, he couldn’t possibly have had “real” psychosis. Anyone reading the article would agree. Now what about the over 18s?

How many of us are really excellent parents? Poor parenting? Yes and no. Parenting is difficult no matter who you are. Nobody, but nobody gets it consistently right. Some parents, such as single and divorced parents, are obvious candidates for criticism, particularly if they are poor, and they are forced to bear the brunt of the criticism because their situation is dysfunctional. The public at large gets this, as the comments to the article attest. What the public doesn’t often grasp when they get on the single parent bandwagon is that no matter who you are or how old you are when you first have children, having children doesn’t give us sudden wisdom. It increases the strain. Just getting married increases our anxieties. Having more children increases stress.

There is a good comment in the comments section from CJ, of Fort Wayne, Indiana. She gets it and is willing to admit that she was struggling, too.

Back in the day (1970) when my eldest son was about 5, I found him difficult to handle, easily distracted and inclined not to obey. Bright and articulate, he nonetheless made me crazy and unable to deal with him, much less his two younger brothers.Around that time, the term “hyperactive” first came into play, a condition with which even his pediatrician was unfamiliar. J. was hospitalized for 2-3 days for observation and then prescribed Ritalin. The results of the medication were that they calmed J. right into oblivion. In other words, it totally knocked him out for the afternoon or… it didn’t effect him at all. We never knew which to expect.

We kept him on it for most of the 30-day prescription, at which time it was either strengthen the dosage or take him off it. I opted to take him off it, without consulting the doctor, “asking” permission or anything else. It was breaking my heart to see what was happening to my bright-eyed firstborn.

Although he’s had his issues throughout the years, at least I know they weren’t caused by over-medication administered by his parents. And today he’s a happily married, soon-to-be-45-year-old –– hard-working, responsible and still employed, despite the economic downturn.

In retrospect, his father and I were 23 when we had him, both emotionally young, hyperactive adults prone to nervousness. What, then, could we expect in our little ones?
It appears today’s parents don’t want to take time to examine themselves, their lifestyles, their parenting skills (or lack thereof) to see what might be affecting their child/ren. In addition, they might look to the schools, who have in many instances effectively taken away all outlets for normal childhood rambunctiousness by eliminating recess and phys ed, and requiring these little ones stay at their desks most of the day.

As for parents and physicians “drugging” infants and preschoolers, well, as they say, you can’t cure dumb.

As a nation, we are doing our youngsters a great disservice, substituting drugs for parenting, and placing the blame on others. Parents, take control. Do this by first taking control of yourselves. Your children –– and their future –– is at risk.


The ties that bind

The excerpt below from the CNN article, Growing up bipolar demonstrates planting a certain belief (in this case “disease mongering”) by people who most stand to benefit. A quick Internet search revealed that Dr. Charles Raison’s Mind-Body Program at Emory University gratefully receives funding from:

Anonymous Donor Support; The Dana Foundation; The Emory-Tibet Partnership; Glaxo Smith-Kline; The National Heart, Lung, and Blood Institute (NHLBI); The National Institute of Mental Health (NIMH); NARSAD; Schering-Plough

Dr. Rakesh Jain is in private practice in Texas.

Is it possible to stop medication?

For the past year, Jennifer has been off of all medications but still sees a therapist, and the family has a relationship with a psychiatrist in case of relapse.

In general, people with bipolar disorder must stay on medication for life because relapses are common, said Raison, who has not treated Jennifer. But some are fine for periods of time without them, he said. (editor: Relapses are not common if you get your act together.)

Jain agreed that some patients who do well can go for stretches without medication, but he has never been able to completely remove a bipolar patient from drugs and say, “you’re cured.” Bipolar disorder should be viewed as a chronic illness like hypertension or diabetes, which require lifelong management, he said. It is wise for anyone who does go off medicine to continue to see a mental health professional and closely watch for symptoms of recurrence, Raison said.

See also another aspect of The ties that bind

“Nobody was on my side”

I sometimes bring up the idea that it is important to be on your relative’s side when a diagnosis has been handed down. I read the CNN article Growing up bipolar and glommed onto the following quote:

Jennifer, the middle child, was always the most sensitive of Konjoian’s three children, her mother said. She never had any episodes at school; they usually happened when she felt overwhelmed by her family: for instance, when her siblings picked on her.

“I felt like nobody was on my side. That’s kind of how I always felt,”

This child was given a label of bipolar (after initially taking an antidepressant, as is so often the case) and yet, here it is, in black and white, that her behavior was a problem at home, not at school. Her family was driving her crazy. She felt that they weren’t on her side. I can identify with this. As a child I was continually angry and lashing out, at home, never at school. It was my family that was driving me crazy and I didn’t learn coping skills  until I finally tired of myself and made a vow to stop. Naturally I felt nobody was on my side at the time.

Being on the person’s side, seeing life from someone else’s point of view, is huge in healing. Most parents are too busy settling disputes amongst siblings to really focus on the child’s point of view.

When we landed in the mental health system, after a while I began to wonder who was really on Chris’s side. It took me a while, but I finally realized that Chris’s perceptions were real, not something that should be dismissed as lunatic ravings. Okay, psychosis is an unusual way to express yourself, but for some people, it is the only way until they master a way of not retreating into psychosis. The doctors claimed they were on Chris’s side, but then they referred to him as a patient, they spoke of his delusions, they gave him drugs to sedate him. They encouraged a view of a limited future.

Parents can easily fall into the same trap and will take the side of the doctor, which is a negative and mechanical view of the individual. Ian and I cajoled Chris into taking his meds because the doctors said it was essential. We looked at Chris as if he was the crazy one. We were not on his side. We confused empathy with pity.

After a while I “got it.”  I decided Chris was right about whatever it was that was bothering him. He had justifiable cause. Chris’s way of expressing himself as a child was not like Jennifer’s. His way was quiet and non-confrontational. Everybody has their own way of dealing with anger or fear.

Why are we so eager to believe somebody else and not our relative when it comes to mental health issues?

Thomas Jefferson, spiritual founder of MindFreedom?

“I have sworn upon the altar of God eternal hostility against every form of tyranny over the mind of man.”
Inscription chiselled below the dome inside the Jefferson Memorial in Washington, DC.
I don’t think Thomas Jefferson was even thinking of women, let alone psychiatrists and mental patients, when he uttered these words, but he seemed reasonably disposed to being open minded about the mind, as we see below.
“I am not an advocate for frequent changes in laws and constitutions, but laws and institutions must go hand in hand with the progress of the human mind. As that becomes more developed, more enlightened, as new discoveries are made, new truths discovered and manners and opinions change, with the change of circumstances, institutions must advance also to keep pace with the times. We might as well require a man to wear still the coat which fitted him when a boy as civilized society to remain ever under the regimen of their barbarous ancestors.”
Fourth panel of Jefferson Memorial, Washington, DC

Faith healer

For therapy to work, both parties must have faith, sometimes against all reason, that their expedition will succeed.

I heartily recommend Gary Greenberg’s article America’s War on Unhappiness in Harper’s Magazine/September 2010. It is an often tongue-in-cheek look at the post-Freudian state of therapy today. Unfortunately, the article is only available to Harper’s subcribers. I have written about it previously here.

Greenberg writes about the “Dodo Bird Effect” as it applies to therapy. The Dodo Bird Effect is a term borrowed from Alice in Wonderland and coined in 1936 by psychologist Saul Rosenzweig. Rosenzweig discovered that it doesn’t really matter what therapy you choose to pursue, because they all work. “Everyone has won and all must have prizes” is the way the dodo bird put it. The Dodo Bird Effect is similar to the better known placebo effect. But what numerous studies have shown since the Rosenzweig study is that the single factor that makes a difference is FAITH, the patient’s faith that the therapy will work and the therapist believing in what he does.

Step back from this insight and marvel. It doesn’t matter what your chosen course of action is re supposedly “treatment resistant” schizophrenia, as long as you believe in its ability to produce the outcome you want. You don’t even have to buy any of the therapies that Chris and I have tested – just find your own version of the truth and run with it. (I recommend not putting all your dodo eggs* in one basket. Spread your therapeutic interventions around and very importantly, find a therapist who believes in what he or she is doing.)

The key here is that if a therapy is to work, not only the patient but the therapist must believe in what he does. Since my son’s initial two year course of day program and drug therapy was what I would call a failure, I came to the conclusion early on that the therapists actually didn’t believe in the approach either. Imagine going to work every day and not believing in what you are doing.

It’s especially critical for therapists to believe in happy endings. The doctors in the day program had a “professed” belief in the medication, where they seemed to put most of their emphasis, but it became obvious to me as it should have been obvious to them, that if the patient isn’t getting better you’d better find approach you actually do believe in or take down your shingle. I could tell that the doctors also didn’t believe that schizophrenia was “curable” and that my son would get through this. One way of measuring their belief is by the words they used and the tone of voice. To them, schizophrenia was a sad, sad business. This doesn’t inspire belief by others, because belief must be positive in order to heal. They couldn’t sell me on a healing outcome because the elaboration of the Dodo Bird Effect says they didn’t believe in one.

We have been lucky. Once I figured out that the program wasn’t going to help Chris, I looked around for doctors who could. I found two excellent psychiatrists. The first one introduced us to the world of holistic healing and energy medicine. Dr. “O” totally believed in what she was doing and her belief was contagious. Dr. Stern passes my litmus test for belief through her commitment to what she does as a Family Constellation therapist amongst other interventions.

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Poetic license, the dodo bird has been extinct since the late 1600s.