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When forced drugging was still debatable: David Oaks speaks after Virginia Tech 12/17/2012

Posted by ALT in Activism, Pharmaceuticals.
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7 comments

In 2007, after the Virginia Tech shootings, David Oaks (director of MindFreedom International and survivor of forced drugging) was invited onto NPR’s Talk of the Nation to debate the merits of forcibly drugging individuals experiencing extreme mental and emotional states.

Back then, forced drugging/commitment was still very debatable.

So was Pluto's status as a planet.

So was Pluto’s status as a planet.

In fact, the host of TOTN described forced drugging as “one of the most polarizing issues in mental health” – and openly acknowledged the serious challenge to civil rights that such a practice poses.

Not so much today. Folks like E. Fuller Torrey and his so-called “Treatment Advocacy Center” have done their work well; “more mental health treatment” (typically, with the added implication of “by force, if necessary”) is being presented as a self-evident solution to the problem of mass murder throughout media coverage of recent events. A few choice quotes from mainstream commentaries on Newtown:

With mass murders increasing in frequency, getting troubled people treatment is a national issue. Nevada and New York are among a few states that have some legal measures parents and relatives can take (with the recommendation of psychiatrists) so that people over the age of 18 get outpatient psychiatric care when warranted. But often, mothers and fathers are left with the all the worry and very little control. (Those laws, like Kendra’s Law and Laura’s Law, are named for people who have been killed by the mentally ill.)

- from TIME magazine

It’s important not to stigmatize the mentally ill. At the same time, there is a small subset of mentally ill people who are dangerous. They are responsible for an estimated 50 percent of rampage killings. In the name of personal autonomy, we have made it almost impossible to force them to get treatment. The horrifying consequences are all around us.

- from National Review Online; reprinted in the Washington Post

From the MindFreedom website: David W. Oaks is a psychiatric survivor who has been given labels such as schizophrenic, bipolar, schizophreniform, clinical depression. He is holding a copy of the American Psychiatric Association's book of psychiatric labels. David directs MindFreedom International and is a human being!

From the MindFreedom website: David W. Oaks is a psychiatric survivor who has been given labels such as schizophrenic, bipolar, schizophreniform, clinical depression. David directs MindFreedom International and is a human being!

In 2007, David Oaks made a well-articulated and compassionate case for pursuing alternatives to forced drugging.

We need more perspectives like David’s in the discourse that’s emerging now. Can we make room for the voice of actual psychiatric survivors, which – then and now – are the first to be excluded from the dialogue?

David describes his own experience with forced drugging

OAKS: [While in college in the 1970s] I entered into extreme and overwhelming mental and emotional problems that were labeled as schizophrenic and bipolar, in other words, psychotic. Things like thinking the CIA was after me, that a neighbor was with the CIA, the TV was talking to me personally, the radio was the voice of God, and all kinds of classic experiences like that during these times.

So Harvard referred me to McLean, which is voted one of the best institutions. I remember the drive to McLean thinking, “now I’ll get some help, some rest, some support.” And, instead, I found a very aggressive approach of forced drugging. I didn’t want to take the psychiatric drugs because I was concerned about the hazards, and they dragged me to a solitary confinement room, forcibly injected me. And I spent days in solitary confinement several times. And that’s actually where I got kind of recruited to this human rights work, because I remember in that solitary confinement cell very distinctly for several days, forcibly drugged, and I looked out that screen of that window and I said, there are better ways to help people with severe mental and emotional problems.

Challenging the “medication as first and ONLY treatment” paradigm

HOST: And have you voluntarily taken medication or sought other sorts of treatment since then?

OAKS: Not the traditional psychiatric care. When people talk about treatment a lot, we need to dive down deeper. They mean drugs. I’m pro-choice about people’s decision to take prescribed drugs, but that’s what it’s about. The current mental health system … it’s about drug, drug, drug, drug, drug, drug, drug…

If you talk to mental health consumer groups, psychiatric survivor groups, you’ll find a whole range of alternatives. Whether or not people are on psych drugs, they want peer support programs, advocacy programs, drop-in centers, peer-run programs such as advocacy and housing programs. There’s all kinds of approaches out there that we need to be talking about. But I think the pharmaceutical industry has kind of taken over the mental health system.

They were talking about the neuroleptic drugs. Back then it was things like Thorazine, Stelazine, Mellaril, Haldol that I was on. Now there’s Clozapine, Risperdal, Zyprexa, and drugs like that. These are the so-called antipsychotics or neuroleptics. And any discussion about forced treatment has to get into what these drugs do. I tell you, okay, with all of my heart, if thirty-some years ago I had stayed on these drugs for the rest of my life like they told me I had to, I would have dementia. And I respect folks that chose that direction, but these drugs can cause brain damage, and current medical evidence is in that long-term high-dosage use of these drugs can cause brain damage.

Is so-called “mental illness” JUST LIKE DIABETES?

HOST: We have an e-mail from Anne in Jackson, Michigan, who says: “I was recently diagnosed with bipolar disorder after being treated for depression and anxiety for 11 years. I firmly support forced treatment for those with serious mental health programs. Free will and informed decisions require a certain level brain function. When the brain is not functioning properly, you can’t expect decision making to be working well.

You wouldn’t ask a diabetic to somehow make his pancreas work at a higher level than possible, but that’s sometimes exactly what you’re asking someone dealing with significant mental illness. You’re asking his brain to function at a level that allows him to make informed decisions.”

OAKS: Two quick replies. One is: there’s no force treatment for diabetics. Why is that? There’s a lot of folks diagnosed diabetic that are eating horrible foods, doing terrible things to their bodies. They’re not being forcibly treated with diabetes medication. But also, the best doctors in diabetes, when you talk to the cutting edge doctors, they’re finding that all kinds of non-tangible things help us, even for diabetes and heart conditions. Things like our community, our culture, our connections to each other, our relationships.

HOST: But what about the specific question of not necessarily being the best judge of the decisions about your own treatment when you are in the middle of a psychotic break?

OAKS: Okay, there I was, middle of the psychotic break. I thought the neuroleptics were poison for me, personally…I thought it felt like it was damaging my brain, that it was potentially harmful to me. I was right. The current medical evidence is that there’s a very high risk from these drugs, including frontal lobe shrinkage. Now that’s shown with CT and MRI scans. So I was right.

What happens if we respond to acts of violence with forced drugging, another kind of violence…

HOST: David Oaks, what do you think the impact will be of the Virginia Tech tragedy on your efforts to fight forced treatment?

Mr. OAKS: If we do nothing, if people who are diagnosed with psychiatric labels and our allies do nothing, horrible disaster. I would predict hundreds of thousands of more young people prescribed powerful drugs without adequate advocacy, information, alternatives…

So let’s hear from mental health consumer psychiatric survivors and perhaps something could somehow be taken from this horrible tragedy that we can hear from people who’ve been there. What has helped them recover? What is it like to be forcibly treated? A lot of us actually see that as violent. I still have traumatic dreams about being forcibly drugged 30 years later. It was a form of violence.

the missing voice again is often people who have been through the mental health system. They tend not to be listened to, almost – in fact, I’d say – I’d go out on a limb and say every mental health consumer group I’ve heard of opposes expanding forced drugging and commitment laws. Why is that? Because they have found other ways to help other than more forced treatment.

***

[Listen to the entire interview here.]

[And if you have a spare moment -- meditate on a quick recovery for David, whose voice is so desperately needed now.]

Experts attempt to persuade parents struggling with the decision to medicate their children that the “benefits outweigh the risks” 12/11/2012

Posted by ALT in Bipolar, Children's Mental Health, Mental Health News, Pharmaceuticals.
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8 comments

When you see a USA TODAY headline like this – “Parents struggle with decision to medicate bipolar kids” – and a subheading like this…

Because treating a child with heavy medication has far-reaching implications, parents wonder whether using psychiatric drugs is the best way to help their children with bipolar disorder.

… you might be surprised to find that what you’re reading is far from a balanced consideration of the true risks and benefits of psychotropic medication and polypharmacy in children. Instead, what you get is an out-and-out endorsement for drugging children, fast and furious.

Let nothing stand in their way!

Never mind the consequences!

We begin with scare tactics:

“Without treatment [read: medication], I see my daughter as killing herself,” says a weeping McQuilkin, 60.

As quoted in USA TODAY’S article Parents struggle with decision to medicate bipolar kids [emphasis added]

Next, prognosis:

Bipolar is a lifelong disease, and you don’t want to diagnose it too early and be wrong, or miss something and be too late.

Gabrielle Carlson, professor of psychiatry & pediatrics at Stony Brook University
As quoted in USA TODAY’S article [emphasis added]

We move quickly on to more expert opinions:

I understand the reason why a parent would be afraid to medicate their child. There are often serious and unknown side-effects to consider. But parents also need to consider that there may be a downside to not medicating and missing an opportunity to interrupt the course of a serious illness. … Not medicating may also carry with it risks.

Janet Wozniak, psychiatrist at Harvard Medical School
As quoted in USA TODAY’S article [emphasis added]

Finally, we are assured that the benefits outweigh the risks:

 There’s no free lunch with medication. But if an eye tic is what a child gets vs. getting kicked out of school because his behavior is unmanageable, then it’s worth the risk.

Gabrielle Carlson [emphasis added]

No free lunch?

An odd choice of words for Gabrielle Carlson, who has this additional list of credentials (from a 2010 Conflict Of Interest [COI] disclosure):

Dr_Gabrielle_Carlson- Advisor/Consultant: Bristol-Myers Squibb Company, Eli Lilly and Company, Otsuka America Pharmaceutical, Inc., Validus

- Honorarium and Travel Expenses: Ortho-McNeil-Janssen Pharmaceuticals, Inc., Shire Pharmaceuticals, Inc.

- Research Funding: Bristol-Myers Squibb Company, Eli Lilly and Company, GlaxoSmithKline, Otsuka America Pharmaceutical, Inc.

Janet Wozniak, too, is no stranger to the free lunch:

janet wozniak- Faculty: Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital (more on that momentarily…)

- Consultant:  to Pfizer, Shire Pharmaceuticals, and Eli Lilly

- Research Funding: Eli Lilly

- Speaker’s Bureau: Eli Lilly and Janssen
(from a COI statement issued 2009)

Don’t you think it’s more fair to say that there IS a free lunch for some (medical experts, or “key opinion leaders” as they’re referred to by pharmaceutical companies) but NOT for others (children subjected to the horrors of polypharmacy and the mortal risks included therein)?

What they forgot to mention

Wozniak, Carlson, and the other experts quoted by USA TODAY neglected to include a few key facts that parents struggling to decide whether or not they should medicate their children for so-called “pediatric bipolar disorder” DEFINITELY ought to consider:

1. The relatively recent (we’re talking mid-90s) rise of the idea that so-called “bipolar disorder” is not an almost exclusively adult phenomenon but a widespread pediatric disease which must be aggressively treated with hardcore psychotropic medications, possibly for life. Authors Joseph Biedermann and Janet Wozniak’s turn-of-the-millennium publications put forth this cash cow of an idea and jump started the 4000% increase of this diagnosis in children between 1994 and 2003.

2. Biedermann et al also established – at (coincidentally!) the very same time – a lucrative partnership with Johnson & Johnson, which generously provided grant funding for the “Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital” in 2001. A report to the funders (that would be J&J) dated 2002 reads, in part:

An essential feature of the Center is its ability to conduct research satisfying… [certain] criteria…. [including that] it will move forward the commercial goals of J&J.

…many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events….

Through the funding provided by J&J, we [the J&J Center for Pediatric Psychopathology] are creating a team of investigators focusing on the following issues:

…We will generate and publish data on the efficacy and safety of medications for improving currently available treatment options for child psychopathology.  This work is an essential precursor to the … widespread use of medications

[more on Biedermann and Wozniak’s collusion with J&J to carve out a market for Risperdal in the pediatric population here.]

risperdal toys

Thanks to the tireless work of the “J&J Center for Pediatric Psychopathology,” the marketing of antipsychotics to children became so acceptable that pharma sales reps could leave these Risperdal-branded legos in pediatricians’ and psychiatrists’ offices around the country.

3. The very serious side effects of antipsychotic medications in children, including extreme weight gain, type 2 diabetes, obesity, and heart conditions, and brain shrinkage. Antipsychotics have also been shown to significantly worsen symptoms of psychosis over time, making a potentially one-time occurrence into a chronic disease.

4. And finally, for children and adults alike, the Physician’s Desk Reference warns that use of antipsychotics can cause suicidal ideation, aggression, and violence. For example, the entry for Seroquel lists “thoughts of suicide or dying,” “feeling very agitated or restless,” “new or worse irritability,” “acting aggressive, being angry, or violent,” “acting on dangerous impulses,” and “mania” as symptoms that may occur in conjunction with use of Seroquel.

Final Thoughts

Bipolar disease is treatable, that’s the most important thing. I always tell young people who are at the beginning of treatment that bipolar is bad, but now is a great time to get it.

Kay Redfield Jamison, professor of psychiatry at John Hopkins School of Medicine
As quoted in USA TODAY’S article Parents struggle with decision to medicate bipolar kids [emphasis added]

Let’s be real: now is a great time for children to get themselves prescribed a whole bunch of pills under the guise of treating their  “lifelong, chronic, REAL bipolar disorders,” so that Wozniak and friends might partake in their free lunches.

But are those lunches really free if the children are the ones paying for them?

Federal Appeals Court rules off-label marketing is “commercial free speech” 12/05/2012

Posted by ALT in Mental Health News, Pharmaceuticals.
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2 comments

On November 30, 2009, pharmaceutical sales representative Alfred Caronia was found guilty in a trial by jury of “conspiracy to introduce a misbranded drug into interstate commerce.” In plain English, he promoted the narcolepsy drug Xyrem for off-label uses to doctors, inciting them to prescribe it for issues – and to populations – NOT approved by the FDA.

There’s absolutely no doubt that he did this. Though Xyrem is only FDA-approved for narcolepsy and cataplexy in individuals aged 16-65, they’ve got Caronia on tape marketing it for a host of other purposes:

(transcript of Caronia speaking to Dr. Stephen Charno, a prospective Xyrem customer/prescriber who also happens to be a “government cooperator.”)

[Caronia]: And right now the indication is for narcolepsy with cataplexy . . . excessive daytime . . . and fragmented sleep, but because of the properties that . . . it has it’s going to insomnia, Fibromyalgia[,] periodic leg movement, restless leg, ahh also looking at ahh Parkinson’s and . . . other sleep disorders are underway such as MS.

[Charno]: Okay, so then so then it could be used for muscle disorders and chronic pain and . . .

[Caronia]: Right.

[Charno]: . . . and daytime fatigue and excessive sleepiness and stuff like that?

[Caronia]: Absolutely. Absolutely. Ahh with the Fibromyalgia.

(transcript of Caronia speaking to Dr. Peter Gleason, a physician hired to promote Xyrem in a speaker program)

[Caronia]: Um, the youngest patients we have are sixteen in the studies as old as sixty-five. Ahh there have been reports of patients as young as fourteen using it and obviously greater than sixty-five.

It’s a very safe drug.

A very safe drug?

Well, the listed side effects include

  • confusion, sleepwalking, and other neuropsychiatric events (eg, psychosis, paranoia, hallucinations, agitation, thought disorders and/or behavior abnormalities), depression
  • CNS adverse events like seizures, sleep apnea, respiratory failure, coma, and DEATH

And there’s a black box warning, too, reading in part:

Sodium oxybate is GHB, a known drug of abuse…Even at recommended doses, use has been associated with confusion, depression and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials.

… GHB? Isn’t that the date rape drug?

Yeah.

Free speech nightmare

So Caronia’s idea of a “safe drug” is a little twisted… so he promoted a drug off-label, as countless detail men have and will continue to do… so what? The courts found him guilty and imposed their penalty.

A real slap on the wrist -- one year of probation, 100 hours of community service, and a $25 "special assessment."

A real slap on the wrist — one year of probation, 100 hours of community service, and a $25 “special assessment.”

If only that were the end of the story.

Caronia decides to appeal. He claims that prosecuting him for off-label marketing is a violation of his right to commercial free speech, and is therefore unconstitutional. And yesterday, in spite of significant legal precedent condemning off-label marketing as a violation of the Food, Drug, and Cosmetic Act [FDCA], 2 out of 3 judges in a US federal appeals court agreed with him. According to the court’s decision:

A pharmaceutical representative’s promotion of an FDA-approved drug’s off-label use is speech. As the Supreme Court has held: “Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.” (Sorrell v. IMS Health)… Caronia argues that he was convicted for his speech — for promoting an FDA-approved drug for off-label use — in violation of his right of free speech under the First Amendment. We agree.

- Judge Chin, in the court’s decision

Right now, this ruling only affects the circuit covered by this particular court – New York, Connecticut, and Vermont – but the FDA is likely to appeal the ruling to the Supreme Court. And if the Supreme Court upholds the decision, a drug, once approved for one purpose, can basically be marketed for any purpose at all.

The comments of Judge Livingston, the one dissenting vote, are sobering indeed:

If drug manufacturers were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses. Prohibiting such promotion is thus “one of the few mechanisms available” to encourage participation in the approval process. And premarket approval improves drug safety and effectiveness only to the extent that drugs are not sold without such approval.

The law generally permits a hardware store to sell turpentine, and though such conduct may not be advisable, the law generally permits a consumer to purchase that turpentine and use it as a pain reliever. Under the majority’s reasoning, then, any substance that may be legally sold for some purpose may be promoted by its manufacturer for any purpose—so long as the manufacturer’s statements are merely unsubstantiated, rather than demonstrably false or misleading. [emphasis added]

One can easily imagine the future that Livingston alludes to. Drug X is in development by a pharmaceutical company. They speed through the approval process by focusing on just one or two indications in a small population. Then, as soon as they get the now very hollow “OK” from the FDA, they start marketing Drug X as a cradle-to-grave miracle drug that will address everything from acne and ingrown toenails to colic and existential crises! A vast new market is created! Stock price charts will have beautiful black lines that go up! Doctors will be hired for speaking tours, shareholders will be counting their electronic dollars with glee, and patients will find themselves a part of the thrillingly inexorable march forward of the pharmaceutical technocracy!

A drug that was tested on only a few indications and populations is unleashed on the public. We discover the potential adverse events and safety issues, not in a small, clinical trial setting, but in the real world – and a certain percentage of people experience the ultimate adverse event: DEATH.

But hey, that’s a small price to pay to preserve the pharmaceutical industry’s commercial freedom of speech, right? To say whatever unsubstantiated thing they want as they peddle their wares? And given modern day scientists’ phenomenal ability to prove that things are inconclusive, given the vast amount of well-researched “may bes” (as in “may be linked to cancer” or “may be linked to brain shrinkage“)… I reckon the right researchers receiving the right amounts of pharmaceutical dollars could keep pharma’s off-label marketing slogans in scientifically unsubstantiated limbo almost indefinitely.

To read the court’s opinion in its entirety (and follow the snarled strands of this spider’s web), click here.


Just for fun – the Xyrem Success Program instructional video! Actual quote: “Be sure you are sitting in bed while you drink it, so you can then lay down immediately afterwards.” Otherwise you might pass out on the floor.

Lemons into Lemonade: How an off-label marketing fine can be good for business 10/30/2012

Posted by ALT in Pharmaceuticals.
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3 comments

2000: Sales of Pfizer’s Neurontin, a medication approved for the treatment of epilepsy, reach nearly $1 billion — a big surprise for a medication geared towards such a small, niche market.

2002: The media breaks the story of a lawsuit (Franklin v. Pfizer) charging that Pfizer illegally marketed Neurontin off-label as a treatment for individuals labeled as “bipolar.”

May, 2004: Pfizer pleads guilty to charges of marketing Neurontin off-label and pays $430 million in fines. By some estimates, around 90% of Neurontin sales were for off-label purposes.

(3 months later)
August, 2004: Generic form of Neurontin (gabapentin) becomes available.

(4 months later)
December, 2004: The FDA approves Pfizer’s Lyrica, a new drug for epilepsy similar to Neurontin. The company begins to aggressively market this new, patented (ie, expensive) drug.

(Can you see where this is going?)

2009: Pfizer settles another off-label marketing suit for $2.3 billion involving Lyrica and several other drugs.

2011: Sales of Lyrica reach $3.1 billion, 2 years before patent is set to expire.

Neurontin was coming off patent anyway and the lawsuits simply accelerated the desired shift from off-label Neurontin use to off-label Lyrica use.

-Dr. Randall S. Stafford, who studies drug marketing

2012: A new study documents an increase in spending on epilepsy drugs prescribed off-label for individuals labeled as “bipolar.” The authors suggest that off-label marketing lawsuits merely caused a substitution  of new epilepsy medications for old ones in the off-label marketing/prescribing equation.

In recent years there have been several large lawsuits setting out to punish pharmaceutical companies for illegal off-label promotion…[I] suspected that it might be possible that there could be unintended consequences of that. The unintended consequences are substitution of similarly unsubstantiated [and patented] products and an increase in spending [on off-label prescriptions] overall.

-Meredith Chance, pharmaceutical policy researcher and co-author of a new study: “Intended and Unintended Consequences of the Gabapentin Off-Label Marketing Lawsuit Among Patients With Bipolar Disorder

The end was near for Neurontin, and Lyrica was waiting in the wings.  Was taking the hit for off-label marketing in 2004 all part of a plan to boost sales for forthcoming Lyrica, now the star performer in the Pfizer portfolio?

A willfully maintained ignorance of the reality of antipsychotic withdrawal syndrome 10/22/2012

Posted by ALT in Mental Health Research, Pharmaceuticals, Psychosis.
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9 comments

SCIENCE. (Read that with a deep, booming, authoritative voice)

SCIENCE has achieved an exalted level of infallibility in our society. Start a sentence with “researchers say…” and you’ll not be questioned.  We mortals can only look to our pantheon of data collectors with wonder and awe. We dare not question their pronouncements, percentages.

“Blessed are the 64.3% of all statistics that are made up on the spot, for they shall make your argument mighty.”

Here’s the thing about SCIENCE as a new religion: the way it’s framed, there’s no faith involved. You’re not asked to believe anything. Instead, you’re given data, objective facts, supposedly THE TRUTH as derived through the scientific process. Either you accept the truth, or you deny it. But you can’t argue with it; the facts don’t lie, do they?

The Facts Don’t Lie; Researchers Do

Lie.  That’s an inflammatory word, not to be used lightly. It means willful deceit.

But what do we call deceit achieved by willfully maintained ignorance? Is that a lie?

Whatever it’s called, that’s what I witnessed time and time again during my employment with the Research Scientists of Children’s Mental Health: careful avoidance of any idea that challenged their painfully constructed, government-funded, biopsychiatric house of cards. And it’s what I saw this morning, staring up at me from a press release about a new study in the New England Journal of Medicine.

HEADLINE: Some with Alzheimer’s better off staying on antipsychotics (study)

Essentially, the study found that abrupt discontinuation of Risperdal doubled the risk of “relapse” (defined as a return of psychotic/aggressive symptoms), when compared to continuation of Risperdal. In the “Conclusions” section, the authors write:

In patients with Alzheimer’s disease who had psychosis or agitation that had responded to risperidone therapy for 4 to 8 months, discontinuation of risperidone was associated with an increased risk of relapse.

Sounds like they just demonstrated that going off antipsychotics can lead to withdrawal symptoms. 

But here’s how principal investigator Dr. D.P.Devanand, who currently has disclosed financial ties to Janssen (makers of Risperdal), Novartis, and Eli Lilly (makers of Zyprexa), interpreted this data:

Caregivers should be aware of the increased mortality associated with these medications in people with dementia… [However] if a patient is taking an antipsychotic and doing reasonably well without any major side effects, they should stay on it.

- D.P. Devanand, principal investigator

Caregivers SHOULD be aware of the increased mortality associated with antipsychotics and dementia patients.  A black box warning issued by the FDA for antipsychotics risperidone, olanzapine, and aripirazole reads (in part) “Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo… These drugs are not approved for the treatment of patients with dementia-related psychosis.”

Caregivers should ALSO be aware of a long and scandalously illegal history of off-label promotion of these drugs to treat dementia when they were not and are not approved for this purpose. Fines for dementia-related off-label marketing prosecuted under the False Claims Act alone have totaled almost $2 billion. And who can forget Lilly’s clever sales pitch for the use of Zyprexa in nursing homes, “5 at 5”?

Lilly even devised a LTC sales slogan used nationwide – ’5 at 5 pm,’ which was shorthand for dosing elderly [nursing home] patients with 5 milligrams of Zyprexa at 5 pm to keep patients calm throughout the night… It’s particularly disturbing that such a potent drug, with so many serious adverse side effects, was so blatantly abused in a vulnerable patient population whose health is already at risk. [A]t many nursing homes this potent antipsychotic was essentially used as a ‘chemical restraint’ for the elderly for whom Zyprexa had no other health benefit.

-Brian Kenney, attorney for the plaintiffs in Zyprexa whistleblower suit resulting in a $1.415 billion fine for off-label marketing

 ONE MORE THING caregivers should be aware of that Devanand et al. neglected to mention:

Antipsychotic Discontinuation Syndrome (IE, withdrawal)

When a person whose brain is accustomed to the presence of an antipsychotic agent abruptly stops ingesting that agent, discontinuation syndrome (withdrawal) is a very likely result. The brain attempts to maintain normal dopaminergic function in the presence of a dopamine-suppressing chemical (antipsychotic) – it does this by significantly enhancing dopaminergic activity.  When the chemical is removed from the equation, there is no longer a counterbalance for the dopamine-enhancing adjustment built up over time in the brain. This is the probable cause of antipsychotic withdrawal symptoms, which can include both psychosis and aggression.

Even in the case of gradual discontinuation of the drug, withdrawal may occur – but take it away abruptly, and you’re essentially guaranteed a display of withdrawal symptoms in a significant portion of the study population.

So Devanand’s study really isn’t all that newsworthy. His data plainly shows that stopping the use of antipsychotics can cause a withdrawal reaction, which is what the FDA-approved label essentially already says – “To prevent serious side effects [read: withdrawal], do not stop taking ZYPREXA suddenly.” And a 2006 literature review summing up many antipsychotic discontinuation studies shows the same thing:

There is evidence to suggest that the process of discontinuation of some antipsychotic drugs may precipitate the new onset or relapse of psychotic episodes. Whereas psychotic deterioration following withdrawal of antipsychotic drugs has traditionally been taken as evidence of the chronicity of the underlying condition, this evidence suggests that some recurrent episodes of psychosis may be iatrogenic.

- Joanna Moncrieff, in “Does antipsychotic withdrawal provoke psychosis? Review of the literature on rapid onset psychosis (supersensitivity psychosis) and withdrawal-related relapse

Here’s the ground-breaking bit: Devanand and co-authors chose not to describe what they observed during the course of the study as “withdrawal” – that word is studiously avoided in the press release and abstract.* Rather, here’s how the results are characterized: the risk of “relapse” should antipsychotic medication be abruptly discontinued is evidence of the need for elderly patients to keep taking their Risperdal.

A classic case of willfully maintained ignorance.

Is it possible that Devanand and co-authors are ignorant of the concept of “withdrawal,” its causes, its symptomatology? Is it possible that they haven’t read the FDA-approved label for Risperdal, haven’t familiarized themselves with the scientific literature surrounding the discontinuation of antipsychotics, and are therefore innocent in their public charactarization of the results of their study as “relapse” best treated with continued use of Risperdal? Yes, it’s possible. It’s even likely that these authors averted their eyes from a mere glimpse of any such information, given the strong financial incentives and conflicts of interest disclosed in conjunction with the publication of this article.

But that’s a shaky foundation to build your innocence on.

The foolish man builds his house upon the sand; the wise man builds his house upon a rock. 

   


* I’d like to tell you the word “withdrawal” is entirely absent from the article itself (and I highly suspect it is!) but, even though this is a publicly funded National Institutes of Health study, the article is not freely available to the funders (we, the people) and I have been thwarted in my attempts to obtain it. Big bonus points if you send it to me.

Why I’m Against Forced Medication 10/15/2012

Posted by ALT in Activism, Patient Rights and Advocacy, Pharmaceuticals.
Tags: , , ,
4 comments

(download printable version here – if you agree with the following, DISTRIBUTE WIDELY!)

WHY I’M AGAINST FORCED MEDICATION:

Long-term use of psychotropic medications causes serious, potentially LIFE-THREATENING ADVERSE EFFECTS. 

  • Antipsychotics cause people to develop diabetes.[1]  They also cause obesity, heart disease,[2] and brain shrinkage.[3]
  • The seriously mentally ill live (on average) 25 years less than the general population.  Use of psychotropic medications is a significant contributing factor to this trend.[4]

A person has the right to refuse treatment that could significantly decrease his/her quality of life and lifespan.

 

Psychotropic medications are LARGELY INEFFECTIVE at healing depression, psychosis, mania, and other mental health issues. 

Medications, if they’re helpful at all, only SUPPRESS SYMPTOMS; long-term use almost always has negative results. 

  • A meta-analysis summing up most known clinical data demonstrated that SSRI antidepressants are no more effective than placebo at treating symptoms of depression.[5]
  • In a 15-year schizophrenia study, those who got off antipsychotic medication were 35% more likely to be recovered than those who took their medications for the duration of the study.[6]
  • The use of antipsychotics causes the brain to become more biologically vulnerable to psychosis over time, a condition called “supersensitivity psychosis.”[7] A similar condition of chronic supersensitivity has also been noted with antidepressants/depression.[8]

A person has the right to refuse treatment that is (at best) ineffective and at worst heightens and/or prolongs symptoms.

    

The argument that “forced medication is justified because it prevents violence” is a Catch-22. 

Supporters of forced psychotropic medication use the fear of violence to justify their position, but individuals with mental health issues are far more likely to be the victims of violence than to perpetrate violent acts.[9]

However, it is true that when a human being is using/abusing many mind-altering substances (like alcohol, most illicit drugs and many psychotropic medications), that person becomes more likely to commit a violent act.[10]

  • Almost all antipsychotics and SSRI antidepressants (and many tranquilizers) have violence-related adverse effects such as “suicidal ideation” “violent thoughts” “aggression” and “homicidal ideation” listed on their FDA-approved labels.[11]
  • Antidepressants approximately double the relative risk of suicide when compared to placebo.[12]

A person has the right to refuse treatment that is known to increase the risk of committing acts of violence against self or others.

We are Americans.  We are full citizens in this free and democratic republic.

We ALL have the right to make an INFORMED and UN-COERCED decision about what we put into our bodies.


[1] Newcomer, J.W. (2007).  Antipsychotic medications: metabolic and cardiovascular riskJ of Clinical Psychiatry 68(4), pp 8-13.

[2] Ibid.  See also: Physician’s Desk Reference.

[3] Ho, B., Andreasen, N., Ziebell, S., Pierson, R., Magnotta, V. (2001) Long-term Antipsychotic Treatment and Brain Volumes, A Longitudinal Study of First-Episode Schizophrenia.  Archives of General Psychiatry 68(2), pp128-137.

[4] Parks, J., Svendsen, D., Singer, P., Foti, M.E. (Eds.) (2006).  Morbidity and Mortality in People with Serious Mental IllnessNASMPHD Medical Directors Council: Alexandria, VA.

[5] Pigott, H.E., Leventhal, A.M., Alter, G.S., and Boren, J.J. (2010) Efficacy and effectiveness of antidepressants: current status of research. Psychotherapy and Psychosomatics, 79(5), pp 267-79.

[6] Harrow, M., Grossman, L.,  Jobe, T., & Herbener, E. (2005) Do Patients with Schizophrenia Ever Show Periods of Recovery?  A 15-Year Multi-Follow-up Study.  Schizophrenia Bulletin 31(3), pp. 723-734.

[7] Chouinard, G. (1980). Neuroleptic-induced supersensitivity psychosis. AJP 137, pp 16-20. Also: Chouinard (1991). Severe cases of neuroleptic induced supersensitivity psychosis. Schizophrenia Research 5, pp 21-23.

[8] Fava, G. (2003) Can long-term treatment with antidepressant drugs worsen the course of depression?  Journal of Clinical Psychiatry, 64(2), pp 123-133.

[9]One study found that individuals with serious mental illness were almost 12 times more likely than the general population to be victims of a violent crime (n = 32,449).  Teplin, L.A., McClelland, G.M., Abram, K.M., & D.A. Weiner (2005).  Crime Victimization in Adults with Severe Mental IllnessArchives of General Psychiatry 62(8), pp 911-921.

[10] Boles, S.M. & Miotto, K. (2003).  Substance abuse and violence: A review of the literatureAggression and Violent Behavior, 8(2), pp 155-174.

[11] Physician’s Desk Reference

[12] Healy, D. (2003) Lines of evidence on the risks of suicide with Selective Serotonin Reuptake Inhibitors. Psychotherapy and Psychosomatics, vol. 72: 71-79.

Your 10 Year Antipsychotics Money-Making Forecast 09/19/2012

Posted by ALT in Bipolar, Children's Mental Health, Pharmaceuticals.
Tags: , , , , , , ,
3 comments

To paraphrase a recently released pharmaceutical industry investment report, your 10 year antipsychotics money-making forecast is as follows: partially cloudy skies in 2011 will give way to full sun by 2021.

In other words, antipsychotic patent expirations will be tempered by the emergence of new BLOCKBUSTER antipsychotic drugs, and investors can expect to make a PILE of money by 2021.

The 208 page report, produced by the market research firm of Decision Resources, goes on to make the following predictions:

  • sales for schizophrenia therapies will drop from $7.4 billion in 2011 to $6.5 billion in 2014 in the developed world, as people switch to newly available generics
  • the launch of new drug therapies will increase profits thereafter to $8 billion by 2021
  • these will include glutamine reuptake inhibitors, which will be marketed as “adjuncts” to antipsychotics which address the so-called “negative” symptoms of schizophrenia (apathy, catatonia, low self-esteem, etc.) and are expected to achieve blockbuster status
  • also included are injectable atypical antipsychotics, sales of which will more than double from $1.4 billion in 2011 to $3 billion in 2021

Well, I’d like to try my hand at a little forecasting myself.  In order for those 8 billion buckaroos (or more!) to find their way into the right pockets, I expect we’ll see:

  • Heavy recruitment of key “opinion leaders” by pharma, supposedly unbiased researchers and clinicians whose endorsements for pharma products are bought and paid for by way of massive bribes (er, I mean funding) for “research” with predetermined outcomes, specifically designed to promote pharma’s commercial interests.
  • A whirlwind of publications promoting the use of long-acting antipsychotic injections, glutamine reuptake inhibitors, the need for polypharmacy in the treatment of schizophrenia, or any combination therein
  • A concerted effort at a.) expanding the members of the population that could be construed as suffering from so-called “schizophrenia” b.) expanding the list of other uses for these drugs, including any and all known or as-yet-unknown “diseases” and “conditions” (even if they must be created out of thin air) and c.) further ingraining the idea that conditions which require the use of these drugs are serious, chronic, and require probably lifelong use of patented medications – no generics, please!
  • If required by the myth-building machine that will lay the foundation for the forthcoming BLOCKBUSTER drugs, paradigm shifts away from currently accepted ideas (perhaps the general public’s abhorrence of forcibly injected, mind-altering drugs?  Or a sly admittance that the whole “dopaminergic” hypothesis regarding the biological cause of schizophrenia was, perhaps, maybe, incorrect?)

The logic behind this forecast is simple: it’s exactly what was done by pharmaceutical companies to promote blockbuster atypical antipsychotics 10 years ago.  And why get creative when the scam worked so well the first time around?

The scam that worked so well

A lot of internal documents never meant for public eyes have come to light in the recent litigation against Johnson & Johnson for Medicaid fraud and the off-label marketing of RISPERDAL.  Two delightful samples will be dissected below:

  1. The full deposition of Alex Gorsky, current CEO of Johnson & Johnson (makers of RISPERDAL), recorded in May, 2012 as part of the national RISPERDAL litigation.
  2. The Annual Report (2002) of The Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital, a research center that presented that was charged by their funders (J&J) to produce specific research outcomes that would support the commercial goals of the company.  This a report from the Center to its funders on their progress towards these goals.

Early in Gorsky’s deposition, we learn that the Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital, headed up by Dr. Joseph Biederman, was established by a grant from J&J and its affiliates for $500,000 in 2001. The center was described in an internal J&J email as “a great way to get the word [about RISPERDAL] out to a big part of the child and adolescent prescribing community.” This was a full 5 years before Risperdal was approved for pediatric use. 

And if the name “Joseph Biederman” sounds familiar, that’s because Biederman is commonly acknowledged as the originator of the idea that childhood bipolar disorder is, in fact, a widespread pediatric disease which must be aggressively treated with medications, specifically antipsychotics.  His turn-of-the-millennium publications with Janet Wozniak are credited with jumpstarting the 4000% increase of this diagnosis in children.

More recently, Biederman gained notoriety for some seriously scandalous behavior: he guaranteed J&J company representatives favorable outcomes for a 2005 trial of RISPERDAL in preschoolers.  This did tarnish his reputation a little, but by no means did it motivate any of the institutions for which he works (Harvard Medical School, Massachusetts General Hospital) to dismiss him.

Interesting aside: As Bob Fiddaman reports on his blog, here’s an excerpt from an earlier (Feb, 2009) deposition from Dr. Biederman: when asked what rank he held at Harvard, he answered “Full professor.”  “What’s after that?” asked a lawyer, Fletch Trammell.
“God,” Dr. Biederman responded.
“Did you say God?” Mr. Trammell asked.
“Yeah,” Dr. Biederman said.

What you’ll see in the documents below is that 2005 was not the beginning of Biederman’s agreement with J&J to produce favorable results validating the research conclusions they specified in advance; that’s been going on at least since 2001, and perhaps earlier. 

And what exactly did Johnson & Johnson want him to prove?  That there is such a thing as childhood bipolar disorder.  It’s a brain disease, likely chronic, that requires lifelong medication adherence.  And most importantly: kids need to be taking RISPERDAL.

From the  Annual Report (2002) of The Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital

An essential feature of the Center is its ability to conduct research satisfying… [certain] criteria…. [including that] it will move forward the commercial goals of J&J.

Considering that nearly all psychiatric medication use in children is off label, studies of safety and efficacy in children are essential for clinicians, parents, and patients to feel comfortable using these medications in children… Equally important to effective use of medications is the demonstration of the validity of disorders.  Because parents, patients, and clinicians are exposed to a media that frequently questions the validity of childhood disorders, genetic and brain imaging studies are needed to show the validity of these disorders as brain disorders that respond to medication.  Epidemiologic studies are needed to show that childhood disorders are frequently chronic and severely debilitating.  Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events….

Through the funding provided by J&J, we [the J&J Center for Pediatric Psychopathology] are creating a team of investigators focusing on the following issues:

We will generate and publish data on the efficacy and safety of medications for improving currently available treatment options for child psychopathology.  This work is an essential precursor to the … widespread use of medications given that most must be used off-label.

[…]
(emphasis added)

From the deposition of Alex Gorsky, CEO of Johnson & Johnson (makers of RISPERDAL)

[by the way, Gorsky is positively the most skilled waffler I have ever encountered!  Twice in the deposition he admits to having given the opening address at a meeting (it was, unfortunately for him, noted in the agenda), but can't recall having been there or any of the other things said, and even goes so far to suggest that he may have given the opening address but then, somehow... left.  Maybe he was the guy they sent to pick up lunch...]

Gorsky, is that you??

Scientific “research” to further Johnson & Johnson’s commercial aims

Q. You see this document is called “Annual Report 2002: The Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital“?… And the director is Joseph Biederman, M.D., whom we’ve spoken about a couple times today, right?
A. Yes.
Q. Let’s turn to page 861, please, Mr. Gorsky, which is it is executive summary of the annual report. The first sentence of the overview says that “The mission of the Center is…a strategic collaboration between Johnson & Johnson and the Pediatric Psychopharmacology Research Program at the Massachusetts General Hospital.” Is that correct?
A. Yes, that’s what it says.
[…]
Q. Let’s turn to the next paragraph, Mr. Gorsky. It says, “An essential feature of the Center is its ability to conduct research satisfying three criteria. . .” Did I read that right?A. Yes.
Q. And if we look at the third criteria, it says “it will move forward the commercial goals of J&J.” Is that correct?
[…Gorsky tries and fails to avoid answering this question. Finally…] A. Yes.
Q. So, this annual report from the Johnson & Johnson Center For Pediatric Psychopathology from 2002 admits that information and research from this supposedly unbiased research center is to benefit the business of sales for Johnson & Johnson. Is that correct? … And commercial goals would include sales of pharmaceuticals. Is that right?
A. Yes, it would.

Promoting the widespread use of medication, specifically RISPERDAL, in children

Q. Okay. And then if we look at the next sentence from the annual report, it says “We strongly believe that the Center’s systematic scientific inquiry will enhance the clinical and research foundation of child psychiatry and lead to the safer, more appropriate and more widespread use of medications in children.” Did I read that correctly?
A. Yes, you did.
Q. So…one of the goals of this center’s inquiry is to lead to the more widespread use of medications in children. Is that right?
A. […extensive verbage from Gorsky, followed by…] yes.
Q. … Mr. Gorsky, let’s look at the next sentence, where it says “Considering that nearly all psychiatric medication use in children is off label. . .”
Q. Do you see that?
A. Yes, I do.
Q. And that would include Risperdal because in 2002, I think we’ve already agreed, Risperdal was not approved for use in children and adolescents. Is that right?
A. Based upon our earlier conversation, it did not have the specific indication at that time, that’s correct.
[…]

Producing lifelong RISPERDAL customers

Q. And it [the J&J Research Center’s 2002 Annual Report] says — and this is interesting — “Showing how pediatric mania evolves into what some have called mixed or atypical mania in adulthood will provide further support for the chronic use of RISPERDAL from childhood through adulthood.”
Do you see that?
A. Yes, I do.
Q. So, one of the specific goals of the center is to show that pediatric mania will evolve into mania in adulthood, which will then require the chronic use of Risperdal from childhood to adulthood. Is that right?
A. […much waffling, and then…] I think if that was the goal as outlined, that was a reasonable research objective.
 […]
Q. And the continuation of Risperdal from childhood to adulthood would be one of those –remember back in the beginning of this document we saw the word there were commercial goals of Johnson & Johnson, right?
A. Yes, I did see that.
Q. All right. And the continuation of a Risperdal prescription from a young man or young boy through adulthood would be a commercial goal of Risperdal, right? Or of Johnson & Johnson, I’m sorry.
A. Successful treatment of patients, if they were responsive on the medication, for them to stay compliant on the medication would be one of our goals, but only if the drug was working and the patient was living better.
Q. So, the way I interpret this is that Johnson & Johnson and Massachusetts General Hospital and Dr. Biederman are collaborating to validate a lifetime use and treatment with Risperdal. Is that correct?
A.[…further waffling…]

(emphasis added)

Dear Allen Frances — how to reduce the “proclivity of the violent” 08/07/2012

Posted by ALT in DSM-5, Pharmaceuticals.
Tags: , , , , , ,
2 comments

Dr. Allen Frances.  We’ve been hearing his name a lot this past year, haven’t we? [and not in conjunction with his excellent tan!]

A fine specimen of “middle way” protesting, which poses as activsm for real psychiatric reform, but does little more than reinforce psychiatric treatment-as-usual, perhaps with a few Orwellian language shifts along the way.  Here’s an instructive string of emails to prove the point — no DSM protest unless it’s Dr. Allen Frances APPROVED DSM protest

Anyhow, in a recent blog for the Psychiatric Times (“Mass Murderer Psychobabble Misses Gun Policy Point“), he writes that “there is no indication that psychiatry can change the statistics of violence or the proclivity of the violent.”

I beg to differ, and wrote him an email to tell him so.

***

From: ALT
To: Allen Frances
Subject: Response to your recent “Psychiatric Times” Blog

Dear Allen Frances,

In a recent blog for the Psychiatric Times, you state that “psychiatry has no way to predict mass murder and no way to prevent it.”  Hammering the point home later on, you write that “there is no indication that psychiatry can change the statistics of violence or the proclivity of the violent.”

Sir, I believe you are in error.

As you may be aware, there are many examples of psychotropic medications (commonly prescribed by psychiatrists to their patients) which list “suicidality,” or “suicidal ideation,” “acting aggressive, being angry, or violent,” “agitation,” and “mania,” as side effects in the Physician’s Desk Reference [PDR], a publication of the official FDA-approved labeling and information for all drugs.  A violent combination of effects, don’t you agree?

For example, clonazepam (Klonopin) and lorazepam (Ativan), two common benzodiazepines, list “suicidal ideation” or “potential to commit suicide” as a side effect.  Doctors are also cautioned about “paradoxical effects” – which could include aggression and hostility.  The Medication Guide for Serqouel, an antipsychotic medication, lists “thoughts of suicide or dying,” “feeling very agitated or restless,” “new or worse irritability,” “acting aggressive, being angry, or violent,” “acting on dangerous impulses,” and “mania” as symptoms that may occur in conjunction with use of Seroquel – something to be brought up with a doctor immediately.  And, perhaps most well-known of all, selective serotonin reuptake inhibitor [SSRI] antidepressants such as paroxetine (Paxil), fluoxetine (Prozac), and citalopram (Celexa) carry a black box warning about the potential to cause suicidality in children, adolescents, and young adults.   Furthermore, a 2004 booklet published by the FDA (which is also inserted at the end of every antidepressant entry in the PDR) lists, under a heading entitled What to Watch Out For in Children or Teens Taking Antidepressants: “thoughts about suicide or dying,” “attempts to commit suicide,” feeling very agitated or restless,” “acting aggressive, being angry, or violent” as potential side effects. 

The list of psychotropic drugs indicated in causing restlessness, agitation, aggression, suicidality, and violence goes on, as I’m sure you know.

There is also a legal precedent acknowledging the reality of drug-induced suicidality and homicidality.  Are you familiar with the case of Tobin v. SmithKline Beecham?  Donald Schell, a 60-year-old man with no psychiatric history, was having trouble sleeping.  His physician prescribed him Paxil, and 48 hours later he murdered his wife, daughter, and granddaughter—then shot himself.  The court awarded $8 million in damages and wrote in its opinion that “Paxil can cause some individuals to commit suicide and/or homicide,” and that “Paxil was the proximate cause of the homicides and suicides involved in this litigation.”*

You may be interested to know that the legal definition of proximate cause is “the primary cause of injury… proximate cause produces particular, forseeable consequences without the intervention of any independent or unforeseeable cause.”**

In other words, the court ruled that Paxil was the primary cause of Schell’s violent actions, and this was a forseeable consequence of his taking Paxil.

Bearing all of this in mind, I think the statement that “there is no indication that psychiatry can change the statistics of violence or the proclivity of the violent” is erroneous.  There is, in fact, something very simple psychiatrists can do:

stop prescribing drugs that, by their manufacturers’ own admissions, cause people to become aggressive, angry, violent, and suicidal.
 

Yours truly,

ALT

Mental health activist and writer
Not a member of the Church of Scientology
Not an “antipsychiatrist” (very much pro- “soul healing,” in fact)
 
 

 
* Tobin v. SmithKline Beecham Pharmaceuticals, 164 F.Supp.2d 1278, 1284.
** West’s Enyclopedia of American Law, Second Edition. (2008).

Beautiful lady and old hag at play on Bipolar Awareness Day! 06/27/2012

Posted by ALT in Bipolar, Depression, Mental Health Research, Pharmaceuticals.
Tags: , , , , ,
3 comments

Two studies with nearly identical data yield very different conclusions.  Beautiful lady or old hag?  Both collected data showing that individuals initially receiving a diagnosis of “depression” and treatment with antidepressants convert to “bipolar” diagnoses at an impressively high rate.

But the survey released today (in honor of the UK’s “National Bipolar Awareness Day”) by Bipolar UK portrays the data on conversion as evidence of misdiagnosis and the need for better awareness of bipolar disorder by mental health professionals, while this study from 2004 attributes conversion, not to misdiagnosis, but largely to antidepressants’ tendency to cause mania (it is a PDR-listed side effect, after all).

Is the rise of bipolar diagnoses in the US (a 56% increase in adults between 1996 and 2004) and Western Europe a largely iatrogenic phenomenon?

I decided to write Bipolar UK to ask them their thoughts on the matter.

***

From: ALT
To: the folks at Bipolar UK
Subject:  Enquiry Related to “Challenges to Diagnosis” Survey

Hello,

First, let me wish you a happy National Bipolar Awareness Day!

I read the executive summary of your recent survey of individuals diagnosed as “bipolar” with great interest.  I was particularly struck by two statistics you presented:

- 85% of respondents were diagnosed with and treated for depression before being diagnosed as bipolar

- 71% of those receiving delayed diagnosis felt that their symptoms had been made worse by antidepressants or sleeping pills

Your data reminds me of a widely cited 2004 study in which 87,920 individuals initially diagnosed with depression were followed for 5 years.  4182 eventually received a diagnosis of bipolar (“converted”) during the course of the study, and 81% of them were being treated with antidepressants.  The authors state in their analysis that “the conversion rate amongst antidepressant-treated patients (7.7% per year) was 3-fold that amongst unexposed patients (2.5% per year).”  These findings are quite consistent with yours.

Your interpretation of this data seems to be that the timely diagnosis of bipolar disorder is an area that needs improvement amongst mental health professionals, who currently are misdiagnosing many bipolar individuals with depression.

However, I would like to suggest to you another interpretation, one that the previously cited study puts forward.  Its authors state that “It has long been known that antidepressant medications can precipitate mania in vulnerable individuals” and that “treatment with antidepressants is associated with … conversion hazards.”  “Mania/hypomania” are also listed in the Physician’s Desk Reference as effects of both SSRIs and tricyclic antidepressants.  The PDR entry on imipramine (the very first tricyclic antidepressant) explicitly states “Manic or hypomanic episodes may occur; consider decrease until episode is relieved.”

Is it possible that many of the respondents to your survey, and many of the individuals you serve – in short, people with “bipolar” diagnoses – are dealing with an entirely iatrogenic phenomenon? 

On this inaugural “Bipolar Awareness Day,” I think it is vital that we pursue awareness, not only of the diagnostic criteria, but also of the very real possibility of diagnostic inflation that is iatrogenic in nature.

I look forward to hearing your thoughts on this.

Yours truly,

Alice Tremont
Writer, mental health activist
http://altmentalities.wordpress.com

 

Psychiatry-as-usual: beautiful lady or old hag? 06/26/2012

Posted by ALT in Mental Health News, Pharmaceuticals.
Tags: , , , , ,
9 comments

There is a famous optical illusion called the young lady and the old hag.

The drawing illustrates how one’s perception of an object can suddenly flip, and in a sense, the dueling histories [of psychiatry]… have that same curious quality.  There is the “young woman” picture of the psychopharmacology era that most of American society believes in, which tells of a revolutionary advance in the treatment of mental disorders, and then there is the “old hag” picture… which tells of a form of care that has lead to an epidemic of disabling mental illness.

… If you think of the [psychotropic] drugs as “anti-disease” agents and focus on short-term outcomes, the young lady springs into sight.  If you think of the drugs as “chemical imbalancers” and focus on long-term outcomes, the old hag appears.  You can see either image, depending on where you direct your gaze.

- Robert Whitaker, Anatomy of an Epidemic

***

It’s my new favorite metaphor for looking at psychiatry (replacing the tried-and-true “Emperor’s New Clothes”).  The gulf between what mainstream psychiatry preaches about mental and emotional distress and what alternative and critical thinkers have to say is vast.  On one side is an almost completely biological interpretation of mental distress as a chronic disease requiring lifelong chemical intervention, “management,” compliance, and across-the-board lowered expectations – for livelihood, and life.  On the other is the idea that extreme emotional states, if not directly iatrogenic, are often the result of environmental, social, and historical factor, are better not pathologized, and in some cases (specifically, a first break into psychosis) may actually be part of a psychic healing process.

The space between being dotted with possibilities as well, though a position located exactly in the middle is about as sturdy as a house built directly over the San Andreas Fault Line.

Not a good idea.

When I look at the illusion, my strongest inclination is to see the young lady.  Only by staring intently for several minutes, carefully searching for the hag, can I find her – it’s the nose that does it, finally. 

And though my strongest inclination is to see psychiatry-as-usual as the old hag, I recently had a experience of the beautiful lady, and in this case, it was the appeal to my heart that did it.

A daughter’s story

When My Crazy Father Actually Lost His Mind,” by Jeneen Interlandi, ran in the New York Times magazine this weekend, and it is moving,  heart-wrenching. 

It’s a daughter’s retelling of her father’s most recent protracted manic episode, and the devastating costs – financial and otherwise – to her entire nuclear family.  During a manic period that lasted from August 2010 until late February 2011, her father endured 5 emergency room visits, 4 arrests and court appearances, numerous police confrontations, 25 days in a psychiatric hospital and 40 in a county jail.  Total medical expenses were more than $250,000.

Ms. Interlandi’s story is one of a frightened family desperately seeking a way to stabilize her father – and they felt that forced medication compliance, a stay in a psychiatric facility, or both, were the way to accomplish this. 

Here’s what I thought should have happened: My father should have been hospitalized against his protestations until his mania subsided. Once it did, he should have been released under supervision and under the condition that he abstain from drinking, which can exacerbate the symptoms of bipolar syndrome, and adhere to a treatment plan involving some combination of talk therapy and medication. I imagined something like probation, but run by a mental health office instead of a criminal court.

- Jeneen Interlandi, in the New York Times magazine piece “When My Crazy Father Actually Lost His Mind

And though we do not hear directly from her father about his experience, it seems he had different ideas about what should happen:

We wanted him to go to a state hospital, where he could be cared for until he came around to taking his medication or until his mania subsided … He wanted to go home.  But he was unwilling to take any of the steps that we were laying out for him to get there.  He insisted that nothing was wrong with him and refused to take mood-stabilizing medication.

- Jeneen Interlandi

Ultimately, Ms. Interlandi’s family got the kind of medication compliance plan they were looking for (complete with probation officer), and the story ends with a scene of domesticity in the Interlandi home. 

I asked him what he remembered about the whole ordeal… He [said he] felt like some other being had possessed him for a time. And he hoped that whatever it was, it was gone for good. My mother echoed those sentiments, shouting from the kitchen that it was the only part of their marriage that she wished to forget. Both of them seemed perfectly happy to ignore the fact that bipolar disorder is considered to be a lifelong condition. They would bury this alongside their other shared tragedies until, eventually, it became just another story they told.

- Jeneen Interlandi

Threats of violence from a man who has fiercely loved his wife all the years of their marriage, half-hearted suicide attempts from this gregarious lover of life – one can understand why the author felt as if “an evil alien had invaded his mind and taken over his body.”  My heart goes out to a family that managed to stick together through this bipolar nightmare (the author’s mother was told she might want to “get a divorce” by her doctor in the midst of the crisis; she promptly got a new one), and I am happy that, at least for now, they have found the stability they so ardently sought. 

The beautiful lady grants them a return to domestic bliss.

BUT

The thrust of Ms. Interlandi’s article was that her family’s worst suffering was directly caused by the difficulty they had in getting her father committed and medicated – if only involuntary commitment were easier and there were more places for such people to be committed to, her father could have (her words) “been cared for until he came around to taking his medication.” 

One can fairly say that stability via medication compliance was a top priority for this family; Mr. Interlandi’s return to his home was conditional and depended upon it.

Is this the only way to achieve stability?

It’s an important question, because the number of adults (and children, too!) experencing severe mania and being diagnosed with bipolar disorder is soaring.  From 1996-2004, the number of adults given the bipolar diagnosis rose by 56%.   And I’m sure most readers are familiar with the 4000% increase of childhood bipolar disorder diagnoses between 1998 and 2004.

How to explain this?

We turn again to the old hag, psychiatry-as-usual.

A person treated with an anti-depressant has a significant chance of experiencing mania and receiving a bipolar disorder diagnosis that is, in reality, describing an entirely iatrogenic (drug-induced) phenomenon.

 A 2004 study of 87,290 people originally diagnosed with depression or anxiety found that those treated with anti-depressants “converted” to bipolar disorder at the rate of 7.7% per year – ultimately adding up to between 20% and 40% of all people treated with anti-depressants.  And this survey found that 60% of people with a bipolar disorder diagnosis said they “had initially fallen ill with major depression and had turned bipolar after exposure to an antidepressant.”

As it turns out, for many with a bipolar diagnosis, medication adherence is the key to instability, to increased mania and ever-more-rapid cycling.  This is especially true for people who withdraw abruptly from their medications (as mania is a well-known symptom of rapid withdrawal from both antidepressants and mood stabilizers).  And folks who do comply with long-term medication adherence have significantly worse mental and physical health outcomes than those who don’t – the science shows this over and over again.

A question

It becomes clear from reading the New York Times comments section that Ms. Interlandi’s experience is not unlike that of many other families, desperate for a loved one’s return to stability that they believe can only be achieved by lifelong medication compliance, enforced, when necessary.

But how many of these beloved family members would never have experienced mania without previous exposure to a psychotropic drug?  How many of these families would’ve been spared the endless cycling through moods, courts, hospitals, and jails, the threats, the attempted suicides if a family doctor had put away the prescription pad?   

How many of the new bipolar diagnoses are iatrogenic

Psychotroipcs as first line treatment, long term medication adherence, psychiatry-as-usual: beautiful lady or old hag?

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