freakoutcrazy

Blog des AK Psychiatriekritik der NFJ Berlin

Monat: Januar, 2012

The Taint of Eugenics In NIMH-Funded Research Today

by Robert Whitaker

Recently, Thomas Insel, director of the National Institute of Mental Health, identified the “NIMH’s Top 10 Research Advances of 2011.” He wrote:

“This has been a year of exciting discoveries and scientific progress . . . Here are 10 breakthroughs and events of 2011 that are changing the landscape of mental health research.”

His words fit neatly into a larger narrative in psychiatry, which is that of science on the march. For the past 30 years (or even longer), leaders in the field have regularly told of “great advances,” and of how “extraordinary” new research is leading to “tremendous advances” in care, and Insel’s list is the latest addition to that narrative. And yet—and this is the puzzling part of this modern tale of scientific progress—the burden of mental illness in our society keeps going up and up, and clinical outcomes have, in anything, worsened in the past 30 years (at least for affective disorders.)

So, in the hope of gaining some insight into this mystery, let’s take a closer look at Insel’s list of “exciting discoveries” and “breakthroughs” from the past year. Here are the titles for the top five:

Complexity: Discovering New Sources of Genetic Variance.
Transcriptome: Developing Brains Have Unique Molecular Signatures.
Induced Pluripotent Stem Cells: Disease in a Dish.
De Novo Genetic Variants.
Epigenomics: How Experience Alters Behavior.

If your initial response is like mine, you may be tempted to say: what a bunch of molecular gobbledygook. But then I took a deep breath and sought to identify, in a more clear-headed way, why this list is so disappointing.

The first reason is a practical one. Researchers have spent the last 30 years trying to identify molecular and genetic explanations for psychiatric disorders, but this effort has not led to any therapeutic advance. In fact, it is proving so barren that many drug companies are shutting down their efforts to develop new psychiatric drugs, precisely because such research has failed to identify promising new molecular targets. So why keep on pursuing this tack? Might it be time to put our federal dollars into research more likely to produce a therapeutic benefit?

But the second reason for disappointment is the more important one. Insel’s list tells of a research enterprise devoted to identifying what is genetically wrong with the “mentally ill.” That is a pursuit—as the history of eugenics reminds us—that inevitably engenders bad social policy and a great deal of harm.

In 1869, Sir Francis Galton, cousin to Charles Darwin, gave birth to eugenics when he published a book titled Hereditary Genius. In it, he concluded that it was nature, rather than nurture, that made the superior man. Thus, he argued, humans were decidedly unequal. Democratic ideals that men were of “equal value,” he wrote, were simply “undeniably wrong and cannot last.”

This was a sentiment that rang true to one group in American society: the ruling elite with a White Anglo Saxon Protestant heritage. Many believed that a large influx of non-WASP immigrants was weakening the country. Soon, American eugenicists were busily ranking ethnic groups along a “more fit and less fit” spectrum, and the “insane” were put at the bottom of the list. Eugenicists then argued that in order to keep America strong, it was necessary to encourage those with “good germ plasm” to have lots of children, and to prevent those with “bad germ plasm” from breeding.

In 1896, Connecticut became the first state to prohibit the “insane” from marrying. Other states followed suit, and by 1933, there were no states left where the insane could legally tie the knot. However, the problem with such laws, eugenicists lamented, was that few people seeking a marriage license declared themselves insane. The insane, one eugenicist noted, are “biased” in their own favor.

Thus, since that social policy didn’t do the trick, eugenicists began arguing that the insane needed to be segregated from society in mental hospitals. They needed to be locked up and kept there until their breeding years passed. This belief—that the “insane” needed to be removed from society—led to a rapid buildup in the number of hospitalized mentally ill, which increased from 31,973 in 1880 to 272,527 in 1929.

At that time, a Journal of Hereditary editorial concluded that “segregation of the insane is fairly complete.” But eugenicists had also been advocating for a more permanent solution to the “breeding” problem, and now they got their wish. In 1907, Indiana had become the first state to authorize forced sterilization of people with “hereditary defects,” and in 1927, the U.S. Supreme Court declared such state laws constitutional. By the end of 1945, more than 45,127 Americans had been sterilized under such laws, 21,311 of whom were patients in state mental hospitals.

As such social policies took hold, a number of scientists at top colleges promoted eugenics as a science. By 1914, 44 colleges in America had introduced eugenics into their curriculums, and such courses were particularly popular at such elite schools as Harvard, Columbia, Cornell and Brown. By 1924, more than 9,000 research papers on eugenics had been published, and the Eugenics Research Association could boast that a third of its 383 members were fellows of the American Association for the Advancement of Science, the national’s most prestigious scientific group.

The physician who took the lead in proving that insanity was an inherited disease was Aaron Rosanoff, a physician at Kings Park State. He charted the family histories of 72 insane patients, but initially he did not find the results he expected. Among the 1,097 relatives of the 72 patients, only 43 had ever been hospitalized for a mental illness, a number far too low to show a causal genetic link. But Rosanoff was determined to prove there was one, and so he decided that he had defined mental illness too narrowly. If he expanded the definition of what could be considered abnormal behavior, and thus could include people who were “high strung, excitable, dictatorial, or abnormally selfish” as mentally ill, he determined that the 72 patients had 351 relatives who were mentally unwell. This was very close to the precise number he needed to conclude that insanity was a single gene recessive disorder, transmitted much like blue eyes. If a child inherited a copy of the normalcy gene from one parent and the insanity gene from another, he or she would grow up to be normal but would be a “carrier” of insanity. A child who got the insanity gene from both parents was doomed to be insane as an adult, he wrote.

This “finding,” and other such findings said to prove that mental illness was a genetic illness, naturally led the public to fear the hospitalized mentally ill. Their genes were a threat to society’s collective gene pool. Meanwhile, in their writings, eugenicists described the mentally ill as “social wastage” and as “unfit” human beings, and talked about the need to remove this “social cancer” from American society. With such declarations influencing the American mind, 66% of the public said in 1937 that they favored sterilizing the “defectives” in society.

This disparagement of the mentally ill naturally led to a drop in public funding for state mental hospitals, and many fell into total disrepair. In addition, it set the stage for psychiatry, in the 1930s and 1940s, to embrace a quartet of medical therapies that were understood to “work” by damaging the brain. The therapeutic reasoning was easy to understand: If the mentally ill had little value, and were generally “unfit” human beings, then therapies that quieted them and made them easier to manage—even if they seemed to knock the patients down to a lower level of being—could be embraced as helpful. The first three such therapies were insulin coma therapy, metrazole convulsive therapy, and repetitious electroshock therapy. The fourth was frontal lobotomy, which at the time was hailed as a miracle brain surgery.

Today, as a society, we would never conclude that we hold “eugenic” ideas about the “mentally ill.” Eugenics became a discredited science at the end of World War II, when it became evident that Hitler had risen to power on a eugenics agenda, and that this grading of humans—into the fit and unfit—had led to the Holocaust. Yet, it is easy to see today that our modern research agenda encourages eugenic conceptions of the mentally ill and encourages the adoption of policies that rob people so diagnosed of their basic rights.

In 1980, when American psychiatry published its third edition of its Diagnostic and Statistical Manual, it informed the public that mental disorders were now to be thought of as “diseases of the brain,” much like diabetes or some other physical illness. The mentally ill were said to have “broken brains,” characterized by faulty “brain chemistry.” Trauma, environmental stressors, difficult family relationships, and other problems were no longer to be seen as primary causes of psychiatric distress. The root cause was an internal biological flaw with the person. With this conception in mind, NIMH-funded researchers renewed a quest, first born in the eugenics era, to identify a genetic basis for psychiatric disorders.

There is, of course, an understandable therapeutic rationale for such research. If a biological pathology, arising from a genetic defect, can be identified, then it would provide a target for drug development. But—and this is important to recognize—this research has not proceeded in an ideologically neutral manner. In 1980, with the publication of DSM-III, the field became ideologically committed to telling a certain story, which is that mental disorders are brain diseases. As such, the field became committed to proving that this was so, and we can see this ideological impulse in many of the published findings. You find it in particular in the MRI studies, in which researchers may announce that some abnormality or another has been found in a group of patients, without making an effort to distinguish whether the abnormality is medication induced. When that happens, ideology is trumping honest inquiry and science, and it is impossible, as such moments, to not be reminded of Aaron Rosanoff, and his desire to report that insanity was a single gene recessive disorder.

In terms of shaping public opinion about mental illness, what has this modern genetics research wrought? When we hear of how people diagnosed with schizophrenia or bipolar disorder have “broken brains,” or that these disorders have a “genetic component” and run in families, we are being encouraged, as a society, to think of people so diagnosed as not quite “right,” or that they are “unfit.” As such, we shouldn’t be surprised that recent studies have found that as the public comes to understand that mental disorders are “biological” in kind, stigma toward the “mentally ill” increases.

In short, thirty years of NIMH-funded research into the possible genetic causes of mental disorders has proven to be both a therapeutically barren enterprise and one that has encouraged eugenic conceptions of the mentally ill. Those eugenic conceptions are now showing up in our social polices, and this can be clearly seen in our society’s embrace of “outpatient commitment” orders. The public has been encouraged to “fear” the mentally ill, and to conceive of them as driven in their behaviors by their faulty brain chemistry and genes, which they can’t control, and thus society embraces the idea that “they”—i.e. the other in our midst—need to be kept under state control.

A century ago, such societal beliefs led to the segregation of the mentally ill in hospitals. Today, people may get released from hospitals, but if they are under an outpatient commitment order, they certainly are not “free” and enjoying the rights of full citizenship. They may be forced to take medications that they do not want to take, and if they complain that the drugs make them feel like “zombies” and rob them of their capacity to feel the world, such complaints are dismissed. They don’t know what is good for them, we say.

This state control of the “mentally ill” extends beyond those under an outpatient order to many who receive government services. Such people may not be under a legal order, but still feel coerced. They may have to take medications they don’t like in order to continue to receive services, and such coercion surely is an impingement on their self-autonomy.

This, of course, is true regardless of the merits of the medications. If a person living in society is being forced to take a medication he or she does not want to take, that is impinging on his or her usual rights as a citizen. Their right to liberty has been compromised.

Now, let’s return to Insel’s list for a second look. Only this time, instead of focusing on what is named on the list, let’s look at what is missing. See if you can find even one item that tells of research designed to help living, breathing human beings get well and stay well. See if you can find anything that tells of research designed to identify the strengths that can be found in people struggling with their minds, and all the ways that, in fact, such struggles can be an ordinary part of human experience.

Once again, history can tell us why it is tragic that such research is missing from the NIMH list.

In the last years of the 18th century, Quakers in York, England, acting in rebellion against the harsh ministrations of English mad doctors, developed a form of care known as “moral therapy.” The medical wisdom at the time was that the mad, by virtue of having lost their reason, had descended to the level of “brutes, but the Quakers in York thought differently: They declared that the “mad” were “brethren” and should be treated as such. The Quakers in York built a small retreat in the countryside, where the mad were given shelter and food, and treated with gentleness and kindness. In this manner, the Quakers hoped to “assist nature” in helping the mad get well. They believed that their mad brethren had a God-given inner capacity for regaining self-control and reason, and thus their therapeutic challenge was to provide a gentle environment that could best promote such healing.

In fairly short order, the Quakers in York reported that this care was proving to be quite successful, and in the first decades of the 19th century, Quakers in the United States built a number of such small retreats, in the countryside outside Boston, Philadelphia, Hartford and other cities. The patients were encouraged to garden, exercise, take long walks, and engage in social activities. And this therapy worked. Modern historians who have reviewed the records of these retreats have determined that than half of the newly insane would be discharged within three years. Moreover, a long-term study of 984 patients discharged from Worcester Asylum in this period found that 58% remained well throughout their lives.

Today, we often hear of how our society is discovering that some people can “recover” from mental illness, as if this is an extraordinary finding. If the Quakers from the early 19th century could hear such pronouncements, they would undoubtedly furrow their brows and wonder, this is considered new?

Imagine if the NIMH revisited this history and funded studies mindful of the lessons to be gleaned from it. NIMH-funded investigators, rather than seeing people with a psychiatric diagnosis as having an innate defect, would see them instead as “brethren,” and thus as human beings having an inner resilience and an inner capacity for getting better. The investigators could then focus their efforts on developing therapeutic approaches that help nurture such inner strengths. The Quakers found that diet, exercise, meaningful work and social engagement were a recipe that could help many disturbed people get better, and I imagine that if the NIMH invested in this idea today, researchers would discover anew their benefits.

Yet—and I know this well—that is a wish-list thought. The NIMH has published a list of its “Top Ten Research Advances of 2011,” and pronounced them to be “exciting discoveries” and “breakthroughs,” and so undoubtedly we will see much more of this type of research, which unfortunately encourages us, as a society, to think of people who may struggle with their minds not as “brethren,” but as fundamentally “unfit.” Even well-meaning research can have unintended consequences, and I think, if we look at our ongoing genetics research within a historical light, we can see why that is so.

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Krankenhaus­gesellschaft kritisiert Pläne für Psychiatrie-Fall­pauschalen

Berlin – Das Bundeskabinett hat am Mittwoch dem „Gesetz zur Einführung eines pauscha­lierenden Entgelt­systems für psychia­trische und psychoso­matische Einrich­tungen“ (PsychEntgG) zugestimmt. „Mit dem Gesetz wird die Qualität der Versor­gung psychisch kranker Menschen gestärkt“, erklärte Bundesgesundheitsminister Daniel Bahr (FDP).

Mit dem neuen Entgeltsystem soll künftig die stationäre Behandlung von Patienten mit psychischen Krankheiten – ähnlich dem DRG-System – über Pauschalen vergütet werden. Den besonderen Bedürfnissen psychisch Kranker würde dadurch Rechnung getragen, dass „grundsätzlich keine Fallpauschalen, sondern tagesbezogene Pauschalen eingeführt werden“, betonte Bahr.

Das Gesetz sieht ab 2013 eine vierjährige Einführungsphase vor, in der die Krankenhäuser zwar ihre Abrechnung schon auf das neue Entgeltsystem umstellen müssen. Die mit den Krankenkassen verhandelten Budgets sind davon jedoch noch unbeeinflusst. Ab 2017 soll eine fünfjährige Konvergenzphase beginnen, in der die Budgets schrittweise auf das neue Vergütungssystem umgestellt werden.

Die Deutsche Krankenhausgesellschaft (DKG) hat die Pläne der Bundesregierung für ein Fallpauschalen-System in der Psychiatrie kritisiert: „Die Besonderheit der psychiatrischen Versorgung macht Sorgfalt vor Schnelligkeit zum obersten Gebot. Am Ende muss eine sachgerechte und bessere Finanzierung der Psychiatrie herauskommen. Dies ist bei dem mit diesem Gesetz vorgelegten Finanzierungsrahmen leider nicht der Fall“, sagte DKG-Hauptgeschäftsführer Georg Baum.

Er betonte, für die Überführung der psychiatrischen Leistungen der Krankenhäuser in ein Entgeltsystem mit bundeseinheitlich kalkulierten behandlungsabhängigen Tagespauschalen gebe es „weltweit kein Vorbild“.

Baum kritisierte insbesondere, dass die Bundesregierung zum Start 2013 plane, die Finanzierung an die Entwicklung der Grundlohnsumme anzubinden und damit an einer „leistungsfeindlichen und sachfremden Deckelung“ festhalte. Außerdem sei geplant, die Basiswerte für alle Krankenhäuser abzusenken, wenn mehr Patienten zu versorgen seien. Dies sei ein „leistungsfeindliches Kollektivhaftungsinstrument“, so Baum.

Darüber hinaus sei der „massive bürokratische Datenerfassungsaufwand in den Krankenhäusern“ nicht zu rechtfertigen. Der DKG-Geschäftsführer forderte sowohl für das somatische Fallpauschalen-Vergütungssystem wie für das neue Psychiatrieentgeltsystem die Abschaffung der Grundlohnanbindung. „Nur wenn das gewährleistet ist, können die Krankenhäuser den Weg weiter mitgehen“, sagte Baum.

Der DKG zufolge betrifft die Reform der Vergütungssystematik jährlich fast eine Million Patienten in 402 Fachabteilungen und 336 Fachkliniken für Psychiatrie und Psychosomatik. Das gesamte Finanzvolumen liege bei sechs Milliarden Euro.

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Peer-Run Respite Webinar Series

Peer-Run respites/hospital diversion programs are increasing in numbers and having positive results across the country. Peer-run respites offer an alternative to traditional mental health hospitalization, are operated by peers, and are cost-effective.

J&J Said to Settle Texas Risperdal Anti-Psychotic Drug Case

By Jef Feeley, Margaret Cronin Fisk and David Voreacos

(Updates with case background beginning in second paragraph.)

Jan. 19 (Bloomberg) — Johnson & Johnson agreed to settle Texas officials’ claims that the drugmaker fraudulently marketed its Risperdal anti-psychotic drug, ending a trial over the allegations.

J&J’s settlement will resolve claims it defrauded the state’s Medicaid program by promoting Risperdal for uses not approved by U.S. regulators, including for children with psychiatric disorders, the people said today. The state also claimed New Brunswick, New Jersey-based drugmaker downplayed the risk of Risperdal.

J&J spokeswoman Teresa Mueller didn’t have an immediate comment on the settlement.

J&J, the world’s largest health-care products company, and its Janssen unit agreed to the accord in the middle of a four- week trial of the state’s lawsuit, which sought at least $579 million in damages over the companies’ Risperdal marketing practices, the people said.

The Texas settlement comes less than a month after J&J officials agreed to pay more than $1 billion to the U.S. and a number of states to end a civil investigation into Risperdal marketing practices, people familiar with the matter told Bloomberg News Jan. 6.

The U.S. government has been investigating Risperdal sales practices since 2004, including allegations the company engaged in so-called off-label marketing of the medication, J&J has said in U.S. Securities and Exchange Commission filings. The company said it has been negotiating with the U.S. to resolve the investigation.

The Texas settlement is the first time J&J and Janssen have agreed to resolve a state’s Medicaid fraud claims over Risperdal prescriptions.

Officials in Louisiana and South Carolina sued J&J partly over marketing letters the company sent to doctors in those states touting Risperdal as superior to rival drugs. Those states’ attorneys general alleged the company falsely claimed Risperdal didn’t cause diabetes to charge a premium for the drug.

The Texas case is Texas v. Janssen LP, D-1GV-04-001288, District Court, Travis County, Texas (Austin).

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Doing the math on Risperdal

by altmentalies

Johnson & Johnson has come under fire recently for sundry illegal marketing practices related to the antipsychotic drug Risperdal (as enumerated here and here in legal documents, and here by a former J&J salesperson). “Recently” isn’t entirely accurate… considering that they were warned in 1994, 1999, and 2004 by the FDA to stop making “false and misleading claims” about Risperdal’s efficacy and superiority to other atypical antipsychotics, this has been a long time coming.

So let’s do the math. How much money will J&J have to pay for the privilege of doing whatever they damn well please in marketing Risperdal, a brain-damaging, diabetes-, obesity-, akathisia-, homicidal/suicidal ideation-causing, so-called “safe” antipsychotic?

$1 billion to the US and some states who have joined in the federal (civil) case against Risperdal

$257.7 million to the state of Louisiana in 2010

$327 million to South Carolina in 2011

$158 million to Texas in a settlement agreed upon last Thursday

$400 million more as a penalty for violating the “Food, Drug, and Cosmetic Act”

______

TOTAL: $2.14 billion (more or less) in fines for illegal marketing practices

That would make Risperdal the most heavily fined of any single drug ever produced by pharma (incidentally, another atypical antipsychotic medication, Lilly’s Zyprexa, comes in a rather distant second at $1.4 billion).

Let’s do a little more math

What percentage of J&J’s total Risperdal profits does this fine represent? In other words, if J&J were to design a business model with fines for off-label marketing built right in, how much money would they have to set aside?

$2.14 billion in fines for illegal marketing practices

$34 billion in worldwide sales from 1994 to 2010*

______

TOTAL: fines are 6.3% of profits

Not too shabby. It becomes a mere line item in the marketing budget, simply a “cost of doing business.”

Never mind the human cost.

The human cost

Since they’re not going to, let’s you and I spend a moment considering the human cost.

Meet Ke’onte Cook, a 12-year-old survivor of the foster system who was wrongfully medicated with antipsychotics.

As you may recall, in November of 2011 an important study published in the journal Pediatrics found that youth in foster homes with behavioral problems were being wrongfully prescribed antipsychotics as a chemical means to ensure docility. On average they were being prescribed these drugs at twice the rate of children outside the foster system. More on that here.

The foster system population is one of the specific groups that J&J is accused of targeting with their off-label marketing practices.

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