Posted by: L | May 26, 2007

V-Tech – the psych time-line

At least as important as the shooting time-line – some would say more – is the psychiatric time-line that preceded the V-Tech shooting:

Wyatt v. Aderhold (Arizona 5th circuit panel decision) in 1974 and later, O’Connor v. Donaldson (Supreme Court), were regarded as having jettisoned the parens patriae basis (the state as custodian for the mentally defective) and left only the police-powers basis (the state as defendant of the community’s safety) for the state’s interest in confining the mentally ill. Both decisions came after numerous exposes and sociological studies of the conditions of state mental hospitals and treatment had led to a trend toward de-institutionalizing mental health patients. That trend became stronger with the discovery of anti-psychotic medications in the 1950s that held out the hope for outpatient treatment for many patients.
Another step in the rise of the psychotropic drug industry came with the expansion of the definition of bipolar illness (manic-depression) in the DSM-IV Manual, the official psychiatric diagnostic manual, in 1994. Now, conditions less intense but presenting similar symptoms were included as abnormal variations requiring treatment. The result was an explosion of bipolar illness in children between 1996 and 2004. While some see this as a legitimate refinement in diagnosis, others see it is a result of the new, expanded definition. Then there are those who say there just isn’t enough known to conclude definitively one way or about how much bipolar disease there really is and whether children are being under or over medicated.

Simultaneously, the FDA backed off putting stronger warnings on the psychotropic drugs:

“The FDA held a hearing in September 1990 at which its Psychotropic Drugs Advisory Committee (most of whose members got funding from antidepressant manufacturers) considered whether SSRIs can induce violent and suicidal thoughts. They voted 9-0 not to recommend a more prominent warning and 6-3 not to recommend a warning in small type that would have read, “In a small number of patients, depressive symptoms have worsened during therapy, including the emergence of suicidal thoughts and attempts. Surveillance throughout treatment is recommended.” (Fred Gardner)

Next came the marketing plan:

“It all started in the mid-90s while George W. Bush was governor. TMAP was developed by what’s referred to as an “expert consensus” made up of a group of “experts” already known to have favorable opinions of certain drugs, chosen by drug company sponsors, Janssen Pharmaceutica, Johnson & Johnson, Eli Lilly, Astrazeneca, Pfizer, Novartis, Janssen-Ortho-McNeil, GlaxoSmithKline, Abbott, Bristol-Myers-Squibb, Wyeth-Ayerst and Forrest Laboratories.

In 1997–98, with pharma funding, a panel was assembled to determine which drugs would be used in treating children and decided that the same drugs used on adults could be used on kids. There were no studies conducted to test the safety of giving the TMAP drugs to kids and most had never been FDA approved for use by children.” (Evelyn Pringle)

 

The next step was taken when Bush established the New Freedom Commission on Mental Health in April 2002 to conduct a “comprehensive study of the United States mental health service delivery system.” The commission issued its recommendations in July 2003. Bush instructed more than 25 federal agencies to develop an implementation plan based on those recommendations.

In April 2003 came the President’s New Freedom Commission on Mental Health‘s radical recommendation is to screen the entire nation for mental illness, beginning with school children:

Schools, wrote the commission, are in a “key position” to screen the 52 million students and 6 million adults who work at the schools. The commission also recommended “Linkage [of screening] with treatment and supports” including “state-of-the-art treatments” using “specific medications for specific conditions.”
The NFC Report promoted two controversial programs the pharmaceutical industry loves : Columbia University’s TeenScreen and TMAP (Texas Medication Algorithm Project), mental health prescribing guidelines formulated under Big Pharma’s sponsorship, including Eli Lilly, Pfizer and Janssen whose products were recommended through the algorithm).

As a Mother Jones article pointed out, while previously, drug companies had sold new products to doctors through ads and articles in journals or directly through television and magazine advertising, from the mid-1990s, they began to go through a handful of state officials who govern prescribing for large public systems like state mental hospitals, prisons, and government-funded clinics.

Furthermore, the focus moved away from anti-depressants – a very broad market – to the smaller but much more lucrative (since they cost about ten times as much) anti-psychotic drugs.

Meanwhile, in a glaring conflict of interest, NFC chairman, Dr. Michael Hogan, served on the advisory committee of Janssen Pharmaceutical, and serves on the advisory council of TeenScreen, the program singled out to promote in the NFL Report.

But research was mounting that SSRIs, especially, were a significant danger –

“Lilly and the other antidepressant manufacturers made more finite, begrudging concessions in the years ahead as evidence linking SSRIs to suicide kept mounting. A turning point came in April 2004, when the British Medical Journal reported that GlaxoSmithKline had concealed data showing that Paxil more than quadrupled suicidal ideation among teenagers. A few months later the FDA acknowledged a study showing that SSRI use induced suicidal thoughts in two out of 100 adolescents and ordered a black box warning. Prozac sales dipped as a result and Lilly et al commissioned the study that JAMA published April 18, showing that SSRI use induces suicidal ideation in only one in 100. Suicidal ideation,” “Suicide gesture,” “Suicide attempt,” and other such terms do not accurately characterize the extremely bizarre flip-outs induced by SSRIs. Carefully planning to annihilate the student body fits the profile. Biting your mother 57 times. Driving your car around in circles until you smash into a tree…”

More by Fred Gardner here at “Prozac Madness.” and at “Fuel for a Killer.”

The dangers were exacerbated by the rates at which psychotropic drugs were being recommended:

“That same issue of JAMA, April 18 [2004], contained a study showing that for-profit dialysis chains give patients much higher doses of Epogen than non-profit clinics. Epogen, made by Amgen Inc., is a synthetic version of a hormone that stimulates the production of red blood cells. During dialysis it is added to the blood as toxins are removed.

The for-profit dialysis chains get a quarter of their income from the sale of Epogen -plus rebates from Amgen based on how much product they move. Investigators from the Medical Technology and Practice Patterns Institute looked at 134,000 patients treated in 2004.

Some patients at for-profit clinics were found to be getting three times more Epogen than their counterparts at non-profits. “It’s clear there is a profit incentive,” says co-author Dennis Cotter.” (NOTE BELOW**) Industry payments to Minnesota psychiatrists rose 6 fold from 2000-2005 while antipsychotics prescribed to children in the state medicaid program rose 9fold. The story focuses on Minnesota because it is the one state that requires disclosure of industry payments to psychiatrists.


The NY Times story went on: Psychiatrists who received $5000 or more from manufacturers of atypical antipsychotics on average wrote three times as many prescriptions for those drugs in children as those who received under that amount.

—Psychiatrists received a median of $1750 each from industry from 2000 to 2005, more than any other medical specialty in Minnesota.

—The cost to the state of antipsychotic drugs used in children increased 14-fold from 2000 to 2005, from $521,000 to $7.1 million.

The Times quotes Steven Hyman, former director of NIMH: “There’s an irony that psychiatrists ask patients to have insights into themselves, but we don’t connect the wires in our own lives about how money is affecting our profession and putting our patients at risk.”

The drug industry pushed to expand its market despite strong expert dissent:

Here is Dr. Stefan Kruszewski’s criticism of TeenScreen made in an interview with the British Medical Journal:

“We can manufacture enough diagnostic labels of normal variability of mood and thought that we can continually supply medication to you. The shameful part is that there’s enough mental illness that requires careful and judicious treatment that we don’t need to find variants of normal. But when it comes to manufacturing disease, nobody does it like psychiatry.”

And about TMAP, another expert, Dr. Grace Jackson, writes,

“the algorithms have arisen from ‘Evidence Based Medicine’—a statistically based approach to studying treatment effects in populations, rather than a reality based approach to discerning treatment effectiveness in each unique individual.”

In brief, TeenScreen amounts to a dangerous intervention in the lives of 50 million children and about 6 million adults in the schools.

That is the background against which one should look at the move to expand Virginia’s mental health laws that was already in the works in October 2006.

Its goal was to “modify the criteria for placing people in emergency care by eliminating a requirement that they pose an ‘imminent’ danger to themselves or others,” precisely what is now being demanded — as a result of the V-Tech shootings

Take, for instance, the case of 13 year old Aliah Gleason, one of 19, 404 Texas teens who underwent involuntary mental health treatement in a state funded program in July-August 2004.

Falsely labeled suicidal, she was given 12 drugs including 4 SSRI’s (Zoloft, Celexa, Lexapro and Desyrel) 3 anti-psychotics (Geodon, Abilify, and Haldol) 2 anti-convulsants (Trileptal and Depakote), anti-anxiety (Ativan), anti-Parkinson’s (Cogentin). When discharged she was on 5 of them to which Risperdal was added.
In early 2005, the FDA issued a warning that antidepressants can cause both suicide and violence and mandated a black-box warning – the most serious – about side effects from panic attacks to hostility, impulsivity and mania. Further, abrupt withdrawal from antidepressants can produce suicide, aggression or psychosis.

But, with what’s at stake financially, the drug companies continue to look for ways to expand their markets.

Eli Lilly paid out $1.2 billion to 28,000 people who claimed injury by the drug Zyprexa in the ten years ( NYT, Jan. 5), but it made $4.2 billion in just one year selling the drug, taken by 20 million people world over since it was introduced in 1996. (statistics from Alliance for Human Research Protection).

That, perhaps, is the rationale for such events as the “colloquium” for national science and healthcare journalists –“Children and Mental Illness”– held at the Columbia University School of Journalism and sponsored by The Columbia University Division of Child and Adolescent Psychiatry, and the Carmel Hill Family Foundation which runs TeenScreen, which attracted plenty of media attention and was funded by Janssen Pharmaceutical Products, LP and McNeilConsumer and Specialty Pharmaceuticals.

In May 2007, the Texas Attorney General joined a whistleblower suit filed in 2004 against Pharma giant Johnson and Johnson that charged it with improprieties in marketing its psychotropic drug Rispertal as part of the TMAP program.

NOTE:

As this petition against TeenScreen points out, there are also broader socio-political implications for the program

“Whereas antipsychotic drugs are not approved by the Food and Drug Administration for children; the FDA’s “black box warning” states antidepressants increase the risk of suicidal thinking and behavior in children and adolescents with psychiatric disorders; and drug safety experts have recommended additional “black box” warnings be placed on ADHD drugs: for the increased risk of stroke and heart attack;

Whereas potential recruits are ineligible for military service if they have taken Ritalin and other stimulants to treat the unscientific “disorder” called ADHD in the previous year;

Whereas most states have laws restricting the purchase of firearms based on an adjudication of mental illnesses or disorders, and mass screening of all American children for mental disorders will increase the number of persons labeled with a mental disorder, directly infringing upon the citizenry’s right to keep and bear arms as guaranteed by the 2nd amendment;

“Whereas TeenScreen only partners with and seeks to immediately refer students to “mental illness” practitioners and does not refer students to medical disciplines that could test for underlying health problems such as allergies, nutrition, toxicities and physical illnesses;

Whereas child suicides are very rare and have been on a decline for years; and even according to former TeenScreen director Rob Caruano, “suicides are so rare that you’d have to screen the whole country to see a difference in mortality between screened and unscreened students………”

Ron Paul again

On May 18, U.S. House Rep. Ron Paul introduced a federal legislative bill – H.R.2387 – http://thomas.loc.gov ( “Paul, Ron” under “Browse Bills by Sponsor”).

The title is: “To prohibit the use of Federal funds for any universal mandatory mental health screening program”.

On May 23, a bill granting the FDA powers to monitor drug safety was pared back during private meetings. And efforts to curb conflicts of interest among FDA advisers and allow consumers to buy cheaper drugs
from other countries were defeated in close votes.

* A measure that blocked an effort to allow drug importation passed, 49-40. The 49 senators who voted against drug importation received about 5 million from industry executives and political action committees
since 2001 – nearly three quarters of the industry donations to current members of the Senate, according to a USA TODAY analysis of data compiled by two non-partisan groups, Center for Responsive Politics and
PoliticalMoneyLine.

* Sen. Pat Roberts, R-Kan., said he demanded removal of language that would have allowed the FDA to ban advertising of high-risk drugs for two years because it would restrict free speech. Roberts has raised $18,000 from drug interests so far this year, records show, and $66,000 since 2001. His spokeswoman, Sarah Little, said he “takes great pains to keep fundraising and official actions separate.”

**Note : I wonder if it is simply the ‘for-profit’ motive on its own that is the cause. Without the state, would we have the incentives of third-party pay, for instance, which distort markets forces? I think not. A genuinely competitive market would also do away with unfair monopoly-like conditions preventing the entry of lower-cost and alternative providers — which would help correct the problem. For the same reason, although I personally think the ideal should be private regulatory bodies in a free market, the immense lobbying power of pharmaceutical companies at this point means that what few regulatory restraints remain cannot be abandoned but must be shored up.

What is undisputed, however, is the need to slowly bleed the Federal government of money, power and influence and return power and autonomy to local and state bodies as far as possible.

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Responses

  1. According to Dr. Irving Kirsch in Prevention & Treatment, “there is now unanimous agreement that the mean difference between response to SSRI antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the SSRI trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents.

    Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome:

    1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout)

    2) Benzodiazepine sedatives were given to mask the SSRI induced agitation.

    3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public.

    4) Miscoding suicidal events as “emotional lability”, and homicidal events as “aggression” to hide suicidal events from regulators.

    5) False attribution of suicide to the placebo arm.

    6) Hiring ghost writers to make the medical articles more favorable.

    7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public.

    For more information and links see my Paxil, Prozac, and SSRI Induced Suicide Newsletter

    Jeffrey Dach MD


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