Sunday, October 30, 2005

How would you react if TeenScreen happened at your child's school?

http://www.daytondailynews.com/blogs/content/shared-gen/blogs/dayton/education/entries/2005/10/28/computer_your_k.html#comments

Dayton Daily News education reporter Scott Elliott writes about schools, kids, teaching and learning

Computer: your kid has “disorders”
October 28, 2005
Scott Elliott

Imagine your teenager comes home from school looking depressed. You ask what’s wrong. She says, “Oh, it’s just my social anxiety disorder.”
 
What?

Yes, she tells you, she has social anxiety disorder. And also obsessive compulsive disorder.

What are you talking about, you ask? Who is telling you this?

They told me at school!

And no, it wasn’t a psychologist, social worker or even the school nurse that told her. It was: a computer! They call it TeenScreen.

Yesterday, I complained about computerized scoring of tests. Now one Indiana school is taking things even further with the computer. They’re letting the computer diagnose you kid’s alleged mental problems!

A civil liberties group called The Rutherford Institute that is suing the South Bend, Ind., school district on behalf of 15-year-old Chelsa Rhodes, described what occurred:

“Students were divided into groups of 10-15, herded into classrooms and placed in front of computers. After completing the examination and being escorted into a private hallway by an employee of Madison Center, Chelsea was informed that based on her responses that she liked to clean and didn’t like to party very much, she suffered from at least two mental health problems, obsessive compulsive disorder and social anxiety disorder.

Chelsea was also told that if her condition worsened, her mother should take her to the Madison Center for treatment. According to Chelsea, a majority of the students who were subjected to the TeenScreen exam were also told that they were suffering from some sort of mental or social “disorder.”

I am amazed first of all that anyone would think a computer could diagnose mental disorders, and that a school district would buy into this, and that it would subject kids to such a test without parental consent or without having the results explained to the kids by some kind of professional.
TeenScreen bills itself as a suicide prevention system. But I found one blogger who alleges TeenScreen is backed by drug companies who would love to see more kids taking meds.

How do you think you would react if this happened at your child’s school?
 

Thursday, October 27, 2005

TeenScreen - Iowa

 
 
Tuesday, October 25, 2005 12:12 PM CDT

Teen Screen critique was correct

LARRY HANUS

WATERLOO --- Judy Meyers, (Beware teen screen tactics, Sept. 30) executive director of National Alliance on Mental Illness (NAMI), accuses me of passing along misinformation about Teen Screen.

According to Marcia Angell, former editor-in-chief of the New England Journal of Medicine and ethics lecturer at Harvard Medical School, "It's (Teen Screen) just a way to put more people on prescription drugs."

Mother Jones magazine states, "between 1996 and 1999, $11.72 million was received by NAMI from the drug industry." and quotes NAMI Director Laurie Flynn, "(The drug companies) want more and greater markets, and we want access and availability to all scientifically proven treatments. We don't think drugs are everything, but for the vast majority they are important."

Rutherford Institute: "The wolf, so to speak, is at the door"

An Orwellian Nightmare: Mandatory Mental Health Screening of Children
by John W. Whitehead
10/18/2004
 
In embracing a major new health initiative, which is based on a report by the New Freedom Commission on Mental Health, the American government has taken a giant step toward an Orwellian nightmare. The commission has recommended mental health screening for all school-aged children, including those in preschool. The recommendations also include expanding school-based mental health programs that require specific treatment for certain conditions, including the wide use of drugs.

Some states have already moved forward to implement recommendations by the commission. For example, the Illinois legislature has passed a plan to screen the mental health of all pregnant women and children up to 18 years of age. The plan also includes the use of antidepressant drugs. Under such a plan, both children and adults will be screened for so-called mental illness during their routine physical exams.

This all began in April 2002 when President Bush launched the new mental health commission. After supposedly conducting a comprehensive study, the commission recommended mental health screening for “consumers of all ages,” including preschool children. Schools, the commission concluded, are in a “key position” to screen the 52 million students and 6 million adults who work in the public schools.

There are many problems with the government’s move to screen our children for mental illness. Such programs are spurious at best since there are no proven “treatments” for the prevention of mental illness. Moreover, to many alleged mental health experts, virtually everything is a mental illness—including mild depression, sadness, shyness, forgetfulness and so on. So why is this happening?

The answer may lie in the Texas Medication Algorithm Project (or TMAP). TMAP was promoted by the commission as a “model” medication treatment plan that “illustrates an evidence-based practice that results in better consumer outcomes.”

The TMAP was started as a pilot program under then-Governor Bush as an alliance of individuals from the University of Texas, the pharmaceutical industry and mental health and corrections systems. But according to World Net Daily, the Texas project recently sparked controversy “when a Pennsylvania government employee revealed that state officials with influence over the plan had received money and perks from drug companies who stand to gain from it.” Allen Jones, an employee of the Pennsylvania Office of the Inspector General, said that the “political/pharmaceutical alliance” that developed the Texas project, which promotes the use of expensive antidepressant and anti-psychotic drugs, was actually behind the recommendation of the New Freedom Commission. As such, they were “poised to consolidate the TMAP effort into a comprehensive national policy to treat mental illness with expensive, patented medications of questionable benefit and deadly side effects, and to force private insurers to pick up more of the tab.”

 Read more here.  

Wednesday, October 26, 2005

Tuesday, October 25, 2005

Government Drops Corrupt Mental-Illness Drug Program

http://www.whistleblower.org/content/press_detail.cfm?press_id=277

Government Drops Corrupt Mental-Illness Drug Program
October 24, 2005

FOR IMMEDIATE RELEASE

Contact: Dylan Blaylock - Communications Director
Phone: 202.408.0034 ext. 137, 202.236.3733 cell
Email: dylanb@whistleblower.org

Government Drops Corrupt Mental-Illness Drug Program
GAP Client Allen Jones Vindicated After Years of Voicing Concerns of
Financial Corruption

Washington, D.C. - The director of the federal government's mental
health agency announced last week that his department no longer endorses
the Texas Medication Algorithm Project (TMAP), a controversial drug
treatment regime supported by President Bush. The reversal by Charles
Currie, director of the Substance Abuse & Mental Health Services
Administration (SAMHSA), came in a meeting on October 17 with numerous
nonprofit health organization representatives. Among those present who
witnessed Currie's remarks was Government Accountability Project (GAP)
client Allen Jones, who has been critical of TMAP for years and was
fired as a result of investigating the program's inner-workings.

Jones, a former fraud investigator for the state of Pennsylvania, blew
the whistle on financial inducements given by drug companies to entice
state officials to favor hyper-expensive "atypical" drugs in treating
depression, bipolar disorder and schizophrenia. A government-funded
study released last month confirmed Jones's findings that atypical drugs
are no better in treating schizophrenia than older, off-patent
medications that sell for a fraction of the cost. Jones initially began
his investigation in 2002, went public with his findings in February
2004, and was terminated that following June as a result.

The development and marketing of TMAP was financed by ten major drug
companies. All of the atypical drugs are recent issues and under patent
to the same drug companies that promoted the adoption of TMAP around
the country. The program has come under fire from numerous therapists
and citizens groups in recent years.

"It is high time that the federal government realizes the sham that
TMAP really is," stated Jones. "This program has been a blatant example
of how big corporations can manipulate and corrupt our government
officials into acting in the best interest of businesses instead of the
public. The states that still operate TMAP should end this corruption
immediately in the interest of taxpayers everywhere."

While an investigator at the Pennsylvania Office of Inspector General,
Jones discovered that drug companies were showering gifts on officials
in charge of determining which drugs were to be prescribed to persons
in state custody suffering mental illness. The exorbitant costs of
these atypical drugs are being borne by taxpayers via Medicaid. Jones
discovered a hidden bank account created by pharmaceuticals for
Pennsylvania officials to receive monetary gifts for implementing TMAP.
Jones was fired for his persistent investigating and exposing of the
program.

"SAMHSA's rejection of TMAP completely vindicates Allen's disclosure,"
stated GAP Food & Drug Safety Director Mark Cohen, continuing "We
anticipate the courts will agree." GAP represents Jones in a federal
suit in Harrisburg, Pennsylvania, in which he alleges he was fired for
exercising his free speech rights.

For a more detailed account of last week's meeting in which SAMHSA
officials signaled a change, please see the Alliance for Human Research
Protection's press release at http://www.ahrp.org/infomail/05/10/24.php

Allen Jones and Mark Cohen are available to speak to the media. Please
contact GAP Communications Director Dylan Blaylock with any media
inquiries at 202.408.0034, ext. 137, or 202.236.3733.

Government Accountability Project
The Government Accountability Project is the nation's leading
whistleblower protection organization. Through litigating whistleblower
cases, publicizing concerns and developing legal reforms, GAP's mission
is to protect the public interest by promoting government and corporate
accountability. Founded in 1977, GAP is a non-profit, public interest
law firm with offices in Washington, D.C. and Seattle, WA.

#####

Dylan Blaylock
Communications Director, Government Accountability Project 202.408.0034
ext. 137 202.236.3733 cell 1612 K St. NW, #1100 Washington, D.C. 20006

Child Suicide

In the long and well-recorded history of what has killed the children of
mankind, prior to 1970, "child suicide" was virtually unheard of. In
nations and populations across the globe, children, the most alive among
us, just didn't kill themselves. Then, along came a whole range of brain
altering chemicals, which psychiatrists began to use to control
children.

The psychiatrists further developed "criteria" designed to select out of
the masses of children, the brightest and most active children of the
Western World and in the 1960s, began the use of their chemicals on the
children they selected. Over time, psychiatrists invented other
"criteria" which they deemed aberrant and indicative of "mental
disorders but which only described other behaviors of predominantly
normal children having normal reactions to the problems of life. By the
1970s, some of those children began to do something for which there was
no precedent in history: children "treated" by psychiatrists began to
"commit suicide."

In the Diagnostic And Statistical Manual Of Mental Disorders Third
Edition Revised (DSM-III-R), the American Psychiatric Association
published the fact (on page 136) that "Suicide is the major complication
of withdrawal" from their (Ritalin, Adderall and the other amphetamines
and from
cocaine) Sympathomimetic (central nervous system and brain stimulant or
speed-type) medications. This was a confession that has now been purged
from their recent texts.

Children are today, the single largest population of involuntary "mental
patients" on Earth. Calling such deaths among children "suicides" is, of
course a "misdirection." In fact, the drugs never committed a single one
of those "homicides," even if death seemed to be self-inflicted. It was
the person who negligently and irresponsibly and perhaps criminally
prescribed the drug or drugs, involuntarily to those children, who in
fact committed the homicide. If such homicides were to be properly
deemed to be a criminal acts, the cause of death in such cases would be
deemed to be "murder."

"Homicide" is the killing of one human by another. "Murder," is the
unlawful killing of one human by another.

It has long been considered to be "legal" to kill "mental patients" if
the act is committed by "medical" means (electric shock treatment,
lobotomy, administration of toxic chemical or chemicals or through the
process of denying the chemical as in withdrawal). This is one of the
liabilities of being in what is considered to be in or of the "sub
human" category: mental patient.

In most States, if any "normal" (non medical) person gives another
person a "medically controlled" substance or a substance deemed to be
"illegal," or gives that person a drug in an "illegal manner," and the
person who receives the drug dies, the cause of death is legally (by
statute in spite of any willful or voluntary participation by the
deceased) considered to be a "murder."

All persons under the control of psychiatrists are involuntary, always,
despite any apparent willful or voluntary participation by the "patient"
as they only remain "voluntary" participants up to the point of refusal
of such control at which point the psychiatrist (and now by statute,
others such as other medical doctors, psychologists and other
"government employees) simply deems the person to be "involuntary" (a
"legal" status") and so forces "treatments" upon the "patient." Only
later does the medical/psychiatric or government employee seek the
rubber stamp of a court.

In any inherently involuntary or statutorily involuntary situation such
as those involving prisoners brought before courts, those in jails,
prisons and mental institutions, wards or in hospital "beds," in all
"care" homes including orphanages and in all other settings and
circumstances involving children, homicides committed by "care givers"
should all be considered and deemed to be "statutory murder," just as
the use of such "held" or controlled persons for the sexual
gratification or other "sexual" purpose, must always be considered a
crime of rape.

Monday, October 24, 2005

"Bush Administration disavows TeenScreen"

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability www.ahrp.org

On October 17, a meeting took place with Charles Currie in Washington DC with some in attendance by conference call. Currie is the Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA), the federal agency charged with implementing the Federal Mental Health Action Agenda as the follow-up to the New Freedom Commission (NFC) report.

In attendance were several AHRP Board Members--Allen Jones, Dr. Karen Effrem,* and Dr. Stefan Kruszewski"as well as representatives of several advocacy groups who have been prominent and outspoken critics of mental health screening and psychiatric drugging of children, beginning in early childhood, as recommended by the NFC. Besides AHRP, groups in attendance were: EdWatch, The International Center for the Study of Psychiatry and Psychology (ICSPP), Eagle Forum, The Association of American Physicians and Surgeons (AAPS), The American Psychoanalytic Association, and Mind Freedom. Michael Ostrolenk, founder of the Liberty Coalition and the Medical Privacy Coalition, organized the meeting.

Steps in the Right Direction:

The administration demonstrated a willingness to face its critics and hear our urgent concerns, for which we commend HHS, SAMHSA, and Charles Currie. In addition, several important and positive outcomes occurred at this meeting, for which we also commend the Bush administration. The following key points that are fundamental to this entire controversy over the NFC Report recommendations were reconsidered:
 
SAMHSA Administrator, Charles Currie indicated that the Bush Administration disavows TeenScreen: 

You will notice that TeenScreen is not a model program nor is it or any other screening program mentioned anywhere in the Federal
Mental Health Action Agenda.

This is an incredible testament to the value of informed and persistent educational efforts against this screening program by AHRP and other groups around the country.

TeenScreen uses vague, subjective questions based on unscientific diagnostic criteria. TeenScreen is itself scientifically not validated, has resulted in high rates of false positives so that normal children who are healthy are misidentified with mental disorders. There is no evidence that screening programs prevent suicide--as is claimed by its promoters. Furthermore, TeenScreen employs passive consent procedures that circumvent parental authority. The net result, so far; is that children are unjustifiably prescribed dangerous and ineffective psychiatric medications. (An AHRP position statement about TeenScreen will be posted shortly on our website).

SAMHSA backs away from TMAP medication algorithms.

The Texas Medication Algorithm Project (TMAP) recommends the atypical antipsychotics and the SSRI " SNRI antidepressants as first line"and sometimes the ONLY treatment. In states that have adopted the TMAP model"as recommended by the NFC Report"the TMAP guidelines are binding. However, a body of scientific evidence recently disclosed to the public has revealed that these drugs lack efficacy and that they are linked to severe, even fatal side effects. The compelling, newly revealed evidence has caused SAMHSA to dissociate from these medication algorithms.

On October 17, Charles Currie said:

"The Action Agenda does not support medication algorithms," and "Medication toolkits have been removed from SAMHSATs other public
materials."  In a reference to the government sponsored CATIE antipsychotic drug trials (see http://www.ahrp.org/infomail/05/09/20.php), Currie said:

"Algorithms needed to be revisited and revised on the basis of what science has taught us about these drugs."
The absence of scientific evidence to support the TMAP recommendations, coupled with the serious risks posed by these drugs has been consistently pointed out by AHRP as well as courageous whistle blowers--most notably, AHRP board members Allen Jones (http://www.ahrp.org/infomail/05/10/14.php) and Stefan Kruszewski (http://www.ahrp.org/infomail/04/07/07.php) "who separately uncovered
evidence of pharmaceutical company corruption of government officials.. This compelling evidence left SAMHSA no other reasonable course.
Currie unequivocally acknowledged that it is the National Association of State Mental Health Program Directors (NASMHPD) that is promoting TMAP around the country. Allen Jones has documented evidence that the meetings of NASMHPD are under the influence of pharmaceutical company representatives; that the industry supports NASMHPD financially; and that many of these state directors serve on pharmaceutical advisory boards.
 
For example, Michael Hogan, chairman of the NFC, is the state director from Ohio, one of the first states to adopt TMAP, who served on an advisory board for Janssen Pharmacia, the manufacturer of Risperidal. Risperdal is an atypical antipsychotic recommended by TMAP as a first-line drug. AHRP calls for legal, Congressional, and journalistic investigation of this corruption of government officials entrusted with the health and welfare of so vulnerable a population as those with mental health issues. 
 
The critical importance of informed parental consent was reinforced. Currie unequivocally stated that parental consent must be documented, signed and fully informed. He said in response to a question by Dominic Riccio (of ICSPP) that consent must be "full knowledge" consent owith a parent's signature before screening, and that oif screening should lead to step 2 [i.e., further evaluation and treatment], parental consent must be revisited.]

AHRP believes that the language of the Action Agenda, although much improved over the NFC report, should be strengthened with specific binding language to ensure that parental informed consent with "full knowledge" is mandatory before any screening is undertaken. (see below).

Informed parental consent will be emphasized in government mental health grants. Currie responded to a major concern raised by Dr. Effrem about the lack of priority given to parental consent in grants funded by SAMHSA, such as Safe Schools, Healthy Students that inspired a grant from a Minnesota county stating that TeenScreen will be administered to all county school districts in the first year of this project to determine needs and baselines, never once mentioning parental consent for that or in the entire 133 page grant. Dr. Effrem wondered what if any information or emphasis on parental consent is communicated by SAMHSA and other relevant federal agencies to grant applicants.

Mr. Currie then promised to take that information back to the agency and make sure that any requests for application for grants involving 
children would emphasize parental consent.

AHRP will follow this particular issue very closely to make sure that parental consent is not circumvented so that children are protected from dubious mental health services. And AHRP will also work to develop a consent form for all government sponsored medical research that provides truly informed consent.
 
There was acknowledgement of other important concerns. Other participants raised many other issues that AHRP is concerned 
about and is following. Mr. Currie acknowledged the importance of each one. They will each need further discussion and clarification
by SAMHSA and include: 

Data Privacy and mental health data bases " Raised by the American Psychoanalytic Association and AAPS
1 Alternative treatments to medication " Raised by Mind Freedom
2 Funding of treatments other than medication " Raised by ICSPP and Mind Freedom
REMAINING CONCERNS AND DISAPPOINTMENTS:
While significant strides were made in the areas discussed above, there were other issues raised that were far less well answered that must be revisited in order to ensure freedom and safety for American citizens involved in mental health treatment and research and to prevent others who do not need it from becoming unnecessarily involved. Those issues include:
 
"Undoing what has already been wrought " SAMHSA administrator made the following statement during his briefing:
 
The New Freedom Commission is not the official position of the Bush administration.

Although that is nice to hear, but practically speaking, that statement means very little. In addition, Congress appropriated $20 million for the
implementation of state mental health transformation grants to implement the NFC recommendations including screening in the current fiscal year and the US House has passed $26 million for the same grants this year, so we will definitely be seeing more state legislation and more state plans to do screening.

The Illinois ChildrenTs Mental Health Act has been enacted whose preliminary implementation plan proposed to mental health screen ALL children 0-18 and all pregnant women for mental illness and never once used the phrase oparental consent. That draft implementation plan clearly referenced the New Freedom Commission, saying, Align systems of care with the President's New Freedom Report, particularly the child and adolescent recommendations. (http://www.isbe.state.il.us/iicc/pdf/icmhp_preliminary_plan.pdf) Although Illinois legislators were appalled when finally understanding what they passed, very little has been done to undo the enormous damage and loss of freedom that
this law will implement.

Minnesota attempted to enact legislation that would have screened the mental health of children as young as three as part of the required screening for kindergarten entry. The Senate author of this bill clearly referenced the New Freedom Commission in his presentation of the bill in committee as witnessed by Dr. Effrem. Texas also attempted to enact legislation that called for screening for co-occurring physical, mental, and substance-abuse disorders, and use ointegrated treatment strategies, such as TMAP. That language is right out of the NFC recommendations. The Minnesota and Texas bills were thankfully stopped by the informed testimony and grassroots work of EdWatch
and Eagle Forum respectively and other state and national groups. (See http://www.edwatch.org/updates05/071805-mhv.htm and
http://www.edwatch.org/updates05/060105-TX.htm.
 
In how many more states will this same battle need to be fought? Unless SAMHSA actually stops funding grants that include screening and TMAP style treatment and the Bush administration puts out some sort of statement to the states that it does not recommend either of these, CurrieTs statement is merely symbolic.
 
SAMHSA Administrator claims agency lacks position on pending legislation " When asked by Dr. Effrem about support of pending federal legislation, HR 181 " The Parental Consent Act by Rep. Ron Paul that prohibits coerced screening and HR 1790 " The Child Medication Safety Act by Rep. John Kline that prohibits coerced psychiatric medication, and that establishes in law the very good statements in the Action Agenda about parental consent so that  those statements live on after this administration, Mr. Currie said that he couldnTt take any position on legislation.

This is very disappointing given that Joe Faha, SAMHSATs Congressional liaison issued a position statement on Congressman PaulTs amendment to the Fiscal Year 2006 Labor/ HHS/Education Appropriations bill that would have denied funding for screening that did not require active, informed voluntary parental consent. This position statement distorted the intent of the Paul amendment and contributed to its defeat and was quoted on the TeenScreen website. (See http://www.teenscreen.org/cms/images/stories//samhsa%20response.pdf)
 
Little concern for the potential harm of mental health screening " When asked by Dr. Effrem about the four year grants received by Columbia University to study the potential harm of the screening process itself, Currie merely stated that if he was in his current position in four years, which he doubted, that he would be very interested in the outcome of that study. When pressed further about whether any screening program should proceed until this study was completed, he stated that the Action Agenda did not propose any specific mental health screening program. Although it is good that the Agenda has backed away from TeenScreen, SAMHSA, HHS, and The Departments of Education and Justice are still currently funding grants that include mental health screening.

AHRP believes that any grants involving mental health screening should be suspended until that study is completed and other data is reviewed.
Barely scratching the surface - Although AHRP greatly appreciates the opportunity for this meeting and the important progress made, this is a very complicated issue that has enormous implications for the health and freedom of every American. The length and structure of the meeting precluded serious discussion of many other crucial issues that AHRP will be working to bring up for discussion and action, such as: 

Is it constitutionally and ethically proper for the federal government to be involved in screening or promoting scientifically unproven, dubious
mental health interventions?
 
What is the scientific justification behind all of the recommended mental health screening initiatives and what is the evidence that the
benefits of the recommended psychiatric drug treatment outweigh the risks"such as specified in the Black Box warnings of each and every
recommended drug ?
 
The Action Agenda targets foster children, children in the welfare and juvenile justice systems, refugees, and crime and terror victims for
mental health interventions. What is the scientific basis for selecting these particular children and adults for unproven interventions?
Finally, what is the scientific evidence for the downward progression from the New Freedom Commission report that recommends beginning
mental health screening of preschoolers to statements of the Federal Mental Health Action Agenda that such mental health interventions
should begin with INFANTS?
In the spirit of full disclosure, Dr. Effrem also serves on the boards of EdWatch and ICSPP.

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

Government Drops Corrupt Mental-Illness Drug Program

http://www.whistleblower.org/content/press_detail.cfm?press_id=277

Government Drops Corrupt Mental-Illness Drug Program October 24, 2005

FOR IMMEDIATE RELEASE

Contact: Dylan Blaylock - Communications Director
Phone: 202.408.0034 ext. 137, 202.236.3733 cell
Email: dylanb@whistleblower.org

Government Drops Corrupt Mental-Illness Drug Program GAP Client Allen Jones
Vindicated After Years of Voicing Concerns of Financial Corruption

Washington, D.C. - The director of the federal government's mental health
agency announced last week that his department no longer endorses the Texas
Medication Algorithm Project (TMAP), a controversial drug treatment regime
supported by President Bush. The reversal by Charles Currie, director of the
Substance Abuse & Mental Health Services Administration (SAMHSA), came in a
meeting on October 17 with numerous nonprofit health organization
representatives. Among those present who witnessed Currie's remarks was
Government Accountability Project (GAP) client Allen Jones, who has been
critical of TMAP for years and was fired as a result of investigating the
program's inner-workings.

Jones, a former fraud investigator for the state of Pennsylvania, blew the
whistle on financial inducements given by drug companies to entice state
officials to favor hyper-expensive "atypical" drugs in treating depression,
bipolar disorder and schizophrenia. A government-funded study released last
month confirmed Jones's findings that atypical drugs are no better in
treating schizophrenia than older, off-patent medications that sell for a
fraction of the cost. Jones initially began his investigation in 2002, went
public with his findings in February 2004, and was terminated that following
June as a result.

The development and marketing of TMAP was financed by ten major drug
companies. All of the atypical drugs are recent issues and under patent to
the same drug companies that promoted the adoption of TMAP around the
country. The program has come under fire from numerous therapists and
citizens groups in recent years.

"It is high time that the federal government realizes the sham that TMAP
really is," stated Jones. "This program has been a blatant example of how
big corporations can manipulate and corrupt our government officials into
acting in the best interest of businesses instead of the public. The states
that still operate TMAP should end this corruption immediately in the
interest of taxpayers everywhere."

While an investigator at the Pennsylvania Office of Inspector General, Jones
discovered that drug companies were showering gifts on officials in charge
of determining which drugs were to be prescribed to persons in state custody
suffering mental illness. The exorbitant costs of these atypical drugs are
being borne by taxpayers via Medicaid. Jones discovered a hidden bank
account created by pharmaceuticals for Pennsylvania officials to receive
monetary gifts for implementing TMAP. Jones was fired for his persistent
investigating and exposing of the program.

"SAMHSA's rejection of TMAP completely vindicates Allen's disclosure,"
stated GAP Food & Drug Safety Director Mark Cohen, continuing "We anticipate
the courts will agree." GAP represents Jones in a federal suit in
Harrisburg, Pennsylvania, in which he alleges he was fired for exercising
his free speech rights.

For a more detailed account of last week's meeting in which SAMHSA officials
signaled a change, please see the Alliance for Human Research Protection's
press release at http://www.ahrp.org/infomail/05/10/24.php

Allen Jones and Mark Cohen are available to speak to the media. Please
contact GAP Communications Director Dylan Blaylock with any media inquiries
at 202.408.0034, ext. 137, or 202.236.3733.

Government Accountability Project
The Government Accountability Project is the nation's leading whistleblower
protection organization. Through litigating whistleblower cases, publicizing
concerns and developing legal reforms, GAP's mission is to protect the
public interest by promoting government and corporate accountability.
Founded in 1977, GAP is a non-profit, public interest law firm with offices
in Washington, D.C. and Seattle, WA.

#####

Dylan Blaylock
Communications Director, Government Accountability Project
202.408.0034 ext. 137
202.236.3733 cell
1612 K St. NW, #1100
Washington, D.C. 20006

Prescription:suicide?

There is a film premiering in Ft. Lauderdale on November 10th called Prescription:suicide?  As you can imagine, it is a film about the dangers of putting children on psych drugs.  It is a documentary that interviews 6 families who have a young family member that committed suicide while taking psych drugs.   

 
If you go to www.prescriptionsuicide.com, you can find more information about the film.

 

 

Sunday, October 23, 2005

Study links ADD and ADHD to misunderstood words and subjects

Study links ADD and ADHD to misunderstood words and subjects, both in children and in adults, says professor Oscar Wegner, director of the OWE, a Florida organization, Educational Division.

 

 The symptoms listed for ADD and ADHD in the now famous diagnostic manual of psychiatric disorders (DSM-IV) can be found to correlate exactly with the symptoms experienced by both adults and children by making them study unfamiliar subjects without permitting the use of a dictionary, nor helping them find out the applicable definition for every word missed.

 

 The most prominent ADD and ADHD symptoms, among others, noted with misunderstood words are inattention, making careless mistakes, not seeming to listen, not following instructions, avoiding tasks, easily distracted, fidgeting with hands or feet, restlessness, blurting answers before questions have been completed, chewing pencils or pens.

 

 While this symptom manifestation was found in both adults and children, children were more prone to lose their attention and lack discipline, while adults, in general, tried harder and with more responsibility to understand the subjects studied.

 

The most amazing find of this study was that once the misunderstood word or words were fully cleared and the subject understood, all of those ADD and ADHD symptoms disappeared, and the student was able to study and behave normally. They then seemed to enjoy their studies and other learning activities, including practicing what they learned. Students regained their overall happiness and willingness to sit in front of a book and study it.

 

Psychiatry, says Oscar Wegner, may be not only missing the boat but capsizing the Titanic. Instead of addressing the root of the schooling problem, we are masking it and creating dummies, drugged dummies.

The FDA, says Wegner, has only seen the tip of the iceberg and warned against these drugs side effects. The government's educational arm, the schools, and also parents, have been misled by the psychiatric profession into believing that drugs are the cure to study and behavioral ills, thus endangering the educational system. We are ruining the future of wonderful children and the future of this country. Children deserve the best of opportunities, education, and drug free lives, whether street drugs or prescribed ones.

FDA May Require Longer Studies Before Approving Psych Drugs

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability www.ahrp.org

The Wall Street Journal reports that the FDA has sent out feelers to
drug manufacturers to provide "longer-term efficacy data" for
psychotropic drugs.

This comes after a mountain of evidence shows placebo "works" just as
well or better than most psychotropic drugs without any of the serious
adverse side-effects.

If manufacturers resist providing long term data, and psychiatrists
continue to misprescribe drugs despite their ill effects and lack of
data demonstrating a benefit, then placebos should be declared first
line treatment.

TeenScreen: Welcome to the Psychiatric State


http://www.prisonplanet.com/articles/october2005/171005teenscreen.htm

TeenScreen: Welcome to the Psychiatric State

Jon Rappoport | October 17 2005

Columbia University has developed a screening questionnaire for
children. It is designed to indicate whether a child may have "a mental
disorder."

The whole Columbia program is called Teen Screen. The program site
stresses that this is a voluntary undertaking resting on parental
consent, and that it does not constiture a medical or psychiatric
diagnosis. If a child "tests positive" on the questionnaire, he is
referred to a "clinician" who does an "in-depth interview"...

Basically, Teen Screen is a feeder line, a funnel. It is organized so
that schools or communities anywhere in the world can set up their own
replicas of the program. Such expansion is encouraged.

The questionnaire is "a testing tool" for revealing that a child may be
clinically depressed, may have anxiety disorder, may have suicidal
thoughts.

In one study conducted on high-school students in New York, 27% of the
group tested showed "positive" on the questionnaire.

As you can see, this whole exercise is a funnel that moves in the
direction of prescribing psychiatric drugs.

The site for the Minnesota Department of Health provides links to a
short and long form of the questionnaire. I assume these versions are
Columbia's, since they are labeled Teen Screen.

Here is the short form.

DO YOU WEAR A SEAT BELT ALL THE TIME?

HAVE YOU BEEN IMMUNIZED FOR HEPATITIS B?

DO YOU SMOKE OR CHEW TOBACCO?

DO YOU DRINK ALCOHOL (BEER, WINE, OR HARD ALCOHOL)?

HAVE YOU TRIED DRUGS (MARIJUANA, SPEED, COCAINE/CRACK, OR ACID)?

HAVE YOU HAD SEX (INTERCOURSE, "DONE IT")?

HAVE YOU HAD AN INFECTION FROM SEX (STD OR VD)?

HAVE YOU EVER THOUGHT OF SUICIDE?

HAS ANYONE EVER HURT YOU PHYSICALLY OR SEXUALLY?

ARE YOU HAVING PROBLEMS GETTING ALONG WITH YOUR FAMILY?

I leave you to imagine the various permutations of yes answers that
could add up to a "positive reading" for possible mental disorders.

My favorite is question 2, which amounts to a survey on the Hep B
vaccine.

I would ordinarily point out that any program which starts out as
voluntary can later become compulsory, but as we know, Bush has already
proposed a nation-wide mental-health screening program for kids that is
mandatory.

Welcome to the Psychiatric State.

Step one is getting adults and children to concede that "mental
disorders" are widespread among children. To falsely concede that these
disorders are well-defined and real and can be pinpointed as organic
(biologically/chemically based).

>From there, everything flows into the arena of toxic drugs.

Schools love programs like Teen Screen. They allow teachers and
counselors to pretend they are possessed of prestigious medical
knowledge. Phony psychiatric terms can be thrown around like gold coins.
And of course it's a way to drug kids who cause problems in the
classroom or on the playground.

Chemical dyes in the school lunches? Vending machines for drinks that
are loaded with sugar and jolts of uppers? Processed snacks containing
scores of chemicals? Forget it? Not relevant. Much too pedestrian. We
are talking about real science here. The brain. Neurotransmitters.
Serious mental disorders. Teachers and counselors unite. You are finally
being called to a higher cause. Diagnosing children and thus saving
them. A bright future awaits in which every child will know exactly what
mental disorder he/she has. This is a crusade for a new world. Sign up
now. Take a workshop. A professional will be on hand.

Clearing a Path for Big Pharma's Marketing Machine

http://www.breitdrescher.com/library/the-new-freedom-initi.cfm

The New Freedom Initiative
Clearing a Path for Big Pharma's Marketing Machine

The pharmaceutical industry's contributions to our national health
during the past fifty years can't be denied. Antibiotics have turned
infections that were once fatal into mere inconveniences. The Human
Immunodeficiency Virus (the precursor to AIDS) was considered a death
sentence no more than ten years ago. Now, with the help of
pharmaceutical advances, the once inevitable progression from HIV to
full blown AIDS can be held at bay indefinitely. Thanks to drugs like
Lithium and Prozac, schizophrenics and those suffering from bipolar
disorder can now keep their conditions in check and lead productive
lives. Even more minor physical grievances (such as impotence and hair
loss) can be treated with a pill. For major and minor antidotes alike,
the pharmaceutical companies that are responsible for these innovations
have deservedly made billions of dollars over the years.

But despite such progress on both a fiscal and humanitarian level, it's
also clear that the big pharmaceutical companies have been corrupted by
their success and are engaging in reckless behavior in the pursuit of
profits. More than ever, today's pill makers concern themselves with
market-share and high visibility, as if they were selling DVD players,
video games or cars rather than medicines that irreversibly affect human
mental health and biology. They aggressively market new medicines using
flashy commercials, sponsorship of sporting events and the paid-for
testimonials of doctors. They want people using their products, whether
they really need those drugs or not.

And to top it all off, now they would like to have a word with your
kids.

Columbia University has initiated a program called "TeenScreen," which
is ostensibly a teen suicide prevention program, but is in reality a
marketing cattle call with the objective being to get as many children
on psychotropic drugs as possible. Parental involvement is deftly
side-stepped by using what is called a "passive permission form," in
which parental consent is implied if the student brings the permission
slip home and the parents fail to send it back. Students as young as
nine years old are lured in with coupons for movie rentals and free
pizza and are asked by "experts" a series of extraordinarily
teen-specific questions such as:

* Has there been a time when you felt you couldn't do anything well or
that you weren't as good-looking or as smart as other people? * How
often did your parents get annoyed or upset with you because of the way
you were feeling or acting? * Have you often worried a lot before you
were going to play a sport or game or do some other activity?

When the answers to these questions are answered with inevitable "Yes,"
"Very Often," and "Very Very Often", the "expert" recommends treatment
with the aid of pharmaceuticals. If this sort of marketing were taking
place with marijuana or cocaine, prison would be the result. Columbia
University has refused to divulge the sources of its funding for this
program, although the TeenScreen Program in Tennessee was funded by
Pharmaceutical giant Eli Lilly.

In witnessing Columbia University at work, one can imagine what
Americans of all ages can expect now that President Bush's "New Freedom
Initiative" has been unveiled. The initiative encourages comprehensive
mental health screening for what the report tellingly calls "Consumers"
of all ages (as opposed to "citizens" or "Americans"), including
pre-schoolers.

The NFI recommends that the studies be "Community-Based" rather than
"Institution-Based," meaning that the money would have to come from
sources other than Federal dollars. It is doubtful that most States or
Municipalities have that sort of revenue, so that means that the money
would have to come from other sources. The State of Tennessee had no
difficulty in locating a sponsor.

Such an open-ended recommendation from the White House might seem hard
to believe, but when you consider that the Pharmaceutical Industry has
donated over $52 million to Republican candidates since the year 2000,
the pill gets a little easier to swallow (although it doesn't taste any
better.)

Its one thing to offer free samples of cola, laundry detergent or
breakfast sausage in order to expand your customer base. That's
capitalism. That's the American Way. But playing politics so you can
"hard-sell" mind and behavior altering pharmaceuticals as if they were
just another product is a low way to make a buck.

ADHD advice secretly paid for by drugs companies


http://news.telegraph.co.uk/news/main.jhtml?xml=/news/2005/10/09/nadhd09.xml&sSheet=/news/2005/10/09/ixhome.html

ADHD advice secretly paid for by drugs companies
By Daniel Foggo
(Filed: 09/10/2005)

Support and advice groups for parents of children with so-called behavioural disorders are being secretly funded by pharmaceutical firms, it can be revealed.

The groups give out advice on stimulant drugs and other controversial medical treatments for young children diagnosed with attention-deficit hyperactivity disorder (ADHD). Their internet sites provide extensive details of medications that doctors can prescribe.

Eli Lilly: 'Small grant'
But at the same time they are also being secretly financed by the pharmaceutical companies which make the controversial "chemical cosh" drugs.

Last night one of the groups, a government-funded charity, admitted receiving five-figure sums from the drug giants and one of the companies involved conceded that a desire to sell more of its product was one of its motives for providing the finance.

The revelation comes amid increasing concern over the huge increase in children being fed powerful drugs in order to control overly exuberant behaviour.

Prescriptions of methyl-phenidate, a stimulant sold under several brand names, have increased 180-fold in the past 14 years.

Nicknamed "the chemical cosh" for its ability to slow down children, methyl-phenidate is predominantly prescribed to under-16s and its side-effects include insomnia, unresponsiveness and loss of appetite.

Critics claim that its use is unnecessary in many instances, as the children are exhibiting natural traits for their age which can be alleviated with dietary measures.

The National Attention Deficit Disorder Information and Support Service
(ADDISS) is a Department of Health-funded charity set up to "provide people-friendly information and resources about ADHD" and its website provides a factsheet giving details of the drugs that can be supplied to children.

It has received funding from three of the major pharmaceutical companies that make methylphenidate and other ADHD medications, which have been accused of sparking suicidal behaviour and liver problems in children.

However, the drug firms' financing is not acknowledged on the site and nor do their names show up on the accounts lodged with the Charity Commission.

Andrea Bilbow, the founder and chief executive of ADDISS, admitted that her group had solicited and received total funding of around £20,000 from Janssen-Cilag, which makes Concerta, a form of methylphenidate, UCB Pharma, which also produces another branded form of the drug, and Eli Lilly, which makes a form of atomoxetine, another ADHD drug which is linked to an increased suicide risk in children.

She said: "From time to time we do go to the pharmaceutical companies to ask for money, but we are not getting massive amounts. We don't sell our soul to the devil but we can't survive without them."

Ms Bilbow said that she did not identify the companies which have funded her charity on its internet site because to do so would be giving them "something in return".

"If we put the names on the site that would be promoting the companies and I've told them I won't do that," she said. "That would be advertising and I'm not getting enough money from them for that."

Another website, Adders.org, run by the Thanet ADDers non-profit support group, also gives detailed instructions on which drugs are available. Thanet ADDers has received money from at least one drug company. A spokesman for Eli Lilly confirmed that it had provided support in the form of a "small grant". Caroline Hensby, who runs the website, did not respond to calls.

The Eli Lilly spokesman said that the company wanted to help educate people about ADHD, but she conceded that there was a degree of self-interest in it doing so.

A spokesman for Janssen-Cilag confirmed that financial support had been given to ADDISS for a "specific meeting" organised by the charity.

A spokesman for UCB Pharma said: "Whilst we have good working relationships with ADDIS and Adders, we have not provided any significant funding or sponsorship."

Not all ADHD help groups take money from the pharmaceutical companies.

Glenn Slater, who has a child with ADHD and runs the website ADDvice.co.uk, which does not receive such funding, said: "Pharmaceutical companies giving money is not a good idea as people on the outside might get the wrong idea about the sites' motives."

Jim Mackie, former chairman of the Overload Network, which provides support for families affected by ADHD, said: "If they [the charities] are being funded by drug companies who are interested in promoting their products then that should be made clear on the websites."

Teen-Screen Moving into High Gear with Troubling Privacy Implications for Children

http://www.guardmycreditfile.org/index.php/content/view/487/135/

August 22, 2005 - In April of 2002, President Bush launched the New
Freedom Commission on Mental Health. The commission's goal was to assess
the impact that undiagnosed mental conditions were having on America in
general, and on the economy specifically. After what they claimed to be
an exhaustive study, the commission went public with a report that
recommended screening all Americans for mental illness, beginning with
school children, school workers and pregnant mothers. The report
recommendations are now kicking into high gear within the nation's
school system and with extremely troubling implications for privacy and
parental rights.

The program, which is known as Teen-Screen is being widely adopted by
schools around the country. It attempts to operate below the radar level
as an opt-out program. This means that schools engaged in Teen-Screen
automatically assume that parents give their permission for mental
health screening unless otherwise notified. Typically, screening is not
talked about by school officials until the day that it is scheduled.
This tactic is used to insure maximum participation.

Not only are these tactics unethical; denying parents to the right to
bring their children up as they see fit. They are also illegal under
current federal law. The Protection of Pupil Rights amendment (PPRA) is
a federal law that specifically requires the informed consent of parents
prior to any form of mental health testing by schools that receive funds
from the Department of Education.

Teen-Screen was originally billed as means to detect issues in teenagers
that might be prone to suicide. But the program now extends well beyond
its original scope. In a recent incident in Indiana, a 15 year old girl
named Chelsea Rhoades was ushered into a room, given a test and then
taken aside and told that she had two mental conditions. Because she
answered that she liked to help clean the house, she was diagnosed as
having Obsessive Compulsive Disorder. And because she said that she
didn't party a lot, she was diagnosed with Social Anxiety Disorder.
Since when did being "a good kid" equate to "that person must be
mentally ill"?

Both of these diagnoses were based on the answer to a single yes or no
question. Hardly what one could call a thorough mental examination. More
troubling is the fact that this information is now in the hands of the
government. With few restrictions on how this data can be used, there
may be some very real consequences for Chelsea over the course of her
life.

If the information falls into the hands of a health insurance company,
will she be uninsurable? If it falls into the hands of a potential
employer, will she be unemployable? If Chelsea was to become an engineer
or a scientist, would she be barred from ever getting a government
security clearance? And what about Chelsea's parents? Could they
possibly lose their family medical coverage because their daughter was
diagnosed with a mental illness?

All of these are very real possibilities.

Illinois has taken mental health screening one step further. The state
now mandates that all school age children, school workers and pregnant
mothers submit to mental health testing. Once diagnosed with a
condition, the law even prescribes the appropriate treatment. Parents
who try to intervene to keep their children off of unnecessary
antidepressant drugs can find themselves being prosecuted for child
endangerment and lose their parental rights.

The Illinois law and Teen-Screen will probably find themselves in
federal court over the next few years. There is a very real possibility
that these laws, will be found to be unconstitutional. But until that
happens Teen-Screen will produce windfall profits for the drug
companies, which are the ones that have been pushing for its adoption.
And it will also cause problems for American families that are trying to
lead their lives free of government interference. A very real
consequence that families may have to deal with is that the FDA has
recently forced drug companies to place warning labels on many
antidepressants. Some teenagers who take these drugs have been found to
have increased suicidal tendencies.

Parents who don't want to have their children go through Teen-Screen do
have some options. First, call your child's school and tell them in no
uncertain terms that they are not to test your child for any mental
health condition without your specific written permission to the
contrary. Secondly, find out if or when Teen-Screen testing is to take
place. Then request an opt-out slip. Concerned parents should then tell
the parents of their children's friends.

Finally, talk to your children about Teen-Screen. Tell them about what
it is and what the consequences to them could be if they take the test.
Tell them to refuse any type of mental health testing that you have not
consented to. Furthermore, tell them that if the school has a problem
with their attitude, that the school can contact you directly. If
someone from the school does call, be prepared to point out to them that
by attempting to test your child without first gaining your permission,
they are breaking the law (PPRA). That may just be enough to get them to
back off on both you and your child.

by Jim Malmberg

Friday, October 21, 2005

Ritalin is More Potent Than Cocaine

http://www.mercola.com/2001/sep/26/ritalin.htm

Ritalin is More Potent Than Cocaine

By Jean West

The children's drug Ritalin has a more potent effect on the brain than
cocaine.

Using brain imaging, scientists have found that, in pill form, Ritalin
- taken by thousands of British children and four million in the United
States - occupies more of the neural transporters responsible for the
'high' experienced by addicts than smoked or injected cocaine. The
research may alarm parents whose children have been prescribed Ritalin
as a solution to Attention Deficit Hyperactive Disorder.

The study was commissioned to understand more about why Ritalin - which
has the same pharmacological profile as cocaine - is effective in
calming children and helping them concentrate, while cocaine produces an
intense 'high' and is powerfully addictive.

In oral form, Ritalin did not induce this intense psychological 'hit'.
But Dr Nora Volkow, psychiatrist and imaging expert at Brookhaven
National Laboratory, in Upton, New York, who led the study, said that
injected into the veins as a liquid rather than taken as a pill, it
produced a rush that 'addicts like very much'.

Interviewed in last week's Journal of the American Medical Association
newsletter, she said: 'They say it's like cocaine.'

Even in pill form, Ritalin blocked far more of the brain transporters
that affect mood change and had a greater potency in the brain than
cocaine. Researchers were shocked by this finding.

A normal dose administered to children blocked 70 per cent of the
dopamine transporters. 'The data clearly show the notion that Ritalin is
a weak stimulant is completely incorrect,' said Volkow. Cocaine is known
to block around 50 per cent of these transporters, leaving a surfeit of
dopamine in the system, which is responsible for the hit addicts crave.

But now it is known that Ritalin blocks 20 percent more of these
auto-receptors.

'I've been almost obsessed about trying to understand [Ritalin] with
imaging,' said Volkow. 'As a psychiatrist I sometimes feel embarrassed
[about the lack of knowledge] because this is by far the drug we
prescribe most frequently to children.'

However, it was still not clear why a drug that has been administered
for more than 40 years was not producing an army of addicted
schoolchildren. Volkow and her team concluded that this was due to the
much slower process of oral ingestion.

It takes around an hour for Ritalin in pill form to raise dopamine
levels in the brain. Smoked or injected, cocaine does this in seconds.

Dr. Joanna Fowler, who worked with Volkow on the project, said: 'All
drugs that are abused by humans release large quantities of dopamine.
But dopamine is also necessary for people to be able to pay attention
and filter out other distractions.'

But opponents of Ritalin, labeled a 'wonder drug' and a 'chemical cosh',
believe it may be addictive and has dangerous side-effects. Moreover,
many believe ADHD is a fraudulent title for a non-existent condition
once put down to the exuberance of youth.

Professor Steve Baldwin, a child psychologist from Teesside University,
who died this year in the Selby rail crash, campaigned against Ritalin.
He pointed out similarities between the drug and amphetamines as well as
cocaine.

Mandy Smith of Banff in Scotland has a son of eight who was prescribed
Ritalin for nine months. 'I am astonished the British Government have
allowed this drug to be prescribed,' she said. 'It can destroy people's
lives. My son was a changed person when he took Ritalin. He was suicidal
and depressed.'

Janice Hill, of the Overload Support Network, a charity for parents of
children with behavioral problems, said: 'Now we have thousands of
children in Scotland taking a drug that is more potent than cocaine.
What does it take before the situation is thoroughly investigated?'

The Observer September 9, 2001

------------------------------------------------------------------------
--------

Dr. Mercola's Comment:

A majority of children with ADHD can be helped through the eating plan
and nutritional optimization. Diet and children's behavior has been
linked for decades, yet this is not addressed at all in traditional
medicine.

Related Articles:

Non-Drug Treatment of ADD/ADHD

The Ritalin Wars Continue

Maybe Attention Deficit Isn't the Real Problem

Ritalin "On the Ropes"

Thursday, October 20, 2005

FDA Incapable of Protecting U.S., Scientist Alleges - Important

Incapable of Protecting U.S., Scientist Alleges

An interview with Dr. David J. Graham, associate director of the FDA's Office of Drug Safety

From the September/October 2005 issue of
Fraud Magazine

Dr. David J. Graham, a scientist at the U.S. Food and Drug Administration for more than 20 years, says the agency could have prevented 60,000 deaths from the arthritis drug Vioxx. But Graham, the recipient of the ACFE's Cliff Robertson Sentinel Award, says the problems at the FDA go beyond the problems of one drug.

The long, sloping wall of the Vietnam Veterans' Memorial in Washington, D.C., contains the names of 58,000 men and women who died during that war.

As Dr. David J. Graham, a scientist at the Food and Drug Administration, says, that's 2,000 less than the estimated U.S. citizens he believes have died from the effects of the arthritis drug Vioxx.

"Between 1999 and 2004, an estimated 20 million Americans took Vioxx, 80 million worldwide," said Graham, the recipient of the 2005 Cliff Robertson Sentinel Award, at the recent 16th Annual ACFE Fraud Conference & Exhibition. "We've estimated that up to 140,000 patients (who took Vioxx) suffered heart attacks. ... Of this number, 60,000 died," said Graham, associate director of the Food and Drug Administration's Office of Drug Safety and an employee of the agency for more than 20 years. "Vioxx is a poster child ... for what's wrong with the FDA and why I believe FDA reform is so urgently needed."

In November of last year, Graham testified before the Senate Finance Committee that the FDA had silenced him and his colleagues from reporting on the risks of Vioxx and other drugs. "The FDA has let the American people down and sadly betrayed a public trust," Graham said during his testimony. He alleged that because the FDA is unduly influenced by the pharmacy industry it is "incapable of protecting America against another Vioxx. We are virtually defenseless." Merck & Co Inc., the maker of Vioxx, has pulled the drug from the marketplace. Meanwhile, Vioxx civil trials continue.

Graham remains at the FDA but says he has been "marginalized by FDA management and not asked to participate in the evaluation of any new drug safety issues. It's a type of ostracism."

In the following interview with Fraud Magazine, Graham says that "if I failed to speak the truth, I would become part of the problem, and all these deaths would in part, be my responsibility, in the same way that FDA was and is, responsible for these deaths. The decision to speak the truth wasn't difficult. My conscience guided me in the way I should go."

What does it mean for you to be awarded the Cliff Robertson ACFE Sentinel Award?
I was taken by surprise when Toby Bishop telephoned to tell me I'd been selected to receive the Cliff Robertson Sentinel Award, and I was humbled by the realization that my efforts were appreciated by an organization dedicated to the pursuit of truth. I found it ironic that while FDA condemned me for speaking truthfully before the Senate Finance Committee, that there were others outside of government who valued and respected what I had done.

In a nutshell, what has occurred in your professional and personal life since you testified before the U.S. Senate Nov. 18, 2004 about the dangers of Vioxx and the inadequacies of the Food and Drug Administration?
Professionally, I've been marginalized by FDA management and not asked to participate in the evaluation of any new drug safety issues. It's a type of ostracism. At the same time, however, I've been able to pursue some research interests of mine. Personally, family life has been extremely stressful since my testimony with isolation and hostility at work and constant apprehension about possible retaliation by FDA management.

Your lawyer has described your position as "filling space under the scrutinizing watch of a babysitter." What are your FDA duties now?
Officially, my duties have not changed, but in reality, I've been isolated. ... I analogize it to Solzhenitsyn's gulag, or to the Soviet Union's internal exile in the city of Gorky.

In your message at the 16th Annual ACFE Fraud Conference & Exhibition you said that between 1999 and 2004 an estimated 20 million Americans took Vioxx. You've estimated that 140,000 of those Americans suffered heart attacks and of that number up to 60,000 died of those heart attacks. How did you calculate those last two figures? Can you talk more about the Vioxx problem?
The estimated number of fatal and non-fatal heart attacks was obtained by taking the results from two large clinical trials conducted by the company, that showed that high-dose Vioxx increased heart attack risk five-fold and lower dose, by two-fold. These risks were applied to the total number of people in the U.S. who took Vioxx, and the resulting numbers were what you mentioned in your question. I think it's important to recognize that the number of Americans who died from Vioxx-related heart attacks could be very similar to the number of American soldiers killed during the Vietnam War. This was an enormous public health disaster which FDA did nothing to prevent. In fact, it is because of FDA's disregard for safety and bias in favor of industry, that the number who died from the drug became so large.

You've worked for the FDA for more than 20 years. Had you come to loggerheads with them in the past? Is this first time that you've protested against its actions in such a public fashion?
Over the course of my career, I have found myself in the minority on many drug safety issues. For most of these, history ultimately showed that I was correct, but because of FDA's reactive denial and delay, many thousands were needlessly injured or killed by the agency's inaction. FDA consistently overrated the benefits of the drugs it approved and rejected, downplayed, or ignored the safety problems that ultimately led to their withdrawal.

Internally, I wrote many reports and gave many presentations where I recommended that serious regulatory action was needed, but this was typically ignored. It was only with Vioxx and the Senate Finance Committee hearing, that I was put in a position where I either spoke truthfully about a system run amok, or betray that truth and join with FDA in covering up the problem. If I failed to speak the truth, I would become part of the problem, and all these deaths would, in part, be my responsibility, in the same way that FDA was and is, responsible for these deaths. The decision to speak the truth wasn't difficult. My conscience guided me in the way I should go.

What specifically do you believe is broken in the FDA and what needs to be done to fix it? What must be done to improve the drug vetting system?
FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs as it can, regardless of whether the drugs are safe or needed. Structurally, the large Office of New Drugs with FDA's Center for Drug Evaluation, which is responsible for reviewing and approving drugs before they come to market, is the same office with the power and responsibility to regulate those drugs post-marketing when a safety issue emerges. This inherent conflict of interest results in unsafe drugs remaining on the market. The people who approved them are very reluctant to admit that a problem exists or that perhaps, a mistake was made by approving the drug in the first place. As a result, many thousands of Americans have died.

FDA's culture is also at fault. The pro-industry bias leads to an environment where FDA tends to see things from industry's perspective. Many are the advisory committee meetings where the drug company presentation and the FDA presentation are virtually super-imposable. It makes you wonder who wrote the presentations. Also, the emphasis at FDA is on approval, and the focus in on efficacy - that is, does the drug have an effect. Safety isn't on the radar screen regardless of what FDA officialdom would have you believe. Scientifically, FDA uses statistics in a biased manner that favors industry at the expense of patient safety. You see, when FDA reviews a new drug, it assumes that the drug is safe, and it facetiously asks the company to prove that it's not safe. Of course, there is no incentive for a company to prove that their drug is not safe because then FDA might not approve it. So, with a nod and a wink, drug companies jump through the very low hoops that FDA sets up for safety, and the public pays in two ways - with its money and its lives. Finally, FDA has a well-established history of suppressing its scientists, of pressuring them to change their recommendations and conclusions if they are unfavorable about a drug and retaliation against those scientists who don't buckle under FDA pressure and threats. FDA calls itself the world's leading consumer protection agency. If the public only knew the truth, they'd demand that Congress fix the problem. Of course, Congress has no intention of doing anything that would upset industry either. What has emerged is a lethal triangle involving FDA, the pharmaceutical industry and Congress. Pharmaceutical money funds FDA and exerts great influence with Congress. FDA allows deadly drugs onto the market and Congress pretends that nothing is the matter.

You've said that the FDA officials view the pharmaceutical industry as its clients and not the American people. Why is this and how did it come to be?
Beginning in 1992, with passage of the Prescription Drug User Fee Act (PDUFA), where drug companies began paying substantial amounts of money to FDA so that FDA could review and approve their drugs more quickly, there has been a steady shift in FDA's cultural orientation. Currently, over 50 percent of the budget for FDA's Center for Drug Evaluation comes from user-fees. If these dried up, it would be like a diver who has run out of air. You've heard the expression "he who eats the king's corn marches to the king's drummer," and "he who pays the piper calls the tune." Well, FDA is marching to the drum beat of industry as if its life depended on it.

This fatal development isn't entirely FDA's fault. When Congress passed this law, I suppose it's possible that it didn't realize that PDUFA would lead to FDA becoming a captive of the industry it's supposed to regulate. However, that is what has happened, and to a disastrous end. With Vioxx alone, up to 60,000 Americans died, and for what? I'll let your readers answer that question for themselves. Congress must admit that this unintended consequence is real, and do something about it. Unfortunately, Congress has for the most part, denied that any problem exists. So, FDA has blood on its hands, and with the next drug safety disaster, that blood will be on the hands of Congress as well. And then maybe as in Shakespeare's MacBeth, we'll hear Congress say "out out damned spot."

In previous interviews, you've said that the FDA places almost complete attention, focus, and value on what it perceives to be the benefit of a product and almost completely discounts the risk side. How does this happen? Can you elaborate?
FDA is evaluated by the pharmaceutical industry and by higher levels of government by the metric of how many drugs does it approve and how quickly does it approve them. Nothing else matters. The "complaint" one sees most often in print, from pro-industry and right-leaning think tanks is that FDA isn't approving drugs quickly enough and as a result, Americans are being denied "lifesaving" medicines. This is pure propaganda and deception. The truth is, most drugs submitted to FDA by the pharmaceutical industry are "me-too" drugs; that is, they're very similar to other drugs already on the market that treat the same ailments. These "me-too"s do not represent a medical advance and do not offer meaningful advantages over existing, and frequently much cheaper, drugs. The reason for the deception and propaganda is money. Industry and its supporters want to make as much money as possible - money that comes out of the pockets of every American in one way or another.

Now, when reviewing a drug to decide if it should be marketed, the FDA focuses on efficacy; that is, does the drug have a biologic or pharmacologic effect. For example, does the drug lower blood sugar or blood pressure? Of critical importance, the efficacy of a drug usually has little or nothing to do with its benefit. In fact, for only a handful of drugs, do we have a quantitative measure of benefit. Health benefits might include things such as prolonging life or delaying the onset of blindness or kidney failure. But this is something FDA doesn't measure and it's really what physicians and patients are looking for when they prescribe or take medicines. So, when FDA approves a drug, it usually has no evidence that the drug will provide a meaningful benefit to patients. The fact that FDA has never performed a formal benefit analysis does not stop it from proclaiming to the world that for a particular drug with a well-defined and serious side effect, that the benefits exceed the risks. This too is propaganda and deception.

Two recent examples illustrate this dishonesty. With Vioxx, we had good clinical trials data as well as a large body of epidemiologic data showing that the drug substantially increased the risk of heart attack and sudden death. FDA never performed a formal evaluation of the actual benefit of Vioxx in the population. By its inaction, FDA implicitly said that the benefits of Vioxx continued to exceed its risks, and so it should remain on the market. When FDA did this, it was acting out of its bias in favor of drug companies. Many Americans died so that Vioxx could continue to be marketed. Interestingly, two published studies looking at benefit found that Celebrex was much better at preventing stomach bleeding than Vioxx.

The second example involves Serevent, a drug used to treat asthma. Before it was marketed in the U.S., FDA reviewed a clinical trial that suggested that Serevent might increase the risk of dying from asthma by three-fold. Because there was only 90 percent certainty that the risk was increased, and not 95 percent certainty, FDA approved the drug, presuming it was safe. If the weather forecaster said there is a 90 percent chance of rain tomorrow, would anyone doubt that it's going to rain? Because of case reports of patient deaths on the drug, another clinical trial was performed. The results of this study were recently made public, showing that Serevent increased the risk of asthma death by four-fold. FDA held an advisory committee meeting where it failed to present data on the population impact of this four-fold increase in risk, and the committee voted unanimously that Serevent remain on the market. This level of risk translates to thousands of unnecessary excess deaths, and for what? FDA has never performed an analysis of benefit, to document the basis for its pronouncement that benefit exceeds risk. If a major point of asthma therapy is to prevent asthma death, what sense does it make to have an asthma drug on the market that has been shown to increase the risk of death from asthma 400 percent?

What's the status of five drugs you mentioned in your Congressional testimony - Meridia, Crestor, Accutane, Serevent, and Bextra?
Ah, the "infamous five." With Accutane, very little has changed and what FDA is planning to do is still far from adequate. Fifteen years ago, I proposed a means of reducing pregnancy exposure to this drug, but it was ignored. Curiously, after more than 45,000 pregnancy exposures to the drug, FDA is finally considering some of what I recommended, and even more curiously, this occurred after the patent on Accutane expired. Of note, the vast majority of these pregnancies were aborted. Sadly, I think the evidence supports the conclusion that FDA and the company used induced abortion as their risk management plan for Accutane, rather than adopt an effective program of pregnancy prevention. Such a program would have seriously cut into profits generated by the drug. So, under FDA's watchful and approving eye, off-label use of Accutane increased nearly 300 percent, as did the number of exposed pregnancies. FDA is planning to announce a new program soon, but if past performance is any guide, this too will be woefully inadequate.

Bextra has been removed from the market. It's interesting to note that the official reasons given by FDA for the withdrawal were all known and apparent either before approval or soon thereafter.

With Crestor, no additional regulatory action has been taken and the same holds for Meridia. As far as Serevent is concerned, FDA recently held an advisory meeting that concluded the drug should remain on the market. However, important safety information from two large clinical trials, both of which showed that Serevent substantially increases asthma deaths, was not presented or discussed. Over the past 11 years, Serevent has probably been a major cause of asthma death in the U.S. There are no benefits that I know of that outweigh the large number of deaths caused by this drug. Nonetheless, FDA orchestrated the advisory meeting to get the pat on the back it was looking for, and still, neither Congress nor the public have ever held FDA accountable for its fatal decisions.

Can you give some examples in which you believe the FDA has pressured you to supply a good review of a drug that didn't deserve it?
With Arava, a drug for the treatment of rheumatoid arthritis, I did a study showing that Arava increased the risk of acute liver failure substantially without a correspondingly important benefit to offset this risk. I and a colleague recommended that Arava be withdrawn from the market. We were severely pressured to change our review, even to the point of being screamed at by a senior FDA manager while his supervisor and my supervisor looked on and did nothing to stop the abuse. Another favorite ploy is for a meeting to be held where multiple FDA managers from the Office of New Drugs criticize what you've done and ridicule you for having done it, with the intent that you'll alter your report. This happened with Arava and with Vioxx.

Can you discuss what you believe to be the conflicts of interest on FDA advisory panels with specific examples?
FDA advisory panels are frequently heavily conflicted in several ways. First, the committee members are usually recruited by the FDA reviewing division directors, who are looking for people on the committee who see the world in a way similar to their own view. So, if you're favorably predisposed to industry, you might look for committee members who are similarly inclined. Frequently, committee members are researchers at academic institutions who have performed studies for various drug companies in the past and may currently be conducting such research. This results in a situation where committee members may have a potential self-interest in adopting a pro-industry point of view. Most distressingly, however, advisory members frequently have active financial conflicts of interest that could influence decision making. This past February, FDA held an advisory meeting on the COX-2 pain relievers. The committee voted 17 to 15 in favor of bringing Vioxx back on the market and 17 to 13 in favor of keeping Bextra on the market. Of note, 10 panel members had financial relationships with drug companies that made COX-2 pain relievers. I did a statistical analysis of the voting and amazingly, if you had a financial conflict of interest, you were 16 times more likely to vote to keep Bextra on the market than if you had no such conflict, and for Vioxx, you were even more likely. The actual number couldn't be calculated because everyone with a conflict voted to bring Vioxx back. Now, if you disqualified these panel members, Vioxx and Bextra were overwhelmingly rejected by the remaining committee members. But the real perpetrator here is FDA because FDA knew about these conflicts and "waived" them. The public needs to understand that FDA advisory meetings are carefully orchestrated, and the information that is presented is scripted and censored, so that a particular point of view is offered without serious challenge or examination. FDA uses its committees to provide it with the shield and support it needs to do what it wanted to do in the first place.

On Nov. 9, 2004, you spoke with then-acting FDA commissioner Lester Crawford. (Crawford is now the confirmed FDA commissioner.) What did you discuss and what was the outcome?
Dr. Crawford asked if I would come to the Commissioner's Office to oversee the revamping of drug safety at FDA. I explained that I was a scientist, not a manager or a bureaucrat, and I could think of 10 or 12 people outside of FDA who would be perfect for this job, especially if at the end of it, this person was told they could be the director of a new Center for Product Safety.

You said that shortly before you appeared before the Senate to testify, senior FDA officials conspired in an organized, coordinated effort to intimidate you. How did you know that the effort was planned and what did they specifically do?
The effort to intimidate me prior to my Senate testimony was organized and premeditated, and though I'm not a lawyer, I would say it amounted to a conspiracy. Why do I say this? Well first, the day before the Senate announced there would be a hearing at which I would be testifying, I was invited to the FDA commissioner's office where I was asked to consider leaving drug safety to move to the commissioner's office. This is very strange because over the two previous months, I had been vilified by FDA management in the press and attacked and harassed by my own management in an attempt to get me to change my conclusions about Vioxx. Why would the commissioner want a vilified and hated "junk scientist" to move to his office to oversee the revamping of drug safety at FDA? It just didn't make sense. And how did he know that I would be testifying? I imagine he was tipped off by senators friendly with industry.

After I turned down this offer, a series of "anonymous" phone calls were made by senior FDA managers to Senator Grassley's office [Sen. Chuck Grassley (R-Iowa) is chair of the Senate Finance Committee. - ed.] and to Tom Devine, legal director of the Government Accountability Project (GAP), a non-profit organization that defends "whistleblowers." These calls amounted to a smear campaign against me, maligning my character and integrity and accusing me of being a dishonest scientist and a liar. Some of these phone calls were made from government telephones (caller ID), which is a federal crime. Now the purpose of these calls was to discredit me as a witness and to possibly convince Senator Grassley that he should not have me testify, or if he did, then not to support or defend me afterwards. With GAP, the purpose was to convince Tom that his group should not represent me. If I lost the support of GAP, maybe I'd back away from testifying, and if I didn't, well, I'd have no legal counsel or defense. But here's the core evidence. There must be 10,000 lawyers in Washington, D.C. How on earth did these FDA managers know to call Tom Devine? The answer is simple. You see, in early 2004, FDA suppressed another FDA scientist who had concluded that SSRI antidepressants increased the risk of suicidality in children. FDA held an advisory committee meeting where it hid this information from the public and from its own advisory committee. This suppression of important safety information was leaked to the press by people within FDA and this embarrassed the agency. My supervisor ordered an internal criminal investigation to identify and imprison the perpetrators. Of course, no one from the Office of New Drugs was investigated. I contacted GAP and Tom Devine at this time because I didn't want to have to hurt people I knew by testifying to these criminal investigators. Before they interviewed you, they made you sign a piece of paper saying that if you lied, and they found out about it, you could go to prison. Tom spoke with the investigators, and explained to them that their investigation was a crime because it violated three different federal laws and because it was simply a whistleblower witch hunt. Within days of this conversation, the investigation abruptly ended but not before the "official purpose" of the investigation was changed. No one knew that I had contacted Tom Devine except these criminal investigators, who put it in their report that was given to my supervisor. So, how did these other senior FDA managers know to call Tom Devine? I suppose it could be dumb luck, but I don't think so.

Why hasn't U.S. law enforcement listened to your complaints about the intimidation by senior FDA officials even though it's a federal crime?
There is no law enforcement when it comes to the government investigating itself. In this regard, the government is above the law. And then there is the code of managerial and organizational loyalty. Basically, they can hang separately or together. By sticking together, FDA's senior management create a barrier that's difficult to penetrate. Finally, there is politics, and the investigations by the inspectors general are subject to the oversight and say-so of political appointees. This has been the case under administrations of both persuasions. So, despite federal laws being broken, none of the FDA managers responsible will ever answer for their offense. Indeed, they'll probably be promoted. Isn't that the American way?

In November of 2004, Sen. Grassley sent a letter to Daniel Levinson, acting inspector general of the Department of Health and Human Services, asking for an official investigation into whether the FDA has attempted to discredit you. What became of that investigation?
To my knowledge, the investigation by the IG has gone nowhere. I've heard rumors that it became biased and didn't gather the appropriate evidence or interview key witnesses. But by now, we should all realize that the government does a really poor job of investigating itself. Talk about conflict of interest and bias.

Is the inspector general of the Department of Health and Human Services investigating any of your allegations? How about the General Accountability Office?
I've been told that the GAO investigation is proceeding and that a report may be available by September. Again, I'm skeptical that the report won't get rewritten by higher-ups in government.

You've said that you have no viable legal rights under the Whistleblower Protection Act. Can you elaborate? Have you been placed under criminal investigation? Can you discuss current introduced legislation that might protect federal workers' rights?
Currently, there is a federal Whistleblower Protection Act that was enacted into law a number of years ago, that was intended to give whistleblower protection to federal workers. Unfortunately, the First Amendment free-speech rights intended by that law have been interpreted away by the administrative courts, resulting in a situation where federal workers have absolutely no protection. In fact, the current WPA has become somewhat of a trap for government employees who see waste, fraud or public endangerment within government and try to bring it to public attention. In the private sector, Congress recently passed the Sarbanes-Oxley Act giving state-of-the-art free-speech rights to corporate truth-tellers (a.k.a. whistleblowers). In light of financial disasters such as Enron and WorldCom, Congress saw that such protection was needed if the country's 401-K and pension plans were to be protected. We're faced with a similar crisis within government, and sometimes, what we're dealing with are the lives of thousands, if not tens of thousands of people like you or me or any of your readers. So, in reality, the public needs to know that if government scientists can't protect themselves, how will they be able to protect them from unsafe drugs?

In both houses of Congress, there is currently a reinvigorated Whistleblower Protection Act that would provide government truth-tellers with the protections needed to ensure their First Amendment free-speech rights to bring into the sunshine waste, fraud, or public endangerment within the federal government. This bill would pass unanimously within both houses if it could come to a floor vote. However, I've been told that the political leadership in the House and the Senate will not allow the bill to come to a floor vote. Apparently, the Department of Justice is opposed to federal employees having the same free-speech rights as their counterparts in the private sector.

A 2002 Health and Human Services survey of almost 400 FDA scientists - almost 1/5 of the total number - found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they're on the market and that more than a third weren't particularly confident of the agency's ability to assess the safety of a drug. More than half of the respondents said they didn't think there was sufficient time to conduct an in-depth, science-based review in the six months required for drugs given priority status. Do you feel the results of the survey (only fully released after your 2004 Congressional testimony) vindicate your concerns?
I think the results of this survey, and several others that have been conducted (one by an outside FDA watch-dog group, Public Citizen, and another by FDA's Center for Drug Evaluation) reveal that there is real substance behind the remarks I made during my Senate testimony. FDA professes to be a scientific and evidence-based organization that is not biased in favor of the industry that pays much of its operating budget. These surveys paint a very different picture. In a scientific organization, especially one dealing with patients' health and lives, there should be no (zero) examples of suppression or intimidation of its scientists. Yet at FDA, this is normative, routine and commonplace. And then FDA goes to Congress and says no one is ever suppressed or pressured to change recommendations. Anyone looking at the objective evidence, and putting aside whether they're a Democrat or Republican, conservative or liberal, would quickly see what the truth of the matter is. Regrettably, however, drug safety has become a political issue. Patient safety and public health should be bipartisan and above politics. But that is not what is happening because the pharmaceutical industry is extremely powerful and carries unimaginable influence within Congress and over the FDA

What are the personal costs from being a sentinel?
The personal costs have been high. From August of 2004, when I first came under fire by FDA management to change my conclusions and recommendations to a large study I had just completed, through this past February or March, life was hellish to say the least. Internal criticism, threats and ostracism, coupled with an orchestrated campaign of slander and innuendo, initiated and carried out by FDA managers, took a great toll on my family. Apparently, pharmaceutical representatives and lobbyists also participated in this smear campaign on Capitol Hill. Why? Because the last thing industry wants to see is an FDA where post-marketing drug safety actually has power and authority to protect the consumer. An investigation of this episode was requested by Senator Grassley, but as I mentioned before, it appears that the Inspector General investigation will cover-up and gloss over what occurred, only empowering FDA to do even worse things in the future.

What are your professional plans from here?
My passion is really with the field of drug safety, as a scientist and researcher, not as a manager or bureaucrat. And FDA is potentially the single best place to be to make a difference in the health and well-being of patients. So if I were able to, I'd like to continue my work at FDA. From time-to-time, I've looked at university jobs, but in this field, most drug safety research outside the government is funded by industry, which can be very constraining and, I believe, compromising. It's well-established now that research funded by industry is four to five times more likely to reach a conclusion favorable to industry than if the research was funded by independent or neutral sources. The idea of working for industry also holds no appeal. Of course, I could always find plenty of work in the litigation field, but I'd much prefer to continue my work at FDA.

Have you received support (either private or public) from your colleagues and peers?
The support I have received from staff (but not management) within the Office of Drug Safety has been overwhelming and positive. It has also been out in the open. I have also received many phone calls or personal comments in the cafeteria or elevator from FDA staff working in other areas of the Center for Drugs. And then there are the hundreds of e-mails, letters, and phone calls I've received from the public, expressing their thanks and offering encouragement and prayers for me and my family.

After all that you've been through, would you do it again?
I have been asked this question several times and have thought about it at some length. I think the most honest answer I can give is that I wouldn't want to have to go through such anxiety and stress again, but faced with the same circumstances, I would have no choice, really, because the pain of knowing that I had contributed to the deaths of patients by my silence would be too much to bear. It gets back to this matter of conscience, and acting in accordance with it, and then trusting in God's providence. Human life is worth far more than a little difficulty at the office, and being able to look my children in the eye and for them to know that I have acted with integrity, is priceless. Plus, I'm able to sleep at night.