US Gov Medical Experiment Radically Departs from medical “Best Practices”

The NY Times reports that an IMS Health report found that the giant pharmaceutical industry  annual growth of pharma sales in the US and Western Europe has slowed to the low single digits in the last 8 years. Last year, US drug sales rose by 5% to about $300 billion. "And even if Congress passes health care legislation, which, according to a recent Credit Suisse report, could increase drug sales by $10.7 billion, the impact on the growth rate would be minimal." 

The US government is initiating several radical medical experiments that will ensure widespread, increased use of mostly toxic drugs whose adverse effects trigger chronic, debilitating illnesses. In accordance with medically unsupportable, "test and treat" protocols,  Americans who are deemed "at risk" on the basis of admittedly flawed screening tests, would be prescribed highly toxic drugs that carry Black Box warnings. Black Box warning labels are issued for the most dangerous drugs that have been linked to permanent or fatal injury in patients at normal prescribed doses.

Below, the Washington Times reports that the US National Institute of Allergy and Infectious Disease, under the directorship of Dr. Anthony S. Fauci, is about to launch a pharmaceutical experiment "on hundreds of mostly black homosexual men and heterosexual women in Washington."

"The experiment radically departs from medical "best practices" of offering antiretroviral chemotherapy for life to HIV-positive persons only after they exhibit depressed levels of CD4 T-cells and are judged to be at significant risk of contracting opportunistic illnesses associated with AIDS." 

The initiative promotes universal voluntary antibody testing of adults "accompanied by immediate administration of the drugs despite a wealth of evidence that the chemicals often cause serious adverse side effects – potentially life-threatening effects."

In a radical departure from civilized ethical medicine, "the experiment isn’t focused on individual impact. Instead, it suggests that the goal is a benefit that might accrue to society if the chemicals decrease sexual retrovirus transmission."

Indeed, an alarm was sounded by Dr. Harold Jaffe of the Department of Public Health at the University of Oxford (2009):

"Within the field of communicable diseases, we are aware of little precedent for the approach of ‘treating for the common good.’ Treatment of diseases such as tuberculosis might have the effect of decreasing transmission, but the primary goal is to decrease morbidity and mortality for the affected person."

Furthermore, evidence demonstrates that "untreated" positives may not experience illness following an HIV test for 10, 15 or 20 years – or ever, in many documented cases. Thus, an expert who has been a conservative voice for years in the drug-intervention debate, Dr. Jay A Levy wrote in an article for the San Francisco Chronicle on Feb. 23, 2001:

"The persistence of HIV in cells argues for a delay in initiating antiviral treatments. Unless the infected person is sick, the very real problems of long-term treatment must be considered: toxicity which may lead to damage of the pancreas, heart, kidney or brain, emergence of resistant viruses and suppression of the body’s natural anti-HIV immune responses." With words presaging the suggestion that immediate drug intervention could have societal benefits with regard to transmission, Dr. Levy wrote, "The increased prevalence of resistant viruses in newly infected people reflects the widespread use of HAART [highly active antiretroviral therapy] and the misconception that this treatment will prevent HIV transmission."

The other radical experiment is sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services (CMHS) which is offering grants to implement "the recommendations laid out by the New Freedom Commission on Mental Health in their 2003 report, ‘Achieving the Promise: Transforming Mental Health Care in America.’"

The New Freedom Commission report has been discredited in light of its primary ("test and treat") recommendations:
TeenScreen and TMAP (Texas Medication Algorithm Project). 

TeenScreen is discredited as a mental health dragnet which mislabels mostly healthy children as mentally ill–its false-positive rate is 84%.

TMAP is at the center of numerous State Attorney General lawsuits for fraud and criminal marketing–manufacturers of psychotropic drugs have paid billions of dollars in settlements and fines.

"Under the Mental Health Transformation State Incentive Grants (MHT SIG), CMHS awarded grants to nine states to transform their mental health services to achieve the goals of the New Freedom Commission."   

The new State Incentive Grants are for an additional $16.5 million.

In addition to being medically unsupportable these government-supported "test and treat" initiatives raise serious concerns about who are the targeted populations.

So, here’s the question:

Is the US government embarking on these immoral "Brave New World" experiments that violate the precautionary principle in medicine, by putting Americans at risk of drug-induced, serious health hazards, in an effort to rescue the pharmaceutical industry from its sales slump?

Contact: Vera Hassner Sharav

THE WASHINGTON TIMES
Wednesday, March 17, 2010
Going too far to battle disease
Terry Michael

A pharmaceutical experiment on hundreds of mostly black homosexual men and heterosexual women in Washington is about to be undertaken by U.S. AIDS czar Dr. Anthony S. Fauci with the enthusiastic backing of the District’s black mayor, Adrian M. Fenty, voiced in a January announcement. The experiment radically departs from medical "best practices" of offering antiretroviral chemotherapy for life to HIV-positive persons only after they exhibit depressed levels of CD4 T-cells and are judged to be at significant risk of contracting opportunistic illnesses associated with AIDS.

The new effort, "test and treat," as it is called, will promote universal voluntary antibody testing of adults accompanied by immediate administration of the drugs despite a wealth of evidence that the chemicals often cause serious adverse side effects – potentially life-threatening effects. However, the experiment isn’t focused on individual impact. Instead, it suggests that the goal is a benefit that might accrue to society if the chemicals decrease sexual retrovirus transmission.

One of the world’s leading HIV-AIDS experts, Dr. Jay A. Levy of the University of California at San Francisco, responded, "No, I wouldn’t," when asked for this article if he would take the drugs if he were a homosexual black man in Washington with a positive antibody test but with normal T-cell counts and no illness.

A conservative voice for years in the drug-intervention debate, Dr. Levy wrote in an article for the San Francisco Chronicle on Feb. 23, 2001: "The persistence of HIV in cells argues for a delay in initiating antiviral treatments. Unless the infected person is sick, the very real problems of long-term treatment must be considered: toxicity which may lead to damage of the pancreas, heart, kidney or brain, emergence of resistant viruses and suppression of the body’s natural anti-HIV immune responses." With words presaging the suggestion that immediate drug intervention could have societal benefits with regard to transmission, Dr. Levy wrote, "The increased prevalence of resistant viruses in newly infected people reflects the widespread use of HAART [highly active antiretroviral therapy] and the misconception that this treatment will prevent HIV transmission."

Scheduled to start midyear, according to the National Institute of Allergy and Infectious Diseases (NIAID), the experiment is based on a controversial Jan. 3, 2009 article in the British medical journal the Lancet by Dr. Reuben Granich of the World Health Organization, titled "Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model."

Director of NIAID for a quarter-century, Dr. Fauci and his director of HIV programs, Carl W. Dieffenbach, announced the experiment with Mr. Fenty on Jan. 12 as part of a larger, $26.4 million study to combat what the District’s HIV-AIDS agency claims is a "generalized epidemic" affecting 3 percent of adults and adolescents. Use of the word "epidemic" suggests widespread disease and mortality, though the vast majority of the agency’s claimed cases have tested positive only for HIV antibodies and have experienced no illness from AIDS. Research shows "untreated" positives may not experience illness following an HIV test for 10, 15 or 20 years – or ever, in many documented cases.

Dr. Fauci and Mr. Dieffenbach published an article in the June 10, 2009 edition of the Journal of the American Medical Association in laudatory response to Dr. Granich’s article. "A recent modeling study… reaches provocative conclusions and provides the theoretical basis for a new and potentially important public health policy strategy," they wrote. "This approach, referred to as ‘test and treat,’ predicts that [with] implementation of an annual voluntary universal HIV testing program for persons older than 15 years and with immediate initiation of [antiretroviral therapy] for those individuals who test positive regardless of their CD4 T-cell count or viral load, the HIV pandemic could be reduced within 10 years."

Critical peer reviews of Dr. Granich’s work were published March 28, 2009 in the Lancet, months before Dr. Fauci and Mr. Dieffenbach published their paper. One notable alarm was sounded by Dr. Harold Jaffe of the Department of Public Health at the University of Oxford: "Within the field of communicable diseases, we are aware of little precedent for the approach of ‘treating for the common good.’ Treatment of diseases such as tuberculosis might have the effect of decreasing transmission, but the primary goal is to decrease morbidity and mortality for the affected person."

Dr. Levy of UC-San Francisco, whose own research has received major funding from NIAID and is sometimes called the "third co-discoverer of HIV," did not directly criticize the Fauci initiative but warned that the test-and-treat theory should be reviewed by an appropriate "human subjects committee."

Statutes mandate such panels for federal projects, a reaction to the U.S. Public Health Service’s infamous mid-20th-century Tuskegee study of black men and women intentionally untreated for syphilis.

The local NIAID initiative will be in collaboration with the embattled District HIV-AIDS administration, cited by a Washington Post investigation in 2009 for misallocating millions of dollars, colluding with HIV-AIDS nonprofits siphoning tax dollars for never-delivered services.

The new $26.4 million would be added to the $85 million currently spent annually by the District’s HIV-AIDS agency, which employs about 160 people, up from 125 just two years ago, though the number who have died in recent years from broadly defined "AIDS" continues to decline and is little more than the few hundred annual cases of death from accidents in the District. The District HIV-AIDS administration reported that 226 people died in 2006 of AIDS or "AIDS-related" causes, which increasingly are heart, liver and other ailments from adverse effects of antiviral drug treatment. That contrasts with more than a thousand cancer deaths and a thousand who die of heart disease annually in the District.

Not only are there relatively few deaths from AIDS in the District, the number of new AIDS (not HIV) cases reported in 2007 was 648 in a jurisdiction with a total population of slightly more than a half-million. That contrasts with a total of 238 new cases of AIDS reported by Canada in 2007 for its entire population of 34 million. Somehow, there were about 128 new AIDS cases per 100,000 residents in the District, compared with 1.4 per 100,000 in all of Canada – a 9,000 percent difference.

Either Canada is really bad at collecting numbers for an apparently sexually transmitted disease, District residents are hypersexually active, or the District’s HIV-AIDS "epidemic" is grossly overstated by an agency charged with ineptness for years and always interested in sustaining its mission and budget.

Terry Michael is a Washington writer.

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CMHS CONSUMER AFFAIRS E-NEWS MARCH 2, 2010
SAMHSA/CMHS Request for Applications:  
Mental Health Transformation Grants Short Title: (MHTG)

Request for Applications (RFA) No. SM-10-010 Posting on Grants.gov: March 1, 2010 Application deadline: April 30, 2010
Catalogue of Federal Domestic Assistance (CFDA) No.: 93.243

The Substance Abuse and Mental Health Services Administration, Center for Mental Health Services is accepting applications for fiscal year (FY) 2010 Mental Health Transformation Grants (MHTG).  The purpose of this program is to foster adoption and implementation of permanent transformative changes in how public mental health services are organized, managed and delivered so that they are consumer-driven, recovery-oriented and supported through evidence-based and best practices.  Funding will support States and local governments to create and/or expand treatment capacity within SAMHSA’s strategic initiatives. 

SAMHSA’s Center for Mental Health Services (CMHS) was charged with responsibility to foster implementation of the recommendations laid out by the New Freedom Commission on Mental Health in their 2003 report Achieving the Promise: Transforming Mental Health Care in America.  In addition, CMHS recognized that the foundation for transformative changes envisioned by the New Freedom Commission was strengthened by incorporation of the recommendations of two additional pivotal reports:  Improving the Quality of Health Care for Mental and Substance-Use Conditions, published by the Institute of Medicine in 2005,and Mental Health: A Report of the Surgeon General, released in 1999.  Under the Mental Health Transformation State Incentive Grants (MHT SIG), CMHS awarded grants to nine states to transform their mental health services to achieve the goals of the New Freedom Commission. 

SAMHSA has demonstrated that – prevention works, treatment is effective, and people recover from mental and substance use disorders. Behavioral health services improve health status and reduce health care and other costs to society. Continued improvement in the delivery and financing of prevention, treatment and recovery support services provides a cost effective opportunity to advance and protect the Nation’s health. To continue to improve the delivery and financing of prevention, treatment and recovery support services, SAMHSA has identified ten Strategic Initiatives to focus the Agency’s work on people and emerging opportunities. More information is available at the SAMHSA website: http://www.samhsa.gov/About/strategy.aspx.

In order to complement but not duplicate the efforts of other CMHS programs, FY 2010 funding for MHTG will focus on services for adults with or at-risk for serious mental illnesses. Applications responsive to this Request for Application must implement evidence-based or best practices that will create or expand capacity to address one or more of the five Strategic Initiatives as follows. 

1.      Prevent mental illness through outreach, screening, and early interventions for adults with early signs of mental illness or who are at risk, and promote wellness through holistic treatment approaches. Services may include a variety of practices related to early intervention or wellness promotion, including psycho-education for consumers and family members, and peer wellness coaching or smoking cessation programs.

2.      Implement Trauma-Informed Care (TIC) as the framework for the practice/service chosen and implement trauma screening, assessment, and recovery support. Within the TIC framework, services are organized and delivered in a manner that meets the unique trauma-related needs of consumers/survivors, and safety, as identified by the service recipient, is the primary concern. The practice approach emphasizes the consumer empowerment and the consumer as driver of services, adopts universal precautions in asking about trauma, builds organizational capacity and knowledge of TIC through on-going training and policy review to ensure do no harm practices.

3.      Create or expand the delivery of screening, treatment and support to active duty, guard and reserve members to recover from mental illness including trauma related disorders and to their families to build resilience and support recovery.  Collaboration with State Veteran Administration (contact http://www.va.gov/statedva.htm) , federal Veteran Health Administration (contact  https://www.vha.com/)  and the State National Guard (contact http://www.agaus.org/Documents/TAGSContact29April09.pdf) are crucial to ensuring that members and their families have access to excellent and comprehensive care.  

4.      Increase the availability of services linked to safe and affordable permanent housing for individuals who are homeless or at risk of homelessness due to mental illness, substance use, HIV/AIDs or long term institutionalization in a nursing home, jail, or other facility. Services may include outreach, Critical Time Intervention, supportive housing and Assertive Community Treatment or other proven evidence based model for service delivery, ensuring fidelity to the practice models.

5.      Increase employment and education for adults diagnosed with mental illness to address high rates of unemployment among this population and to promote the development of skills, aptitudes and employability. Services will include evidence based practices such as supported employment and supported education, implemented with fidelity to practice models, if tools are available.

The MHTG program is one of SAMHSA’s services grant programs.  SAMHSA’s services grants are designed to address gaps in mental health treatment services and to increase the ability of States, units of local government, and American Indian/Alaska Native Tribes and tribal organizations to help populations with or at-risk for serious mental health problems.  SAMHSA intends that its services grants result in the delivery of services as soon as possible after award.  Service delivery should begin by the 6th month of the project at the latest.

MHTG are authorized under Section 520A of the Public Health Service Act, as amended.  This announcement addresses Healthy People 2010 focus area 18 (Mental Health and Mental Disorders).

Eligibility
Eligible Applicants

Eligible applicants are State and local governments and federally recognized American Indian/Alaska Native (AI/AN) Tribes and tribal organizations.  Applicants are expected to have an existing relationship with community-level service providers to ensure that services are implemented in local environments. Tribal organization means the recognized body of any AI/AN Tribe; any legally established organization of American Indians/Alaska Natives which is controlled, sanctioned, or chartered by such governing body or which is democratically elected by the adult members of the Indian community to be served by such organization and which includes the maximum participation of American Indians/Alaska Natives in all phases of its activities.  Consortia of tribal organizations are eligible to apply, but each participating entity must indicate its approval.

Eligibility is limited to States, local governments, and tribes because these entities administer public mental health systems and have the capacity to implement transformative changes and services.  Including both state and local governments as applicants also fosters the implementation of “top down” and “bottom up” approaches to transformational change and can better support required stakeholder involvement.  This also allows for more customized approaches where there are variations in population density, access to providers, and the need for customized services.

Award Information
Funding Mechanism:      Grant 
Anticipated Total Available Funding:    $16.5 million 
Anticipated Number of Awards:   22    
Anticipated Award Amount:       Up to $750,000 per year
Length of Project Period:       Up to 5 years 
Proposed budgets cannot exceed $750,000 in total costs (direct and indirect) in any year of the proposed project.  Annual continuation awards will depend on the availability of funds, grantee progress in meeting project goals and objectives, timely submission of required data and reports, and compliance with all terms and conditions of award.