Fwd: US Gov Medical Experiment Radically Departs from medical Best Practices

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>>Eligible applicants are State and local governments and federally recognizedAmerican Indian/Alaska Native (AI/AN) Tribes and tribal organizations<<======== ALLIANCE FOR HUMAN RESEARCH PROTECTION A Catalyst for Public Debate: Promoting Openness, Full Disclosure, andAccountability http://www.ahrp.org FYIThe NY Times reports that an IMS Health report found that the giantpharmaceutical industry annual growth of pharma sales in the US and WesternEurope 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 passeshealth care legislation, which, according to a recent Credit Suisse report,could increase drug sales by $10.7 billion, the impact on the growth ratewould be minimal."http://www.nytimes.com/2010/03/17/business/global/17drug.html?ref=todayspaper The US government is initiating several radical medical experiments thatwill ensure widespread, increased use of mostly toxic drugs whose adverseeffects trigger chronic, debilitating illnesses. In accordance withmedically unsupportable, "test and treat" protocols, Americans who aredeemed "at risk" on the basis of admittedly flawed screening tests, would beprescribed highly toxic drugs that carry Black Box warnings. Black Boxwarning labels are issued for the most dangerous drugs that have been linkedto permanent or fatal injury in patients at normal prescribed doses. Below, the Washington Times reports that the US National Institute ofAllergy and Infectious Disease, under the directorship of Dr. Anthony S.Fauci, is about to launch a pharmaceutical experiment "on hundreds of mostlyblack homosexual men and heterosexual women in Washington.The experiment radically departs from medical "best practices" of offeringantiretroviral chemotherapy for life to HIV-positive persons only after theyexhibit depressed levels of CD4 T-cells and are judged to be at significantrisk 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 ofevidence that the chemicals often cause serious adverse side effects -potentially life-threatening effects."In a radical departure from civilized ethical medicine, "the experimentisn't focused on individual impact. Instead, it suggests that the goal is abenefit that might accrue to society if the chemicals decrease sexualretrovirus transmission." Indeed, an alarm was sounded by Dr. Harold Jaffe of the Department of PublicHealth at the University of Oxford (2009): "Within the field of communicable diseases, we are aware of little precedentfor the approach of 'treating for the common good.' Treatment of diseasessuch as tuberculosis might have the effect of decreasing transmission, butthe primary goal is to decrease morbidity and mortality for the affectedperson." Furthermore, evidence demonstrates that "untreated" positives may notexperience 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 voicefor years in the drug-intervention debate, Dr. Jay A Levy wrote in anarticle for the San Francisco Chronicle on Feb. 23, 2001: "The persistence of HIV in cells argues for a delay in initiating antiviraltreatments. Unless the infected person is sick, the very real problems oflong-term treatment must be considered: toxicity which may lead to damage ofthe pancreas, heart, kidney or brain, emergence of resistant viruses andsuppression of the body's natural anti-HIV immune responses." With wordspresaging the suggestion that immediate drug intervention could havesocietal benefits with regard to transmission, Dr. Levy wrote, "Theincreased prevalence of resistant viruses in newly infected people reflectsthe widespread use of HAART [highly active antiretroviral therapy] and themisconception that this treatment will prevent HIV transmission." The other radical experiment is sponsored by the Substance Abuse and MentalHealth Services Administration (SAMHSA), Center for Mental Health Services(CMHS) which is offering grants to implement "the recommendations laid outby 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 itsprimary ("test and treat") recommendations: TeenScreen and TMAP (Texas Medication Algorithm Project). TeenScreen is discredited as a mental health dragnet which mislabels mostlyhealthy children as mentally ill--its false-positive rate is 84%.TMAP is at the center of numerous State Attorney General lawsuits for fraudand criminal marketing--manufacturers of psychotropic drugs have paidbillions 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 servicesto achieve the goals of the New Freedom Commission."http://www.samhsa.gov/Grants/2010/SM-10-010.aspx 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 thetargeted 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 puttingAmericans at risk of drug-induced, serious health hazards, in an effort torescue the pharmaceutical industry from its sales slump?Contact: Vera Hassner Sharavveracare212-595-8974http://www.washingtontimes.com/news/2010/mar/17/going-too-far-to-battle-disease/THE WASHINGTON TIMESWednesday, March 17, 2010 Going too far to battle diseaseTerry Michael A pharmaceutical experiment on hundreds of mostly black homosexual men andheterosexual women in Washington is about to be undertaken by U.S. AIDS czarDr. Anthony S. Fauci with the enthusiastic backing of the District's blackmayor, Adrian M. Fenty, voiced in a January announcement. The experimentradically departs from medical "best practices" of offering antiretroviralchemotherapy for life to HIV-positive persons only after they exhibitdepressed levels of CD4 T-cells and are judged to be at significant risk ofcontracting opportunistic illnesses associated with AIDS. The new effort, "test and treat," as it is called, will promote universalvoluntary antibody testing of adults accompanied by immediate administrationof the drugs despite a wealth of evidence that the chemicals often causeserious adverse side effects - potentially life-threatening effects.However, the experiment isn't focused on individual impact. Instead, itsuggests that the goal is a benefit that might accrue to society if thechemicals decrease sexual retrovirus transmission. One of the world's leading HIV-AIDS experts, Dr. Jay A. Levy of theUniversity of California at San Francisco, responded, "No, I wouldn't," whenasked for this article if he would take the drugs if he were a homosexualblack man in Washington with a positive antibody test but with normal T-cellcounts and no illness. A conservative voice for years in the drug-intervention debate, Dr. Levywrote in an article for the San Francisco Chronicle on Feb. 23, 2001: "Thepersistence of HIV in cells argues for a delay in initiating antiviraltreatments. Unless the infected person is sick, the very real problems oflong-term treatment must be considered: toxicity which may lead to damage ofthe pancreas, heart, kidney or brain, emergence of resistant viruses andsuppression of the body's natural anti-HIV immune responses." With wordspresaging the suggestion that immediate drug intervention could havesocietal benefits with regard to transmission, Dr. Levy wrote, "Theincreased prevalence of resistant viruses in newly infected people reflectsthe widespread use of HAART [highly active antiretroviral therapy] and themisconception that this treatment will prevent HIV transmission." Scheduled to start midyear, according to the National Institute of Allergyand Infectious Diseases (NIAID), the experiment is based on a controversialJan. 3, 2009 article in the British medical journal the Lancet by Dr. ReubenGranich of the World Health Organization, titled "Universal voluntary HIVtesting with immediate antiretroviral therapy as a strategy for eliminationof HIV transmission: a mathematical model." Director of NIAID for a quarter-century, Dr. Fauci and his director of HIVprograms, Carl W. Dieffenbach, announced the experiment with Mr. Fenty onJan. 12 as part of a larger, $26.4 million study to combat what theDistrict's HIV-AIDS agency claims is a "generalized epidemic" affecting 3percent of adults and adolescents. Use of the word "epidemic" suggestswidespread disease and mortality, though the vast majority of the agency'sclaimed cases have tested positive only for HIV antibodies and haveexperienced no illness from AIDS. Research shows "untreated" positives maynot experience illness following an HIV test for 10, 15 or 20 years - orever, in many documented cases. Dr. Fauci and Mr. Dieffenbach published an article in the June 10, 2009edition of the Journal of the American Medical Association in laudatoryresponse to Dr. Granich's article. "A recent modeling study... reachesprovocative conclusions and provides the theoretical basis for a new andpotentially important public health policy strategy," they wrote. "Thisapproach, referred to as 'test and treat,' predicts that [with]implementation of an annual voluntary universal HIV testing program forpersons older than 15 years and with immediate initiation of [antiretroviraltherapy] for those individuals who test positive regardless of their CD4T-cell count or viral load, the HIV pandemic could be reduced within 10years." Critical peer reviews of Dr. Granich's work were published March 28, 2009 inthe Lancet, months before Dr. Fauci and Mr. Dieffenbach published theirpaper. One notable alarm was sounded by Dr. Harold Jaffe of the Departmentof Public Health at the University of Oxford: "Within the field ofcommunicable diseases, we are aware of little precedent for the approach of'treating for the common good.' Treatment of diseases such as tuberculosismight have the effect of decreasing transmission, but the primary goal is todecrease morbidity and mortality for the affected person." Dr. Levy of UC-San Francisco, whose own research has received major fundingfrom NIAID and is sometimes called the "third co-discoverer of HIV," did notdirectly criticize the Fauci initiative but warned that the test-and-treattheory 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 blackmen and women intentionally untreated for syphilis. The local NIAID initiative will be in collaboration with the embattledDistrict HIV-AIDS administration, cited by a Washington Post investigationin 2009 for misallocating millions of dollars, colluding with HIV-AIDSnonprofits siphoning tax dollars for never-delivered services. The new $26.4 million would be added to the $85 million currently spentannually 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 recentyears from broadly defined "AIDS" continues to decline and is little morethan the few hundred annual cases of death from accidents in the District.The District HIV-AIDS administration reported that 226 people died in 2006of AIDS or "AIDS-related" causes, which increasingly are heart, liver andother ailments from adverse effects of antiviral drug treatment. Thatcontrasts with more than a thousand cancer deaths and a thousand who die ofheart disease annually in the District. Not only are there relatively few deaths from AIDS in the District, thenumber of new AIDS (not HIV) cases reported in 2007 was 648 in ajurisdiction 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 in2007 for its entire population of 34 million. Somehow, there were about 128new AIDS cases per 100,000 residents in the District, compared with 1.4 per100,000 in all of Canada - a 9,000 percent difference. Either Canada is really bad at collecting numbers for an apparently sexuallytransmitted disease, District residents are hypersexually active, or theDistrict's HIV-AIDS "epidemic" is grossly overstated by an agency chargedwith ineptness for years and always interested in sustaining its mission andbudget. Terry Michael is a Washington writer.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ http://www.samhsa.gov/Grants/2010/SM-10-010.aspxCMHS CONSUMER AFFAIRS E-NEWS MARCH 2, 2010SAMHSA/CMHS Request for Applications: Mental Health Transformation Grants Short Title: (MHTG)Request for Applications (RFA) No. SM-10-010Posting on Grants.gov: March 1, 2010Application deadline: April 30, 2010Catalogue of Federal Domestic Assistance (CFDA) No.: 93.243The Substance Abuse and Mental Health Services Administration, Center forMental Health Services is accepting applications for fiscal year (FY) 2010Mental Health Transformation Grants (MHTG). The purpose of this program isto foster adoption and implementation of permanent transformative changes inhow public mental health services are organized, managed and delivered sothat they are consumer-driven, recovery-oriented and supported throughevidence-based and best practices. Funding will support States and localgovernments to create and/or expand treatment capacity within SAMHSA'sstrategic initiatives. SAMHSA's Center for Mental Health Services (CMHS) was charged withresponsibility to foster implementation of the recommendations laid out bythe New Freedom Commission on Mental Health in their 2003 report Achievingthe Promise: Transforming Mental Health Care in America. In addition, CMHSrecognized that the foundation for transformative changes envisioned by theNew Freedom Commission was strengthened by incorporation of therecommendations of two additional pivotal reports: Improving the Quality ofHealth Care for Mental and Substance-Use Conditions, published by theInstitute of Medicine in 2005,and Mental Health: A Report of the SurgeonGeneral, released in 1999. Under the Mental Health Transformation StateIncentive Grants (MHT SIG), CMHS awarded grants to nine states to transformtheir mental health services to achieve the goals of the New FreedomCommission. SAMHSA has demonstrated that - prevention works, treatment is effective, andpeople recover from mental and substance use disorders. Behavioral healthservices improve health status and reduce health care and other costs tosociety. Continued improvement in the delivery and financing of prevention,treatment and recovery support services provides a cost effectiveopportunity to advance and protect the Nation's health. To continue toimprove the delivery and financing of prevention, treatment and recoverysupport services, SAMHSA has identified ten Strategic Initiatives to focusthe Agency's work on people and emerging opportunities. More information isavailable 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-riskfor serious mental illnesses. Applications responsive to this Request forApplication must implement evidence-based or best practices that will createor expand capacity to address one or more of the five Strategic Initiativesas follows. 1. Prevent mental illness through outreach, screening, and earlyinterventions for adults with early signs of mental illness or who are atrisk, and promote wellness through holistic treatment approaches. Servicesmay include a variety of practices related to early intervention or wellnesspromotion, including psycho-education for consumers and family members, andpeer wellness coaching or smoking cessation programs. 2. Implement Trauma-Informed Care (TIC) as the framework for thepractice/service chosen and implement trauma screening, assessment, andrecovery support. Within the TIC framework, services are organized anddelivered in a manner that meets the unique trauma-related needs ofconsumers/survivors, and safety, as identified by the service recipient, isthe primary concern. The practice approach emphasizes the consumerempowerment and the consumer as driver of services, adopts universalprecautions in asking about trauma, builds organizational capacity andknowledge of TIC through on-going training and policy review to ensure do noharm practices.3. Create or expand the delivery of screening, treatment and support toactive duty, guard and reserve members to recover from mental illnessincluding trauma related disorders and to their families to build resilienceand support recovery. Collaboration with State Veteran Administration(contact http://www.va.gov/statedva.htm) , federal Veteran HealthAdministration (contact https://www.vha.com/) and the State National Guard(contact http://www.agaus.org/Documents/TAGSContact29April09.pdf) arecrucial to ensuring that members and their families have access to excellentand comprehensive care. 4. Increase the availability of services linked to safe and affordablepermanent housing for individuals who are homeless or at risk ofhomelessness due to mental illness, substance use, HIV/AIDs or long terminstitutionalization in a nursing home, jail, or other facility. Servicesmay include outreach, Critical Time Intervention, supportive housing andAssertive Community Treatment or other proven evidence based model forservice delivery, ensuring fidelity to the practice models. 5. Increase employment and education for adults diagnosed with mentalillness to address high rates of unemployment among this population and topromote the development of skills, aptitudes and employability. Serviceswill include evidence based practices such as supported employment andsupported education, implemented with fidelity to practice models, if toolsare available. The MHTG program is one of SAMHSA's services grant programs. SAMHSA'sservices grants are designed to address gaps in mental health treatmentservices and to increase the ability of States, units of local government,and American Indian/Alaska Native Tribes and tribal organizations to helppopulations with or at-risk for serious mental health problems. SAMHSAintends that its services grants result in the delivery of services as soonas possible after award. Service delivery should begin by the 6th month ofthe project at the latest. MHTG are authorized under Section 520A of the Public Health Service Act, asamended. 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 recognizedAmerican Indian/Alaska Native (AI/AN) Tribes and tribal organizations.Applicants are expected to have an existing relationship withcommunity-level service providers to ensure that services are implemented inlocal environments. Tribal organization means the recognized body of anyAI/AN Tribe; any legally established organization of American Indians/AlaskaNatives which is controlled, sanctioned, or chartered by such governing bodyor which is democratically elected by the adult members of the Indiancommunity to be served by such organization and which includes the maximumparticipation of American Indians/Alaska Natives in all phases of itsactivities. Consortia of tribal organizations are eligible to apply, buteach participating entity must indicate its approval.Eligibility is limited to States, local governments, and tribes becausethese entities administer public mental health systems and have the capacityto implement transformative changes and services. Including both state andlocal governments as applicants also fosters the implementation of "topdown" and "bottom up" approaches to transformational change and can bettersupport required stakeholder involvement. This also allows for morecustomized approaches where there are variations in population density,access to providers, and the need for customized services.Award InformationFunding Mechanism: Grant Anticipated Total Available Funding: $16.5 million Anticipated Number of Awards: 22 Anticipated Award Amount: Up to $750,000 per yearLength 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 dependon the availability of funds, grantee progress in meeting project goals andobjectives, timely submission of required data and reports, and compliancewith all terms and conditions of award._____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.