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

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Wednesday, 03/17/10         Alliance for Human Research Protection

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.

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.

***

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

see here for complete RFA (scroll down)

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2 Responses

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  1. Hello! Excellent site, keep up the good work!

    Online

    March 27, 2010 at 8:46 am

  2. […] US Gov Medical Experiment Radically Departs from Medical “Best Practices” Wednesday, 03/17/10 Alliance for Human Research Protection 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. 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.” US Gov Medical Experiment Radically Departs from Medical “Best Practices” Wake-up Call […]


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