Health and Safety Versus Profit

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Homeland Security Contractors Hearing: "Attitude & Effort"

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Vaccine rule stokes fears over autism

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Throughout modern history, world governments and private industry have aligned themselves as partners. Governments and private industry never approach any endeavor for altruistic reasons.

Governmental actions may be predicated by a variety of statements citing various concerns but, power and control are the outcome desired from any alliance. For private industry, profit is the main motivation. For both of these entities, financial capital or money enables wielding of influence and power.

The Office of Legislative Policy and Analysis (OLPA) , as identified at its website, is an organization that:

.... facilitates and enhances the relationship between (the) National Institutes of Health (NIH) and the Congress; advances NIH legislative priorities; and ensures that the NIH community receives essential information, advice, and guidance regarding developments in the Congress that affect NIH.

Committees of specific interest to the Office of Legislative Policy and Analysis (OLPA), acting as liaison for the National Institutes of Health (NIH), committees hosted by the United States' Senate and the U.S. House of Representatives, can be found here. 

At the OLPA web site, Senate bill S. 1873 was listed as a bill of interest to the National Institutes of Health (NIH). This bill has been replaced by Senate bill S. 2563, submitted with minor revisions. The principal NIH organization conducting research related to biodefense and bioterrorism is the National Institute of Allergy and Infectious Diseases (NIAID).

Senate bill S. 1873, known as the Biodefense and Pandemic Vaccine and Drug Development Act of 2005 and was introduced on October 17, 2005.

An excerpt from the Alliance for Human Research Protection (AHRP), provides an analysis of S. 1873:

Any vaccine or drug used during a public health emergency, the declaration of which is solely determined and defined by the Secretary of Health and Human Services (HHS), and even if contaminated during manufacturing or distribution, as is often the case,[6] [7] is exempt from a liability trial by jury.

[Sec. 6(b)(1)(A)(i)] of S 1873 reads:

IN GENERAL- No cause of action shall exist against a person described in subsection (a) for claims for loss of property, personal injury, or death arising out of, reasonably relating to, or resulting from the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a security countermeasure or qualified pandemic or epidemic product distributed, sold, purchased, donated, dispensed, prescribed, administered, or used in anticipation of and preparation for, in defense against, or in response to, or recovery from an actual or potential public health emergency that is a designated security countermeasure or a qualified pandemic or epidemic product by the Secretary in a declaration described in paragraph (2).

Senate bill S. 2563, replacing Senate bill S. 1873, is known as the Biodefense and Pandemic Vaccine and Drug Development Act of 2006 and was introduced in April 2006. As was the case under the previous bill, there will be an agency created called Biomedical Advanced Research Development Agency (BARDA).

Biomedical Advanced Research Development Agency (BARDA) will be the first-ever government agency granted total immunity from disclosure under the Freedom of Information Act (FOIA), as one form of incentive to assist and encourage private industry in developing products to be used as countermeasures to a possible pandemic or terrorist act.

BARDA, created as a result of the Biodefense and Pandemic Vaccine and Drug Development Act, initially slated to have an expenditure of $1 billion set aside, will exist with accounting for the use of its funding shielded from disclosure.

In addition, the bill allows: a fast-track approach to release of vaccines and medicines for use on the public, protection of the pharmaceutical companies from prosecution due to any possible harm or fatal results of vaccines or medicines distributed and provides anonymity for members of the advisory board that approves the use of any drugs dispensed to the public.

On November 1-3, 2005, the Time Global Health Summit was held in New York City, N.Y. This conference brought together leaders of the world from business, medicine, government, public policy and others, to discuss health crises affecting the world.

A new funding strategy, that partners pharmaceutical companies with private industry, has emerged with foundations and organizations being funded by private individuals and in turn incorporating hospitals and universities, with all entities becoming linked through liaison or direct organizational ties to the drug companies.

All of the above mentioned entities exist with ties to numerous agencies under the auspices of the National Institutes of Health (NIH) and the Centers for Disease Control (CDC), with both of these agencies under the control of the Department of Health and Human Services (DHHS).

The CDC is a collaborator and partner with the World Health Organization (WHO), whose stated goal is, “...the attainment by all peoples of the highest possible level of health.”

On May 22 through 27, 2006 in Geneva, Switzerland, the WHO opened its 59th session of the World Health Assembly, the decision-making body for WHO. Delegates from the 192 Member States of WHO were scheduled to be in attendance.

The major function of the World Health Assembly is to determine the policies of the organization. A significant item of focus on the 2006 agenda was strengthening pandemic-influenza preparedness and response.

At the WHO web site, from Media Release Centre, dated May 19, 2006:

The World Health Organization (WHO) is urging research institutions and companies to register all medical studies that test treatments on human beings, including the earliest studies, whether they involve patients or healthy volunteers.

As part of the International Clinical Trials Registry Platform, a major initiative aimed at standardizing the way information on medical studies is made available to the public through a process called registration, WHO is also recommending that 20 key details be disclosed at the time studies are begun.

A release, posted at the WHO web site in May 2006, stated that groups, such as the International Federation of Pharmaceutical Manufacturers and Associations and Pharmaceutical Researchers and Manufacturers of America issued a joint statement with fellow members of the industry, raising concerns that these proposed requirements could, according to the WHO web site, “ .... jeopardize academic or commercial competitive advantage if they apply to preliminary trials of new interventions.”

We, the people of the world, must demand regulations and practices that ensure our safety as the calculated introduction of rapidly developed drugs increases, with ongoing medical and genetic research in progress and future projects poised on the horizon.

These series of events are aided by legislation and policies being introduced and enacted that will govern these processes, with a heightened concern for encouraging private industry's participation through promised cost saving methodologies and profit.

We, as patients in need of medical expertise and as consumers, should not be lulled into a false sense of security, deciding that we should leave these matters to others to act on our behalf.

We must act against any and all proposed scenarios where those who may be responsible for causing harm and fatalities, are allowed to step off the path of accountability and become cloaked in a bureaucratic web of invisibility.