Transparancy Lacking on Human Clinical Trials in America

 Commission builds database of scientific trials

http://blog.bioethics.gov/2011/08/30/commission-builds-database-of-scientific-trials/

Written by John Donnelly on August 30, 2011 

 One basic issue in today’s federally funded research involving human subjects around the world: There’s no single database.

Dr. Amy Gutmann, President of the University of Pennsylvania and Chair of the Presidential Commission for the Study of Bioethical Issues, noted the absence of a database during the second day of meetings, which are examining the current oversight of human subjects research.

Gutmann said that the Commission started a study of all federally funded research and found no central electronic collection of them. “We know about ClinicalTrials.gov, but it is not at all comprehensive,” she said.

The issue arose during a presentation by Ezekiel J. Emanuel, M.D., Ph.D., former chief of Clinical Center Department of Bioethics at the National Institutes of Health, who talked about current efforts under way by the federal government to consider revisions to U.S. regulations for human subjects protection. Emanuel agreed with Gutmann about the need for such a database.

“I’ve been saying for the last 15 years it is a scandal that neither the head of the FDA or NIH can report how many people are on clinical trials, or how many people have had an adverse event, or had died” in connection to a trial, Emanuel said.

Later in today’s meeting, Dr. Jeremy Sugarman, a Senior Advisor to the Commission and the Harvey M. Meyerhoff Professor of Bioethics and Medicine at Johns Hopkins Center for Global Health, and Michelle Groman, a Senior Policy & Research Analyst at the Commission, reported that the Commission was getting closer to creating a single database of federally funded research.

Sugarman said the Commission had canvassed 18 federal agencies that conduct a scientific research and had received detailed responses from 17 of them, including the NIH and FDA. The 18th agency, the Department of Defense, has been able to give only “aggregate” information of its studies, saying that its method of collecting data did not allow for more specific information on research projects.

Sugarman said the Commission will hire a statistician to analyze the material.

Gutmann said the Commission will wait to see the outcome before deciding next steps. “It seems we have to see first how good a database we can get,” she said.

Vice Chair James W. Wagner, President of Emory University, said the database “has the potential to be an incredible contribution” in better understanding the scope of the research and spotlighting future trends.

Genetically Engineered Cows Produce Human Milk_No Safety Studies for Children

Genetically modified cows have been engineered to produce a human lysozyme in their milk.  This milk is headed for commercial futures, intended for children.  The American public will have no choice of consumption or understandings of the milk's bad health effects since genetically engineered foods are not mandated to be labeled .  Adequate safety studies are not provided to the public.

http://www.telegraph.co.uk/earth/agriculture/geneticmodification/8423536/Genetically-modified-cows-produce-human-milk.html

Human Rights Go Wrong in Worker's Compensation_Depraved Indifference

Patrice Woeppel On "Depraved Indifference: the Workers' Compensation System"



http://www.blip.tv/file/4383774
Patrice Woeppel, author of ;"Depraved Indifference: the Workers' Compensation System"

talks about the systemic crisis and failure of the workers comp system which punishes

workers while harming injured workers. This interview was done on October 14, 2010.

For more information go to: www.patricewoeppel.us

Production of Labor Video Project laborvideo.blip.tv www.laborvideo.org

Embryonic Stem Cell Research Funding Threatens Human Rights and Public Interest

Human Rights at Risk with Public Funding of Embryonic Stem Cell Research

By Becky A. McClain

As an embryonic stem cell scientist and an injured worker, I would caution the public about the recent political movement to reverse the Dickey Amendment and, thereby, legalize federal funding for embryonic stem cell research. Matter a fact, the public should be alarmed.


Why?

Disregard for human rights issues, which rise up and above the “religious right” concerns, have already adversely impacted the public. And, unfortunately, more adversities toward the public are on their way as embryonic stem cell research advances. These critical issues deserve thoughtful attention before a reversal of the Dickey Amendment should be even considered.

I should know.

I was denied directed medical care for exposures from dangerous embryonic stem technologies incurred while at work. Unbelievably, I was denied under the premise that “trade secrets” supersede a worker’s right to specific exposure information.

Really? Yes, really.

Welcome to the embryonic stem cell world, a world of legal quagmire where human rights and public rights are slated toward the chopping block. Chop! Chop! One down for worker’s rights.

Public Beware. If the embryonic stem community does not care about worker safety and worker rights, you had better believe they also do not care about public rights or public safety either.

In fact, the public has been fooled. The embryonic stem cell research industry is far from the altruistic persona it has painted itself to be. Rather, embryonic stem cell research is about big money, first and foremost. It is about securing a position of power within the economic and legal mainstream of the American public. That is why biotech worker’s rights regarding safety and healthcare have been denied. That is why, unfortunately, the public’s right will be denied too.

And the media has not helped. The media has purposely turned the human embryonic stem cell debate into a polarized “religion versus science” contest.

But issues lying in-between those two polarities contain much of the tainted meat that can negatively impact the public toward human rights. These concerns get no media attention. The public remains ignorant. In fact, the public lacks an understanding of the legal, social and cultural effects that could negatively impact them as advanced technologies move forward.

The “religious right” issue is only one of many concerns surrounding the controversial funding of human embryos for research. But it is not, necessarily, the most important.

For example, public health and safety is yet another concern in this unregulated research. But the public remains clueless. The public is not even aware that human embryos are being used for biological warfare research purposes in the United States.

The public is also not aware that other dangerous embryonic stem cell technologies are being developed in their neighborhood universities and biotech companies without adequate biocontainment measures, regulations or oversight. The public is not aware of how this unregulated and dangerous research can make them sick. Real sick.

And that’s not all. Human rights, scientific integrity, public transparency, patent issues, public rights, women’s rights, egg donations, workers rights, and legal rights, along with public health and safety are all important issues that have been left out of the human embryonic stem cell debate.

Under the current lack of public and human right protections, Americans should be on guard regarding allowing unfettered public funding toward human embryonic stem cell research.

It is in the public’s best interest to protect itself. And I assure you, as an embryonic stem cell researcher and injured worker, who has seen the dark side of the embryonic stem cell industry and who has personally experienced its immense power to thwart human rights, reversing the Dickey Amendment is far from being in the public’s interest.

Until the legal, social and cultural effects of human embryonic stem cell research can be brought to light, with more meaningful discussions to protect the rights and interests of the American people, the public should demand upholding the Dickey Amendment. The public should not advocate for public funding toward human embryonic stem cell research.

Becky McClain is an injured biotechnology worker who while working as a molecular biologist at Pfizer, Groton, became ill after she incurred exposures to dangerous genetically engineered viruses used in an embryonic stem cell lab. She recently won a freedom of speech and whistleblower claim in federal court against Pfizer which involved her public health and safety claims.

Human Rights Violations Against Workers

HUMAN RIGHTS OF WORKERS WITH INJURIES

In our current fragmented system of health care financing, adequate and accessible workers’ compensation health insurance is essential for the protection of the right to health. In the United States, state level workers’ compensation systems are the only source of health coverage for injuries on the job.

Nearly a quarter of a million workers in the state of New York become injured on the job each year. Even when injured due to employers’ negligence, they have no recourse to the courts as workers’ compensation is intended as a substitute for law suits arising from injury. In exchange, workers are supposed to have a no fault system that covers everyone expeditiously and equitably.

Instead, workers with injuries are generally forced to prove their need for health care and wage replacement benefits in a grossly unbalanced match against powerful insurance companies and lawyers. Early in the process, workers are forced to go to low quality doctors paid by insurance companies to assess whether a worker has been injured on the job. In conflict with medical ethics, these doctors, misleadingly called Independent Medical Examiners (IMEs), go to great lengths to deny claims.

Much too often, the process turns into a bureaucratic and procedural nightmare, where workers are humiliated, stigmatized and subject to investigations that violate their right to privacy. Very little of this process is shaped by objective medical review or public health considerations. Indeed, the Workers' Compensation Board is rife with unjustified delays in access to medical care and wage replacement, rejection of legitimate injuries, obstacles for non-English speakers and inadequate rates of compensation.

The strain on workers can be extremely severe. Many workers develop new mental or physical problems as a result of their experiences with the Workers' Compensation Board, for which they might never receive support. With limited resources and inability to work, these workers and their families face hunger, extreme insecurity, and a heavy burden of guilt that they are no longer providing for their families. Essentially, workers begin with sickness and injury and often end up sicker and more injured, creating a devastating impact on human dignity and well-being.

NESRI is working with workers with injuries in upstate New York to develop analysis, documentation, public education materials and a human rights report on violations of the right to health and social security in New York’s workers’ compensation system. NESRI has also trained workers with injuries in participatory human rights documentation, and in turn, they have conducted dozens of interviews of fellow workers with injuries.

NESRI: National Economic & Social Rights Initiative

http://www.nesri.org/support_nesri/index.html

Genetically Engineered Salmon Is Going to Market_FDA calls it safe_Public has no rights

A genetically engineered (GE) salmon which grows twice as fast as natural salmon claims to be safe by FDA.    Many critics questions the validity of the study and the conflict of interests within the FDA.

This GE salmon will be the first animal approved to be eaten as food.  Unfortunately, the American people still do not have rights to have their food properly labeled as GE or not. 

The GE salmon have been modified with the addition of two genes:  one is linked to the production of growth hormone and the other it to ensure continued growth through cold temperatures.  The picture of the two salmon denotes the difference between large GE salmon and its natural counterpart which is the same age.

Critics also are frightened that these GE fish could escape into the environment causing havoc for natural salmon.  Containment of animals and organism can be problematic.  Remember the killer bees?

http://www.indybay.org/newsitems/2010/09/03/18657545.php

http://www.telegraph.co.uk/foodanddrink/foodanddrinknews/7983700/Fast-growing-GM-salmon-safe-to-be-farmed-and-eaten.html

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf

http://the-pathogen.livejournal.com/485318.html

See this recent updated post by CRG entitiled "Fishy business at the FDA".
http://www.councilforresponsiblegenetics.org/GeneWatch/GeneWatchPage.aspx?pageId=289

Commercialization of the Human Genome_Issues of Privacy and Protection

Last week, the California Department of Public Health (CDPH) instructed UC Berkeley to modify its “Bring Your Genes to Cal” program. From the beginning, UCB’s controversial plan to test the DNA of incoming freshman for three genes, brought into bold relief many of the complex questions that engulf emerging biotechnologies, for example: how best to protect privacy rights; informed consent; the integrity of medical testing and research; and how to identify and reduce conflicts of interest?

Mark Schlissel, UC Berkeley’s dean of biological sciences, underscored another issue likely to be the subject of ongoing consideration: academic freedom. Defending the UCB program against the CDPH’s interpretation of relevant law, Schlissel declared that, "We have taken every precaution and are committed to following the letter of the law…, but we believe this is a flawed reading of the statute that raises questions about who has control over teaching at the university…" How expansively we view academic freedom depends, in part, on recognizing the conflicts of interest that exist on the part of those doing the “teaching.”

Deep structural conflicts of interest exist when science-entrepreneurs, who may stand to benefit downstream from emerging biotechnologies, use their positions as university academics to normalize the commercialization of those technologies. UCB’s press release describes the lead professor associated with the program, Jasper Rine, as a “genetics professor.” Yet he, like many of his academic colleagues, has strong commercial ties to the industry developing genetic technologies. Rine has served on the advisory boards of a number of biotech companies and has co-founded several California biotech companies, including his own genetics testing company. UCB’s implicit endorsement of genetic testing as consumerism is especially audacious given the serious criticism that this type of testing has come under. Testifying at last week’s California Assembly Committee on Higher Education oversight hearing, Council for Responsible Genetics President, Jeremy Gruber, related that federal sources had dubbed such testing “snake oil,” and “not ready for prime time.”

From the 1940's to the 1960's, Princeton, Yale, Wellesley, and many other elite universities required incoming freshman to participate in medical anthropology/eugenic research by posing nude for photographs designed to document posture and body type, seeking correlations between physique and temperament. Since then, in the clear-sightedness of another era, many such photos have been destroyed. But many yet remain. How much humiliation and trauma could have been prevented if more disinterested authority could have prevailed? Those incoming freshmen who laid bare their DNA revealed the most intimate biological information not only of themselves but of those related to them. They chose to do so without prior opportunity to discuss the ramifications of their decision, without full disclosure of the scope of the conflicts of interest involved, and without clarity as to when or how the information would ultimately be disposed. They, and those who come after them, need protection from the overzealous interests and conflicts of interest of the institutions in which they arrive, trusting, to learn.

M. L. Tina Stevens, PhD
Director, Alliance for Humane Biotechnology
Visit AHB online

Becky McClain Speaks on Biotechnology and Public Health and Safety

On July 17, 2010 in San Francisco, Pfizer injured biotech molecular biologist Becky McClain discussed her firing for making OSHA complaints and also the potential and real dangers of unregulated development of products in the biotech and nanotech industry without proper oversight. The first US conference on biotechnology and health and safety was sponsored by the California Coalition For Workers Memorial Day www.workersmemorialday.org Additional presentations at the conference are Biotech, CA Osha & Health And Safety Presentation With Dr. Larry Rose http://blip.tv/file/3916683 The Toxic Environment, Public Health, ACOEM And Pfizer:Presentation By Dr. Jack Thrasher http://blip.tv/file/3921769 Conflict of Interest By Judge Says Sandi Trend, Mother of Injured Agraquest Biotech Worker Bell http://blip.tv/file/3924484 Dina Padilla Speaks At Biotech & Health And Safety Conference http://www.youtube.com/watch?v=c_-_XEnaiNg It was also endorsed by Council For Responsible Genetics www.councilforresponsiblegenetics.org For additional information go to http://www.cpab.info/

http://www.blip.tv/file/3960030

Physicians GAGGED to Speak about Problems with Patient Care

The Independent published a report on August 2, 2010 providing a good overview about legally gagging physicians who would otherwise talk about serious problems in patient care.  See story at this link.

BIOTECH INDUSTRY DENIES INJURED WORKERS RIGHTS_SANDI TREND SPEAKS

Sandi Trend, human rights and public health and safety activist speaks out about the injustices and coverup within the biotech industry against biotech workers.

Her son, David Bell was exposed to harmful biological agents while working at Agraquesta, a biotech company.  Bell immediately became seriously ill and has been denied directed medical care for his work-related exposures. 

Trend spells out some of the problems and fraud that workers face when trying to obtain medical care from dangerous biological exposures at biotech companies.  She emphasizes the lack of workers rights in this industry and the dangers of working in the industry.

See her talk here at the National Conference on Biotechnology, Health and Safety, Labor and the Public:  http://blip.tv/file/3924484

OBAMA Removes Human Embryonic Stem Cell Restrictions under the Guise of Separation of Science and Politics

President OBAMA removed the government ban on federal funding of hESC (human embryonic stem cell research) in what was described as a move that “is part of the administration’s broader effort to separate science and politics”.

But the politics still remain as the biomedical community continues to use “think tank” media strategies, using the wheelchair bound paraplegic as their poster child to engender sympathy against the human rights issues involved in human embryonic stem cell research.

There is little of a remote chance that embryonic stem cells will provide a therapeutic cure toward paraplegia or quadriplegia. Scientists know it and have known it. But now they strategize by telling the public that “cures won’t happen overnight”…still allowing the desperate to cling on to hopeless hope with the embryonic stem cell.

At the same time the biomedical community avoids any mention of the public safety dangers, lack of regulations and lack of worker rights associated with the embryonic stem cell research. They also would not dare to mention the current use of human embryonic stem cells in our biowarfare laboratories.

Instead the biomedical think tank experts do brilliant work to avoid these issues and in its place exploit the anti-abortion stance to their advantage, painting pro-life groups as radical, against science and unsympathetic to the plight of the disabled.

This has been a good tactic and a successful one, casting shadows on the human rights and safety issues underlying the use of human embryos in research while promising hopeless cures.

While all the time….Human embryonic stem cell research is about big money and big business. Billions of dollars. Period.

Despite what he says, President OBAMA’s move was in a fact, a political move. It will establish policy so that scientists can move ahead without responsibility for public health and safety on the use of human embryos in research and without any realistic ethical constraints. It will limit public transparency, making this research on human embryos more private and secretive. The NIH will make sure it…of course, under their appointed guise of developing “ethical standards.”

In describing his decision to eliminate the ban on federal funding of human embryonic stem cell research, Obama said, “Our government has forced …a false choice between sound science and moral values.” These are fine tuned words that carry a great deception.

Supreme Court UPHOLDS International Right to Sue Pfizer in U.S. Courts

The U.S. Supreme Court yesterday upheld an appeals court decision to allow Nigerian families to sue Pfizer in U.S. courts due to international law violations. Pfizer conducted unethical clinical trials on Nigerian children using a drug called Trovan in 1996 resulting in deaths of 11 children and leaving many other children blind, deaf, paralyzed or brain damaged. Whistleblower and medical doctor, Dr. Juan Walterspiel warned top level Pfizer management regarding the unethical trial, but Pfizer proceeded anyway, terminating Walterspiel. The case is Pfizer vs. Abdullahi, 09-34. For more see this article: http://online.wsj.com/article/SB10001424052748704103904575336750320252326.html?mod=googlenews_wsj

Old Connecticut Yankees at Hartford Courant Gag and Terminate Consumer Protection Writer, Gombossy

A celebrated columnist from the Hartford Courant, George Gombossy was terminated after writing about consumer protection topics involving major advertisers of the Hartford Courant. Gombossy's column became successful and was well liked by the public and Harford Courant's readers. Unfortunately, Gombossy stepped on the toes of some major advertizers ($500,000) in his columns. Subsequently, Gombossy was told by a newspaper executive that the Hartford Courant could not afford to have major advertisers angry because of Gombossy’s column. He was then terminated. Gombossy filed a freedom of speech lawsuit in October 2009.

For more info see this link: http://ctwatchdog.com/2009/09/29/watchdog-tribune-accuses-courant-of-violating-its-written-news-mission

And you wonder why the Hartford Courant is struggling for readership?

BIOTECH LAWSUIT

Scientist blames Pfizer for illness

By Lee Howard

Article published Jan 19, 2010 in New London Day

Day Staff Writer

Molecular biologist's lawsuit goes to trial in March in Hartford. A former Pfizer Inc. scientist who claims to have been infected by an unknown virus at the company's Groton laboratories will have her civil lawsuit heard in U.S. District Court in Hartford.Becky McClain of Deep River, a molecular biologist who filed her suit nearly three years ago in New London Superior Court, confirmed last week that the jury trial is scheduled to commence in March on allegations that Pfizer violated whistleblower laws and exposed her to a hazardous workplace. McClain, who also charges that Pfizer violated her freedom of speech by terminating her after she pressed workplace complaints, is a former member of the company's safety committee.McClain's attorney, Bruce E. Newman of Bristol, originally had filed suit on 11 counts, but eight of the complaints have been dismissed. Newman said in a phone interview that he considers the case to be precedent-setting because there are few government standards regulating the bioengineering field.Pfizer denies all of the suit's most substantive charges. The company "does not retaliate against employees who raise health and safety concerns," according to Pfizer's response to the suit. The response also denies that McClain was wrongfully discharged. "We have thoroughly investigated Ms. McClain's claims and our investigation concluded that her workplace was safe and that she was not infected by any virologic materials while she was employed by Pfizer," company spokeswoman Liz Power said in an e-mail. "Pfizer is committed to protecting the health and safety of our colleagues and the communities in which we operate," Power said. McClain, who worked at Pfizer for nearly a decade before being terminated in 2005, was employed in Groton's embryonic stem cells program when she said she became ill after being subjected to repeated noxious fumes coming from the hood of a device at Lab B313. She said her supervisor also became ill, but later conspired to cover up the incident, warning her that she "would lose her job if she made too big an issue out of lab safety," according to the suit.McClain said she asked for a transfer out of Lab B313 because of ongoing health concerns. Later, she developed chronic fatigue symptoms, according to the suit, and discovered that a co-worker had been working next to her with a "dangerous lentivirus material and embryonic stem cells on an open lab bench without biological containment."McClain later went on medical leave, according to the suit, but "continued to raise safety concerns which were never addressed," including filing five complaints about Pfizer's lab with the federal Occupational Safety and Health Administration. She received a termination notice during her medical leave, the suit said, despite the fact that "Pfizer had promised McClain that she would not be retaliated against in any way for raising health and safety concerns."OSHA never moved forward on her complaints, McClain said in a separate interview, largely because federal worker-safety laws have not kept pace with the rising hazards in U.S. laboratories."McClain was penalized in terms of her performance appraisals at Pfizer and ultimately terminated as a result of exercising her free-speech rights," according to the suit.The lawsuit, which seeks more than $75,000 in damages, said McClain had counted on Pfizer to maintain a safe work environment. Instead, her continued exposure to genetically engineered viruses, according to the documents, has resulted in the 51-year-old scientist developing a condition that leads to periodic paralysis, joint pain and fatigue."During these attacks, it is difficult for her to speak and she has no voluntary muscle control," the suit stated. "The attacks themselves are accompanied by a severe chest pain and spinal pain."The suit said the condition is believed to be permanent, and there is no known cure.

Sparks on Pfizer_Repercussions of Losing Eminent Domain Battle

Bulldozed in New London: The Latest on Kelo and Eminent Domain
By Dr. John A. Sparks on Jan 18, 2010
article from link: http://catholicexchange.com/2010/01/18/126175/

Pfizer, the huge drug company, has announced that it will be leaving a large research complex in New London, Connecticut and moving several hundred jobs to nearby Groton. Such belt-tightening in tough economic times would normally draw little criticism. In this case, however, it should.
Recall that Pfizer played a central role in getting New London to seize the homes of local residents who lived adjacent to the Pfizer site. Pfizer, according to accounts, wanted that mixed residential area, called the Ft. Trumbull section, to be leveled and replaced with an upscale development that would include a five-star luxury hotel, top-tier condos, and private office space for Pfizer’s suppliers, workers, and visitors. Now Pfizer is leaving New London “high and dry.” How did this happen?
A little less than a decade ago, New London and Pfizer wanted to “redevelop” a portion of that old coastal city, spurred on by a large state grant. What they did not predict was the local outcry against this “revitalization” when Ft. Trumbull residents learned that their homes would be taken by the process known as “eminent domain.” Among the residents was the kind but spunky Susette Kelo, who, with the help of an outside legal advocacy organization, the Institute for Justice, and the institute’s lead attorney, Mr. Scott Bullock, took her case all the way to the U.S. Supreme Court. It became known as the “Kelo case.”
Kelo’s contention was that when the government takes property by eminent domain, the seizure must be for a “public use.” This is the language of the U.S. Constitution, where it says in the Fifth Amendment that private property shall not be taken except for a public use, and then only with just compensation from the government. New London was offering to pay Ms. Kelo for her property, but her contention was that in taking her property, and giving it to another private party for development-in the way the New London Development Corporation and Pfizer desired-was no longer a public use.
New London officials argued that greater tax revenues would be produced by the revitalization and, therefore, some public good was done by the restructuring of the Fort Trumbull area. Kelo and the Institute for Justice pointed to such a contention as ominous for all homeowners, since local governments could almost always imagine a “higher use” to which individual residential properties could be put.
Unfortunately, the Supreme Court found in favor of New London and against Kelo, but the case produced a firestorm of protest across the country, leading over 40 states to more tightly control eminent-domain abuse.
What about Pfizer? Well, a firm that should have been devoted to liberty and private property was in effect complicit with New London in ushering Ms. Kelo and others out of homes they had chosen and purchased. Pfizer even received special tax treatment, paying only one-fifth of the usual property taxes for the first 10 years of occupancy of its research site.
What thanks did New London receive from Pfizer for putting its own citizens out of their homes? That brings us to the latest development: Pfizer is moving the research jobs elsewhere.
The city probably will not “get back” its tax forgiveness. State tax monies from Connecticut used to entice New London to revitalize have been expended. Local businesses that depended upon Pfizer and the development for patronage are now looking at financial decline. What remains is a barren undeveloped site where homeowners once kept their homes with pride.
It is a sad story of local governments drawn into projects by the promise of large state grants. The grant then allowed them to accede to the special demands of large enterprises like Pfizer for tax breaks and special treatment. What is even sadder is that in their rush to redevelop, these same local governments bulldozed the fundamental rights of their own constituents and, then, their “business partner,” Pfizer, cast them aside whenever it chose to do so. Ms. Kelo has a perfect right to say “I told you so.”

Human Rights and Science_International Advocacy

As we view this snapshot of a man being used in human experimental trials in Nazi Germany, we should not forget that human rights issues surrounding application of science and technology do exists and must be protected, especially now, in what is now considered the age of biological revolution and development.

Here is a link to an interesting website and organization called Front Line who report and defend the protection of human rights. Although they report on numerous issues, the protection of human rights surrounding the use of science and public health and safety should also be defended.

Here is Front Line's mission: Front Line is working to ensure that the principles and standards set out in the UN Declaration on Human Rights Defenders are known, respected and adhered to worldwide. The Declaration, which was adopted by consensus at the UN General Assembly, makes clear that all Governments have a duty to protect, promote and implement all human rights and fundamental freedoms. It states in article 1 that "'Everyone has the right, individually and in association with others, to promote and to strive for the protection and realization of human rights and fundamental freedoms at the national and international levels.'"

Federal Task Force on Biosafety Needs Broader Oversight For Public Health and Safety

A Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight was finalized on June 2009. This report outlines the need to optimize biosafety oversight in BL3-BL4 high and maximum containment facilities.

Unfortunately the report for oversight does not cover infectious agents used in BL2 laboratories which are more numerous in number, found in every major research institute and which also pose significant worker and public health and safety threats.

Some information in the report is a bit shocking. The government doesn’t even have a current registry of all BL3-BL4 labs where extremely hazardous and contagious biological agents are being used. In addition, the government does not have a centralized incident-reporting analysis for injuries or mishaps in biological laboratories.

Some of the information in the report is also a bit skewed in my opinion. For example, the report includes a table of injury statistics in R&D facilities from OSHA which I find to be unreliable data. The result of this OSHA study gives the impression that R&D facilities have a much lower average of injuries than general private industry. But “not all private R&D facilities were surveyed, and no Federal high or maximum containment research facilities were surveyed”

Also, through my own personal experience, I am more than skeptical regarding OSHA data. When I was employed as a biologist working in R&D in 2002, at least 5 people became ill (incapacitating, headaches, nausea or vomiting) from an exposure from a biological hood and NOT one of the illnesses was reported to OSHA. So much for trusting OSHA data and the dangers at R&D facilities.

Although the report does a good job summarizing the current agencies and regulations which impact biological laboratories, it is a bit slanted in not reporting the weakness of the laws and oversight. For example, the report gives a good summary of the OSHA laws but never mentions that the statute of limitations are so restrictive that the OSHA law is impractical for scientists to report safety problems or illness in biological laboratories.

Similarly they mention that the State of Connecticut instituted a law regarding agents capable of infecting humans. But what they do not mention is that this law does not cover genetically engineered agents or recombinant DN A infectious agents.

The other major weakness in the report is that it does not address our poor whistleblower laws which currently are so weak they provide no protections for scientists and protections for public health and safety. In addition, important human rights issues such as the lack of worker’s right to obtain appropriate exposure records necessary for medical care after incurring a biological exposure was purposely left out of the report.

Despite the fact of its deficiencies, the report is a step in the right direction in an attempt to clarify some objectives needed for better governmental oversight on the most dangerous biological research laboratories in the United States. In short, the report identifies eight new objectives to increase biological safety in these labs. They are listed below:

Summary of Objectives

1. Enhance the overarching framework for biosafety and biocontainment oversight of high and maximum containment research through improved coordination of oversight activities.

2. Encourage a robust culture of accountability characterized by individual and institutional compliance with biosafety and biocontainment regulations, guidelines, standards, and policies.

3. Develop a national strategy to enable and ensure the appropriate training and technical competence of all individuals who work in, oversee, support, or manage high or maximum containment research laboratories.

4. Obtain and analyze information about laboratory incidents to enable trend analysis, minimize the number of future incidents, and share lessons learned, with the overall goals of optimizing laboratory safety and oversight.

5. Ensure that biosafety and biocontainment regulations and guidelines cover current and emerging hazardous biological agents, and develop an agricultural equivalent of the BMBL.

6. Ensure that the infrastructure and equipment necessary for biosafety and biocontainment at high and maximum containment research facilities are in place and properly maintained.

7. Develop and support a national research agenda for applied biosafety and biocontainment to improve the management of biohazard risks.

8. Improve and share strategies to ensure effective public communication, outreach, and transparency about biosafety and biocontainment issues.

Pfizer Cares More About Animal Rights Than Human Rights.

Fired Worker Stages Protests at Pfizer
TowerShim Dong-hee, right, leader of the Pfizer Animal Health “labor union,” holds a signboard saying “I will never bow down to unfair pressure” with a colleague in front of Pfizer Tower in Myeongdong, downtown Seoul, Friday afternoon. The multinational firm does not recognize the union.
/ Korea Times photo by Shim Hyun-chul

Article By Kang Shin-who Staff Reporter
A usually busy footpath in front of the Pfizer Korea building in downtown Seoul turned into the scene of a small disturbance Friday. Only five people participated in this condemnation of the multinational pharmaceutical firm's labor practices. But banners and placards they used were big enough to catch the attention of passersby. This demonstration has been going on three times a week since August. Shim Dong-hee, 38, the fired head of a workers' organization at Pfizer Animal Health, demanded that he be reinstated and that the company recognize their right to organize as a union. "The company disbanded our union three times since the late 1990s," Shim told The Korea Times during Friday's protest. He was attempting to set up a union for the fourth time but was fired instead. Shim and his colleagues chanted a slogan calling for dialogue, with pickets saying "Pfizer Is No Good" and "Pfizer Cares More About Animal Rights Than Human Rights.""I will continue to fight and will not stop protesting until the vicious company comes to the negotiating table," he said. Pfizer's animal health department, which Shim used to work for, has 46 workers, making it eligible for union formation. Company officials were not available for comments despite repeated calls. Pfizer Korea, however, allows a union separately from the animal experimentation department. This union has 320 workers as members out of 700 workers.kswho@koreatimes.co.kr

Monkey scientific advance raises hope for the “Genetically Engineered Child”.

• Yes, it is true. In the future it looks like a child may be born from three biological parents. But just like the hype with human embryonic stem cells promising that “the paralyzed will walk”, here comes more “save mankind from disease” propaganda in an attempt to legalize genetic engineering and cloning of humans.
  
  A team of scientists from Oregon have cloned a monkey from three different parents using an advanced genetically engineered reproductive technique.
  
  Let me explain. In a natural birth in forming a fertilized egg, the mother contributes both the mitochondrial DNA and her female set of chromosomes in her egg, while the father contributes only his male set of chromosomes from his sperm. All three sets of DNA are needed for normal development of the fetus.
  
  In this monkey experiment, the scientists engineered a fertilized egg from three parents by artificial means: They isolated mitochondrial DNA from one female donor, isolated a female set of chromosomes from another female donor and retrieved a male set of chromosomes from a male donor. Add all three sets of DNA to an egg in a test tube and Waaaalaaa…a cloned genetically engineered fetus from three different parents! (Well the later was simplified a bit..but you get the point.)
  
  What was the scientist’s explaination to why they genetically engineer these baby monkeys? To cure inherited mitochondrial disease.
  
  What were their real reason to do this experiment?…To initiate the first step toward legalizing the ability to genetically engineer and clone human beings.
  
  The fact of the matter is that this technology CANNOT cure any born human being who carries a defective mitochondrial DNA. It can only be used to scientifically create a test tube baby whose one of two mothers has a known transferrable mitochondrial defect.
  
  Before we start singing alleluia over this scientific advancement we should ask ourselves these questions:
  
  If a woman KNOWS she has bad mitochondrial genes, then why doesn't she adopt a child instead of making a genetically engineered child that is essentially not naturally her own but is constructed from three different parents?
  
  Alternatively why doesn’t the mother who has defective mitochondrial genes choose to do surrogate birthing instead of the genetically engineered option?
  
  Why does our society have such a fetish of finding all types of scientific ways to create children, when our earth is already over-populated with limited resources?
  
  What purpose does this advanced reproductive technology really serve humanity in allowing parents to genetically engineer their children?
  
  What is the cost of this technology to our society?
  
  In light of our current healthcare cost and access woes, is our public funding of these advanced reproductive technologies being used efficiently and appropriately in regards to our limited resources?
  
  Again, this advanced reproductive technology cannnot be used to help any born human being. Using mitochondrial disease as an excuse to create cloned genetically engineered babies from three parents is the first step toward using advanced reproductive technology to clone human beings for any purpose.
  
  Yes, human mitochondrial disease is a very serious and debilitating disorder, but should we as a society permit genetic engineering of a fetus to make babies from three parents when there are other viable options? Or alternatively should parents have the rights to scientifically create any baby they want when society has to pay for the development of this technology?
  
  What do you think?
  
  Other links:
  http://watchdogonscience.blogspot.com/search/label/human%20cloning-gene%20therapy http://www.news-hub.eu/2009/08/monkey-advance-raises-diseases-hope/

Biotech Worker's Rights DENIED

Biotech worker, David Bell is denied Health and Safety Protections and Workers' Compensation after exposure to Agraquest's biological agents.

Below is a complaint written by David Bell's mother to the Commission on Health and Safety and Worker's Compensation in California.


August 27, 2009
Commission on Health and Safety and Workers' Compensation
1515 Clay St,
Oakland, CA 94612

RE: Complaint

California is NOT protecting employees rights to work in safe and healthy
environments nor are injured employees given the right to know of the hazards they
have been exposed to.

California employers, who willfully violate Federal and state laws are not held
accountable, they are given the green light to continue to violate the law and there
misdeeds of fraud and concealment are hidden under the umbrella of protection
within the corrupt California worker’s compensation system.

My son, David Bell worked as a laboratory Assistant Researcher/Microbiologist (to
obtain lab hours for his Bachelor of Science Degree) for one of these employers,
Agraquest Inc. (AQ) a biotechnology company that discovers, screens and
experiments with known and unknown microorganisms, AQ searches the world for
microorganisms; and brings them into the U.S., mostly in soil, They receive
microorganisms from “microbe hunters” and other biotech companies; not known is
whether they were natural or mutations and had been genetically modified. At last
count there were over 23,000 microorganisms in AQ’s “microbe collection”.
David also worked with and was exposed to larvae and live insects.

After 5 months and 9 days at AQ, after vomiting and being sick for days David had
purulent bloody pus draining from his nose. He told his supervisor he was sick and
clocked out. He then went to Immediate Care Medical Clinic; was placed on the broad
spectrum antibiotic Zithromax and told to see an ear, nose and throat specialist. This
he did; now the left side of his face and teeth were numb. He was scheduled for the
first, of what would become four major sinus surgeries only seven ( 7 ) days after
seeking emergency medical care. He’s had countless other sinus procedures in
physicians offices through the years.

David stopped producing enough B-cells for an intact immune system; for 3 years,
every 28 days he was hooked up to an IV pump receiving IMMUNOGLOBULIN
infusions at the hospital; each lasting up to 7 hours.

Several of David’s vital organs have been affected as the result of his employment at
the AQ laboratory; respiratory, lungs, heart, liver, spleen and GI tract.
Denied by AQ as being the result of David’s workplace illness and disease were
nineteen (19 ) fungus and bacteria that have been identified in David’s blood, sputum
and/or nose cultures and/or lab results showing levels of antibodies as a result of
exposure; ranging from positive to HIGH POSITIVE. ALL of these fungus and bacteria
are linked to AQ’s products, patents and/or other companies patents that the
scientists at AQ are listed as inventors.

This is David’s medical from 1995-1998; seven ( 7 ) pages total, 1 page is a
Confidential Health Information Form. This is his medical costs after working for AQ
beginning 1999 through 2005 with a cost of over $333,000, mostly paid by medicare
and none by AQ’s workers comp carrier. I stopped calculating after 2005 although to
this day he is still sick and has mucous of every shade of the rainbow coming from
his nose. That is, when he can get it out.

As David’s mother, I swear to you; he has never been sick like this before he went to
work at AQ. He had seasonal allergies, normal colds and flu and he did have a
hernia surgery at the age of 6 because of a car accident.
California has to stop protecting businesses and start protecting it’s workers.

Thank you,
Sandi Trend

cc: file
attachments: Three ( 3 ) photo’s
1) David Bell medical prior to working at AQ; 3 years (1995-1998)
(7 pages ; (1 page is a Confidential Health Information Form) and
comparison to David Bell Medical billings after working at AQ;
(1999-2005)
2) David Bell medical billings after working at AQ (1999-2005)
3) Comparison of David Bell medical prior to working at AQ; 3 years
(1995-1998) and David Bell medical billings after working at AQ (1999-
2005)