Tuesday, September 29, 2009

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

After 10 years Gene Therapy Death Still a Secret

Jesse Gelsinger: Ten Years Later

Posted by Osagie Obasogie from Genetics and Society on September 25th, 2009

Last Thursday marked the ten-year anniversary of Jesse Gelsinger’s death. The 18-year-old died while participating in a gene therapy clinical trial at the University of Pennsylvania. News of his death in September 1999 and the shady circumstances surrounding it rocked the medical research world. These circumstances included a failure to disclose the deaths of monkeys in pre-clinical trials, adverse reactions among humans in prior tests, and financial ties between a researcher and a private biotech company, in which the main investigator stood to make millions if the trial was successful. In the wake of this tragedy, investigative journalists and federal hearings dug up mounds of evidence concerning the inadequacy of human research protections and, in particular, the many failings that led to Jesse’s death. While some of the findings from the federal investigation were made public, several key documents remain hidden from public view to this very day. Last week in a Philadelphia Inquirer op-ed, Jesse’s father renewed his plea for their release:
I thought the lawsuits brought by me and the government would change research practices and the rules governing research. When I settled, real reform seemed likely. The Senate had held hearings, the FDA was investigating whether mistakes were made in the trial, and influential medical bodies such as the Association of American Medical Colleges had begun to examine disclosure practices and financial ties.But, sadly, we have not yet learned enough from Jesse's death. The shroud of secrecy that envelops legal settlements has helped hinder reform. No one has publicly accounted for the mistakes that led to Jesse's death.We don't know whether the FDA was misled or dropped the ball. We don't know whether the researchers' claims of efficacy had any basis in fact or were just wishful thinking. We don't know why Penn approved the deal despite warnings. And we don't know whether the researchers' decision to administer the virus to Jesse was reasonable or reckless.Ten years ago today, my son died in a science experiment. A complete record of what the researchers and FDA regulators knew is the best precaution against future tragedies like Jesse's death.I am asking that the University of Pennsylvania and the FDA finally do the right thing and release their records. If they did nothing wrong, let us see the proof. If they made a mistake, let us all learn from it and do better in the future. We owe it to Jesse to make his life and death mean something.

Monday, September 21, 2009

The Plague of Biosafety

The Plague of Biosafety

There is mounting evidence that biosafety is not being regulated efficiently in the biotech and academic laboratories. Despite the fact that the media altogether downplays the public health and safety ramifications of biological research, this is serious stuff. It costs lives in more ways than one.

Recently, University of Chicago Professor Malcolm Casadaban died from the plague bacteria he was studiying. For more on this story click here.

Public Health and Safety has taken a back seat when it comes to biological research and development. Laws and regulations are lacking in this field of research. It is increasingly difficult to obtain information about laboratory aquired infections since institutions are self-policing. Bio-terrorism could easily be produced from a lab in the U.S.

As new emerging disease and chronic illness rise, laboratories, using dangerous genetically engineered organisms and other infectious agents, fail to ensure public health and safety. People with chronic illness or new disease remain to suffer with unexplained ailments, conditions that could be a result of biological research.

Laboratory Aquired Infection Leads to Death at Univerisity of Chicago

USA. Plague Bacteria May Have Killed Chicago Researcher - cbs2chicago.com
Sep 19, 2009 3:45 pm US/CentralPlague Bacteria May Have Killed Chicago ResearcherUniversity Of Chicago Insists The Public Is Not In DangerCHICAGO (CBS)

A University of Chicago researcher died Sunday, Sept. 13 from an infection which may be from a weakened strain of the bacteria that causes the plague, a University of Chicago Medical Center news release said.The Chicago Tribune identified the researcher as 60-year-old Malcolm Casadaban, a professor who was studying what school officials call a weakened strain of the bacteria in a school lab.The researcher was studying the genetics of harmful bacteria, including Yersinia pestis, a weakened strain of the plague bacteria. An initial autopsy showed no obvious cause of death except for the presence of the bacteria. Cultures of the researcher's blood grew the weakened strain of the bacteria, but whether it is the cause of the fatal illness remains unknown, the news release said.The researcher died at the University of Chicago Medical Center's Bernard Mitchell Hospital.Dr. Kenneth Alexander, chief of pediatric infectious diseases at the U of C Medical Center, said the public has "nothing to fear at this point.""What has become a mystery in this case is why this gentleman appeared to have succumbed to an organism which is not normally fatal in humans," Alexander said.People exposed to the bacteria typically develop symptoms within two to 10 days--none of the potential contacts reported any illnesses, the news release said.The strain is not known to cause illness and has been used in some countries as a vaccine to protect against the plague. It has been approved by the Centers for Disease Control and Prevention for laboratory studies.The plague is rare in the United States but remains a problem in the developing world where up to 3,000 cases are reported every year, the release said.Medical Center officials notified the Chicago Department of Public Health as well as the researcher's family, friends, colleagues and anyone else who may have had contact with the researcher.

read full article here: http://www.suntimes.com/news/metro/1780803,CST-NWS-plague20.article

Also see:http://www.examiner.com/x-7707-Infectious-Disease-Examiner~y2009m8d4-What-is-the-difference-between-bubonic-and-pneumonic-plague

Tuesday, September 8, 2009

Pfizer Pays $2.3 Billion for Being a REPEATING CORPORATE CHEAT

WASHINGTON (AP) — Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world's largest drugmaker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.
Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs. "There's so much money in selling pills, that there's a tremendous temptation to cheat," said Bill Vaughan, an analyst at Consumers Union, the nonprofit publisher of Consumer Reports. "There's a kind of mentality in this sector that (settlements) are the cost of doing business and we can cheat.
This penalty is so huge I think consumers can have some hope that maybe these guys will tighten up and run a better ship."
Excerpts above taken from "Repeat offender Pfizer paying record $2.3B settlement for illegal drug promotions" by Devlin Barrett. For complete article click HERE.