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At the same time, with funding for more research on defenses against select agents, the decision was made to increase the numbers of high containment laboratories. Today, according to the Sunshine Project office in Austin, Texas, as many as 15 BSL4 laboratories exist in the United States or are planned. The two newest ones are in San Antonio and Galveston, Texas. In addition, there are approximately 21 Level 3 high containment laboratories in the United States. Some of these may not be in use. The Sunshine Project estimates these numbers from documents in the open literature and has asked that visitors to its web site submit corrections.
From the Sunshine Project:
"Map of the US Biodefense Program: High Containment Labs and Other Facilities" is now available under the biodefense tab of the Sunshine Project website. It and an accompanying key may be downloaded in PDF format or viewed as (large) images. This map is a revised and updated version of the US biodefense program map first published in October 2003.
Two dozen facilities across the country have been added. New types of facilities tracked include open air testing sites. Also added are sites conducting secretive research and/or which appear to be conducting classified studies.
The US biodefense program continues to change and to expand rapidly, including classified research. Thus, it is difficult to comprehensively track. This map is based on open sources and open records requests and is periodically updated. The Sunshine Project believes that it is the best compilation of US biodefense sites that is publicly available. Reader comments and submissions are welcomed and will be incorporated, as appropriate, into future versions.
The direct URL to view the map is: http://www.sunshine-project.org/biodefense/
The Sunshine Project
News Release
3 July 2007
Texas A&M Bioweapons Accidents More the Norm than an Exception
• From anthrax in Albuquerque to tuberculosis in New York, the public is kept in the dark about many biolab incidents
• It is unclear if the government is aware of the extent, the danger continues to grow with mushrooming biodefense research
• Need for stronger federal biolab oversight, reduced and rationalized biolab system
• "Instead of a 'culture of responsibility', the federal government has instilled a culture of denial... so labs hide problems, and think that accident reporting is for masochists... "
Far more accidents have happened in biodefense and other high containment labs in recent years than the public knows about. It is not clear if the federal government is even aware of the extent of the problems. The rash of biolab accidents is a result of the massive expansion of the biodefense program, which has brought research on bioweapons agents to scores of new labs in recent years.
What is needed, according to the Sunshine Project, is to reduce the number of facilities and people handing bioweapons agents in the United States and to bring the fragmented and frequently unenforced hodgepodge of federal biolab rules and suggestions together into a unified, mandatory, and enforced system that ensures laboratory safety and public accountability.
The Sunshine Project has recently released information about unreported accidents with biological weapons agents that resulted in an order from the US Centers for Disease Control (CDC) for Texas A&M University to cease and desist all research with "select agents", as bioweapons agents are called in federal regulations.
Here, the Sunshine Project releases information on other accidents that it has confirmed involving select agents and/or biosafety level three (BSL-3) labs. None of these accidents, to the Project's knowlege, have been made public before:
- In mid-2003, a University of New Mexico (UNM) researcher was jabbed with an anthrax-laden needle. The following year, another UNM researcher experienced a needle stick with an unidentifed (redacted) pathogenic agent that had been genetically engineered;
- At the Medical University of Ohio, in late 2004 a researcher was infected with Valley Fever (C. immitis), a BSL-3 biological weapons agent. The following summer (2005), a serious lab accident occurred that resulted in exposure of one or more workers to an aerosol of the same agent;
- In mid-2005, a lab worker at the University of Chicago punctured his or her skin with an infected instrument bearing a BSL-3 select agent. It was likely a needle contaminated with either anthrax or plague;
- In October and November of 2005, the University of California at Berkeley received dozens of samples of what it thought was a relatively harmless organism. In fact, the samples contained Rocky Mountain Spotted Fever, classified as a BSL-3 bioweapons agents because of its transmission by aerosol. As a result, the samples were handled without adequate safety precautions, until the mistake was discovered. Unlike nearby Oakland Children's Hospital, which previously experienced an anthrax mixup, UC Berkeley never told the community;
In addition to lab-acquired infections and exposures, other types of dangerous problems have occurred, such as unauthorized research, equipment malfunction, and disregard for safety protocols:
- In February 2005 at the University of Iowa, researchers performed genetic engineering experiments with the select agent tularemia without permission. They included mixing genes from tularemia species and introducing antibiotic resistance. The University reported the incident to the National Institutes of Health, but public disclosure was (to our knowlege) never made;
- In September 2004 at the University of Illinois at Chicago, lab workers at a BSL-3 facility propped open doors of the lab and its anteroom, a major violation of safety procedeures. A alarm that should have sounded did not;
- In March 2005 at the University of North Carolina at Chapel Hill, lab workers were exposed to tuberculosis when the BSL-3 lab's exhaust fan failed. Due to deficiences in the lab, a blower continued to operate, pushing disease-laden air out of a safety cabinet and into the room. An alarm, which would have warned of the problem, had been turned off. The lab had been inspected and approved by the US Army one month earlier;
- In December 2005 at the Albert Einstein College of Medicine at Yeshiva University in New York City, three lab workers were exposed (converted) to tuberculosis following experiments in a BSL-3 lab. The experiments involved a Madison Aerosol Chamber, the same device used in the February 2006 experiments that resulted in the Texas A&M brucella case;
- In mid-2004, a steam valve from the biological waste treatment tanks failed at Building 41A on the NIH Campus in Bethesda, Maryland. The building houses BSL-3 and BSL-4 labs. Major damage was caused, and the building was closed for repairs;
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Back in November 2008, I investigated allegations that Pfizer conducted an illegal clinical trial on Nigerian children during a 1996 meningitis outbreak. At the time, the Nigerian government was seeking $8.5 billion in restitution and damages as well as jail terms for various Pfizer officials, including former Pfizer chief executive William Steere.
The Nigerian suit claimed Pfizer drafted children into its clinical trial without their consent, intentionally low-dosed its control drug to boost the profile of its own antibiotic, Trovan, and may be responsible for the deaths of 11 children and injuries to dozens of others. (See: “Pfizer’s Nigerian Nightmare.”)
In reporting the story, sources confirmed the two parties were nearing a $150 million settlement. Five months later, Pfizer agreed to settle the case for half that much: $75 million.
Now, a Wikileaks’ cable, published by the Guardian, may provide insight into the discrepancy in settlement amounts.
According to the cable, classified confidential by U.S. economic counselor Robert Tansey, Pfizer hired investigators to uncover corruption links to Nigeria’s Federal Attorney General Michael Aondoakaa and leaked reports of alleged corruption to local Nigerian media outlets in February and March of 2009.
According to the cable, “A series of damaging articles detailing Aondoakaa’s ‘alleged’ corruption ties were published in February and March.” As a result, “Aondoakaa’s cronies were pressuring him to drop the suit for fear of further negative articles,” the cable said.
One month after publication of those articles, both parties agreed to the $75 million payout, half of what we initially reported. According to the cable, “Pfizer’s image in Nigeria has been damaged due to this ongoing case. Pfizer’s management considers Nigeria a major growth market for its products and having this case behind it will help in efforts to rebuild its image here.”
Neither Pfizer, Robert Tansey, nor Michael Aondoakaa could be reached for immediate comment.
Pfizer maintains the children documented in the suit died from meningitis, not the drug trial, and describes its trial largely as a humanitarian effort aimed at saving lives during a 1996 epidemic–an ugly trifecta of meningitis, cholera and measles–that killed 12,000 Nigerians, many of them children.
Before Pfizer’s 1996 trial, oral Trovan had never been tested for efficacy in children, in part because of concerns over side effects. Trovan belongs to a powerful class of antibiotics called quinolones, which can have serious side effects, including liver problems and cartilage and tendon abnormalities. In early-stage testing, quinolones had caused liver and joint damage in young rats and dogs–making testing in children more problematic. Although Pfizer insists that scientific articles supported the testing and use of quinolones in children as medically indicated and ethically justified.
Pfizer enrolled 200 children, between 3 months and 18 years old, in its Trovan trial. Of those, half received a full dose of Trovan. The control group was given Rocephin, a Hoffman-La Roche drug considered the “gold standard” for meningitis treatment, albeit less than the then-approved dose.
A month after the trial, five children in the Trovan group and six in the Rocephin group had died. Dozens of others were left paralyzed or with crippling arthritis. Pfizer says the deaths and injuries are tragic. Nevertheless, it maintains the study proved its drug’s efficacy, given that the epidemic killed 10% of all those infected.
“With a survival rate of 94.4%, Trovan helped save lives and was at least as effective as the best treatment available at Kano’s Infectious Disease Hospital. For patients who did not participate in the Trovan investigative study, the survival rate was slightly less than 90%,” Pfizer said in a statement.
Using its trial data, Pfizer initially applied to use Trovan for pediatric meningitis. Pfizer then withdrew that use from its application after a Food and Drug Administration audit found dozens of discrepancies in its trial records. The company says it intended to renew its application following results of a global pediatric trial that was already underway.
But Pfizer never had the opportunity to apply for pediatric use. After approving Trovan for 14 other uses in 1997, the FDA advised the company to pull the drug entirely– two years and over 2.5 million prescriptions later– citing reports of liver damage.
http://blogs.forbes.com/nicoleperlroth/ ... nnelforbes
The Hartford Courant describes the virus as "similar to the one that can lead to acquired immune deficiency syndrome, or AIDS." Health experts testified that the virus has affected the way McClain's body processes potassium, which they say causes McClain to suffer complete paralysis as often as a dozen times per month, the Courant reports.
A month after the trial, five children in the Trovan group and six in the Rocephin group had died. Dozens of others were left paralyzed or with crippling arthritis.
[NEW YORK, Dec 9 (Reuters) - Two executives closely involved in Pfizer Inc's push into emerging markets are leaving the world's largest drugmaker. Jean-Michel Halfon, who has been Pfizer's head of its emerging markets business, will retire during the first quarter. David Simmons, who has led the company's established products business unit, will also take charge of the company's emerging markets division. Separately, Steve Yang, who headed up research and development for Pfizer in Asia, will take a similar post at AstraZeneca Plc. Pfizer confirmed the departures on Thursday, only days after the company announced the surprise retirement of Chief Executive Officer Jeffrey Kindler. http://www.cnbc.com/id/40592240
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