Thursday, March 22, 2012

Mystery Illness Attacks Children

Thousands of Children Attacked by Mystery Disease

A crippling mystery illness has attacked thousand of once healthy young children in Uganda. Medical officials throughout the world are perplexed as thousands of children become completely disabled mentally and physically with neurological effects such as seizures and brain disfunction. Some children have even succumb to death.  The children are left unable to cope or maintain normal lives. The illness has placed great hardships upon families and communities. Medical officials are looking into food sources or infectious disease as sources of the problem.  But as epidemic grows, no answers or therapies are currently available.

Tuesday, March 20, 2012

Lab Shuts Down after another Biocontainment Problem

University of Chicago lab closed after infection case

Science News

CHICAGO, Sept. 15 (UPI) -- University of Chicago officials say they've suspended research in a school lab after a scientist contracted an infection from a bacteria being studied there.

The unidentified female scientist was admitted Aug. 27 to the university's medical center with a skin infection from B. cereus, a bacteria that can cause food poisoning, the Chicago Sun-Times reported Thursday.

The infected tissue was removed surgically and after a course of antibiotics she was released, school officials said.

The incident at the Cummings Life Science Center did not pose a risk to the campus or community as the bacteria is not transmitted through the air or from human to human, officials said. But the Centers for Disease Control and Illinois state and local health agencies were notified as a precaution, they said.

"We assessed there was a very small possibility the contaminant had gotten out of the room," said Conrad Gilliam, a dean in the school's biological science division.

"As an added precaution, this particular agent and all others at that biosafety level have been moved off site to Argonne (National Laboratory), pending decontamination and a thorough review of protocol."

Two years ago a U. of C. researcher studying the origins of plague-causing bacteria in a different lab in the same building contracted the disease and died, the Sun-Times reported.

There were significant differences between the two incidents, school officials said.

Thursday, March 8, 2012

Investment Potential for Human Embryonic Stem Cell Research Looks Dim

Questionable Investment Potential for Human Embryonic Stem Cell Program_StemCONN 2011

In 2005 without going to a public referendum Connecticut’s General Assembly and Governor passed into law an Act authorizing state funding of human embryonic stem research. The Act mandated that $100 Million dollars of public funds be used to support this research over a 10 year period. This research endeavor was initiated as an economic development plan for the state of Connecticut.

Is Connecticut’s plan working? Will hESC research generate economic development by attracting sufficient investor-based business to Connecticut?

The answer does not look promising.

“Investors are fearful to invest due to the unlimited risks. Investors want to make sure that they will be reimbursed”, said one panelist at the “Stem Cells for Profit” StemConn 2011 event last Tuesday in Farmington.

As of today, there is still no embryonic stem cell therapy to market.

Thee human clinical trials using hESC, however, have been approved by the FDA for phase 1 Safety trials in other states. But many scientists shared grave concerns about this at StemCell 2011. Since hESC technologies still holds serious risks and dangers for human subjects, investors justifiably worry that a bad trial outcome could devastate the industry.

One positive factor for investment is that FDA regulations do not appear to be a deterrent. In fact, one panelist commented that the “FDA relies on the scientific community to craft regulations”.

Instead, the immediate and critical problem for investors seems to point to the technical limitations of hESC research.

The lack of understanding of the complex molecular and cellular processes in both the undifferentiated and differentiated forms of the stem cell is a major shortcoming in getting a hESC therapy into market. Each embryonic stem cell line behaves differently, mandating each to be characterized. Not only does this compound the scientific and technical hurdles, but also, the cost to do business.

Dr. Kevin Eggan, a researcher from Harvard gave ample evidence of the enormous work it takes to tackle such technical problems during his presentation at StemConn 2011. Eggan’s research compared a number of different human embryonic stem cells to induced pluripotent stem cell (iPS) which took four years to complete, working full time.

The technical shortcomings related to basic embryonic stem cell biology constrain the likelihood of hESC therapies to make it to market. Until these scientific hurdles are overcome, robust investment potentials will most likely be lacking.

“Where is the money going to come from” to move science to a point where it will attract investment for economic development? Currently, the vast majority of funding which supports hESC comes from federal funding. “In 2009 Obama provided $143 million dollars to 330 hESC research projects”, said a panelist on “Current Status of Litigation Related to Federal Funding of hESC Research” at StemConn 2011.

With the fact that the federal government now funds hESC research, the $100 million dollar question remains for Connecticut: Will additional state funding toward hESC research provide competitive advantage to the state?

Connecticut should balance their decision to allocate future state-funding to hESC with caution and careful planning.

B. McClain
March 2011

Tuesday, March 6, 2012


Commission Calls for Transparency in U.S. Government-Funded Research

Written by Michelle Groman on November 16, 2011 —
As the Presidential Commission for the Study of Bioethical Issues continued its assessment of current protections for human subjects in research at its public meeting in Boston this afternoon, Commission member, Christine Grady, proposed that the Commission recommend improving transparency in U.S. Government-funded research. Grady said that federal agencies could develop systems – or improve existing systems – to establish a publicly available listing of federally supported human subjects research. The call for such systems is in line with increasing appeals for government transparency and public access to information about research.

The recommendation stems in part from the Commission’s own Landscape Project. As it worked to define the volume and scope of scientific studies supported by the government, the Commission found information to be incomplete, with no single listing available. The Commission therefore requested basic data directly from eighteen federal departments and agencies to define the “landscape” of federally supported human subjects research.

Commission Member, Lonnie Ali, expressed surprise at the lack of publicly available information because this research “involves individuals and people” – surprise echoed by other Commission members as well.

Amy Gutmann, Commission Chair, explained that such a database is not a “magic bullet” in assuring that human subjects are adequately protected from harm or unethical treatment. But, she continued, although not sufficient, such a database is absolutely necessary to ensure ethical research. Without transparency into what research the federal government is supporting, there cannot be accountability in the conduct of that research.

Commission Member, Dan Sulmasy, echoed that thought, saying that although a listing of U.S. Government-supported research projects cannot, in and of itself, reveal problematic research, it can provide insight into where to look to further to examine the ethics of research taking place.

The Commission’s final report, with recommendations, will be presented to the President and posted for public view in mid-December.


Below is a great story from researcher Celeste Monforton at Georgetown University relaying the facts surrounding a worker's death at her university and the difficulty of her finding adequate disclosure by OSHA.  Her story shows how difficult the government is making it for the public to understand the facts surrounding the numbers and the degree of injuries and deaths that workers face in America every day.  This type of secrecy and non-disclosure is used to protect industry from liability and regulations.  The public needs more transparancy and disclosure of work-related deaths, injuries and illnesses.  It is time to priotize protecting hard working Americans from injury and death.

Interpreting OSHA’s on-line data

Last fall, Mr. Rosaulino Montano, 46, a worker on my campus at the George Washington University, died when he fell seven stories while installing windows on a new $75 million residence hall. Mr. Montano was an employee of Engineered Construction Products, and because his work-related death occurred at my place of employment, I was particularly interested in tracking the OSHA investigation until the case was closed. I wondered whether there was a “controlling employer,” such as a general contractor or even if my employer, GWU, and whether they had some responsibility for safety at the site.

Over the next few months, I used OSHA’s Establishment Search Page in an effort to monitor progress on the investigation, but consistently received the same unsatisfactory message: “Your Establishment search returned O results.”

Figuring that I was probably not using the search tool correctly, I spoke to a very helpful woman in Balt/DC OSHA Area Office. She informed me that if a case is still open, it will not appear in the publicly available database, even though the search tool allows you to select “Open” for the prompt “Case Status.” I chalked this up to a glitch in the system, and decided I would simply file a FOIA request at about OSHA’s 6-month statutory deadline for issuing citations and penalties.

I sent my FOIA request to OSHA’s Balt/DC Area Office, and they responded promptly, sending me a copy of the citation and notification of penalty for Engineered Construction Products. The firm received one serious violation for violating OSHA’s fall protection standard (1926.501(b)(1)) and a monetary penalty of $2,500. This was the only citation and penalty issued in relation to Mr. Rosaulino Montano, 46, fatal injury. No other employers, such as my employer George Washington University, was deemed responsible for ensuring safety at the site.

Now that the case is closed, when I use OSHA’s Establishment Search Page, I no longer get the “O results” message. Instead, I get a response that raises more questions than it answers. Here’s a screenshot, and note the message:

“This violation item has been deleted.”

What does OSHA mean the “violation item has been deleted”? I searched OSHA’s Field Operations Manual and didn’t find a single entry explaining how a violation is deleted. Can someone explain what this means, or better yet, can OSHA put a legend or explanatory text on this webpage to help us interpret this on-line data?

If you look at the screenshot, the page offers other data points that are not self-explanatory. For example:

•ViolType: Serious

If the “violation item has been deleted,” what is this serious violation?

What about these entries:

•NrInstances: 1

•NrExposed: 3

Is it correct to assume Nr means “number,” as in ”number of instances” and “number of exposed”? Here too, a little legend explaining these data points and why they are relevant would be helpful. For example, does “NrExposed:3″ mean that three workers on the site were also not provided with appropriate fall protection, as required by 1926.501(b)(1):

“Each employee on a walking/working surface (horizontal or vertical surface) with an unprotected side or edge which is g feet or more above a lower level must be protected from falling by the use of guardrail systems, safety net systems, or personal fall arrest systems.”

The data points “NrInstances:1″ and “NrExposed:3″ may mean something to those inside OSHA, but not to us on the outside.

Similarly, can someone fill me in on the meaning of: “REC: A”??

Finally, the screenshot shows a datapoint for “Gravity” with the notation:

•Gravity: 10

Because there is not legend for these entries, is it safe to assume that this value of “10″ refers to the IMIS codes listed on page 6-6 of OSHA’s Field Operations Manual. According to the table on page 6-6, a violation of “High Severity,” “Greater Probability” and “High Gravity” gets an IMIS Code of “10,” the highest possible code. That’s a troubling finding by OSHA, right?: a high severity, greater probability and high gravity violation. Sounds like something that should go on the company’s permanent records, ESPECIALLY since a worker lost his life in the situation.

So, back to my original question: looking at the screenshot for the citaitons and penalty associated with the investigation of Mr. Rosaulino Montano’s death, it looks like the company agreed to pay a $2,500 penalty in exchange for having the violation deleted? OSHA Underground, OSHA Above Ground, am I understanding that correctly?

Better yet, because not everyone is on one-on-one blogging terms with OSHA Underground and OSHA Above Ground, a simple solution would be explanatory legend for this OSHA’s Establishment data. It would really help the public interpret the data that OSHA makes available to us, and understand better how the agency’s enforcement system really works.


Experts say US needs better tracking of lab accidents

Robert Roos News Editor

Jan 5, 2012 (CIDRAP News) – In releasing safety guidelines today for workers in medical diagnostic laboratories, a panel of experts convened by the US Centers for Disease Control and Prevention (CDC) said the nation needs a system for "nonpunitive" surveillance and reporting of laboratory-acquired infections (LAIs).


Except for requirements in the CDC's Select Agent Program, which covers certain dangerous biological agents and toxins, such as Bacillus anthracis, there is no national system for reporting medical laboratory exposures and resulting infections, says the lengthy report.


"Because of the lack of an official surveillance mechanism for reporting LAIs and because of the fear of punitive action by an oversight agency if injuries are reported, the data needed to determine the extent and cause of LAIs are unavailable," the report states. "In addition, there is a dearth of science-based insights on prevention of LAIs."


 The panel calls for a "voluntary, nonpunitive surveillance and reporting system with the potential for anonymity to be implemented in the United States."


The comments are part of Guidelines for Safe Work Practices in Human and Animal Diagnostic Laboratories, which was released by the CDC as a supplement to Morbidity and Mortality Weekly Report. It was prepared by a "Biosafety Blue Ribbon Panel" of experts from the CDC and a number of university and private labs.


 The report is intended to supplement the fifth edition of Biosafety in Microbiological and Biomedical Laboratories, which was not specifically designed to address the routine operations of diagnostic labs in human and veterinary medicine.


The new guidelines are not designed to replace existing guidance, but have the general aims of improving safety in clinical labs, encouraging lab workers to think about safety issues they might not have considered, and encouraging them "to create and foster a culture of safety." The US Bureau of Labor Statistics estimates that workers in human and animal diagnostic labs number about 500,000, the report says.


 Given the shortage of solid data, the number of LAIs is unknown, but "Laboratory exposures occur more often than is generally suspected," the report says. It notes that hepatitis B has been the most frequent lab-acquired viral infection, with a rate of 3.5 to 4.6 cases per 1,000 workers, which is two to four times the rate in the general population.


 The five most common ways that lab workers acquire infections on the job, according to the guidelines, are:
  • Parenteral inoculations with syringe needles or other contaminated sharps
  • Pills and splashes onto skin and mucous membranes
  • Ingestion or exposure through mouth pipetting or touching mouth or eyes with fingers or contaminated objects
  • Animal bites and scratches (research laboratories or activities)
  • Inhalation of infectious aerosols

But the first four of those routes account for less than 20% of infections, the experts found. Studies over the years have shown that in many cases no specific exposure events were identified, which suggests that unsuspected infectious aerosols may play a large role in LAIs.

The guidelines address all functions of human and animal diagnostic labs, including microbiology, chemistry, hematology, and pathology. They include a specific section addressing veterinary lab issues not shared by human labs.

Recommendations intended for all laboratories include "use of Class IIA2 biological safety cabinets that are inspected annually; frequent hand washing; use of appropriate disinfectants, including 1:10 dilutions of household bleach"; risk assessments for many activities; written safety protocols that address chemical-related risks; the need for negative airflow into labs; and lab areas in which use of gloves is optional or recommended.

Each section of recommendations was reviewed by CDC experts and relevant national organizations, such as the College of American Pathologists, American Society for Microbiology, American Clinical Laboratory Association, Association of Public Health Laboratories, and several others, the report says.
CDC. Guidelines for Safe Work Practices in Human and Animal Diagnostic Laboratories: recommendations of a CDC-convened, Biosafety Blue Ribbon Panel. MMWR 2012 Jan 6;61(01):1-101 (supplement)



Saturday, March 3, 2012

Whistleblower Complains of Pfizer Hiding Adverse Events

Pfizer May Be Liable for Firing Whistle-Blower


SAN JOSE, Calif. (CN) - A former Pfizer executive can pursue claims that the pharmaceutical giant fired her for blowing the whistle on "dirty" data, a federal judge ruled Thursday.

Delina Ferretti, who worked for Pfizer as lead clinical protocol manager, worked with a molecule that showed promise as a cancer inhibitor in a project known as PanHER. When she noticed problems with her data, she discovered more than 200 instances of study participants using prohibited medications, as well as instances of adverse events and changes from baseline that went unreported in Pfizer's brochure and report to the Food and Drug Administration, according to her original complaint.

Pfizer "refused to do anything about the 'dirty' study results," Ferretti's suit claims.

The company allegedly reacted to her report of the trial defects by creating a hostile work environment that made Ferretti feel "vilified and disregarded." Ferretti says she was alternately "shut out" of meetings or forced to meetings necessary preparation time.

Though Pfizer let Ferretti transfer out of the PanHER program, it further subjected her to a hostile work environment, the complaint states. In March 2010, she reported her concerns about study safety, unreported adverse events and the hostile work environment to Pfizer's compliance hotline. After responding to and refuting two performance improvement plans, Ferretti learned she would be terminated in August 2010.

Ferretti filed suit the following year, but U.S. District Judge Lucy Koh severed her retaliation claim Wednesday, finding that it should have first gone to the labor commissioner.

Ferretti's wrongful termination action does not need to meet that requirement, however. "Unlike a statutory retaliation claim under [labor code], a common law wrongful termination in violation of public policy is not subject to the exhaustion requirement," Koh wrote.

Under California's labor code, an employer may not retaliate against an employee for refusing to participate in activities that violate state or federal law. Pfizer argued that Ferretti's refusal to participate in its alleged defective testing does not constitute protected activity.

Koh disagreed. "Even assuming that none of plaintiff's 'protected disclosures' exceeded the bounds of her official duties, plaintiff alleges that she not only made 'protected disclosures, but that she also refused to participate in illegal activity," the decision states.

The ruling notes Ferretti's claim that she refused to participate in PanHER because it violated five federal regulations for Investigational New Drugs (IND).

"Thus, taking all the facts in the light most favorable to plaintiff, as the court must on a motion to dismiss, it is reasonable to infer that plaintiff refused to participate in defendant's PanHER program because defendant's PanHER program violated and would continue to violate several federal IND regulations," Koh wrote.

"'Refusing to participate in an activity that would result in a ... violation or noncompliance with a ... federal rule or regulation' is explicitly protected under California Labor Code," Koh wrote, adding that the alleged activity is thus protected.

Koh also disagreed that Ferretti's activities were within the scope of her employment duties, and therefore not protected.

"A jury could construe her refusal to 'accede to an alleged practice' of not complying with and masking violations of IND regulations by requesting to be transferred out of the program 'as a position adverse to [defendant],'" Koh wrote, citing 2010 precedent.

Ferretti has also properly alleged that the company knew why she requested a transfer out of PanHER, the decision states.

"Thus, taking the facts in the light most favorable to plaintiff, plaintiff has alleged sufficient facts to draw the reasonable inference that defendant had either actual or constructive notice that plaintiff requested to be transferred because she refused to participate in illegal activity when defendant terminated her in September 2010," Koh ruled.

Ferretti's claim of wrongful termination regarding unsafe working conditions cannot proceed, however, as she did not demonstrate that she reported such conditions.

Koh also rejected Ferretti's claim of intentional infliction of emotional distress. "Indeed, besides alleging that she had 'concerns,' plaintiff has not alleged any facts to support her conclusory allegation that she suffered 'severe emotional distress,'" Koh concluded (italics in ruling).

Ferretti can seek attorneys' fees and file an amended complaint within 21 days to address the granted motions, Koh sa

Thursday, March 1, 2012

Pfizer Groton Occupied

Video from Occupy Shoreline

Close to one hundred people in Connecticut gathered on March 29, 2012 to protest Pfizer in front of their large facility in Groton, Connecticut.  Pfizer, the largest pharmaceutical company in the world, is a member of a controversial group called the American Legislative Exchange Council (ALEC).  ALEC aligns with government and legislators to make laws that unfairly favor corporations over working people. 

This protest at Pfizer Groton was one of many protests all over the nation against Pfizer by Occupy Wallstreet groups.  Pfizer which made more than $68 billion in business last year was recently cited for a $2.3 billion settlement  for repeat offenses of illegal off-label marketing of their drugs to make extra profits.  Under a federal law, Pfizer was supposed to be excluded from selling drugs within Medicare because of their serious repeated criminal acts of fraud.  Pfizer, however, was later classified as "too big to nail" and was not penalized allowing them to participate within Medicare without restrictions.

While Pfizer was not prosecuted to the fullest extent for crossing the line of legal and ethical standards, eight people during the protest were alleged to have crossed Pfizer-police lines and were arrested at Groton Pfizer.  They were cited for first degree criminal trespass.  These eight people, acting on behalf of the 99%, were Alex Suarez, Danielle Digirolamo, Ashley Gillece, Cassandra Johnson, James Crombie, Joshua Heltke, Gregory Walker and Erin Mitchell.  Unlike Pfizer which is "too big to nail", these citizens were apparently "too small and got nailed".

People around the nation continue to protest against corporations like Pfizer and members of ALEC.  These bad corporate actors take actions and make laws that are not on the working people's side.

Other links:

Video from Occupy Shoreline