60 Minutes Biased Reporting on FDA’s Oversight Debacle of NECC

FDA inspects NECC after deaths occur

Last night on March 10, 2013, 60 Minutes presented an improperly slanted report on the NECC (New England Compounding Company) oversight debacle which has currently caused 48 deaths from a release of a fungal-contaminated injectable medicine. The 60 Minutes’ story failed to report on important facts behind FDA’s role within the current regulatory framework which could have prevented this public health disaster.


One statement that Scott Pelley from 60 Minutes incorrectly reported in his story is when he said “It was up to the Massachusetts Board of Pharmacy to inspect NECC”. Pelley claims that a 1998 law prevents the FDA from inspecting compounding pharmacies. This is simply untrue. Unfortunately, 60 Minutes left the audience believing that the main problem with the FDA was a lack of jurisdiction under the federal law to inspect NECC.

Despite 60 Minutes’ erroneously claims that a 1998 law prevents the FDA from inspecting compounding pharmacies, the FDA had indeed inspected many compounding pharmacies after 1998, including NECC. In fact, an inspection of NECC resulted in a FDA Warning Letter in 2006 for unsafe practices and unapproved new drugs. Regrettably, the FDA subsequently failed to follow through with another inspection at NECC after the warning letter.

The fact remains, that the Boston FDA Field Inspection Division, Office of Regulatory Affairs in Massachusetts did have authority to inspect NECC, but failed to enforce jurisdiction, fully knowing that NECC had serious safety problems. Most disturbingly, prior to the release of the fungal-contaminated methyprednisone injectable medicine, the FDA had received several official complaints from various states regarding NECC’s unsafe practices and suspected manufacturing status. These complaints should have automatically mandated an inspection at NECC to assess federal oversight. Yet FDA took no action to inspect NECC after receiving these complaints.

What is odd is that standard procedure dictates that the FDA should have followed up on the 2006 FDA Warning Letter with an additional FDA inspection of NECC, even without the notification of additional complaints against the company. Yet the New England Boston FDA again took no action. The New England FDA district did not even perform the basic FDA enforcement required of them.

Obviously, the FDA had authority and jurisdiction to inspect NECC. In fact with clear authority they could have used the 2006 Warning Letter to perform an inspection at NECC to investigate the additional complaint-driven evidence that they had on hand. And even if the FDA would have somehow still worried about jurisdictional concerns, there were other methods they could have employed to invoke their authority. In fact, the current standard practice within the FDA would have been to request a joint inspection of NECC with the Massachusetts’s Board of Pharmacy to clarify their jurisdiction. Yet, despite all the many notifications of complaints to the FDA and the prior FDA warning letter which warranted an inspection of NECC, the FDA in Boston chose not to inspect NECC when they had every right, jurisdiction, and avenue to do so. Clearly, the FDA New England Boston district failed in accountability to uphold even the basic facets of the law.

Where was Scott Pelley from 60 Minutes on this issue of accountability?

In Pelley’s report last night 60 Minutes avoids any mention toward accountability of the FDA’s wrong-doing within the NECC debacle. Instead of presenting the facts, 60 Minutes gives the audience the false impression that a complete lack of federal laws caused the problem of the lack oversight by the FDA.

Even, given the assumption that stronger federal laws are indeed needed and would benefit efficient regulation of compounding pharmacies in the future, it still gives 60 Minutes no justification not to report on improper oversight within the FDA. Especially in light of the fact, that even working with weak laws, the FDA could have prevented the NECC disaster with an inspection by a qualified inspector. 60 Minutes should have reported the facts instead of slanting the story untruthfully.

The former FDA commissioner, David Kessler, was right when he said “There is no reason that people had to die” because of NECC. The truth is that the NECC oversight debacle involved a complete system break down, involving not only corruption within NECC, but also, included obvious faults of the FDA. It was not a lack of federal jurisdiction that was the main problem as 60 Minutes suggests, but rather, it was the FDA’s lack of action to enforce any oversight of NECC even when obvious public health threats were imminent. This lack of oversight resulted in the release of contaminated medicine causing the deaths of 48 people. It also inflicted a horrendous illness in over 700 hundred people who remain fighting infections from a fungus that attacks their bones, nerves and brains while enduring a painful treatment of no proven cure.

Making new or stronger laws will not protect the public when leadership within the FDA is either incompetent or is corrupted with conflicts of interests. Simply put…laws without the accountability of enforcement just do not work. We must force our government officials to be accountable. Even now, the FDA has not disciplined anyone within the FDA for an obvious lack of duty to inspect NECC.

Conflicts of interests within the ranks of our government can have a devastating impact on public health. We need credible leadership in our agencies to ensure responsible actions that protect the public and enforce laws. Despite the fact that 60 Minutes gave stark reports on the terrible suffering of persons exposed to the fungus-contaminated medicine and on the corruption inside NECC, they failed to take justifiable aim at the lack of government accountability in the NECC case. 60 Minutes should be embarrassed by their biased reporting and obvious omission regarding the irresponsible lack of oversight of NECC by the New England FDA district.

Congressional Hearing on Deadly Meningitis Outbreak Wants Answers from FDA

The Commissioner of the FDA, Dr. Margaret A. Hamburg was called on the carpet at a congressional hearing yesterday after the FDA failed to take action to prevent a deadly meningitis outbreak throughout the country.

NECC (New England Compounding Company) made and distributed batches of a fungal contaminated medicine, which caused numerous deaths and serious illness throughout the country. The FDA had had a troubled past with NECC for over a decade. State agencies from several states had also reported unsafe practices by NECC to the FDA. Yet the FDA New England District office, headed by Capt. Mutahar Shamsi, did nothing to regulate NECC to prevent the manufacturing of tainted medicine which caused the meningitis outbreak.

Congressional members pelted FDA Commissioner Hamburg with questions about FDA's lack of oversight where she appeared evasive in most instances, yet was consistent in parroting for more laws and more money for the FDA due to lack of jurisdiction and resources. The FDA presently receives about 4.5 billion a year through tax payer’s money and user fees. Many congressional members did not buy into Commissioner Hamburg’s line.

What made it even more frustrating for many congressional members was that the FDA had failed to cooperate with congress in providing related internal documents from the FDA New England District, even when the documents had been requested a month earlier. The other red flag was that the FDA was well aware that the company was a manufacturer and not just a standard compounding pharmacy. This fact alone made it difficult for many congressional members to swallow Commissioner Hamburg’s answer that FDA had no jurisdiction over NECC.  Some members of congress believed that the FDA had to have had some form of authority to prevent the release of tainted medicine.  Yet, Hamburg could not address the issue of the FDA's lack of due diligence. Rep Cliff Stearns from Florida, who chaired the congressional hearing, said that someone in the FDA was not watching.

Distribution of the tainted drug has already resulted in 32 deaths and hundreds of serious illnesses. Many more deaths are expected since thousands of patients where exposed to the deadly fungus through injection of the medicine by physicians in at least 23 states.

Congress does well to demand more transparency and accountability to why the FDA failed in oversight and enforcement which led to distribution of an unsafe medicine and tragic deaths throughout the country.

Will New Laws Prevent Future Meningitis Outbreaks?

Legislators Should Examine FDA before Creating New Laws


Today an article from the Wall Street Journal reports that Rep Edward J. Markey (D., Mass) and Rep Rosa De Lauro (D., Conn) plan to introduce a bills that would “give the FDA clearer authority to regulate large pharmacies that mix customize drugs like the one tied to a deadly meningitis outbreak”.

But legislators may be on the wrong track. Prior to the outbreak, the FDA had sufficient jurisdiction to inspect NECC, the compounding pharmacy who manufactured in bulk, injectable medicines that caused the meningitis outbreak.

Mutahar Shamsi, the District Director for the New England FDA Office of Regulatory Affairs, during an October 2012 press conference, however, was quoted as stating that an inspection occurred on October 1st, 2012, only after the outbreak. No other inspectional information on NECC has been released by the FDA depite the fact that this company was on the FDA's inspection list. The big question is why did the FDA fail to perform at least minimal oversight of NECC where they had jurisdiction to do so?

The lack of oversight of NECC by the FDA raises questions to the possibility of either incompetence or conflicts of interests within FDA leadership in the New England Boston district. Conflicts of interests can  undermine enforcement of laws since FDA regulators can pick and choose whom they inspect or regulate.  

Excuses to a lack of jurisdiction or lack of resources are often made to cover up inadequacies, unethical standards or poor leadership within government agencies. 

Making new laws will not protect the public when regulators act in capricious ways to favor industry and are not held accountable to uphold current law.The New England Boston District FDA office needs to be thoroughly examined regarding their prior oversight of NECC or their lack there of. The public should have transparency as to the real reason why the FDA did not properly inspect NECC prior to the meningitis outbreak that caused 28 deaths, when in fact, they had jurisdiction to do so, and when in fact, NECC had a history of prior complaints.

New Emerging Disease in Vietnam

A new mystery illnes has hit Vietnam causing concern from government officials.  At least 19 people have died and 171 are sickened.  Patients first experience a fever with rashes on their hands and feet.  Organ failure can result leading to death.

http://worldnews.msnbc.msn.com/_news/2012/04/20/11299851-vietnam-pleads-for-help-as-mystery-disease-kills-19-sickens-171

Almost Pizza_Almost Synthetic Biology

See this Saturday Night Live skit showing a synthetic bio-nanotech pizza (by Pfizer)

http://www.hulu.com/watch/348484/saturday-night-live-almost-pizza
http://climate-connections.org/2012/04/09/almost-pizza-synthetic-biology-hits-saturday-night-live/

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.

http://www.rawstory.com/rs/2012/03/21/mysterious-zombie-disease-afflicts-thousands-of-ugandan-children/

Lab Shuts Down after another Biocontainment Problem

University of Chicago lab closed after infection case

Science News

 http://www.upi.com/Science_News/2011/09/15/University-of-Chicago-lab-closed-after-infection-case/UPI-86931316102258/


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.

Lab Acquired Infection--JEANNETTE'S STORY

http://www.youtube.com/watch?v=5j91bKUUsZM

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

LACK OF TRANSPARENCY IN U.S. GOVERNMENT-FUNDED RESEARCH

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


Written by Michelle Groman on November 16, 2011 —
http://blog.bioethics.gov/2011/11/16/commission-calls-for-transparency-in-u-s-government-funded-research/
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.

INJURY AND DEATHS OF WORKERS HIDDEN FROM PUBLIC_ A LACK OF DISCLOSURE

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.

http://thepumphandle.wordpress.com/2009/07/20/interpreting-oshas-on-line-data/

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.

UNREPORTED LAB ACCIDENTS MAKES FOR FALSE CLAIMS OF SAFETY IN LABS

Experts say US needs better tracking of lab accidents

 

Robert Roos News Editor

 

http://www.cidrap.umn.edu/cidrap/content/bt/bioprep/news/jan0512labsafe.html
 

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)

 

 

Whistleblower Complains of Pfizer Hiding Adverse Events

Pfizer May Be Liable for Firing Whistle-Blower


By WILLIAM DOTINGA

http://www.courthousenews.com/2012/03/02/44377.htm

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

Pfizer Groton Occupied

Video from Occupy Shoreline CT.org 
http://occupyshorelinect.org/content/f29-pfizer-alec-protest-groton-ct#comments

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:
http://www.theday.com/article/20120301/NWS01/303019537/1017

Video from Occupy Shoreline CT.org

http://occupyshorelinect.org/content/f29-pfizer-alec-protest-groton-ct#comments

Texas Rat Snake and Lizard in Action

  

Experimenting with Danger
http://www.csb.gov/videoroom/detail.aspx?VID=61

See the link above to a CSB video that highlights the lack of safety, regulations, and oversight in research laboratories in the United States.  With no obligatory uniform minimum standard of safety mandated for all research labs in the United States, serious injuries and deaths that could have been prevented continue to occur.  A serious lack of accountability and responsibility exist in the world of science.

Congentital Lyme Disease Induces Autism

A report by FOX news reports on congenital Lyme Disease having the potential to cause autism in children:

http://www.fox40.com/news/headlines/ktxl-treating-lyme-induced-autism-20110926-001,0,65417.premiumvideo

Pfizer Biotech Whistleblower Speaks Out

Public Health and Safety_Biotech Worker Made Ill from Unsafe Biotech Laboratories at Univ of Chicago

University of Chicago Microbiologist Infected From Possible Lab Accident

by Jocelyn Kaiser on 12 September 2011, 5:17 PM

http://news.sciencemag.org/scienceinsider/2011/09/university-of-chicago-microbiologist.html?ref=hp
 

Another laboratory-acquired infection may have occurred in a University of Chicago building where 2 years ago a researcher contracted plague and later died. Late last month, a researcher who worked in the same general lab area was hospitalized with a skin infection caused by a common bacterium being studied in her lab.

The researcher became infected with Bacillus cereus, which can cause food-borne infections, while working on a project headed by microbiologist Olaf Schneewind, according to the university. She was hospitalized on 27 August; after receiving surgery and antibiotics, she was released. In her lab, where B. cereus was studied in biosafety-level 2 conditions (on the lower end of four biosafety levels), the university suspended research to decontaminate the area as a precautionary measure (it was expected to open later this week).

The researcher was likely exposed through an open wound. The university is still investigating whether she acquired the infection in the lab, said University of Chicago Medical Center spokesperson Lorna Wong. B. cereus is not contagious as long as standard procedures such as good hand-washing hygiene are followed, but family members and co-workers were screened for infection risk and some were offered precautionary antibiotics.

Two years ago, a researcher who worked in the same area in the Cummings Life Science Center, geneticist Malcolm Casadaban, a co-principal investigator with Schneewind, died after becoming infected with a weakened strain of the Yersinia pestis bacterium that was not thought to infect healthy adults. According to a report in the Centers for Disease Control and Prevention's Mortality and Morbidity Weekly Report, Casadaban may have become sick because he had hemochromatosis, or an overload of iron in the body. The Y. pestis strain had been weakened by making it less able to acquire iron, and the excess iron in Casadaban's body might have allowed it to be become more virulent, the MMWR report says.

That report said Casadaban, who was known to use gloves inconsistently, may have become infected through dermal exposure—possibly the same exposure route as the researcher infected with B. cereus. The university said that Chicago's public health department has visited the campus and reviewed the lab's safety procedures.

Neither case involved a select agent—a pathogen on CDC's list of potential agents in a biological attack. (Although Y. pestis is on the list, the strain Casadaban studied was excluded.) But Schneewind also directs the Great Lakes Regional Center of Excellence for Biodefense and Emerging Infectious Diseases Research, a consortium funded by the National Institute of Allergy and Infectious Diseases (NIAID) to study select agents and natural threats. The center does some of its work at a major biosafety level-3 lab on the campus of Argonne National Laboratory, one of a dozen such regional biocontainment labs built partly with NIAID funding after the 2001 anthrax attacks.

Schneewind did not respond to an e-mail this morning seeking comment.
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Not all infections are bacteria. Fungi and viruses can also infect wounds.

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.