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Elizabeth Weise’s USA Today article about potential health effects of the Gulf oil disaster and its cleanup notes that we don’t have a whole lot of research to draw on about this kind of exposure. Residents and cleanup workers alike will be exposed both to the oil itself and to cleanup agents, particularly the chemical dispersants.

Weise references a Korean study conducted following the 2007 sinking of an oil tanker of the Korean coast, which found that residents had an increased risk of headaches, nauseau, and neurological and respiratory symptoms. With regards to the dispersants, she reports, “The potential human hazard for the two dispersants being used to break up the oil is rated high for one of them, moderate for another, according to the Material Data Safety Sheets posted on the government’s Deepwater Horizon Response website.”

But the section of Weise’s article that really caught my attention was this one (emphasis added):

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The Pump Handle is pleased to provide the full text of an article, published in the Bureau of National Affairs’ “Occupational Safety & Health Reporter,” on SKAPP’s Scientists in Government project report.*

by Stephen Lee

A study of scientists’ opinions at 13 federal agencies, including the National Institute for Occupational Safety and Health, found that many feel political pressure guides much of their work.  The research, published March 3 by the George Washington University Project on Scientific Knowledge and Public Policy, said scientists at NIOSH felt the agency deliberately avoided research that might lead to controversial findings for fear the agency might be eliminated.  One senior NIOSH scientist was quoted in the report as saying,

“All research areas are dictated from management, and you must be limited to doing research in these specific areas. As a consequence, eight people have left within the last two years alone. They felt they weren’t being treated as full scientists.”

The 100-page report , Strengthening Science in Government: Advancing Science in the Public’s Interest, interviewed 37 participants at 13 federal agencies, including the Centers for Disease Control and Prevention, Environmental Protection Agency, and Department of Agriculture.

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By David Egilman

On September 15, 2008 pharmaceutical giant Eli Lilly pleaded guilty to committing the crime of off-label marketing of Zyprexa, an antipsychotic.  Lilly has profited handsomely from the marketing of this drug, making over $30 billion. The Department of Justice (DOJ) claims that the $1.42 billion dollar fine agreed to by Lilly as part of its guilty plea is the largest ever paid to settle such a violation, but it represents only 3.5% of the company’s Zyprexa sales.   DOJ’s willingness to accept a misdemeanor plea and a trivial fine is troubling given Lilly’s two prior convictions for criminal conduct in the marketing of its drugs.  In 1985, Lilly pleaded guilty to 25 counts of unintentional deception in the marketing of its anti-arthritic drug Oraflex, including hiding 23 death cases from the FDA.  And in 2005, Lilly pleaded guilty to off-label marketing of Evista, a drug used to treat and prevent osteoporosis in postmenopausal women. 

Under statutes like California’s notorious “three strikes” law, repeat criminals receive life sentences for committing non-violent crimes that involve far less money or harm to society (e.g., shoplifting $153 worth of videotapes). Even excluding Zyprexa, Lilly’s crimes resulted in the deaths of tens, if not thousands, of innocent victims, but have had far less severe consequences for the company than for individuals convicted of petty crimes.
 
I have a certain personal familiarly with the Zyprexa case, since I released some of the documents upon which the criminal case was based.  These same documents had been sealed by a federal judge at the request of both plaintiffs’ and defense counsel. (About a year before I released the documents to a lawyer in Alaska, some plaintiffs’ counsel sought to unseal them, but the Judge never ruled on this motion.)  In the end, these same documents were used by DOJ to build its criminal case against Lilly, and it is unclear whether that case would ever have proceeded had the documents remained secret.  Most judges should be able to recognize that documents that reveal evidence of crimes should not be treated as “trade secrets” and protected from disclosure.  After all, some drug companies are convicted felons for doing similar things (Pfizer and AstraZeneca) and almost all have violated FDA marketing rules, so the techniques of off-label marketing and lying are well known and commonly practiced. 

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An attorney representing a large group of PFOA-exposed individuals sent a letter to EPA Administrator Stephen Johnson and ATSDR Director Howard Frumkin, urging them not to delay any further the release of hazard information and risk assessments on the contaminant perfluorooctanoic acid (PFOA, a.k.a. C8).  Mr. Bilott was writing on behalf of residents who live near DuPont’s Washington Works plant near Parkersburg, WV and 

“who continue to be exposed to this poison in their residential drinking water on a daily basis.”   

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The Palm Beach (Florida) Post is reporting that Ag-Mart has settled a civil suit filed by a migrant farmworker family who alleged their son’s serious birth defects were associated with the company’s improper handling of pesticides.  Earlier reporting in March 2005 by the PB Post exposed the working and living conditions of this family and other farmworkers, and birth defects among some of their children.  

At the same time this settlement was reported, another Florida newspaper wrote that violations against Ag-Mart for failure to comply with the State’s pesticide use rules had nearly all been dropped by an administrative law judge.  Oddly, these violations (e.g., failing to provide protective equipment for employees working with pesticides, allowing workers to harvest crops too soon after chemicals were sprayed, burning pesticide containers) all seem like the type of practices that might have contributed to the workers’ exposure and possible link with the infants’ malformations.  This development, coupled with the fact that the Ag-Mart case settlement is protected by a confidentiality agreement, creates serious obstacles for public health prevention.

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The following post is by Dr. David Egilman, a familiar figure to those who have been following the case of Eli Lilly’s schizophrenia drug Zyprexa. See Alex Berenson’s New York Times articles on the case for more background, or read David Michaels’s post about Zyprexa and sequestered science. — Editor

“The Truth is Not Free”
By David Egilman
September 11, 2007

All that is needed for the forces of evil to succeed is for enough good people to remain silent.
– Edmund Burke

The consequences of silence can be devastating.  My father spent WWII in a German concentration camp largely as a consequence of silence. In response to the Holocaust, which was facilitated by the silence of a nation, I have devoted much of my professional career to studying and reporting the effects of silence on public health.

Last December, I was subpoenaed for copies of internal documents that I acquired as a consulting witness in litigation against the pharmaceutical company Eli Lilly. I released all of the documents I had, which made their way to The New York Times and became the basis for four major articles. After the Times stories ran, 30 states subpoenaed documents detailing Lilly’s sales, marketing and promotional practices for Zyprexa as part of civil investigations under state consumer protection laws.

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At first, the FOIA request for workplace inspection data seemed straight forward.  The requester asked for all records contained in OSHA’s database of industrial hygiene samples for the contaminant beryllium during the period 1979 to 2005.   Previously, OSHA had provided on numerous ocassions comparable information to other requesters, and in some cases, even without requiring a formal FOIA request.  Moreover, OSHA’s sister agency, MSHA, already provides full access to this kind of data right on its website. 

But in this case, the requester was Adam M. Finkel, ScD CIH, a former OSHA regional administrator.  He was not just any former employee.  In 2003, Finkel won a whistleblower case against the agency after OSHA’s Assistant Secretary John Henshaw tried to fire him after complaining about the agency’s refusal to offer medical tests to inspectors who had been potentially exposed to beryllium while conducting inspections. 

Now, after a two-year legal battle over Finkel’s FOIA request, a federal judge ruled that OSHA had not made case for withholding the data.

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By David Michaels

An editorial in the latest issue of Nature takes up a problem that public health advocates have been battling for years: confidentiality orders that keep important scientific data hidden from the public, scientists, and even regulatory agencies.

One recent case of such data being kept secret, which Nature reporter Jim Giles covers in an accompanying article, is Eli Lilly’s schizophrenia drug Zyprexa. David Egilman, a physician who had access to confidential documents about Zyprexa’s dangers, is being threatened with jail time for his role in the release of the papers to, among others, New York Times reporter Alex Berenson. The story Berenson broke was front page news:

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By David Michaels

The state of Pennsylvania has filed lawsuits against three drug manufacturers, claiming the firms fraudulently marketed antipsychotic drugs. According to Bloomberg News, the state alleges that Eli Lilly & Co. “hid the risks and exaggerated the benefits of its antipsychotic medication Zyprexa while persuading doctors to prescribe it for unapproved uses.” AstraZeneca and Johnson & Johnson’s Janssen Pharmaceutical are accused of doing the same for other drugs:

The defendants cost Pennsylvania’s Medicaid and drug assistance for the elderly program millions of dollars for “reimbursing for non-medically accepted indications and non- medically necessary uses of Zyprexa, Seroquel and Risperdal,” as well as “significant sums of money for the care and treatment” of patients injured by the drugs, the state said in a complaint.

State law suits (Louisiana, West Virginia, Alaska and Mississippi have filed similar suits against Eli Lilly) are an important component of the ongoing saga of the anti-psychotic drugs that cost too much and are more dangerous than their manufacturers like to admit.

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