Protest to EPA re: stacked advisory panel, bias against mesothelioma victims and chrysotile causation

April 30, 2007

Ms. Vivian Turner
Designated Federal Officer
Science Advisory Board (1400F)
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460

Anthony F. Maciorowski
Associate Director for Science
Science Advisory Board (1400F)
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460

Re: Nominations of Bruce W. Case, Dennis Paustenbach, and Art Langer to EPA Task Panel

Dear Ms. Turner and Mr. Maciorowski,

I oppose the inclusion of Dr. Case, Dr. Paustenbach, and Dr. Langer on EPA’s scientific advisory board regarding asbestos toxicity.

The advisory board is charged with reaching conclusions about asbestos toxicity that are scientific and non-partisan. Members of the board are obligated to demonstrate through their professional backgrounds and conflict of interest disclosures that they can serve on the board with scientific objectivity and nonpartisanship.

Scientific Objectivity

Dr. Case served as a consultant to a 2003 EPA peer panel on asbestos risks. He was given all relevant studies and charged with providing an unbiased evaluation of all the data. In his analysis, Dr. Case made a mockery of his scientific duties when he chose to use only those studies that supported the asbestos industry, ignoring his own research which showed that fiber dimension did not affect toxicity.[1] A 2003 report to the Office of the Inspector General documents Dr. Case’s public statements that chrysotile asbestos does not cause cancer, and his claim that the scientific community agrees with him.[2] The International Agency for Research on Cancer,[3] the European Union,[4] as well as experimental and epidemiologic studies have all affirmed the carcinogenicity of chrysotile. One member of the scientific community that supposedly “agrees” with Dr. Case publicly rebuked him in the New England Journal of Medicine[5] for his outlandish claims. Dr. Case clearly lacks the scientific objectivity to evaluate asbestos toxicity.

Dr. Paustenbach conceived, drafted, edited, and submitted to a peer-reviewed medical journal a redacted Chinese study on chromium-6 under the names JianDong Zhang and ShuKun Li that suppressed key cancer data despite a letter of objection from the scientist who led the original study.[6] The Journal of Occupational and Environmental Medicine took the rare step of retracting the article when it learned that the real author was Paustenbach’s industrial consulting firm, ChemRisk, and that the cancer data had been intentionally ignored.[7] This scandal was written up in the Wall Street Journal.[8] Dr. Paustenbach also devised a “scientific” probabilistic risk assessment methodology for a DOW Chemical flood plain soil study that was explicitly rejected by the EPA as inadequate and not accepted by the scientific community.[9] Paustenbach’s methodological flaw was labeled a critical deficiency to the study.[10] Dr. Paustenbach lacks the capacity to serve on any panel requiring scientific objectivity or personal integrity.

Dr. Langer has a distinguished record as a scientific investigator, and published pioneering work on asbestos toxicity in the 1970’s. Although I believe his early career demonstrates unimpeachable scientific research, he should be barred from this panel for the reasons set out below.

Nonpartisanship

Dr. Case is listed on the EPA’s short list as a consultant to attorneys representing “plaintiffs and/or defendants in asbestos litigation.”[11] We challenge Dr. Case to prove a single consulting job for a plaintiff in asbestos litigation, ever. To the contrary, he is an established consultant for asbestos companies, having worked on behalf of AC&S, U.S. Gypsum, Garlock, Mobil, and Georgia-Pacific, to name only a few.[12] Dr. Case has denied that any his research was ever funded by the asbestos industry, when the Archives of Environmental Health explicitly acknowledges that his research funding was partially obtained from JM Asbestos Corporation.[13] Dr. Case has also admitted in legal testimony that a 1989 study in which he participated was sponsored by the Quebec Mining Companies.[14] In addition to open partisanship for asbestos manufacturers, Dr. Case has attacked the honesty and integrity of scientists who disagree with him, including researchers Dodson, Egilman, Suzuki, and Landrigan.[15] In 1998, in response to a short story about a young woman who contracted mesothelioma by playing with a chrysotile rock from a Canadian mine posted on my website, he warned me to take them down “for my own protection,” a threat he later confessed was “silly” under penalty of perjury.[16] Dr. Case is unqualified to pursue the scientific question of asbestos toxicity due to his extreme partisanship.

Dr. Paustenbach is not simply partisan—he is for hire.[17] His industrial research as corporate vice-president for Exponent, and his position as CEO of ChemRisk have put him consistently on the side of asbestos manufacturers and corporations. He cannot be expected to fairly pursue research objectives for asbestos toxicity unless the research conclusions are favorable to the asbestos industry for which his corporation works.

Dr. Langer’s work as a consultant for defendant asbestos companies has led him to repudiate his earlier, sound research that demonstrated the toxicity of joint compound and brake linings. Dr. Langer, like Drs. Case and Paustenbach, can hardly be expected to pursue or endorse toxicity findings at loggerheads with his consulting clients.

Conclusion

I believe that EPA’s short list has numerous other candidates whose scientific background and personal history ensure that they will follow the tenets of objective investigation and analysis, as well as behave with honesty and integrity.

Sincerely,

Roger G. Worthington, Esq.

RGW/cr

CC: Sen. Barbara Boxer
Sen. Diane Feinstein


 [1] EPA internal memorandum, April 16, 2004, by Case Jenkins, Ph.D., “Bruce Case, MD, EPA consultant for asbestos: conflict of interest misrepresentations and slander against other scientists.”
[2] Id.
[3] International Agency for Research on Cancer (IARC) – Summaries & Evaluations, 1987, http://www.inchem.org/documents/iarc/suppl7/asbestos.html
[4] News story, http://ban.org/ban_news/wto_will.html
[5] Letters 006-009, New England Journal of Medicine, October 1, 1998, Vol. 339 #14, pp. 999-1002
[6] Environmental Working Group report, April 2006, http://www.ewg.org/reports/chromium/part1.php
[7] Letter to editorial board members, Journal of Occupational and Environmental Medicine, May 31, 2006, NOTICE OF RETRACTION: It has been brought to our attention that an article published in JOEM in the April, 1997 issue by Zhang and Li1 failed to meet the journal’s published editorial policy in effect at that time. Specifically, financial and intellectual input to the paper by outside parties was not disclosed. Although it is impossible to know what the impact of such disclosure would have been, it is possible that full knowledge of the circumstances may have altered the review process or the subsequent interpretation of the study by readers. Therefore, after thorough investigation, consultation with outside experts and consideration by the Editorial Board, I have decided that retraction is necessary. It should be understood that there is no evidence to suggest the existence of scientific fraud in this work and that the factual content of the article has not been re-evaluated. This decision is based solely on the violation of the journal’s policy regarding disclosure. The corresponding author of this article (Dr. Zhang) has since died. However, the co-author (Dr. Li) has been informed of this decision and has agreed to the retraction of the article. We will also make appropriate notification to the National Library of Medicine regarding future citation of this paper. Paul Brandt-Rauf, M.D., Sc.D., Ph.D., Editor, 1 Zhang J, Li S. Cancer mortality in a Chinese population exposed to hexavalent chromium in water. JOEM 1997;39:315-319.
[8] Wall Street Journal, Dec. 23, 2006
[9] EPA Region 5 Critical Deficiency Comments on the Tittabawassee River Floodplain Remedial Investigation Work Plan and Midland Area Soils Remedial Investigation Work Plan Midland, Michigan, Feb. 10, 2006
[10] Id.
[11] Invitation for Comments on the Short List Candidates for the Asbestos Panel of the EPA Science Advisory Board, April 19, 2007, http://www.epa.gov/sab/pdf/asbestos_panel_shortlist_biosketches.pdf
[12] EPA internal memorandum, supra
[13] Id.
[14] Id.
[15] Id.
[16] http://www.mesothel.com/pages/case.htm
[17] http://www.ChemRisk.com


World Health Organization: Asbestos kills thousands in the workplace each year

April 28, 2007

Reuters, 2007-04-28

GENEVA – At least 200,000 people die every year from cancers related to their workplaces, mainly from inhaling asbestos fibers and second-hand tobacco smoke, the World Health Organisation (WHO) said on Friday.

The U.N. agency said every 10th lung cancer death is related to occupational hazards, and about 125 million people worldwide are exposed to asbestos at work, leading to at least 90,000 deaths each year.

Thousands more die of leukemia from workplace exposure to benzene — an organic compound used in rubbers, dyes, drugs, and pesticides, widely used in chemical and diamond industries — and those exposed to second-hand smoke at work have twice the risk of lung cancer than those in a smoke-free environment.

“Known and preventable exposures are clearly responsible for hundreds of thousands of excess cancer cases each year,” Maria Neira, WHO director of public health and environment, said in a statement released in Geneva.

The WHO urged governments and industry to tighten safety standards to ensure workers are not exposed to carcinogens. Stopping the use of asbestos, using benzene-free organic solvents and banning tobacco in the workplace could help prevent hundreds of thousands of unnecessary deaths, it said.


Review of mesothelioma treatments suggests promising future

April 27, 2007

Read this summary of a mesothelioma treatment review from Cancer Monthly. Quote from one of the review’s authors:

“This is a very exciting time for advances in mesothelioma, and slow but definite progress is being made,” Raz says. “The scientific community is starting to understand a lot more about the biology of this terrible disease, which means that more targeted therapies are being introduced that could potentially help people.”
* Lee AY, Raz DJ, He B, Jablons DM, Update on the Molecular Biology of Malignant Mesothelioma. Cancer, 2007 Mar 8:109(8):1454-1461


California judge rejects defense “removal” caper, gives mesothelioma victim his day in court

April 26, 2007

General Electric chose not to warn about asbestos, faces lawsuit for poisoning veteran

A federal judge in California recently ruled that General Electric must stand trial in California state court for its failure to warn navy sailors about asbestos contained in the products and equipment GE installed on naval vessels. In an effort to transfer the case to federal court, where asbestos lawsuits languish and rarely see light of day, General Electric sought to use a discredited legal argument whose sole purpose is to avoid ever having to compensate its victim.

On April 13, 2007, United States District Judge for the Central District of California Gary Klausner rejected GE’s tactics. Judge Klausner ruled that General Electric must stand trial in state court. General Electric’s asbestos-containing equipment includes turbines, generators, and condensers, among many others. These products have been a source of asbestos exposure among sailors, exposure that later leads to fatal mesothelioma, an aggressive cancer of the lung lining.

Samuel Scarbrough was exposed to GE’s asbestos-containing turbines while serving in the navy aboard the USS West Virginia. As a result, he developed mesothelioma and died. General Electric’s attempt to move the case to federal court was based on a “federal officer” argument, essentially claiming that GE used asbestos because the navy required it. See this article for a detailed review of this favorite defense tactic to keep asbestos victims from ever having their day in court.

Judge Klausner rejected the maneuver on several grounds, pointing out that none of GE’s evidence showed that that navy instructed GE not to warn sailors of asbestos hazards. The judge also rejected the defense stratagem on the grounds that GE failed to produce a shred of evidence showing that any of the navy’s equipment specifications forced GE not to warn Scarborough about asbestos.

In the court’s words, “Defendant (General Electric) has submitted numerous exhibits, declarations, and specifications from the United States Navy demonstrating that the Navy exercised control over the design and manufacturing of Defendant’s machines…Defendant has not shown that the Navy required it to refrain from issuing warnings nor has it shown that the Navy provided reasonably precise specifications affecting Defendant’s provision of Warnings.” (emphasis added). [Link to PDF of court ruling.]

Significance for asbestos victims

When a manufacturer knew or should have known of a danger inherent in one of its products, the manufacturer has a duty to provide adequate warnings so that potential users will know about the danger. This type of lawsuit is known as “failure to warn.”

General Electric could have included warnings with their products, potentially saving thousands of lives. Instead they chose not to warn navy sailors about the lethal danger of asbestos, with tragic results. Thousands of people die every year from asbestos poisoning, many of them veterans exposed during service in the navy.

Throughout the United States, when asbestos victims seek restitution from the companies that knowingly poisoned them, the defendant companies generally try to permanently remove the case to federal court. Thanks to this ruling by Judge Klausner and similar rulings in other federal courts, navy veterans like Scarbrough can have their day in court.

RGW, PC
4/26/2007


Virotherapy shows promise treating mesothelioma

April 26, 2007

By Jeni Baker

In the rapidly emerging field of virotherapy, scientists are researching many viruses as prospective agents, and many diseases as prospective targets. Mesothelioma, in particular, is long overdue for advances in treatment.

A recently published study* suggests that virotherapy may be a viable treatment option for this lethal form of lung cancer, as well as for other cancers. “Normally, viruses replicate to increase their number, and by virtue of that process, healthy cells are killed,” explains David T. Curiel, MD, PhD, director of the Division of Human Gene Therapy at the University of Alabama at Birmingham. “Virotherapy is about engineering viruses so that they replicate only in tumor cells – and kill only tumor cells.”

The catch is that in order to engineer an effective virus, scientists must first understand the molecular workings of the cancer. An adenovirus-based virotherapy agent is engineered by incorporating a tumor specific promoter (TSP) into virus genes. The TSP restricts the expression of certain genes and viral replication in tumor cells, while sparing in normal cells.

“Not much is known about the biology of mesothelioma,” Curiel says, so it was a significant step forward when his team – led by Zeng B. Zhu, MD – identified a new TSP called survivin and confirmed its relationship to mesothelioma with laboratory and animal studies. (All studies were supported by the Mesothelioma Applied Research Foundation.)

This discovery set the stage for the team to design a virotherapy agent effective against mesothelioma – a disease that has not seen an improvement in outcomes resulting from new therapies in 20 years, Curiel says – and the researchers have engineered a virus that replicates in mesothelioma cells and spares normal cells.

But while the scientific community is starting to make strides toward treating patients with mesothelioma – “a population with no real treatment alternatives,” Curiel says – and people at high risk for developing the disease, Curiel warns that “simply because we’re beginning to understand mesothelioma on this level, we shouldn’t expect to see a downtick in the number of cases.”

That’s because of mesothelioma’s long latency period. Although the disease is caused primarily by asbestos exposure – and asbestos has been disappearing in this country for a long time – mesothelioma’s life cycle and predictable demographic are such that we’ll continue to see an increase in cases for years, making the disease an ideal target for virotherapy, says Curiel.

“Mesothelioma is typically localized in the chest cavity, and virotherapy can optimize our ability to target and contain it,” he says. “We can concentrate the virus in the area where it will be most effective – and cause minimal damage to healthy cells.”

In addition to their virotherapy work with mesothelioma, University of Alabama researchers also have adapted an early diagnostic test for the disease, which will be the subject of future work.

There is evidence that virotherapy can be effective in treating other types of cancer, as well, Curiel says. Last month the University of Alabama at Birmingham got FDA approval to begin investigating the use of virotherapy as a treatment for ovarian cancer, and a national clinical trial will begin in May.

Alabama researchers are also collaborating with scientists at MD Anderson Cancer Center and the Free University of Amsterdam to investigate the efficacy of virotherapy in treating glioma, an aggressive form of brain cancer.

* Zhu et al, Targeting Mesothelioma Using an Infectivity Enhanced Survivin-Conditionally Replicative Adenoviruses. J Thorac Oncol. 2006 Sep; 1(7):701-711.

Copyright © 2004-2007 Cancer Monthly


The scientific basis for a total asbestos ban

April 24, 2007

La Medicina del lavoro, 2006 Mar-Apr; 97(2):383-92

Numerous countries have already enacted total bans on asbestos, while others continue to use it as if the documented dangers over the last century never existed. This disparity, with developed countries tending to ban asbestos and poorer countries serving as dumping grounds for asbestos makers, led the University of Turin’s Center for the Study of Asbestos to conduct a review of the scientific basis for a total asbestos ban.

The review concluded that in order to ensure adequate protection for workers, their families, and people involved in everyday activities, there is no alternative to a total ban. The review concluded that the evidence for carcinogenicity of chrysotile is as good as for the amphibole type fibers, and it noted that while the carcinogenic potency of chrysotile is lower than that of the amphiboles, risk estimates must be based on the fact that chrysotile represents 95% of asbestos used worldwide. The review insisted that the role of asbestos as the cause of mesothelioma does not warrant reconsideration.

The review also rejected calls for “controlled use,” pointing out that the safety of the controlled use theory has not been tested scientifically and that it is impractical in the countries that are currently the major consumers of asbestos.

 Citation


All types of asbestos related to high incidence of mesothelioma in Australia

April 24, 2007

American Journal of Industrial Medicine, 2002 Mar; 41(3):188-201

Rebutting the misrepresentation that chrysotile asbestos does not cause mesothelioma, a 2002 article published by the Center for Occupational and Environmental Health, Department of Public Health and Community Medicine in Sydney, Australia reviewed mesothelioma in that country between 1945-2000.

The review, based on a national malignant mesothelioma case registry begun in 1980, noted a marked increase in the incidence of mesothelioma in the last twenty years. The article concluded that Australia’s high incidence of mesothelioma is related to high past asbestos use of all fiber types across a wide spectrum of occupational and environmental settings. This conclusion directly rebuts the claim of defense lawyers and asbestos manufacturers that mesothelioma is caused by some fiber types and not by others.

The article chronicled the scope of the asbestos epidemic in Australia, and predicted that the number of cases is expected to reach 18,000 by 2020, with about 11,000 yet to appear. Currently 450-600 cases are notified annually in a population of 20 million. The review used registry data to calculate time trends in mesothelioma incidence. The article analyzes incidence by age, sex, anatomical site, and state of notification, and describes the association of occupational and environmental asbestos exposure histories. Australia has the highest number of reported mesothelioma cases in the world.

Citation