Archive for May, 2008

Last week, W.R. Grace & Company won an appeal it had asked for last year, concerning a ruling made by U.S. District Judge Donald Molloy. Another appeal the company has asked for concerns regulations governing the types of minerals with which the company’s Libby, Montana vermiculite mine was contaminated.

The appeal last week was concerned with U.S. District Judge Donald Molloy’s request for a pretrial list of witnesses and evidentiary documents from the government. The request was made in connection to the government’s asbestos case against W.R. Grace & Co.

W.R. Grace & Co. was indicted in 2005 on charges of conspiring to conceal the health risks of the Libby mine and its asbestos-contaminated vermiculite for residents of the town. In March 2005, Judge Molloy set a discovery schedule for the case, giving the government approximately six months to create a final list of the witnesses and exhibits it planned to use in the trial.

However, the government continued expanding on its witness and document list well after the six month limit. In response Judge Molloy ordered in December 2005 that the government cease adding new witnesses. The government appealed, saying that Molloy’s ordered were an abuse of his discretion.

In July 2007, a panel of three 9th US Circuit Court of Appeals judges agreed, and said that the district court had stepped outside the bounds of its authority. However, W.R. Grace & Co. asked for a review by a larger panel of judges. The new panel issued their opinion last week, and upheld the orders issued by Judge Molloy.

At the same time, W.R. Grace & Co. has been appealing for another reason.

The company’s attorneys are arguing that winchite and richterite, the minerals that made up the asbestos contaminating the Libby mine, weren’t regulated by the federal government. The attorneys say that this means the company can’t be prosecuted under the federal Clean Air Act.

Again, Judge Molloy agreed with the company, and again his ruling was overturned by the 9th US Circuit Court of Appeals. And W.R Grace & Co. is now asking that the Supreme Court reserve the decision.

W.R Grace & Co.’s petition says that the government “is trying to convict defendants of violating the Clean Air Act by releasing substances that the government itself has excluded from the list of substances covered by the act.”

The government must file a response within thirty days, after which the Supreme Court will decide whether or not it will hear the case. If the court declines, the decision will stand.

That means the trial itself might finally get started. If the Supreme Court decides to hear the case, it won’t do so until October 2008 at the earliest.

A coalition of public health experts, doctors, and consumer organizations is petitioning the federal government, asking that warning labels be added to cosmetic talcum powder products.

The petition addresses Mike Leavitt, the Secretary of Health and Human Services, and Andrew C. von Eschenbach, M.D., the Commissioner of Food and Drugs and a former director of the National Cancer Institute.

Frequent use of talcum powder products, which are used by many women, has been linked to ovarian cancer. Women who frequently use talc in the genital region have up to a threefold increased risk of developing the cancer.

In addition, many of the same products—particularly commercial talc products—
are thought to contain traces of asbestos, which can cause mesothelioma cancers.

The coalition is currently concerned mainly with the ovarian cancer risk, and is asking that labels such as “Frequent application of talcum powder in the female genital area substantially increases the risk of ovarian cancer” be added to all talc products.

Both ovarian cancer and mesothelioma are particularly deadly because they are cancers which show few recognizable symptoms until the disease has significantly advanced.

However, while discontinuing the use of talc will significantly reduce the risks of ovarian cancer, there are other ways in which people can be exposed to asbestos, so ceasing talc use may not entirely prevent the development of mesothelioma.

The word “talc” is used to describe a wide variety of different natural minerals and rocks. Most of these are magnesium silicates. In general commercial talc is more likely than cosmetic talc to contain asbestos, but some types of consumer talc (and other products such as modeling clay) may contain traces of asbestos. An example is the talc-like powder in toy CSI fingerprint kits that were found by the Asbestos Disease Awareness Organization to contain traces of asbestos.

According to the federal Agency for Toxic Substances, tremolite asbestos may be present in talc (as well as in other natural deposits such as vermiculite, as in the case of the mine which once operated in Libby, Montana).

Talc producer Specialty Minerals Inc. said that “Some commercial talc may be harder because of the presence of impurities and associated minerals such as dolomite, calcite, tremolite and quartz.” These commercial preparations are used in the automobile and appliance industries, and have many other uses. Lab counter tops and electrical switchboards of ten contain the substance, and it is used as filler for insecticides, rubber, and paints.

The Mesothelioma Research Foundation recently announced that its National Mesothelioma Virtual Bank is now open and operative, thanks to four years worth of scientific and advocacy effort.

The Mesothelioma Research Foundation (Meso Foundation) is a collaboration of patients, their families, physicians, advocates, and researchers, and is a non-profit organization. The Meso Foundation provides patients and their families with treatment information, help, and support, and also hosts an annual symposium for people who affected with or by mesothelioma. This year’s symposium is to be held on June 26-28 in Washington, D.C.

The Virtual Bank has been create to provide institutions and medical researchers involved in investigating mesothelioma with a resource of mesothelioma tissue samples that are clinically annotated and collected in an accessible database. The new tissue bank is the first of its kind.

Christopher Hahn, Executive Director of the Mesothelioma Applied Research Foundation said, “This is a great accomplishment for those of us in the meso community. We have long advocated for federal research funding and the creation of a mesothelioma tissue bank. It is an important resource, expected to greatly advance the genetic and protein profiling of the meso cancer cell. This will further the development of mesothelioma treatment and the search for a cure. This is truly significant progress, and we are proud of the Meso Foundation’s contribution and initiative.”

The National Mesothelioma Virtual Bank is a bioinformation bank with data from mesothelioma specimens. The specimens have been described and annotated and added to a database that mesothelioma researchers can access. In addition, researchers can apply to use specimens from the tissue bank in their own mesothelioma research.

The goal of the NMVB is to help in the investigation of treatments, therapies, and ultimately, a cure for mesothelioma. The collection will particularly aid researchers in evaluating diagnostic and prognostic markers.

Researchers will be able to search the tissue bank for samples according to the stage of the disease, the types of treatment the patient received, and other categories. The tissue bank currently has more than 600 annotated cases and around 900 specimens.

A large number of organizations collaborated in their efforts to set up the tissue bank, including the Centers for Disease Control and Prevention, which in association with the National Institute for Occupational Safety and Health contributed an initial one million dollar donation to set up the bank.

Other doctors and institutions who contributed to setting up the bank include Dr. Harvey Pass at New York University Medical Center, and Dr. Steven M. Albelda at University of Pennsylvania Medical Center. Both doctors are members of the Meso Foundation.

Researchers who conducted a long-term study of chemotherapy treatment for mesothelioma have said that adding chemotherapy to an active symptom-control treatment regimen for malignant pleural mesothelioma appears to have little benefit.

The research appears in the May 17 issue of The Lancet. According to researcher Richard Stephens, of the Medical Research Council Clinical Trials Unit in the U.K., the two chemotherapy regimens the research group investigated did not extend patients’ lifespans significantly and did not significantly improve quality of life.

However, a preliminary analysis of one chemotherapy drug used in the study—Vinorelbine (also known as Navelbine)—suggested the drug may have some benefits and should be further investigated. The current standard of care for people with mesothelioma is chemotherapy with Cisplatin and Pemetrexed.

The study was originally designed in the 1990s, and was planned as a comparison of various chemotherapy agents in conjunction with active symptom control. Active symptom control is the use of medications and procedures to control symptoms of pain and discomfort for people with malignant mesothelioma.

The drugs used in the trial were Vinorelbine, Mitomycin, Vinblastine, and Cisplatin.

Another trial, using Cisplatin and Ralitrexed (a drug which is no longer available) found that the combination of these two drugs did in fact provide a slightly extended lifespan.

However, the researchers found that for people who were already receiving active symptom control treatment, adding chemotherapy to the treatment regimen did not provide any statistically significant benefits.

The researchers point out that this doesn’t mean chemotherapy is useless in itself. Several studies have shown that two-drug chemotherapy treatment can extend a patient’s lifespan. In general, however, only two-drug chemotherapy can provide a benefit, whereas adding only a single chemotherapy agent to a treatment regimen has little beneficial effects.

Dr. Vogelzang, who led a trial using the Cisplatin and Pemetrexed combination, said in an article that accompanied the research report, “I believe that single-agent chemotherapy offers little to patients in the way of palliation or survival, since [active symptom control] plus Vinorelbine was statistically indistinguishable from [symptom control] alone.”

The research was financed by Cancer Research UK, the Medical Research Council, the British Thoracic Society, and the June Hancock Mesothelioma Research Fund.

Montana – A federal appeals court has ruled that U.S. District Judge Donald Molloy’s request for a pretrial list of witnesses and evidentiary documents from the government is not an abuse of the Judge’s discretion.

The request was made in connection to the government’s asbestos case against W.R. Grace & Co. and involves public asbestos exposure in Libby, Montana, where the company once operated a vermiculite mine.

The vermiculite mine turned out to be contaminated with asbestos, and as a result more than two hundred Libby residents—including people who never worked at the vermiculite mine—have died from asbestos-related diseases, and almost two thousand residents have been diagnosed.

W.R. Grace & Co. was indicted in 2005 on charges of conspiring to conceal the health risks of the Libby mine and its asbestos-contaminated vermiculite for residents of the town.

In March 2005, Judge Molloy set a discovery schedule for the case, giving the government approximately six months to create a final list of the witnesses and exhibits it planned to use in the trial.

The government was able to meet the six month deadline, but said it would continue its investigation and “reserved the right to update its witness list and exhibit list through the close of all evidence at trial.”

The defense subsequently became concerned about the government’s witness list, the size of which continued to increase long after the six month period. In response Judge Molloy entered an order in December 2005 to limit the government’s pretrial list to “those witnesses that have been disclosed as of the filing of this order.”

Upon appealing the ruling, the government argued that the judge did not have the authority to either require or enforce the pretrial list. In addition, the government said that even if he did have the authority, the orders were an abuse of the judge’s discretion.

In July 2007, a panel of three 9th US Circuit Court of Appeals judges agreed, and said that the district court had stepped outside the bounds of its authority.

However, W.R. Grace & Co. asked for a review by a larger panel of judges. The new panel issued their opinion this week, and upheld the orders issued by Judge Molloy.

In making the ruling, the panel said, “We hold that the District Court did have the authority to issue and enforce its pretrial orders compelling the government to disclose its witness list and did not abuse its discretion in doing so.”

Neither the government nor W.R. Grace & Co. has so far commented on the new ruling.

The Environmental Protection Agency has filed a complaint against a company that it believes intends to scrap a liner that contains large amounts of asbestos and PCBs.

The company is Global Shipping LLC, based in Cumberland, Maryland. The EPA believes that the company has plans to scrap the SS Oceanic, a 682-foot liner, at a port in Gujarat, India.

The complaint was filed by the EPA in San Francisco, and was subsequently denied by Global Shipping. The EPA complaint imposes a fine of $32,500 per day.

The SS Oceanic was built in 1951 and reportedly carries 250 tons of asbestos, and 210 tons of PCBs within its framework. Both of these materials were widely used in ship-building prior to the late 1970s. Both materials are known human carcinogens, and asbestos exposure can also cause chronic lung conditions, including asbestosis.

Many environmental organizations are concerned about the possibility environmental and health effects of the dismantling of ships such as the SS Oceanic, not only because workers may be exposed to large amounts of the contaminants, but also because these toxic chemicals can be released in large amounts into soil and groundwater.

Dismantling and scrapping of ships is often done in Bangladesh, India, and China.

Founder and President of Global Shipping, Dr. Anil Sharmer, told an Indian newspaper that the SS Oceanic will not be scrapped in India, but is actually intended to be sold to buyers in Dubai or Macau. However, Sharmer said he could not confirm the current location of the ship.

The EPA, and a non-profit environmental group known as Basel Action Network, believes that the SS Oceanic is bound for a port called Alang in Gujarat, where older ships are often scrapped for their valuable steel.

However, according to Rich Vaille, the EPA’s Pacific Southwestern Region Associate Director for Waste Program Enforcement, federal law prohibits companies from exporting PCBs in any form, including in ships that are being sent overseas for scrapping.

According to the federal Toxic Substances Control Act, says Vaille, companies that illegally export PCB waste in this way are circumventing U.S. requirements for safe and proper disposal of the waste.

Another EPA spokesperson, Dean Higuchi, said that the agency wants the ship to be cleaned of asbestos and PCBs before being scrapped.

In response to the EPA’s complaint, Global Shipping says that it did not have to notify the EPA before moving the ship, and also that the EPA did not ask the company what it planned to do with the ship before filing its complaint.

Jim Puckett, director of the Basel Action Network, says that workers in the Alang port who are involved in scrapping the ships are exposed to extreme hazards, and don’t have the knowledge or equipment needed to safety work on the ships. Puckett also pointed to a 2006 government survey of Alang shipyard workers that indicated one in six of the workers had developed asbestosis symptoms.

Arizona - The Environmental Protection Agency has fined Portable Practical Education Preparation, Inc. for alleged violations of the Asbestos Hazard Emergency Response Act (AHERA).

Portable Practical Education Preparation, Inc. holds charters for twelve charter schools in Arizona.

In May 2006, the EPA inspected one of the twelve schools, the Celestino Fernandez Learning Center, and found that the school was unable to disclose its asbestos management plan. All schools that contain asbestos are required to create and maintain such a plan according to AHERA.

Subsequently the EPA found that PPEP, Inc. had not carried out asbestos inspections or created asbestos management plans for some of its twelve schools. Another school in violation of AHERA was the Alice S. Paul School, which had an asbestos management plan but which had not been inspected within the time frame that federal law requires.

Katherine Taylor, Associate Director for the Communities and Ecosystems Division in the EPA’s Pacific Southwest region, said “Organizations responsible for charter schools need to understand their facilities must meet all of the federal asbestos in schools requirements, as failure to do so can result in penalties.”

“Asbestos can potentially endanger the health of students, teachers, and maintenance workers at schools, so we are pleased the PPEP charter schools have now conducted inspections and its asbestos management plans are in place.”

In August 2006, accredited asbestos inspectors carried out inspections of PPEP, Inc.’s twelve schools, including “Lito” Pena Learning Center, Manuel Bojorquez Learning Center, Raul H. Castro Learning Center, Cesar Chavez Learning Center, Jose Yepez Learning Center, Celestino Fernandez Learning Center, John David Arnold Learning Center, Victor Soltero Learning Center, Eugene Lopez Learning Center, and Robles Junction Learning Center.

The inspections discovered around 600 square feet of asbestos-containing materials at the Raul H. Castro Learning Center and the Celestino Fernandez Learning Center, and around 500 square feet of asbestos at the Manuel Bojorquez Learning Center. After the inspections asbestos management plans were created for each of the schools.

Federal laws require that schools conduct initial inspections with accredited inspectors, to determine if asbestos is present on the premises. If asbestos is discovered, the school must then prepare a management plan to address the problem. Even if no asbestos is discovered, the school must develop a plan that includes building inspection results or an architect’s statement.

Schools must also designate a trained person to oversee asbestos abatement in the school and ensure that the school remains safe and complies with federal requirements. In addition schools must make their plan available to staff and parents.

The EPA fined Portable Practical Education Preparation, Inc. a total of $18,500 for its AHERA violations.

Galveston, Texas - A woman from Galveston, Texas, claims that she developed mesothelioma as a result of secondary exposure, and has filed suit against the Marathon Petroleum Company and several other defendants, including the Todd Shipyards Corporation and the BASF Corporation.

Cynthia Leigh Chason filed suit on May 8, 2008, claiming that her asbestos exposure occurred as a result of her father’s work on asbestos-containing products.

The petition filed on May 8 states that “Ms. Chason was exposed to asbestos through household contact from her father, Loy Garner, who was employed by Marathon from 1969 through at least 1979. In addition, Ms. Chason was exposed through her father who also worked at Smith Douglass in Texas City from 1961 to 1969; and additionally he did some short-term contracting work in the 1970s for BASF in Freeport, Todd Shipyard in Galveston, and Monsanto in Texas City.”

The suit claims that Cynthia Leigh Chason was “exposed to large quantities of asbestos” as a result of her father’s occupations, some of which involved handling asbestos-containing products, or working with or around asbestos-containing machinery.

The suit also argues that the defendants in the case were aware that asbestos was a dangerous substance and that they failed to warn their employees that exposure to asbestos was a health hazard. In addition, claims the lawsuit, the defendants also failed to warn employees that asbestos fibers could be transported home and that other family members could be exposed to the fibers.

Asbestos-related disease caused by secondary asbestos exposure is relatively rare. In most, if not all, cases of secondary exposure, the resulting diseases is mesothelioma rather than asbestosis, because the cancer can develop after relatively small amounts of asbestos exposure. Asbestosis usually develops after long-term or heavy exposure to airborne asbestos fibers.

Secondary exposure to asbestos usually occurs in people who live with a family member who works with or around asbestos or asbestos-containing products. If the family member working with asbestos does not take the precautions needed to prevent their own exposure, they are able to expose the people they live with if they arrive home with asbestos fibers adhering to their clothing.

Mesothelioma is a particularly devastating disease due to the aggressiveness of this type of cancer. The disease spreads quickly and is highly resistant to all current forms of treatment. Mesothelioma has a very high mortality rate, and around half those diagnosed with the disease will die within two or three years.

The lawsuit states that litigation will continue even after Cynthia Leigh Chason dies.

Newport News, Virginia - The Virginia Department of Environmental Quality is investigating reports of a subcontractor or contractor who may have illegally dumped asbestos-contaminated construction debris at a Suffolk landfill.

The construction project in question is a new $14 million Navy housing project in downtown Newport News.

John Holland, owner of the Suffolk landfill known as John C. Holland Enterprises Inc., said that earlier this week, debris from the Navy construction site was quarantined and was undergoing testing for asbestos.

The state allows the Holland landfill to accept and dispose of non-friable asbestos materials. These are materials that are largely intact, with asbestos fibers still contained within the matrix of the material.

Friable asbestos is generally considered to be much more dangerous, as the material is deteriorating, can be crumbled easily, and can allow fibers to become airborne.

Asbestos was heavily used in construction materials between the 1940s and 1980s, due to its light-weight, durable, and fire resistant nature. However, airborne asbestos fibers are highly dangerous. Inhalation of the fibers can cause serious lung diseases, including a type of asbestos cancer called mesothelioma.

Due to the dangers of asbestos, any construction materials that contain the substance must be removed and disposed of carefully during renovation and demolition work. The asbestos materials must be removed via a process called wet-removal, in which the materials are wetted to reduce the dispersal of dust. In addition the materials must be sealed and wetted before disposal at a landfill that is licensed to deal with asbestos waste. Failure to comply with these regulations can result in heavy fines and in some cases, a prison sentence.

Holland said he can not say whether the material that was disposed of at his landfill contains asbestos or is harmless. “There is a possibility [it contains asbestos]. It’s quarantined. For right now it’s not going anywhere.”

State officials confirmed that John Holland had contacted the Virginia Beach office of the DEQ to inform the office of his suspicions about the potentially contaminated material. The DEQ then sent an inspector to the landfill to collect samples and quarantine the remaining materials.

A sample that had previously been taken from siding at the construction site was tested by an environmental laboratory and was found to contain 15% asbestos.

Of the material at the landfill, Bill Hayden, a DEQ spokesman, said “We are waiting for a copy of the lab results.” Holland says the test results are expected to be available some time next week.

Minnesota – The Minnesota Partnership for Biotechnology and Medical Genomics has announced its 2008 research projects, including a new experimental program involving virotherapy for the treatment of mesothelioma.

The research partnership involves the Mayor Clinic, the University of Minnesota, and the state of Minnesota. The partnership’s laboratory headquarters is located in Rochester on the Mayo Clinic campus. Working collaboratively, the Mayo Clinic and the University of Minnesota focus on research projects that neither group would be able to accomplish separately, in an attempt to increase the pace of potentially useful research.

Eric Wieben, Partnership program director at Mayo, said in a statement from the partnership, “We’re beginning to explore ways to use biotechnology and nanotechnology to do analysis and to make Minnesota’s environment healthier by avoiding toxic chemicals in pest control.”

Among the partnership’s new research projects are those exploring epilepsy, new pesticides that are non-toxic for humans, gene therapy for the treatment of heart disease, breast cancer diagnosis technology, fungal infection treatments, and mesothelioma research.

Noting that taconite miners in northeast Minnesota have a substantially higher risk of developing mesothelioma, the research group has decided to allot $867,114 and two years to study the potential of a type of treatment called virotherapy.

The research will be led by Dr. Stephen Russell of the Mayo Clinic, and Dr. Robert Krattzke of the University of Minnesota. The goal of the research project is to use a genetically altered measles virus developed at the Mayo Clinic to target mesothelioma.

Mesothelioma is an aggressive cancer that is particularly difficult to treat. Conventional treatments don’t tend to greatly improve a patient’s prognosis, and more than half of people diagnosed with the cancer die within two or three years.

Virotherapy is still a largely experimental type of cancer treatment, but it has shown promising results in treating certain types of cancer.

The therapy uses biotechnology techniques to convert viruses into diseases that attack only cancer cells, while leaving healthy cells unharmed.

Virotherapy is a new technology, but the idea isn’t new—scientists noticed as early as the 1950s that cancer patients who had a viral infection, or who had recently been vaccinated, sometimes showed improvement. This discovery was largely attributed to the fact that viral infections cause the immune system to generate cytokines called tumor necrosis factor and interferon, both of which sometimes have mild anti-cancer effects.

The viruses used in virotherapy are somewhat different in that they are genetically altered specifically to target and kill cancer cells, but the therapy has been shown to have similar results. In 2006, researchers succeeding in using an avian virus to target cancer cells in people with a type of brain tumor, and achieved some encouraging results.

Virotherapy may be particularly promising for the treatment of cancers where surgery is not likely to be effective, which is often the case for people with mesothelioma. Virotherapy can be administered via an injection, just like chemotherapy, and doesn’t involve removing tumors, meaning that a patient who isn’t a good candidate for surgery may still be a suitable candidate for virotherapy.