Click Here for a Free
Information Packet

FOR MORE INFORMATION
Please call
1-800-780-2686

We will gladly answer your
questions and send a free
packet with additional
information on:

• New treatment options
  
• New clinical trials
  
• Doctors
  
• Hazardous jobs and products
• Veteran's Resources
  
• Financial Assistance

Mesothelioma and Lung Cancer News - June 2004

Alcoa workers at higher risk of mesothelioma

Tuesday, June 29, 2004
ALCOA workers are more likely to contract mesothelioma and other cancers than the rest of the Australian population, a new study has revealed. The latest Healthwise study of Alcoa employees in Western Australia and Victoria shows that, although the overall risk of death amongst staff is lower than the general population, workers are more likely to contract several cancer types.

In WA, the cancer incidence rates for mesothelioma usually caused by exposure to asbestos were higher for Alcoa employees than the general population, as were skin cancers and cancers of the thyroid and endocrine gland. Among Victorian Alcoa workers, mesothelioma cases, stomach and kidney cancers were found to be more prevalent than in the rest of the country.

In both states, the death rates from mesothelioma were higher than the national average, while Victorian workers were also more prone to die from prostate cancer. Dr Michael Donoghue, Alcoa's occupational physician, said the findings surrounding mesothelioma, particularly in Victoria, were not unexpected.

"Mesothelioma is almost always caused by asbestos exposure and like many companies in the 1960s and 70s, Alcoa used asbestos in the early operation of the Point Henry Smelter and Rolling Mill (at Geelong)," Dr Donoghue said. "It is likely that these cases relate to occupational exposure at Alcoa".

The company was keen to stress the results showed the lower overall risk of death amongst company employeesbut did admit surprise at some of the other results. "This research demonstrates that on the whole Alcoa employees live longer and are healthier than the general population but also raises a number of issues we wish to follow up with further investigation," Dr Donoghue said.

The higher skin cancer rates amongst WA workers were similar across production, maintenance and office workers which the company said suggested it was not work related. "This is most likely due to UV exposure from the sun and more work is required to understand where and when this exposure has occurred either in childhood, outdoor leisure activity or outdoor work," Dr Donoghue said.

But the reasons behind higher rates of thyroid cancer in WA, and stomach and kidney cancers in Victoria could not be explained. "The excess in stomach cancers was present in the combined Victorian operations cohort, but when broken down by work group, was only evident in office workers," a background document to the study said.

"At this stage the reason for this excess is unknown, and further analyses of cancer incidence in relation to duration of employment and exposure may clarify this." The Healthwise study comes two months after a panel of medical experts was convened to determine if a full investigation into cancers suffered by workers at a Alcoa's WA refinery in Kwinana, south of Perth, was needed.

That move followed a report by occupational physician Andrew Harper which found clusters of unusual cancers such as leukaemia and lymphoma among 32 men who had worked at the plant. Alcoa said more detailed studies would now be undertaken of those cancers found "to occur in excess".

Study Points to the Prospect of “Individualized” Cancer Treatment

June 1st, 2004
Alexandria, VA - Genetic variations in an individual’s ability to repair DNA damage may help predict survival in lung cancer patients treated with the common chemotherapy drugs cisplatin or carboplatin, a new study shows. The findings, if verified in larger studies, may help oncologists tailor chemotherapy to patients based on their genetic make-up. The study and an accompanying editorial will be published online June 1 in the Journal of Clinical Oncology (JCO).

“The concept of selecting a chemotherapy drug based on a patient’s genetic make-up is relatively new and very exciting,” said lead investigator Sarada Gurubhagavatula, MD, of Massachusetts General Hospital. “We hope that this type of research will one day enable doctors and patients to make more informed decisions about chemotherapy treatments.”

Study investigators evaluated genetic variations (also called polymorphisms) in two DNA repair genes – XPD and XRCC1 – in 103 patients diagnosed with stage III or IV non-small cell lung cancer who were treated with cisplatin or carboplatin.

The XPD and XRCC1 genes are involved in correcting mistakes that sometimes occur when DNA is copied in preparation for cell division. Researchers suspected that the inability to repair DNA damage may lead to more aggressive lung tumors that spread more rapidly to other organs, thereby decreasing survival.

By comparing combinations of variations in both genes, researchers found that more variations were associated with decreased median survival. Patients with a total of three variations in the XPD and XRCC1 genes survived a median of 6.8 months, while those with no variations survived a median of 20.4 months. Patients with two variations survived a median of 11 months, and those with one variation survived 16.6 months.

The presence of genetic variations independently predicted survival even after researchers took into account patients’ ability to carry out daily activities, their stage of disease, and the type of chemotherapy they received.

While other researchers have investigated the link between XPD and XRCC1 gene variations in patients with other cancers, particularly those with colorectal cancer, this is the first study to look at variations in these genes in patients with lung cancer.

Researchers noted that the retrospective nature of the study presented certain limitations. Because evaluation of clinical response and time to disease progression is often imprecise in the retrospective setting, the study focused on overall survival, the most objective outcome. However, they noted that future studies measuring clinical outcome and time to disease progression may be critical to further understand the mechanism by which DNA repair affects patient outcome.

An accompanying editorial by Heinz-Josef Lenz, MD, Associate Professor of Medicine and Preventive Medicine at the USC Norris Comprehensive Cancer Center discusses the application of polymorphisms in clinical oncology and the potential for including analyses of germline (inherited) polymorphisms known to have an effect on the efficacy and toxicity of certain common chemotherapeutic agents into clinical trials, and eventually into clinical practice.

“This paper is a good example of the potential future using these polymorphisms in the clinic but at the same time of the limitations and the need for a better functional understanding in our quest to elucidate the role of germline polymorphisms in clinical oncology,” said Dr. Lenz.

"XPD and XRCC1 Genetic Polymorphisms are Prognostic Factors in Advanced Non-Small Cell Lung Cancer Patients Treated with Platinum Chemotherapy.” Sarada Gurubhagavatula et al, Massachusetts General Hospital Cancer Center, Boston, MA.

The Journal of Clinical Oncology is the semi-monthly peer-reviewed journal of the American Society of Clinical Oncology (ASCO), the world’s leading professional society representing physicians who treat people with cancer.

ATTRIBUTION TO THE JOURNAL OF CLINICAL ONCOLOGY IS REQUESTED IN ALL NEWS COVERAGE.

For the full text of any JCO article, contact (703) 519-1423 or (212) 584-5014.

The JCO News Digest is also distributed via e-mail. Please let us know if you would like to be added to our e-mail distribution list.

Gene variants influence survival in lung cancer

Reported by Susan Aldridge, PhD, medical journalist

A study shows that variants in genes that repair DNA damage may affect survival in non-small cell lung cancer. There is increasing interest in genetic variations that affect response to chemotherapy and survival in cancer. Researchers at Massachusetts General Hospital now report on a study of such variants in patients with lung cancer being treated with carboplatin or cisplatin.

Variants were found in genes involved in DNA repair called XPD and XRCC-1. It?s thought that where DNA repair ? which fixes damaged genes ? is defective, tumors tend to be more aggressive. Patients who had three gene variants had a shorter survival time ? around seven months ? compared to those not carrying these variants who survived for as long as 20 months or so. Those with one or two variants survived for intermediate times. It is possible that such findings could be used to tailor chemotherapy more precisely to patients who have non-small cell lung cancer.

Source
Journal of Clinical Oncology online 1st June 2004

Enzon Provides Clinical Updates on Three Oncology Candidates at Annual Meeting of American Society of Clinical Oncology

40th Annual Meeting of the American Society of Clinical Oncology

BRIDGEWATER, N.J.--(BUSINESS WIRE)--June 7, 2004--Enzon Pharmaceuticals, Inc. (NASDAQ:ENZN)
-- Onco TCS Demonstrates Potential in the First-Line Setting for NHL
-- Pegamotecan Phase 2 Study Meets Primary Endpoint
-- SS1P Phase 1 Study Shows Evidence of Anti-tumor Activity and Clinical Benefit

Enzon Pharmaceuticals, Inc. (NASDAQ:ENZN) today provided a summary of clinical advancements at the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, Louisiana. Poster presentations included follow-up results from a Phase 2 study that demonstrated the promise of Onco TCS (vincristine sulfate liposomes injection) in combination therapy for the first-line treatment of aggressive non-Hodgkin's lymphoma (NHL). Also presented were results from a Phase 2 study for Pegamotecan, a novel pegylated camptothecin conjugate, for the treatment of gastric and gastroesophageal cancers and results from a National Cancer Institute (NCI) Phase 1 study for SS1P, a recombinant immunotoxin under investigation as a potential therapy for mesothelin-expressing cancers, (e.g. mesothelioma, ovarian cancer, and pancreatic cancer). Investigators from each of the studies presented the data from their respective trials during the ASCO meeting, June 5 through June 7, 2004. Key highlights from the presentations have been included below.

"Enzon is continuing to make significant progress in advancing its clinical pipeline of oncology drug candidates. The multiple presentations at this year's ASCO meeting exemplifies our team's ability to successfully execute Enzon's strategy and further underscores our commitment to expand and advance our clinical pipeline," stated Uli Grau, Ph.D., Enzon's Chief Scientific Officer.

Onco TCS

Investigators presented follow-up results of a Phase 2 clinical trial, which demonstrated the potential of Onco TCS as part of a combination regimen in the first-line treatment of aggressive NHL. The study is being sponsored by Enzon and its partner Inex Pharmaceuticals Corporation (TSX:IEX). Results were released from 68 evaluable patients in a Phase 2 open-label study conducted at the University of Texas M.D. Anderson Cancer Center in Houston, Texas in which Onco TCS was used in combination with cyclophosphamide, doxorubicin hydrochloride, and prednisone. Rituxan(R) was also administered to those patients with B-cell lymphoma.

Key findings from the study were as follows:

-- Sixty-three patients, (93%) of patients, responded to the therapy. Sixty-two patients had their tumors completely eliminated for a complete response rate of 91% and one patient's tumor volume decreased by more than 50% for a partial response rate of 1% and an overall response rate of 93%.

-- Of the 68 patients, 37 patients were over the age of 60 years and 91% of these patients were complete responders. In the 31 patients under the age of 60 years, 90% were complete responders and 3% were partial responders. Treatment was well tolerated by both groups with only 6% of patients withdrawing during the trial from adverse events.

-- 88% of courses were delivered at full dose with no dose capping. Adverse events observed were consistent with those seen with the standard first-line chemotherapy combination (neurotoxicity, anemia, neutropenia and thrombocytopenia).

-- Investigators also presented positive patient survival data. At a median follow-up of 22 months, median progression-free survival and median overall survival were not yet reached. Overall survival was 99% (1 death) and progression-free survival was 87% (9 relapses). Progression-free survival for the elderly patient group was 86% (5 relapses) and 87% for the younger patient group (4 relapses).

-- Based on these data the investigators concluded that Onco TCS may represent an important new drug when used in combination for aggressive NHL.

One-year interim results of this study were released in December 2002 at the American Society of Hematology (ASH) meeting and provided the initial analysis of the data. The ASCO results provide data analysis after a longer period of follow-up.

The current standard first-line treatment for the aggressive form of NHL is the CHOP chemotherapy combination, comprising the drugs cyclophosphamide, doxorubicin hydrochloride, Oncovin(R) (vincristine) and prednisone. In this open-label Phase 2 clinical trial the Oncovin(R) (vincristine) component is substituted with Onco TCS, which is vincristine encapsulated in Inex's proprietary sphingosomal drug delivery technology. Patients diagnosed with B-cell lymphoma also received Rituxan(R) (rituximab), a monoclonal antibody.

In addition to the Phase 2, first-line study, investigators also presented a pharmacokinetics study of Onco TCS in Patients with Metastatic Melanoma. The data presented supported the extended release formulation and longer circulation half-life of Onco TCS compared to vincristine.

Pegamotecan

Results were presented from a Phase 2 study in which Pegamotecan was evaluated as a single-agent treatment for gastric and gastroesophageal junction cancers. Thirty-five patients with gastric and gastroesophageal junction cancers were treated: 28 patients were treatment naive and seven patients had received one prior chemotherapy regimen. The primary endpoint for the study was response rate with the criteria for moving forward being at least 5 responses.

Key findings from the study were as follows:

-- Nineteen (19) of the 35 patients (54%) experienced a response or stabilization of disease. Five patients (14%) achieved a partial response and 14 patients (40%) experienced stable disease.

-- Pegamotecan showed promising activity based on time to response and duration of response. For those patients that achieved a partial response, the median time to response was 46 days, with a range of 40 days to 124 days, and the median duration of response was 127 days, with a range of 108 days to 208 days.

-- Pegamotecan appeared to be well tolerated for a cytotoxic agent. Grade 4 toxicities occurred in 23% of patients, the most common being granulocytopenia, neutropenia and anorexia. The most common adverse events were nausea and vomiting. Patients were not pre-treated in the study and future studies will attempt to control nausea and vomiting with prophylactic use of anti-emetics.

-- Based on these data, the investigators concluded that Pegamotecan may be a promising treatment for patients with gastric and gastroesophageal cancers.

SS1P

The National Cancer Institute (NCI) presented results of a multi-center Phase 1 study of SS1P as a targeted therapy of mesothelin-expressing cancers. The primary objective of the study was to determine the toxicities and maximum tolerated dose of SS1P. Secondary objectives were to determine the pharmacokinetics and immunogenicity and observe any anti-tumor activity. Twenty-three patients with mesothelin-expressing mesotheliomas, ovarian cancer, or pancreatic cancer were treated. All of the patients had failed a first-line therapy.

SS1P was administered intraveneously over 30 minutes every other day for 6 or 3 doses. The maximum tolerated dose for the 6 dose schedule was determined. All dose-limiting toxicities were observed during the second week of treatment. Therefore, the study protocol was amended so that SS1P was administered every other day for a total of 3 doses in one week. Dose escalation is ongoing to determine the maximum tolerated dose for the 3 dose schedule.

Key findings from the study were as follows:

-- Of 22 evaluable patients, a response or stabilization of the disease was achieved in 14 patients or 64%.

-- Clinical benefit was observed in several patients including complete resolution of abdominal and pelvic ascites.

-- Based upon these data, investigators concluded that SS1P shows evidence of anti-tumor activity. Enzon and the NCI are planning additional studies in patients with mesothelin-expressing cancers.

About Onco TCS

Onco TCS is a proprietary drug comprised of the widely used off-patent anticancer drug vincristine encapsulated in INEX's sphingosomal drug delivery technology. INEX's technology is designed to provide prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. These characteristics are intended to increase the effectiveness and reduce the adverse effects of the encapsulated drug.

In May 2004, Enzon and Inex announced that the U.S. Food and Drug Administration (FDA) had accepted the New Drug Application (NDA) for Onco TCS (vincristine sulfate liposomes injection). The FDA has established a target date of January 15, 2005 for completion of review of the Onco TCS NDA. The NDA is seeking marketing approval for Onco TCS as a single-agent treatment for patients with relapsed aggressive non-Hodgkin's lymphoma (NHL) previously treated with at least two combination chemotherapy regimens.

In addition to the lead indication, relapsed aggressive NHL, Enzon and INEX intend to develop Onco TCS for use as a single-agent therapy or in combination therapy for several cancers in which vincristine is now used.

In January 2004, Enzon and INEX announced a strategic partnership to develop and commercialize Onco TCS. Under the terms of the agreement, Enzon has the exclusive North American commercialization rights for Onco TCS for all indications, subject to certain co-promotion rights of INEX. INEX retains commercialization rights outside North America.

About Pegamotecan

Pegamotecan is a polyethylene glycol (PEG)-enhanced version of camptothecin, a small molecule that is a potent anti-cancer compound in the class of topoisomerase I inhibitors. Using its proprietary PEG technology, Enzon designed Pegamotecan to improve solubility, extend the circulating half-life, and enable preferential accumulation at tumor sites. Due to the increased molecular size of Pegamotecan compared to native camptothecin, it appears that Pegamotecan passively targets certain tumors due to their enhanced vascular permeability, thereby attaining enhanced permeation and retention within these tumors (EPR effect).

In January 2004, patient dosing was initiated in a pivotal clinical trial designed to evaluate Pegamotecan as single-agent therapy for the treatment of gastric and gastroesophageal junction cancers in patients who had received prior chemotherapy. Enzon is focusing its development program for Pegamotecan on second-line therapy for gastric and gastroesophageal junction cancers, as there are no single-agent drug approvals for this indication. The Company believes that Pegamotecan may be eligible for accelerated approval under Subpart H of the Food and Drug Act for the treatment of these cancers.

About SS1P

SS1P is a fusion protein consisting of a disulfide linked antibody fragment linked to domains II and III of Pseudomonas exotoxin A. The antibody fragment targets mesothelin, a cell surface antigen overexpressed in mesothelioma, ovarian and pancreatic cancers. Importantly, mesothelin is not expressed in normal pancreas, pancreatitis (inflammation of the pancreas), or benign pancreatic adenoma.

In November 2003, Enzon announced a Collaborative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH). The development program will center on the recombinant immunotoxin SS1P. Enzon and the NCI plan to begin a Phase 2 clinical trial around the end of 2004.

About Enzon

Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics to treat life-threatening diseases. The Company has developed or acquired a number of marketed products, including PEG-INTRON(R), marketed by Schering-Plough, and ABELCET(R), ONCASPAR(R), ADAGEN(R), and DEPOCYT(R), marketed in North America by Enzon's specialized sales force. Enzon's science-focused strategy includes an extensive drug development program that leverages the Company's macromolecular engineering technology platforms, including PEG modification and single-chain antibody (SCA(R)) technologies. Internal research and development efforts are complemented by strategic transactions that provide access to additional products and technologies. Enzon has several drug candidates in various stages of development, independently and with partners, including Onco TCS, for which a U.S. marketing application is currently being reviewed by the FDA for the treatment of relapsed aggressive non-Hodgkin's lymphoma. Further information about Enzon and this press release can be found on the Company's web site at www.enzon.com.

There are forward-looking statements contained herein that are not based on historical fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimates," "continue," "anticipates," "intends," "expects," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments discussed above. Such factors include the risk that Onco TCS may not receive regulatory approval from the FDA under Subpart H of the Food and Drug Act and the fact that any such approval, if granted, will include post approval commitments, the risks that Pegamotecan and SS1P will not successfully progress through their clinical studies, as well as those described in Enzon's Form 10-K and Forms 10-Q on file with the SEC, such as Enzon's ability to successfully launch and market Onco TCS, Enzon's ability to sustain profitability, and positive cash flow; risks in obtaining and maintaining regulatory approval for indications and expanded indications for Enzon's products; market acceptance of and continuing demand for Enzon's products; timing and results of clinical trials, including, without limitation, the ongoing clinical trials of Pegamotecan for the treatment of gastric and gastroesophageal cancers and SS1P for the treatment of mesotheliomas, ovarian cancer, or pancreatic cancer; the risk that the FDA may not deem Pegamotecan eligible for accelerated approval under Subpart H of the Food and Drug Act; and the impact of competitive products and pricing. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. All information in this press release is as of June 7, 2004 and the Company undertakes no duty to update this information.

Contacts

Enzon Pharmaceuticals, Inc.
Susan M. Mesco, 908-541-8777
or
Euro RSCG Life NRP
Mark R. Vincent, 212-845-4239

Asbestos: Powder traces

James Hardie might face a big payout to deal with asbestos claims, but the deadly material will have a much bigger legacy.

By Beth Quinlivan
BRW. 02 June 2004

In recent weeks, executives of the building products company James Hardie have faced a sustained grilling over the company’s underfunding of the foundation it established three years ago to compensate former employees and others hurt by the asbestos it once mined and manufactured.

A New South Wales Government inquiry, running since March, is investigating whether Hardie, the country’s largest manufacturer of asbestos products, deliberately minimised and then capped the amount of money it allocated to pay asbestos claims. According to the latest estimates provided by the Medical Compensation and Research Foundation, the funding shortfall is as much as $800 million, which means that from 2008 it will not have enough money to pay injury claims.

Evidence presented at the inquiry has not been flattering of Hardie and its executives. Each day, information has emerged about the complex way the company distanced itself from asbestos injuries suffered by its former employees and others who have used its products.

A senior lawyer with the company admitted he knew that the figures used to calculate and provide funds to cover the liabilities were grossly inaccurate. It was also revealed that important information about the pattern of claims had not been provided by Hardie either to directors of the foundation or to the actuaries on whose calculations the funding was estimated.

In recent years, Hardie has been one of the success stories of Australian manufacturing. Its United States fibre-cement business has been growing strongly, and the company reported net profit of $US125 million, up from $US85 million, in the year to March 31.

Hugh McNally, head of equities at Private Portfolio Managers, says: “We love the business, but we’re just waiting to see what comes out of the inquiry. My suspicion is that they are going to have to pay out a substantial sum of money, although even if they put in the full $800 million, it’s less than has been wiped off the market capitalisation as a result of all the uncertainty.”

James Hardie has recently been in the firing line, but it is hardly alone in being called to account for its history. The asbestos legacy in Australia, as in the US and Europe, is an increasingly costly one for companies, governments and insurers.

CSR, which mined and manufactured asbestos products, reported in its latest results (for the year to March 31) that it had 638 claims pending for asbestos-induced injury in Australia, and a further 2354 in the US.

The company said that, since 1989, it had settled 1441 claims in Australia and 127,000 in the US. At March 31, its provision for known and probable future claims was $324 million.

BHP Billiton is also a target. The Austra-lian Manufacturing Workers Union (AMWU) has been lobbying the South Australian Government for an inquiry into the use of asbestos by BHP in the shipyards in Whyalla until the end of the 1970s. According to Terry Miller, of the Asbestos Victims Assoc-iation in South Australia, 20,000 people worked in the shipyards through the 1970s. “Not all were exposed to asbestos, but there are significant numbers of people who did work there and who have asbestos-related diseases.

“We need an inquiry to find what BHP knew about the dangers of asbestos through the 1970s, when asbestos usage was at its peak. If BHP knew about the dangers and didn’t make the environment safe for people working there, we have a right to know.”

The AMWU believes that 174 workers in the Whyalla shipyards have been injured by asbestos — 67 have died of the fatal asbestos-induced cancer, mesothelioma. According to the union’s South Australian state secretary, John Camillo, the inquiry is needed to test BHP’s claims that manufacturers did not pass on to the industry information about the dangers of asbestos. BHP has been quiet about its asbestos liabilities, and declines to comment to BRW on the union’s push.

Although companies have a large exposure to asbestos injury claims, the largest liabilities are with state and federal governments. The Federal Government has not publicly released the report by actuarial group Trowbridge Deloitte that was the basis for estimating its asbestos liability at $945 million — up from about $300 million previously — in the latest Audits of Financial Statements of Australian Government Entities, released by the Australian National Audit Office early this year. The bulk of the liabilities are believed to have accrued in the defence forces and among dock workers.

A paper published in 2003 in the International Journal of Occupational and Environmental Health, by University of Sydney medical specialists James Leigh and Tim Driscoll, said members of the navy and the merchant navy faced a 5.1% risk — just over a one-in-20 chance — of contracting mesothelioma in their lifetimes. Waterside workers faced a lifetime risk of 2.1%, the paper said.

State government exposure to asbestos claims is also sizeable. Until the privatisations of the 1980s and 1990s, power station workers were all state government employees. According to Leigh and Driscoll, they are the second most likely occupational group to contract mesothelioma (after workers at CSR’s Wittenoom mine), with a lifetime risk of 11.8%, or one in eight. Railway laborers, also state employees, are another high-risk group, with a 6.4% lifetime risk.

Insurers are fighting their own battles. Some big groups, including Allianz, Promina and Suncorp, have potentially hefty asbestos liabilities, a legacy of the workers’ compensation coverage provided for asbestos manufacturers and users as far back as the late 1950s and 1960s. Companies and insurers have been battling over the extent of each others’ liabilities for asbestos injury claims.

In the latest round, a court decision in New South Wales in November last year gave insurers a reprieve, in turn leaving companies to pick up the rising cost of claims. In that decision, the NSW Court of Appeal ruled that the insurer CGU did not have to pay a claim under an old Orica workers’ compensation policy. The employee inhaled asbestos dust between 1959 and 1961 when the CGU policy was in place, and contracted mesothelioma nearly four decades later.

The Insurance Council of Australia and individual insurers have also urged state and federal governments to change the way asbestos claims are managed and paid. Insurers and their advisers repeatedly push the line that the present common-law claims system is not the best way to manage assets, provides no clarity about entitlements, and allows lawyers to siphon off resources that would be better used paying injured people.

Over-exposure

Predicting the eventual cost of Australia’s heavy use of asbestos is a difficult exercise. Last year, Trowbridge Deloitte estimated Australia’s asbestos liability for future claims at $6 billion, split between the Federal Government (17% or $1 billion); state governments (14% or $840 million); insurers and reinsurers 22% ($1.3 billion); companies 27% ($1.6 billion); and the NSW Dust Diseases Board 20% (or $1.2 billion). But other actuaries have predicted higher amounts, and Trowbridge’s estimates have increased sharply in recent years. Two years earlier, Trowbridge had estimated the national exposure at $4 billion.

The probable cost of asbestos is increasing because of several factors. For a start, in Australia the incidence of asbestos injuries is still rising. Second, the size of individual payouts is increasing. And third, there is a growing trend for people with other cancers, specifically lung cancer, who were exposed to asbestos, to file claims.

Australia is not alone in paying a steep price for its heavy use of asbestos in the past. Asbestos was widely used in industrial and residential settings in the US and across Europe until the 1970s, and is still used in developing countries. It is easy and cheap to mine and process. As a building material, it is strong and durable and it is an excellent insulator and fire preventive.

The health consequences, however, are horrendous. Mesothelioma is the most deadly of the diseases linked to asbestos exposure. It is a cancer of the chest cavity, and asbestos is its only demonstrated cause. Some people contract mesothelioma after only a brief exposure — such as pulling down a garden shed made of asbestos. Others worked for long periods in places thick with asbestos dust, but remain healthy. One of the most disturbing aspects of the disease is the long time between exposure and the onset of disease: it is typically 40 years or more from exposure to diagnosis.

Despite the increasing efforts of scientists, mesothelioma is inevitably fatal — after diagnosis, life expectancy is typically 12–18 months. The newest drugs, such as Eli Lilly’s Alimta, have shown they can increase life expectancy by six to 12 months, but a cure is a long way off.

Many other cancers have also been linked to asbestos, particularly lung cancer, although it is a legally contentious issue. There is a general agreement that asbestos can cause lung cancer. But lung cancer risks are increased by other factors such as smoking, which was common among the mainly blue-collar workers most exposed to asbestos at work. Other asbestos-induced diseases include asbestosis and pleural plaques. Asbestosis is scarring of the lungs as a result of inhaled asbestos fibres. Although it can be debilitating, it is not usually fatal.

In the US, the incidence of mesothelioma is about 2800 new cases a year, although epidemiologists believe the numbers are starting to fall. In Britain, about 2200 people a year are diagnosed with mesothelioma, but this is tipped to increase to 3300 over the next 15 years. Germany has one of the highest incidences in Europe, with about 5600 people a year diagnosed with the disease.

In Australia in 2001, 678 people contracted the disease, compared with 328 in 1991 and 104 in 1981. Since 1945, about 7000 Australians have died of mesothelioma.

However, the incidence will continue to rise over the next 15 years, reflecting the fact that asbestos was still being mined, and used in many workplaces, through the 1970s. For example, Australia’s last asbestos mine, at Woodsreef in NSW, was closed only in 1981, and James Hardie’s asbestos pipe plant at Camellia in Sydney’s west was still operating well into the 1970s, with heavy asbestos dust in the plant.

New asbestos products have been banned only since January 1 this year. Leigh and Driscoll estimate that 18,000 people will have died of mesothelioma by 2020.

Adding to the cost for companies, insurers and governments, the size of payouts has also increased in recent years. According to Andrew Dimsey, a lawyer specialising in asbestos injuries for the Melbourne firm Maurice Blackburn Cashman, a general damages payout that might have been set at $100,000 a decade ago is likely to be $180,000 now. Typically, payouts are between $250,000 and $350,000.

Another factor underpinning the predictions of more sharp increases in claims is the expansion of litigation to include other cancers. Dimsey says: “The law in terms of lung cancer is pretty fluid.” In several cases, people who have been exposed to asbestos and have contracted lung cancer have been able to successfully claim against the asbestos manufacturer or the employer, even if they have also been a heavy smoker.

“For every person who contracts mesothelioma, there are at least double the number who have asbestos-induced lung cancer,” Dimsey says. Leigh and Driscoll estimate that the incidence of asbestos-related cancers can be expected to be between 30,000 and 40,000 by 2020.

For James Hardie, there are some gloomy pointers about how the liabilities for asbestos injuries will eventually play out. Andrew Smith, an employee of the plaintiff law group Turner Freeman, reviewed all the claims and payouts by the NSW Dust Diseases Tribunal from 1992 to 2002. He found that claims against Hardie from former employees were reasonably stable (13% in 2002, 14% in 2001), but a growing number of consumer claims were being made against Hardie relating to its products.

In 2002, 42% of the claims filed with the Dust Diseases Tribunal related to Hardie products, compared with 37% in 2001. Total claims against James Hardie in 2002 accounted for 52% of the claims filed with the tribunal.

For companies, governments and insurers with asbestos liabilities, looking to the US for a clue to the future must be terrifying.

The Rand Institute last year released a report on US asbestos litigation. Among other things, the report said that more than 600,000 people had filed claims for asbestos-related personal injuries to the end of 2000, annual filing of new claims had risen sharply in recent years and, although the number of mesothelioma claims was rising slowly, claims for non-malignant asbestos injuries were rising far more quickly.

The institute said a total of $US54 billion had already been spent on asbestos litigation, and that by some estimates, only 20% of claims had so far been filed. It said predictions for the total cost of all asbestos claims ranged from $US200–265 billion.

A bill was put before Congress in April to establish a $US114-billion trust fund financed by businesses and insurance companies to limit the ability of individuals to sue the companies. It was defeated.

The story in figures

$800-million shortfall in James Hardie’s fund to pay asbestos claims.

25% drop in James Hardie’s share price since late last year.

$324 million set aside by CSR for asbestos claims.

$6 billion in estimated future asbestos claims in Australia.

7000 Australians dead from mesothelioma since 1945.

18,000 Australians estimated to die from mesothelioma by 2020.

$250,000 average payout for an asbestos claim.

600,000 people in the United States who have filed for asbestos-related injuries to 2000.

$US54 billion spent on asbestos litigation in US.

The buck stops where?

Future asbestos claims in Australia, expected to total $6 billion, are likely to be met as follows:

$1.6 billion: Companies such as James Hardie and CSR.
$1.3 billion: Insurers and re-insurers.
$1.2 billion: NSW Dust Diseases Board.
$1 billion: Federal Government.
$840 million: Various state governments.

Source: Trowbridge Deloitte

Alfacell Corporation Welcomes David Sidransky, M.D. to Board of Directors

BLOOMFIELD, N.J., June 2 /PRNewswire-FirstCall/ -- ALFACELL Corporation (OTC Bulletin Board: ACEL - News), a biopharmaceutical company focused on the discovery, development and commercialization of ribonucleases for anti-cancer and other therapeutic applications, today announced the appointment of David Sidransky, M.D., to the Company's Board of Directors. Dr. Sidransky has nearly 20 years of experience in the practice and instruction of medicine with expertise in oncology and molecular pathology, and has provided scientific guidance to a number of institutions and corporations.

Dr. Sidransky is Director of the Head and Neck Cancer Research Division at Johns Hopkins University School of Medicine. In addition, he is Professor of Oncology, Otolaryngology (Head and Neck Surgery), Cellular & Molecular Medicine, Urology, Genetics, and Pathology at John Hopkins University and Hospital. Dr. Sidransky is certified in Internal Medicine and Medical Oncology by the American Board of Medicine.

"Doctor Sidransky's appointment brings to our Board invaluable expertise in oncology and the application of pharmaceutical compounds to the treatment of cancer," stated Kuslima Shogen, Ph.D., Chairman of the Board and CEO of Alfacell Corporation. "He will bring added insight into key issues and challenges the Company will face as it continues to develop and commercialize ONCONASE® and the other products in its oncology pipeline. We are honored that Dr. Sidransky will co-chair Alfacell's presentation and advisory meeting entitled Ribonucleases, A New Horizon in Cancer Treatment at the upcoming American Society of Clinical Oncology ("ASCO") meeting in New Orleans."

Dr. Sidransky is a founder of several private biotechnology companies and has served on scientific advisory boards for numerous private and public companies, including Medimmune, Telik, Roche and Amgen. He was formerly on the board of scientific counselors at the National Association of Dental and Craniofacial Research ("NIDCR") and is currently a member of the Recombinant DNA advisory committee at the National Institutes of Health ("NIH") (RAC). Dr. Sidransky serves on a number of editorial boards and is senior editor of Clinical Cancer Research. He was appointed to the Board of Directors of ImClone Systems in January 2004.

Dr. Sidransky has been responsible for over 250 peer-reviewed publications, has contributed more than 40 cancer reviews and chapters, and has numerous issued biotechnology patents. He has received many awards and honors, including the 1997 Sarstedt International prize from the German Society of Clinical Chemistry, the 1998 Alton Ochsner Award Relating Smoking and Health by the American College of Chest Physicians and the 2004 Hinda and Richard Rosenthal Award from the American Association of Cancer Research. Dr. Sidransky earned his B.S. at Brandeis University and received his M.D. from the Baylor College of Medicine.

HOUSEHOLDERS URGED TO TEST FOR RADON GAS

11:00 - 01 June 2004
People living with record levels of radon gas in their homes are playing a game of chance with their long-term health, a Westcountry expert has warned.

Record concentrations of the natural radioactive gas - up to 85 times higher than the safe limit - have been discovered in two homes in the Kerrier district of west Cornwall.

Those householders asked for a free test - but many in the same area are still living in ignorance about the possible level of radon in their homes.

Now Dr Richard Cranage, director of medical physics at the Royal Cornwall Hospital in Truro, has warned that people who live over a long period with such high levels of radon could have a "50-50 chance" of developing lung cancer. He said the level in the two homes in question - 17,000 bequerels of radon per cubic metre of air in one, and 12,000 bequerels in the other - were "incredibly high".

He said: "Certainly at these very high levels, the risk is very high. There is probably a 50-50 risk of getting lung cancer if you lived in that house for 20 years. If you smoked as well you would be in serious trouble, because smoking adds to the risk. These levels are incredibly high - far higher than I've heard of before. The action level is 200, and quite a few houses might be at 400, but the risk then is still very low, possibly one in 1,000."

In some areas of West Devon, Dartmoor and Cornwall, more than 30 per cent of homes are estimated to be above the level of radon deemed safe. This is due to the higher concentration of granite in the soil, where the gas naturally occurs. Layland Branfield, a farmer on Dartmoor, is one of the many people who took precautions against radon in the 1980s when fears surrounding the gas first surfaced.

He said yesterday: "We have got a system in place in our house because we had a very high level of radon. It seems people have turned their houses into big chimneys. We close them up and heat them, and so the radon is drawn up into the house. And, if you happen to live in an area with a low density of housing, then levels are higher.

"But, if you investigate what the 'safe' level is - 200 bequerels - you'll find it's the equivalent of smoking just one cigarette a day. To get the radon down to an acceptable level isn't a big job. The person we rent from paid for our system to be put in, and if I was given money to do the work, I would do it again. But, the other side of the argument is that radon isn't a new thing, generations of people have lived with it."

Dr Cranage has urged people to take up the offer of free testing, but accepted that some would not be willing to pay for remedial works. "London has low levels of radon. I'm sure if it had high levels, people would probably get grants for doing the remedial work," he said. "Not everyone takes remedial measures with a high reading because of course it costs money."

Radon safety levels are set by the National Radiological Protection Board (NRPB). The highest reading found previously in Britain was reportedly 10,000 bequerels per cubic metre. The average in UK homes is just 20 bequerels.

Dr Martin Green, from the NRPB, said with high readings, remedial work should be carried out as soon as practically possible. "It's the highest we've recorded in the UK to date," he said.

"The risk from radon is a lifetime risk, so it's not like being run down by a car which would kill you immediately. The detriment from radon is a much increased risk of lung cancer, especially at these levels, particularly over 15 to 20 years.

"We estimate that between 2,000 and 2,500 cases of lung cancer a year are caused by radon in our buildings. That sounds like a big figure but of course more are caused by smoking."

Both properties with the record readings are in the Kerrier district. One is a privately-owned house and the other a rented flat. Each occupier has been informed and warned of the health risks they face and are being advised on what remedial action can be taken. Neighbours are also to be offered tests.

Radon is a natural radioactive gas that enters buildings from the ground and can, over extended periods of time, lead to an increased risk of lung cancer. Installations designed to protect homes from radon typically cost between £500 and £1,500.

Common systems involve creating an impermeable barrier between the earth and the property and proper ventilation. Three-month radon detector test kits can be purchased direct from the Cornwall Radon Gas C Centre, mail order on 01822 832816. They cost £37.60 for two.

A free information pack on radon can also be obtained by calling 0800 614529, or by post from NRPB, Chilton, Didcot, Oxon OX11 0RQ.

Benefits of lung cancer screen not proven

Reported by Susan Aldridge, PhD, medical journalist

Early detection of lung cancer by computed tomography screening does not necessarily save lives, according to a new study.

There is a lot of interest in using computed tomography (CT) to screen for early lung tumors. CT can show up smaller nodules in the lungs than conventional X-rays. It sounds like this is a good thing - after all, early detection generally means earlier treatment. Doctors at the Mayo Clinic disagree - after reviewing the evidence.

Their analysis of two screening studies suggests that there is little difference in lung cancer mortality whether people are screened or not. They say that just because a tumor is small does not mean it is not advanced. And many of the nodules detected on CT are not lung cancer at all. There is, they conclude, no justification for widespread use of CT for lung cancer screening - and it is wrong to charge smokers for them, as is the growing trend. So, while early screening does save lives where other cancers are concerned, this is not necessarily the case in lung cancer.

Source
Journal of Clinical Oncology 1st June 2004

Ill-focused protest is too destructive

John Denham
Thursday June 3, 2004
The Guardian

Anger has often been a spur to political action. Alongside human compassion and solidarity, anger at the state of the world has got many activists out of bed in the morning and kept them working late into the night.

But as a guide to action, anger is rarely a reliable friend. A year after I left the government I still believe the Iraq war was a major, traumatising misjudgment. Yet I have lost none of my enthusiasm for campaigning for Labour votes in next week's elections. If anything, the daily task of working the phones, the streets, the visits and the meetings underlines how futile and counter-productive the angry, incoherent protest vote urged by George Galloway (and with more subtlety by the Liberal Democrats) would be.

A protest vote will not change the future of Iraq. We are where we are; it will be the Labour government that has to work with the Iraqis to find the best way forward and undo as far as possible the damage that has been done. But those who would damage Tony Blair for the war cannot shirk responsibility for damaging the whole of Labour and its work.

Let me take you through some of last week's campaigning. The new oncology department at Southampton general hospital is not a figment of my imagination, but a huge improvement in cancer care. It might sound like a PR dream to tell you I got to it by walking past the modernised A&E department and the footings of the new multimillion pound cardiac unit, but these are real changes, too.

When you visit a hospital it's not all plaudits, of course. There's lively debate about how best to reform the NHS and to make the most of the new money flowing in. But these are debates about the new possibilities that have opened up and the chance to do things better; debates that hardly took place in the Tory years, when any change, improvement or investment seemed unimaginable.

Outside Weston Park infants on Friday I carried out my regular school-gate survey on women, work and childcare. Once again the discussion is not all praise for the changes Labour has made, but it starts from them: about how next to improve the working family tax credit; how to publicise childcare support; how to build on the new free half-time, pre-school provision so that we can meet more of the needs of families whose working lives are complex and difficult. Labour hasn't just brought improvements to family income, pre-school education and the work-life balance; we've made it possible to believe that things could be better still.

Days before, I had opened a new community nursery, offering childcare from 8am to 6pm. It's one of many new nurseries and children's centres across the country that might meet the needs of the mothers at the school gate. The nursery is in the brand-new buildings of the Woodlands specialist school. For years "common sense" said that children in the local area wouldn't achieve much. After a 70% improvement in A-C GCSE grades last year, we can begin to believe that such low expectations will never be tolerated again.

I don't imagine that I will ever overcome my feelings about the decision to go to war when and in the way we did. But this government has made changes and created the possibilities for further changes that, for most of my political life, have been dreams. No other party offers that. (I've spent too much of the past year trying to stop the local Liberal Democrat-led council shutting sports halls and pitches to have any illusions on that score.)

No matter how strong our feelings about Iraq, no vote on June 10 can prevent the war. There is much to campaign on about Iraq, the wider Middle East crisis and terrorism. But these issues require well thought-out, targeted campaigns for practical solutions, not an ill-focused protest vote.

Some may feel these elections don't matter too much and the harm of a protest vote will be limited. That's dangerous. It's not just MPs that enable Labour to make changes. Labour councillors, often unsung and unknown outside their communities, have been the key to turning central policy into local action. MEPs play their role, too. Not only do they deserve to keep their seats; Labour's changes need them in office.

I visited the cancer centre with Peter Skinner, a Labour MEP. Like most Southampton residents, I have known all too many people who have died in the current epidemic of mesothelioma and asbestosis. Peter and his colleagues across Europe, with the support of a British Labour government, brought about the early ban on asbestos that the Tories had resisted. Many in the Labour movement get angry when people suffer simply because they had to go to work. I'm working for votes for Labour people who have shown they will do something about it.

· John Denham is Labour MP for Southampton Itchen; he was minister at the Home Office until he resigned in March over the Iraq war

Turnaround seen in diagnoses of lung cancer among women

By Lauran Neergaard

Associated Press Thu, Jun. 03, 2004
WASHINGTON - Lung cancer is inching down among women after decades of smoking-fueled increases -- and overall survival rates are improving for most kinds of tumors among both men and women.

Not everyone is reaping the gains: Members of minority groups still are more likely than whites to die from cancer, according to the nation's annual report on cancer, to be published today in the journal Cancer.

But largely, the news remains optimistic. Death rates from cancer in general have dropped 1.1 percent a year since 1993, and today's report confirms that decline continued in 2001. Rates of new cases are declining about a half-percent a year, too.

Most striking in this latest tally is what's happening with the No. 1 cancer killer: Rates of female lung-cancer diagnoses have declined about 2 percent a year since 1998, years after men began a similar improvement. Also, female death rates from lung cancer have leveled off, remaining virtually unchanged since 1995, the report said.

``For the first time, we are turning the corner in the lung-cancer epidemic in women,'' said Ahmedin Jemal of the American Cancer Society, who co-wrote the report with scientists from the National Cancer Institute, the Centers for Disease Control and Prevention and the North American Association of Central Cancer Registries. ``We have been anticipating . . . this for a long, long time,'' Jemal said. ``It has been overdue.''

Smoking became rampant among men long before women, and the resulting lung cancer consequently struck men sooner.

Lung cancer remains the nation's top-killing malignancy for both sexes, and the second-most-common cancer. But it slowly declined among men starting in the early 1990s as older smokers died and fewer young men took up the habit.

The report's other new finding: More people are living at least five years after a diagnosis of most kinds of cancer.

Five-year survival is a major milestone for cancer patients, and the scientists found significant gains over the past two decades in how often that milestone was met.

For men, survival rates improved the most -- more than 10 percent -- for cancers of the prostate, colon and kidney, and for melanoma and leukemia. For women, the biggest survival improvements came in colon, kidney and breast cancers.

Today, 99.3 percent of men diagnosed with prostate cancer will live five years, up from 70 percent in the 1970s. Five-year survival for breast cancer is 88 percent, up from 75 percent in 1970s.

But that survival is strongly connected to how early cancer is caught, stressed co-author Brenda Edwards of the NCI's cancer-control division.

For example, five-year survival for lung cancer is just 15 percent, largely unchanged from the 1970s, because more than half of patients are diagnosed after the disease has spread beyond their lungs. In the few cases where tumors are caught early, five-year survival jumps to 49 percent -- but there is no proven early screening method for lung cancer.

Mesothelioma cancer on the rise in NWFP

PESHAWAR: The number of mesothelioma, a type of cancer, cases is on the rise in the NWFP due to unchecked use of asbestos, a natural occurring fibrous found in rocks, said Professor Dr Arshad Javed, president of the Pakistan Chest Society (PCS).

He was speaking at symposium on the World Environment Day, jointly organised by the Postgraduate Medical Institute (PGMI), Abaseen Foundation, PCS and Environmental Protection Agency (EPA) at the Peshawar Press Club on Saturday.

"We have been receiving 100 cases of mesothelioma a year which very alarming," he added. Some 800 to 1000 or more cases might go undiagnosed, he remarked.

He was of the view that asbestos was found naturally in rocks, which were used in many industries. He said the disease was more prevalent in northern parts of the province. About 90% of the patients having the disease are from Swat, Mardan, Malakand, Khyber, Mohmand and Bajuar agencies, while two/three cases were identified in North and South Waziristan tribal agencies, he added.

He said the ailment was caused due to persistent exposure to the asbestos in stone-crushing factories etc. According to him, the asbestos, the known carcinogenic agent was also used in talcum powder that was responsible for causing cancer among 10-15 per cent of the patients. Dr Javed, who is also dean of the PGMI, underlined the need to amend the Environmental Protection Act, allowing mining of asbestos only under special licenses and banning its unchecked use in industries. The law should also make the employers of industries, using asbestos, to compensate the workers in case they got the disease. He said after unearthing of such a scandal in South Africa in 1960, the factory-owners had to pay billion of dollars in compensation to the victims.

Dr Mukhtiar Zaman Afridi, a chest specialist at the Khyber Teaching Hospital, screened a film showing labourers working in a coalmine in inhuman conditions. He said these workers received less than Rs 50 for 12 hours work a day and without any protection form the hazards in mines. He said working in such inhuman conditions had darkened their lungs and chests. He said the government should take measure for saving these workers from health hazards.

He also pointed towards another alarming issue of use of coal and rubber in brick kilns in Peshawar district. He said 102 tones of coal was burnt in brick kilns in the district on daily basis, producing carbon mono-oxide and sulphurdi-oxide that were injurious to health. Brick kiln workers were seven times more prone to lungs disease as compare to other people, Dr Afridi added.

Director of the EPA, Dr Mohammad Bashir, underlined the need of public awareness in controlling the growing environmental pollution. He was of the view that a citizen aware of environmental hazards would never throw waste in the streets.

He said underscored coordination between government and non-government organizations for protecting environment from further depletion.

Provincial Secretary Forest and Environment, Noorul Haq, said the government had allocated a "record amount" of Rs 22 million and a number of measures were underway to cleanse the environment. He said it was collective responsibility of the people, government and the NGOs to save the society from the harmful affects of noise, air, and water pollution.

The EPA, he added, had established its offices in Malakand, Hazara and Dera Ismail Khan to cope with environment-related problems and mobilize people for protecting environment.

MNA Shabbir Ahmad Khan was chief guest on the occasion. He distributed CNG kits among select 20 rickshaw drivers. Dr Akmal Naveed also spoke on the occasion. To commemorate the Environment Day, a seminar was held at Hazara University, Mansehra. Prof Dr Javed Qazi delivered a lecture on the Green House Effect and Global Warming, said a press release.

He pin pointed sources environmental pollution and their possible remedies. He also talked about toxic effects of smoking and heavy metals on human health. A large number of students and teachers attended the event.