An international multi-center phase II trial of pemetrexed (Alimta®) and gemcitabine (Gemzar®) has shown good tolerance and promising overall survival with extended 1- and 2-year survival rates in the treatment of patients with advanced non-small cell lung cancer (NSCLC). [1]

The Food and Drug Administration (FDA) recently approved Alimta® for second-line therapy of NSCLC. Alimta® is the only approved agent for the treatment of malignant mesothelioma and is being evaluated in clinical trials for various types of cancers. The clinical trial that prompted the approval of Alimta® for second-line therapy of NSCLC was a randomized phase III clinical trial that directly compared Taxotere® to Alimta® in 571 patients. [2]

Overall survival and response rates were statistically non-significant between the two groups of patients, while those treated with Alimta® suffered from fewer grade III/IV side effects. Overall survival was 8.3 months for those treated with Alimta®, compared to 7.9 months for those treated with Taxotere®. Patients treated with Alimta® suffered from less severe neutropenia, infection, diarrhea, alopecia and hospitalization from side effects of treatment compared to those treated with Taxotere® and these findings suggested that Alimta® would be the preferred standard second-line therapy for NSCLC.

In the recent international study, 57 patients with advanced NSCLC were treated initially with Alimta® and Gemzar®. The following table summarizes the results of this trial:

Complete response	0%
Partial response	15.5%
Stable disease	50.0%
Median duration of response	3.3 months
Median durvival	10.1 months
Median progression-free survival	5.0 months
1-year survival	42.6%
2-year survival	18.5%

Major toxicities were neutropenia, fever and liver-function abnormalities.

Comments: This combination appears to be reasonably active and should be compared to other non-platinum combinations in advanced NSCLC.

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[1] Monnerat C, Le Chevalier T, Kelly K, et al. Phase II study of pemetrexed-gemcitabine combination in patients with advanced-non-small cell lung cancer. Clinical Cancer Research 2004;10:5439-5446.

[2] Hanna N, Shepherd FA, Fossella FV, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. Journal of Clinical Oncology 2004;22:1589-1597.

National Children's Study
September 8, 2004
Jen Christensen

Environment and Health
Environmental hazards can be found all around us -- in the air, within the earth and in the water. Some contaminants are man-made (like pesticides and pollutants), while others are natural substances (like UV radiation and radon). Here are some common environmental problems and their potential health effects:

Arsenic. Arsenic is a natural element found in soil, rocks, water and air. Long-term exposure has been linked to increased risk for heart and lung problems, disruption of the immune system, neurological problems and certain types of cancer (bladder, lungs, skin, kidney, liver and prostate). It can be found in drinking water, preserved woods, and in some paints, dyes, drugs and soaps.

Asbestos. Asbestos is a mineral fiber that at one time was commonly added to products for fire resistance and as a strengthener. Studies have found higher rates of lung scarring (asbestosis) and lung cancer (mesothelioma) in workers exposed to high levels of asbestos. Although asbestos is rarely used today, it can still be found in some older products, like floor and ceiling tiles, insulation, some types of shingles and siding and soundproofing or decorative materials.

Benzene. Benzene is a chemical mainly found in coal tar. It can also be found in water, gasoline and coal emissions, certain plastics, inks, paints and dry cleaning solvents. Low levels of benzene can interfere with immune function and blood cell production. High levels affect the central nervous system and can lead to death. Chronic low-level exposure is linked to chromosome aberrations and increased risk for cancer.

Carbon Monoxide (CO). Carbon monoxide is a colorless, odorless gas produced by the burning of fossil fuels. In the home, sources of exposure include blocked chimneys and fireplaces, unvented kerosene heaters and wood stoves, gas stoves, automobile exhaust from an attached garage and tobacco smoke. In tightly closed homes, CO can quickly build up to toxic levels. Low levels can cause concentration problems and fatigue. Higher levels can cause flu-like symptoms, vision problems, headaches, dizziness, confusion, loss of consciousness and death.

Formaldehyde. Formaldehyde is a chemical found in building materials and household products. It may be found in permanent press clothing, drapery, glues and adhesives, paints, pressed wood, plywood paneling and fiberboard. It is also a component of environmental tobacco smoke. Formaldehyde is released from materials in the form of a colorless, pungent gas. Exposure can cause burning eyes and throat, watery eyes, nausea and breathing problems. In some people, formaldehyde exposure can trigger an asthma attack. Although studies have linked formaldehyde with cancer in animals, human studies are inconclusive.

Lead. Lead is a heavy metal that may be found in the air, drinking water, food, contaminated soil and some older paints. At one time, it was commonly used in water pipes, paint and gasoline. In the home, the most common source of lead exposure is old lead-based paint. In the body, lead can affect the central nervous system, kidneys and blood cells. Young children who are exposed to lead have higher rates of learning problems, developmental delays, shorter attention spans and an increased risk for behavioral problems. Exposure to high levels of lead can cause convulsions, coma and death.

Mercury. Mercury is a common element in the environment. Coal-fired power plants release mercury in the air. When mercury enters water, it’s transformed into a highly toxic substance that can be ingested by fish. Humans ingest the toxic form when they drink affected water or eat contaminated fish. Exposure can cause vision disturbances, numbness or tingling of the hands, muscle weakness, coordination problems, speech or hearing impairment, skin rash, mood swings, memory problems, and kidney or brain damage.

Mold. Mold is a natural fungus that grows in damp or wet environments. There are many different types of mold. They reproduce by releasing tiny spores into the air. Exposure to mold can cause an allergic reaction, respiratory problems, skin rash and eye irritation.

Pesticides. Pesticides are substances used to repel or kill pests like insects, rodents, weeds and microbes. The chemicals may be used indoors or outdoors. The Environmental Protection Agency (EPA) estimates 75 percent of households use at least one indoor pesticide. Even with careful use, pesticide exposures can occur, causing eye, nose and throat irritation, damage to the kidneys and central nervous system and an increased risk for cancer.

Children and Environmental Impact
Compared to adults, children may be more vulnerable to the effects of environmental contaminants for several reasons. First, while children have a smaller body mass, proportionally, they eat more food, drink more water and breathe more air. Thus, a child may be exposed to higher doses of dangerous chemicals and compounds. Second, young children crawl on their hands and knees and thus are closer to many ground contaminants. Children may be exposed by placing a contaminated object in their mouths (i.e., peeling paint or a toy that has come into contact with a pesticide). Third, children have immature organ systems whose development may be disrupted by an environmental exposure. Children are also less able to metabolize, detoxify or excrete contaminants.

In 1997, President Clinton created the Task Force on Environmental Health Risks and Safety Risks to Children to develop strategies to study and protect the health and safety of children’s environmental health. Out of that initiative comes the National Children’s Study. It is the first large-scale proposal to monitor long-term environmental influences of the health of children. Researchers hope to recruit women before or during pregnancy. Participants will be followed during fetal life, after birth, through childhood and up to age 21. More than 100,000 children eventually will be enrolled. Investigators will examine natural and man-made environmental influences, biological and chemical exposures, physical surroundings, social and cultural influences, behavioral influences and outcomes, genetics and geographic location.

The study is a massive undertaking and many details have yet to be worked out. Investigators hope to enroll the first participants by the end of 2006. Initial results from pregnancy outcomes may be available as soon as 2009. However, since the study will monitor participants until they are 21, the final results won’t be available for 25 to 30 years.

AUDIENCE INQUIRY
For information about the study: http://nationalchildrensstudy.gov

For general information on environment and health risks:
CDC, National Center for Environmental Health, http://www.cdc.gov/nceh
Environmental Protection Agency, http://www.epa.gov
National Institute of Environmental Health Sciences, http://www.niehs.nih.gov

Pfizer To Settle Asbestos Claims

POSTED: 1:26 pm EDT September 3, 2004

NEW YORK -- Pfizer is taking steps to resolve all pending and future asbestos claims. The drug maker said Friday it would take a third-quarter pretax charge of $369 million in connection with personal injury claims from exposure to asbestos, silica or mixed dust.

In last year's third quarter, Pfizer earned $2.2 billion, or 29 cents a share. Analysts polled by Thomson First Call expect the company to earn almost $4.1 billion, or 54 cents a share, in the upcoming third quarter.

Pfizer is addressing claims against its Quigley unit, which it acquired in 1968. Quigley sold some products containing asbestos until the early 1970s. Pfizer and Quigley have been named in more than 170,000 asbestos lawsuits.

Under a reorganization plan meant to settle all claims, Pfizer said Quigley will file for federal Chapter 11 bankruptcy protection, if approved by 75 percent of the claimants.

As part of the bankruptcy petition, Pfizer said it reached settlement agreements with lawyers representing more than 80 percent of existing asbestos claimants that provide for a total of $430 million in payments.

Breathing asbestos dust can cause scarring of the lungs and a form of cancer in the lining of the lungs called mesothelioma, which typically develops 30 to 40 years after exposure, even to trace amounts of the mineral.

James Hardie: the great escape
September 5, 2004
Reporter :Sarah Ferguson
Producer : Thea Dikeos

For seven decades, all-Australian company James Hardie has marketed products containing asbestos which have become our biggest industrial killer. Mesothelioma has already killed 7000 Australians — within 14 years, asbestos will have caused an estimated 50,000 cancers. In 2001 James Hardie Industries made its great escape, 19,000 kilometres away, to the Netherlands.

It's alleged the company used this move to escape the claims of thousands of future asbestos victims by not leaving enough money behind to fund them. The NSW Commission of Inquiry is due to hand down its findings on September 21. Today on Sunday, in a special report, Sarah Ferguson details how the board and management of James Hardie used lawyers, public relations consultants and lobbyists to create and sell the move ...

Transcript
SARAH FERGUSON: For seven decades James Hardie marketed a range of asbestos products that have become our biggest industrial killers.

ADVERTISEMENT: And today's young moderns, not to mention their architects, are swinging to the James Hardie style.

SARAH FERGUSON: Now the iconic fibro is responsible for the latest surge of asbestos cancer victims.

ADVERTISEMENT: Builders and home owners too both have welcomed the wonderful contemporary range of wall and ceiling sheets manufactured by James Hardie and company.

SARAH FERGUSON: One of those builders was Stewart Beckworth.

STEWART BECKWORTH: Wasn't aware that the dust was dangerous at that stage, love, I really didn't have a clue. Nobody else, not the foreman on the site, the other tradesmen, they made no effort to sort of protect themselves in any way.

SARAH FERGUSON: From the age of 15, as an apprentice, Stewart worked on fibro shacks and houses all over this peaceful corner of Victoria. In February, Stewart was diagnosed with mesothelioma, an aggressive cancer caused by exposure to asbestos dust. There is no cure.

STEWART BECKWORTH: I didn't know what mesothelioma was but he said to me, "Do you want a prognosis?" and my wife to said to him, "What does prognosis mean?" and he said, "How much time you've got left" and I said ,"Oh, my godfather", you know, and he said, "six weeks to 16 months at the most".

SARAH FERGUSON: Stewart has seven children and seven grandchildren. They are an especially close family. For his wife, Virginia, that prognosis came as an appalling shock.

VIRGINIA BECKWORTH: Well, we'd planned to do so much together, you know, we love fishing, we do little markets, I'm thinking, how can I do this on my own? I need him. We're like a pigeon pair. Everywhere we go we go together. We're never apart a night.

SARAH FERGUSON: In their own papers, the board and management of James Hardie refer to asbestos victims like Stewart as "management distractions". In 2001, the company made its great escape, to avoid those "distractions".

PETER GORDON, SLATER AND GORDON: Taking off to the Netherlands as part of a grand scheme to leave victims in the lurch is about as reprehensible a set of corporate conduct as you could possibly imagine.

SARAH FERGUSON: This is the story of the shameful effort by one of Australia's largest companies to avoid paying compensation to its victims; people who had innocently used its products exactly as they were intended to be used. A story of how the board and management of James Hardie paid consultants and lawyers, public relations companies and lobbyists to create and then sell their escape plan.

BOB CARR: Put yourself in the position of someone who's got pieces of asbestos lodged in his or her lung because they worked with the product. A product that made a big profit over all the years since 1920 for James Hardie. And the company's given every impression of vanishing in a puff of smoke to escape liability.

SARAH FERGUSON: They used to call this building "Asbestos House", but by early 2001, the offending word was gone. The company's power brokers were working frantically on a deal they called the ultimate resolution, a scheme to cut off James Hardie once and for all from its killer product. The first step - creating a foundation for asbestos victims, the vehicle they'd leave behind when they executed their plan to move offshore.

BOB CARR: My office was told in February, 2001, that they were setting up the foundation. And of course there wasn't the faintest signal or indication that they were going to restructure their corporate affairs and go offshore. If they'd said that, or even hinted at that, there would have been alarm bells ringing.

SARAH FERGUSON: Above all, Hardies wanted to avoid setting off those alarm bells. The board had paid big PR companies for advice and their first recommendation was simple. "Attract as little attention as possible." The CEO Peter MacDonald had set a time horizon, a strict deadline to be met in order to bury the news of the company's rebirth.

TANYA SEGELOV, TURNER FREEMAN: There was an air of urgency which was self-created. They wanted to announce the foundation at a time they were announcing their third-quarter results and that that would be a good way to keep it a business story and out of the front end of the newspaper.

SARAH FERGUSON: The transaction was complex, but the idea behind it simple enough. Almost all of Hardie's victims get sick from products made from two of its subsidiaries - James Hardie and Company and Hardie Ferodo Brakes. The plan was to take those two companies and their assets and put them lock stock and barrel into a trust fund, creating a pool of money to pay out existing asbestos victims and new ones in the future. The reborn James Hardie would be squeaky clean and asbestos-free; a much better prospect for investors.

Involved that evening, either directly or by phone, were a main cast and supporting players whose actions are now being scrutinised by the NSW inquiry. The two key James Hardie men, CEO Peter MacDonald and his chief counsel, Peter Schafron. Their hired guns from Sydney's leading law firm, Allens, David Robb and Peter Cameron. Also present - the four men Hardies had chosen to run the new fund, including chairman Sir Llew Edwards.

The new directors found the events of the evening confusing. After midnight, they saw for the first time the indemnity document that took away their right to sue James Hardie if they ever needed more money for victims.

TANYA SEGELOV, TURNER FREEMAN: They shouldn't have blindly accepted what was put to them by the company and that even the most basic questions would have revealed holes in the reports that were provided to them.

PETER GORDON, SLATER AND GORDON: Whatever sins may be visited upon them pale into insignificance compared to the very active deliberate misrepresentations which were made to them in relation to this fund.

SARAH FERGUSON: The fund's directors were certainly kept in the dark about one of the most critical facts. Hours earlier, Allens' lawyer David Robb was reviewing the so-called Trowbridge report. Trowbridge are the actuaries who use data given to them by James Hardie to predict the cost of future asbestos claims.

TANYA SEGELOV, TURNER FREEMAN: Trowbridge report is very important because it is something that is relied upon by Hardies to say, "Well, we obtained expert actuarial advice." The underlying assumptions of that report were wrong and the management of James Hardie knew they were wrong.

SARAH FERGUSON: Robb learned that the last nine months of claim figures were not there.

TANYA SEGELOV, TURNER FREEMAN: That data showed an increase in claims and an increase in the average payment of claims.

SARAH FERGUSON: The missing data put a huge question mark over Trowbridge's predictions and whether the fund would have enough money to compensate future victims. Concerned, Robb spoke to Hardie's chief council Peter Schafron. Schafron was blunt, the missing figures didn't matter. Robb wasn't satisfied. He and senior partner Peter Cameron rang Schafron's boss, Peter MacDonald.

PETER GORDON, SLATER AND GORDON: He had been contacted again by his own lawyers on the day of the transaction, apparently in a state of some alarm because the lawyers had just found out that the last nine months of data had been withheld. And they pressed him, apparently, on a couple of occasions in that conversation, as to whether they ought to proceed and he instructed them to proceed.

SARAH FERGUSON: Day breaks over Sydney's CBD, the marathon meeting is over. In nine hours no mention was made to the incoming directors of the missing data. James Hardie's asbestos-producing subsidiaries were no longer part of the company. Step one was complete. A few hours later, Hardie's CEO Peter MacDonald announced the creation of the new fund.

PETER MACDONALD: So today James Hardie has effectively resolved its asbestos liability to the mutual benefit of both its shareholders and future claimants - current and future claimants, as a result of asbestos injury.

SARAH FERGUSON: Following the board's communication strategy, the announcement was buried in routine business briefing to avoid scrutiny by the general media. As the strategy notes: "If we did it in mid-January there would be too many journalists chasing too few stories ... and a higher risk that the trust would be become a hot story."

PETER MACDONALD: Investors will also be able to look at the company as the company that it is now and not be concerned about asbestos tales. James Hardie will therefore, in our view, become more attractive to investors.

SARAH FERGUSON: The key message was that the fund had enough money to look after all of James Hardie's victims.

PETER MACDONALD: The foundation is fully funded as of today. The foundation is fully funded. But of course the foundation is fully funded.

SARAH FERGUSON: Since it's now estimated the fund is short by as much as $2 billion, Peter MacDonald could face fraud charges if prosecutors decide he knew his statements were false. Hardie's executives followed up the presentation with phone calls to reassure the so-called stakeholders including Hardie's traditional enemies, the plaintiff lawyers.

ARMANDO GARDIMAN, TURNER FREEMAN: They told me the amount of the figure and I can remember putting the phone down and the first thought that I had was, "That just can't be enough money." I didn't appreciate at all why they were ringing me until I read the communications and the risk strategies that were in the board papers of 15 February, 2001, and I now appreciate that I wasn't special at all. I was just one of a whole lot of people that they rang up in an effort to ensure that any critical comment might be neutralised.

RICHARD ACKLAND: This is all part of the sort of modern apparatus and what the sort of piranha pool of PR and spin doctors, you know, spend their time preying on, basically, that there are all these stakeholders to be stroked and they're out there doing this. You know, this is what commissions are terrific at. They scratch back the gloss a bit and there's a festering smell there.

SARAH FERGUSON: Hardies employed two sets of spin doctors - Gavin Anderson to lobby the Federal Government, but more importantly, Hawker Britton to work on the NSW Labor Government.

Bruce Hawker and David Britton used to work for Bob Carr. They gave the James Hardie board detailed analysis of the main players and threats in Labor circles. "Bob Carr ... pro-business ... would be influenced by unions and public opinion if it created political exposure."

BOB CARR: That's absolutely fair, absolutely fair.

SARAH FERGUSON: It's not a flattering portrait though, is it? It suggests you're more sensitive to political risk than you are to the rights of victims.

BOB CARR: No, but that's - they're a group of lobbyists, they've got no more claim to insight than other lobbyists.

SARAH FERGUSON: That PR firm did have special insight into your government. Hawker Britton came out of your office.

BOB CARR: I'm not arguing with their shorthand description. I'm concerned about the reputation of the Government. But there was nothing in what they presented. There were no alarm bells ringing for members of the foundation, for the Supreme Court, for the financial press, or above all, for the Federal Government which has the corporations power.

SARAH FERGUSON: But Hardies were taking no chances. They paid an $11,000 success fee to former ALP state secretary Stephen Loosley to make sure no action was taken. Loosley organised a meeting with the Premier's Chief of Staff Graeme Wedderburn. "The briefing was much more positive than expected - Loosley described it as 'a pearler' - they don't get much better than that.'"

BOB CARR: I think everyone welcomed the establishment of a foundation. A foundation with nearly $300 billion in it to look after the interests of victims and even, if I recollect correctly, some actuarial data that suggested that would be adequate, but hang on, they deceived everyone.

SARAH FERGUSON: Not quite everyone.

PAUL BASTIAN: As soon as they announced what they were doing blind Freddy knew what was on it. It was nothing more than - nothing short of trying to sanitise their name, get out of the asbestos liability system and move on.

SARAH FERGUSON: Paul Bastian, NSW secretary of the Manufacturing Workers Union, has a long history defending asbestos victims. He was identified by Hawker Britton as a possible threat to the plan.

PAUL BASTIAN: We kicked in only a couple of days later with a letter to the Premier and where we actually said to the Premier not only that it was a rort, but there's 10 or 12 questions you should be asking James Hardie about how they can possibly say $293 million will cover future victims.

SARAH FERGUSON: Why did they receive no response to that letter?

BOB CARR: Well because the existence of that letter is in doubt. You realise that we've looked at the records of the Cabinet Office, we've looked at the records of the Attorney-General's Department, and this Industrial Relations Minister, there's no record of that letter.

SARAH FERGUSON: The union insist they sent the letter and alerted the Premier. No-one disputes the fact they raised the alarm in meetings with the Industrial Relations Minister John Della Bosca. So your Industrial Relations Minister is meeting with them regularly.

BOB CARR: Over a range of issues, I should make clear.

SARAH FERGUSON: Indeed. He's in possession of the knowledge that the unions are very concerned, that they have a template of questions to put to James Hardie and no-one tells you?

BOB CARR: Well, no-one told me.

SARAH FERGUSON: The lobbying effort had succeeded. The head of PR at James Hardie wrote to the Premier's chief of staff, Graeme Wedderburn, after the announcement. "The reaction from stakeholders has been neutral to positive ... the next-day media coverage was limited but positive ... stock is up by 3 per cent ... if there is anything we can do to assist the Government, please let me know my home number should you need it is ..."

SARAH FERGUSON: Premier Carr may have ignored his own union comrades, but he sat up and listened when the fund's chairmen Sir Llew Edwards came to him for help early this year. Edwards told him the fund was running out of money fast. Carr instigated a powerful commission of inquiry to find out what had gone wrong.

MICHAEL SLATTERY, QC: To say that James Hardie treated the plight of victims of its asbestos products with disdain would be an understatement. It embarked upon a course of doing all it could to ensure that even legitimate claims made in the interests of asbestos victims would go unsatisfied.

SARAH FERGUSON: The case against James Hardie is now being examined in excruciating detail. Hundreds of e-mails, letters and telephone conversations never meant to see the light of day, exposed to reveal the inner workings of a deal that put the needs of shareholders before the victims, and possibly even before the law.

PETER GORDON, SLATER AND GORDON: Reckless indifference, how does that fit in with the dishonesty? They're different concepts, aren't they?

SARAH FERGUSON: These lawyers have a long history of fighting James Hardie in asbestos cases.

TANYA SEGELOV, TURNER FREEMAN: If his conduct is dishonest, that should be a finding that's made and is made against him publicly.

SARAH FERGUSON: They believe criminal charges should be laid against the Hardies executives chiefly responsible for the scheme.

TANYA SEGELOV, TURNER FREEMAN: ... was to primarily focus on Schafron and MacDonald and finding against them on the basis of fraud, deceit, negligence, dishonest conduct and misleading and deceptive conduct.

SARAH FERGUSON: A crucial part of the case against the CEO, Peter MacDonald, is that his very announcement of the birth of the foundation was fraudulent.

PETER MACDONALD: The directors of James Hardie Industries Limited took a lot of advice, a lot of independent advice, PriceWaterhouseCoopers, Access, the actuaries Trowbridge, who have worked with the company for many years, and then formed the view that this was the right amount of money.

SARAH FERGUSON: But MacDonald knew that PriceWaterhouse and Access had not said the fund was the right amount of money.

PETER GORDON, SLATER AND GORDON: In the words of Peter Schafron himself, Hardie's legal counsel, these companies were asked not to investigate or understand the assumptions, they simply wanted those organisations to give it their blessing.

SARAH FERGUSON: So those firms were not asked to do genuine scrutiny of the overall project?

PETER GORDON, SLATER AND GORDON: No, in fact all of their reports were in that sense completely meaningless. All of the critical matters which went to this entire fiasco were in the assumptions.

SARAH FERGUSON: Phil Morley, James Hardie's Chief Financial Officer, shared the stage with MacDonald that day. He was cross-examined under oath about the use of the financial experts. Morley admitted they were simply there as part of the media strategy. "Can you think of any other reason why PricewaterhouseCoopers and Access Economics would be invited to indulge in this arid exercise rather than an exercise of substance. This was all about how we're going to go to the media and both Mr MacDonald and Baxter wanted to be able to say that at least the work we'd done had been checked out by PWC and Access."

SARAH FERGUSON: A further revelation came from Hardie's in-house asbestos expert Wayne Attrill. He admitted they knew the whole Trowbridge report was based on false assumptions.

TANYA SEGELOV, TURNER FREEMAN: The one piece of evidence in the commission that stands out in my mind is that of Mr Attrill who was their counsel when all of these things were put to him. "You would have appreciated in February 2001 that Trowbridge was using $135,000 as the average settlement figure in mesothelioma and general liability claims? Yes, sir, that would be right. Thus you would have been aware that the likelihood of their projections being grossly inaccurate was a reality? Yes."

SARAH FERGUSON: Given the alleged extent of Hardie's prior knowledge of the gross inaccuracies in the Trowbridge report and their complicity in supplying the dodgy figures, the Commissioner is now considering whether Peter MacDonald committed fraud with his claims in 2001 that the foundation was fully funded.

Peter MacDonald for his part is blaming Trowbridge. Three weeks ago, Peter MacDonald announced James Hardie's first-quarter results for the year. He went on a phone hook-up to analysts and financial journalists. Sunday got in the queue to put to him some questions he'd refused to answer publicly.

Peter MacDonald, you seem to be putting the blame squarely at the hands, of the actuaries but you knew perfectly well in 2001 that the Trowbridge report was not a reliable means of establishing an amount of money for the fund.

PETER MACDONALD: That's a statement, Sarah, with which I don't agree and the materials before the inquiry refute that, I believe, completely.

SARAH FERGUSON: So are you saying you had perfect confidence in the Trowbridge report to establish a figure that would cover your asbestos costs, liabilities into the future?

PETER MACDONALD: No, Sarah, I couldn't say that. It's not possible to have perfect confidence in an actuarial estimate, it is by definition, an estimate.

SARAH FERGUSON: So what was driving the James Hardie executives to cut corners?

What they desperately wanted was to tap into American wealth, investment to drive the company's expanding business in the US.

PETER GORDON, SLATER AND GORDON: Hardies had sought to float the company in the United States in the several years before these events. They had conducted what they referred to as road shows. Those road shows had been spectacularly unsuccessful, principally because, they believed, of the association with asbestos liabilities.

SARAH FERGUSON: The victims' lawyers believe the company was afraid of being swamped by a third wave. People who'd never worked for Hardies but who used their asbestos products.

TANYA SEGELOV, TURNER FREEMAN: It had been something that was a long time coming and that James Hardie knew was coming. And particularly in home renovations where the fibro house was built in the '40s or '50s and '60s and then in '70s or '80s there were renovation or extension work carried out.

How are you going?

SARAH FERGUSON: Tanya Segelov is visiting one of her clients Mark Hollis in the Sydney suburb of Blacktown. He's one of the home renovation cases. Mark is 44 years old. The father of two young girls. And tomorrow he'll have one of his lungs removed. He has mesothelioma.

Mark Hollis represents the future for claims against James Hardie. One of a relatively new wave of victims whose exposure to asbestos was brief and transient.

TANYA SEGELOV, TURNER FREEMAN: All right, well, in relation to the court case, the proceedings have been finalised - have been commenced, which is really important because once the proceedings have been commenced if anything happens to you the claim can be continued at its full value.

SARAH FERGUSON: In Mark's case, he was working alongside his brothers and sisters, 30 years ago with Hardies fibro.

MARK HOLLIS: I was helping my dad cutting, sweeping up and then after that we brought another house back in Adelaide again and another extension there as well, cutting at the same time and sweeping up.

SARAH FERGUSON: Now, they have to concentrate on the present. Giving Mark as much time as possible with the girls, Katie and Tara.

ANNETTE HOLLIS: Being a kid I don't know how she's dealing with it in her mind. She doesn't like talking about it, I know that, because every time I say to her, "Look, you've got to be good around the house." She goes, "I know, Dad's sick." So she knows, yeah.

SARAH FERGUSON: Mark is hoping to be here for Christmas.

MARK HOLLIS: Get someone dressed up in Santa so I might do it myself. So have Santa here on the 23rd and the 24th December this year, if I'm feeling all right. So, yes.

SARAH FERGUSON: Dr David Bryant is one of Australia's leading experts on mesothelioma.

DR DAVID BRYANT: Well it's very difficult to predict because you don't know who is the population at risk. So that it is not as if you can go to a defined set of industries and say well look, we will screen all these people. You could do that, but what about the other people who have been exposed to it inadvertently or in an innocent bystander situation or even when they were a child.

SARAH FERGUSON: James Hardies executives and its board knew a great deal about people like Mark Hollis.

TANYA SEGELOV, TURNER FREEMAN: There was regular reporting to the board at each board meeting as to the settlements that were paid and the asbestos liabilities and it was something that the chief legal counsel, Peter Schafron, and the Chief Executive Officer, Peter MacDonald, kept a very close eye on. They were in a very good position to know that in the months preceding this establishment of the foundation the number of claims against them were increasing and the amount of those claims were increasing.

SARAH FERGUSON: Faced with this new generation of victims, the untold and uncounted cost of compensating them, the board's plan was to move the company overseas, beyond the reach of Australian law. In August 2001, having successfully launched the foundation, the schemers had one major obstacle - the NSW Supreme Court.

PETER GORDON, SLATER AND GORDON: The way in which that was going to be done was by a scheme of arrangement which transferred these massive assets and it required court approval. It required the court to be satisfied that the interests of creditors wouldn't be affected.

SARAH FERGUSON: Hardies assured the court that they had created a lifeline - $1.9 billion in partly paid shares to protect creditors in Australia, including the asbestos victims.

RICHARD ACKLAND: In terms of the application for the approval to restructure the company, to move its headquarters to the Netherlands and all of that, the partly paid shares were a sort of crucial element because they were the assurance to the judge there was enough cash in, you know, in the bikkie tin to meet all these claims.

SARAH FERGUSON: In 2003, James Hardie was safely ensconced in its new home in the Netherlands. As the fund's directors in Sydney increased their demand for more money, the James Hardie board quietly cancelled the partly paid shares, severing the so-called lifeline.

Now a key question for the inquiry is whether Hardies and their lawyers, Allens, misled the Supreme Court. Hardies CEO Peter MacDonald offered this explanation.

PETER MACDONALD: At the time of the submissions to the Supreme Court, to create the James Hardie industries NV in the Netherlands, the company did not have an intent to cancel the partly paid shares.

SARAH FERGUSON: Looking for answers, Sunday's Ross Coulthart went to James Hardie's new corporate headquarters, a modest office suite in Amsterdam.

ROSS COULTHART: Hello, the Sunday program, Channel 9 in Australia. We were wondering if we can do an interview with James Hardie about the situation in Australia.

SARAH FERGUSON: Even on these far flung shores they know the value of PR.

ROSS COULTHART: One of the reasons we've come to you directly is because this is now your corporate headquarters, your world headquarters for James Hardie and we can't find anybody else other than a PR man to talk to us about these issues. Wouldn't it be a good idea for someone to, from the company ...

SARAH FERGUSON: Hardie's communication strategy to attract as little attention as possible had blown up in the company's face. They're now exposed and under pressure from all sides.

PHILIP RUDDOCK: The Treasurer is responsible for the corporations power and I regard, and I think he does too, those who have liabilities avoiding those liabilities as engaging in behaviour which is unconscionable.

SARAH FERGUSON: The Attorney-General is examining ways to pursue James Hardie's assets overseas.

PHILIP RUDDOCK: And that's one of the reasons that we've initiated the discussions both with the Dutch. And the reason that we have also sought to look at those same issues in relation to the United States of America.

SARAH FERGUSON: In the final days of the inquiry, all the parties waited to hear Hardie's plan for the future. When it came, it was brief. An offer to fund all its victims. But with a catch - and one targeted at their adversaries, the plaintiff lawyers. Hardies want the NSW Government to introduce a statutory scheme that will take asbestos out of the courts. An outcome they've been after for many years.

PETER GORDON, SLATER AND GORDON: We now get into a situation where they say, "Forget about how badly we've behaved, forget about how wrong we've been, we're outside the jurisdiction now and you've got a real problem it's going to cost you a fortune, take you years to get us. So here's our proposition - you legislate exactly as we say and you might see some of the money again."

SARAH FERGUSON: To plug the idea, Hardie's new chairman Meredith Hellicar was prepped for a quick round of media appearances.

MEREDITH HELLICAR: That I can then say sorry. I can do no more than say sorry.

RICHARD ACKLAND: It smacked of those sort of performances that are very carefully sculpted by your PR advisors. You've got to hit these two buttons every interview you do, you know, we're sorry, sorry, sorry, you can say that in all sorts of configurations as you like and you can even say very, very sorry or extremely sorry.

SARAH FERGUSON: James Hardie's last throw of the dice is still in play and the NSW Government has to decide whether the company's making a genuine offer or if this is just more spin - James Hardie business as usual.

Given what we've learned about the way Hardies have operated during the course of the inquiry, I wonder can you trust them, can you take at face value any commitment they make?

BOB CARR: I think we'd be very sceptical.

SARAH FERGUSON: The one person Hardie's spin won't touch is the man now poring over thousands of pages of evidence and submissions. David Jackson's inquiry has peered behind the corporate veil. He may make observations about the company's morality, but his key findings will be whether laws were broken. And if so, who should face criminal charges in one of the sorriest sagas in Australian corporate history.

LNJP Hospital to host meet on exposure to asbestos

Express News Service

New Delhi, September 7: The Centre for Occupational and Environmental Health (COEH) is organising an international conference on ‘Asbestos Exposure in India’ on September 12 at the Lok Nayak Jaya Prakash Narayan Hospital.

Leading international experts like Barry Castleman from the US will participate in the conference, which will address issues relating to the use of asbestos, including resultant health hazards, and ways to phase it out. The World Health Organisation, the International Agency for Research in Cancer, the United States Environmental Protection Agency, the Department of Health and Human Services and Collegium Ramazzini have stated that all sorts of asbestos are responsible for mesothelioma and lung cancer.

Many countries have imposed restrictions on its use, or banned it entirely. In Europe, the use of asbestos or products containing asbestos will not be allowed after June 2005.

Over seventy per cent of the world’s asbestos is used in Eastern Europe and Asia. Canadian asbestos manufacturers have tried to promote asbestos use in India. Interestingly, in Western Europe, Scandinavia, North America and Australia, the manufacture of asbestos peaked in the 1970s. Canada dominated the world trade with its annual export of about 3,00,000 tons.

COEH, the technical arm of the Delhi government, is part of the Maulana Azad Medical College. The Centre was created to deal with occupational and environmental health concerns.

ALFACELL Shares to Trade on NASDAQ SmallCap Market

Investor Conference Call Scheduled for September 15, 2004

BLOOMFIELD, N.J., Sept. 9 /PRNewswire-FirstCall/ -- ALFACELL Corporation (Nasdaq: ACEL), a biopharmaceutical company focused on the discovery, development and commercialization of ribonucleases for anti-cancer and other therapeutic applications, today announced that The Nasdaq Stock Market, Inc. has approved the company for re-listing on the NASDAQ SmallCap Market. The Company's common stock will begin trading on the NASDAQ SmallCap Market at 9:30 a.m. on Thursday, September 9, 2004. Bruce Aust, Executive Vice President of The NASDAQ Stock Market said: "Alfacell as a leader in the biopharmaceutical industry embodies the innovation that defines our marketplace.

We are honored that Alfacell has joined the NASDAQ SmallCap Market and we look forward to helping them achieve increased recognition within the investment community." "The relisting of Alfacell on the NASDAQ SmallCap Market represents another significant milestone for the Company in its quest to commercialize its novel ribonuclease technologies for cancer and other therapeutic applications," noted Kuslima Shogen, Chief Executive Officer of Alfacell Corporation.

"We continue to move forward in our efforts to complete our pivotal Phase III trials and prepare for an NDA filing for our lead product, Onconase(R) for the treatment of malignant mesothelioma." The Company will host a conference call at 11:00 a.m. Eastern Time on September 15, 2004, to update investors regarding recent developments. To participate in the conference call, investors should dial 913-981-4901 approximately five minutes prior to 11 a.m. on September 15, 2004. A replay of the conference call will be available through September 22, 2004 by dialing 719-457-0820. The Access Code for the replay will be 884252.

About Alfacell Corporation
Alfacell Corporation is a global leader and pioneer in the research,
development and commercialization of ribonucleases. Our mission is to develop new therapeutics based on our ribonuclease technology for the treatment of cancer, infectious diseases and other life-threatening conditions. For more information, please visit http://www.alfacell.com.

This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe", "estimate", "project", "expect" or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, uncertainties involved in transitioning from concept to product,
uncertainties involving the ability of the Company to finance research and development activities, potential challenges to or violations of patents, uncertainties regarding the outcome of clinical trials, the Company's ability to secure necessary approvals from regulatory agencies, dependence upon third-party vendors, and other risks discussed in the Company's periodic filings with the Securities and Exchange Commission. By making these
forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.

For further information, please contact: Kuslima Shogen, CEO, or Andrew Savadelis, CFO, both of Alfacell Corporation, +1-973-748-8082, info@alfacell.com; or Financial Inquiries, Investor Relations Counsel of RJ Falkner & Company, Inc., +1-800-377-9893, info@rjfalkner.com, for Alfacell Corporation.

SOURCE Alfacell Corporation
Web Site: http://www.alfacell.com

Promising result for mesothelioma drug
Sep 11 2004

The first people to test a new mesothelioma treatment drug were so impressed with the results they asked to keep taking the medication after the trial had ended.

Thirteen people with advanced solid tumours were given the drug, derived from a noxious weed known as Devil's Apple, for just one week during the trial in Perth.

Tumours started to shrink in a number of trial participants, all of whom had been told their cancer was terminal.

"The trial didn't actually set out to find out how well the product worked, it was just trying to find the right dose to use," said Greg Barrington, a spokesman for Solbec, the Perth-based company that makes the drug.

"Right near the beginning of the trial, where the doses were low, we got some positive results.

"It was the last thing we expected but the first thing we wanted, obviously."

Many of the patients elected to continue taking the drug, known as SBP002, beyond the end of the trial, Mr Barrington said.

"To get involved in a trial like that you have cancer that's not responded to anything else, and the doctors have said `perhaps you should enjoy your last few months'," he said.

"So if they get a response as these people have, then clearly they say `can we have more of that', so they've carried on."

A phase two trial of SBP002, in which the drug will be tested on about 40 people, is expected to begin next year in either Australia or the United States.

"Obviously it's early days to know what's going to happen to people taking it longer-term," Mr Barrington said.

"But we've had very encouraging results so the scientists are pretty excited."

US scientists affiliated with Solbec were also testing SBP002 on a variety of human cancer cells in the laboratory, to determine which cancers responded best to the drug.

The asbestos disease mesothelioma and skin cancer melanoma were thought to be the main targets, but the drug may also have an effect on colon, renal and lung cancers.

Hardie caves in on accounts
By Leonie Wood
September 11, 2004

James Hardie has bowed to pressure from government authorities, unions and institutional shareholders and decided to defer approving its annual accounts until the size and nature of its potential liabilities for asbestos-related diseases become clearer.

The board also said it would launch an internal investigation into allegations raised in the NSW special commission of inquiry, which earlier this year heard that a special trust set up by James Hardie to meet asbestos compensation claims would be hopelessly short of funds.

The inquiry, headed by David Jackson, QC, has heard the Medical Research and Compensation Foundation may need as much as $2 billion to meet projected liabilities as more cases emerge of diseases such as mesothelioma.

James Hardie left the fund with $293 million in founding assets, but soon after the MRCF was set up in 2001 its trustees told James Hardie's most senior executives, including chief executive Peter Macdonald and internal legal counsel Peter Shafron, that the fund would quickly become insolvent.

By the fund's own estimates last year, its shortfall would be about $800 million. But the latest estimates run to $2 billion.

The inquiry also heard allegations that James Hardie's senior executives engaged in fraud or misleading conduct as they devised a structure to ringfence James Hardie from the operating subsidiaries that inevitably would bear the brunt of legal suits for asbestos compensation. The company has denied the allegations.

Mr Jackson is expected to present his final report into the inquiry on September 21.

James Hardie chairman Meredith Hellicar yesterday said in a statement that considering the allegations raised in the inquiry, and to ensure the company complied with its reporting requirements in the US, the board's audit committee would launch an internal investigation.

That investigation would be done by "independent legal advisers" with a brief to "investigate allegations of illegal acts and any potential impacts on the financial statements".

"It is expected that this internal inquiry may not be completed until the company has access to the inquiry report from commissioner Jackson to the NSW Governor (Professor Marie Bashir)," James Hardie said.

The company's accounts for the year ended March 31 have already been signed and submitted to the Australian Stock Exchange; the Dutch version was due to be submitted for approval to shareholders attending James Hardie's annual meeting in Amsterdam next Friday.

The March 2004 accounts do not include any provisions for asbestos claims because James Hardie had contended that the funds it left MRCF would be sufficient to cover future liabilities.

James Hardie shares closed 9 ¢ lower at $. 5.29.

Major new study geared toward children
9/13/2004 12:12 PM
By: Medstar.com

Remember the big Framingham heart study and the women's health initiative? Both were studies that followed participants for years. Soon there will be a new study on kids and how the interaction between the environment and their genetics can make them sick.

No parent likes to see a sick child. But the world is full of diseases from the common cold to cancer. It's safe to say we understand some illnesses better than others. Now a government task force wants to study how the environment, combined with genetics, causes disease in kids.

Dr. Peter Scheidt stated, “The size of the study is driven by the frequency of conditions like autism, diabetes, cerebral palsy.” He is the director of the project that will follow 100,000 children from the womb to age 21. Some women will be followed before a baby is even conceived.

“So that we can study the potential effects of the environmental exposures and factors on that very vulnerable first few weeks of pregnancy,” Dr. Scheidt said.

Major new study geared toward children

Soon there will be a new study on kids and how the interaction between the environment and their genetics can make them sick. The study could start before they're even conceived.

As the child matures, researchers will collect data on a wide range of exposures to pesticides, air pollution, even a lack of supervision at home. "It's really exciting to see this effort," Dr. Jonathan Clemens expressed.

As a pediatrician, Dr. Clemens said the study has great potential for making a difference, especially for some growing problems such as “conditions like asthma, obesity, ADHD, hyperactivity disorder. Even some of the more common causes of cancer in children."

Dr. Scheidt, who has nine grandkids, says the study is an extremely important investment for the future of our children. "I can't emphasize how much we think it can contribute."

The national children's health study is scheduled to start in 2006.

Asbestos Diseases Foundation of Australia: Asbestos Victims Travel from Australia, UK & Europe to Protest at James Hardie AGM in Amsterdam
Monday September 13, 11:53 pm ET

SYDNEY, Australia, Sept. 13 /PRNewswire/ -- Asbestos victims from as far away as Australia will protest at James Hardies' AGM. Asbestos victims' support groups from the UK and Europe will join them. A Special Commission in Australia has found that James Hardie, the largest manufacturer of asbestos products in Australia has short changed the Foundation it set up to compensate its victims, by as much as $2 billion.
The Commission revealed scandalous conduct and senior executives could face criminal charges. Hardies has quarantined its assets from its Foundation and the CEO has said the company has no moral or legal duty to victims.

In Australia more than 600 people died last year of asbestos related illness. By 2020 it is estimated more than 53000 people will have asbestos disease, 15000 of them will die from the cancer mesothelioma. Asbestos disease can take more than 30 years to develop.

Ella Sweeney from the Asbestos Diseases Foundation of Australia, a victim of asbestos disease herself, will be at the meeting. "James Hardies restructured its companies and moved to the Netherlands leaving victims facing a bleak future," explains Ella Sweeney.

With her will be Paul Bastian, Secretary of the Australian Manufacturing Workers Union in New South Wales, Australia.

They are asking Hardie's Chair, Meredith Hellicar, directors and shareholders to vote according to their consciences.

Victims are demanding full funding for compensation for all current and future victims and Hardie's reveal details of its proposal for a statutory scheme to replace the current common law system. Paul Bastian says, "we believe their scheme will deny victims fair compensation."

There's no reference to Hardie's huge insurance policies. "Why should Hardie's insurers be allowed to collect premiums and not cover their liabilities? It's a windfall for Hardies and their insurers," says Bastian.

"Hardies is not the victim. We are," says Mrs Sweeny. "Hardie's products killed people. Hardies should pay."

JAMES HARDIE INDUSTRIES N.V.
AGM
Meeting Rooms 4 and 5, Courtyard by Marriott, Amsterdam Airport,
Kruisweg 1401, 2131 MD Hoofddrop, Netherlands
Friday 17 September 2004 9am, Central Europe Time (CET)

Daschle Agrees to $140 Billion Asbestos Relief Fund (Update1)

Sept. 15 (Bloomberg) -- U.S. Senate Minority Leader Tom Daschle accepted a Republican proposal limiting a trust fund for asbestos victims to $140 billion to break a deadlock that has stalled the legislation in Congress. The Democrats previously insisted the fund be $145 billion. The plan, financed by companies such as Armstrong Holdings Inc. that make products with asbestos and their insurers, would end lawsuits that have bankrupted more than 70 U.S. companies.

Daschle, 56, of South Dakota and Senate Majority Leader Bill Frist, 52, a Tennessee Republican, have been exchanging proposals to reach a compromise for months. In a letter to Frist, Daschle said he is ``hopeful that resolution can be achieved'' before Congress completes its session Oct. 8. Frist is also optimistic, said spokeswoman Amy Call. ``We are hopeful that this process can move forward and we can reach an agreement,'' she said. Frist hasn't seen the proposal, she said.

USG Corp. rose $1.58, or 8.7 percent, to $19.73 in composite New York Stock Exchange trading at 1:33 p.m. Owens Corning shares rose almost 13 cents, or 24 percent, to 62 cents at 1:32 p.m. New York time in over-the-counter trading. A spokeswoman for insurers expressed doubts the compromise would work.

``The prospects are not good'' for passage by Congress this year because ``many very important structural elements of the fund are still open and nowhere near closure,'' said Julie Rochman, a spokeswoman for the American Insurance Association.

Pending Lawsuits

Under Daschle's new proposal, some pending lawsuits wouldn't be covered by the fund and could still be pursued in court. For example, he would exempt any cases involving mesothelioma, a fatal illness caused by the cancer-causing fiber, that already have a trial date; all cases in which trial has begun; cases with a trial date within 60 days of the fund's creation, and proposed settlements awaiting court approval.

Last month, Frist said manufacturers and insurers would never agree to the Democrats' original demand of exempting all current cases from the fund. Bill Samuel, legislative director of the AFL-CIO, estimated that more than 300,000 claims are pending. The Daschle proposal would block any future claims.

To contact the reporter on this story:
Jeff Bliss at jbliss@bloomberg.net

To contact the editor responsible for this story:
Glenn Hall at ghall@bloomberg.net

Last Updated: September 15, 2004 13:54 EDT

9/11 Search-and-Rescue Dogs Exhibit Few Effects from Exposure to Disaster Sites
September 15, 2004

PHILADELPHIA -- The search-and-rescue dogs deployed following the Sept. 11, 2001, terrorist attacks have not suffered either immediate or short-term effects from exposure to the disaster sites, researchers from the University of Pennsylvania School of Veterinary Medicine report. The findings, presented in the Sept. 15 issue of the Journal of the American Veterinary Medical Association, should help relieve fears about the after-effects of working at the 9/11 sites.

For the last three years, the Penn researchers tracked the health of dogs and handlers from the World Trade Center, the Pentagon and the Fresh Kills Landfill site on Staten Island, where debris from the World Trade Center was further searched.

"Overall, the lack of clear adverse medical or behavioral effects among the 9/11 dogs is heartening, both for the animals and the human rescue workers," said lead researcher Cynthia M. Otto, associate professor of critical care in Penn's School of Veterinary Medicine. "Since dogs age more rapidly than humans, they can serve as sentinels for human disease. We are encouraged that we do not see significant increases in cancer and respiratory diseases."

The Penn researchers compared the dogs to a control group of search-and-rescue dogs that were trained similarly but not deployed.

Although there is no single registry of all dogs deployed to search the 9/11 sites, the Penn researchers identified 212 deployed handlers, and 97 consented to participate.

Despite rumors of numerous deaths of 9/11 search-and-rescue dogs, only one was confirmed to have died during the search period. In addition, the study was able to demonstrate that the injuries and ill effects of the search itself were minor. After the first year of surveillance, of the 97 deployed dogs enrolled in the study, only one died. During the past three years, 15 deployed dogs have died, of which eight had cancer. At the current time, neither the death rate nor the cancer rate is different from that of the control group.

"Given the mature age of these dogs and their expected lifespan, the few deaths that did occur were not statistically significant," Otto said. "We can say that these findings preclude illness later in life, but it is clear that we don see any trends in the current physical or behavioral wellbeing of these dogs that would be cause for alarm."

Initially, blood tests showed that the deployed dogs exhibited higher bilirubin concentration and alkaline phosphatase activity, which indicates that their livers were actively filtering toxins from their bloodstream. The serum globulins were also higher in the first year in deployed dogs, suggesting activation of the immune system. As the study progressed, however, these numbers came down to close to those of the dogs in the control group. "Early on, it is clear that these dogs were dealing with some stress from toxins, although we don't currently have evidence of adverse effects, continued surveillance is still warranted," Otto said.

Since there was a concern about airborne pollutants, such as asbestos, Otto and her colleagues also examined X rays taken of the dogs. The examinations showed no apparent lung abnormalities. While it usually takes humans at least 20 years to develop mesothelioma after asbestos exposure a major fear at all three sites the shorter life span of dogs often means a relatively shorter latency period for developing cancer.

To assess the psychological wellbeing of the dogs, their handlers were given questionnaires that focused on behavioral disorders, such as aggression or fearfulness, which may have arisen since 9/11. Here also the deployed dogs seemed similar to those of the control group. An ongoing study led by Melissa Hunt of Penn's Department of Psychology is looking at the long-term psychological consequences for the human handlers.

"Since this is the first major study on search-and-rescue dogs and their handlers, we hope this data can be used to establish a baseline for future studies," Otto said. "Not only will it help ensure the health and safety of search-and-rescue dogs, but it will also help anticipate human disease as well."

Support for the study came from the AKC Canine Health Foundation, the American Kennel Club, Ralston Purina Co., the Veterinary Pet Insurance Co. and the Geraldine R. Dodge Foundation. The study also includes researchers at Michigan State University and the Centers for Disease Control in Atlanta.

Alfacell Corporation Signs License Agreement With National Institutes of Health
Wednesday September 15, 8:30 am ET

BLOOMFIELD, N.J., Sept. 15 /PRNewswire-FirstCall/ -- Alfacell Corporation (Nasdaq: ACEL - News), a biopharmaceutical company focused on the discovery, development and commercialization of ribonucleases (RNases) for the treatment of cancer and other therapeutic applications, today announced it has entered into a licensing agreement with the National Institutes of Health (NIH) to evaluate a humanized, single-chain form of a proprietary B-cell specific monoclonal antibody. Dr. Susanna Rybak of the National Cancer Institute (NCI), a branch of the NIH, developed the antibody. Financial terms of the agreement were not disclosed.
ADVERTISEMENT

Under the agreement, Alfacell receives rights to evaluate commercial applications for the antibody, such as immunotherapeutics derived from the combination of the antibody with the Company's family of cytotoxic RNases -- including Onconase® (ranpirnase), currently in pivotal Phase III trials as a treatment for malignant mesothelioma.

Kuslima Shogen, Chief Executive Officer at Alfacell, stated, "We are pleased to expand our ongoing collaboration with the NIH in the area of targeted cancer therapies. We look forward to conducting a thorough evaluation of Dr. Rybak's recombinant, humanized antibody with our proprietary RNase technology."

"This agreement represents an important opportunity for Alfacell to accelerate the development of novel, RNase-based therapeutics," stated Andrew Aromando, Senior Vice President, Commercial Development and Operations at Alfacell. "We will continue to aggressively pursue licensing opportunities in alignment with our business strategy to optimize and expand our groundbreaking technology platform and robust pipeline."

400,000 New Yorkers Breathed the most Toxic Pollutant. Asbestos Poisoning Symptoms. Are you at Risk?

Recent study of U.S. government provides the latest evidence of a systematic cover-up of the health toll from pollution after the 9/11 disaster, which doctors fear will cause more deaths than the attacks themselves.

(PRWEB) September 16, 2004 -- Recent study of U.S. government provides the latest evidence of a systematic cover-up of the health toll from pollution after the 9/11 disaster, which doctors fear will cause more deaths than the attacks themselves.

Belfast Telegraph says, The Bush administration suppressed evidence of increasing danger and officially announced that the air around the felled buildings was "safe to breathe".

But results of the government study, conducted by a consortium of researchers at Mount Sinai School of Medicine, Columbia University, New York University, Johns Hopkins University, The University of Medicine and Dentistry of New Jersey, and the University of North Carolina-Chapel Hill, show exposure-related increases in new-onset cough, wheeze, shortness of breath, and bronchial hyperreactivity more than 2½ years after the disaster.

Ambient air samples showed that asbestos levels in the WTC area were initially elevated following the September 11 attacks, but fell to within federal standards after the first few days.

"More research is needed to determine whether long-term exposure to asbestos fibers might lead to an increased risk of lung mesothelioma, a rare cancer that has been linked to asbestos exposure," said Landrigan. "Previous studies have shown the short chrysotile fibers found in the WTC dust to be the predominant fiber in lung mesothelioma tissue."

It is important to note that symptoms of mesothelioma may not appear until 30-50 years after exposure to asbestos.

Often symptoms of pleural mesothelioma are:
* shortness of breath,
* pain in the chest

Peritoneal mesothelioma symptoms include:
* weight loss,
* abdominal pain,
* swelling,
* bowel obstruction,
* blood clotting,
* anemia,
* fever.

If the cancer has spread beyond the mesothelium to other parts of the body, symptoms may include pain, trouble swallowing, or swelling of the neck or face. It is very important to see a doctor about any of these symptoms. Only a doctor can make a diagnosis.

Experimental Surgery Gives Cancer Patient Hope
Woman Diagnosed With 'Untreatable' Disease

September 15, 2004

BOSTON -- Nine months ago, Karen Grant was diagnosed with a cancer that doctors said was untreatable, but an experimental surgery gave her a sliver of hope. Now, more than ever, the Chadwicks are savoring time spent together. "I feel, at least, that I'm making sure that I capture every moment somewhere up here, so that I can keep it there," said Grant's sister, Rusty Chadwick.

Karen, who had been married for two years and hoping to start her own family, was given a horrific diagnosis -- mesothelioma.

"It was a very scary moment when (the doctor) told us. I have never even heard of this disease before. I never even heard of it," Karen said. But without immediate treatment, there's very little time. "I'm worried about whether she will survive this," Karen's husband, Geoffrey Grant, said.

The rare cancer comes from exposure to asbestos -- an insulation product banned in 1975, when Karen was 1-year-old. At age 29, she's the youngest person ever documented to have it on both lungs. "It came as a shock because here I am, a healthy person, and all of the sudden, I get this disease on my lungs that I have no idea how I got," Grant said.

Searching for answers, her father tested their Haverhill, Mass., home. But asbestos-covered pipes -- sealed years ago for safety -- were airtight. And at this point, finding the source of Karen's exposure is the least of her worries. First there was a risky surgery.

"The advantage to her is that we're not removing either lung," Brigham and Women's Hospital Dr. David Sugarbaker said. A cutting-edge technique pioneered in Boston by Sugarbaker was her only shot. It's an experimental surgery with no guarantees. But for Karen, there was nothing to lose. "I am fighting every day. And I don't think once that I am not going to win," she said.

In the operating room, Sugarbaker and his team carefully cut away the aggressive tumor that lined her lungs, and lasered the tissue to burn away cells that might have been missed. Then they filled Karen's chest cavity with a hot chemotherapy, which gave her lungs an hour long soaking.

"When you heat up chemotherapy, you increase the metabolic rate or the activity of the cancer cells that are left, and cancer cells that are very active are sucking up chemotherapy as a poison," Sugarbaker said. Grant came through the surgery, but complications nearly killed her. She spent six weeks in intensive care -- unable to breathe and eat on her own, or even talk.

NewsCenter 5 saw her again almost three months later at Youville Rehabilitation Hospital, where she was fighting to get her strength back. At that time, she just wanted to come home. "I miss my family and not being able to see them all the time," Karen said.

And after 114 days, Karen's big moment finally arrived. "I made it home. I made it home. I made it. I made it," she said. Karen knows her cancer may come back, but she's living for the moment -- one breath at a time. "I shouldn't be here, but I'm here, and it just takes time," she said.

Grant's circumstances are extraordinary. The treatment was very aggressive. Doctors determined it was right for her because she was so young and physically fit. Her fight isn't over. Doctors are awaiting test results before starting her on traditional chemotherapy, but they do believe the worst is behind her.

Despite the ban on asbestos, the number of cases of this cancer have continued to climb in Massachusetts. Sugarbaker said that he is seeing an increase in the number of young people with the disease.

Gemzar® and Platinol® Neoadjuvant Chemotherapy May Improve Outcome of Pneumonectomy for Mesothelioma

Researchers from Switzerland have reported the outcomes of 19 patients with mesothelioma scheduled to be treated with extrapleural pneumonectomy and radiation therapy after neoadjuvant chemotherapy with Gemzar® (gemcitabine) and Platinol® (cisplatin). The details of this report appeared in the September 1, 2004 issue of the Journal of Clinical Oncology .

In the recent past, standard therapy for mesothelioma was surgery and radiotherapy. However, the use of doublet chemotherapy regimens has become the standard approach, with the active agents being Alimta®, Gemzar® and Platinol® and possibly Paraplatin®. The role of neoadjuvant chemotherapy has been less well defined and there have been no randomized trials comparing surgery to no surgery for potentially operable mesothelioma. However, most patients have disease that cannot be removed with surgery.

In the current study, 19 patients were scheduled to receive neoadjuvant therapy with Gemzar® and Platinol® followed by extrapleural pneumonectomy and post-operative radiation therapy. Sixteen of the 19 patients underwent surgery and 13 patients received post-operative radiation therapy. They reported that the overall response rate to chemotherapy was 32%, with the major toxicity being thrombocytopenia. The median time to disease progression was less than 12 months and the median survival was approximately 23 months. Importantly, two patients remain alive and disease-free at 41 and 38 months after therapy.

Comments: These data suggest that neoadjuvant chemotherapy, surgery and post-operative radiation therapy are feasible in selected patients with advanced mesothelioma. However, it is not clear what role each of these components has in the management of advanced mesothelioma. It is impressive that there are two long-term survivors from this group. However, only randomized trials can determine if these three modalities are necessary for successful treatment of mesothelioma.

Reference: Weder W, Kestenholz, Taverna C, et al. Neoadjuvant chemotherapy followed by extrapleural pneumonectomy in Malignant Mesothelioma. Journal of Clinical Oncology. 2004;22:3451-3457.

Industrial disease will kill more next decade

Sep 17 2004

By Selena O'Donnell, Chester Chronicle

THE human cost of Cheshire's industrial past is likely to soar in the next decade as a generation's exposure to asbestos claims lives across the region. Thousands of people are being robbed of their retirement through the devastating effects of the toxic material, effects which can take up to 50 years to present themselves.

One flake of the synthetic product ingested years before can develop into a number of debilitating illnesses, most tragically, and commonly, an aggressive cancer called mesothelioma. Those struck by mesothelioma face symptoms including pain in the lower back or chest, persistent coughs, fevers and dramatic weight loss.

It's difficult to diagnose and almost always fatal, with 10,000 deaths recorded in the UK last year. As the cases of asbestos-related deaths increase a pattern clearly emerges. Those working in the building, engineering and shipyard trades before strict regulations governing the use of asbestos were introduced are at highest risk, and nearly all victims are male.

It's a profile Cheshire coroner Nicholas Rheinberg is all too familiar with. He said: 'I hate industrial disease - if someone dies as a result of going to work it is a wicked, wicked thing. I think the cases we see now are a consequence of people living longer, the disease is having an opportunity to present itself.

'Throughout Cheshire there has been a lot of industry that relied on asbestos and we are now reaping the cost of that. Mesothelioma has such a latent period and it's now that problems are being exposed.' John Flanagan, a trustee for Merseyside Asbestos Victims Support, agrees the county should steady itself for a dramatic increase in the incidences of asbestos-related fatalities.

He said: 'The age group is definitely lowering, we have cases that are now presenting with mesothelioma at 51 years old. There are cases in Leeds of as young as 37. Obviously that is the exception but it is happening. We are seeing more and more people in their early 50s. There was an enormous amount of asbestos used in the 1960s and a 57-year-old now would have been just starting out in their working lives then.'

Scores of ex-employees or their bereaved families are pursuing compensation from their old employers, many of which have ceased to trade. 'Almost exclusively the people we are dealing with have never claimed anything in their lives and, equally, they will have gone out to work in total ignorance,' added Mr Flanagan.

'They were young people working 40-plus hours a week, trying to earn a decent living for themselves and, eventually, for their family.

'At a certain age they are expecting a few years of rest and they are pilfered of that, through asbestos.'

New Guidelines Issued for Asbestos-Related Nonmalignant Disease
News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd

Release Date: September 16, 2004; Valid for credit through September 16, 2005

Physicians - up to 0.25 AMA PRA category 1 credit(s)

Sept. 16, 2004 — The American Thoracic Society (ATS) updated the 1986 criteria for diagnosing and treating patients with nonmalignant disease related to asbestos, according to a report in the Sept. 15 issue of the American Journal of Respiratory and Critical Care Medicine. These conditions include asbestosis, pleural thickening or asbestos-related pleural fibrosis (plaques or diffuse fibrosis), "benign" (nonmalignant) pleural effusion, and airflow obstruction.

"Asbestos has been the largest single cause of occupational cancer in the United States and a significant cause of disease and disability from nonmalignant disease," write Tee L. Guidotti, MD, MPH, from George Washington University Medical Center in Washington, D.C., and colleagues. "To this demonstrable burden of asbestos-related disease is added the burden of public concern and fear regarding risk after minimal exposure."

The purpose of these guidelines is to assist the physician in arriving at a specific diagnosis leading to an individual treatment plan. Although subclinical disease may not be sufficiently advanced to be detected on histology, imaging, or functional studies, the association of nonmalignant disease with risk of malignancy warrants careful attention to diagnosis and monitoring for development of malignant disease, particularly lung cancer and pleural or peritoneal mesothelioma. However, most patients with nonmalignant asbestos-related disease do not develop cancer.

On Dec. 12, 2003, the ATS Board of Directors adopted this official statement covering diagnostic criteria and guidelines for documenting asbestos as a hazard, asbestos in lung tissue, clinical evaluation and indicator symptoms, occupational and environmental history, physical examination, conventional imaging, computed tomography (CT), bronchoalveolar (BAL) lavage, pulmonary function tests (PFT), disease outcomes, asbestosis, pleural abnormalities, chronic airway obstruction, implications of diagnosis for patient treatment, and actions required before the appearance of disease and after diagnosis.

As stated in 1986, the diagnosis of nonmalignant asbestos-related disease should be based on the essential criteria of a compatible structural lesion, evidence of exposure, and elimination of other plausible conditions.

Each of these criteria may be met by one of several findings or tests, including future testing modalities if and when they are validated. Because high-resolution CT (HRCT) has greatly increased the sensitivity of detection, it has recently become a standard imaging procedure. Evidence for exposure is still based on the occupational history, the demonstration of asbestos fibers or bodies, or pleural plaques. Conditions in the differential diagnosis are better understood than previously, such as idiopathic pulmonary fibrosis, or less common, such as tuberculosis, facilitating diagnosis.

If the three criteria described above suggest asbestos-related disease, there is also an additional requirement for functional impairment assessment, which is largely unchanged from 1986. This assessment should rate the impairment based on ATS criteria incorporated into the American Medical Association guides.

After diagnosing nonmalignant asbestos-related disease, the authors recommend notifying the patient, informing him or her of work-related illness and compensation options, and reporting occupational disease to the appropriate authority, as required by law.

Tertiary prevention should include smoking cessation, withdrawal from further excessive asbestos exposure, immunization against pneumococcal pneumonia and influenza, and management of concurrent respiratory and other diseases.

For optimal monitoring, patients should have a chest film and PFTs every three to five years, periodic screening for colon cancer, and observation and elevated index of suspicion, but not screening for lung cancer, mesothelioma, and gastrointestinal cancers other than colon cancer. Symptomatic disease mandates development of a patient-specific treatment plan.

"These criteria and the guidelines that support them are compatible with the Helsinki criteria, developed by an expert group in 1997, which represents substantial consensus worldwide," the authors write. "The guidelines supporting these criteria will undoubtedly change again in future, but the present guidelines should provide a reliable basis for clinical diagnosis for some years to come."

Am J Respir Crit Care Med. 2004;170:691-715

Learning Objectives for This Educational Activity
Upon completion of this activity, participants will be able to:
List the possible manifestations of nonmalignant diseases related to asbestos. Describe the 2004 updates to the 1986 diagnostic criteria for asbestos-related nonmalignant diseases created by the ATS.

Clinical Context
Asbestos is the single largest cause of occupational cancer in the U.S. and a significant cause of disability from nonmalignant disease. Asbestos is a commercial industrial term that refers to hair-like long fibers of certain minerals, including chrysotile, crocidolite, and amosite asbestos. It is still a hazard for 1.3 million U.S. workers involved in building maintenance and was a hazard, until recently, for those working with brake linings, flooring, cement, paint, textiles, and insulation.

Nonmalignant diseases related to asbestos exposure include asbestosis, pleural thickening or fibrosis, benign pleural effusion, and airflow obstruction. Asbestosis is pulmonary parenchymal fibrosis with or without pleural thickening, developing many years after asbestos exposure. For example, 20 years after cessation of exposure, a prevalence of 20% of parenchymal opacities was documented with intense exposures as short as one month, as reported by Ehrlich and colleagues in the April 1992 issue of the British Journal of Industrial Medicine. Asbestosis tends to occur in the lower lung fields and is associated with restrictive impairment.

This statement from the ATS updates 1986 guidelines for the diagnosis and initial management of asbestos-related nonmalignant disease.

Study Highlights
Demonstration of functional impairment is not required for the diagnosis of nonmalignant asbestos-related disease.
Identification of asbestos fibers in lung tissue is not required for diagnosis because a systematic analysis for asbestos fibers is not generally available. Light microscopy is inadequate and scanning-transmission electron microscopy is usually needed.

Asbestos bodies can be identified and quantified in lung tissue and BAL specimens. Transbronchial lung biopsy is less reliable compared with BAL or open lung biopsy.
Nonmalignant diseases presenting similarly to asbestos-related disease should be ruled out in the workup.
Symptomatic assessment includes history of insidious onset of dypsnea, nonproductive cough, positive ATS-DLD-78A ATS respiratory questionnaire, which predict diminished ventilatory capacity.
Persistence of new-onset respiratory symptoms is correlated with accelerated loss of lung function and predicts future risk.

Exposure history is usually more than 15 years before presentation. Diagnosis is based on duration, intensity, time of symptom onset, and setting of exposure. Short heavy exposures of one month to a year can result in asbestosis.
Pertinent physical examination findings are basilar rales characterized by end-inspiratory crackles.
The plain chest x-ray using the International Classification of Radiographs for Pneumoconiosis (or International Labor Organization [ILO] classification) is useful for diagnosis of asbestosis and asbestos-related pleural disease. The ILO profusion score correlates with mortality risk, reduced diffusion capacity, and diminished ventilatory capacity.
Conventional CT is now replaced by HRCT at 2-cm intervals for evaluation because it is more sensitive for detecting parenchymal disease.

The extent of asbestos plaque formation does not correlate with cumulative asbestos exposure and cannot be used to estimate exposure.
If sputum analysis is negative, asbestos bodies in BAL may be needed to document exposure. In the absence of asbestosis, the presence of asbestos bodies indicates exposure, not disease.

Lung function tests should include spirometry with flow-volume loop documented. The tests should discriminate between restrictive, obstructive, and mixed impairment. Restrictive impairment is most common and can occur with pleural disease. Isolated obstructive impairment is unusual.
Exercise testing is generally not required.
The College of American Pathologists recommends a histologic grading system based on alveolar involvement, ranging from mildest (grade I) to most severe (grade IV). Extent of disease is graded from A to C (or I to III) based on number or proportion of bronchioles involved.

Asbestosis is more prevalent and more advanced in cigarette smokers (current and former) because of reduced clearance of asbestos from lung. Smoking does not affect the presentation of asbestos-related pleural fibrosis.
Regression of asbestosis is rare and progression is more common.

Pleural thickening is determined by duration from first exposure, and the International Classification of Radiographs for Pneumoconiosis provides classification for thickening based on indices of exposure and lung function measures.
The plain chest x-ray is sensitive for locating plaques, whereas HRCT is not a practical screening method. Plaques are associated with significant reduction in lung function averaging 5% forced vital capacity even when interstitial fibrosis is absent.

Slow progression of plaques is typical, and they are associated with greater risk of mesothelioma due to greater exposure burden rather than malignant degeneration.
Pearls for Practice

Nonmalignant asbestos-related diseases include asbestosis, pleural thickening and plaques, pleural effusion, and airflow obstruction, all of which contribute to early disability and mortality.
Essential diagnostic criteria include a compatible structural lesion, evidence of exposure, and exclusion of other plausible causes. HRCT has increased the sensitivity of detection and is a standard method of imaging for asbestosis.

Fears after killer dust scare

By Eryl Crump, Daily Post Sep 17 2004 WORKERS are involved in an asbestos health scare at a North Wales university. They fear they may have been exposed to the potentially fatal fibres during work to remove asbestos from Bangor's students union building. University bosses have confirmed there was a leak in an area not open to the public, but say there is no danger to staff. Health and Safety experts have been alerted to the problem. Last night workers claimed they have been told to visit medics.
One worker, who asked not to be named, said: "We were told everyone who had worked or passed through the contaminated area should seek medical advice. "Work is being carried out in the building by contractors and that area is blocked off and boarded up. But it is possible to walk past and it is this area where the leak occurred. "Some people involved simply walked through this area, but others worked there for up to four hours. "It is a worry. I don't know what will happen to me," he said. Last night a college spokeswoman said: "The university can confirm an asbestos removal contract is currently underway at the Time building, in Deiniol Road. "As part of this contract the university has commissioned continuous atmospheric monitoring of public and staff areas to ensure the safety of all persons on site.
This is undertaken by an independent environmental monitoring consultancy. "The continuous monitoring programme identified a possible small leak of asbestos fibres into a neighbouring area. The university put into action its contingency procedures until a specialist contractor confirmed there is no risk whatsoever to staff, students or the public. "All staff have been reassured there is no foreseeable risk from asbestos exposure within the building. "The matter has also been referred to the Health and Safety Executive." The Time building is at the heart of student activity in the university and during term-time teems with students making use of the facilities, which include a bar and student union offices. The complex also includes the popular Time/Amser nightclub, open to the public.

A spokesman for the students union said the leak occurred in an area not open to students and members of the public. He said: "As a result it was nothing to do with us. "We are not happy that a leak occurred but accidents do happen and we are satisfied the steps taken by the university authorities have prevented further leaks." Five years ago several workers were involved in an asbestos health scare at the university. The scare happened after illegal and dangerous material was found in the college. A Health and Safety Executive investigation was launched when asbestos insulation boards - banned 14 years previously - were found in the estates workshop in Dean Street. The university sent several staff and former workers for X-rays and scans after the incident. Lung specialist Dr John Williams, from Halton Hospital, Runcorn, Cheshire, said exposure to asbestos fibres could be disabling and lead to breathing difficulties. But the condition, which is caused by asbestos exposure, did not necessarily lead to deadly diseases such as asbestosis and mesothelioma.

Threat of disease
SIGNIFICANT exposure to any type of asbestos will increase the risk of lung cancer, mesothelioma and non-malignant lung and pleural disorders, including asbestosis, pleural plaques, pleural thickening, and pleural effusions. Experts said diseases from asbestos exposure take a long time to develop, with most cases of lung cancer or asbestosis in asbestos workers occurring 15 or more years after initial exposure to asbestos. Cases of mesotheliomas have been reported after household exposure of family members of asbestos workers and in individuals without occupational exposure, who live close to asbestos mines. But experts added tobacco smokers who have been exposed to asbestos at any stage run a far greater risk of developing lung cancer than do non-smokers.

Ludwig Institute for Cancer Research and PowderMed Initiate A Phase I Clinical Trial for a Novel Therapeutic Cancer Vaccine

Phase I Clinical Trial of Therapeutic Cancer Vaccine Commences in New York, in Patients With Non-small Cell Lung Cancer (NSCLC), Using PowderMed's Novel DNA-on-Gold Technology

OXFORD, England, September 17, 2004 /PRNewswire/ -- PowderMed Ltd (PowderMed), a company focusing on the development of therapeutic DNA vaccines, in collaboration with its partner, the Ludwig Institute for Cancer Research (LICR), have announced that they have initiated a Phase I trial of a novel therapeutic DNA cancer vaccine that uses DNA encoding for the NY-ESO-1 tumour specific antigen and the Particle Mediated Epidermal Delivery (PMED(TM)) technology owned by PowderMed. The trial, being carried out at the Weill Medical College of Cornell University in New York, will be conducted in patients with non-small cell lung cancer (NSCLC) and will recruit up to 18 patients with NSCLC stages IIIA, IIIB or IV.

This clinical trial forms part of the Cancer Vaccine Collaboration (CVC), which is an innovative clinical research program designed and directed by LICR and the Cancer Research Institute in New York. DNA vaccines offer a promising new therapeutic intervention for a wide range of cancers. By stimulating the immune system to produce cytotoxic T-cells and antibodies specifically directed against cancer cells, these vaccines direct the immune system to attack and control or even remove the cancerous tissue. The therapeutic DNA vaccine being developed by PowderMed and LICR elicits an immune response that targets cells expressing the NY-ESO-1 cancer antigen on their surface. NY-ESO-1, discovered and patented by LICR, is expressed by many different types of human tumours and it is one of the most highly immunogenic tumour antigens discovered to date, eliciting both cellular and humoral immune responses, a combination that is best suited to attack tumours.

Such characteristics make vaccines based upon NY-ESO-1 potentially useful for treating a sizeable percentage of cancer sufferers. Dr Clive Dix, CEO of PowderMed, said: "When we launched PowderMed in May of this year we indicated that five of our programmes would enter clinical development before the end of 2005. This trial is our first step towards that commitment, but is also our first step in demonstrating why the PowderMed technology is ideal for cancer therapy." PowderMed's therapeutic vaccines use the company's proprietary PowderJect® DNA particle mediated epidermal delivery (PMED) technology, which uses DNA bound to microscopic gold particles that are propelled at high speed into the skin. PMED is particularly well suited for therapeutic vaccines, which require the induction of both humoral and cellular immunity. Commenting on the clinical trial, Dr. Eric Hoffman, the Director of LICR's Office of Clinical Trials Management, said: "The goal of this CVC trial is to evaluate the ability of NY-ESO-1 DNA formulated on gold particles to induce an antigen-specific immune response. We consider the PMED technology to have great potential as a means of safely and effectively delivering cancer antigens". Notes for Editors 1.

About PowderMed Ltd - www.powdermed.com PowderMed Ltd, a leader in the development of therapeutic DNA vaccines, based in Oxford, UK, was launched in May 2004 as a management spin out of the PowderJect therapeutic DNA vaccine programmes, previously owned by Chiron Vaccines. The Company has the rights to the PowderJect® DNA particle mediated epidermal delivery (PMED) technology which it plans to use, in the first instance, in the development of therapeutic vaccines in the areas of chronic viral diseases and cancer. PowderMed has five preclinical lead programmes targeting genital herpes, hepatitis B, genital warts, HIV/AIDS (partnered with GSK) and lung cancer (partnered with Ludwig Institute for Cancer Research). 2.

About the Ludwig Institute for Cancer Research - www.licr.org The Ludwig Institute for Cancer Research (LICR) is the largest international academic institute dedicated to understanding and controlling cancer. With ten Branches in seven countries, and numerous Affiliates and Clinical Trial Centers in many others, the scientific network that is LICR quite literally covers the globe. The uniqueness of LICR lies not only in its size and scale, but also in its philosophy and ability to drive its results from the laboratory into the clinic. LICR has developed an impressive portfolio of reagents, knowledge, expertise and intellectual property, and has also assembled the personnel, facilities, and practices necessary to patent, clinically evaluate, license, and thus translate, the most promising aspects of its own laboratory research into cancer therapies. 3. PowderJect® DNA particle mediated epidermal delivery (PMEDTM) technology Using the PowderJect device, DNA precipitated onto microscopic gold particles, is propelled by pressurised helium gas at near supersonic speeds into the epidermis. The microscopic gold particles (mean particle diameter 1 - 3 microns) are used as the carrier because they have the appropriate size and density needed to deliver the DNA directly into the immunologically active antigen presenting cells (APCs) of the epidermis. These cells have a mean diameter 20 microns and thus the microscopic gold can easily enter the cell.

Studies have shown that once inside the nuclei of APCs, the DNA elutes off the gold and becomes transcriptionally active, producing the encoded protein that when presented by the APCs to lymphocytes, triggers strong T-cell mediated immune responses. It is this ability of PMED to produce a robust and reproducible T-cell mediated immune response to a broad range of viral and cancer antigens, that provides PowderMed with its unique competitive advantage in the field of therapeutic vaccines. 4. Therapeutic vaccines Therapeutic vaccines are a new class of product, which harness the immune system in order to produce a therapeutic effect. The PowderJect technology has previously been tested in the clinic as a vaccine for prophylaxis against Hepatitis B but will be used by PowderMed in the development of therapeutic vaccines for chronic viral diseases and, in the present instance, cancer. 5. Non-Small Cell Lung Cancer Lung cancer is the leading cause of cancer-related deaths. There are 177,000 new cases of lung cancer per year in the United States. Despite continuous development of chemotherapeutic agents, the five-year survival of patients with lung cancer remains at only 13%. Over 80% of lung tumors are non-small cell lung cancer (NSCLC) and only 30% of patients with the diagnosis of NSCLC are surgical candidates.

The remaining 70% are considered unresectable due either to locally advanced (stages IIIA or IIIB) or metastatic (stage IV) disease. Thus, while surgery currently offers the only hope for cure, few patients are amenable to such treatment. While complete resection for early stage NSCLC is possible, patients nonetheless face a high rate of recurrence. The recurrence rate for stage I disease is as high as 40%. 6. A therapeutic vaccine targeting NY-ESO-1 PowderMed has produced a DNA Plasmid (pPJV7611), which encodes the NY-ESO-1 protein. PPJV7611 is precipitated onto the surface of gold particles 1 to 3 microM in diameter and will be administered to patients by particle mediated epidermal delivery (PMED). NY-ESO-1 antigen, which was discovered by LICR, is expressed in a range of human cancers, including melanoma, breast cancer, prostate cancer, lung cancer, ovarian cancer and bladder cancer. NY-ESO-1 shows restricted expression in normal tissues, with high-levels found only in the germ line cells in testis. Since germ line cells do not carry HLA molecules on their surface they cannot present antigens to T cells. To date, over 100 patients with NY-ESO-1 expressing tumors have received NY-ESO-1 vaccination using various formulations. This clinical data has established an extensive safety profile for NY-ESO-1, with toxicities limited to Grade 1 or 2 injection site reactions or flu-like symptoms, e.g., fever, malaise, etc. Vaccination with these agents has generated or enhanced NY-ESO-1 specific antibodies and CD8+ T-cells in the majority of patients whose serum and/or TT blood has been subjected to standardised immune monitoring. 7.

Phase I Clinical trial in Non-Small Cell Lung Cancer (NSCLC) patients Phase I clinical trials are the first trials of a drug in humans. They are usually short term trials in a small number of individuals designed to evaluate preliminary safety of a compound in the human. In the present trial, up to 18 patients with NSCLC stages IIIA, IIIB or IV expressing either NY-ESO-1 or LAGE-1 (an antigen closely related to NY-ESO-1) will have the vaccine administered via PMED on three occasions over a twelve-week period. Over that time the vaccine's safety will be assessed in the patients through blood tests and an assessment of likely adverse drug reactions. 8. The Cancer Vaccine Collaborative The Cancer Vaccine Collaborative (CVC) is a partnership between two not-for-profit academic institutions, the Cancer Research Institute and the Ludwig Institute for Cancer Research, which has developed an unparalleled programme that conducts a systematic analysis in humans comparing immunological approaches to the creation of therapeutic cancer vaccines through a coordinated global effort. This clinical trial forms part of the CVC. Unlike conventional, stand-alone trials-where data from one trial are often incomparable to data from another because of the number of uncontrolled variables between the two-investigators for the CVC will use standardised tests to evaluate different ways to deliver the same vaccine agent, the antigen NY-ESO-1.

This standardised methodology and data collection will allow for direct comparison with other trials in the CVC and help the researchers understand why certain vaccine strategies might result in a more robust immune response while others might not. 9. The Cancer Research Institute Since its inception in 1953, the Cancer Research Institute (CRI) has had a singular mission-to foster research that will yield an understanding of the immune system and its response to cancer, with the ultimate goal of developing immunological methods for the control and prevention of the disease. To accomplish these goals, CRI supports scientists at all stages of their careers and funds every step of the research process, from basic laboratory studies to clinical trials testing novel immunotherapies. Guided by a Scientific Advisory Council, which includes 4 Nobel Prize winners and 24 members of the National Academy of Sciences, CRI awards fellowships and grants to scientists around the world. Additionally, the Institute has more recently taken on a new leadership role in the areas of preclinical and clinical research by serving as the integrating force and facilitator of collaborations among leading experts. CRI has thus become a catalyst for accelerating the development of cancer vaccines and antibody therapies.

Improved Survival for Patients Diagnosed With Lung Cancer Who Have Never Smoked

The results of a recent study published in the journal Chest indicate that patients who have never smoked and have been diagnosed with adenocarcinoma have improved survival compared to patients who are current smokers. Lung cancer is the leading cause of cancer-related deaths in the United States and Europe. Non-small cell lung cancer is a malignancy that arises from the cells within the lung. Adenocarcinoma is one of 5 types of non-small cell lung cancer. Other types of non-small cell lung cancer include squamous cell, adenosquamous carcinoma, large cell carcinoma, and undifferentiated carcinoma. Each type of non-small cell lung cancer is defined by the physical characteristics of the cells and how they appear under the microscope.

Smoking can be attributed to 85% of diagnosed cases of lung cancer due to the damage of lungs caused by cigarettes. Factors determining a smoker’s risk include the number of years the person has been smoking, as well as the number of cigarettes smoked each day. In this recent study, data were gathered at the H. Lee Moffit Cancer Center regarding 132 never smokers and 522 current smokers, all diagnosed with adenocarcinoma of the lung. Former smokers were not included in the study. Detailed demographic information was compiled for survival information. When compared, the age at diagnosis was higher for patients who had never smoked compared to the current smokers. In addition, there was an increased percentage of women among those who had never smoked (78% vs. 54%).

Finally, 5-year survival was 23% for the patients who had never smoked compared to 16% for current smokers. Researchers concluded that patients who had never smoked and were diagnosed with adenocarcinoma were largely female, were diagnosed at a higher age and had improved survival when compared to current smokers. The survival benefit may be partly attributed to the health status of the non-smoker, who is less likely to have other chronic conditions often associated with smoking, such as heart disease or chronic obstructive pulmonary diseases. Future studies of non-smokers will be necessary in order to learn more about the differences in non-smokers diagnosed with lung cancer and such studies may be useful for determining the characteristics of cancer in this specific population. Reference: Nordquist L, Simon G, Cantor A, et al. Improved survival in never-smokers vs. current smokers with primary adenocarcinoma of the lung. Chest. 2004; 126: 347-351.

Further Classification of Lung Cancer may Better Predict Survival

(Ivanhoe Newswire) September 17, 2004 -- A new system of subcategorizing tumors in lung cancer patients may predict survival better than the current system of classification, according to a new study. The current system classifies stage I tumors as either stage IA (smaller than three centimeters) or stage IB (larger than three centimeters). While past studies have shown differences in patient survival rates between these two groups, researchers now recognize a statistically significant difference in survival rates among patients with tumors smaller than three centimeters.

Researchers from Mount Sinai Hospital and Columbia Presbyterian Hospital-Weill Cornell Medical Center in New York evaluated data on 7,620 individuals with stage I non-small cell lung cancer. The researchers note over 12 years, cure rates for stage IA lung cancer increased as tumor size decreased. People with the smallest tumors, five millimeters to 15 millimeters in diameter, had the highest cure rate at 69 percent. Those with the largest tumors, over 45 mm, had a 43-percent cure rate. The authors conclude, "Smaller tumor size at diagnosis is associated with improved curability within stage I non-small cell lung cancers. These results suggest that further subclassification by size within stage I may be important." This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/. SOURCE: CHEST, 2004;126:761-765

Vivant begins trial for use of VivaWave in lung cancer

By Holland Johnson Medical Device Daily Associate Managing Editor Vivant Medical (Mountain View, California)September 17, 2004 reported that it has teamed up with Rhode Island Hospital (Providence, Rhode Island) to begin a clinical study to determine the effectiveness of microwave ablation for treatment of lung cancer. In the study, Rhode Island Hospital will be using Vivant's VivaWave ablation system, which has received FDA 510(k) clearance for coagulation of soft tissue. Damian Dupuy, MD, director of minimally invasive therapy and ultrasound at the hospital, is the principal investigator for the study.

Microwave ablation is a heat-based treatment used to destroy tumors. Under the lead of Dupuy, Rhode Island Hospital's staff has already performed procedures in more than 50 patients using VivaWave to ablate multiple masses in soft tissues, including kidney, liver, bone and adrenal glands. Due to its consistency, predictability, safety, reduced procedure times and ability to treat large lesions, microwave ablation is being developed as a promising and attractive option for patients with lung cancer who are typically not candidates for surgery and may not be able to be treated with current thermal therapy such as radio frequency (RF) ablation. To date, Rhode Island Hospital is the largest user of microwave ablation. Privately held Vivant was founded about five years ago by the well-known cardiac surgeon and inventor, Thomas Fogarty, MD.

The company's goal was to develop a microwave ablation system to overcome what it saw as the limitations of current thermal ablation technologies and to provide an attractive option for local control and/or pain palliation of unresectable tumors. "The product we're really trying to develop is what we would view as a next-generation technology that allows the clinician to heat and kill the tumor in places where surgery is not an option," CEO Rod Young told Medical Device Daily. At this time, he noted that surgery to excise tumors is the current standard of care. However, he said most patients with, for example, lung or liver tumors "really are not surgical candidates." While Young noted that thermal ablation via radio frequency energy has been used for about five years to treat some of these cancers, he said that technology has some limitations. These include small ablation size (3 cm or less) and being limited to using one probe at a time during surgery. "For both of those reasons," he said, "the procedures have taken a long time if you're trying to treat a larger tumor in any fashion, and in most cases you want a margin around a tumor and that takes even longer."

While Young said that the device already has already received FDA clearance for the various-sized probes (over the past six to eight months), he said Vivant elected not begin commercial sales because "we really wanted to get substantial clinical use and feedback before we did it." The strategy, he said, was to find clinicians who already were using the existing RF technology, get them use the VivaWave "and to really confirm the advantage that we thought we had with it." Enter Dupuy, one of the pioneers in the development of RF ablation, the current industry standard in thermal ablation. Attracted by VivaWave's potential vs. RF ablation, Dupuy actively sought out the newer technology. Dupuy said that he has used RF ablation technology since 1993 to treat more than 800 patients. However, he told MDD that he had come to a place in what by all accounts has been an envelope-pushing career, where he had maxed out the existing RF technology in his bid to treat increasingly more difficult tumors. "When I saw some of the early research that was coming out with this new Vivant device, I basically said `I've got to get my hands on it.'"

Dupuy said he first used the device on liver tumors, and was very impressed with the results. Since then, he said he also has used the system to treat lung, kidney, pelvis and bone tumors. He said that one of the things that has really struck him about the technology is that because it is a microwave energy source and not an electrical current, "it's less painful," to the patient. "When you use radio frequency," he said, "you have to put grounding pads on the patient's legs or their back to create the electrical circuit." Another advantage Dupuy said that the VivaWave has is a higher degree of convection energy than for RF. It has a much greater radius from the source than RF and it is hotter. This, he said, helps to overcome what he termed the "heat sink effect" that limit the effectiveness of other technologies. Dupuy said this is important because it allows surgeons to treat larger vessels, including those presented in liver tumors. The VivaWave also has the ability to treat multiple, larger tumors at a greatly reduced time when compared to RF, allowing the surgeon to perform more procedures in a day. Dupuy said that this procedure's time savings translate to less room time, which means the procedure can be done faster and cheaper and with less sedation, "and it makes my time more efficient. I can do more ablations in a day." He stressed that the microwave technology will not just be used to treat large tumors, and said the company already has designed a smaller applicator to treat these smaller tumors.

The VivaWave was designed to overcome limitations of current thermal ablation technologies, the standard of treatment for oncology patients who are not candidates for surgery. Of patients with liver and lung tumors, 80% fall into this category. For these patients, microwave ablation would not preclude adjuvant treatment with chemotherapy and/or radiation. It can be an option for patients where other thermal modalities cannot be used due to tumor size or location. Dupuy said that right now, a lot of the ablation and minimally invasive techniques are being used in patients who are not good candidates for surgery. However, he said, "In our lifetime, there's no question that image-guided ablative techniques will replace surgery in many solid tumors." He went a step further and said that for primary tumors of the lung, liver and kidney, "I think this technology will probably replace surgery in 10 years." Dupuy said he has treated five patients in the lung study and those have so far shown the technology to be successful. "Our imaging right after [the surgeries] has shown that we've killed the target tissue volume and there haven't been any unexpected complications." Young is optimistic that this new study will reap big benefits for his company. "We are pleased with the initiation of this study and look forward to broadening the use of the VivaWave system for the treatment of lung cancer," he said. "Approximately 174,000 new cases of lung cancer will be diagnosed in 2004, accounting for 13% of all new cancer cases. We believe that the VivaWave has the potential to aid doctors in effectively and safely treating patients with lung cancer who are left with precious few alternatives," he added.

New guidance out on asbestos-related ills

WASHINGTON, DC, Sep. 15 (UPI) -- New American Thoracic Society guidelines recommend using lung function tests and an expansive work history to help diagnose asbestos-related disease. Asbestos is a mineral fiber once used extensively in insulation. If breathed in it can scar the lungs and cause the membrane covering the lungs and walls of the chest to thicken, develop plague or swell with fluid. Some 1.3 million construction industry and maintenance workers still face asbestos risks today, said the 11-member ATS panel of experts in a statement Wednesday. ATA said doctors suspecting asbestos-related ailments should get at least a 15-year work history. Workers who are or were involved in the manufacture of asbestos products, asbestos mining and milling are at risk, as are those in the construction trades -- insulators, sheet metal workers, electricians, plumbers, pipe fitters and carpenters. Power plant workers, boilermakers and shipyard workers may also face asbestos exposure. While X-rays are useful in diagnosis, high resolution computed tomography offers a more sensitive analysis, said the ATS. Doctors should also perform a lung function test and sometimes collect samples from deep in the lung. The statement appears in the second September edition of the American Journal of Respiratory and Critical Care Medicine.

2004 Mesothelioma Lung Cancer News
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