Verastem Inc. recently announced that they have received orphan drug status from the European Commission for a new drug that has been designed to treat mesothelioma. The goal of orphan status, both in Europe and in the United States, is to encourage the development of drugs for rare diseases such as this.

“Mesothelioma is a devastating disease with limited treatment options,” said Dr. Joanna Horobin, Verastem chief medical officer, in a recent press release. “We are working with investigators throughout Europe and internationally to bring a new treatment option for these patients.”

The name of the new drug candidate is VS-6063, announced the company. It will be studied in a Phase 2, registration-directed, clinical trial that is scheduled to begin later this summer. Currently, the drug maker, along with LabCorp, is developing a biomarker test to determine which mesothelioma victims are the best candidates for the trial. In addition, a Phase I/Ib trial using VS-6063 along with another chemotherapy drug is currently being offered to some ovarian cancer patients.

In Europe, Orphan Medicinal Product Designation allows for the drug developer to take advantage of up to 10 years exclusivity if the drug is approved for use in Europe. The status also allows U.S. companies to have greater interaction with the European drug regulatory agency in regards to clinical trials, notes an article in the Boston Business Journal.

Currently, the most widely-used drug in the United States for the treatment of malignant pleural mesothelioma is Alimta©, a chemotherapeutic agent developed by pharmaceutical giant Eli Lilly. It is often used in conjunction with other forms of mesothelioma treatment, including surgery and/or radiation. Still, the prognosis for most meso patients is not good, hence the need for better drugs that prolong lives.

In a press release published earlier this week, the Asbestos Disease Awareness Organization (ADAO) pronounced that it could not support the new “Chemical Safety Improvement Act of 2013” until significant changes are made to protect the public from dangerous materials such as asbestos.

The ADAO noted in the press release that the chemical industry was quite pleased with the bill, but stressed that they are disappointed in a number of specifics, including the fact that the organization’s suggested amendments in regards to asbestos exposure and use were stripped from the bill, known as S. 1009.

“We are encouraged by bipartisan efforts to overhaul the outdated and ineffective Toxic Substances Control Act (TSCA) from 1976, but we cannot support it unless critical clarifications and changes are adopted,” said Linda Reinstein, ADAO Co-Founder and mesothelioma widow. “The facts are irrefutable – asbestos is a known carcinogen. Congress has known for more than 100 years that asbestos exposure causes diseases, yet exposure continues. ADAO urges Congress immediately amend S. 1009. One life lost from an asbestos-caused disease is tragic; hundreds of thousands of lives lost is unconscionable.”

As a result of their disappointment, the ADAO is launching a “six-word quote campaign” encouraging asbestos victims and their families to write brief messages to Congress about how asbestos has affected their lives. Reinstein notes that pass messages have included, “Asbestos has stolen my Dad’s life” and “Asbestos is a creeping thief…stealing families.”

“If the legislation as currently written becomes law, future generations of Americans will fall victim to mesothelioma and other life-changing afflictions from exposure to dangerous chemicals,” adds 37-year-old asbestos victim Janelle Bedel. “Americans need to know asbestos is deadly and has not been banned in the U.S.”

With a group of doctors recently in the news complaining about the high cost of new cancer drugs, others say it’s actually time we spend more money on those drugs because they truly bring down the cost of cancer care overall, often eliminating the need for costly hospital stays that are mostly caused by complications from older, less-targeted drugs that cause countless side effects.

An article in Forbes by Dr. Scott Gottlieb explains that America is seeing plenty of overall progress in the field of cancer care, despite the fact that total spending on oncology care has been remarkably constant over the last 20 years, accounting for just less than 5% of total healthcare spending. The newer, more expensive cancer drugs, he adds, not only have produced markedly better clinical outcomes but also cheaper care overall.

“Far less money is being spent on services like hospitalizations, and far more on outpatient medicines,” Gottlieb explains. “Cancer treatments that used to make patients very sick and require costly hospitalizations have been replaced with targeted drugs that can allow patients to be more easily treated at home.”

“Part of the shift to outpatient treatment was driven by economic incentives that made it more profitable to prescribe cancer drugs in doctors’ offices,” he adds, “But this shift was also driven by the wider use of less toxic, more effective medicines that let patients be safely treated while at home.”

While inpatient cancer admissions accounted for 64 percent of total cancer care spending in 1987, that figure is now closer to 27 percent, Gottlieb explains. Unfortunately, however, most insurance companies cover hospital admissions better than they cover care delivered in the community. This is especially true for cancer drugs. This is where the catch-22 situation enters the picture, he explains. At that point, individuals become responsible for large out-of-pocket treatment costs, especially for newer drugs.

Because of government rules, Gottlieb goes on to explain, drug companies are forced to price their products as high as possible as soon as they enter the market, recognizing that they may not be able to make price increases later.

“The price tag of new medicines isn’t trivial, nor is the high cost of treating cancer,” Gottlieb stresses. “But the clinical and economic data shows that when it comes to technological advances and new drugs, we continue to get increasingly more for our money.”

When it came time to remove asbestos-containing materials from the now-defunct Nestle plant in Fulton, New York, there was a right way to do it and a wrong way. Plant owner Edward Palmer chose the wrong way.

According to an account in the Syracuse Post-Standard, Palmer, age 47, decided that the laws governing asbestos handling and removal didn’t apply to him. First, he failed to tell the U.S. Environmental Protection Agency that asbestos removal would be taking place at the plant, which opened in 1899 and has been closed since 2003.

Next, Palmer hired unlicensed workers who weren’t trained in asbestos abatement to tackle the job. They failed to use the proper methods to remove the material, including wetting it first. Wetting the asbestos keeps fibers from becoming airborne. Lastly, Palmer, who owns Carbonsted LLC, did not instruct workers to take the hazardous debris to a state-approved landfill for disposal.

This week, Palmer admitted his guilt in federal court and was charged with violating the federal Clean Air Act by improperly removing a portion of approximately 2,000 feet of friable asbestos insulation from pipes inside the old building, which was the birthplace of Nestle Quik and a variety of other well-known Nestle-manufactured products.

According to the newspaper story, Palmer could potentially receive a sentence of as much as five years in prison and a $250,000 fine. Sentencing will happen on October 30 in the court of U.S. District Judge Frederick Scullin.

Unfortunately, scenarios such as this are not uncommon around the United States. Individuals purchase old factories and allow them to decay. When it comes time to either demolish or renovate the building, they must tackle the task of asbestos removal. Many building owners decide to take short cuts and their workers, as well as the general public, are often subject to unnecessary asbestos exposure, which can cause them to develop serious diseases later in life, such as mesothelioma cancer.

Last week, state and federal environmental agencies raided the Hilton Center in Rensselaer, New York, prompted by suspicions that “asbestos-related projects” carried out at the industrial park during the last five years may have involved illegally handling of the toxic material. Now, a federal grand jury is investigating to determine whether infractions incurred.

According to an article in the Times Union, a subpoena filed by the Syracuse-based grand jury seeks “any and all documents pertaining to any renovation, demolition or any other project, to include asbestos related projects, filed” by Arthur Hilton, Hilton Management LLC or PRO Manufacturing Co.

Among the documents requested are financial records as well as environmental and asbestos surveys from the city’s code enforcement office and building department. Specifically, the grand jury is seeking project files, notices of violations, permits, notes and communications.

Apparently, the Hilton Center industrial park has a history of asbestos issues, including illegal asbestos removal from its buildings. The city closed the center last month, driven by these suspicions of wrongdoing.

Indeed, Arthur Hilton is no stranger to asbestos handling problems. In 2004, he pleaded guilty to violating the federal Clean Air Act and Superfund laws, having illegally removed countless bags of asbestos from the property in question. In addition, it was proven that he hired workers to dump the bags of debris by various highways near the Massachusetts state line. The article did not indicate how Hilton was punished for his infractions.

The fear remains that workers hired by Hilton would have been exposed to asbestos, which can be deadly if inhaled. If the workers were without protective gear, chances are they breathed in countless airborne fibers, which may eventually cause them to develop diseases such as pleural mesothelioma or asbestosis.

Australia’s major provider of cable and mobile phone service, Telstra, has come under fire as the company works to prepare underground pipes and pits currently used by copper phone lines to house its fiber-optic cables, making way for the new National Broadband Network (NBN). According to extensive media reports, contractors working in the asbestos-filled pits have been accused of improper handling of the material.

Telstra reported today that it has now employed 200 specialists to look into the poor asbestos management by its contractors, many of whom have been accused of improper asbestos abatement that could cause workers and even the general public to suffer asbestos exposure.

“Telstra retains ownership of the pit and pipe infrastructure and retains the primary responsibility for the remediation of its infrastructure to make it fit for NBN practice,” NBN Co chief executive Mike Quigley told a parliamentary hearing on Thursday. NBN is leasing the pits from Telstra for the new network.

Prime Minister Julia Gillard agreed that Telstra needs to see that the problems are addressed, citing the fact that many workers are now concerned about asbestos exposure. “All safety procedures must be adhered to,” she added.

“Telstra has acknowledged that the handling of the material has been insufficient, hasn’t followed procedure and requirements,” Communications Minister Stephen Conroy stressed.

Issues were cited in at least three locations – Ballarat, Hobart, and South Australia – and officials fear that there are more pit sites that may have been affected. Some referred to the situation as an “asbestos minefield”. As a matter of fact, Conroy says he’s been made aware of several other incidents outside of those that have already been made public.

Australia’s News 9 notes that the Australia Post has even stopped delivering mail in some locales, mainly streets near contaminated pits, fearing that their employees may be exposed to hazardous asbestos dust.

Local news media outlets report that The Communications Electrical and Plumbing Union (CEPU) has asked that Telstra create a fund for workers affected by asbestos, and the company has already set up a hotline for residents concerned about asbestos remediation work in their area. Asbestos exposure can cause myriad respiratory diseases, including mesothelioma cancer.

]]> http://www.maacenter.org/news/australians-worried-about-%e2%80%9casbestos-minefield%e2%80%9d.html/feed 0 http://www.maacenter.org/news/tornado-destruction-prompts-concerns-about-asbestos.html http://www.maacenter.org/news/tornado-destruction-prompts-concerns-about-asbestos.html#comments Thu, 23 May 2013 15:58:36 +0000 PatGuth http://www.maacenter.org/news/?p=2880

Experts from the U.S. Environmental Protection Agency (EPA) are already warning residents of Moore, Oklahoma that the debris left behind after this week’s killer tornado could be hazardous to their health.

EPA spokesman Chris Whitley told the media that the scene in Moore is eerily similar to what he experienced last year in Joplin, Missouri, a scene he described as “unlike anything I’d ever seen.” Now, his job and the job of other EPA experts is to warn locals of the danger of sifting through the rubble that was once their house or business.

Besides the obvious hazards, which include things like nails, shattered glass, and loose wires, the people of Moore, Oklahoma need to be on the lookout for less obvious dangers, such as exposure to asbestos materials that were damaged and tossed about by the high winds brought on by the tornado. It’s something most people don’t consider during search-and-rescue or simply while sifting through the rubble for their belongings

“As they search for their loved ones, the threat of asbestos is far from people’s minds,” said Linda Reinstein, president of the nonprofit Asbestos Disease Awareness Organization. “We’ve seen this in Joplin, and after Hurricane Sandy. We know that residential areas were constructed with asbestos-contaminated products. After natural disasters, asbestos is a prevalent toxin.”

“But we can’t see it, taste it, smell it or touch it,” added Reinstein, noting that anyone who “suspects or expects asbestos in materials” to leave it alone so that it can be removed by someone licensed and trained in asbestos abatement.

Asbestos is of special concern, notes an article in the Huffington Post, because the area of Moore hit by the tornado contained many homes built in the 1960s and 1970s, an era when asbestos use was still commonplace. These homes may have contained asbestos insulation, roofing materials, siding, or other building products.

“If there is a dust hazard, whether there’s asbestos or not, you should be taking precautions,” said Dr. Mark Keim, environmental health specialist for the Centers for Disease Control. “During cleanups, take frequent breaks, and wash your hands before eating or touching your mouth.” He also recommended the use of respirators and rubber gloves.

A French Socialist party leader who was charged with manslaughter related to the death of thousands of French citizens who were exposed to asbestos has been cleared of the charges by an upper-level court. The decision paves the way for Martine Aubry to re-enter the political scene.

“The courts today [recognized] that no fault or negligence could be attributed to me,” said Aubry, who is presently the mayor of the northern city of Lille. The statement appeared in The Local, a publication that profiles France’s news in English.

“Everybody knows that I have always acted as an official and as a minister to defend and reinforce the rights of workers and protect them from occupational hazards,” she added.

It was alleged that Aubry, who served as the director of industrial relations for the ministry of social affairs from 1984-1987, worked to delay the implementation of a 1983 European Union directive that was designed to strengthen the protection of workers who regularly dealt with asbestos in the workplace. Opponents say she caved in to pressure from lobbyists that were fighting a complete ban on the use of asbestos in France. They claim she ignored warnings from the French health community stating that the number of cases of mesothelioma and lung cancer from asbestos exposure was growing rapidly.

The case in which she was cleared was specifically related to workers at the Fereo-Valeo auto components factory in Normandy. Workers at that plant encountered asbestos daily as it was long used in the manufacture of brake pads, clutches, and other friction products.

Two separate recent studies have addressed two common aspects of cancer care, raising questions about whether the protocols for treating patients with the disease may need to change in the near future, both lessening side effects and lowering patient costs.

Results of the two studies were released this week in advance of the American Society of Clinical Oncology’s annual meeting in Chicago, which will begin on May 31, reports Bloomberg. The first studied 1,800 men with early-stage testicular cancer, determining that post-surgical radiation or chemotherapy had no significant effect on long-term survival. The men were followed for ten years and it was determined that 99.6 percent of those who didn’t undergo radiation or chemo immediately after surgery were still alive at the end of that period.

The second study involved patients with lymphoma and determined that patients receiving treatment for that disease weren’t necessarily helped by the expensive imaging scans often used after their treatment, especially scans that use radioactive tracers.

Experts say that these studies are among many that are aiming to help cut down on the nasty side effects experienced by cancer patients, including hair loss and DNA damage, and also aim to address the exorbitant costs of dealing with cancer and its treatment.

“The economics of health care and the quality of care are really being looked at more closely than in the past,” stressed Phil Kantoff, a professor of medicine at Harvard Medical School. “Why are you doing this? If the answer is ‘that’s what we do,’ rather than ‘there’s a study that shows we save lives this way,’ that’s not good.”

Often, researchers say, the complications of certain conventional therapies outweigh the benefits. They suggest doctors be more proactive in reviewing studies to determine whether what they prescribe will benefit their patients and/or whether to consider other alternatives or none at all.

Researchers note that lowering treatment costs is also essential, especially given some of the sky-high prices charged for newer cancer drugs. Do to the high cost of treatments, cancer patients are shown to be 2.6 percent more likely to file bankruptcy than others their age who do not have the disease.

Customers who store their items in two storage sheds at the decommissioned K.I. Sawyer Air Force Base in Marquette County, Michigan may not be able to retrieve their items for quite some time now that asbestos has been discovered at the two 40,000-square-foot facilities.

An article in The Mining Journal reports that the two sheds, owned by the Sault Saint-Marie Tribe of Chippewa Indians, were found to contain loose, damaged asbestos. The discovery was made about two weeks ago. Now, professional asbestos consultants will need to be called in to access the extent of the problem, the article adds.

“The tribe is doing everything it can to expedite this and make sure everyone is safe,” said Saulius Mikalonis, a Plunkett Cooney attorney representing the tribe from Bloomfield Hills.

Mikalonis confirmed that the tribe had been leasing the two sheds to Second Street Storage since 2010 but recently had to repossess the buildings when the temporary storage company fell severely behind on its rental payments. Last month, when they cut off locks and pushed open doors to inspect the premises, they found asbestos-containing pipe fitting tape on the floor. The tribe is now assuming that there is an asbestos problem in both sheds, though testing was only done on one of the buildings.

In the meantime, they are keeping the proper authorities apprised of the situation, including the Michigan Department of Environmental Quality and the Michigan Occupational Health and Safety Administration.

Unfortunately, it could be quite some time before customers have access to the items inside the two sheds, which include boats and recreational vehicles stored their during the winter months. It’s a disappointing situation for those who were awaiting the start of summer and the chance to use their boats and RVs.

“If the amount of disturbed asbestos present is significant or widespread, a specific sequence of steps to wet and dispose of the materials would be required,” the article points out. At this point, no one has the answer.

“It is a complicated, time consuming, and expensive process,” Mikalonis confirmed, stressing that the tribe is determined to do the right thing lest they be hit with expensive fines for violations of asbestos laws, which are designed to help prevent asbestos exposure, which can cause cancers such as mesothelioma as well as other respiratory diseases. Asbestos is often found on U.S. military bases and was long used in naval shipyards as well.