Posts Tagged ‘OMB’

Why is EPA proposing relaxed asbestos rules?

6 Aug 2008 by under News, Organizations

The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Asbestos Committee held public meetings July 21 and 22 in Washington, D.C., to discuss changes in the way it measures the risk posed by inhalation exposure to asbestos. Results of this meeting are coming under fire, as environmental groups, labor safety leaders, physicians, scientists and politicians object to the EPA’s proposed revised evaluation standards.

According to recent report in the Seattle Post-Intelligencer, there were 20 experts appointed to the SAB’s asbestos panel, charged with evaluating the validity of the EPA’s plan to change how the toxicity of the six types of asbestos regulated by the government differ in danger. Its findings would be submitted to the White House Office of Management and Budget (OMB).

According to the PI report, scientific advisors say the EPA used the asbestos panel to submit new studies that contradict longstanding research into the dangers of asbestos. The new studies say chrysolite, in particular, the most common type of asbestos, isn’t dangerous and doesn’t cause mesothelioma.

PI quotes Dr. David Egilman, an occupational medicine specialist, who testified at the public meeting, as saying the new study was financed by mining and other asbestos-related industries, and said the studies have no scientific credibility.

Another vocal spokesperson at the hearing was Sen. , who sponsored S. 742, the Ban Asbestos in America Act of 2007, which passed the Senate on Oct. 4, 2007. Currently, it is the companion bill to H.R. 3339, the Bruce Vento Ban Asbestos and Prevent Mesothelioma Act, sponsored by Rep. Betty McCollum, which currently is in committee in the House of Representatives.

Sen. Murray has long been an advocate for a total asbestos ban, calling for better worker protection. The PI quotes Sen. Murray as telling the committee, “I’d like the political appointees at the EPA to look into the eyes of a mesothelioma patient and say that asbestos isn’t dangerous. It appears that this administration is once again putting politics before public health.” Murray is currently chairwoman of the Senate Employment and Workplace Safety Subcommittee.

The EPA asserts the new system is needed to improve how asbestos-contaminated Superfund sites are evaluated. The organization can move forward with its proposal without approval from the OMB or the SAB, if it so chooses.


CDC grant for possible Ground Zero illnesses

31 Jul 2008 by under News, Research/Treatment

The Centers for Disease Control (CDC) recently announced a new program to provide $30 million in grant money for health screenings, assessments, monitoring and tracking, and improved access to health care services and treatments for those who may have been impacted by the World Trade Center collapse on Sept. 11. The grant will be available not only to first responders and other workers, but also to hundreds of thousands of Manhattan residents who live or lived near the Twin Towers.

The buildings’ collapse released thousands of pounds of hazardous material into the atmosphere, which may have included a combination of glass, asbestos, fiberglass, pulverized concrete, lead, mercury, cadmium, dioxins and PCBs. Construction of the World Trade Center buildings was begun before the use of asbestos was banned in the U.S., and some estimates say as much as 400 tons of asbestos fiber was in the buildings.

People near could experience a number of medical problems as a result of their exposure to this toxic dust, including respiratory problems and including mesothelioma.

In an official release from the CDC, Christine Branche, acting director of the CDC’s National Institute for Occupational Safety and Health (NIOSH), said, “These public health dollars extend the reach of our efforts so that they help support the provision of the health care services to residents, students, an others who were in the vicinity of the attacks of September 11, 2001.”

The release says the NIOSH-administered grants provide up to $10 million per year for three years, and the money can be used to help cover gaps when individuals’ public or private insurance is insufficient to fully cover the costs associated with care or treatment.

Funding will be provided to one to three organizations, with the deadline for proposal submission set for Aug. 25, 2008. For more information about how to apply for one of these grants, visit www.Grants.gov. The CDC encourages health and medical care facilities to apply.

The CDC says it already has invested at least $925 million in programs to support responders to the 9/11 emergency.


Chemo combo highly effective for mesothelioma

22 Jul 2008 by under News, Research/Treatment

Researchers in Denmark have discovered a chemotherapy combination that is proving to be highly effective for people with non-resectable malignant mesothelioma, according to a recent report on CancerConsultants.com. The study was published in a June issue of the British Journal of Cancer.

According to the report, the study evaluated a regimen of Navelbine (vinorelbine) and Platinol (cisplatin) for the treatment of 54 patients with newly diagnosed non-resectable mesothelioma. The median number of cycles of chemotherapy administered was four. There were two complete responses and 14 partial responses.

The median survival was 16.8 months, and the median time to tumor progression was 7.2 months. The one-year survival was 61 percent, the two-year survival was 31 percent, and the three-year survival was 4 percent.

The authors of the study say these results are as good as or better than currently used combinations for treatment of mesothelioma.


Clinical trial for mesothelioma at NY hospital

8 Jul 2008 by under News, Research/Treatment

A New York medical center specializing in the treatment of mesothelioma has announced a new clinical trial accepting patients. The within the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital and Columbia University Medical Center is launching a program of targeted radiation and chemotherapy protocol for pleural mesothelioma, a cancer of the lung’s lining that is almost always caused by previous exposure to asbestos.

It is hoped the new treatment will replace or delay the need for the standard treatment in these cases, a pleural pneumonectomy, which involves removal of the lung and which can be extremely debilitating to patients.

According to a press release from the medical center, Dr. Robert Taub, the study’s principal investigator, director of the Mesothelioma Center at NewYork-Presbyterian/Columbia and professor of clinical medicine at Columbia University College of Physicians and Surgeons, says, “Current surgical and chemotherapy treatments of patients with malignant pleural mesothelioma are unsatisfactory, and have not been shown to significantly prolong survival. In this study, we will investigate whether a combination of chemotherapy and radiation targeted directly at the lung’s lining can improve outcomes while avoiding surgery. In addition, this approach has shown to have minimal toxic side effects compared to systemic chemotherapy.”

The Mesothelioma Center is the only one nationwide that is offering this experimental therapy to treat pleural mesothelioma.

The study is being conducted at the Mesothelioma Center within the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital and Columbia University Medical Center. According to the release, participating patients will receive several rounds of targeted chemotherapy using the drugs cisplatin and doxorubicin via surgically implanted catheters. Some patients will be randomly selected to receive additional systemic (intravenous) chemotherapy using the drugs cisplatin and pemetrexed. All patients will receive targeted radiotherapy using the P-32 radioisotope.

Patients may elect to receive additional surgical treatment, including removal of the affected lung lining or lung. Subsequently, patients will be offered outpatient systemic chemotherapy with cisplatin and pemetrexed.

For more information, visit www.hiccc.columbia.edu.


Senate introduces lung cancer legislation

25 Jun 2008 by under Legal, News

Today, the U.S. Senate is considering landmark legislation that will create a multi-agency, comprehensive program to target lung cancer, and that will authorize $75 million for the first phase of a five-year program to reduce lung cancer mortality. the Lung Cancer Mortality Reduction Act of 2008 was co-sponsored by Sen. Dianne Feinstein (D-CA) and (R-NE). Mesothelioma sufferers can benefit as a result of this increased focus on lung cancer research and early detection.

Senators Feinstein and Hagel were instrumental in authoring a policy resolution in 2007 to designate lung cancer as a public health priority, which was passed unanimously. The resolution called for research, better treatments, and early detection, with a goal of reducing lung cancer mortality by 50 percent by 2015.

This new bill would establish that comprehensive program under law and authorize funding, according to a release from the , which today issued a call to action for its support.

“We have seen great advancements in prostate and breast cancer survival rates and we must commit ourselves to making the same progress with lung cancer,” Sen. Hagel said, noting that lung cancer currently accounts for 28 percent of all cancer deaths in the United States.

Each year, lung cancer kills more people than breast, prostate, colon, kidney, melanoma and liver cancer, combined.

Senator Feinstein said, “It’s time for the federal government to step up its efforts and make fighting lung cancer a national priority.”

Contact your Senator TODAY!


Debbie’s mesothelioma tumor shrinks!

23 Jun 2008 by under News

debbie and dr vogl 150x150 Debbies mesothelioma tumor shrinks!In April I shared a web site, Mesothelioma and Me, by UK resident Debbie Brewer, who was recently diagnosed with mesothelioma. The site is Debbie’s personal journal about her experiences as she battles mesothelioma, as well as shares stories about her family and daily life.

Some of you who are following Debbie on her journal have already heard the good news – on June 20, she learned that her tumor (which she wittily nicknamed Theo) has shrunk by 10 percent after the first of three scheduled chemoembolization treatments. She had her first treatment May 20, and the second June 20, when she learned Theo had gotten smaller.

According to www.radiologyinfo.org, chemoembolization is a combination of chemotherapy and a procedure called embolization to treat cancer, most often of the liver. According to the web site, catheter embolization is the deliberate introduction of foreign (“embolic”) material such as gelatin sponge or metal coils to stop bleeding or cut off blood flowing to a tumor or arteriovenous malformation.

Debbie traveled to Frankfurt, Germany, to have the procedure, which is still a trial, done by Dr. Thomas J. Vogl, Chairman, Department of Radiology, Department of Diagnostic and Interventional Radiology – University Hospital, Johann Wolfgang Goethe, University of Frankfurt am Main.

In this procedure, Dr. Vogl catheterizes the tumor and administers localized chemotherapy directly into the arteries feeding the tumor. Once the chemotherapy has been administered, other agents can be administered to block off the blood supply to the tumor.

Debbie’s description of the procedure is a little more colorful:

“A small incision will be made to expose the artery that feeds the tumour which is in the femour. A catheter is inserted and pushed up into the area affected. Embolization is a glue like substance which is put in to seal off the tumour and the chemo is then added and the whole area sealed off. The chemo is left to do its job. It is something like having a room with 2 doors, sealing off the back door and throwing in an explosive and sealing up the front door.”

One of the strangest things? The clinic where Debbie visits Dr. Vogl for these treatments is located on a street of the same name as her tumor’s nickname! Theodore Stern Kia 7. Visit Debbie’s blog to read all about her experiences with Dr. Vogl and this treatment. She even has photos of herself at the clinic.

Debbie points out that chemoembolization is not a cure for mesothelioma, but is thought to slow the growth of the tumor or reduce it, allowing the patient a longer life.

In conjunction with or following this treatment, Debbie will undergo a dendritic cell vaccine. According to the web site drugresearcher.com, dendritic cells – a part of the body’s immune system that detects foreign proteins in the body – can be used as vaccines by mixing them with genetic material from the patient’s tumour and infusing the treated cells back into the patient. The dendritic cells present the tumour antigens to the body’s white blood cells (T lymphocytes) for destruction.


Minnesota examines taconite meso danger

12 Jun 2008 by under News

In its last legislative session, Minnesota approved $4.9 million for research into the mesothelioma epidemic among its workers. To date, 58 people have died of mesothelioma. Governor signed the bill, which funds a five-year study of the taconite mining industry and the mineral’s asbestos-like properties as a likely cause for the extremely high rate of mesothelioma among workers.

Minnesota Public Radio reports that researchers and politicians will meet today to discuss progress in establishing the study. According to the report, the University of Minnesota School of Public Health is assessing the health of active and retired miners, reviewing death certificates, and delving into the 58 deaths from mesothelioma. The Natural Resources Research Institute is analyzing iron ore samples and dust in the air in Iron Range communities, to see how closely they match asbestos dust, says MPR.

According to the Iron Mining Association of Minnesota web site, the industry’s six iron mining and processing operations produce two-thirds of the iron ore used to make steel in the United States. Combined, they represent a $4 billion capital investment and employ nearly 4,000 men and women. These companies contribute over $1.5 billion each year to the state’s economy in the form of purchases, wages and benefits, royalties and taxes.These companies contribute over $1.5 billion each year to the state’s economy in the form of purchases, wages and benefits, royalties and taxes.

Taconite is an extremely hard rock that contains about 25 percent iron, according to an IMA fact sheet. It is found on the Mesabi Range in northeastern Minnesota, which extends 110 miles in a southwesterly direction. After World War II, when natural high-quality iron ore deposits were beginning to be depleted, two companies began making major investments in taconite, and began producing pellets in 1956 and 1957, and a decade later taconite was in production in all of the area’s six mines.

To date, Minnesota mines have produced more than 1.2 billion tons of taconite pellets, IMA reports.

Information about taconite on the Minnesota Department of Natural Resources web site says “taconite saved Minnesota’s iron ore mining industry.”

How heartbreaking that Minnesotans are only now finding out the cost.


Cancer treatment costs rise, affect Medicare

11 Jun 2008 by under News, Research/Treatment

There has been a lot in the news lately about the development of new drugs to treat . But with this boon comes a perhaps unforeseen complication – the increasing cost of treatment. A recent study conducted by the U.S. National Cancer Institute (NCI) and published in the Journal of the National Cancer Institute indicates that costs for treating patients with cancer has increased substantially from 1991-2002.

The article, which studied the cost of care for elderly cancer patients in the United States, used Surveillance, Epidemiology, and End Results-Medicare files to identify 718,907 cancer patients and 1,623,651 noncancer control subjects. Researchers estimated net costs of care for elderly cancer patients for the 18 most prevalent cancers and for all other tumor sites combined.

The study reports that costs of care were estimated for each phase by use of Medicare claims data from January 1, 1999 through December 31, 2003. They found that costs to Medicare were highest for lung, colorectal and prostate cancers.

An article in HealthDay News examining this latest report says study co-author Robin Yabroff attributes rising costs to a growing population of seniors in the U.S., as well as the inclusion of more prescription drugs in Medicare coverage. Yabroff is an epidemiologist at the U.S. NCI.

The report states that the number of patients receiving chemotherapy for lung, colorectal and breast cancer rose from 1991 to 2002, and that those increasing costs do not even reflect many of the newest, most expensive drugs now in use.

The HealthDay report quotes Dr. Len Lichtenfeld, deupty chief medical officer at the American Cancer Society, as saying that “the impact to Medicare is going to be substantial.” He goes on to say that the increasing costs for new drugs may actually prevent some patients from getting the treatment they need. Even if the drug is covered by Medicare, he says, the cost of the patient’s co-pay may be too high for them to afford it.


Merck begins vorinostat Phase III meso trial

10 Jun 2008 by under News, Research/Treatment

Merck & Co. announced May 27 that it is proceeding to Phase III clinical trials for vorinostat, which is currently marketed under the name Zolinza. The drug is an oral histone deacetylase (HDAC) inhibitor, and is being tested in patients with advanced malignant pleaural mesothelioma previously treated with systemic chemotherapy. Merck is currently enrolling patients in the Phase III trial.

According to the company’s news release, available in its entirety on the Mesothelioma Applied Research Foundation web site, the trial is moving forward after a favorable review of currently available safety and efficacy data from the Phase II portion of the study. This is an international study, expected to enroll 660 patients with testing centers in the United States, Belgium, Germany, the Netherlands, New Zealand, Spain, Sweden and the United Kingdom. It will be an ongoing randomized, double-blind, placebo-controlled trial.

Information provided by Merck says the trial will examine the safety, tolerability and anti-tumor activity of oral vorinostat with best supportive care as compared to best supportive care plus placebo in patients with advanced mesothelioma who have failed or are intolerant to prior chemotherapy, icnlucing pemetrexed in combination with either cisplatin or carboplatin.

Primary endpoints of the Phase III trial include overall survival as well as characterization of the overall safety and toxicity of vorinostat in patients with advanced malignant mesothelioma.

Patients interested in more information about the trial and how to enroll should call toll-free 1-866-890-6619 (in the U.S.) and 1-888-577-8839 (outside the U.S.) or visit the Merck Cancer Trials web site.

Zolinza is currently approved in the U.S. for treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recrruent disease on or following two systemic therapies.


Onconase fails in primary late-stage trial

30 May 2008 by under News, Research/Treatment

Alfacell Corp., a biotechnology company that manufactures Onconase, released a disappointing report Wednesday regaring its Onconase product, which was hoped to be a significant treatment for mesothelioma. The drug already has orphan-drug status for the treatment of malignant mesothelioma in the U.S., Europe and .

Results of the company’s late-stage trial of the drug showed that Onconase did not achieve significantly higher survival rates among patients with unresectable malignant mesothelioma when given in combination with doxorubicin, another cancer chemotherapy drug.

According to a report on Pharmaceutical Online, the preliminary results are based on 320 evaluable events that occurred in the clinical trial out of a total of 428 patients randomized. The analysis of the data did not show a statistically significant improvement for evaluable patients receiving Onconase plus doxorubicin. The median survival time (MST) for evaluable patients who received Onconase plus doxorubicin was 11.1 months as compared to 10.7 months for patients who received doxorubicin as a single agent.

However, there is a silver lining to the study. Pharmaceutical Online reports those patients who failed a previous chemotherapy regimen who received Onconase plus doxorubicin experienced a MST of 10.5 months compared with 8.7 months for those patients who received doxorubicin, which is considered a statistically significant result.

Reuters reports as a result of this secondary finding, Alfacell will now submit a marketing application to the Food and Drug Administration for use of the drug on those patients, with hopes to have it approved by the end of the year.