EPA to Move Aggressively on Cleanup and HHS to Assist Area Residents with Medical Care  

WASHINGTON – U.S. Environmental Protection Agency Administrator Lisa P. Jackson today announced the agency has determined that a public health emergency exists at the Libby asbestos site in northwest Montana.  Over the past years, hundreds of asbestos-related disease cases have been documented in this small community, which covers the towns of Libby and Troy. The announcement was made today at a joint press conference with Department of Health and Human Services Secretary Kathleen Sebelius and U.S. Sens. Max Baucus and Jon Tester.  

This is the first time EPA has made a determination under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) that conditions at a site constitute a public health emergency.  This determination recognizes the serious impact to the public health from the contamination at Libby and underscores the need for further action and health care for area residents who have been or may be exposed to asbestos. Investigations performed by the Agency for Toxic Substance and Disease Registry have found the incidence of occurrence of asbestosis, a lung condition, in the Libby area staggeringly higher than the national average for the period from 1979-1998. EPA is working closely with the Department of Health and Human Services, which is making available a short-term grant to provide needed asbestos-related medical care to Libby and Troy residents.  

During her Senate confirmation hearing, Administrator Jackson committed to review the situation at the Libby asbestos site based on current site information, sound science and EPA’s legal authorities. As a result of her review, the Administrator has decided that conditions at the site present a significant threat to public health and that making a public health emergency determination is appropriate.  

“This is a tragic public health situation that has not received the recognition it deserves by the federal government for far too long. We’re making a long-delayed commitment to the people of Libby and Troy. Based on a rigorous re-evaluation of the situation on the ground, we will continue to move aggressively on the cleanup efforts and protect the health of the people,” said EPA Administrator Lisa P. Jackson. “We’re here to help create a long and prosperous future for this town.” She added, “Senator Max Baucus has been a tireless advocate for the people living in Libby and Troy who have confronted this public health tragedy for generations and we commend him for his work. We look forward to working with him and Senator Tester who has been working diligently since being elected to the Senate to bring much needed support to these communities.”  

“Senator Baucus and Senator Tester have powerfully brought the voices of the people of Libby and Troy to Washington so the nation could hear and understand what happened. They refused to give up on finding the best ways to help those who have suffered so much. Today’s announcement reflects our Administration’s concern for the residents of Lincoln County and our intention to act decisively to protect and improve their health and quality of life,’ said Secretary Sebelius. “The Department of Health and Human Services has been working closely with the EPA and the residents of Lincoln County for a number of years to conduct screenings and help provide access to care. Now, we have come together with Senator Baucus and Senator Tester, Administrator Jackson, and agencies across HHS, to offer a new grant to provide short-term medical assistance for screening, diagnostic and treatment services in a comprehensive and coordinated manner in partnership with local officials on the ground in Lincoln County. “  

Sen. Max Baucus, a long-time advocate on this issue, consistently sought out a determination of a public health emergency in this region.  

“This is a great day for Libby. This is a town that was poisoned by W.R. Grace, then had to wait year after year as the last administration failed to determine that public health emergency exists. But today is a new day,” said Sen. Baucus. “Today is the day that Administrator Jackson did the right thing and made this vital determination. Today is the day that Secretary Sebelius declared that people in Libby will get the health care they need. Today is the day that after years of work we were able to succeed in getting this done. Yet, we won’t stop here. We will continue to push until Libby has a clean bill of health.”  

“This is a long-overdue, common-sense decision that will go a long way for Libby and the thousands of folks who were poisoned there,” Sen. Tester said. “This decision will help make quality health care more accessible and it will open the door to get new resources on the ground.  We still have a long way to do right by the folks in Libby.  Working together with the Department of Health and Human Services and the Environmental Protection Agency, we’re making very good progress.”   

Secretary Sebelius tasked two HHS agencies – the Health Resources and Services Administration and the Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry – to help county residents. These two agencies will support a new grant to assist affected residents who need medical care. Local officials are currently putting together a grant proposal that will lay out options for provision of medical care that will work for the residents of Lincoln County. HHS anticipates that this grant can be awarded in August 2009.  

The Libby asbestos site has been on the EPA’s Superfund National Priorities List since 2002, and cleanup has taken place since 2000.  EPA has made progress in helping to remove the threat of asbestos in the land and air, and with it, the increased risks of lung cancer, asbestosis, and other respiratory problems. While EPA’s cleanup efforts have greatly reduced exposure, actual and potential releases of amphibole asbestos remain a significant threat to public health in that area.  

The Libby asbestos site includes portions of the towns of Libby and Troy and an inactive vermiculite mine seven miles northeast of the town. Gold miners discovered vermiculite in Libby in 1881; in the 1920s the Zonolite Company formed and began mining the vermiculite.  In 1963, W.R. Grace bought the Zonolite mining operations. The mine closed in 1990. It is estimated that the Libby mine was the source of over 70 percent of all vermiculite sold in the United States from 1919 to 1990.  

More information: http://www.epa.gov/libby 

EPA, EPA Announces Public Health Emergency in Libby, Montana,  June 17, 2009  

‘No Family History’ author makes compelling case for environmental link to breast cancer and urges women, advocates, and policymakers to focus on prevention.   

PHILADELPHIA – Has the key to reducing breast cancer gotten lost in the race for a cure? A new book, No Family History, presents compelling evidence that exposure to everyday products such as cosmetics and toiletries, hormones in food, household cleaners and pesticides is behind the dramatic increase in breast cancer and argues that the solution is simple: prevention.  

“Every three minutes, one woman in the United States is diagnosed with breast cancer. Yet, most women with breast cancer defy most or all of the risk factors, including weight, diet, whether they gave birth and breast fed, and family history,” says No Family History author Sabrina McCormick, Ph.D., a Robert Wood Johnson Foundation Health & Society Scholar at the University of Pennsylvania. 

The incidence of breast cancer has increased at an alarming rate over the past 60 years. In 1940, around one in 24 women who lived to be 80 was afflicted. By 2006, that number rose to one in eight.  

In her book, McCormick cites compelling evidence showing that the reason for this dramatic increase is the rise in the production and use of cancer-causing chemicals women are exposed to on a daily basis.  

Breast cancer “hot spots” from Long Island, N.Y., to Northern California have two common threads—industrial pollution and agricultural pesticides. These “hot spots” are pockets of the United States where breast cancer has risen six times faster than the national rate. In Long Island, the incidence of breast cancer is 200 percent higher than the national average. 

“In our race for a cure for breast cancer, we have ignored the overwhelming body of evidence that demonstrates a link between products from cosmetics to pesticides and breast cancer,” McCormick says. “We must focus on prevention by demanding safer products, reducing our exposure to chemicals and urging our policymakers to ban cancer-causing chemicals in everyday products.” 

European governments responded to this scientific evidence by banning cosmetic products with certain chemicals from being sold in their countries. According to No Family History, one American cosmetics company known as much for its “pink ribbon” marketing campaigns as for its pink lipstick removed these chemicals from products sold in Europe, but these same chemicals remain in the products the company sells in the United States. 

“Women and girls should not have to check the ingredients in every stick of lipstick and each bottle of moisturizer. Better regulation to ensure that these products are safe would go a long way to reducing the incidence of breast cancer,” McCormick says. 

Many companies that profit from “pink” marketing campaigns or breast cancer treatments, McCormick argues, are the same ones fighting against tougher regulations of cancer-causing chemicals in everyday products. McCormick dubs this the “political economy” of breast cancer.

“In the case of breast cancer, many activists have unwittingly bought into campaigns leading down the road away from a cause, and instead into more and more breast cancer,” McCormick writes in her book. 

No Family History: The Environmental Links to Breast Cancer (Rowman & Littlefield) is a provocative glimpse into environmental links to breast cancer, profiling research as well as women’s stories. McCormick recommends that women reduce their exposure to many cosmetics and toiletries and urges policymakers to strengthen regulations to ban cancer-causing chemicals from being used in everyday products. 

Reference: Robert Wood Johnson Foundation Health & Society Scholars, Are everyday products from cosmetics to household cleaners causing the high rates of breast cancer? June, 15, 2009 

For more information on the book (in stores in June) and a documentary McCormick produced on the subject, visit www.nofamilyhistory.org

A study involving 678 individuals who apply pesticides, culled from a U.S. Agricultural Health Study of over 50,000 farmers, recently found that exposure to certain pesticides doubles one’s risk of developing an abnormal blood condition called MGUS (monoclonal gammopathy of undetermined significance) compared with individuals in the general population. The disorder, characterized by an abnormal level of a plasma protein, requires lifelong monitoring as it is a pre-cancerous condition that can lead to multiple myeloma, a painful cancer of the plasma cells in the bone marrow. The study will appear in the June 18 issue of Blood, the official journal of the American Society of Hematology.  

“Previously, inconclusive evidence has linked agricultural work to an increased multiple myeloma risk. Our study is the first to show an association between pesticide exposure and an excess prevalence of MGUS,” said lead author Ola Landgren, MD, PhD, of the National Cancer Institute (NCI), which is part of the National Institutes of Health, U.S. Department of Health and Human Services. “This finding is particularly important given that we recently found in a large prospective cancer screening study that virtually all multiple myeloma patients experienced a MGUS state prior to developing myeloma.”  

“As several million Americans use pesticides, it’s important that the risks of developing MGUS from the use of pesticides is known,” added senior study author and NCI investigator Michael Alavanja, DrPH. 

The blood of study participants, who were individuals licensed to apply restricted-use pesticides, was assessed for MGUS prevalence. The median age of participants was 60 years (range 30-94 years), and all lived in either Iowa or North Carolina. Participants also completed questionnaires providing comprehensive occupational exposure information for a wide range of pesticides, including information such as the average number of days of pesticide use per year, years of use, use of protective gear while applying pesticides, and pesticide application methods. Information on smoking and alcohol use, cancer histories of the participants’ first-degree relatives, and other basic demographic and health data were also obtained. Individuals with prior histories of lymphoproliferative malignancies (such as multiple myeloma or lymphoma) were excluded. Cancer incidence and mortality were monitored annually, and, after five years, follow-up interviews were conducted to update the information about participants’ occupational exposures, medical histories, and lifestyle factors. 

For comparison, data were obtained from a large MGUS-screening study conducted by the Mayo Clinic, and the results from the pesticide-exposed group were compared with the assessments of 9,469 men from the general population of Olmsted County, Minnesota. The two groups were similar in terms of age, race, and educational attainment. Because of the low prevalence of women among workers who apply pesticides, women were excluded from the study.  

In the pesticide-exposed group, no MGUS cases were observed among those who were less than 50 years of age, but the prevalence of MGUS in those older than 50 was 6.8 percent, which is 1.9 times higher than the general population study group of men in Minnesota. 

The researchers also evaluated the potential association between MGUS prevalence and 50 specific pesticides for which usage data were known. Of the chemicals studied, a significantly increased risk of MGUS was observed among users of dieldrin (an insecticide), carbon-tetrachloride/carbon disulfide (a fumigant mixture), and chlorothalonil (a fungicide). The MGUS risk for these agents increased 5.6-fold, 3.9-fold, and 2.4-fold, respectively. Several other insecticides, herbicides, and fungicides were associated with MGUS, but not significantly.  

“There is great concern regarding the increase in frequency in mature B-cell malignancies in the Western world and what may be the cause of this. A number of reports in the past have linked exposure to pesticides with increased risk of these types of cancers, but the present study is the first to link agricultural work to a pre-malignant condition,” said John G. Gribben, MD, DSc, Professor of Experimental Cancer Medicine at Barts and the London School of Medicine, who is not affiliated with the study. “It is vital to assess the risk of workplace exposure and disease, and the results lend further support to providing safe workplace practices to limit exposure to potential carcinogens.”

“Our findings are intriguing,” stated Dr. Landgren. If replicated in a larger sample from our study and other large studies, further work should focus on gaining a better understanding of the molecular basis of MGUS and multiple myeloma. Ultimately, this will result in the identification of novel molecular targets involved in the progression from MGUS to multiple myeloma and in the development of targeted therapies.”   

Reference: American Society of Hematology, Individuals Who Apply Pesticides Are Found to Have Double the Risk of Blood Disorder, Press Release, WASHINGTON, June 12, 2009

Patients with curable early-stage breast cancer died from chemotherapy solvent
A chemotherapy drug that is supposed to help save cancer patients’ lives, instead resulted in life-threatening and sometimes fatal allergic reactions.

A new study from the Research on Adverse Drug Events and Reports (RADAR) pharmacovigilance program at Northwestern University Feinberg School of Medicine identified 287 unique cases of hypersensitivity reactions submitted to the FDA’s Adverse Event Report System between 1997 and 2007 with 109 (38 percent) deaths in patients who received Cremophor-based paclitaxel, a solvent-administered taxane chemotherapy.

Adverse event reports generally only represent from 1 to 10 percent of actual incidence, so the number of hypersensitivity reactions and deaths is likely significantly higher. The severe allergic reactions are believed to be caused by Cremophor, the chemical solvent – a derivative of castor oil — that is used to dissolve some insoluble drugs before they can be injected into the blood stream.

Two patients who died from an allergic reaction had early-stage breast cancer, which had been surgically removed, and were being treated with Cremophor-containing paclitaxel to prevent the cancer from coming back. Both of these patients had received medications before the chemotherapy to reduce the risk of hypersensitivity reactions.

The study was led by Charles Bennett, M.D., RADAR program coordinator and a professor of hematology/oncology at Northwestern’s Feinberg School, and Dennis Raisch, a professor of pharmacy at the University of New Mexico.

“The deaths of women with early-stage breast cancer are particularly disturbing because without the adverse reaction, they could have likely had 40 years of life ahead of them,” Bennett said.

RADAR investigators also found that 22 percent of all fatalities occurred in patients despite patients having received premedication to prevent hypersensitivity reactions, while another 15 percent of such patients experienced life-threatening respiratory arrest.

The report was presented at the 45th Annual Meeting of the American Society of Clinical Oncology held recently in Orlando, Fla.

Cremophor-containing paclitaxel has been associated with hypersensitivity reactions, with responses ranging from mild skin conditions to more severe effects, including anaphylaxis and cardiac collapse. Current U.S. product labeling for Cremophor containing paclitaxel includes a black-box warning alerting physicians and patients of potential toxicity and recommending the use of corticosteroids and other medications before chemotherapy administration to reduce the risk of hypersensitivity reactions.

“The results of our review suggest that physicians should be vigilant in monitoring the safety of their patients undergoing chemotherapy treatment,” said Bennett, who also is the A.C. Buehler Professor in Economics and Aging at the Feinberg School and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

“Patients receiving Cremophor-based paclitaxel should be given medications to prevent hypersensitivity reactions, but what is sobering, as the study has shown and as the black-box warning indicates, women suffer anaphylaxis despite receiving steroid premedication,” Bennett said. “Physicians should be diligent in reporting adverse events to regulatory agencies to better monitor the impact of Cremophor on patient safety. Physicians may also want to consider exploring other alternative chemotherapy options that do not include Cremophor.”

In addition to the two women with early-stage breast cancer who died after treatment with the Cremophor-based paclitaxel, four other women with early-stage breast cancer experienced life-threatening anaphylaxis reactions. Each of them had received prior medications to prevent the reactions.

“The fatal outcomes observed in patients with early-stage breast cancer were particularly striking as this is a patient population with a good prognosis that is generally treated with curative intent,” said Raisch.

For the report, Bennett and Raisch reviewed adverse event reports submitted to regulatory agencies in the U.S., Europe and Japan. The most common cancer diagnosis for these patients with allergic reactions was lung cancer followed by breast cancer and ovarian cancer.

Reference: Northwestern University, Common chemotherapy drug triggers fatal allergic reactions, Press Release, 8-Jun-2009