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ImClone Systems And Bristol-Myers Squibb Announce Revisions To ERBITUX(R) (cetuximab) U.S. Product Labeling For Metastatic Colorectal Cancer
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company (NYSE: LLY), and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved revisions to the U.S. prescribing information for ERBITUX® (cetuximab) concerning the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC). The labeling revisions include a modification to the indication, which now includes a statement that retrospective subset analyses of metastatic or advanced colorectal cancer trials have not shown a treatment benefit for ERBITUX in patients whose tumors had K-ras mutations in codon 12 or 13 and that the use of ERBITUX is not recommended for the treatment of colorectal cancer with these mutations. Revisions concerning the use of ERBITUX in colorectal cancer tumors with K-ras mutations were also made to the clinical studies and clinical pharmacology sections of the product"s prescribing information.
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Obama In Notre Dame Speech Calls For 'Open Hearts, Open Minds' In Abortion-Rights Debate
In his address at the University of Notre Dame"s commencement ceremony on Sunday, President Obama urged advocates on both sides of the abortion-rights debate to treat each other with civility and find ways to work together on common goals, such as reducing the number of unintended pregnancies, the New York Times reports. Obama, who also received an honorary degree from the Roman Catholic university, called for more "open hearts, open minds, fair-minded words" on an issue that has long polarized the U.S. Obama said that although not all will agree on abortion rights, people "can still agree that this heart-wrenching decision for any woman is not made casually" and "has both moral and spiritual dimension." He continued, "So let us work together to reduce the number of women seeking abortions," by reducing unintended pregnancies, making "adoption more available," and providing "care and support" to women who carry pregnancies to term. Obama also said he supports a "sensible conscience clause" that would allow health care workers to withhold services they find morally or religiously objectionable, the New York Times reports. The president said that "[e]ach side will continue to make its case to the public with passion and conviction. But surely we can do so without reducing those with differing views to caricature" (Baker/Saulny, New York Times, 5/18).According to the Wall Street Journal, Notre Dame"s invitation to Obama "amplified longstanding tensions" between the Catholic Church"s position against abortion rights and Catholic universities" academic freedom. Several Catholic bishops and antiabortion-rights advocates argued that it was wrong to honor Obama because of his support for abortion rights, while the university"s leadership and others said it is necessary to communicate with people of opposing views (Meckler, Wall Street Journal, 5/18). Notre Dame"s president, the Rev. John Jenkins, in his introduction of Obama praised the president for agreeing to speak at the ceremony. He said that although some individuals "might have avoided this venue" because of the abortion issue, Obama "is not someone who stops talking to those who differ with him" (Evans, USA Today, 5/18). Jenkins also said, "If we want to extend courtesy, respect and love and enter into dialogue, then surely we can start by acknowledging what is honorable in others" (Dinan, Washington Times, 5/18).The New York Times reports that about 100 abortion-rights opponents protested on the edge of Notre Dame"s campus, and nearly 40 protesters were arrested trying to enter the campus (New York Times, 5/18). According to the Washington Post, more than 70 Catholic bishops criticized the university"s invitation, and more than 360,000 people signed a petition calling for the university to rescind the invite. The Post also reports that 26 of the 2,900 graduates chose to skip the commencement ceremony in protest of Obama"s speech (Shear, Washington Post, 5/18). However, the bulk of the audience at the ceremony "enthusiastically supported" the president, the New York Times reports. A few graduates pasted crosses and replicas of infants" feet on their mortarboards in protest of Obama"s visit, while some supporters displayed Obama"s campaign logo. Four protesters interrupted the speech with shouting and were removed by security guards; audience members responded to the shouting with Notre Dame chants and shouts of "Yes, we can," an Obama campaign slogan. The New York Times reports that while Obama has tried to avoid confrontation on the issue of abortion rights, the controversy over this Notre Dame speech and his pending nomination to replace retiring Supreme Court Justice David Souter have "pushed the issue to the forefront" (New York Times 5/18). Obama"s speech comes as his administration initiates its first meetings between advocates on both sides of the debate to discuss ways to reduce unintended pregnancies and the need for abortion. The meetings, which began at the beginning of May, are expected to continue for the next few
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Terrence Higgins Trust Tells Gay Men To Learn Their ABCs On World Hepatitis Day
Terrence Higgins Trust (THT) is encouraging gay men to learn more about hepatitis A, B and C today - World Hepatitis Day (May 19).
Endocrinology

Increased Risk Of Emphysema Following Childhood Exposure To Tobacco Smoke

Chronic exposure to tobacco smoke in childhood may contribute to early emphysema later in life, according to new research. Environmental tobacco smoke (ETS) is known to be associated with a variety of serious health problems, but it had not previously been associated with the development of emphysema over the life course. The data was presented on Tuesday, May 19, at the 105th International Conference of the American Thoracic Society in San Diego. "Emphysematous "holes" in the lung that begin as small areas of damage or impaired development may expand according to a fractal trajectory after an earlier insult," said Gina Lovasi, M.P.H., Ph.D., of Columbia University. "We hypothesized that environmental tobacco smoke in childhood may be one such early insult, associated with signs of early emphysema detectable on computed tomography (CT) scan in adulthood and perhaps lower lung function detectable by spirometry." Emphysema is an anatomically defined condition that overlaps substantially with chronic obstructive pulmonary disease, the fourth leading cause of death worldwide. Although smoking leads to emphysema in the upper lobes of the lungs, people who have never smoked may also have tissue destruction patterns that indicate emphysema. However, emphysema in people who have never smoked is more likely to appear as diffuse damage throughout the lungs. To determine whether chronic exposure to ETS in childhood could lead to the development of early emphysema later in life, Dr. Lovasi and colleagues analyzed data from a diverse sample of 3,964 relatively healthy adults recruited as part of the Multi-Ethnic Study of Artherosclerosis (MESA) study, focusing on 1,781 adults who had never smoked. The MESA-lung study assessed childhood exposure to ETS by asking each participant "In your childhood, did you live with a regular cigarette smoker who smoked in your home?" The MESA-lung study was also the first large study of healthy adults to collect CT images that show most of the lungs, allowing for the classification of some areas of the lungs as having indications of early emphysema: large contiguous areas of air-like density ("holes", in contrast to lung tissue, which is more dense than air) or the total percentage of lung volume with air-like density. After adjusting for a number of potentially confounding variables, including childhood asthma and living with a smoker as an adult, the researchers found that non-smokers who reported childhood exposure to ETS were more likely to have CT patterns that looked like early emphysema: large holes were relatively more common, and more of the lung volume appeared to have low, air-like density. The association was not detectable among current or former smokers, perhaps due to the relatively strong influence of one"s own smoking history. They did not find an association for childhood ETS exposure and lung function as measured by spirometry. "The take-home message from our analysis is that exposure to tobacco smoke during childhood may be associated with detectable differences in lung structure, and perhaps early emphysema, later in life among people who do not themselves smoke," Dr Lovasi said. "These findings might also help researchers to understand how lung damage develops. However, the observed associations are small and the implications of the novel CT-based measures for long-term health this research needs to be replicated." Keely Savoie American Thoracic Society


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