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Pakistani Refugees Continue To Be At High Risk For Disease, U.N. Says
The 2 million Pakistani refugees forced from their homes due to a military offensive against Taliban militants in the northwestern Swat Valley continue to be at high risk for diseases "as they cope with damaged water and sewage systems in towns and villages," according to the U.N., Bloomberg reports. "Displaced people are threatened with diarrhea, measles and respiratory infections as a result of the strain on the health service, [Eric] Laroche, [assistant director-general of the Health Action in Crises Cluster of the WHO], said. So far, the WHO"s early warning system has managed to identify and control more than 30 potential communicable disease outbreaks, he said," Bloomberg writes (Tighe/Qayum, 7/3).
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Ohio Supreme Court Restricts Mifepristone Use In State To Scope Of FDA's Approval Letter
In answering two certified questions from the U.S. Court of Appeals for the 6th Circuit, the Ohio State Supreme Court on July 1 declared that a state law regulating the use of mifepristone -- which is used in medication abortion -- bars physicians from prescribing it for off-label use, BNA reports. The court confirmed that doctors who use the drug to induce abortion must do so in compliance with the 49-day gestational limit included in FDA"s 2000 drug approval letter. Doctors also must prescribe the drug in accordance with the protocols and dosage indications included in its FDA-approved labeling.Interpretation of State Law in ContentionThe Ohio General Assembly in 2004 passed a law (Section 2919.123 (A)) that required any health care professional prescribing or dispensing mifepristone to comply with "all provisions of federal law that govern the use" of the drug. The law defines "federal law" as "any law, rule or regulation of the United States or any drug approval letter" from FDA "that governs or regulates the use of" mifepristone for inducing abortion. FDA"s approval letter states that the drug "is indicated for use in the termination of pregnancy (through 49 days" pregnancy) and has no other approved indication for use during pregnancy." In addition, the drug"s label states the recommended dosage and that its use requires three office visits by the patient. Planned Parenthood Southwest Ohio Region challenged the law in district court, arguing that neither FDA"s approval letter nor any other federal provision bans the off-label use of mifespristone to induce abortion beyond 49 days" gestation. The group also argued that the state law was unconstitutionally vague because it did not notify abortion providers in advance regarding which FDA documents were included in the state"s criminal law. In addition, Planned Parenthood said that prohibiting the evidence-based use of the drug would infringe on the rights of women, requiring them to take higher-than-necessary dosages of the drug or to undergo surgical abortions when a noninvasive alternative is available. The district court ruled in favor of Planned Parenthood, saying that the law was void because of vagueness. The state appealed the decision to the 6th Circuit, which then submitted two questions to the state Supreme Court seeking its interpretation of the law.The state Supreme Court ruled that FDA"s drug approval letter is included in the definition of "federal law" and that the state law is not ambiguous, according to BNA. The court said that because the drug approval letter incorporated FDA"s labeling text, Ohio physicians cannot prescribe or provide mifepristone to induce abortion outside of the stipulations of the drug approval letter and approved label. According to BNA, product liability law experts say the ruling will not have an impact outside of mifepristone or the state of Ohio.Case Returns to Appeals CourtRoger Evans of Planned Parenthood Federation of America said that he is not sure if the court"s decision helps or hurts the group"s case. Evans said that the district court declared the law unconstitutional based on an interpretation that the statute operates in the same way the state Supreme Court ruled it does. He noted that there are other possible interpretations of the law that would have solved the constitutional issues at the center of the litigation. However, because those issues were not resolved, the case now returns to the 6th Circuit, which will decide if the statute is constitutional based on the state Supreme Court"s interpretation. If the circuit court agrees with the district court that the statute is unconstitutionally vague, the state of Ohio could seek a U.S. Supreme Court review. If the circuit court finds that the statute is constitutional, the case likely will be sent back to the district court for resolution of some other issues in the case, according to BNA (BNA, 7/6).
News of the day
Majority Of U.S. Residents Support Confirming Supreme Court Nominee Sotomayor, Poll Finds
Sixty-two percent of U.S. residents want Supreme Court nominee Sonia Sotomayor to be confirmed, and 55% say she is "about right" on a liberal-to-conservative scale, according to a recent Washington Post/ABC News poll, the Post reports. For the survey, pollsters randomly surveyed a national sample of 1,001 adults by telephone between June 18 and June 21. The poll has a margin of sampling error of plus or minus three percentage points.The poll found that about three-fourths of abortion-rights supporters want Sotomayor to be confirmed, compared with less than half of abortion-rights opponents. According to the poll, six in 10 U.S. residents would want the new Supreme Court justice to vote to uphold Roe v. Wade. Most Republican men would want the next Supreme Court justice to vote to overturn Roe, while Republican women were split about evenly on the issue, the poll found. The poll also found that support for Sotomayor"s confirmation was equal between men and women. In addition, nearly eight in 10 Democrats and about two-thirds of independents said they supported Sotomayor"s confirmation, compared with 36% of Republicans. The poll found that most Republicans deemed Sotomayor a "more liberal" nominee than they would prefer. Among Republicans, those self-identifying as conservative Republicans were largely opposed to Sotomayor"s confirmation, with more than seven in 10 conservative Republicans saying she is too liberal. Sotomayor received support from Republicans self-identifying as moderate or liberal, with fewer than four in 10 saying she is too liberal. However, about one in five who opposed Sotomayor"s confirmation said that she is not liberal enough. The poll also found that among the 33% of U.S. residents who said that Sotomayor"s gender plays a role, more than twice as many said that is a positive attribute as opposed to a negative attribute (Cohen/Barnes, Washington Post, 6/28).Sessions Requests More InformationSenate Judiciary Committee ranking Republican Jeff Sessions (Ala.) on Friday sent a letter to the White House requesting additional information on Sotomayor, the New York Times" "The Caucus" reports. According to Sessions, the Obama administration has yet to provide members of the committee with information about a number of cases that Sotomayor brought to trial while working as a district attorney in New York. In addition, Sessions requested information regarding a case that Sotomayor argued on appeal. He also requested information about her work with Latino Justice PRLDEF, formerly known as the Puerto Rican Legal Defense and Education Fund. Sotomayor"s confirmation hearing is scheduled to begin July 13. Republicans have criticized the schedule, saying it gives them insufficient time to review Sotomayor"s record. Democrats have said that Republicans are seeking to create unnecessary delays and noted that the timeline is similar to that of past nominees (Herszenhorn, "The Caucus," New York Times, 6/26).
Diagnostics

Celsion And Yakult Honsha Announce Start-up Of Japanese Clinical Trial Sites In Celsion's Global Phase III ThermoDox(R) Trial For Primary Liver Cancer

Celsion Corporation (NASDAQ: CLSN) and Yakult Honsha Co., Ltd. (Tokyo: 2267) announced that Celsion"s global Phase III ThermoDox trial for the treatment of primary liver cancer will be extended to Japan by Yakult"s expertise. This is an important step towards a potential application to market the drug in Japan. Yakult Honsha is the exclusive licensor of Celsion"s ThermoDox in Japan. "We are proud to announce that Yakult will initiate trial sites and begin patient enrollment in Japan for our Phase III liver cancer trial, and we look forward to working with Yakult," stated Michael H. Tardugno, President and Chief Executive Officer. "The extension of our PIII study to Japan will enable us to accelerate patient enrollment in the trial and has the potential to decrease the time to market in Japan." "Japan has the highest rate of liver cancer in industrialized countries," said Dr. Kiyoshi Terada, Head, Pharmaceutical Division/Senior Managing Director, Member of the Board of Yakult Honsha. "Given there are limited effective treatment options for these patients, we are pleased to have the opportunity to provide ThermoDox to them in the clinical trial setting," Under the license agreement between Celsion and Yakult, Yakult is financially responsible for the patients enrolled in clinical trials in the Japanese sites and all the data generated in Japan will be jointly owned by Celsion and Yakult and can be used by Celsion to support regulatory filings in territories outside of Japan. Additional information on Celsion"s Phase III ThermoDox trial for primary liver cancer can be found at http://www.clinicaltrials.gov/ About ThermoDox ThermoDox in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor. ThermoDox has also demonstrated evidence of efficacy in a Phase I study for primary liver cancer. Celsion has been granted FDA Orphan Drug designation for ThermoDox and is conducting a pivotal global Phase III study in primary liver cancer under a FDA Special Protocol Assessment. ThermoDox® is a registered trademark of Celsion Corporation About Primary Liver Cancer Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States and is rapidly growing worldwide at approximately 1,000,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries. The standard first line treatment for liver cancer is surgical resection of the tumor, however 80% to 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasingly become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors. There are few non-surgical therapeutic treatment options available as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer. About Yakult Yakult is a leading Japanese company focused on the development and marketing of pharmaceuticals, foods, beverages, and cosmetics with an emerging presence in oncology. For more information on Yakult, visit: www.yakult.co.jp or view the following company profile: http://www.yakult.co.jp/english/pdf/profile2008-2009.pdf Celsion


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