Drug & Device News

Side-Effect of Anti-Baldness Drug: Better Prostate Health

A study of men who took baldness-treatment drug finasteride for many years shows that the medication has a significant side benefit: It appears to reduce by 30% the chance of a man's developing' prostate cancer. Thompson, Ian M. Jr., et. al, “Long-Term Survival of Participants in the Prostate Cancer Prevention Trial,” N Engl J Med 2013; 369:603-610 Aug. 15, 2013DOI: 10.1056/NEJMoa1215932. The connection between finasteride and prostate health is not completely unexpected, as men have been prescribed the drug for years for reducing the size of enlarged prostate glands, athough this off-label use has not been approved by the FDA. The results of this latest study found that 14.9% of men who did not take finasteride developed prostate cancer, while only 10.5% of the group who took the drug were so afflicted. This suggests that men may want to take the medication as a preventive measure, particularly if they are at a higher risk for the cancer, even though the kind of prostate cancer apparently prevented by finasteride use is the low-grade type that is not likely to lead to death. Preventing this type is worthwhile because the damage done to men who are treated for prostate cancer that is not likely to shorten their lives often leaves them impotent and/or incontinent.

GAO Sees Doctors Ordering Treatments for Financial Gain

The Government Accountability Office (GAO) is calling for a requirement that doctors disclose on Medicare claim forms any financial relationships they have with entities to which they refer their patients. This recommendation came after the GAO, focusing on prostate cancer patients and their treatments, found that doctors who have financial interests in radiation service providers or the equipment they use tend to order radiation treatments for their patients more often than do those doctors with no such financial ties. The non-financially interested physicians tended to treat their patients more often using other equally effective methods that might be less expensive for Medicare and for patients, or even with no treatment at all where the risks possibly outweighed the benefits.

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Federal Jurisdiction and the Amount in Controversy: Ninth Circuit Announces New Standard

The U.S. Court of Appeals for the Ninth Circuit cited to new guidance from the U.S. Supreme Court to make it more difficult for plaintiffs in class action lawsuits to preserve state-court jurisdiction by limiting the amount of damages sought. Rodriguez v. AT&T Mobility Services, 13-56149 (9th Cir. 8/27/13). Pointing to Standard Fire v. Knowles, 133 S. Ct. 1345 (2013), the three-judge panel overruled its own 2007 decision in Lowdermilk v. U.S. Bank National Association by holding that plaintiffs are not “masters of the complaint” who may avoid federal jurisdiction under the Class Action Fairness Act of 2005 (CAFA) by foregoing damages. Although not a pharmaceuticals lawsuit, Justice Richard Clifton's pronouncement of the law will apply equally to such cases: “We hold that Lowdermilk has been effectively overruled, and that the proper burden of proof imposed upon a defendant to establish the amount in controversy is the preponderance of the evidence standard.”

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Side-Effect of Anti-Baldness Drug: Better Prostate Health

A study of men who took baldness-treatment drug finasteride for many years shows that the medication has a significant side benefit: It appears to reduce by 30% the chance of a man's developing' prostate cancer. Thompson, Ian M. Jr., et. al, “Long-Term Survival of Participants in the Prostate Cancer Prevention Trial,” N Engl J Med 2013; 369:603-610 Aug. 15, 2013DOI: 10.1056/NEJMoa1215932. The connection between finasteride and prostate health is not completely unexpected, as men have been prescribed the drug for years for reducing the size of enlarged prostate glands, athough this off-label use has not been approved by the FDA. The results of this latest study found that 14.9% of men who did not take finasteride developed prostate cancer, while only 10.5% of the group who took the drug were so afflicted. This suggests that men may want to take the medication as a preventive measure, particularly if they are at a higher risk for the cancer, even though the kind of prostate cancer apparently prevented by finasteride use is the low-grade type that is not likely to lead to death. Preventing this type is worthwhile because the damage done to men who are treated for prostate cancer that is not likely to shorten their lives often leaves them impotent and/or incontinent.

GAO Sees Doctors Ordering Treatments for Financial Gain

The Government Accountability Office (GAO) is calling for a requirement that doctors disclose on Medicare claim forms any financial relationships they have with entities to which they refer their patients. This recommendation came after the GAO, focusing on prostate cancer patients and their treatments, found that doctors who have financial interests in radiation service providers or the equipment they use tend to order radiation treatments for their patients more often than do those doctors with no such financial ties. The non-financially interested physicians tended to treat their patients more often using other equally effective methods that might be less expensive for Medicare and for patients, or even with no treatment at all where the risks possibly outweighed the benefits.

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Federal Jurisdiction and the Amount in Controversy: Ninth Circuit Announces New Standard

The U.S. Court of Appeals for the Ninth Circuit cited to new guidance from the U.S. Supreme Court to make it more difficult for plaintiffs in class action lawsuits to preserve state-court jurisdiction by limiting the amount of damages sought. Rodriguez v. AT&T Mobility Services, 13-56149 (9th Cir. 8/27/13). Pointing to Standard Fire v. Knowles , 133 S. Ct. 1345 (2013), the three-judge panel overruled its own 2007 decision in Lowdermilk v. U.S. Bank National Association by holding that plaintiffs are not “masters of the complaint” who may avoid federal jurisdiction under the Class Action Fairness Act of 2005 (CAFA) by foregoing damages. Although not a pharmaceuticals lawsuit, Justice Richard Clifton's pronouncement of the law will apply equally to such cases: “We hold that Lowdermilk has been effectively overruled, and that the proper burden of proof imposed upon a defendant to establish the amount in controversy is the preponderance of the evidence standard.”

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