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Technology Discovered At University of Virginia Now Helps Men To Monitor Their Fertility After Vasectomy
A new home test kit called SpermCheck Vasectomy, based on a protein discovered at the University of Virginia (UVA) Health System, marks the launch of a product line that could revolutionize the way men monitor their reproductive status. Based on antibodies that bind to SP-10, a protein discovered in the laboratory of John C. Herr, PhD, SpermCheck Vasectomy is the only FDA-approved immunodiagnostic test for monitoring sperm after vasectomy.
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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
Moderates Wooed In House As They Cross Party Lines To Shape Health Legislation
As attempts to gain support for health reform across party lines and from stoic interest groups like the American Medical Association continue, House leaders are seeking to rally centrist members of their own caucus, CQ Politics reports. "House Speaker Nancy Pelosi, whose liberal committee leaders will write health care legislation is attempting to engage moderate Democrats whose votes she will need on the floor."
Endocrinology

How Immune Cells May Help Predict Alzheimer's Risk

What if you could test your risk for Alzheimer"s disease much like your cholesterol levels - through a simple blood test? UCLA scientists have discovered a way to measure the amount of amyloid beta that is being absorbed by immune cells in the blood. Amyloid beta forms the plaques considered the hallmark of Alzheimer"s disease, and if the immune system isn"t adequately clearing amyloid beta, it may indicate Alzheimer"s risk, according to the researchers. MP Biomedicals LLC, a global life sciences and diagnostics company dedicated to Alzheimer"s disease research, has received an exclusive, worldwide license to commercialize the UCLA technology and create a diagnostic blood test for public use to screen for Alzheimer"s risk. "Early diagnosis is the cornerstone of preventive approaches to Alzheimer"s disease," said Dr. Milan Fiala, lead author of the UCLA study and a researcher at the David Geffen School of Medicine at UCLA and the Veterans Affairs Greater Los Angeles Healthcare System. "We are pleased that the process we"ve identified using immune cells to help predict Alzheimer"s risk will be further developed by MP Biomedicals." "We are excited by the opportunity to forward the UCLA science in creating a cost-effective blood test to screen for Alzheimer"s risk that could be used in any hospital or lab," said Milan Panic, CEO of MP Biomedicals. Dr. Miodrag Micic, vice president of research and development for MP Biomedicals, noted that other blood tests for Alzheimer"s diagnosis measure factors such as inflammation and infection, which are also present in other diseases like atheroclerosis and may complicate the interpretation of results. The recently published study on the process identified by UCLA, which uses the "innate" immune system present at birth, appeared in the May issue of the Journal of Neuroimmunology. In the study, researchers took blood samples and isolated monocytes, which from birth act as the immune system"s janitors, traveling through the brain and body and gobbling up waste products - including amyloid beta. The monocytes were incubated overnight with amyloid beta, which was labeled with a fluorescent marker. Using a common laboratory method known as flow cytometry, researchers then measured the amount of amyloid beta ingested by the immune cells by assessing how much fluorescence was being emitted from each monocyte cell. The 18 Alzheimer"s disease patients in the study showed the least uptake of amyloid beta; the healthy control group, which consisted of 14 university professors, demonstrated the highest uptake. The method was able to distinguish with adequate sensitivity and specificity the Alzheimer"s disease patients. The results were found to be positive in 94 percent of the Alzheimer"s patients and negative in 100 percent of the university professor control group. In addition, the results were found to be positive in 60 percent of study participants who suffered from mild cognitive impairment, a condition that increases the risk of developing Alzheimer"s. "Patients and control subjects were also tracked over time to see if their immune response changed," Fiala said. For example, an Alzheimer"s disease patient over time showed declining results, while a university professor continued to demonstrate a high uptake of amyloid beta. Micic noted that the new method could be a flag for further testing and interventions. "Similar to screening patients for heart disease risk by a cholesterol test, a positive result for Alzheimer"s risk in some patients may suggest further interventions and advanced diagnostics, such as a brain PET scan and neurocognitive testing." The study was funded in part by MP Biomedicals LLC. Fiala is a consultant for the company and also served in the company"s speakers bureau. Rachel Champeau University of California - Los Angeles


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