From Staff Reports

The Cardiothoracic Surgical Trials Network is a major collaborative effort focusing on surgical approaches for cardiac disease. Two of their trials recently reached enrollment milestones, according to the CTSN.

In August the University of Pennsylvania randomized the 200th patient in the severe ischemic mitral regurgitation (SMR) trial. As of the end of the month, the Network randomized 205 patients in the trial designed to evaluate the efficacy and safety of mitral valve repair and replacement for severe MR patients.

There is a companion trial, the moderate MR (MMR) trial, to evaluate the safety and efficacy of mitral valve repair and coronary artery bypass grafting (CABG) vs. CABG alone.

The goal of these trials is to determine the optimal approach to treatment of patients with ischemic MR, a controversial subject involving significant variations in surgical practice. Investigators expect to complete enrollment in the SMR trial (n=250) in the fall of 2011, and in the MMR trial (n=300) by summer of 202.

Also in August, the University of Virginia randomized the 100th patient in the atrial fibrillation (AF) trial. The Network designed a comparative effectiveness randomized trial of surgical ablation with left atrial appendage (LAA) closure versus LAA closure alone in patients with (longstanding) persistent AF undergoing MVS. According to CTSN, nested within this trial, is a further randomized comparison of 2 different lesions sets (pulmonary vein isolation only and Maze lesion set).

The FDA recently approved expansion from 13 to 23 clinical centers and these new sites are now being launched to enable completion of enrollment in 2012.

Two new CTSN-sponsored cell therapy trials are also in the works.

Left ventricular assist device (LVAD) therapy has become widely used and outcomes have improved over time. However, adverse events are still noted and could be minimized. In addition, quality of life could be improved if the duration of support could be limited. One potential way to do this is by inducing myocardial recovery through cell therapy, according to the CTSN.

In collaboration with the Cardiovascular Cell Therapy Research Network, CTSN has developed a translational trial that is intended to evaluate the safety, and explore the efficacy, of direct myocardial injection of off-the-shelf mesenchymal precursor cells in LVAD recipients. The FDA recently approved the protocol, and start-up activities are underway. The ttraining of site coordinators is scheduled to begin in mid-fall 2011.

The second cell therapy trial planned involves the use of intracoronary injections of autologous cardiac stem cells to be performed following cardiac transplantation. According to the CSTN, this trial will be designed to provide "important exploratory information regarding safety and the ability of stem cells to engraft and differentiate within the scaffold of the transplanted heart."

The rationale for this research is to modulate tolerance of the transplanted heart in order to reduce the incidence of allograft rejection. A pre-IND meeting to discuss the protocol was initiated with the FDA.

In the important area of drug support for cardiac surgery patients, CTSN is collaborating with the VA Cooperative Clinical Studies Program, to design what is intended to be a large, simple trial evaluating the effect of adding ticagrelor to aspirin after coronary artery bypass grafting.

The primary efficacy endpoint in the trial will be MACCE and the primary safety endpoint will be severe bleeding. The sample size will be close to 5,000 patients, and the trial is designed to detect a 20% reduction in the primary efficacy endpoint.

Further information on these and other upcoming and ongoing trials can be found on the CSTN website: www.ctsurgerynet.org along with access to their monthly newsletter.n

The Cardiothoracic Surgical Trials Network is a major collaborative effort focusing on surgical approaches for cardiac disease. Two of their trials recently reached enrollment milestones, according to the CTSN.

In August the University of Pennsylvania randomized the 200th patient in the severe ischemic mitral regurgitation (SMR) trial. As of the end of the month, the Network randomized 205 patients in the trial designed to evaluate the efficacy and safety of mitral valve repair and replacement for severe MR patients.

There is a companion trial, the moderate MR (MMR) trial, to evaluate the safety and efficacy of mitral valve repair and coronary artery bypass grafting (CABG) vs. CABG alone.

The goal of these trials is to determine the optimal approach to treatment of patients with ischemic MR, a controversial subject involving significant variations in surgical practice. Investigators expect to complete enrollment in the SMR trial (n=250) in the fall of 2011, and in the MMR trial (n=300) by summer of 202.

Also in August, the University of Virginia randomized the 100th patient in the atrial fibrillation (AF) trial. The Network designed a comparative effectiveness randomized trial of surgical ablation with left atrial appendage (LAA) closure versus LAA closure alone in patients with (longstanding) persistent AF undergoing MVS. According to CTSN, nested within this trial, is a further randomized comparison of 2 different lesions sets (pulmonary vein isolation only and Maze lesion set).

The FDA recently approved expansion from 13 to 23 clinical centers and these new sites are now being launched to enable completion of enrollment in 2012.

Two new CTSN-sponsored cell therapy trials are also in the works.

Left ventricular assist device (LVAD) therapy has become widely used and outcomes have improved over time. However, adverse events are still noted and could be minimized. In addition, quality of life could be improved if the duration of support could be limited. One potential way to do this is by inducing myocardial recovery through cell therapy, according to the CTSN.

In collaboration with the Cardiovascular Cell Therapy Research Network, CTSN has developed a translational trial that is intended to evaluate the safety, and explore the efficacy, of direct myocardial injection of off-the-shelf mesenchymal precursor cells in LVAD recipients. The FDA recently approved the protocol, and start-up activities are underway. The ttraining of site coordinators is scheduled to begin in mid-fall 2011.

The second cell therapy trial planned involves the use of intracoronary injections of autologous cardiac stem cells to be performed following cardiac transplantation. According to the CSTN, this trial will be designed to provide "important exploratory information regarding safety and the ability of stem cells to engraft and differentiate within the scaffold of the transplanted heart."

The rationale for this research is to modulate tolerance of the transplanted heart in order to reduce the incidence of allograft rejection. A pre-IND meeting to discuss the protocol was initiated with the FDA.

In the important area of drug support for cardiac surgery patients, CTSN is collaborating with the VA Cooperative Clinical Studies Program, to design what is intended to be a large, simple trial evaluating the effect of adding ticagrelor to aspirin after coronary artery bypass grafting.

The primary efficacy endpoint in the trial will be MACCE and the primary safety endpoint will be severe bleeding. The sample size will be close to 5,000 patients, and the trial is designed to detect a 20% reduction in the primary efficacy endpoint.

Further information on these and other upcoming and ongoing trials can be found on the CSTN website: www.ctsurgerynet.org along with access to their monthly newsletter.n

The Cardiothoracic Surgical Trials Network is a major collaborative effort focusing on surgical approaches for cardiac disease. Two of their trials recently reached enrollment milestones, according to the CTSN.

In August the University of Pennsylvania randomized the 200th patient in the severe ischemic mitral regurgitation (SMR) trial. As of the end of the month, the Network randomized 205 patients in the trial designed to evaluate the efficacy and safety of mitral valve repair and replacement for severe MR patients.

There is a companion trial, the moderate MR (MMR) trial, to evaluate the safety and efficacy of mitral valve repair and coronary artery bypass grafting (CABG) vs. CABG alone.

The goal of these trials is to determine the optimal approach to treatment of patients with ischemic MR, a controversial subject involving significant variations in surgical practice. Investigators expect to complete enrollment in the SMR trial (n=250) in the fall of 2011, and in the MMR trial (n=300) by summer of 202.

Also in August, the University of Virginia randomized the 100th patient in the atrial fibrillation (AF) trial. The Network designed a comparative effectiveness randomized trial of surgical ablation with left atrial appendage (LAA) closure versus LAA closure alone in patients with (longstanding) persistent AF undergoing MVS. According to CTSN, nested within this trial, is a further randomized comparison of 2 different lesions sets (pulmonary vein isolation only and Maze lesion set).

The FDA recently approved expansion from 13 to 23 clinical centers and these new sites are now being launched to enable completion of enrollment in 2012.

Two new CTSN-sponsored cell therapy trials are also in the works.

Left ventricular assist device (LVAD) therapy has become widely used and outcomes have improved over time. However, adverse events are still noted and could be minimized. In addition, quality of life could be improved if the duration of support could be limited. One potential way to do this is by inducing myocardial recovery through cell therapy, according to the CTSN.

In collaboration with the Cardiovascular Cell Therapy Research Network, CTSN has developed a translational trial that is intended to evaluate the safety, and explore the efficacy, of direct myocardial injection of off-the-shelf mesenchymal precursor cells in LVAD recipients. The FDA recently approved the protocol, and start-up activities are underway. The ttraining of site coordinators is scheduled to begin in mid-fall 2011.

The second cell therapy trial planned involves the use of intracoronary injections of autologous cardiac stem cells to be performed following cardiac transplantation. According to the CSTN, this trial will be designed to provide "important exploratory information regarding safety and the ability of stem cells to engraft and differentiate within the scaffold of the transplanted heart."

The rationale for this research is to modulate tolerance of the transplanted heart in order to reduce the incidence of allograft rejection. A pre-IND meeting to discuss the protocol was initiated with the FDA.

In the important area of drug support for cardiac surgery patients, CTSN is collaborating with the VA Cooperative Clinical Studies Program, to design what is intended to be a large, simple trial evaluating the effect of adding ticagrelor to aspirin after coronary artery bypass grafting.

The primary efficacy endpoint in the trial will be MACCE and the primary safety endpoint will be severe bleeding. The sample size will be close to 5,000 patients, and the trial is designed to detect a 20% reduction in the primary efficacy endpoint.

Further information on these and other upcoming and ongoing trials can be found on the CSTN website: www.ctsurgerynet.org along with access to their monthly newsletter.n

Liver Injury With Dronedarone

The Food and Drug Administration issued a safety announcement about reports of rare but severe liver injury in patients taking dronedarone, including two patients who had acute liver failure that required transplantation.

Dronedarone (Multaq) is used to treat abnormal heart rhythm in patients who have those symptoms for the past 6 months, according to FDA.

The announcement warned physicians and patients to be alert for signs and symptoms of liver injury or toxicity, including anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching. Physicians are encouraged to consider ordering periodic hepatic serum enzymes, particularly during the initial 6 months of treatment with dronedarone.

The label's adverse reactions and warnings and precautions sections are being updated to include information about the potential risk of liver injury.

Lower Acetaminophen Doses Sought

The FDA has asked manufacturers of prescription pain products containing acetaminophen to include no more than 325 mg of the drug in each capsule, tablet, or other dosage unit.

According to a safety announcement by the agency, the action was taken to address the ongoing problem of acetaminophen overdose, a leading cause of severe liver injury in the United States.

The FDA requests that manufacturers of these combination products – including Vicodin and Percocet – add a boxed warning to product labels about the potential risk of severe liver injury if acetaminophen is taken in excessive doses or with alcohol.

Manufacturers have until January 2014 to comply with the recommendations, so a shortage of these medications is not anticipated, according to the agency.

The FDA is also asking clinicians to educate their patients about the dangers of acetaminophen overdose and to advise patients to take no more than the maximum daily dose of acetaminophen (4,000 mg).

“For physicians and other health care providers, we want to emphasize that it's important to talk to patients and make sure that they are aware of the risks of using prescription pain medicines with acetaminophen,” Dr. Sandra Kweder said during a press briefing.

Currently, prescription acetaminophen products contain up to 750 mg of acetaminophen per dosage unit, but there are no data indicating that more than 325 mg of acetaminophen per unit provides greater pain relief, according to the FDA.

The agency's request does not apply to over-the-counter products, which can contain as much as 500 mg per tablet or capsule in the products marketed as extra strength.

Almost half of acetaminophen-related cases of liver failure in the United States are caused by overdoses from prescription opioid-acetaminophen products, which are among the most commonly prescribed products in the United States, accounting for almost 200 million prescriptions dispensed per year.

Rules on Tobacco Tightened

Certain tobacco products – including cigarettes, roll-your-own, and smokeless varieties – that were introduced or changed in the United States after Feb. 15, 2007, must be reviewed by the FDA to show that they are “substantially equivalent” to existing products, Dr. Lawrence Deyton, director of the agency's Center for Tobacco Products, said in a press briefing.

The FDA action is driven by the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. The law allows the FDA to regulate tobacco products with the goal of protecting public health.

The substantial equivalence provisions are “meant to ensure that new tobacco products or changes to existing products are evaluated by the FDA before they enter the marketplace and are consumed by millions of people,” Dr. Deyton said. “Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming,” he said.

The Tobacco Control Act allows tobacco companies to market products that were available after Feb. 15, 2007, if the companies submit at least a preliminary report to the FDA by March 22, 2011, to show that these products are not significantly different from pre-existing products. Products in existence before Feb. 15, 2007, are not subject to the new FDA review, said Ann Simoneau, director of the Center for Tobacco Products' Office of Compliance and Enforcement.

New products introduced after March 22 will follow a different regulatory pathway, Dr. Deyton said.

Physicians should know that the FDA is now examining certain tobacco products and that manufacturers are required to submit information to the FDA about the products and changes to them, “particularly if those changes might raise new questions about public health,” Dr. Deyton said.

Liver Injury With Dronedarone

The Food and Drug Administration issued a safety announcement about reports of rare but severe liver injury in patients taking dronedarone, including two patients who had acute liver failure that required transplantation.

Dronedarone (Multaq) is used to treat abnormal heart rhythm in patients who have those symptoms for the past 6 months, according to FDA.

The announcement warned physicians and patients to be alert for signs and symptoms of liver injury or toxicity, including anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching. Physicians are encouraged to consider ordering periodic hepatic serum enzymes, particularly during the initial 6 months of treatment with dronedarone.

The label's adverse reactions and warnings and precautions sections are being updated to include information about the potential risk of liver injury.

Lower Acetaminophen Doses Sought

The FDA has asked manufacturers of prescription pain products containing acetaminophen to include no more than 325 mg of the drug in each capsule, tablet, or other dosage unit.

According to a safety announcement by the agency, the action was taken to address the ongoing problem of acetaminophen overdose, a leading cause of severe liver injury in the United States.

The FDA requests that manufacturers of these combination products – including Vicodin and Percocet – add a boxed warning to product labels about the potential risk of severe liver injury if acetaminophen is taken in excessive doses or with alcohol.

Manufacturers have until January 2014 to comply with the recommendations, so a shortage of these medications is not anticipated, according to the agency.

The FDA is also asking clinicians to educate their patients about the dangers of acetaminophen overdose and to advise patients to take no more than the maximum daily dose of acetaminophen (4,000 mg).

“For physicians and other health care providers, we want to emphasize that it's important to talk to patients and make sure that they are aware of the risks of using prescription pain medicines with acetaminophen,” Dr. Sandra Kweder said during a press briefing.

Currently, prescription acetaminophen products contain up to 750 mg of acetaminophen per dosage unit, but there are no data indicating that more than 325 mg of acetaminophen per unit provides greater pain relief, according to the FDA.

The agency's request does not apply to over-the-counter products, which can contain as much as 500 mg per tablet or capsule in the products marketed as extra strength.

Almost half of acetaminophen-related cases of liver failure in the United States are caused by overdoses from prescription opioid-acetaminophen products, which are among the most commonly prescribed products in the United States, accounting for almost 200 million prescriptions dispensed per year.

Rules on Tobacco Tightened

Certain tobacco products – including cigarettes, roll-your-own, and smokeless varieties – that were introduced or changed in the United States after Feb. 15, 2007, must be reviewed by the FDA to show that they are “substantially equivalent” to existing products, Dr. Lawrence Deyton, director of the agency's Center for Tobacco Products, said in a press briefing.

The FDA action is driven by the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. The law allows the FDA to regulate tobacco products with the goal of protecting public health.

The substantial equivalence provisions are “meant to ensure that new tobacco products or changes to existing products are evaluated by the FDA before they enter the marketplace and are consumed by millions of people,” Dr. Deyton said. “Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming,” he said.

The Tobacco Control Act allows tobacco companies to market products that were available after Feb. 15, 2007, if the companies submit at least a preliminary report to the FDA by March 22, 2011, to show that these products are not significantly different from pre-existing products. Products in existence before Feb. 15, 2007, are not subject to the new FDA review, said Ann Simoneau, director of the Center for Tobacco Products' Office of Compliance and Enforcement.

New products introduced after March 22 will follow a different regulatory pathway, Dr. Deyton said.

Physicians should know that the FDA is now examining certain tobacco products and that manufacturers are required to submit information to the FDA about the products and changes to them, “particularly if those changes might raise new questions about public health,” Dr. Deyton said.

Liver Injury With Dronedarone

The Food and Drug Administration issued a safety announcement about reports of rare but severe liver injury in patients taking dronedarone, including two patients who had acute liver failure that required transplantation.

Dronedarone (Multaq) is used to treat abnormal heart rhythm in patients who have those symptoms for the past 6 months, according to FDA.

The announcement warned physicians and patients to be alert for signs and symptoms of liver injury or toxicity, including anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching. Physicians are encouraged to consider ordering periodic hepatic serum enzymes, particularly during the initial 6 months of treatment with dronedarone.

The label's adverse reactions and warnings and precautions sections are being updated to include information about the potential risk of liver injury.

Lower Acetaminophen Doses Sought

The FDA has asked manufacturers of prescription pain products containing acetaminophen to include no more than 325 mg of the drug in each capsule, tablet, or other dosage unit.

According to a safety announcement by the agency, the action was taken to address the ongoing problem of acetaminophen overdose, a leading cause of severe liver injury in the United States.

The FDA requests that manufacturers of these combination products – including Vicodin and Percocet – add a boxed warning to product labels about the potential risk of severe liver injury if acetaminophen is taken in excessive doses or with alcohol.

Manufacturers have until January 2014 to comply with the recommendations, so a shortage of these medications is not anticipated, according to the agency.

The FDA is also asking clinicians to educate their patients about the dangers of acetaminophen overdose and to advise patients to take no more than the maximum daily dose of acetaminophen (4,000 mg).

“For physicians and other health care providers, we want to emphasize that it's important to talk to patients and make sure that they are aware of the risks of using prescription pain medicines with acetaminophen,” Dr. Sandra Kweder said during a press briefing.

Currently, prescription acetaminophen products contain up to 750 mg of acetaminophen per dosage unit, but there are no data indicating that more than 325 mg of acetaminophen per unit provides greater pain relief, according to the FDA.

The agency's request does not apply to over-the-counter products, which can contain as much as 500 mg per tablet or capsule in the products marketed as extra strength.

Almost half of acetaminophen-related cases of liver failure in the United States are caused by overdoses from prescription opioid-acetaminophen products, which are among the most commonly prescribed products in the United States, accounting for almost 200 million prescriptions dispensed per year.

Rules on Tobacco Tightened

Certain tobacco products – including cigarettes, roll-your-own, and smokeless varieties – that were introduced or changed in the United States after Feb. 15, 2007, must be reviewed by the FDA to show that they are “substantially equivalent” to existing products, Dr. Lawrence Deyton, director of the agency's Center for Tobacco Products, said in a press briefing.

The FDA action is driven by the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. The law allows the FDA to regulate tobacco products with the goal of protecting public health.

The substantial equivalence provisions are “meant to ensure that new tobacco products or changes to existing products are evaluated by the FDA before they enter the marketplace and are consumed by millions of people,” Dr. Deyton said. “Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming,” he said.

The Tobacco Control Act allows tobacco companies to market products that were available after Feb. 15, 2007, if the companies submit at least a preliminary report to the FDA by March 22, 2011, to show that these products are not significantly different from pre-existing products. Products in existence before Feb. 15, 2007, are not subject to the new FDA review, said Ann Simoneau, director of the Center for Tobacco Products' Office of Compliance and Enforcement.

New products introduced after March 22 will follow a different regulatory pathway, Dr. Deyton said.

Physicians should know that the FDA is now examining certain tobacco products and that manufacturers are required to submit information to the FDA about the products and changes to them, “particularly if those changes might raise new questions about public health,” Dr. Deyton said.

DSM-5 Field Trials Begin

The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) is getting its first real-world trial at 11 large medical centers and among nearly 4,000 mental health professionals, the American Psychiatric Association has announced. The field trials will test whether proposed diagnostic criteria are understandable and easy for practitioners to use, accurately describe psychiatric problems, and yield consistent diagnoses. Psychiatrists, psychologists, social workers, and psychiatric/mental health nurses will test the new criteria by using them repeatedly to evaluate new and existing patients. After this testing phase, the manual will undergo a second round of public comment, editing, and more field trials lasting into 2012. “It is important that the proposed diagnostic criteria are subjected to rigorous and empirically sound field trials before DSM-5 is published in 2013,” Dr. David Kupfer, DSM-5 Task Force chair, said in a statement.

Grants Fund Lupus Research

The Lupus Foundation of America has made six new grants for studies into what it considers neglected areas of lupus research: pediatric lupus, reproductive health issues in lupus, lupus nephritis, and neuropsychiatric lupus. “The research funded this year tackles some of the most complex and challenging areas of lupus research,” said Sandra C. Raymond, president and CEO of the Washington-based foundation. “These areas of research have suffered from a lack of resources, and in some cases have seen little advancement.” With the new grants, Dr. Bruce C. Richardson of the University of Michigan in Ann Arbor will study the genetics of male lupus; Dr. Richard K. Burt of Northwestern University in Chicago will look at hematopoietic stem cell transplantation in lupus; Dr. Richard J. Quigg of the University of Chicago will study complement manipulation in lupus nephritis; Dr. Martin G. Pomper of the Johns Hopkins School of Medicine in Baltimore will assess imaging microglial activation in neuropsychiatric lupus; Dr. Michelle A. Petri of Johns Hopkins will study the use of levothyroxine in pregnant systemic lupus erythematosus (SLE) patients; and Dr. Kathleen M. O'Neil of the University of Oklahoma in Oklahoma City will look at the effect of puberty on SLE.

Giving Back to the DEA

Americans turned in more than 242,000 pounds of unused or unwanted prescription drugs for disposal as part of the first national prescription drug “Take-Back” campaign, the Drug Enforcement Administration reports. The agency reported a huge turnout of people turning in large quantities of old drugs at more than 4,000 disposal sites being run by law enforcement personnel across the country. For example, at one site a woman turned in nearly 50 years' worth of medications for disposal, while at another site, a man dumped a kitchen drawer full of medications, a DEA announcement said. “The Take-Back campaign was a stunning nationwide success [and] a crucial step toward reducing the epidemic of prescription drug abuse that is plaguing this nation,” said DEA Acting Administrator Michele Leonhart in the announcement.

IOM Backs Nursing Expansion

The roles and responsibilities of nurses should change significantly to meet the increased demand for care created by health care reform, according to an Institute of Medicine report that immediately drew criticism from the American Medical Association. The report urged removal of regulatory and institutional obstacles that prevent nurses from taking on additional patient-care duties. To handle these new responsibilities, nurses should receive higher levels of training through an improved educational system, including a new residency program and additional opportunities for lifelong learning, the institute report said. The AMA took issue with the report's call to expand nurses' scope of practice, saying that nurses do not have nearly the amount of training and clinical experience that doctors do. “With a shortage of both nurses and physicians, increasing the responsibility of nurses is not the answer to the physician shortage,” AMA board member Rebecca J. Patchin said in a statement.

New Rules Target Fraud

The Department of Health and Human Services has proposed new rules aimed at fighting waste, fraud, and abuse in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). The rules are authorized by the Affordable Care Act and would tighten screening of providers wishing to bill government programs for services, for example, by using broader criminal background checks and even fingerprinting. The rules also require states to terminate from their Medicaid and CHIP programs any provider who has been thrown out of Medicare or another state's health programs. The proposed rule asked for advice on how best to ensure provider compliance.

DSM-5 Field Trials Begin

The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) is getting its first real-world trial at 11 large medical centers and among nearly 4,000 mental health professionals, the American Psychiatric Association has announced. The field trials will test whether proposed diagnostic criteria are understandable and easy for practitioners to use, accurately describe psychiatric problems, and yield consistent diagnoses. Psychiatrists, psychologists, social workers, and psychiatric/mental health nurses will test the new criteria by using them repeatedly to evaluate new and existing patients. After this testing phase, the manual will undergo a second round of public comment, editing, and more field trials lasting into 2012. “It is important that the proposed diagnostic criteria are subjected to rigorous and empirically sound field trials before DSM-5 is published in 2013,” Dr. David Kupfer, DSM-5 Task Force chair, said in a statement.

Grants Fund Lupus Research

The Lupus Foundation of America has made six new grants for studies into what it considers neglected areas of lupus research: pediatric lupus, reproductive health issues in lupus, lupus nephritis, and neuropsychiatric lupus. “The research funded this year tackles some of the most complex and challenging areas of lupus research,” said Sandra C. Raymond, president and CEO of the Washington-based foundation. “These areas of research have suffered from a lack of resources, and in some cases have seen little advancement.” With the new grants, Dr. Bruce C. Richardson of the University of Michigan in Ann Arbor will study the genetics of male lupus; Dr. Richard K. Burt of Northwestern University in Chicago will look at hematopoietic stem cell transplantation in lupus; Dr. Richard J. Quigg of the University of Chicago will study complement manipulation in lupus nephritis; Dr. Martin G. Pomper of the Johns Hopkins School of Medicine in Baltimore will assess imaging microglial activation in neuropsychiatric lupus; Dr. Michelle A. Petri of Johns Hopkins will study the use of levothyroxine in pregnant systemic lupus erythematosus (SLE) patients; and Dr. Kathleen M. O'Neil of the University of Oklahoma in Oklahoma City will look at the effect of puberty on SLE.

Giving Back to the DEA

Americans turned in more than 242,000 pounds of unused or unwanted prescription drugs for disposal as part of the first national prescription drug “Take-Back” campaign, the Drug Enforcement Administration reports. The agency reported a huge turnout of people turning in large quantities of old drugs at more than 4,000 disposal sites being run by law enforcement personnel across the country. For example, at one site a woman turned in nearly 50 years' worth of medications for disposal, while at another site, a man dumped a kitchen drawer full of medications, a DEA announcement said. “The Take-Back campaign was a stunning nationwide success [and] a crucial step toward reducing the epidemic of prescription drug abuse that is plaguing this nation,” said DEA Acting Administrator Michele Leonhart in the announcement.

IOM Backs Nursing Expansion

The roles and responsibilities of nurses should change significantly to meet the increased demand for care created by health care reform, according to an Institute of Medicine report that immediately drew criticism from the American Medical Association. The report urged removal of regulatory and institutional obstacles that prevent nurses from taking on additional patient-care duties. To handle these new responsibilities, nurses should receive higher levels of training through an improved educational system, including a new residency program and additional opportunities for lifelong learning, the institute report said. The AMA took issue with the report's call to expand nurses' scope of practice, saying that nurses do not have nearly the amount of training and clinical experience that doctors do. “With a shortage of both nurses and physicians, increasing the responsibility of nurses is not the answer to the physician shortage,” AMA board member Rebecca J. Patchin said in a statement.

New Rules Target Fraud

The Department of Health and Human Services has proposed new rules aimed at fighting waste, fraud, and abuse in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). The rules are authorized by the Affordable Care Act and would tighten screening of providers wishing to bill government programs for services, for example, by using broader criminal background checks and even fingerprinting. The rules also require states to terminate from their Medicaid and CHIP programs any provider who has been thrown out of Medicare or another state's health programs. The proposed rule asked for advice on how best to ensure provider compliance.

DSM-5 Field Trials Begin

The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) is getting its first real-world trial at 11 large medical centers and among nearly 4,000 mental health professionals, the American Psychiatric Association has announced. The field trials will test whether proposed diagnostic criteria are understandable and easy for practitioners to use, accurately describe psychiatric problems, and yield consistent diagnoses. Psychiatrists, psychologists, social workers, and psychiatric/mental health nurses will test the new criteria by using them repeatedly to evaluate new and existing patients. After this testing phase, the manual will undergo a second round of public comment, editing, and more field trials lasting into 2012. “It is important that the proposed diagnostic criteria are subjected to rigorous and empirically sound field trials before DSM-5 is published in 2013,” Dr. David Kupfer, DSM-5 Task Force chair, said in a statement.

Grants Fund Lupus Research

The Lupus Foundation of America has made six new grants for studies into what it considers neglected areas of lupus research: pediatric lupus, reproductive health issues in lupus, lupus nephritis, and neuropsychiatric lupus. “The research funded this year tackles some of the most complex and challenging areas of lupus research,” said Sandra C. Raymond, president and CEO of the Washington-based foundation. “These areas of research have suffered from a lack of resources, and in some cases have seen little advancement.” With the new grants, Dr. Bruce C. Richardson of the University of Michigan in Ann Arbor will study the genetics of male lupus; Dr. Richard K. Burt of Northwestern University in Chicago will look at hematopoietic stem cell transplantation in lupus; Dr. Richard J. Quigg of the University of Chicago will study complement manipulation in lupus nephritis; Dr. Martin G. Pomper of the Johns Hopkins School of Medicine in Baltimore will assess imaging microglial activation in neuropsychiatric lupus; Dr. Michelle A. Petri of Johns Hopkins will study the use of levothyroxine in pregnant systemic lupus erythematosus (SLE) patients; and Dr. Kathleen M. O'Neil of the University of Oklahoma in Oklahoma City will look at the effect of puberty on SLE.

Giving Back to the DEA

Americans turned in more than 242,000 pounds of unused or unwanted prescription drugs for disposal as part of the first national prescription drug “Take-Back” campaign, the Drug Enforcement Administration reports. The agency reported a huge turnout of people turning in large quantities of old drugs at more than 4,000 disposal sites being run by law enforcement personnel across the country. For example, at one site a woman turned in nearly 50 years' worth of medications for disposal, while at another site, a man dumped a kitchen drawer full of medications, a DEA announcement said. “The Take-Back campaign was a stunning nationwide success [and] a crucial step toward reducing the epidemic of prescription drug abuse that is plaguing this nation,” said DEA Acting Administrator Michele Leonhart in the announcement.

IOM Backs Nursing Expansion

The roles and responsibilities of nurses should change significantly to meet the increased demand for care created by health care reform, according to an Institute of Medicine report that immediately drew criticism from the American Medical Association. The report urged removal of regulatory and institutional obstacles that prevent nurses from taking on additional patient-care duties. To handle these new responsibilities, nurses should receive higher levels of training through an improved educational system, including a new residency program and additional opportunities for lifelong learning, the institute report said. The AMA took issue with the report's call to expand nurses' scope of practice, saying that nurses do not have nearly the amount of training and clinical experience that doctors do. “With a shortage of both nurses and physicians, increasing the responsibility of nurses is not the answer to the physician shortage,” AMA board member Rebecca J. Patchin said in a statement.

New Rules Target Fraud

The Department of Health and Human Services has proposed new rules aimed at fighting waste, fraud, and abuse in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). The rules are authorized by the Affordable Care Act and would tighten screening of providers wishing to bill government programs for services, for example, by using broader criminal background checks and even fingerprinting. The rules also require states to terminate from their Medicaid and CHIP programs any provider who has been thrown out of Medicare or another state's health programs. The proposed rule asked for advice on how best to ensure provider compliance.

FDA Clears Glucose Monitoring Strip

Abbott has received Food and Drug Administration clearance to market its FreeStyle Lite blood glucose monitoring strip. First shipments will go out in July; widespread availability is expected by the end of August. The test trips use a glucose dehydrogenase flavin adenine dinucleotide, which is unaffected by common nonglucose sugars such as maltose and galactose, and which minimizes the potential for other interference, according to a company statement. The new strips are designed to ensure faster blood application and a reduction in the number of error messages and wasted strips. These features provide a “better testing experience … especially for people who use insulin to manage their diabetes,” said Heather L. Mason, senior vice president of Abbott Diabetes Care. The FDA clearance follows Abbott's announcement of the product's European availability.

GSK Inks Deal With Dong-A Pharmaceutical

In an alliance designed to help GlaxoSmithKline gain a share in the rapidly growing Korean pharmaceutical market, GSK is paying 142.9 billion South Korean won ($128.7 million) to acquire a 9.9% stake in Dong-A Pharmaceutical, South Korea's leading prescription and over-the-counter drug company. The deal will make GSK Dong-A's second largest shareholder after Kang Shin-Ho, Dong-A's chairman, who holds a 10.6% share. According to GSK, the initial focus of the collaboration will be to copromote products from both firms in Korea's primary care market. A new business unit will be established within Seoul-based Dong-A to capture additional synergies. These could include partnerships on select Dong-A chemical entities leveraging GSK's global commercial infrastructure and expertise, as well as codevelopment of branded generics, the company added. “It's an innovative partnership to support GSK's growth and diversification strategy,” said Kim Jin-Ho, general manager of GSK Korea. The partnership could serve as a cushion for GSK's pending loss of patent protection on some of its drugs, said Bae Ki-Dal of Shinhan Investment Corp. “It's fair to say that GSK and Dong-A are forming a united front against potential setbacks,” he said.

Takeda Cuts Jobs, Boosts R&D

Citing patent loss on key products sold in North America along with the strong yen against the U.S. dollar and other currencies, the Japanese pharmaceutical company Takeda reported revenue decreases of 4.7% in fiscal 2009, its first sales decline in 19 years. The type 2 diabetes drug Actos (pioglitazone), one of Takeda's core products, will lose its U.S. patent in 2011. The company's settlement of patent infringement lawsuits with six of eight generic firms for Actos and Actoplus Met (pioglitazone/metformin) will delay the generics' penetration until August 2012. Anticipating a 5% reduction revenues and a 26% loss in operating income for fiscal 2010, Takeda will boost research and development expenditures to accelerate pipeline development. The company plans to launch alogliptin, which it positions as a key post-Actos product, in 2012. Basen (voglibose), a type 2 diabetes treatment, and several other company products also are facing expirations. In light of patent expiries and revenue loss, Takeda announced that it will let go 10% of its employees—about 2,000 people. Most of the cuts are expected in the company's U.S. subsidiary, Takeda Pharmaceuticals North America.

Pfizer, Washington U. in 5-Year Deal

Pfizer has announced a 5-year deal with Washington University in St. Louis, during which time the university will receive $22.5 million and its researchers will have access to a searchable, proprietary database of Pfizer compounds and related information. It will be a “truly collaborative partnership,” said Don Frail, chief scientific officer of Pfizer's Indications Discovery Unit. The arrangement enables the pharmaceutical company to take advantage of external research and development capabilities at a nominal price. Pfizer's history of partnerships with Washington University, which goes back nearly 30 years, has shown that the school's Center for Genome Sciences has significant expertise in a broad range of diseases, including diabetes and related metabolic disorders, asthma, chronic obstructive pulmonary disease, and Alzheimer's, Mr. Frail said.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

FDA Clears Glucose Monitoring Strip

Abbott has received Food and Drug Administration clearance to market its FreeStyle Lite blood glucose monitoring strip. First shipments will go out in July; widespread availability is expected by the end of August. The test trips use a glucose dehydrogenase flavin adenine dinucleotide, which is unaffected by common nonglucose sugars such as maltose and galactose, and which minimizes the potential for other interference, according to a company statement. The new strips are designed to ensure faster blood application and a reduction in the number of error messages and wasted strips. These features provide a “better testing experience … especially for people who use insulin to manage their diabetes,” said Heather L. Mason, senior vice president of Abbott Diabetes Care. The FDA clearance follows Abbott's announcement of the product's European availability.

GSK Inks Deal With Dong-A Pharmaceutical

In an alliance designed to help GlaxoSmithKline gain a share in the rapidly growing Korean pharmaceutical market, GSK is paying 142.9 billion South Korean won ($128.7 million) to acquire a 9.9% stake in Dong-A Pharmaceutical, South Korea's leading prescription and over-the-counter drug company. The deal will make GSK Dong-A's second largest shareholder after Kang Shin-Ho, Dong-A's chairman, who holds a 10.6% share. According to GSK, the initial focus of the collaboration will be to copromote products from both firms in Korea's primary care market. A new business unit will be established within Seoul-based Dong-A to capture additional synergies. These could include partnerships on select Dong-A chemical entities leveraging GSK's global commercial infrastructure and expertise, as well as codevelopment of branded generics, the company added. “It's an innovative partnership to support GSK's growth and diversification strategy,” said Kim Jin-Ho, general manager of GSK Korea. The partnership could serve as a cushion for GSK's pending loss of patent protection on some of its drugs, said Bae Ki-Dal of Shinhan Investment Corp. “It's fair to say that GSK and Dong-A are forming a united front against potential setbacks,” he said.

Takeda Cuts Jobs, Boosts R&D

Citing patent loss on key products sold in North America along with the strong yen against the U.S. dollar and other currencies, the Japanese pharmaceutical company Takeda reported revenue decreases of 4.7% in fiscal 2009, its first sales decline in 19 years. The type 2 diabetes drug Actos (pioglitazone), one of Takeda's core products, will lose its U.S. patent in 2011. The company's settlement of patent infringement lawsuits with six of eight generic firms for Actos and Actoplus Met (pioglitazone/metformin) will delay the generics' penetration until August 2012. Anticipating a 5% reduction revenues and a 26% loss in operating income for fiscal 2010, Takeda will boost research and development expenditures to accelerate pipeline development. The company plans to launch alogliptin, which it positions as a key post-Actos product, in 2012. Basen (voglibose), a type 2 diabetes treatment, and several other company products also are facing expirations. In light of patent expiries and revenue loss, Takeda announced that it will let go 10% of its employees—about 2,000 people. Most of the cuts are expected in the company's U.S. subsidiary, Takeda Pharmaceuticals North America.

Pfizer, Washington U. in 5-Year Deal

Pfizer has announced a 5-year deal with Washington University in St. Louis, during which time the university will receive $22.5 million and its researchers will have access to a searchable, proprietary database of Pfizer compounds and related information. It will be a “truly collaborative partnership,” said Don Frail, chief scientific officer of Pfizer's Indications Discovery Unit. The arrangement enables the pharmaceutical company to take advantage of external research and development capabilities at a nominal price. Pfizer's history of partnerships with Washington University, which goes back nearly 30 years, has shown that the school's Center for Genome Sciences has significant expertise in a broad range of diseases, including diabetes and related metabolic disorders, asthma, chronic obstructive pulmonary disease, and Alzheimer's, Mr. Frail said.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

FDA Clears Glucose Monitoring Strip

Abbott has received Food and Drug Administration clearance to market its FreeStyle Lite blood glucose monitoring strip. First shipments will go out in July; widespread availability is expected by the end of August. The test trips use a glucose dehydrogenase flavin adenine dinucleotide, which is unaffected by common nonglucose sugars such as maltose and galactose, and which minimizes the potential for other interference, according to a company statement. The new strips are designed to ensure faster blood application and a reduction in the number of error messages and wasted strips. These features provide a “better testing experience … especially for people who use insulin to manage their diabetes,” said Heather L. Mason, senior vice president of Abbott Diabetes Care. The FDA clearance follows Abbott's announcement of the product's European availability.

GSK Inks Deal With Dong-A Pharmaceutical

In an alliance designed to help GlaxoSmithKline gain a share in the rapidly growing Korean pharmaceutical market, GSK is paying 142.9 billion South Korean won ($128.7 million) to acquire a 9.9% stake in Dong-A Pharmaceutical, South Korea's leading prescription and over-the-counter drug company. The deal will make GSK Dong-A's second largest shareholder after Kang Shin-Ho, Dong-A's chairman, who holds a 10.6% share. According to GSK, the initial focus of the collaboration will be to copromote products from both firms in Korea's primary care market. A new business unit will be established within Seoul-based Dong-A to capture additional synergies. These could include partnerships on select Dong-A chemical entities leveraging GSK's global commercial infrastructure and expertise, as well as codevelopment of branded generics, the company added. “It's an innovative partnership to support GSK's growth and diversification strategy,” said Kim Jin-Ho, general manager of GSK Korea. The partnership could serve as a cushion for GSK's pending loss of patent protection on some of its drugs, said Bae Ki-Dal of Shinhan Investment Corp. “It's fair to say that GSK and Dong-A are forming a united front against potential setbacks,” he said.

Takeda Cuts Jobs, Boosts R&D

Citing patent loss on key products sold in North America along with the strong yen against the U.S. dollar and other currencies, the Japanese pharmaceutical company Takeda reported revenue decreases of 4.7% in fiscal 2009, its first sales decline in 19 years. The type 2 diabetes drug Actos (pioglitazone), one of Takeda's core products, will lose its U.S. patent in 2011. The company's settlement of patent infringement lawsuits with six of eight generic firms for Actos and Actoplus Met (pioglitazone/metformin) will delay the generics' penetration until August 2012. Anticipating a 5% reduction revenues and a 26% loss in operating income for fiscal 2010, Takeda will boost research and development expenditures to accelerate pipeline development. The company plans to launch alogliptin, which it positions as a key post-Actos product, in 2012. Basen (voglibose), a type 2 diabetes treatment, and several other company products also are facing expirations. In light of patent expiries and revenue loss, Takeda announced that it will let go 10% of its employees—about 2,000 people. Most of the cuts are expected in the company's U.S. subsidiary, Takeda Pharmaceuticals North America.

Pfizer, Washington U. in 5-Year Deal

Pfizer has announced a 5-year deal with Washington University in St. Louis, during which time the university will receive $22.5 million and its researchers will have access to a searchable, proprietary database of Pfizer compounds and related information. It will be a “truly collaborative partnership,” said Don Frail, chief scientific officer of Pfizer's Indications Discovery Unit. The arrangement enables the pharmaceutical company to take advantage of external research and development capabilities at a nominal price. Pfizer's history of partnerships with Washington University, which goes back nearly 30 years, has shown that the school's Center for Genome Sciences has significant expertise in a broad range of diseases, including diabetes and related metabolic disorders, asthma, chronic obstructive pulmonary disease, and Alzheimer's, Mr. Frail said.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.