Jonathan Gardner

U.S. and European drug regulators have announced “intensified” information sharing and dialogue to increase cooperation in drug approval and surveillance activities in the world's two largest pharmaceutical markets.

At a March review meeting in Brussels, the Food and Drug Administration, the European Medicines Agency, and the European Commission judged as a success the implementation of a confidentiality agreement that has enabled greater transatlantic information sharing and dialogue on pharmaceutical regulations protecting 753 million people in 26 countries.

The agencies hope to particularly strengthen joint activities on vaccines in preparation for potential pandemic flu outbreaks, as well as cancer, children's, and orphan drugs, and pharmacogenomics. Future activities will address counterfeit drugs.

The original agreement, signed in September 2003, paved the way for quarterly exchanges of information on new drug applications, regulatory guidance, and inspections of manufacturing plants, which began in 2004. The agreement also authorized ad hoc exchanges of information on drug safety and public health, including advance notice of regulatory actions such as pulling drugs from the market.

Such an exchange prevents other agencies from issuing contradictory advice when one agency takes regulatory action.

The ad hoc exchanges also have enabled “parallel” scientific guidance for drug applicants seeking the advice of the three agencies on how to proceed with research at such milestones as the conclusion of clinical trials. The first such meeting was in September 2003, and as part of the initial confidentiality arrangement, a 1-year pilot project was begun in 2005.

Those parallel meetings focus on breakthrough drugs, drugs for rare conditions, medication for children, or other new medicines considered important.

The agencies agreed to extend the project but did not say for how long. A spokesman for the European Commission said the meetings do not guarantee joint advice from the agencies but give applicants guidance on how to seek international drug approvals.

U.S. and European drug regulators have announced “intensified” information sharing and dialogue to increase cooperation in drug approval and surveillance activities in the world's two largest pharmaceutical markets.

At a March review meeting in Brussels, the Food and Drug Administration, the European Medicines Agency, and the European Commission judged as a success the implementation of a confidentiality agreement that has enabled greater transatlantic information sharing and dialogue on pharmaceutical regulations protecting 753 million people in 26 countries.

The agencies hope to particularly strengthen joint activities on vaccines in preparation for potential pandemic flu outbreaks, as well as cancer, children's, and orphan drugs, and pharmacogenomics. Future activities will address counterfeit drugs.

The original agreement, signed in September 2003, paved the way for quarterly exchanges of information on new drug applications, regulatory guidance, and inspections of manufacturing plants, which began in 2004. The agreement also authorized ad hoc exchanges of information on drug safety and public health, including advance notice of regulatory actions such as pulling drugs from the market.

Such an exchange prevents other agencies from issuing contradictory advice when one agency takes regulatory action.

The ad hoc exchanges also have enabled “parallel” scientific guidance for drug applicants seeking the advice of the three agencies on how to proceed with research at such milestones as the conclusion of clinical trials. The first such meeting was in September 2003, and as part of the initial confidentiality arrangement, a 1-year pilot project was begun in 2005.

Those parallel meetings focus on breakthrough drugs, drugs for rare conditions, medication for children, or other new medicines considered important.

The agencies agreed to extend the project but did not say for how long. A spokesman for the European Commission said the meetings do not guarantee joint advice from the agencies but give applicants guidance on how to seek international drug approvals.

U.S. and European drug regulators have announced “intensified” information sharing and dialogue to increase cooperation in drug approval and surveillance activities in the world's two largest pharmaceutical markets.

At a March review meeting in Brussels, the Food and Drug Administration, the European Medicines Agency, and the European Commission judged as a success the implementation of a confidentiality agreement that has enabled greater transatlantic information sharing and dialogue on pharmaceutical regulations protecting 753 million people in 26 countries.

The agencies hope to particularly strengthen joint activities on vaccines in preparation for potential pandemic flu outbreaks, as well as cancer, children's, and orphan drugs, and pharmacogenomics. Future activities will address counterfeit drugs.

The original agreement, signed in September 2003, paved the way for quarterly exchanges of information on new drug applications, regulatory guidance, and inspections of manufacturing plants, which began in 2004. The agreement also authorized ad hoc exchanges of information on drug safety and public health, including advance notice of regulatory actions such as pulling drugs from the market.

Such an exchange prevents other agencies from issuing contradictory advice when one agency takes regulatory action.

The ad hoc exchanges also have enabled “parallel” scientific guidance for drug applicants seeking the advice of the three agencies on how to proceed with research at such milestones as the conclusion of clinical trials. The first such meeting was in September 2003, and as part of the initial confidentiality arrangement, a 1-year pilot project was begun in 2005.

Those parallel meetings focus on breakthrough drugs, drugs for rare conditions, medication for children, or other new medicines considered important.

The agencies agreed to extend the project but did not say for how long. A spokesman for the European Commission said the meetings do not guarantee joint advice from the agencies but give applicants guidance on how to seek international drug approvals.

Outpatient thyroidectomies performed with local anesthesia on eligible patients can achieve clinical results and patient satisfaction comparable with those done under general anesthesia, according to results of a prospective, randomized clinical trial.

Researchers at Texas A&M University in Temple, Tex., monitored 58 patients at Scott & White Memorial Hospital in Temple who underwent thyroidectomies between January 2000 and July 2001 (Arch. Surg. 2006;141:167–73). The patients' ages ranged from 19 to 80 years; 53 of the patients (91%) were women.

The patients were randomized into two groups of 29, and thyroidectomies were performed under general anesthesia in one group and under local anesthesia with monitored anesthesia care in the other. The same surgeon treated all patients.

Researchers found statistically significant differences in the amount of time patients in the two groups spent in postsurgical care, which included time spent in postanesthesia care and the combined time spent in postanesthesia care and the hospital's day surgery unit.

On average, patients who received local anesthesia spent 4 minutes in the postanesthesia care unit, compared with 80 minutes for those treated under general anesthesia. The combined time spent in the postanesthesia care unit and the day surgery unit for those treated under local anesthesia was 165 minutes, compared with 229 minutes for those under general anesthesia.

As a result of the earlier discharge, researchers estimated the per-patient savings at $315 for those treated with local anesthesia.

The researchers found no statistically significant differences in the number of patients undergoing either procedure who were admitted to the hospital after surgery or in the 30 days after initial discharge, the number of complications, or the overall satisfaction with their surgery or anesthesia management.

The researchers also noted a statistically significant difference in physician practice before and after the study. They compared a group of 58 consecutive thyroidectomy patients treated before the study with a group of 58 consecutive patients treated afterward. The share of outpatient procedures performed with local anesthesia and monitored anesthesia care rose from 21% to 50%, and the share of outpatient procedures performed with general anesthesia dropped from 79% to 50%.

Outpatient thyroidectomies performed with local anesthesia on eligible patients can achieve clinical results and patient satisfaction comparable with those done under general anesthesia, according to results of a prospective, randomized clinical trial.

Researchers at Texas A&M University in Temple, Tex., monitored 58 patients at Scott & White Memorial Hospital in Temple who underwent thyroidectomies between January 2000 and July 2001 (Arch. Surg. 2006;141:167–73). The patients' ages ranged from 19 to 80 years; 53 of the patients (91%) were women.

The patients were randomized into two groups of 29, and thyroidectomies were performed under general anesthesia in one group and under local anesthesia with monitored anesthesia care in the other. The same surgeon treated all patients.

Researchers found statistically significant differences in the amount of time patients in the two groups spent in postsurgical care, which included time spent in postanesthesia care and the combined time spent in postanesthesia care and the hospital's day surgery unit.

On average, patients who received local anesthesia spent 4 minutes in the postanesthesia care unit, compared with 80 minutes for those treated under general anesthesia. The combined time spent in the postanesthesia care unit and the day surgery unit for those treated under local anesthesia was 165 minutes, compared with 229 minutes for those under general anesthesia.

As a result of the earlier discharge, researchers estimated the per-patient savings at $315 for those treated with local anesthesia.

The researchers found no statistically significant differences in the number of patients undergoing either procedure who were admitted to the hospital after surgery or in the 30 days after initial discharge, the number of complications, or the overall satisfaction with their surgery or anesthesia management.

The researchers also noted a statistically significant difference in physician practice before and after the study. They compared a group of 58 consecutive thyroidectomy patients treated before the study with a group of 58 consecutive patients treated afterward. The share of outpatient procedures performed with local anesthesia and monitored anesthesia care rose from 21% to 50%, and the share of outpatient procedures performed with general anesthesia dropped from 79% to 50%.

Outpatient thyroidectomies performed with local anesthesia on eligible patients can achieve clinical results and patient satisfaction comparable with those done under general anesthesia, according to results of a prospective, randomized clinical trial.

Researchers at Texas A&M University in Temple, Tex., monitored 58 patients at Scott & White Memorial Hospital in Temple who underwent thyroidectomies between January 2000 and July 2001 (Arch. Surg. 2006;141:167–73). The patients' ages ranged from 19 to 80 years; 53 of the patients (91%) were women.

The patients were randomized into two groups of 29, and thyroidectomies were performed under general anesthesia in one group and under local anesthesia with monitored anesthesia care in the other. The same surgeon treated all patients.

Researchers found statistically significant differences in the amount of time patients in the two groups spent in postsurgical care, which included time spent in postanesthesia care and the combined time spent in postanesthesia care and the hospital's day surgery unit.

On average, patients who received local anesthesia spent 4 minutes in the postanesthesia care unit, compared with 80 minutes for those treated under general anesthesia. The combined time spent in the postanesthesia care unit and the day surgery unit for those treated under local anesthesia was 165 minutes, compared with 229 minutes for those under general anesthesia.

As a result of the earlier discharge, researchers estimated the per-patient savings at $315 for those treated with local anesthesia.

The researchers found no statistically significant differences in the number of patients undergoing either procedure who were admitted to the hospital after surgery or in the 30 days after initial discharge, the number of complications, or the overall satisfaction with their surgery or anesthesia management.

The researchers also noted a statistically significant difference in physician practice before and after the study. They compared a group of 58 consecutive thyroidectomy patients treated before the study with a group of 58 consecutive patients treated afterward. The share of outpatient procedures performed with local anesthesia and monitored anesthesia care rose from 21% to 50%, and the share of outpatient procedures performed with general anesthesia dropped from 79% to 50%.

U.S. and European drug regulators have announced “intensified” information sharing and dialogue aimed at increasing cooperation in drug approval and surveillance activities in the world's two largest pharmaceutical markets.

At a March review meeting in Brussels, representatives from the Food and Drug Administration, the European Medicines Agency, and the European Commission judged as a success the implementation of a confidentiality agreement that has enabled greater transatlantic information sharing and dialogue on pharmaceutical regulations protecting 753 million people in 26 countries.

The three agencies hope to strengthen joint activities on vaccines in preparation for potential pandemic flu outbreaks, as well as cancer, children's, and orphan drugs, and pharmacogenomics. Future activities will address counterfeit medicines.

The original agreement, signed in September 2003, paved the way for quarterly exchanges on information on new drug applications, regulatory guidance, and inspections of manufacturing plants, which began in 2004. The agreement also authorized ad hoc exchanges of information on drug safety and public health, including advance notice of significant regulatory actions such as pulling drugs from the market. Such an exchange prevents other agencies from issuing contradictory advice when one agency takes significant regulatory action.

The ad hoc exchanges also have enabled “parallel” scientific guidance for drug applicants seeking the advice of the three agencies on how to proceed with research at such milestones as the conclusion of clinical trials. The first such parallel scientific meeting occurred in September 2003, and as part of the initial confidentiality arrangement a 1-year pilot project was initiated in 2005.

The focus of those parallel meetings is breakthrough drugs, those for rare conditions, medication for children, or other new medicines considered important.

The three agencies agreed to extend the pilot project, although the document released by the agencies did not say how long it would be extended.

U.S. and European drug regulators have announced “intensified” information sharing and dialogue aimed at increasing cooperation in drug approval and surveillance activities in the world's two largest pharmaceutical markets.

At a March review meeting in Brussels, representatives from the Food and Drug Administration, the European Medicines Agency, and the European Commission judged as a success the implementation of a confidentiality agreement that has enabled greater transatlantic information sharing and dialogue on pharmaceutical regulations protecting 753 million people in 26 countries.

The three agencies hope to strengthen joint activities on vaccines in preparation for potential pandemic flu outbreaks, as well as cancer, children's, and orphan drugs, and pharmacogenomics. Future activities will address counterfeit medicines.

The original agreement, signed in September 2003, paved the way for quarterly exchanges on information on new drug applications, regulatory guidance, and inspections of manufacturing plants, which began in 2004. The agreement also authorized ad hoc exchanges of information on drug safety and public health, including advance notice of significant regulatory actions such as pulling drugs from the market. Such an exchange prevents other agencies from issuing contradictory advice when one agency takes significant regulatory action.

The ad hoc exchanges also have enabled “parallel” scientific guidance for drug applicants seeking the advice of the three agencies on how to proceed with research at such milestones as the conclusion of clinical trials. The first such parallel scientific meeting occurred in September 2003, and as part of the initial confidentiality arrangement a 1-year pilot project was initiated in 2005.

The focus of those parallel meetings is breakthrough drugs, those for rare conditions, medication for children, or other new medicines considered important.

The three agencies agreed to extend the pilot project, although the document released by the agencies did not say how long it would be extended.

U.S. and European drug regulators have announced “intensified” information sharing and dialogue aimed at increasing cooperation in drug approval and surveillance activities in the world's two largest pharmaceutical markets.

At a March review meeting in Brussels, representatives from the Food and Drug Administration, the European Medicines Agency, and the European Commission judged as a success the implementation of a confidentiality agreement that has enabled greater transatlantic information sharing and dialogue on pharmaceutical regulations protecting 753 million people in 26 countries.

The three agencies hope to strengthen joint activities on vaccines in preparation for potential pandemic flu outbreaks, as well as cancer, children's, and orphan drugs, and pharmacogenomics. Future activities will address counterfeit medicines.

The original agreement, signed in September 2003, paved the way for quarterly exchanges on information on new drug applications, regulatory guidance, and inspections of manufacturing plants, which began in 2004. The agreement also authorized ad hoc exchanges of information on drug safety and public health, including advance notice of significant regulatory actions such as pulling drugs from the market. Such an exchange prevents other agencies from issuing contradictory advice when one agency takes significant regulatory action.

The ad hoc exchanges also have enabled “parallel” scientific guidance for drug applicants seeking the advice of the three agencies on how to proceed with research at such milestones as the conclusion of clinical trials. The first such parallel scientific meeting occurred in September 2003, and as part of the initial confidentiality arrangement a 1-year pilot project was initiated in 2005.

The focus of those parallel meetings is breakthrough drugs, those for rare conditions, medication for children, or other new medicines considered important.

The three agencies agreed to extend the pilot project, although the document released by the agencies did not say how long it would be extended.

Infliximab therapy for rheumatoid arthritis improves patients' levels of high-density lipoprotein but does not make them any less vulnerable to cardiovascular disease because it also raises their levels of low-density lipoprotein, according to a new study.

Infliximab therapy had the effect of increasing serum levels of total cholesterol and both HDL and LDL cholesterol, correlating with a decrease of joint inflammation.

But infliximab does not reduce the risk of cardiovascular disease, the most common cause of premature death in rheumatoid arthritis patients.

Researchers at Cochin Hospital in Paris analyzed the cholesterol levels of 56 consecutive rheumatoid arthritis patients undergoing infliximab therapy. The researchers compared their cholesterol levels with those of a group of 56 rheumatoid arthritis patients not receiving infused infliximab and a control population of 56 without rheumatoid arthritis.

The researchers found that because the infliximab therapy did not change the ratio of HDL to LDL or total cholesterol, the cardiovascular risk did not change for the infliximab therapy patients (Clin. Chim. Acta. 2006;365:143–8).

At baseline, both of the rheumatoid arthritis groups had significantly higher atherogenic profiles than the control group, both in their ratio of LDL to HDL and HDL to total cholesterol. They also had significantly higher HDL levels.

After treatment at baseline, 2 weeks, 6 weeks, and every 8 weeks thereafter, total cholesterol levels in the study group increased from 5 mmol/L at baseline to 5.9 mmol/L at 6 weeks and 6 mmol/L at 30 weeks.

The mean ratio of LDL to HDL did not change significantly, however—2.6 at baseline, 2.7 at 6 weeks, and 2.5 at 30 weeks.

The mean ratio of total cholesterol to HDL did not change, either: 4.3 at baseline, 4.8 at 6 weeks, and 4.4 at 30 weeks.

The results are a departure from those from classic disease-modifying antirheumatic drugs, which have been shown to lower patients' atherogenic profiles, coauthor Dr. Didier Borderie said in an interview.

The study results show that “physicians have to be attentive to the lipid profile of their patients and to evaluate the atherogenic ratio of their patients before and regularly during infliximab therapy,” according to Dr. Borderie, of Cochin Hospital.

Infliximab therapy for rheumatoid arthritis improves patients' levels of high-density lipoprotein but does not make them any less vulnerable to cardiovascular disease because it also raises their levels of low-density lipoprotein, according to a new study.

Infliximab therapy had the effect of increasing serum levels of total cholesterol and both HDL and LDL cholesterol, correlating with a decrease of joint inflammation.

But infliximab does not reduce the risk of cardiovascular disease, the most common cause of premature death in rheumatoid arthritis patients.

Researchers at Cochin Hospital in Paris analyzed the cholesterol levels of 56 consecutive rheumatoid arthritis patients undergoing infliximab therapy. The researchers compared their cholesterol levels with those of a group of 56 rheumatoid arthritis patients not receiving infused infliximab and a control population of 56 without rheumatoid arthritis.

The researchers found that because the infliximab therapy did not change the ratio of HDL to LDL or total cholesterol, the cardiovascular risk did not change for the infliximab therapy patients (Clin. Chim. Acta. 2006;365:143–8).

At baseline, both of the rheumatoid arthritis groups had significantly higher atherogenic profiles than the control group, both in their ratio of LDL to HDL and HDL to total cholesterol. They also had significantly higher HDL levels.

After treatment at baseline, 2 weeks, 6 weeks, and every 8 weeks thereafter, total cholesterol levels in the study group increased from 5 mmol/L at baseline to 5.9 mmol/L at 6 weeks and 6 mmol/L at 30 weeks.

The mean ratio of LDL to HDL did not change significantly, however—2.6 at baseline, 2.7 at 6 weeks, and 2.5 at 30 weeks.

The mean ratio of total cholesterol to HDL did not change, either: 4.3 at baseline, 4.8 at 6 weeks, and 4.4 at 30 weeks.

The results are a departure from those from classic disease-modifying antirheumatic drugs, which have been shown to lower patients' atherogenic profiles, coauthor Dr. Didier Borderie said in an interview.

The study results show that “physicians have to be attentive to the lipid profile of their patients and to evaluate the atherogenic ratio of their patients before and regularly during infliximab therapy,” according to Dr. Borderie, of Cochin Hospital.

Infliximab therapy for rheumatoid arthritis improves patients' levels of high-density lipoprotein but does not make them any less vulnerable to cardiovascular disease because it also raises their levels of low-density lipoprotein, according to a new study.

Infliximab therapy had the effect of increasing serum levels of total cholesterol and both HDL and LDL cholesterol, correlating with a decrease of joint inflammation.

But infliximab does not reduce the risk of cardiovascular disease, the most common cause of premature death in rheumatoid arthritis patients.

Researchers at Cochin Hospital in Paris analyzed the cholesterol levels of 56 consecutive rheumatoid arthritis patients undergoing infliximab therapy. The researchers compared their cholesterol levels with those of a group of 56 rheumatoid arthritis patients not receiving infused infliximab and a control population of 56 without rheumatoid arthritis.

The researchers found that because the infliximab therapy did not change the ratio of HDL to LDL or total cholesterol, the cardiovascular risk did not change for the infliximab therapy patients (Clin. Chim. Acta. 2006;365:143–8).

At baseline, both of the rheumatoid arthritis groups had significantly higher atherogenic profiles than the control group, both in their ratio of LDL to HDL and HDL to total cholesterol. They also had significantly higher HDL levels.

After treatment at baseline, 2 weeks, 6 weeks, and every 8 weeks thereafter, total cholesterol levels in the study group increased from 5 mmol/L at baseline to 5.9 mmol/L at 6 weeks and 6 mmol/L at 30 weeks.

The mean ratio of LDL to HDL did not change significantly, however—2.6 at baseline, 2.7 at 6 weeks, and 2.5 at 30 weeks.

The mean ratio of total cholesterol to HDL did not change, either: 4.3 at baseline, 4.8 at 6 weeks, and 4.4 at 30 weeks.

The results are a departure from those from classic disease-modifying antirheumatic drugs, which have been shown to lower patients' atherogenic profiles, coauthor Dr. Didier Borderie said in an interview.

The study results show that “physicians have to be attentive to the lipid profile of their patients and to evaluate the atherogenic ratio of their patients before and regularly during infliximab therapy,” according to Dr. Borderie, of Cochin Hospital.

U.S. and European drug regulators have announced “intensified” information sharing and dialogue that aims to foster cooperation in drug approval and surveillance activity in the world's two largest pharmaceutical markets.

At a March meeting in Brussels, Food and Drug Administration, European Medicines Agency, and European Commission representatives judged as a success the implementation of a confidentiality agreement that has enabled greater transatlantic information sharing and dialogue on pharmaceutical regulations protecting 753 million people in 26 countries. The three agencies hope to particularly strengthen joint activities on vaccines in preparation for potential pandemic flu outbreaks, as well as cancer, children's, and orphan drugs, and pharmacogenomics. Future activities will address counterfeit medicines.

The original agreement, signed in September 2003, paved the way for quarterly exchanges on information on new drug applications, regulatory guidance, and inspections of manufacturing plants, which began in 2004. The pact also authorized ad hoc exchanges of information on drug safety and public health, including advance notice of significant regulatory actions such as pulling drugs from the market.

Such an exchange prevents other agencies from issuing contradictory advice when one agency takes significant regulatory action.

The ad hoc exchanges also have enabled “parallel” scientific guidance for drug applicants seeking the advice of the three agencies on how to proceed with research at such milestones as the conclusion of clinical trials. The first such parallel scientific meeting occurred in September 2003, and as part of the initial confidentiality arrangement a 1-year pilot project was initiated in 2005.

The focus of those parallel meetings is breakthrough drugs, those for rare conditions, medication for children, or other new medicines considered important.

The three agencies agreed to extend the pilot project, although the document released by the agencies did not say how long it would be extended.

U.S. and European drug regulators have announced “intensified” information sharing and dialogue that aims to foster cooperation in drug approval and surveillance activity in the world's two largest pharmaceutical markets.

At a March meeting in Brussels, Food and Drug Administration, European Medicines Agency, and European Commission representatives judged as a success the implementation of a confidentiality agreement that has enabled greater transatlantic information sharing and dialogue on pharmaceutical regulations protecting 753 million people in 26 countries. The three agencies hope to particularly strengthen joint activities on vaccines in preparation for potential pandemic flu outbreaks, as well as cancer, children's, and orphan drugs, and pharmacogenomics. Future activities will address counterfeit medicines.

The original agreement, signed in September 2003, paved the way for quarterly exchanges on information on new drug applications, regulatory guidance, and inspections of manufacturing plants, which began in 2004. The pact also authorized ad hoc exchanges of information on drug safety and public health, including advance notice of significant regulatory actions such as pulling drugs from the market.

Such an exchange prevents other agencies from issuing contradictory advice when one agency takes significant regulatory action.

The ad hoc exchanges also have enabled “parallel” scientific guidance for drug applicants seeking the advice of the three agencies on how to proceed with research at such milestones as the conclusion of clinical trials. The first such parallel scientific meeting occurred in September 2003, and as part of the initial confidentiality arrangement a 1-year pilot project was initiated in 2005.

The focus of those parallel meetings is breakthrough drugs, those for rare conditions, medication for children, or other new medicines considered important.

The three agencies agreed to extend the pilot project, although the document released by the agencies did not say how long it would be extended.

U.S. and European drug regulators have announced “intensified” information sharing and dialogue that aims to foster cooperation in drug approval and surveillance activity in the world's two largest pharmaceutical markets.

At a March meeting in Brussels, Food and Drug Administration, European Medicines Agency, and European Commission representatives judged as a success the implementation of a confidentiality agreement that has enabled greater transatlantic information sharing and dialogue on pharmaceutical regulations protecting 753 million people in 26 countries. The three agencies hope to particularly strengthen joint activities on vaccines in preparation for potential pandemic flu outbreaks, as well as cancer, children's, and orphan drugs, and pharmacogenomics. Future activities will address counterfeit medicines.

The original agreement, signed in September 2003, paved the way for quarterly exchanges on information on new drug applications, regulatory guidance, and inspections of manufacturing plants, which began in 2004. The pact also authorized ad hoc exchanges of information on drug safety and public health, including advance notice of significant regulatory actions such as pulling drugs from the market.

Such an exchange prevents other agencies from issuing contradictory advice when one agency takes significant regulatory action.

The ad hoc exchanges also have enabled “parallel” scientific guidance for drug applicants seeking the advice of the three agencies on how to proceed with research at such milestones as the conclusion of clinical trials. The first such parallel scientific meeting occurred in September 2003, and as part of the initial confidentiality arrangement a 1-year pilot project was initiated in 2005.

The focus of those parallel meetings is breakthrough drugs, those for rare conditions, medication for children, or other new medicines considered important.

The three agencies agreed to extend the pilot project, although the document released by the agencies did not say how long it would be extended.

U.S. and European drug regulators have announced “intensified” information sharing and dialogue aimed at increasing cooperation in drug approval and surveillance in the world's two largest pharmaceutical markets.

At a March review meeting in Brussels, representatives from the Food and Drug Administration, the European Medicines Agency, and the European Commission judged as a success the implementation of a confidentiality agreement that has enabled greater transatlantic information sharing and dialogue on pharmaceutical regulations protecting 753 million people in 26 countries.

The three agencies hope to strengthen joint activities on vaccines in preparation for potential pandemic flu outbreaks, as well as cancer, children's, and orphan drugs, and pharmacogenomics. Future activities will address counterfeit medicines.

The original agreement, signed in September 2003, paved the way for quarterly information exchanges on new drug applications, regulatory guidance, and inspections of manufacturing plants, which began in 2004. The agreement also authorized ad hoc exchanges of information on drug safety and public health, including advance notice of significant regulatory actions such as pulling drugs from the market. Such an exchange prevents other agencies from issuing contradictory advice when one agency takes significant regulatory action.

The ad hoc exchanges also have enabled “parallel” scientific guidance for drug applicants seeking the advice of the three agencies on how to proceed with research at such milestones as the conclusion of clinical trials. As part of the initial confidentiality arrangement a 1-year pilot project was initiated in 2005. The three agencies agreed to extend the pilot project, although the document released by the agencies did not say how long it would be extended.

U.S. and European drug regulators have announced “intensified” information sharing and dialogue aimed at increasing cooperation in drug approval and surveillance in the world's two largest pharmaceutical markets.

At a March review meeting in Brussels, representatives from the Food and Drug Administration, the European Medicines Agency, and the European Commission judged as a success the implementation of a confidentiality agreement that has enabled greater transatlantic information sharing and dialogue on pharmaceutical regulations protecting 753 million people in 26 countries.

The three agencies hope to strengthen joint activities on vaccines in preparation for potential pandemic flu outbreaks, as well as cancer, children's, and orphan drugs, and pharmacogenomics. Future activities will address counterfeit medicines.

The original agreement, signed in September 2003, paved the way for quarterly information exchanges on new drug applications, regulatory guidance, and inspections of manufacturing plants, which began in 2004. The agreement also authorized ad hoc exchanges of information on drug safety and public health, including advance notice of significant regulatory actions such as pulling drugs from the market. Such an exchange prevents other agencies from issuing contradictory advice when one agency takes significant regulatory action.

The ad hoc exchanges also have enabled “parallel” scientific guidance for drug applicants seeking the advice of the three agencies on how to proceed with research at such milestones as the conclusion of clinical trials. As part of the initial confidentiality arrangement a 1-year pilot project was initiated in 2005. The three agencies agreed to extend the pilot project, although the document released by the agencies did not say how long it would be extended.

U.S. and European drug regulators have announced “intensified” information sharing and dialogue aimed at increasing cooperation in drug approval and surveillance in the world's two largest pharmaceutical markets.

At a March review meeting in Brussels, representatives from the Food and Drug Administration, the European Medicines Agency, and the European Commission judged as a success the implementation of a confidentiality agreement that has enabled greater transatlantic information sharing and dialogue on pharmaceutical regulations protecting 753 million people in 26 countries.

The three agencies hope to strengthen joint activities on vaccines in preparation for potential pandemic flu outbreaks, as well as cancer, children's, and orphan drugs, and pharmacogenomics. Future activities will address counterfeit medicines.

The original agreement, signed in September 2003, paved the way for quarterly information exchanges on new drug applications, regulatory guidance, and inspections of manufacturing plants, which began in 2004. The agreement also authorized ad hoc exchanges of information on drug safety and public health, including advance notice of significant regulatory actions such as pulling drugs from the market. Such an exchange prevents other agencies from issuing contradictory advice when one agency takes significant regulatory action.

The ad hoc exchanges also have enabled “parallel” scientific guidance for drug applicants seeking the advice of the three agencies on how to proceed with research at such milestones as the conclusion of clinical trials. As part of the initial confidentiality arrangement a 1-year pilot project was initiated in 2005. The three agencies agreed to extend the pilot project, although the document released by the agencies did not say how long it would be extended.

Biomarkers in cerebrospinal fluid may indicate whether patients with mild cognitive impairment will progress to Alzheimer's disease and could assist in the development of new screening tools or treatments, according to Dr. Oskar Hansson of Lund University, Malmö, Sweden, and his associates.

The investigators followed 137 patients with mild cognitive impairment who had consulted the memory disorder clinic at the university hospital between July 1998 and June 2001. A control population of 39 healthy volunteers with no memory complaints, good cognitive functioning, and without neurologic or psychiatric disease was recruited from Malmö.

The researchers followed the populations for 4–6 years after scientists took cerebrospinal fluid from a lumbar puncture.

A total of 57 patients with mild cognitive impairment at baseline developed Alzheimer's disease during the study period, and 21 developed other forms of dementia. Those patients with abnormal concentrations of the biomarkers β-amyloid, total tau, and phosphorylated tau at the beginning of the study were more likely to have progressed to Alzheimer's disease (Lancet Neurol. 2006;5:228–34).

Concentrations of total tau greater than 350 ng/L and of β-amyloid less than 530 ng/L at baseline were defined as pathologic. Patients with pathologic levels of the biomarkers were more than 20 times as likely to progress to Alzheimer's disease as those with mild cognitive impairment but without the pathologic levels of biomarkers, reported the authors.

Earlier studies followed those biomarkers in patients for only 1–2 years. Because of this study's long follow-up, “the diagnosis of stable [mild clinical impairment] is more reliable in this study, compared with previous investigations,” the investigators said.

Biomarkers in cerebrospinal fluid may indicate whether patients with mild cognitive impairment will progress to Alzheimer's disease and could assist in the development of new screening tools or treatments, according to Dr. Oskar Hansson of Lund University, Malmö, Sweden, and his associates.

The investigators followed 137 patients with mild cognitive impairment who had consulted the memory disorder clinic at the university hospital between July 1998 and June 2001. A control population of 39 healthy volunteers with no memory complaints, good cognitive functioning, and without neurologic or psychiatric disease was recruited from Malmö.

The researchers followed the populations for 4–6 years after scientists took cerebrospinal fluid from a lumbar puncture.

A total of 57 patients with mild cognitive impairment at baseline developed Alzheimer's disease during the study period, and 21 developed other forms of dementia. Those patients with abnormal concentrations of the biomarkers β-amyloid, total tau, and phosphorylated tau at the beginning of the study were more likely to have progressed to Alzheimer's disease (Lancet Neurol. 2006;5:228–34).

Concentrations of total tau greater than 350 ng/L and of β-amyloid less than 530 ng/L at baseline were defined as pathologic. Patients with pathologic levels of the biomarkers were more than 20 times as likely to progress to Alzheimer's disease as those with mild cognitive impairment but without the pathologic levels of biomarkers, reported the authors.

Earlier studies followed those biomarkers in patients for only 1–2 years. Because of this study's long follow-up, “the diagnosis of stable [mild clinical impairment] is more reliable in this study, compared with previous investigations,” the investigators said.

Biomarkers in cerebrospinal fluid may indicate whether patients with mild cognitive impairment will progress to Alzheimer's disease and could assist in the development of new screening tools or treatments, according to Dr. Oskar Hansson of Lund University, Malmö, Sweden, and his associates.

The investigators followed 137 patients with mild cognitive impairment who had consulted the memory disorder clinic at the university hospital between July 1998 and June 2001. A control population of 39 healthy volunteers with no memory complaints, good cognitive functioning, and without neurologic or psychiatric disease was recruited from Malmö.

The researchers followed the populations for 4–6 years after scientists took cerebrospinal fluid from a lumbar puncture.

A total of 57 patients with mild cognitive impairment at baseline developed Alzheimer's disease during the study period, and 21 developed other forms of dementia. Those patients with abnormal concentrations of the biomarkers β-amyloid, total tau, and phosphorylated tau at the beginning of the study were more likely to have progressed to Alzheimer's disease (Lancet Neurol. 2006;5:228–34).

Concentrations of total tau greater than 350 ng/L and of β-amyloid less than 530 ng/L at baseline were defined as pathologic. Patients with pathologic levels of the biomarkers were more than 20 times as likely to progress to Alzheimer's disease as those with mild cognitive impairment but without the pathologic levels of biomarkers, reported the authors.

Earlier studies followed those biomarkers in patients for only 1–2 years. Because of this study's long follow-up, “the diagnosis of stable [mild clinical impairment] is more reliable in this study, compared with previous investigations,” the investigators said.