Journal articles often list a long string of putative authors. I once counted 47 on a physics paper. But where journal articles in the natural sciences often appear overly conscientious about acknowledging all contributors, the opposite has become a nagging problem in biomedicine. Here, not all authors on a research project – or even, necessarily, the most important ones – may be identified as a contributor.
The existence of these ghost authors, as they’re called, evoked frustration and anger yesterday in a large share of the 400 journal editors and clinical research scientists taking part in a quadrennial international workshop on peer review and biomedical publication. This year’s venue: Vancouver, British Columbia.
The concern, speakers complained, is that ghost writers can be little more than hired guns. The expectation is that they will describe research findings in ways that aid their benefactors – drug or biomedical device companies that wish to avoid the appearance of directly influencing a clinical trial’s interpretation.
Often aiding and abetting the situation is another group of poseurs known as honorary authors. Their names show up on papers – despite their having done nothing – to lend credibility to research, to reward a friend of someone connected with the study, or to help hide the contributions of a ghost.
READ MORE @ SCIENCE NEWS
Saturday, September 12, 2009
Thursday, September 10, 2009
Children with emotional difficulties at higher risk for adult obesity
Previous research has shown that low self-esteem and emotional problems are found in people who are overweight or obese– but not which influences which. Research published today in the open access journal BMC Medicine, sheds light on this issue showing that children with emotional difficulties are at higher risk for obesity in adult life.
Andrew Ternouth, David Collier and Barbara Maughan from the MRC Social, Genetic and Developmental Psychiatry Centre at the Institute of Psychiatry, King's College London, studied data from around 6,500 members of the 1970 British Birth Cohort Study who, as 10 year-olds, had been assessed for emotional problems, self-perceptions and BMI, and who reported on their BMI again at age 30. The researchers found that children with a lower self-esteem, those who felt less in control of their lives and those who worried often were more likely to gain weight over the next 20 years. They also found that girls were slightly more affected by these factors than boys.
READ MORE @ EUREKALERT
Andrew Ternouth, David Collier and Barbara Maughan from the MRC Social, Genetic and Developmental Psychiatry Centre at the Institute of Psychiatry, King's College London, studied data from around 6,500 members of the 1970 British Birth Cohort Study who, as 10 year-olds, had been assessed for emotional problems, self-perceptions and BMI, and who reported on their BMI again at age 30. The researchers found that children with a lower self-esteem, those who felt less in control of their lives and those who worried often were more likely to gain weight over the next 20 years. They also found that girls were slightly more affected by these factors than boys.
READ MORE @ EUREKALERT
Wednesday, September 9, 2009
Depression After ACS Worsens Outcomes
Persistent depression after acute coronary syndrome continues to be a risk factor for early death for up to seven years, researchers said.
With a median of 6.7 years of follow-up, patients who encountered major depression after acute coronary syndrome -- and whose depression did not improve with treatment -- had a hazard ratio for death of 2.39 (95% CI 1.50 to 3.81) compared with those showing substantial improvement, according to Alexander Glassman, MD, of Columbia University, and colleagues.
The study involved patients in the randomized SADHART trial, which involved treatment with , sertraline (Zoloft) or placebo. Those who took their medications on schedule were more likely to show improvement in depression scores, the researchers wrote in the September issue of Archives of General Psychiatry.
Hence, they said, "physicians need to aggressively treat depression and be diligent in promoting adherence to guideline cardiovascular drug therapy."
The SADHART study (Sertraline Antidepressant Heart Attack Randomized Trial) began in 2000 with 369 patients hospitalized for acute coronary syndrome who were found to have major depression on screening.
READ MORE @ MEDPAGE TODAY
With a median of 6.7 years of follow-up, patients who encountered major depression after acute coronary syndrome -- and whose depression did not improve with treatment -- had a hazard ratio for death of 2.39 (95% CI 1.50 to 3.81) compared with those showing substantial improvement, according to Alexander Glassman, MD, of Columbia University, and colleagues.
The study involved patients in the randomized SADHART trial, which involved treatment with , sertraline (Zoloft) or placebo. Those who took their medications on schedule were more likely to show improvement in depression scores, the researchers wrote in the September issue of Archives of General Psychiatry.
Hence, they said, "physicians need to aggressively treat depression and be diligent in promoting adherence to guideline cardiovascular drug therapy."
The SADHART study (Sertraline Antidepressant Heart Attack Randomized Trial) began in 2000 with 369 patients hospitalized for acute coronary syndrome who were found to have major depression on screening.
READ MORE @ MEDPAGE TODAY
Tuesday, September 8, 2009
Brain Defect Implicated In Early Schizophrenia
In the first functional magnetic resonance imaging (fMRI) study of its kind, neurologists and psychiatrists at Columbia University have identified an area of the brain involved in the earliest stages of schizophrenia and related psychotic disorders.
Activity in this specific region of the hippocampus may help predict the onset of the disease, offering opportunities for earlier diagnosis and for the development of drugs for schizophrenia prevention.
Details of the findings were published in the September 7, 2009, issue of Archives of General Psychiatry.
In the study, the researchers scanned the brains of 18 high-risk individuals with "prodromal" symptoms, and followed them for two years. Of those individuals who went on to develop first-episode psychotic disorders such as schizophrenia, 70 percent had unusually high activity in this region of the hippocampus, known as the CA1 subfield.
SCIENCE DAILY
Activity in this specific region of the hippocampus may help predict the onset of the disease, offering opportunities for earlier diagnosis and for the development of drugs for schizophrenia prevention.
Details of the findings were published in the September 7, 2009, issue of Archives of General Psychiatry.
In the study, the researchers scanned the brains of 18 high-risk individuals with "prodromal" symptoms, and followed them for two years. Of those individuals who went on to develop first-episode psychotic disorders such as schizophrenia, 70 percent had unusually high activity in this region of the hippocampus, known as the CA1 subfield.
SCIENCE DAILY
Monday, September 7, 2009
3 Genetic Variants Are Found to Be Linked to Alzheimer’s
Two teams of European scientists say they have discovered new genetic variants associated with Alzheimer’s disease. The variants account for about 20 percent of the genetic risk of the disease, and may lead to a better understanding of its biology, the scientists say.
One of the teams, led by Julie Williams of Cardiff University in Wales, scanned the genomes of about 19,000 patients, the largest study so far conducted on Alzheimer’s, and turned up two variants that have a statistically significant association with the disease. A second study, led by Philippe Amouyel of the University of Lille in France, also found two variants, one of which is the same as detected by the Cardiff team.
The fact that two studies could agree on at least one gene is an advance. More than 550 genes have been proposed in various small-scale studies as the cause of Alzheimer’s, but all have failed the test of replication by others, Dr. Amouyel said.
READ MORE @ NY TIMES
One of the teams, led by Julie Williams of Cardiff University in Wales, scanned the genomes of about 19,000 patients, the largest study so far conducted on Alzheimer’s, and turned up two variants that have a statistically significant association with the disease. A second study, led by Philippe Amouyel of the University of Lille in France, also found two variants, one of which is the same as detected by the Cardiff team.
The fact that two studies could agree on at least one gene is an advance. More than 550 genes have been proposed in various small-scale studies as the cause of Alzheimer’s, but all have failed the test of replication by others, Dr. Amouyel said.
READ MORE @ NY TIMES
Saturday, September 5, 2009
Depressed Teens Continue to Suffer Those with mild depression more likely to suffer major episode later, researchers say
Mildly depressed teenagers
are more likely to have major depression, anxiety disorders and eating disorders as adults, a new study suggests.
In 1983, researchers interviewed 755 teenagers who were about age 16 about mood, anxiety and eating disorders, disruptive behaviors and substance abuse.
About 8 percent were found to have minor depression, defined as feeling down, losing interest in normal activities, and having insomnia or difficulty concentrating for two weeks or more. The symptoms
of minor depression are similar to, but less severe, than those of a major depressive episode.
Researchers followed up with the teens when they were in their early 20s and in their early 30s, and found that teenagers who had had minor depression were significantly more likely to have major depression in adulthood.
READ MORE @ U.S. NEWS & WORLD REPORT
are more likely to have major depression, anxiety disorders and eating disorders as adults, a new study suggests.
In 1983, researchers interviewed 755 teenagers who were about age 16 about mood, anxiety and eating disorders, disruptive behaviors and substance abuse.
About 8 percent were found to have minor depression, defined as feeling down, losing interest in normal activities, and having insomnia or difficulty concentrating for two weeks or more. The symptoms
of minor depression are similar to, but less severe, than those of a major depressive episode.
Researchers followed up with the teens when they were in their early 20s and in their early 30s, and found that teenagers who had had minor depression were significantly more likely to have major depression in adulthood.
READ MORE @ U.S. NEWS & WORLD REPORT
Friday, September 4, 2009
More drug firms doing follow-ups than thought--FDA
More pharmaceutical companies have completed studies required by U.S. health regulators after their products were allowed on the market than previously thought, according to an analysis released on Thursday.
But the study found that FDA database errors had obscured the issue, and critics said the post-approval studies, even when completed, still did not necessarily provide useful long-term information about the safety and effectiveness of the drugs.
Often, the Food and Drug Administration approves drugs and devices for sale on condition that companies keep studying the products for possible additional side effects or other issues.
For years, critics lamented such approvals because the FDA could only request more studies, but could not order them. The critics say companies had little incentive to do the studies once they won approval.
A 2007 law gave the agency more power to require the follow-up studies and ordered the analysis, which found more drug companies than previously thought had completed their studies. Results of the audit by Booz Allen Hamilton Inc were given to the FDA.
"Most companies are doing these studies and they are submitting the reports," said Dr. John Jenkins, director of the FDA's Office of New Drugs.
READ MORE @ REUTERS
But the study found that FDA database errors had obscured the issue, and critics said the post-approval studies, even when completed, still did not necessarily provide useful long-term information about the safety and effectiveness of the drugs.
Often, the Food and Drug Administration approves drugs and devices for sale on condition that companies keep studying the products for possible additional side effects or other issues.
For years, critics lamented such approvals because the FDA could only request more studies, but could not order them. The critics say companies had little incentive to do the studies once they won approval.
A 2007 law gave the agency more power to require the follow-up studies and ordered the analysis, which found more drug companies than previously thought had completed their studies. Results of the audit by Booz Allen Hamilton Inc were given to the FDA.
"Most companies are doing these studies and they are submitting the reports," said Dr. John Jenkins, director of the FDA's Office of New Drugs.
READ MORE @ REUTERS
Thursday, September 3, 2009
Pfizer Pays $2.3 Billion to Settle Marketing Case
The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.
It was the largest health care fraud settlement and the largest criminal fine of any kind ever.
Although the investigation began and largely ended during the Bush administration, top Obama administration officials held a news conference on Wednesday to celebrate the settlement, thank each other for resolving it and promise more crackdowns on health fraud.
“It’s another step in the administration’s ongoing effort to prosecute any individual or organization that tries to rip off health care consumers and the federal government,” said Kathleen Sebelius, secretary of health and human services.
Republicans and Democrats on Capitol Hill have accused the Obama administration of failing to crack down adequately on health care fraud, arguing that huge savings in government health programs could be found with better enforcement. The settlement had been expected. Pfizer, which is acquiring a rival, Wyeth, reported in January that it had taken a $2.3 billion charge to resolve claims involving Bextra and other drugs. It was Pfizer’s fourth settlement over illegal marketing activities since 2002.
READ MORE @ NY TIMES
It was the largest health care fraud settlement and the largest criminal fine of any kind ever.
Although the investigation began and largely ended during the Bush administration, top Obama administration officials held a news conference on Wednesday to celebrate the settlement, thank each other for resolving it and promise more crackdowns on health fraud.
“It’s another step in the administration’s ongoing effort to prosecute any individual or organization that tries to rip off health care consumers and the federal government,” said Kathleen Sebelius, secretary of health and human services.
Republicans and Democrats on Capitol Hill have accused the Obama administration of failing to crack down adequately on health care fraud, arguing that huge savings in government health programs could be found with better enforcement. The settlement had been expected. Pfizer, which is acquiring a rival, Wyeth, reported in January that it had taken a $2.3 billion charge to resolve claims involving Bextra and other drugs. It was Pfizer’s fourth settlement over illegal marketing activities since 2002.
READ MORE @ NY TIMES
Wednesday, September 2, 2009
Pills and America's pursuit of happiness
Antidepressant use has soared during the recession but reaching for the pill bottle goes back decades.
Of all the bitter pills Americans are swallowing nowadays, from joblessness to home foreclosures to runaway national debt, it might come as no surprise that a pill of another sort is flying off the shelves at a recession-defying pace – the antidepressant.
It's an easy jump to conclude that hard times are turning the country comfortably numb, as the Washington Post suggested in a weekend report on the sales of the drug Cymbalta, up 14 per cent since the summer of 2008 and now among America's most popular happy pills.
Drill deeper and you will find that the U.S., though far and away a world leader with its $10-billion-a-year antidepressant habit, is not alone.
Over the summer, British politicians fretted over the impact of recession on mental health amid data showing a spike of 2.1 million antidepressant prescriptions last year, when the downturn took its first precipitous dive.
Same in India, where pharmaceutical firms reported a 20 per cent expansion of the antidepressant market in the year ending December 2008. And in New Zealand, where the global plunge was linked to reports of a near doubling in antidepressant prescriptions between 2002 and 2008.
But drill down deeper still and the story behind the flurry of cause-and-effect headlines is far more nuanced.
While many researchers acknowledge there is likely an uptick in med sales as a consequence of the poor economy, most say it is driven as much or more by trends decades in the making.
READ MORE @ TORONTO STAR
Of all the bitter pills Americans are swallowing nowadays, from joblessness to home foreclosures to runaway national debt, it might come as no surprise that a pill of another sort is flying off the shelves at a recession-defying pace – the antidepressant.
It's an easy jump to conclude that hard times are turning the country comfortably numb, as the Washington Post suggested in a weekend report on the sales of the drug Cymbalta, up 14 per cent since the summer of 2008 and now among America's most popular happy pills.
Drill deeper and you will find that the U.S., though far and away a world leader with its $10-billion-a-year antidepressant habit, is not alone.
Over the summer, British politicians fretted over the impact of recession on mental health amid data showing a spike of 2.1 million antidepressant prescriptions last year, when the downturn took its first precipitous dive.
Same in India, where pharmaceutical firms reported a 20 per cent expansion of the antidepressant market in the year ending December 2008. And in New Zealand, where the global plunge was linked to reports of a near doubling in antidepressant prescriptions between 2002 and 2008.
But drill down deeper still and the story behind the flurry of cause-and-effect headlines is far more nuanced.
While many researchers acknowledge there is likely an uptick in med sales as a consequence of the poor economy, most say it is driven as much or more by trends decades in the making.
READ MORE @ TORONTO STAR
Tuesday, September 1, 2009
Depressed teens 'face adult risk'
Teenagers who have minor depression are at a higher risk of mental health problems later in life, a study says.
Psychiatrists at Columbia University and the New York State Psychiatric Institute spoke to 750 people.
Anxiety, severe depression and eating disorders were all far more common in 20 and 30-year-olds who had had minor depression as adolescents, they found.
The British Journal of Psychiatry report said further research was needed to unpick the reasons for the link.
UK charities said specialist services for young people were vital.
The study was based on interviews with 750 14 to 16-year-olds who were then assessed again as adults.
READ MORE @ BBC NEWS
Psychiatrists at Columbia University and the New York State Psychiatric Institute spoke to 750 people.
Anxiety, severe depression and eating disorders were all far more common in 20 and 30-year-olds who had had minor depression as adolescents, they found.
The British Journal of Psychiatry report said further research was needed to unpick the reasons for the link.
UK charities said specialist services for young people were vital.
The study was based on interviews with 750 14 to 16-year-olds who were then assessed again as adults.
READ MORE @ BBC NEWS
Monday, August 31, 2009
Generic versions of biologic medications are coming Companies most likely to produce biogenerics
The days of market exclusivity could soon come to an end for the biotech industry if Congress moves forward with plans to finally allow generic biologics on the U.S. market.
Because of their eye-popping price tags, pressure to rein in the cost of biologics has been mounting on Capitol Hill for some time. A process for approving generic versions of traditional chemical medications has been in place for more than a decade, but Congress has yet to establish a similar legal pathway for biologics.
But all that could change in the next few months. Currently, almost all of the leading healthcare reform bills circulating on the Hill call for allowing the Food and Drug Administration to establish an approval process for generic biologics, also known as biogenerics or biosimilars.
Unlike traditional drugs, which are comprised of chemicals, biologics use living cells to treat diseases and disorders. The drug category includes some of the most popular therapies on the market: Cancer treatments such as Roche's /quotes/comstock/11i!rhhby (RHHB.Y 39.12, -0.72, -1.81%) Avastin and Herceptin; rheumatoid arthritis drugs such as Amgen Inc.'s /quotes/comstock/15*!amgn/quotes/nls/amgn (AMGN 58.98, -0.80, -1.34%) and Wyeth's /quotes/comstock/13*!wye/quotes/nls/wye (WYE 47.79, -0.06, -0.13%) Enbrel, Johnson & Johnson's /quotes/comstock/13*!jnj/quotes/nls/jnj (JNJ 59.94, -0.50, -0.83%) and Schering-Plough Corp.'s /quotes/comstock/13*!sgp/quotes/nls/sgp (SGP 27.79, -0.39, -1.38%) Remicade, and Abbott Laboratories' /quotes/comstock/13*!abt/quotes/nls/abt (ABT 45.12, -0.11, -0.24%) Humira; and multiple sclerosis therapies such as Biogen Idec's /quotes/comstock/15*!biib/quotes/nls/biib (BIIB 49.24, -0.96, -1.91%) Avonex.
READ MORE @ MARKET WATCH
Because of their eye-popping price tags, pressure to rein in the cost of biologics has been mounting on Capitol Hill for some time. A process for approving generic versions of traditional chemical medications has been in place for more than a decade, but Congress has yet to establish a similar legal pathway for biologics.
But all that could change in the next few months. Currently, almost all of the leading healthcare reform bills circulating on the Hill call for allowing the Food and Drug Administration to establish an approval process for generic biologics, also known as biogenerics or biosimilars.
Unlike traditional drugs, which are comprised of chemicals, biologics use living cells to treat diseases and disorders. The drug category includes some of the most popular therapies on the market: Cancer treatments such as Roche's /quotes/comstock/11i!rhhby (RHHB.Y 39.12, -0.72, -1.81%) Avastin and Herceptin; rheumatoid arthritis drugs such as Amgen Inc.'s /quotes/comstock/15*!amgn/quotes/nls/amgn (AMGN 58.98, -0.80, -1.34%) and Wyeth's /quotes/comstock/13*!wye/quotes/nls/wye (WYE 47.79, -0.06, -0.13%) Enbrel, Johnson & Johnson's /quotes/comstock/13*!jnj/quotes/nls/jnj (JNJ 59.94, -0.50, -0.83%) and Schering-Plough Corp.'s /quotes/comstock/13*!sgp/quotes/nls/sgp (SGP 27.79, -0.39, -1.38%) Remicade, and Abbott Laboratories' /quotes/comstock/13*!abt/quotes/nls/abt (ABT 45.12, -0.11, -0.24%) Humira; and multiple sclerosis therapies such as Biogen Idec's /quotes/comstock/15*!biib/quotes/nls/biib (BIIB 49.24, -0.96, -1.91%) Avonex.
READ MORE @ MARKET WATCH
Sunday, August 30, 2009
Antidepressants Vary More in Side Effects, Not Efficacy
Summary
[SIDE EFFECTS] The main differences among the newer antidepressants are side effects and drug interactions. See the Commentary for a drug-by-drug list of these key differences. [PCP's] This review comes from a group of primary care docs, which is important because most depression is treated by PCPs. [FOLLOW-UP] It emphasizes the need for follow-up 1-2 weeks after initial prescription, which is KEY to improving adherence and addressing new side effects.
READ MORE @ GERSON LEHMAN GROUP
[SIDE EFFECTS] The main differences among the newer antidepressants are side effects and drug interactions. See the Commentary for a drug-by-drug list of these key differences. [PCP's] This review comes from a group of primary care docs, which is important because most depression is treated by PCPs. [FOLLOW-UP] It emphasizes the need for follow-up 1-2 weeks after initial prescription, which is KEY to improving adherence and addressing new side effects.
READ MORE @ GERSON LEHMAN GROUP
Saturday, August 29, 2009
Depression and The Recession: Cymbalta Sales Are on the Rise
During a downturn, we tend to seek the "bright spots" -- sectors or products that are doing well when all the rest are struggling. For example, there were plenty of reports over the past year about retail items -- lipstick, chocolate, and macaroni and cheese -- that were bucking downward trends and selling well during the slump. While these stories were cautiously upbeat, news of an uptick in antidepressant sales despite -- or perhaps because of -- the recession was just plain depressing.
Helplessness, pessimism and persistent sadness -- the main symptoms of depression -- didn't seem to abate as the economy crumbled. About 164 million antidepressant prescriptions were written in 2008, 4 million more than in 2007, according to IMS Health, a health-care information and consulting company.
Antidepressants were the third most prescribed type of drug in 2008, hitting $9.6 billion in sales, up from $9.4 billion the year before. Last month, Eli Lilly reported that second-quarter sales for Cymbalta -- which is on the verge of surpassing Effexor as the nation's best-selling antidepressant -- increased 14 percent over the past year. Our national reliance on these drugs is a stubborn trend. A study published in the August issue of Archives of General Psychiatry found that from 1996 to 2005, antidepressant use in the United States doubled.
READ MORE @ WASHINGTON POST
Helplessness, pessimism and persistent sadness -- the main symptoms of depression -- didn't seem to abate as the economy crumbled. About 164 million antidepressant prescriptions were written in 2008, 4 million more than in 2007, according to IMS Health, a health-care information and consulting company.
Antidepressants were the third most prescribed type of drug in 2008, hitting $9.6 billion in sales, up from $9.4 billion the year before. Last month, Eli Lilly reported that second-quarter sales for Cymbalta -- which is on the verge of surpassing Effexor as the nation's best-selling antidepressant -- increased 14 percent over the past year. Our national reliance on these drugs is a stubborn trend. A study published in the August issue of Archives of General Psychiatry found that from 1996 to 2005, antidepressant use in the United States doubled.
READ MORE @ WASHINGTON POST
Friday, August 28, 2009
New Antipsychotic Eases Schizophrenia Symptoms
The novel antipsychotic lurasidone appears to improve acute schizophrenia symptoms without the weight gain or metabolic problems common among second generation agents, according to a preliminary report from the drug's second pivotal trial.
Patients treated with the 40 and 120 mg doses of the drug had reductions of 25.7 and 23.6 points on the Positive and Negative Syndrome Scale (PANSS) total score, significantly greater than the 16.0 decline among placebo treated patients, according to data released by drug developer Dainippon Sumitomo Pharma.
In the phase III PEARL 2 (Program to Evaluate the Antipsychotic Response to Lurasidone) trial, 53% of patients on the lower dose and 47% on the higher dose had at least a 30% improvement on symptom score from baseline whereas only 38% on placebo did.
The company press release also announced that lurasidone met key secondary efficacy endpoints at both doses in the trial, including change from baseline on the Clinical Global Impressions Severity scale (-1.5 and -1.4 versus -1.1, respectively).
The results are expected to be reported in greater detail at the American College of Neuropsychopharmacology meeting later this year.
aread more @ medpage today
Patients treated with the 40 and 120 mg doses of the drug had reductions of 25.7 and 23.6 points on the Positive and Negative Syndrome Scale (PANSS) total score, significantly greater than the 16.0 decline among placebo treated patients, according to data released by drug developer Dainippon Sumitomo Pharma.
In the phase III PEARL 2 (Program to Evaluate the Antipsychotic Response to Lurasidone) trial, 53% of patients on the lower dose and 47% on the higher dose had at least a 30% improvement on symptom score from baseline whereas only 38% on placebo did.
The company press release also announced that lurasidone met key secondary efficacy endpoints at both doses in the trial, including change from baseline on the Clinical Global Impressions Severity scale (-1.5 and -1.4 versus -1.1, respectively).
The results are expected to be reported in greater detail at the American College of Neuropsychopharmacology meeting later this year.
aread more @ medpage today
Thursday, August 27, 2009
Antidepressants: Selective Serotonin And Norepinephrine Reuptake Inhibitor Drugs Show Benefits In German Study
The Institute for Quality and Efficiency in Health Care (IQWiG) was commissioned by the Federal Joint Committee (G-BA) to investigate whether patients with depression benefit from taking drugs belonging to the selective serotonin and norepinephrine reuptake inhibitor (SNRI) drug class. Up till now, 2 of these drugs have been approved as antidepressants in Germany: venlafaxine and duloxetine. The Institute published its final report on 18 August. According to this report, the benefit of both drugs has been proven compared to a sham drug (placebo): patients respond better to the therapy and suffer less from the symptoms of depression. Moreover, there are indications that both drugs protect against relapse in addition to alleviating symptoms.
Interplay of biological and psycho-social factors
There are various assumptions about when and how depression occurs. The possible causes and influencing factors are manifold. What is not disputed is that the complete clinical picture of depression is the result of a complex interplay of biological and psycho-social factors. There are indications that a modification or reduction in the transfer of certain messenger substances in the central nervous system plays a part. This is where most drug therapies start their effect. The comparatively new SNRI drug class is intended to influence two of these messenger substances (neurotransmitters) by inhibiting the reuptake of serotonin and norepinephrine.
READ MORE @ SCIENCE DAILY
Interplay of biological and psycho-social factors
There are various assumptions about when and how depression occurs. The possible causes and influencing factors are manifold. What is not disputed is that the complete clinical picture of depression is the result of a complex interplay of biological and psycho-social factors. There are indications that a modification or reduction in the transfer of certain messenger substances in the central nervous system plays a part. This is where most drug therapies start their effect. The comparatively new SNRI drug class is intended to influence two of these messenger substances (neurotransmitters) by inhibiting the reuptake of serotonin and norepinephrine.
READ MORE @ SCIENCE DAILY
Wednesday, August 26, 2009
Abuse of ADHD Drugs on the Rise
As more and more prescriptions are being written for medications to treat attention-deficit hyperactivity disorder (ADHD), more and more children are abusing these drugs.
That's the conclusion of new research in the September issue of Pediatrics that found the rate of ADHD medication abuse was up 76 percent from 1998 to 2005, and at the same time, the rates of prescriptions for these medications rose about 80 percent.
"We looked at all the poison control centers across the nation and found a significant increase in the number of calls for ADHD medication abuse that parallels the amount of prescriptions being written," said Dr. Jennifer Setlik, an emergency physician at Cincinnati Children's Hospital Medical Center in Ohio and a study author.
What's more, Setlik said, is that this study is "not an estimate of the total problem" because it looks only at data from poison control centers, but it gives doctors and parents a snapshot of the trend toward rising abuse of these medications with increasing availability.
ADHD affects between 8 percent and 12 percent of children, and as many as 4 percent of adults worldwide, according to background information in the study. The disorder is commonly treated with stimulant medications, which have a seemingly paradoxical effect on people with ADHD, allowing them to concentrate and function more effectively. The drugs most often prescribed are mixed amphetamine salts (Adderall) and methylphenidate (Ritalin, Concerta), according to the study.
READ MORE @ ATLANTA JOURNAL CONSTITUTION
That's the conclusion of new research in the September issue of Pediatrics that found the rate of ADHD medication abuse was up 76 percent from 1998 to 2005, and at the same time, the rates of prescriptions for these medications rose about 80 percent.
"We looked at all the poison control centers across the nation and found a significant increase in the number of calls for ADHD medication abuse that parallels the amount of prescriptions being written," said Dr. Jennifer Setlik, an emergency physician at Cincinnati Children's Hospital Medical Center in Ohio and a study author.
What's more, Setlik said, is that this study is "not an estimate of the total problem" because it looks only at data from poison control centers, but it gives doctors and parents a snapshot of the trend toward rising abuse of these medications with increasing availability.
ADHD affects between 8 percent and 12 percent of children, and as many as 4 percent of adults worldwide, according to background information in the study. The disorder is commonly treated with stimulant medications, which have a seemingly paradoxical effect on people with ADHD, allowing them to concentrate and function more effectively. The drugs most often prescribed are mixed amphetamine salts (Adderall) and methylphenidate (Ritalin, Concerta), according to the study.
READ MORE @ ATLANTA JOURNAL CONSTITUTION
Tuesday, August 25, 2009
Iloperidone Approved as “Second-Generation” Benefits Debated
The FDA recently approved iloperidone (Fanapt, Vanda Pharmaceuticals) for the treatment of schizophrenia, reversing a July 2008 determination that the New Drug Application (NDA) was “not approvable.” An FDA spokesperson explained in an interview in Forbes (May 8), “Vanda provided the FDA with additional data and arguments that led us to reinterpret results of several of their studies.”
The favorable judgment culminated a circuitous product development path. The compound had been developed by Hoechst Marion Roussel, but the rights were sold to Titan Pharmaceuticals in 1997, and then to Novartis in 1998, before Vanda Pharmaceuticals acquired them in 2004. Vanda succeeded in garnering regulatory approval, in large part by redesigning the clinical trials supporting the NDA.
Rather than comparing the efficacy of iloperidone with risperidone and haloperidol, which had not previously favored iloperidone, the new trials compared iloperidone with placebo and used ziprasidone as an active control. In this design, the active agents were shown to have comparable efficacy in improving symptoms measured on the 30-item Positive and Negative Syndrome Scale (PANSS) and were both statistically superior to placebo.
READ MORE @ PSYCHIATRIC TIMES
The favorable judgment culminated a circuitous product development path. The compound had been developed by Hoechst Marion Roussel, but the rights were sold to Titan Pharmaceuticals in 1997, and then to Novartis in 1998, before Vanda Pharmaceuticals acquired them in 2004. Vanda succeeded in garnering regulatory approval, in large part by redesigning the clinical trials supporting the NDA.
Rather than comparing the efficacy of iloperidone with risperidone and haloperidol, which had not previously favored iloperidone, the new trials compared iloperidone with placebo and used ziprasidone as an active control. In this design, the active agents were shown to have comparable efficacy in improving symptoms measured on the 30-item Positive and Negative Syndrome Scale (PANSS) and were both statistically superior to placebo.
READ MORE @ PSYCHIATRIC TIMES
Monday, August 24, 2009
Touted "Depression Risk Gene" May Not Add to Risk After All
A gene variation long thought to increase a person’s risk for major depression when paired with stressful life events may actually have no effect, according to a new analysis. The result challenges a common approach to studying depression risk factors.
Most mental disorders are thought to be caused by a combination of many genetic risk factors interacting with environmental triggers. Finding the exact combinations of factors, however, has been a significant challenge. Advances during the past decade have led to powerful tools for studying how genes and the environment interact to affect the risk for disease. In 2003, these advances allowed scientists to show that variation in a gene called the serotonin transporter gene affected the risk of major depression in people who had a number of stressful life events over a 5-year period.
Serotonin is a chemical messenger that helps brain cells communicate. The serotonin transporter directs serotonin from the space between brain cells back into the cell for reuse. Since the most widely prescribed class of medication for treating major depression acts by blocking this protein, it’s been a prime suspect in mood and anxiety disorders.
READ MORE @ NIH Research Matters
Most mental disorders are thought to be caused by a combination of many genetic risk factors interacting with environmental triggers. Finding the exact combinations of factors, however, has been a significant challenge. Advances during the past decade have led to powerful tools for studying how genes and the environment interact to affect the risk for disease. In 2003, these advances allowed scientists to show that variation in a gene called the serotonin transporter gene affected the risk of major depression in people who had a number of stressful life events over a 5-year period.
Serotonin is a chemical messenger that helps brain cells communicate. The serotonin transporter directs serotonin from the space between brain cells back into the cell for reuse. Since the most widely prescribed class of medication for treating major depression acts by blocking this protein, it’s been a prime suspect in mood and anxiety disorders.
READ MORE @ NIH Research Matters
Sunday, August 23, 2009
Cymbalta's waning patent and generic rivals soon could threaten Lilly's sales
Eli Lilly has enjoyed a wave of success with antidepressants, but analysts say such expertise must now bring new revenue growth.
Eli Lilly and Co. built a large part of its fortune selling medications for gloom, anxiety and withdrawal.
Now the question is: Can the Indianapolis drug maker keep riding the antidepressant wave? Can it find its next Prozac, its next Cymbalta?
Use of antidepressants in the U.S. doubled from 1996 to 2005, as more people sought out treatment and the stigma of depression has fallen, according to a study published in the August issue of the Archives of General Psychiatry. All told, about 10 percent of Americans, or 27 million people, were prescribed an antidepressant in 2005, up sharply from 13 million people a decade earlier.
"There's a huge increase in the recognition of depression and its symptoms," said Dr. Jim Martinez, an Indianapolis psychiatrist and adviser to Lilly. "And I think we've seen a growing improvement in public attitudes around seeking care for this disease."
But in recent years, the market has faced growing headwinds. Industry sales from antidepressants dipped nearly 14 percent in the past four years, even as the number of prescriptions dispensed for the pills has continued to climb. Medco Health Solutions, a huge pharmacy company that studies drug trends, is forecasting that use of antidepressants is likely to grow slowly over the next three years.
READ MORE @ INDIANAPOLIS STAR
Eli Lilly and Co. built a large part of its fortune selling medications for gloom, anxiety and withdrawal.
Now the question is: Can the Indianapolis drug maker keep riding the antidepressant wave? Can it find its next Prozac, its next Cymbalta?
Use of antidepressants in the U.S. doubled from 1996 to 2005, as more people sought out treatment and the stigma of depression has fallen, according to a study published in the August issue of the Archives of General Psychiatry. All told, about 10 percent of Americans, or 27 million people, were prescribed an antidepressant in 2005, up sharply from 13 million people a decade earlier.
"There's a huge increase in the recognition of depression and its symptoms," said Dr. Jim Martinez, an Indianapolis psychiatrist and adviser to Lilly. "And I think we've seen a growing improvement in public attitudes around seeking care for this disease."
But in recent years, the market has faced growing headwinds. Industry sales from antidepressants dipped nearly 14 percent in the past four years, even as the number of prescriptions dispensed for the pills has continued to climb. Medco Health Solutions, a huge pharmacy company that studies drug trends, is forecasting that use of antidepressants is likely to grow slowly over the next three years.
READ MORE @ INDIANAPOLIS STAR
Saturday, August 22, 2009
Online Psychiatric Counseling Appears Effective New Study Shows Remote Counseling Online Can Have Mental Health Benefits
If you're feeling depressed but can't see a shrink in person, the next best thing may be instant messaging, according to a new British study.
Online cognitive behavioral therapy for depression -- with patients and therapists communicating in real time via instant messaging, or IM -- was not only effective, but could broaden access to treatment, researchers reported in the Aug. 22 issue of The Lancet.
After four months, 38 percent of patients who had participated in the Internet-based therapy program had recovered from depression, compared with 24 percent of those in a control group, according to Dr. David Kessler of the University of Bristol.
After eight months' follow-up, 42 percent of the treatment group -- but only 26 percent of controls -- had recovered.
READ MORE @ ABC NEWS
Online cognitive behavioral therapy for depression -- with patients and therapists communicating in real time via instant messaging, or IM -- was not only effective, but could broaden access to treatment, researchers reported in the Aug. 22 issue of The Lancet.
After four months, 38 percent of patients who had participated in the Internet-based therapy program had recovered from depression, compared with 24 percent of those in a control group, according to Dr. David Kessler of the University of Bristol.
After eight months' follow-up, 42 percent of the treatment group -- but only 26 percent of controls -- had recovered.
READ MORE @ ABC NEWS
Subscribe to:
Posts (Atom)
