Posts Tagged ‘bipolar disorder’
Drug Research Contracts: Keeping Pharmaceutical companies out of reach from prosecution?
Posted on: July 6, 2018
Drug Research Contracts: Keeping Pharmaceutical companies out of reach from procsecution?An article published in the NYT in November 29, 2004 “Of the 12 studies for (the church of Pfizer), all 5 of the reports claiming positive results, meaning the drug worked without worrisome side effects, that were submitted for possible regulatory approval were published.The 7 other studies were inconclusive or negative, which can mean that the drug failed to work or that the test failed because of its design.(Two of the studies were never submitted to the Food and Drug Administration to support an application for the drug’s approval.)”“In her Zoloft study, Dr. Wagner acknowledged that she had received “research support” over the years from several drug manufacturers including Pfizer, which paid $80,000 to the Galveston center in connection with the Zoloft test.But she did not state that she also received sizable payments from the company for work she did related to the study.”
|
Dr. Karen Dineen Wagner of the University of Texas Medical Branch at Galveston Published in November 29, 2004 under “Contracts Keep Drug Research Out of Reach” |
(Page 3 of 5)
Dr. Wagner, vice chairwoman of the department of psychiatry and behavioral sciences at the Galveston center, declined to be interviewed for this article but did reply to some questions in writing. Officials of the Galveston center insisted that the industry money she received did not affect her work.
A Researcher’s Role
It was hardly surprising that many manufacturers of popular antidepressants already approved for use in adults would turn to an established researcher like Dr. Wagner to test them in young patients.
In the late 1990’s, she was one of a small number of researchers with experience in testing drugs intended to treat children with problems like attention deficit disorder and bipolar disorder.
Over the last decade, Dr. Wagner has led or worked on some 20 studies published in medical journals, and the government has financed some of her work.
She has also attracted a large number of including those aimed at testing whether antidepressants approved for use in adults were safe and effective in children and adolescents.
Dr. Wagner’s role varied in 12 industry-sponsored trials in which antidepressants were tested against placebos for depression or other problems. On three of them, including a Zoloft trial, she was a lead investigator, working with company researchers to plan, analyze and write results up for publication.
On the others, her duties were limited to overseeing test patients at her clinic.
Of the 12 studies, all five of the reports claiming positive results, meaning the drug worked without worrisome side effects, that were submitted for possible regulatory approval were published. The seven other studies were inconclusive or negative, which can mean that the drug failed to work or that the test failed because of its design. (Two of them were never submitted to the Food and Drug Administration to support an application for the drug’s approval.)
Because many of the antidepressant studies were unpublished, many doctors never heard about the results.
Their findings were typically disclosed in limited settings, like talks at meetings of medical specialists or on a poster displayed in a room with dozens of other posters, which is a typical way of disseminating research results at professional conferences.
Several researchers who worked on the pediatric antidepressant trials said that in many cases they had little incentive to submit ambiguous or failed trials to medical journals because they thought the papers would be rejected by journal editors.
One of those researchers, Dr. Neal Ryan, a professor of psychiatry at the University of Pittsburgh, said there has typically been little publishing interest in studies with inconclusive findings or those that failed to work because of study design, a type sometimes referred to as a negative study.
“No one gets famous from publishing negative studies,” Dr. Ryan said.
In response to a question, Dr. Wagner wrote that in all the cases where she was the lead investigator, test results had been or would soon be published or presented at medical meetings.
It was her study of Zoloft for childhood depression, financed by Pfizer, that attracted the most attention and criticism. Results were published last summer in The Journal of the American Medical Association as the debate on pediatric antidepressant use was rising; the study concluded that the drug effectively treated depression.
The finding received widespread publicity in newspapers, including The New York Times.
“This study is both clinically and statistically significant,” Dr. Wagner said last year. “The medication was effective.”
But some academic researchers said that the difference in improvement that the study found between young depressed patients taking Zoloft and similar patients who received a placebo – 10 percentage points – was not substantial.
Asked about complaints about the trial, Dr. Wagner referred to a statement in The Journal of the American Medical Association in which she responded last year to critical letters.
In that statement, Dr. Wagner said she believed that the 10 percentage point difference was “clinically meaningful.”
A Possible Conflict (of interest?)
In her Zoloft study, Dr. Wagner acknowledged that she had received “research support” over the years from several drug manufacturers including Pfizer, which paid $80,000 to the Galveston center in connection with the Zoloft test. But she did not state that she also received sizable payments from the company for work she did related to the study.
Note: Dr. Karen Dineen Wagner participated in more than a dozen industry-financed pediatric trials of antidepressants and other types of drugs from 1998 to 2001.
| Continued <<Previous | 1 | 2 | 3 | 4 | 5 | Next>> |
How the trauma of life is passed down in SPERM,
Affecting the mental health of future generations
- The changes are so strong they can even influence a man’s grandchildren
- They make the offspring more prone to conditions like bipolar disorder
The children of people who have experienced extremely traumatic events are more likely to develop mental health problems.
And new research shows this is because experiencing trauma leads to changes in the sperm, among other changes.
These changes can cause a man’s children to develop bipolar disorder and are so strong they can even influence the man’s grandchildren.
Psychologists have long known that traumatic experiences can induce behavioural disorders that are passed down from one generation to the next.
However, they are only just beginning to understand how this happens.
Researchers at the University of Zurich and ETH Zurich now think they have come one step closer to understanding how the effects of traumas can be passed down the generations.
The researchers found that short RNA molecules – molecules that perform a wide range of vital roles in the body – are made from DNA by enzymes that read specific sections of the DNA and use them as template to produce corresponding RNAs.
Other enzymes then trim these RNAs into mature forms.
Cells naturally contain a large number of different short RNA molecules called microRNAs.
They have regulatory functions, such as controlling how many copies of a particular protein are made.
The researchers studied the number and kind of microRNAs expressed by adult mice exposed to traumatic conditions in early life and compared them with non-traumatised mice.
They discovered that traumatic stress alters the amount of several microRNAs in the blood, brain and sperm – while some microRNAs were produced in excess, others were lower than in the corresponding tissues or cells of control animals.
These alterations resulted in misregulation of cellular processes normally controlled by these microRNAs.
After traumatic experiences, the mice behaved markedly differently – they partly lost their natural aversion to open spaces and bright light and showed symptoms of depression.
Men who have experienced traumatic events are more likely to have children with mental health problems
These behavioural symptoms were also transferred to the next generation via sperm, even though the offspring were not exposed to any traumatic stress themselves.
The metabolisms of the offspring of stressed mice were also impaired – their insulin and blood sugar levels were lower than in the offspring of non-traumatised parents.
‘We were able to demonstrate for the first time that traumatic experiences affect metabolism in the long-term and that these changes are hereditary,’ said Professor Isabelle Mansuy.
‘With the imbalance in microRNAs in sperm, we have discovered a key factor through which trauma can be passed on.’
However, certain questions remain open, such as how the dysregulation in short RNAs comes about.
Professor Mansuy said: ‘Most likely, it is part of a chain of events that begins with the body producing too many stress hormones.’
Importantly, acquired traits other than those induced by trauma could also be inherited through similar mechanisms, the researcher suspects.
Note: The epigenetics field is concerned with alteration of DNA passed on from community rituals and habits.
Read more: http://www.dailymail.co.uk/health/article-2611317/How-trauma-life-passed-SPERM-affecting-mental-health-future-generations.html#ixzz3wOzg2eNy
Follow us: @MailOnline on Twitter | DailyMail on Facebook
Found a little bit of heaven? Have you been in Hell?
She was “away with the fairies”.
She was drinking and smoking from the moment she woke up. “A pint of Strongbow” and “20 Mayfair” were often the only words she spoke.
“I was doing it because it was something to do. I used pubs like day centres, because nobody knows who you are.”
I’ve found a little bit of heaven for those who’ve been in hell
When Sarah Wheeler told me that she had been away with the fairies, she didn’t mean that she was feeling a bit fed up. What she meant was that she was battling the psychosis that she has had to live with since she was eight years old.
It has driven her, at times, to sleep in empty houses because she couldn’t face the chaos of her “rabbit hutch” flat. She couldn’t manage her money. She couldn’t manage housework, or meals. She spent two years sleeping on people’s sofas and living in bed and breakfasts.
Sarah has been diagnosed with borderline personality disorder, bipolar disorder and depression. She has tried to kill herself 13 times. And 13 times she has failed to kill herself. No wonder, when she had the idea for a “creative endeavour”, she decided to call it Mental Fight Club. The battles she has fought make Brad Pitt’s fisticuffs look like the Sugar Plum Fairy’s pirouette.
You wouldn’t guess any of this when you meet her, at the weekly pop-up cafe she has started in a church crypt. What you notice, when you walk in on a cold winter’s day, is the warmth. There’s singing, and art, and writing, and bean bags, and massage, and fairy lights, and cakes.
There are even little rose bushes in pots on a carpet laid out like a lawn. They made me think of Louis MacNeice’s poem about snow and roses. “World is crazier,” says MacNeice in Snow, “and more of it than we think.”
There is certainly something “crazy” about the Dragon Cafe, which Wheeler founded in the crypt of the church of St George the Martyr, in the London borough of Southwark, and which marks its 100th Monday opening next week. It’s “crazy” not because it’s aimed mostly at people who have struggled with mental illness, but because it seems like an almost crazily visionary project in an often cruel world – many of the people who come to the cafe spend most of their time on their own, and many are living in fear of having their benefits slashed.
“The whole point,” Wheeler told me when I went there this week, “is to be a complete antithesis to your average mental health service.” People like it, she said, because there’s “no pressure to do anything at all”. They can sing, if they want to. They can write. They can paint. But they can also just collapse on a bean bag and snore.
The cafe is run by volunteers. Many of those have known what it’s like to be mentally ill. “We keep it simple,” said Wheeler. “You don’t have to do anything outside your four-hour shift.”
And what they do in those shifts is make “an open-hearted place”. In other words, they make a place that can seem like a kind of heaven when you have been in a kind of hell.
I was never sure what David Cameron meant when he used to talk about the “big society”, but I think he would find it here. He would find people who have been through terrible things, and who know what people who have also been through those things need. He would find volunteers who love their role, and are properly trained, and turn up. And he would find people who are often made to feel like the scrapings at the bottom of society’s barrel getting a tiny taste of what it feels like to be treated with respect.
The Dragon Cafe has some funding. But to survive, it needs much more. I really hope the place gets it. I also hope that dragon cafes, or phoenix cafes, or whatever you want to call them, will spring up throughout the land. Mental healthcare, said the Royal College of Psychiatrists this week, “is at breaking point”; and yet another trust faces being placed in special measures. Even if you are given the right bed, in the right place, that place can still feel pretty damn cold.
My sister had her first breakdown when she was 14 years old. Going into hospital only made her worse. One of the things that kept her going was a cafe that she went to three times a week. It had been started by someone whose brother had schizophrenia. It was funded by grants and run by volunteers.
It was a place where people used to fighting daily battles with their mind could paint or cook or sew. It was a place where they could get some respite from that fight – a place where they knew they were not alone.
When my sister died, her friends at the cafe clubbed together, and in the tiny garden they planted a rose. Let’s plant more roses like this.
Adonis Diaries 