Adonis Diaries

Posts Tagged ‘bipolar disorder

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>>

Here’s how you can connect to friends who are depressed

Dec 15, 2017 

Writer Bill Bernat has been there

Talk to a depressed person as if their life is just as valuable, intense and beautiful as yours. If you focus on that, it might just be the most uplifting conversation of their life.

When I lived with severe depression and social anxiety, I found it extremely difficult to talk to strangers.

Yet the one conversation that uplifted me more than any other occurred in the dining hall of the mental health wing of a mountain-town hospital. I met a woman who told me that a few days earlier, she’d driven her Jeep Wrangler to the edge of the Grand Canyon. She sat there, revving the engine and thinking about driving over.

She described what had been going on in her life in the days and months leading up, what her thoughts were at that exact moment, why she wanted to die, and why she didn’t do it.

We nodded and half-smiled, and then it was my turn to talk about my journey to our table in that fine dining establishment.

I had taken too many sleeping pills. After the doctors treated me, they were like, “Hey, we’d love it if you would be our guest in the psych ward!”

That day, she and I talked shop.

She allowed me to be deeply depressed and simultaneously have a genuine connection to another person. For the first time, I identified as someone living with depression and I felt, oddly, good about it — or rather, like I wasn’t a bad person for having it.

Imagine one of the people at that table was a member of your family or a close friend who told you they were really depressed. Would you be comfortable talking to them?

Depression doesn’t diminish a person’s desire to connect with other people, just their ability to carry this desire.

The World Health Organization says that depression is the leading cause of ill health and disability worldwide, affecting more than 300 million people.

In the United States, the National Institute of Mental Health reports 7%  of Americans experience depression in a year.

But while depression is super common, in my experience most folks don’t want to talk to depressed people unless we pretend to be happy. So we learn to put on a cheerful façade for casual interactions, like buying a pumpkin spice latte.

The average barista doesn’t want to know that a customer is trapped in the infinite darkness of their soul.

And despite what you might think, talking to friends and family living with depression can be easy and maybe fun. Not like Facebook-selfie-with-Lady-Gaga-at-an-underground-party fun — instead, I’m talking about the kind of fun where people enjoy each other’s company effortlessly, no one feels awkward, and no one accuses the sad person of ruining the holidays.

The chasm: On one side are people with depression, and on the other side is everyone else and they’re asking, “Why you gotta be so depressed?

People living with depression, who may act in off-putting or confusing ways because they’re fighting a war in their head that nobody else can see.

I began battling depression when I was eight, and decades later, to my surprise, I started winning that battle. I shifted from being miserable much of the time to enjoying life. Today I live pretty well with bipolar disorder, and I’ve overcome some other mental health conditions, like overeating, addiction and social anxiety.

As someone who lives on both sides of this chasm, I want to offer you some guidance based on my experiences to help you build a bridge across. I’ve also talked to a lot of people who’ve lived with depression to refine these suggestions.

Please don’t let our lack of bubbly happiness freak you out. Sadness doesn’t need to be treated with the urgency of a shark attack.

Before I get to the dos, here are the don’ts — some things you might want to avoid when talking to someone who’s depressed.

Don’t say “Just get over it.” That’s a great idea – we love it —  but there’s just one problem: we already thought of that. The inability to “just get over it” is depression. Depression is an illness, so it’s no different from telling someone with a broken ankle or cancer to “just get over it.” Try not to fix us — your pressure to be “normal” can make us depressed people feel like we’re disappointing you.

Don’t insist that the things which make other people feel better will work for us. For example, you cannot cure clinical depression by eating ice cream, which is unfortunate because that would be living the dream.

Don’t take it personally if we respond negatively to your advice. I have a friend who, about a year ago, messaged me saying he was feeling really isolated and depressed. I suggested some things for him to do, and he was like, “No, no, and no.” I got mad, like, “How dare he not embrace my brilliant wisdom!”

Then I remembered the times I’ve been depressed and how I thought I was doomed in all possible futures and everybody hated me. It didn’t matter how many people told me otherwise; I didn’t believe them. So I let my friend know I cared, and I didn’t take his response personally.

Don’t think that being sad and being OK are incompatible. Please don’t let our lack of bubbly happiness freak you out. Sadness does not need to be treated with the urgency of a shark attack. Yes, we can be sad and OK at the exact same time. TV, movies, popular songs and even people tell us if we’re not happy, there’s something wrong. We’re taught that sadness is unnatural, and we must resist it. In truth, it’s natural and it’s healthy to accept sadness and know it won’t last forever.

Talk to a depressed person as if their life is just as valuable, intense and beautiful as yours.

And here are some dos.

Do talk to us in your natural voice. You don’t need to put on a sad voice because we’re depressed; do you sneeze when you’re talking to somebody with a cold? It’s not rude for you to be upbeat around us.

Do absolve yourself of responsibility for the depressed person. You might be afraid that if you talk to them, you’re responsible for their well-being, that you need to “fix” them and solve their problems. You’re not expected to be Dr. Phil — just be friendly, more like Ellen. You may worry that you won’t know what to say, but words are not the most important thing — your presence is.

Do be clear about what you can and cannot do for us. I’ve told people, “Hey, call or text me anytime, but I might not be able to get back to you that same day.” It’s totally cool for you to make a narrow offer with really clear boundaries. Give us a sense of control by getting our consent about what you’re planning to do. A while back when I was having a depressive episode, a friend reached out and said, “Hey, I want to check in with you. Can I call you every day? Or, maybe text you every day and call you later in the week? What works for you?” By asking for my permission, she earned my confidence and remains one of my best friends today.

Do interact with us about normal stuff or ask us for help. When people were worried about a friend of mine, they’d call him and ask if he wanted to go shopping or help them clean out their garage. This was a great way to reach out. They were engaging with him without calling attention to his depression. He knew they cared, but he didn’t feel embarrassed or like a burden. (Yes, your depressed friends could be a good source of free labor!) Invite them to contribute to your life in some way, even if it’s as small as asking you to go see a movie that you wanted to see in the theater.

This is, by no means, a definitive list.

All of these suggestions are grounded in one guiding principle: speaking to someone like they belong and can contribute.

That’s what allowed the woman in the Jeep Wrangler to start me on my path to recovery without even trying: She spoke to me like I was OK and had something to offer exactly as I was at that moment.

Talk to a depressed person as if their life is just as valuable, intense and beautiful as yours. If you focus on that, it might just be the most uplifting conversation of their life.

This piece was adapted from a talk given at TEDxSnoIsleLibraries2017. 

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

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.


adonis49

adonis49

adonis49

October 2020
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