Category: seroxat

Psychiatry Has Destroyed Sinead O’ Connor..


 

https://www.facebook.com/profile.php?id=100006731236998

Irish singer, Sinead O’ Connor, has hit the headlines again, with an impassioned and heartbreaking cry for help to her family through an online video. In distressing and harrowing Facebook posts over the last few weeks, Sinead has been crying out for her family to reach out to her. From the videos and messages she has been posting for almost two years now, it is obvious that Sinead is in a very bad state, and has been for at least a decade, but what has her led her to this crisis?

How did one of the most talented, and famous, female singers- in the world- end up alone, isolated, and severely ‘mentally ill’ to the point of suicide, in a motel in the outskirts of New Jersey?

Sinead, now 50, has been ‘under the care’ of psychiatry (that’s if you could call it ‘care’), and under the ‘treatment’ of psychiatric drugs for years, and if her recent video is anything to go by, the effects of this (mis) treatment have utterly destroyed her mental and physical health, her relationships with family and friends, and possibly her career, and her life too.

Sinead is one of milions (globally) destroyed by the polypharmacy medication merry go round of psychiatric drug treatment. Those of us that have been through this system of psychiatric drugging and mis-treatment (and suffered side effects which made our condition worse), know all too well the dire consequences of it. It’s difficult to see, or to understand, the damage been done to you while you are in it. The meds keep you sedated, and suppressed, so much so that you can be completely unaware. Tragically, people like Sinead  end up stuck in the psychiatric system, not realizing that the system itself is damaging them, but so vulnerable that they are helpless to get out of its grip.

Robert Whitaker’s book ‘Anatomy of an epidemic‘ details the results of mass drugging of the population, and the outcomes are not good, in fact they are extremely grim, particularly for those who have been medicated long term…

 

 “…Whitaker has persuaded me that American psychiatry, in collusion with the pharmaceutical industry, may be perpetrating the biggest case of iatrogenesis—harmful medical treatment–in history….” (Scientific American)

 

Leonie Fennell did an excellent post about Sinead and her experiences with psychiatry 4 years ago-

 

“….Here’s a recent clip of Sinead O’Connor speaking on her treatment by an Irish Psychiatrist.

Sinead says that she was misdiagnosed with Bipolar Disorder and subsequently prescribed ‘toxic’ doses of Lamictal (400mgs) and Amitriptyline (200mgs). She describes her psychiatrist as a horrible ‘b’ who did not inform her of the side-effects while on the drugs, or while coming off them.

Dishing out the pills is always the first-line treatment for people that psychiatry see as ‘abnormal’. Sinead O’Connor is perfectly normal by the way, and fabulously outspoken; she didn’t need fixing! Strange that dangerous drugs can be given to a person for years for an ‘illness’ which didn’t exist. Never mind all that comes with that, not least the weight gain, depersonalization, worsening depression and huge expense; would any other profession get away with such sloppy work? Reported adverse effects of these drugs on the RxISK website: Lamictal and Amitriptyline.

The full video can be viewed here….”

 

 



 

In the video above, Sinead seems to be aware that the medications she’s being prescribed are toxic, as she details the various side effects she has had over the years, however it seems that she is stuck in the psychiatric system, without realizing that it is in fact- the psychiatric system that is the problem.

In another article from 2013 she says –

https://truthman30.wordpress.com/2015/12/02/sinead-oconnors-past-psychiatric-drug-use/

 “They are extremely debilitating drugs. Tiring to the extreme. Ironically, extremely depressing. They can cause suicidal or self-harm type thinking. They can mess up your menstrual cycle very badly and cause you to be incapacitated for a week before.

“[They] f**k up your liver, your kidneys, your eyes, your appetite, your entire way of thinking and generally your entire life..”


Sinead will only get better when she gets away from the psychiatric system and the regime of drugging that the psychiatrists subject patients to. The psychiatric survivor movement is now global, and I hope that Sinead doesn’t end up just another casualty of mass psychiatric drugging. I hope she gets off the psych drugs, and then she can start her journey of healing.

If you haven’t heard the song ‘Troy’ from Sinead’s first album – The Lion and The Cobra- you really should, it’s spine-tingling. It’s Sinead at the height of her creative power, only 19 at the time. Compare that with the video from her facebook cry for help -above (30 years later), and bear witness to the damage that over a decade of psychiatric ill- treatment and psychiatric drugging does to an individual.


UK fraud office expects decision on GSK Case Next Year..


cash_cow__mary_zins

 

I’m going to make a prediction about this..

I think that the UK Serious Fraud Office will either let GSK off the hook completely (due to some technicality of law or loop-hole) or GSK will get off very lightly (a slap on the wrist). Either way, I would be extremely surprised if justice is adequately served.

In a just world, one where corporations like GSK don’t get to operate above the law- the top executives at GSK would all be in jail. However we don’t live in a just world, we love in a corporate driven world, one where corporations get to decide on what laws they can break at a whim, with little consequence from the establishment or the authorities.

It will be interesting to see whether the serious fraud office in the UK has the balls, or even the power, to bring the GSK Goliath to book…

Judging from past examples, of GSK criminality, I won’t hold my breath…

They are the UK’s prized Pharma Cash-cow…

Too many people, in places of power, are generating too much wealth from this cash cow for it- to ever be -put out to pasture…


 

https://www.reuters.com/article/us-britain-sfo-idUSKBN1AQ21T

 

UK fraud office expects decision on GSK, Rolls-Royce cases next year

LONDON (Reuters) – The UK Serious Fraud Office (SFO) said on Thursday it expects to decide next year whether it will file criminal charges in bribery investigations related to drugs giant GlaxoSmithKline (GSK.L) and aero engine company Rolls-Royce (RR.L).

The SFO launched an investigation into GSK and its subsidiaries in 2014. Britain’s biggest drugmaker has already been fined a record 3 billion yuan ($452 million) by Chinese authorities for paying bribes to doctors to use its drugs.

The SFO’s continued investigation into Rolls-Royce is focusing on individuals after the aero engine maker paid 671 million pounds ($870 million) in January to settle British, U.S. and Brazilian bribery investigations.

David Green, the head of the SFO, told Reuters in an interview that he hoped a decision about charges would be made before he steps down after six years in the job next April.

“I would expect resolution in both these cases in 2018, and hopefully prior to my departure in April,” he said.

Separately, a spokeswoman for the Attorney General’s Office, which is responsible for SFO director appointments, said the recruitment process for Green’s successor had yet to begin. But she said there was “still plenty of time” and that there “will be an appointment in due course”.

Prime Minister Theresa May’s Conservative Party pledged in May to abolish the specialist investigator and prosecutor and roll it into the four-year-old National Crime Agency (NCA) to “strengthen Britain’s response to white collar crime”.

But the proposal drew sharp criticism from white collar crime lawyers, lawmakers and anti-corruption groups and was later dropped from the minority government’s official two-year policy program.

Lawyers said the omission could signal a reprieve for the agency, which in June charged Barclays (BARC.L), one of the country’s biggest banks, and four former senior executives with fraud over undisclosed payments to Qatari investors in 2008.

 

 

Paxil (Seroxat) Implicated In Steven DeValle Trial..


http://www.uppermichiganssource.com/content/news/Steven-DeValles-second-day-sees-the-victim-on-the-stand-436603253.html

Steven DeValle’s second day sees the victim on the stand

MARQUETTE, Mich. (WLUC) – Opening statements started day two in the Steven DeValle attempted murder trial in Marquette, also on the stand today, the victim.

DeValle is charged with four counts, including strangulation and criminal sexual conduct against his ex-girlfriend last july.

Prosecuting attorney Matt Wiese calling his first witness, the victim herself, who we are not naming or showing.

In the prosecution’s opening statement, Prosecutor Matt Wiese told the jury to trust the evidence of those who were on the scene.

He also established for the jury DeValle was unstable and capable of attempting to kill the victim.

“He went from being enraged to being eerily calm and his mood she will tell you went in that way and when he became eerily calm is when she most feared for her life,” Prosecuting Attorney Matt Wiese said.

In the defense’s opening statement, attorney Ted fulsher told the jury DeValle and the victim were recently in a 15 month relationship, having only just days before gone on a family vacation together.

Fulsher told the jury about DeValle’s recent problems with mental issues, and of the recent switch in medication from Zoloft to Paxil.

“Paxil has numerous side-effects,” Defense Attorney Ted Fulsher said.

Those symptoms include, suicidal tendencies, erratic behavior and amnesia.

After opening statements, Wiese called the victim to the stand as his first witness.

The victim was asked when she saw a change in the defendant.

“I started noticing maybe some anger tendencies and maybe some anxiety tendencies about 1:30AM,” the victim said.

At that time, the victim says she messaged her police officer friend online to drive by and non-threateningly check in on them.

The victim claimed she then dialed in 911, to have it available if she needed to call, before the defendant knocked the phone out of her hand.

The defendant then became immediately concerned.

“He got angry and started making comments, you know, you’re calling the police on me and you know if you do that I’ll lose everything,” the victim said.

Wednesday, testimony from Forsyth Township Police and other medical personnel will be heard.


 

Steven DeValle trial enters day 4 as defendant takes the stand

MARQUETTE, Mich. (WLUC) – The Steven DeValle attempted murder trial entered its fourth day on Thursday July 27, with the defense calling a series of witnesses to the stand.

The first witness was Steven DeValle’s step mother. After that, his ex-wife in Illinois then delivered testimony via video conference. Both women claim that DeValle has never had a history of violence or abuse.

“As far as violence, that I know nothing of,” said Amy DeValle, ex-wife of the defendant.

The defense then heard from the officer who found Steven DeValle on the side of the road July 6, 2016, the morning after the incident. The deputy from Delta County said that DeValle seemed depressed and suicidal, it was then that he brought him to Escanaba’s St. Francis hospital.

The defense then submitted into evidence video of DeValle that morning when he was being arrested. In the video, DeValle appears manic, asking what he had done, claiming to have no memory of the incident.

Next, the defense called to the stand pharmacist Tyler Jenema, who said that while the medicine DeValle was taking, Paxil, could change his behavior, it was very unlikely that he would suffer from memory loss because of the medicine.

“The percentages are anywhere from half a percent or a little less, maybe up to one percent we think of patients maybe potentially experience amnesia,” said Jenema.

DeValle himself then took the stand, staying firm to his claim that he suffered from memory loss, even when his stories started to change. His original testimony to Forsyth Officer, Chief Warchock claimed that he had no recollection of the night of July 5, 2016 after 6pm but in court DeValle claimed he remembered events up to 9pm and even 10pm.

DeValle will continue to be examined and cross examined Friday, July 28 as the trial seems to be on track to that afternoon.

Meds Like Seroxat (Paxil) Can Cause Violent Reactions..


The Royal College of psychiatry UK is currently under fire on Twitter from (what some of us see as) its biased ideological slant in regards to the benefits and risks of SSRI’s. Personally, I believe that the Royal college of Psychiatry knows full well that there can be severe risks to SSRI’s, but it simply cannot acknowledge them, because to do so would risk professional suicide.

However, ironically, because psychiatry keeps on denying these serious side effects, it  has already been committing professional suicide for quite some time. The internet, and social media in particular- has no mercy. Mainstream psychiatry has come under an onslaught of criticism online, mainly because patients, and patient advocates, are sick to our back teeth of psychiatry’s arrogant deflection, and deliberate promotion of misinformation. I have experienced horrible side effects of aggression, mania, akathsia, personality changes, and worse from the SSRI Seroxat/Paxil and there are thousands of others who have also.

James Homes was the pin head tip of a massive iceberg of cases…

http://www.dailymail.co.uk/health/article-4726134/Can-pills-depression-turn-killer.html

Can pills for depression turn you into a killer? In a shocking interview, a man who calls himself a loving father tells how he killed his son during a psychotic episode, caused, he says, by medication

  • David Carmichael, 59, killed his son Ian, 11, during a psychotic episode 
  • A judge ruled he was ‘not criminally responsible on account of a mental disorder’
  • David has always believed that his psychosis was caused by a type of antidepressant known as a selective serotonin re-uptake inhibitor (SSRI) 

David Carmichael, 59, calmly and methodically describes the events leading up to the day he killed his 11‑year-old son Ian.

He maintains his composure right up to the point when he describes his boy: ‘Oh man, he was the most loving child.’

His face clouds and he rocks with pain. ‘We spent so much time together and we got along great. He was a beautiful boy, a beautiful gift. I miss him so much.’

David Carmichael, 59, killed his son Ian, 11, during a psychotic episode. But a judge ruled he was ‘not criminally responsible on account of a mental disorder’

David Carmichael, 59, killed his son Ian, 11, during a psychotic episode. But a judge ruled he was ‘not criminally responsible on account of a mental disorder’

Ian had epilepsy and very mild dyslexia, but had no problems other than being a little behind with his reading. David was a nurturing and devoted dad, a sports coach from Toronto, Canada, who’d spent his entire professional life working with children.

But when David took Ian’s life during a psychotic episode, he was convinced that his wife Beth and daughter Gillian would thank him for getting rid of the ‘intolerable’ burden Ian had become.

David was tried for first-degree murder, but the judge ruled he was ‘not criminally responsible on account of a mental disorder’. Two forensic psychiatrists diagnosed him as being in a ‘major depression with psychotic episodes’ when he killed Ian.

David was sent to a psychiatric hospital where he spent four years. On December 4, 2009, he received an absolute discharge: a finding of guilt, but with no criminal record.

When David took Ian’s life during a psychotic episode, he was convinced that his wife Beth and daughter Gillian would thank him for getting rid of the ‘intolerable’ burden Ian had become. Pictured: Ian Carmichael

When David took Ian’s life during a psychotic episode, he was convinced that his wife Beth and daughter Gillian would thank him for getting rid of the ‘intolerable’ burden Ian had become. Pictured: Ian Carmichael

It is a truly shocking and bitterly tragic story, and one that will divide opinion. David has always believed that his psychosis was caused by a type of antidepressant known as a selective serotonin re-uptake inhibitor (SSRI). But it has not yet been proven that SSRIs were to blame.

David was taking paroxetine (sold as Paxil in the U.S. and called Seroxat in the UK). While the drugs appear to work for some people, SSRIs, like all medicines, can cause side-effects. Drowsiness, nausea, insomnia and loss of libido are some of the recognised ones.

However, as Good Health has previously highlighted, there is growing concern about other SSRI side-effects such as anxiety, agitation, hallucinations and paranoid delusions, which, although more rare, can have a devastating impact.

In these pages filmmaker Katinka Blackford Newman, a previously super-fit mother of two, has described her terrifying experiences. Hours after taking her first SSRI dose she became psychotic.

‘I didn’t harm my kids, Lily, now 15, and Oscar, now 14, but it still terrifies me that I might have done,’ she says.

Three days after David killed his son Ian (pictured), reality finally filtered through. The pain was so excruciating David cried for ‘whole days. I’d shut my eyes, praying I’d die in my sleep’

Three days after David killed his son Ian (pictured), reality finally filtered through. The pain was so excruciating David cried for ‘whole days. I’d shut my eyes, praying I’d die in my sleep’

Katinka has since investigated other adverse reactions, meeting David Carmichael and others affected, ‘who made me realise it was pure luck I didn’t kill my children. I was determined to make this issue public, and so took my research to BBC Panorama.’

Tomorrow, Panorama takes up the story, asking: is it possible that a pill prescribed by your doctor can turn you into a killer?

More than 60 million prescriptions for anti-depressants were written in the UK in 2015.

Clearly very few people on them become suicidal or homicidal, but according to David Healy, a professor of psychiatry at Bangor University and a leading critic of SSRIs, as many as one in 1,000 people taking the medication is severely affected.

‘There are probably up to an extra 2,500 suicides in Europe triggered by an SSRI antidepressant,’ claims Professor Healy, who founded rxisk.org, a website that helps identify potential drug risks. Chillingly, he believes the figures are similar for episodes of violence, including mass killings.

In March 2012, 28 Belgian and Dutch schoolchildren and teachers were killed when the coach they were travelling in drove into the wall of a tunnel.

Investigators hired by the parents found that the driver was withdrawing from Seroxat. They believe he killed himself while suffering delirium caused by fluctuating levels of the drug.

In the same year, at the premiere of a Batman film in Aurora, Colorado, James Holmes, a 24-year-old PhD student with no record of violence, murdered 12 people and injured 70.

He is serving multiple life sentences in jail, but questions have been asked as to whether the SSRI he’d been prescribed played a part.

Andreas Lubitz, the German pilot who on March 24, 2015, deliberately crashed a Germanwings flight into the French Alps, killing all 150 people on board, was taking antidepressants, including the SSRI mirtazapine.

While no one knows for sure why SSRIs may adversely affect some people and not others, Professor Healy believes David Carmichael was ‘almost certainly’ in the grip of SSRI psychosis when he killed Ian.

At the time, David was running sports camps while his wife stayed at home to look after their children.

‘I wanted to be the best worker, the best provider, the best father, and I stressed myself out to provide for my family,’ he tells me.

‘I got into the shower one morning and I started to shake. Over the next few weeks, I was conscious that my heart was racing and I lost confidence in things I’d always been able to do.’

His doctor diagnosed depression and prescribed 40mg of Paxil. ‘Right from the outset, I experienced akathisia — a compulsion to be in constant motion.’

This is a recognised side-effect of antidepressants and antipsychotics: statistics from clinical trials suggest that as many as one in 20 patients stops taking SSRI drugs because of agitation, with one in 100 experiencing hallucinations.

‘I felt like I was coming out of my skin,’ David says. ‘I was so agitated, I’d be pacing the floor in the middle of the night.’

But the agitation died down after ten days and David began to feel better within six weeks.

‘I started to feel great. I thought I was recovered.’

But there were side-effects David didn’t like: excessive sweating, weight gain and sexual dysfunction. ‘These got me down, so I began to wean myself off,’ he says.

He doesn’t know why he didn’t go back to the doctor. Nor does he know why he didn’t consult his doctor before taking them again a year later. ‘I felt the symptoms coming on again: I was anxious and I could feel my confidence drain away.

‘I had a full three-month prescription left over from the year before, so on July 8, 2004, I put myself back on 40mg a day.’

Almost immediately, David began to feel agitated again. ‘I started to feel incredibly negative, and suicidal thoughts raced through my mind,’ he says.

Thinking his depression was getting worse, he increased the dose to 60mg.

‘I believed it would help me recover more quickly, like taking two aspirin instead of one for a headache,’ he says.

Over the next few days the akathisia subsided and, outwardly, David appeared to be functioning normally.

‘I’d get up, go to work. But inside, I was disintegrating. I became detached, unemotional and fixated on ending my life.’

David became convinced that he should end Ian’s life, too. ‘I felt strongly that it was my role as his dad to send him to a better place with me,’ he says.

David describes a chilling state of calm as he worked his plan through. He decided to take Ian to the family’s weekend cottage where he would drown them both by going out in the family boat.

But when he found he’d forgotten to pack his own bathing shorts, he changed his mind.

‘I’ve never been spiritual, and I don’t go to church, but I began to think that it was a message from God that I was not supposed to die, just Ian.

‘It’s still hard for me to believe I could have been in that mindset. But I really thought I was doing everyone a favour. I thought they’d understand.

‘In my mind, Ian’s mild epilepsy had become permanent brain damage; his challenges in school meant he had no future.’

David decided to kill Ian with medication he bought specifically for that purpose from a chemist. The day after buying it, he calmly researched how much time he’d spend in prison for murder, and what jail would be like.

David arranged to take Ian on a trip to an indoor BMX park he knew his son would love, followed by a night in their favourite hotel in London, Ontario.

Three days after buying the medication, David told Ian to kiss his mother goodbye and they headed off. ‘I wasn’t worried,’ David recalls. ‘I knew in my wildly distorted mind that killing Ian was the right thing to do.’

The pair checked into the hotel on Saturday, July 30, ordering room service of all Ian’s favourite food and watching a superhero movie. All the while, David was fixated with the idea that he would sacrifice his freedom and go to prison for 25 years so Ian could go to a better place.

‘Nothing kicked in, no innate sense that I was doing the wrong thing,’ he says.

Just after 10pm, he poured the medication into a glass of orange juice for Ian.

But, instead of becoming sleepy, his son became agitated and began to hallucinate. At 3am David ‘very calmly’ strangled him.

I remember every detail. It is as unbelievable to me as it is to you. But back then, I felt nothing other than a total conviction that everyone was going to thank me for what I’d done.

‘I’m a man with no history of violence, a loving father whose life up to that point had been spent working with children,’ he says. ‘To this day, I cannot imagine myself doing it.’

David falters and for the first time during the interview, he breaks down. ‘I remember every detail. It is as unbelievable to me as it is to you,’ he says, shaking his head. ‘But back then, I felt nothing other than a total conviction that everyone was going to thank me for what I’d done.’

When David was sure Ian was dead, he kissed him, told him he loved him and folded his hands over his chest. Then he watched TV ‘without any tears’ for six hours before calling emergency services.

For two weeks, David remained in a psychotic state, with no comprehension of what he had done. CCTV from the police station shows him calmly shaking the hand of the pathologist who had attended the scene, as if nothing untoward had happened.

‘I didn’t feel anything,’ he says. ‘I thought that everyone would understand why I had to do what I’d done.’

When Beth was told that her son was dead and her husband was in custody, she collapsed, screaming.

‘A former boss came to see me and he said: “She will never forgive you.” I remember saying: “What? Of course she will! I did this for all of us,” ’ says David.

Three days after this, reality finally filtered through. The pain was so excruciating David cried for ‘whole days. I’d shut my eyes, praying I’d die in my sleep.’

David’s daughter Gillian has never blamed him. He says her unconditional love and forgiveness gave him the motivation to carry on living. Alone in his cell he’d repeat the mantra: ‘I’m a good dad. I’m going to be a good dad again.’

David credits Gillian with saving his marriage ‘by loving us both’.

Did Gillian, then only 14, understand? ‘She understands that it wasn’t her dad who killed her brother,’ he says carefully. ‘She understands I was mentally ill.’

Gillian, now 27, explains: ‘ I knew him. I knew that something was terribly wrong and didn’t make sense. My father would never harm another person, especially his own children.’

The question now, says David, is: ‘What caused my psychosis? That’s what we’re dealing with now.’

David believes akathisia is the key to recognising a potential risk. ‘Anyone who has been prescribed SSRIs who becomes agitated and restless should be monitored closely and, if necessary, taken off the drug,’ he says.

‘If doctors screened patients for akathisia, lives could potentially be saved.’ David, who now volunteers with families dealing with loss, says he feels ‘a duty to speak out about the dangers of prescription drugs’.

He has taken out a $20 million lawsuit against Glaxosmithkline, the maker of Seroxat, on the grounds of personal injury and product liability.

‘I believe there have been many, many deaths associated with Seroxat and I want to see the data on the table,’ says David.

When he was discharged from the psychiatric institution, the community and some family shunned David.

‘People didn’t understand how anyone could take the life of a loved one, even when suffering from a mental illness. They still don’t.’ No one, he says, can punish him harder than he’s already punished himself.

David and Beth now live in a different part of Canada, with Ian’s treasured BMX bike sitting in the hall. ‘Gillian and I have talked about Ian a lot, but Beth and I have only started talking about him,’ he says. ‘Sometimes, we don’t even talk, we just hug.’

David says he has forgiven himself for Ian’s death. ‘I stopped beating myself up a long time ago. I recognise it was the drug and not me that killed my son.’

A spokesman for Glaxosmithkline said: ‘Mr Carmichael’s case is clearly a tragedy, but medicines like paroxetine are an important option for treating depression and have helped many people.

‘Patient safety is our priority and there is no scientific evidence that paroxetine causes homicidal, psychotic, or violent behaviour.

‘We continue to monitor paroxetine’s safety and make our research available. It is important that patients do not change how they take their medicine, or stop taking it altogether, without speaking to their doctor.’

The Pill That Steals Lives, by Katinka Blackford Newman (John Blake, £8.99). A Prescription for Murder? is on BBC1, at 9pm tomorrow.

 

 

Should A Proven Felon And Criminal (GSK) Have Any Credibility At All In A Court Of Law?…


Think about it..

Would you trust the word of a convicted felon and fraudster? one that had to pay the department of justice 3 Billion dollars for fraud, bribery and ‘harm to patients’ offenses dating back many years? Would you trust the word of a sociopathic organization like this? It would be absurd to afford GSK any credibility in trustworthiness and truth wouldn’t it?

See Whistle-Blower Greg Thorpe’s hair raising legal complaint about GSK here-

https://truthman30.wordpress.com/2015/08/28/whistleblower-greg-thorpes-7th-ammended-complaint/


 

https://www.law360.com/articles/950287/reed-smith-atty-s-doctor-knew-of-suicide-risk-gsk-says

 

Reed Smith Atty’s Doctor Knew Of Suicide Risk, GSK Says

Law360, New York (August 1, 2017, 10:12 PM EDT) — GlaxoSmithKline pressed an Illinois federal court Monday to undo a $3 million verdict in favor of the widow of a Reed Smith LLP lawyer who committed suicide after taking generic Paxil, saying the prescribing doctor’s knowledge of the risks relieved the drugmaker of responsibility.
Wendy Dolin sued GSK in 2012, two years after her husband Stewart stepped in front of a train in downtown Chicago. Stewart Dolin had struggled with anxiety and depression off and on, and began taking paroxetine just a few days before his death. A jury this spring awarded $2 million for wrongful death and $1 million for pain and suffering in the days before he took his life.

Glaxo’s new brief elaborates on earlier arguments it has made in favor of a new trial, after Wendy Dolin urged against the move in recent weeks. The drugmaker said that the trial testimony of Stewart Dolin’s prescribing doctor revealed that he believed paroxetine could increase Dolin’s suicidality. Via the learned-intermediary doctrine, Glaxo said, that would mean it had washed its hands of the matter.

“Plaintiff fails to identify a single Illinois decision holding that a manufacturer can be held liable for failure to warn” in a suit like this, the company said.

The trial testimony of prescribing doctor Martin Sachman “shows that he was aware of the very risk that mattered to him when deciding to prescribe paroxetine for Mr. Dolin.”

GSK included an excerpt of his questioning where he was asked, “When you reinitiated paroxetine for Mr. Dolin in 2010, you went over with him the fact that he needed to be on the [lookout] for the signs and symptoms of agitation, increased restlessness or insomnia, panic attacks, worsening depression, or suicidal thoughts or behavior after he started the medication?”

Sachman replied, “Right.”

The company pushed back against Wendy Dolin’s claim that the risk Sachman was saying he was aware of was the obvious depression-related suicide risk, not a medication-related risk; Dolin “selectively cites” Sachman’s testimony to reach that conclusion, the drugmaker said, and didn’t try to push back against Sachman’s agreement that he didn’t realize that a 2006 label that warned him properly about what happened to Dolin was later changed before Dolin’s death.

GSK also said its hands were tied because drug regulators would not allow the company to use the specific warning language that it wanted. The label for the drug changed more than once between 2006 and 2010 as the U.S. Food and Drug Administration examined it.

And the company also took issue with a myriad of jury instructions that it says didn’t fully separate out different elements necessary for liability.

According to Wendy Dolin, the doctor testified that when he decided to prescribe the drug he relied on the 2010 Paxil label, which didn’t warn that Paxil could lead to suicidality in adults over 24. The doctor also testified that if GSK had warned of that risk, he wouldn’t have prescribed paroxetine to Dolin in 2010, Wendy Dolin said.

But Dolin says GSK never proposed her desired warning: A short statement that taking Paxil is associated with suicidality in adults over 24. “Since GSK never attempted to insert that simple warning anywhere into the Paxil label, GSK cannot meet its burden of providing ‘clear evidence’ that the FDA would have rejected such a labeling change, especially when the only FDA expert to testify at trial rejected that notion,” Dolin said.

Dolin argued the company had failed to alert drug regulators that research showed increased suicide risk in adults. With a short exception, the potential for suicide in adults was left off, and doctors were left uninformed, the suit said.

The FDA also invited GSK to discuss the inclusion of language specific to adult suicidality in the label at a formal meeting in 2007, but the company didn’t take the agency up on its offer, Dolin said.

Representatives for the parties were not immediately available for comment Tuesday.

Wendy Dolin is represented by R. Brent Wisner, Michael Baum, Bijan Esfandiari and Frances Phares of Baum Hedlund Aristei & Goldman PC, and David Rapoport and Matthew Sims of Rapoport Law Offices PC.

GSK is represented by Andrew Bayman, Todd Davis, Ursula Henninger and Heather Howard of King & Spalding LLP and Alan Gilbert and Anders Wick of Dentons.

The case is Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403, in the U.S. District Court for the Northern District of Illinois.

–Additional reporting by Emily Field. Editing by Brian Baresch.

Myth Busting New Post On SSRI Dangers From AntiDepAware..


The royal college of psychiatry UK would have you believe that anti-depressants are nothing but a positive thing for mental health patients. They’d have you believe that these pills are relatively harmless, mostly effective, and that the benefits outweigh the risks. They’d like you to think that SSRI’s are ‘saving lives’ and ‘helping millions’. They don’t want you to know that some people might become homicidal, aggressive, volatile or even commot murder because of them.

They don’t want you to know the truth, because the truth about side effects undermines the psychiatric profession and its ideology and power (and we can’t have that now can we?).

Well, the website Antidepaware does want you to know the truth about SSRI’s, check out the new post from the Antidepaware website here…

 

http://antidepaware.co.uk/great-myth-buster/

The Great Myth Buster

On Wednesday July 26th, BBC showed a thoughtful, well-researched Panorama documentary called A Prescription for Murder?. The programme was directed and introduced by Shelley Jofre (left), who, several years ago, exposed The Secrets of Seroxat.

Most of the recent documentary was devoted to the so-called “Batman killer” James Holmes (right), a neuroscience graduate who shot dead 12 people and injured 70 in a Colorado cinema in 2012. He had been taking the SSRI antidepressant Sertraline (Zoloft), along with Clonazepam, a benzodiazepine.

In the run-up to the programme, two significant interviews were published. In the Sunday Times on July 23rd, Katinka Blackford Newman (left) was interviewed by Oliver Thring.

Katinka, who was one of the principal researchers on the Panorama documentary, was the author of The Pill That Steals Lives. At its launch a year ago, I was privileged to have met David Carmichael, who had travelled from Canada.

In 2004 David (right), who had never shown any symptoms of psychosis before being prescribed Seroxat, strangled his 11-year-old son Ian. He was judged to be “not criminally responsible on account of a mental disorder” for murdering his son and, in 2009, he received an absolute discharge. Caroline Scott’s interview with David was published in the Daily Mail on the day before the documentary was shown.

Another guest at the launch of Katinka’s book was Leonie Fennell, who had travelled from Ireland. In 2009, Leonie’s son, 22-year-old student Shane Clancy (left) fatally stabbed his ex-girlfriend’s new boyfriend, injured two others, then died after stabbing himself 19 times. Shane had no history whatsoever of violence, self-harm or mental instability of any sort. However, a few weeks before the tragedy, Shane had gone to see a doctor as he was feeling low after breaking up with his girlfriend, and was prescribed the antidepressant Citalopram (Celexa). At Shane’s inquest, the jury decided that Citalopram had probably caused Shane’s death and thus rejected a suicide verdict.

Although most of the Panorama documentary was devoted to James Holmes, both David and Leonie appeared in short interviews with Shelley Jofre.

But, before the documentary had even been shown, the Science Media Centre orchestrated a campaign of mis-information and denigration against the programme. Among the psychiatrists enlisted to provide “expert comments” were Allan Young (right) and Carmine Pariante, both of whom have financial links to pharmaceutical companies that make antidepressants. Moreover, the two professors are employed by Kings College, London, which recently welcomed the UK managing director of Pfizer (makers of Sertraline) on to its board.

Another contributor was Wendy Burn (left), the new president of the Royal College of Psychiatrists, who also wrote an article for The Times, published the morning after the broadcast, entitled “Stop this dangerous scaremongering over antidepressants”.

There was little criticism of the programme after it had actually been shown.

But then, on Twitter, the Royal College of Psychiatrists (@rcpsych) announced that Wendy Burn and Carmine Pariante would be holding an hour-long Q and A session on August 3rd, using the hashtag #ADsMythBuster (right). It seemed as if the college’s intention was to use Twitter to “bust” what they regarded as “myths” surrounding antidepressants.

The questions started to come in well before the session, but no replies were tweeted before the appointed hour.

It wasn’t long before the first myth was busted by Wendy and Carmine. The surprise was that this particular myth had been perpetrated for many years by their colleagues, as well as other prescribers: “The old idea that ADs correct a chemical imbalance in the brain is an over-simplification and we do not support this view.”

I felt optimistic, and asked, to no avail: “Now that you’ve busted the “chemical imbalance” myth, are you going to bust the “no causal link with violence” myth next?

Alas, it was not to be. This was the nearest we would get to a proper myth buster during the hour. Before long, the assertion that “ADs do have measurable biological effects; increasing new brain cells & reducing stress hormones” produced a number of retorts, both serious and light-hearted, from those who found this quite difficult to believe.

Asked about withdrawal, the reply was: “Not everyone gets withdrawal symptoms. You must come off ADs slowly over 8-12 weeks with support of your doctor.” This response was queried by a participant, who was told: “Everyone is different & you need to plan this with your doctor. Most people are okay with 8-12 weeks to reduce and stop”.

Somebody asked about the best ADs for a mother to use before and after birth and was told: “Preferred choice are SSRIs esp Fluoxetine in pregnancy & Sertraline in breastfeeding”. The questioner was not told that the best option was to avoid antidepressants altogether during this period.

When a question was asked about whether antidepressants can be used to treat bi-polar, the reply was “Yes they can, but preferably with a mood stabiliser”. Aine O’Beirne (left) was quick to retort: “You say use SSRIs to treat Bipolar when SSRIs are one of the causes of Bipolar epidemic”.

To a question about side-effects causing sexual problems, the reply was: “Yes they are common with SSRIs, usually improves but if not discuss with your doctor”.

And when they were asked about the length of treatment, the professors answered: “Patients are taking ADs for longer according to the correct guidelines for treatment & this is a good thing”.

The reply to a question about the record high numbers of antidepressants prescribed was: “We believe it’s because more people are coming forward & reduced stigma – this is a good thing”.

The person who asked about the benefits of taking antidepressants was told: “Sadness improves within days, new studies show that improvement is faster than we originally thought – within weeks”.

And to the person whose antidepressants weren’t working, the answer was: “There are recommended combinations of ADs & other meds for patients who don’t respond”.

To a question about the link with violence, Wendy and Carmime (right) stuck with the ridiculous line: “In adults there is no evidence ADs increase hostility & aggressiveness”. This prompted my question: “Did you actually watch “Panorama” last week?

I asked several questions, and received replies to two of them. The first, about sanctioning members for not following NICE Guidelines, elicited the response: “The guidelines are guidelines not the law, we encourage people to follow them”.

In the other, I asked “Is it acceptable to compel somebody to take ADs in order to be given sickness benefit?”. The reply, “Nobody should be forced to have any treatment to be given sickness benefit”, gave me encouragement, although this message needs to be passed on to the guilty GPs.

It was obvious that only a small proportion of questions could be answered, but I had a feeling that the more difficult ones were avoided in favour of those for which pre-prepared replies were available.

One of the most frustrated participants was Lucy Johnstone (left), who submitted the three questions that had the most re-tweets, but never received an answer to any of them. Eventually, to the question “Why are rocketing prescribing levels not reducing rates of depression and suicide, if the drugs are effective?”, Lucy commented: “71 retweets & 88 likes. Deserves an answer”.

A complete list of questions and answers has been compiled by James Moore, while Aine has published a selection on Storify.

The following day, the overriding impression was that if the College saw their “MythBuster” session as a PR exercise, then they had failed. The reaction of Fiona French (right), writing in the BMJ, was typical: “The online support community submitted many, many intelligent and probing questions. The responses were few in number and lacking in substance. We were advised that the Royal College ‘thinks’ the benefits of antidepressants outweigh the harms but no supporting evidence was provided.”

My contribution was to suggest that: “Next time @rcpsych need an #ADsMythBuster, they should call @PGtzsche1.”

I was, in fact, referring to Professor Peter Gøtzsche (top), one of the world’s most knowledgeable and influential professors in this field. In September 2015, I attended a conference in Copenhagen which Peter had organised. The theme of the event was Psychiatric drugs do more harm than good. I wouldn’t have expected the Pharma-influenced Royal College of Psychiatrists to agree, but the arguments were compelling.

In January 2014, Dr David Healy (left) published an article on his website which Peter had written, and in which he blew apart 10 myths that GSK, Lundbeck, Eli Lilly, Pfizer, etc would like us to believe. Here is Peter’s article:

At the Nordic Cochrane Centre, we have researched antidepressants for several years and I have long wondered why leading professors of psychiatry base their practice on a number of erroneous myths. These myths are harmful to patients. Many psychiatrists are well aware that the myths do not hold and have told me so, but they don’t dare deviate from the official positions because of career concerns.

Being a specialist in internal medicine, I don’t risk ruining my career by incurring the professors’ wrath and I shall try here to come to the rescue of the many conscientious but oppressed psychiatrists and patients by listing the worst myths and explain why they are harmful.

Myth 1: Your disease is caused by a chemical imbalance in the brain

Most patients are told this but it is completely wrong. We have no idea about which interplay of psychosocial conditions, biochemical processes, receptors and neural pathways that lead to mental disorders and the theories that patients with depression lack serotonin and that patients with schizophrenia have too much dopamine have long been refuted. The truth is just the opposite. There is no chemical imbalance to begin with, but when treating mental illness with drugs, we create a chemical imbalance, an artificial condition that the brain tries to counteract.

This means that you get worse when you try to stop the medication. An alcoholic also gets worse when there is no more alcohol but this doesn’t mean that he lacked alcohol in the brain when he started drinking.

The vast majority of doctors harm their patients further by telling them that the withdrawal symptoms mean that they are still sick and still need the medication. In this way, the doctors turn people into chronic patients, including those who would have been fine even without any treatment at all. This is one of the main reasons that the number of patients with mental disorders is increasing, and that the number of patients who never come back into the labour market also increases. This is largely due to the drugs and not the disease.

Myth 2: It’s no problem to stop treatment with antidepressants

A Danish professor of psychiatry said this at a recent meeting for psychiatrists, just after I had explained that it was difficult for patients to quit. Fortunately, he was contradicted by two foreign professors also at the meeting. One of them had done a trial with patients suffering from panic disorder and agoraphobia and half of them found it difficult to stop even though they were slowly tapering off. It cannot be because the depression came back, as the patients were not depressed to begin with. The withdrawal symptoms are primarily due to the antidepressants and not the disease.

Myth 3: Psychotropic drugs for mental illness are like insulin for diabetes

Most patients with depression or schizophrenia have heard this falsehood over and over again, almost like a mantra, in TV, radio and newspapers. When you give insulin to a patient with diabetes, you give something the patient lacks, namely insulin. Since we’ve never been able to demonstrate that a patient with a mental disorder lacks something that people who are not sick don’t lack, it is wrong to use this analogy.

Patients with depression don’t lack serotonin, and there are actually drugs that work for depression although they lower serotonin. Moreover, in contrast to insulin, which just replaces what the patient is short of, and does nothing else, psychotropic drugs have a very wide range of effects throughout the body, many of which are harmful. So, also for this reason, the insulin analogy is extremely misleading.

Myth 4: Psychotropic drugs reduce the number of chronically ill patients

This is probably the worst myth of them all. US science journalist Robert Whitaker demonstrates convincingly in “Anatomy of an Epidemic” that the increasing use of drugs not only keeps patients stuck in the sick role, but also turns many problems that would have been transient into chronic diseases.

If there had been any truth in the insulin myth, we would have expected to see fewer patients who could not fend for themselves. However, the reverse has happened. The clearest evidence of this is also the most tragic, namely the fate of our children after we started treating them with drugs. In the United States, psychiatrists collect more money from drug makers than doctors in any other specialty and those who take most money tend to prescribe antipsychotics to children most often. This raises a suspicion of corruption of the academic judgement.

The consequences are damning. In 1987, just before the newer antidepressants (SSRIs or happy pills) came on the market, very few children in the United States were mentally disabled. Twenty years later it was over 500,000, which represents a 35-fold increase. The number of disabled mentally ill has exploded in all Western countries. One of the worst consequences is that the treatment with ADHD medications and happy pills has created an entirely new disease in about 10% of those treated – namely bipolar disorder – which we previously called manic depressive illness.

Leading psychiatrist have claimed that it is “very rare” that patients on antidepressants become bipolar. That’s not true. The number of children with bipolar increased 35-fold in the United States, which is a serious development, as we use antipsychotic drugs for this disorder. Antipsychotic drugs are very dangerous and one of the main reasons why patients with schizophrenia live 20 years shorter than others. I have estimated in my book, ‘Deadly Medicine and Organized Crime’, that just one of the many preparations, Zyprexa (olanzapine), has killed 200,000 patients worldwide.

Myth 5: Happy pills* do not cause suicide in children and adolescents

Some professors are willing to admit that happy pills increase the incidence of suicidal behavior while denying that this necessarily leads to more suicides, although it is well documented that the two are closely related. Lundbeck’s CEO, Ulf Wiinberg, went even further in a radio programme in 2011 where he claimed that happy pills reduce the rate of suicide in children and adolescents. When the stunned reporter asked him why there then was a warning against this in the package inserts, he replied that he expected the leaflets would be changed by the authorities!

Suicides in healthy people, triggered by happy pills, have also been reported. The companies and the psychiatrists have consistently blamed the disease when patients commit suicide. It is true that depression increases the risk of suicide, but happy pills increase it even more, at least up to about age 40, according to a meta-analysis of 100,000 patients in randomized trials performed by the US Food and Drug Administration.

Myth 6: Happy pills have no side effects

At an international meeting on psychiatry in 2008, I criticized psychiatrists for wanting to screen many healthy people for depression. The recommended screening tests are so poor that one in three healthy people will be wrongly diagnosed as depressed. A professor replied that it didn’t matter that healthy people were treated as happy pills have no side effects!

Happy pills have many side effects. They remove both the top and the bottom of the emotions, which, according to some patients, feels like living under a cheese-dish cover. Patients care less about the consequences of their actions, lose empathy towards others, and can become very aggressive. In school shootings in the United States and elsewhere a striking number of people have been on antidepressants.

The companies tell us that only 5% get sexual problems with happy pills, but that’s not true. In a study designed to look at this problem, sexual disturbances developed in 59% of 1,022 patients who all had a normal sex life before they started an antidepressant. The symptoms include decreased libido, delayed or no orgasm or ejaculation, and erectile dysfunction, all at a high rate, and with a low tolerance among 40% of the patients. Happy pills should therefore not have been marketed for depression where the effect is rather small, but as pills that destroy your sex life.

Myth 7: Happy pills are not addictive

They surely are and it is no wonder because they are chemically related to and act like amphetamine. Happy pills are a kind of narcotic on prescription. The worst argument I have heard about the pills not causing dependency is that patients do not require higher doses. Shall we then also believe that cigarettes are not addictive? The vast majority of smokers consume the same number of cigarettes for years.

Myth 8: The prevalence of depression has increased a lot

A professor argued in a TV debate that the large consumption of happy pills wasn’t a problem because the incidence of depression had increased greatly in the last 50 years. I replied it was impossible to say much about this because the criteria for making the diagnosis had been lowered markedly during this period. If you wish to count elephants in Africa, you don’t lower the criteria for what constitutes an elephant and count all the wildebeest, too.

Myth 9: The main problem is not overtreatment, but undertreatment

Again, leading psychiatrists are completely out of touch with reality. In a 2007 survey, 51% of the 108 psychiatrists said that they used too much medicine and only 4 % said they used too little. In 2001–2003, 20% of the US population aged 18–54 years received treatment for emotional problems, and sales of happy pills are so high in Denmark that every one of us could be in treatment for 6 years of our lives. That is sick.

Myth 10: Antipsychotics prevent brain damage

Some professors say that schizophrenia causes brain damage and that it is therefore important to use antipsychotics. However, antipsychotics lead to shrinkage of the brain, and this effect is directly related to the dose and duration of the treatment. There is other good evidence to suggest that one should use antipsychotics as little as possible, as the patients then fare better in the long term. Indeed, one may completely avoid using antipsychotics in most patients with schizophrenia, which would significantly increase the chances that they will become healthy, and also increase life expectancy, as antipsychotics kill many patients.

How should we use psychotropic drugs?

I am not against using drugs, provided we know what we are doing and only use them in situations where they do more good than harm. Psychiatric drugs can be useful sometimes for some patients, especially in short-term treatment, in acute situations. But my studies in this area lead me to a very uncomfortable conclusion:

Our citizens would be far better off if we removed all the psychotropic drugs from the market, as doctors are unable to handle them. It is inescapable that their availability creates more harm than good. Psychiatrists should therefore do everything they can to treat as little as possible, in as short time as possible, or not at all, with psychotropic drugs.

At least Wendy Burn and Carmine Pariente admitted the first of Peter Gøtzsche’s myths. I look forward to a time when Myths 2-10 are dispelled by those who are at present prescribing a ridiculously high and ultimately harmful number of antidepressants.

* I am not comfortable with the phrase “happy pills”, but I have left the original text intact. It is possible that, in this context, the phrase emanates from a literal translation from Danish.

Related Articles:

More Harm than Good

Hope in Copenhagen

Mental Health Disability: the Antidepressant Connection

Suicide Prevention: a Conflict of Interest

‘Chemical imbalance’


How many people were harmed by the promotion of the ‘chemical’ imbalance myth?

seroxat secrets...

There’s a lot of chat around at the moment about ‘chemical imbalance’… and I’ve written a lot over the years about it and here’s a link to the collected articles.

The term Selective Serotonin Reuptake Inhibitor (SSRI) was invented by a marketing company to sell Seroxat/Paxil to the public. Along with this serious medical sounding piece of jargon, came the fairy tale of the ‘chemical imbalance’

When I started taking Seroxat in 1997, I wanted to know how this great new drug worked – the PIL (the leaflet that came with the tablets) told me “it boosts the levels of serotonin in your brain and that’s what makes you stop feeling depressed”. It’s a simple chemical imbalance said the PIL.

In 2003, GSK said in it “Seroxat is one of a group of medicines called selective serotonin reuptake inhibitors (SSRIs) and works by bringing the levels of serotonin…

View original post 110 more words

Paxil (Seroxat) And The Dangers Of Suppressing Medical Research..


https://www.vox.com/the-big-idea/2017/8/1/16012946/clinical-trial-research-public-transparency

 

 

A surprising amount of medical research isn’t made public. That’s dangerous.

Dan Kitwood / Staff

When the results of clinical trials aren’t made public, the consequences can be dangerous — and potentially deadly.

Consider the case of the anti-depressant Paxil, produced by the drug company SmithKline Beecham (now part of GlaxoSmithKline). GSK got approval from the FDA in 1999 for treatment of depression in adults, but not in teenagers. That meant that while doctors could prescribe the drug to adolescents — a so-called “off label” prescription — GSK could not promote the drug to doctors for that purpose.

But the company did just that, according to criminal and civil complaints filed by the Justice Department and a suit by then-New York Attorney General Eliot Spitzer. What’s more, the Justice Department claimed, GSK selectively and misleadingly released information about three studies it had conducted of the drug: It hired a consulting company to write a journal article that played up evidence from one study that the drug worked better as a treatment for pediatric depression than a placebo, played down (better) evidence from the same study that it hadn’t, and soft-pedaled the side effects.

These side effects included suicidal thoughts and actions.

It buried two other studies, the Justice Department noted, in which Paxil had failed to show efficacy in treating depression.

In the end, GSK paid the US government $3 billion in fines for illegal and misleading promotion Paxil and other drugs, and, in 2004, the FDA required manufacturers to put a “black box” warning label on Paxil and other antidepressants about the potential risks of increased suicidal thoughts and actions when used in children and teenagers.

In 2015, researchers published a second look at the data and clinical study reports underlying the study GSK had relied on for promoting Paxil’s use in adolescents. They affirmed the drug “was ineffective and unsafe in this study.” This was part of a much bigger problem afflicting drug research, they said: “There is a lack of access to data from most clinical randomised controlled trials, making it difficult to detect biased reporting.”

You might think a crisis of that scope, involving teenage suicide and billions of dollars, would rouse the scientific establishment to make sure that the results of all clinical trials be made public. But it didn’t happen. Despite public campaigns, and even legal requirements, many clinical trials still report results publicly late or not at all. What, if anything, will prod researchers — and universities and drug companies — to act?

The issue at stake here isn’t the FDA’s approval process. The FDA makes drugmakers go through an intensive application process before it deems new drugs or medical devices safe and effective. When drug companies seek FDA approval for a drug or device, they aren’t allowed to cherry-pick which results they report. The agency requires that companies submit plans outlining all trials they’ll submit for approval, and scrutinizes the trial results (even conducting its own statistical review). But the FDA does not ensure that all of those trial results also enter the public view.

That means doctors and researchers trying to get a full picture of a drug’s effects are out of luck.

During the Paxil legal battles, there was not yet a law in the United States requiring that clinical trials publicly share their results. What is remarkable is that today there is such a law — yet researchers and companies often ignore it.

Some researchers do share their trial results through journal publications. However, one synthesis of studies on the topic found that from one quarter to one half of clinical trials are never published — or are published only years after trials end. In that same report, from 2012, new research found that roughly half of all trials funded by the National Institutes of Health remained unpublished 30 months after the end of a trial (though 68 percent were ultimately published at some point). The reasons for delays and non-publication vary, from researchers’ lack of interest in reporting negative results — the infamous “file drawer problem” — to constraints on the time of researchers.

Progress on transparency legislation

The research transparency movement has been gaining steam, but still can’t declare victory. A 1997 federal requirement mandated that researchers register some trials in a public database (those pertaining to serious or life-threatening diseases). Then in 2005, an association of medical journals started requiring that any study published in one of their publications be registered in an online database before the time of first patient enrollment. That didn’t guarantee results would be made public, but it at least provided an incentive to researchers to make some information about the trial available.

A few years later, an even bigger shift occurred. Congress passed the FDA Amendments Act of 2007, which required that “applicable clinical trials” register and publicly report results within one year of trial completion. (The requirement excluded some trials, such as Phase 1 trials of drug safety as opposed to efficacy.) The site ClinicalTrials.gov, run by the National Library of Medicine, had started posting general information about trials in 2000 — so sick people could sign up, for example — but now became the place where those results were posted. And the law included a penalty: Those who failed to report on time could face fines of up to $10,000 per day.

Yet nearly a decade later, it’s clear that many researchers and institutions basically ignore the law. They report trials late or not at all, but the FDA has yet to levy a fine. An investigation by the health journalism organization STAT, published in December 2015, looked at about 9,000 trials across 98 institutions, from 2008 to 2015. Of trials that were required by the FDA to report their results, 74 percent of industry trials were either not reported or reported late. The figure, maybe surprisingly, was even worse for academic institutions: 90 percent late or unreported.

By STAT’s calculation, if the FDA had enforced the law using the $10,000-per-day day fine, it could have collected over $25 billion since 2008, funding the agency several times over.

And the thrust of STAT’s conclusions has been echoed by other investigations. (After the Paxil episode, GSK, for its part, has been posting trial results to the company website; it also fares better than many other companies and institutions in several recent transparency scorecards.)

A medical culture too comfortable with non-publication and non-reporting

Why hasn’t the FDA enforced the 2007 law on publicizing results, and why hasn’t it levied financial penalties?

One reason, according to several of those that I spoke with, including Deborah Zarin, director of ClinicalTrials.gov, is that the 2007 law contained ambiguity about some of the requirements, including which trials were subject to the law.

Jennifer Miller, founder of Bioethics International, agrees that some researchers have been, at least till very recently, uncertain about whether the 2007 law applied to their trial. The language used in the law to describe applicable studies included the phrase “controlled clinical trials,” and there was some uncertainty about which trials would count as “controlled.” “How can you impose fines on an ambiguous law?” Miller said.

Researchers I spoke to emphasized, however, that clinical trial results are not just a legal issue: It’s an ethical matter, too. Regardless of the law, shouldn’t reporting results be part of the culture of doing clinical trials?

If so, there’s a problem with the current culture. Researchers are rewarded primarily for publishing as much as possible in the highest-ranked journals that they can, says Joseph Ross, an associate professor of medicine at Yale and an associate editor at JAMA Internal Medicine. “There’s no clear incentive for investigators to have a member of their staff do everything required by ClinicalTrials.gov. It gets deprioritized because it is a substantial amount of work, and investigators don’t put it at the top of their list.”

Competition may play a role. Someone who is running a trial might think: “My competitor has similar molecules in the pipeline, why should I tell them why it failed so that they don’t pump money into it?” says Tomasz Sablinski, co-founder of the drug development firm Transparency Life Sciences, who was previously with the pharmaceutical company Novartis.

How to change the norms, so that there’s an internal commitment to reporting results from researchers and institutions? Steven Goodman, an associate dean and professor of medicine at Stanford, notes that it will be important for institutions to provide education to researchers on how to report results, and pay for staff support.

AllTrials, a nonprofit organization founded by medical doctor and public intellectual Ben Goldacre, took on the mission of pushing for clinical trial transparency. AllTrials, which started in the UK and also has a campaign in the US, thinks the laws don’t go far enough: None of the regulations governing clinical trial reporting require sharing results retroactively (that is, before the laws are passed), which leaves many results for already-approved drugs unreported.

Goldacre also collaborated with a web developer and scientist, Anna Powell-Smith, to create the automatically updated Trials Tracker. The tracker scans ClinicalTrials.gov and PubMed to identify how many clinical trials have been reported by companies and institutions with 30 clinical trials or more. After working on transparency for many years, Goldacre believes “naming and shaming” is the main thing that will really grab the attention of those who haven’t reported their trials.

Momentum seems to be gathering, although the Trump administration’s commitment to the cause remains uncertain. In September 2016, Health and Human Services, which oversees the FDA, issued a “final rule” clarifying and expanding the requirements of the 2007 law: It specifies what was meant by “controlled clinical trials,” among other things. (“All interventional studies with prespecified outcome measures.”) The rule also expands the scope of the requirement to include results from certain trials of new drugs and devices which haven’t yet been approved by the FDA.

The National Institutes of Health (NIH) also announced a policy in September 2016 requiring that all its grant recipients publicly report their clinical trial results. The NIH policy and HHS final rule took effect on January 18. Will the organizations ramp up pressure to comply with the law, and will researchers take this obligation seriously? It’s too soon to say.

The obligation to research participants

One reason to care about whether clinical trial results are shared is that hundreds of thousands of patients have put themselves on the line as research subjects. We owe it to them not to let the information their participation enabled get stuck in a file drawer.

“If we made a pact with a person to enter into this experiment, then we have an ethical and scientific obligation to have the results out there, no matter what happened,” said Stanford’s Goodman.

Everyone who conducts a clinical trial should report their results, whatever the outcome. It’s the law, and it’s past time that it was followed. When researchers fail to do so, we should point that out early and often — for the sake of public health.

Stephanie Wykstra is a freelance writer and consultant with a focus on research transparency. She has recently worked with nonprofits including AllTrials USA and Robert Wood Johnson Foundation. Twitter: @Swykstr.