“….One person wrote about her son: “He was a 35-year-old young man with everything to live for, good job, happily married, no financial problems. He was experiencing some anxiety and chest pains and saw a doctor, who prescribed Paxil. Three days later, my son committed suicide. Something needs to be done to stop this from happening to others….’’
Interesting article today in the UK Daily Mail about UK Boyband member- Duncan James- and his horrific experience on Seroxat (GSK’s notorious suicide inducing anti-depressant). Many thousands upon thousands of people have had horrific experiences both on, and coming off, Seroxat. Many of us have had these embarrassing experiences on the drug, however many more people killed themselves from Seroxat side effects. It’s amazing how GSK’s current CEO- Emma Walmsley- can sleep at night considering the damage GSK has caused people for decades now. All those dead bodies from defective drugs don’t seem to bother the executives of pharmaceutical companies at all.
Anyhow, I agree with Duncan James though, Seroxat should have been banned a long long time ago…
Published: 09:54, 24 October 2017 | Updated: 11:20, 24 October 2017
They’re currently on a book tour for their autobiography All Rise.
And it seems that boy band Blue are making sure there are absolutely zero skeletons left in their closet as even more truths have come spilling out of the mouths of Antony Costa, Simon Webbe, Lee Ryan and Duncan James.
Speaking to Now! magazine, the quartet have opened up about their past with drugs – with Duncan, 39, explaining how easing off anti-depressants caused him to lose control of his bowels live on the National Lottery once.
‘I was always high!’ Boy band Blue reveal dependency on cannabis and anti-depressants in their early days of stardom… as Duncan James explains THAT National Lottery poo story
‘I will never take anti-depressants again,’ the hunky singer declared. ‘I was coming off an anti-depressant called Seroxat, which is so hard. You get anxiety and panic attacks – so horrible.
‘I was filming The National Lottery and it had to come out somewhere! It’s the worst drug in the world. People have committed suicide trying to come off it. It should be banned.’
“…Pharmaceutical maker GlaxoSmithKline will not get a chance to undo a jury’s verdict, finding it owes $3 million to the widow of a Chicago lawyer who committed suicide, allegedly after taking a generic equivalent of GSK’s anti-depressant drug, Paxil….”
Great news for those of us who have been blogging about all things GSK/Paxil and Seroxat related for the past decade or more. It’s good to see the truth finally emerge about the dangers of GSK’s Seroxat/Paxil SSRI ‘antidepressant’.
Wendy Dolin should be very proud. This lawsuit will help bring awareness of akathisia – a horrible side effect which I and many others endured from Paxil and other SSRI’s. It will save lives..
Lawsuit Over a Suicide Points to a Risk of Antidepressants
The last dinner Wendy Dolin had with her husband, Stewart, he was so agitated that he was jiggling his leg under the table and could barely sit still. He had recently started a new antidepressant but still felt very anxious. “I don’t get it, Wen,” he said.
The next day, Mr. Dolin, a 57-year-old Chicago lawyer, paced up and down a train platform for several minutes and then threw himself in front of an oncoming train.
Ms. Dolin soon became convinced that the drug her husband had started taking five days before his death — paroxetine, the generic form of Paxil — played a role in his suicide by triggering a side effect called akathisia, a state of acute physical and psychological agitation. Sufferers have described feeling as if they were “jumping out of their skin.”
The distress of akathisia may explain the heightened risk of suicide in some patients, some psychiatrists believe. The symptoms are so distressing, a drug company scientist wrote in the Journal of Psychopharmacology, that patients may feel “death is a welcome result.”
Ms. Dolin sued the original manufacturer of Paxil, GlaxoSmithKline, claiming the company had not sufficiently warned of the risks associated with the drug. In April, a jury awarded Ms. Dolin $3 million in damages.
The case is a rare instance in which a lawsuit over a suicide involving antidepressants actually went to trial; many such cases are either dismissed or settled out of court, said Brent Wisner, of the law firm Baum Hedlund Aristei Goldman, which represented Ms. Dolin.
The verdict is also unusual because Glaxo, which has asked the court to overturn the verdict or to grant a new trial, no longer sells Paxil in the United States and did not manufacture the generic form of the medication Mr. Dolin was taking. The company argues that it should not be held liable for a pill it did not make.
Concerns about safety have long dogged antidepressants, though many doctors and patients consider the medications lifesavers.
Ever since they were linked to an increase in suicidal behaviors in young people more than a decade ago, all antidepressants, including Paxil, have carried a “black box” warning label, reviewed and approved by the Food and Drug Administration, saying that they increase the risk of suicidal thinking and behavior in children, teens and young adults under age 25.
The warning labels also stipulate that the suicide risk has not been seen in short-term studies in anyone over age 24, but urges close monitoring of all patients initiating drug treatment.
“The scientific evidence does not establish that paroxetine causes suicide, suicide attempts, self-harm or suicidal thinking in adult populations,” Frances DeFranco, a company spokeswoman, said in an email. “Any suicide is a tragedy, and a reminder that depression and other mental illnesses can be fatal.”
Ms. Dolin’s lawsuit, however, has lifted the curtain on data from early clinical trials of Paxil, renewing concerns that older adults, who use antidepressants in far greater numbers than young people, may also be at greater risk of self-harm when taking the drugs.
The documents indicate that several suicides and suicide attempts in early clinical trials that were attributed to patients on a placebo — and which made Paxil look safer by comparison — should not have been counted, and that an F.D.A. reviewer later told the company as much. Glaxo eventually reanalyzed its data, and in 2006 enhanced the warning on Paxil, cautioning that among adults of all ages with major depressive disorder, “the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo” — 6.7 times higher.
But that label was replaced a year later, in June 2007, by the F.D.A.-mandated warning now carried on all antidepressants, which says only that the increased risk has been seen among people under age 25.
A Delicate Risk Calculation
Some 325 million prescriptions for antidepressants were filled last year in the United States, including 15 million for Paxil and paroxetine, according to IMS Health, a health care information company.
But while one in 10 Americans aged 12 and older has filled an antidepressant prescription, one in seven adults aged 40 and over has done so, including nearly one in five middle-aged women, according to the National Center for Health Statistics.
Many psychiatrists say the benefits of antidepressants far outweigh the risks, even for younger patients, and that the drugs are highly effective and generally well tolerated. Several prominent experts have been critical of what they say is excessive attention to the dangers, which they say could potentially dissuade people who could benefit from treatment from accessing care.
The issue is complicated by the fact that depression and other mental illnesses can themselves lead to suicide.
“Antidepressants prevent more suicides than they cause, probably by a large multiple,” said Dr. Peter Kramer, a psychiatrist and clinical professor emeritus at Brown University and the author of several books about antidepressants, including “Listening to Prozac.”
Dr. Kramer, who was not involved in the Dolin litigation, said he urges patients to contact him right away if they have a bad reaction during the first weeks after starting treatment with the drugs — and especially in the first five days.
“When I put people on medication for the first time, I say we’re going to be very cautious in the early going,” he said.
The prescribing information on antidepressants specifically warns that patients should be monitored for symptoms like anxiety, agitation, panic attacks, mania and akathisia. “There is concern that such symptoms may represent precursors to emerging suicidality,” the labels say, especially if they were “abrupt in onset” or “not part of the patient’s presenting symptoms.”
Akathisia is, by definition, a drug-induced syndrome. The word comes from Greek and means “not to sit,” referring to an inability to sit still. Akathisia is characterized by anxiety, restlessness and a compulsion to move or walk about; patients may pace back and forth, or fidget endlessly in their chairs.
It may develop when a patient, adult or younger, begins treatment, but it can also emerge when the dosage of the drug is increased, decreased or discontinued. Patients who have tolerated a drug in the past may develop akathisia when they start a new course of treatment, experts say.
Akathisia is a fairly common and well-known side effect of antipsychotic medications, commonly used to treat disorders like schizophrenia but increasingly given for a variety of mental health complaints, including depression. But the association with antidepressants is not as well recognized, experts say, and incidence rates are hard to pin down.
A group of psychopharmacologists who reviewed over 100 studies found the reported rate of what they broadly called “jitteriness/anxiety syndrome” — which they defined as a worsening of anxiety, agitation and irritability — ranged from 4 percent to 65 percent among patients initiating treatment with selective serotonin reuptake inhibitors, or S.S.R.I.s, the popular class of antidepressants to which Paxil belongs.
Psychiatrists linked S.S.R.I.-induced akathisia to suicidal behavior in a 1991 paper describing three patients who survived violent suicidal attempts — including jumping off the roofs of buildings and off a cliff — shortly after they had started fluoxetine or had the dose increased.
The patients were removed from the drug, but then agreed to try another course of treatment with fluoxetine under close observation. All three became extremely agitated and had a recurrence of suicidal thoughts.
“This is exactly what happened the last time I was on fluoxetine, and I feel like jumping off a cliff again,” one of the patients reportedly said. Another said she had tried to kill herself “because of these anxiety symptoms. It was not so much the depression.”
Dr. Anthony J. Rothschild, one of the study’s co-authors, has since disavowed the paper, saying it was an observation that has been disproved by subsequent drug company clinical trials.
He testified as an expert witness for Glaxo in the Dolin trial.
Akathisia symptoms so closely resemble symptoms of anxiety and depression that it may be hard for a doctor to distinguish between the underlying illness and what could be a side effect of the drug used to treat it, said Dr. Joanna Gedzior, an assistant clinical professor of psychiatry at the Fresno Medical Education Program of the University of California, San Francisco.
If a doctor thinks the patient’s condition is deteriorating, he or she may increase the dose of the medication, which could be disastrous if the drug itself is causing the problem.
“We have to be very careful about this and ask, ‘Is it something I’m giving the patient that’s causing this?’” said Dr. Gedzior, who wrote a paper on akathisia.
Doctors at Southern Illinois University School of Medicine last year described the case of a 45-year-old man who developed akathisia just days after he was put on an antidepressant but was misdiagnosed as having panic attacks. When doctors doubled his dose, he attempted suicide.
The doctors warn that akathisia “can be one of the most ambiguous clinical diagnostic presentations in all of psychiatry” and is “often underdiagnosed or misdiagnosed.”
“We know that anxiety and akathisia create a sense of hopelessness, especially if the feelings are not validated,” Dr. Gedzior said, and hopelessness can lead to suicidal thoughts. The combination of akathisia, anxiety and depression puts patients at risk of suicide, she believes.
Explaining to patients that their emotional turmoil may be caused by a drug side effect can alleviate their distress, she said. Doctors can reduce the patient’s discomfort by discontinuing the drug, or adding another prescription, such as an anti-anxiety medication.
During the Dolin trial, a therapist testified that Mr. Dolin had called to schedule a same-day session on July 14, the day before his suicide. But Mr. Dolin was unable to sit still during their meeting, shifted nervously in his chair, and could not calm down.
The therapist was so worried that she called him at work the next day — the day of his suicide — to urge him to ask his doctor for anti-anxiety medication.
Ms. Dolin is convinced her husband was not suicidal until he developed akathisia as a side effect to paroxetine. Her husband was having “one of his best years ever,” she said. The couple were high school sweethearts who had been married for 36 years, and had adult children who were thriving and a large circle of friends.
“Stewart occasionally had stress and anxiety associated with being a high-powered attorney, but he had great coping skills, and he would seek counseling and move on,” said Ms. Dolin, who has started an organization called Missd to raise awareness about the warning signs of akathisia.
“The only thing different this time was that he had started Paxil.”
Some of you may have watched the Victoria Derbyshire programme on Wednesday this week (19th October 2016) from 9.00 am onwards. She presented a report by a researcher into the effects of anti-depressants. Claire, who first took the SSRI Seroxat whilst studying for her degree and caring for her unwell mother, immediately felt terribly ill on the drug, and was later hospitalised, having seizure after seizure. We also saw ‘Darren’ (not his real name) unable to stop the muscle involuntary judders, in extreme akathesia.
I write this here because after taking RoAccutane/isotretinoin to hopefully clear his acne (it didn’t, by the way, diet and Blue light treatment and laser therapy eventually did), but I digress. After the low mood which so many people experience on taking RoAccutane, (as well as many other horrendous side effects which are listed on our Olly’s Friendship Foundation site under ‘RoAccutane’), he was given Seroxat, an SSRI, to lift away his dark thoughts. This drug had the same effect on him as it did on Claire, and thousands of others. He was overwhelmed with suicidal thoughts. He was never his old cheery anxiety-free self again, although for 11 years he made a brave attempt to cover this up and put on a good show for his friends. He was given other courses of RoAccutane and other SSRIs and antipsychotics intermittently over that time.
On Victoria’s excellent piece, many sufferers had sent in their stories. Katinka Newman spoke movingly about what had happened to her, and how she nearly died like Olly but was just lucky in that she was suddenly taken off all her meds because she was moved to a different hospital. Dr David Healy, Professor of Psychiatry at Bangor University explained how seriously under-estimated the problem is for people taking these SSRIs when they react badly to them. Half the people who have them prescribed stop taking them early on because they feel so ill. Others are not so lucky. Like Olly and others on the programme, they appear to be suddenly psychotic. They are not. It is the drug. But then they are treated as though they are mentally ill and MORE drugs are fed into them. They get worse and worse. You couldn’t make it up, could you? It is simply so terrible, and even some family members don’t understand, and ostracise you.
Now, GSK who make Seroxat, know perfectly well what terrible effects their drug can have on many many people. Google ‘Study 329’ for insight into the mammoth cover up about this. Back in 2003 this issue was raised in Parliament. A bit of tweaking went on. The MHRA were asked to look at things. And guess what, folks, here we are 13 years later and sufferers have again gone to Parliament with their concerns. It’s actually rather like all the times over a period of 30 years that concerns have been raised in high places about RoAccutane/isotretinoin and Roche who sold it. But little has changed. Lots of people like Olly are dying, because they trusted medical opinion. And we have to assume that medical opinion is conveniently based on what the drug companies have convinced them of.
Olly died, believing he was a loser, to blame for the terrible tricks his mind was playing on him. The Home Treatment psychiatrist actually told him that too. But he wasn’t. His many friends knew that. So did we. It was the drugs, right from the start. But poor Olly believed the power figures, the doctors. He fell into the Stockholm syndrome, totally.
A GP on the show, Dr Sarah Jarvis, gave a very plausible account of how useful anti-depressants are in saving life. She played down the stories of terrible anxiety, akathisia and suicide by implying that of course these sufferers ‘may have had complex issues’, in other words, be comforted dear viewers, these things are very rare so surely unlikely to afflict most of us because those reporting them could be unreliable, to put it kindly. But Professor Healy says no, it is more like 1 in 4 who take them become very very anxious and far far worse than how they started.
Trying to see Dr Jarvis’ dilemma, just think about it. You are feeling very down, for some reason, life is getting on top of you, so you go to the doc for some relief of anxiety or sleeplessness. They have got 7-10 minutes in which to help, make a difference. They will listen kindly (we hope) but all they have to immediately offer is medication. Once on the pills, if you react like Olly, you are now manifesting madness. So you need more meds to calm you down or lift you up or whatever. The meds however, seriously mess with your brain. In some cases, that brain never mends itself properly. So SSRIs need to be evaluated VERY carefully by all those who consider taking them. Weigh up the risks against the benefits. It is, as with RoAccutane/ isotretinoin, like Russian roulette.
I cannot bear to think that Olly died blaming himself and carrying the can for the appalling ineptitude of doctors, duped by the subterfuge of the drug companies. His wish was that we should help others like him. In a few days’ time, it will be 25th October, the day 4 years ago when so many of his friends and family came together in Worcester Cathedral to say goodbye to him in this life. We, his parents, who loved him so much, and fought to the very end to save him and to get those in charge to listen, we feel we MUST do something, and fast.
We have to get together in little supportive groups and care for each other, talk through worries, offer ideas on how to live happier lives. GPs and psychiatrists can’t offer the time that we can all give each other. They can mostly only offer ‘quick fixes’. Amazingly the NHS spends £780,000 PER DAY on these medications! Just think what that money could do if used for one-to-one psychological support, and on lovely centres where people could go, rest, be creative, appreciate nature, and stop the world for a while. And above all, be listened to with empathy.
Please watch the Victoria Derbyshire programme. Please look out for yourselves and your loved ones. Please realise that we can heal our lives if they feel broken, by reaching out to each other and caring. Please analyse carefully all you are told about risks and side effects before you ever swallow any drug. Olly took Seroxat in 2002/3, at the very time concerns were being raised with Government. Plenty of agencies knew the dangers. But no one dared join up the dots for him. And it was swept under the carpet ever after. So much easier to tell him he had ‘brought it on himself’. So much easier to discount withdrawal symptoms as lack of co-operation. Surely this is dastardly behaviour of the very worst kind, inflicting torture on already vulnerable desperate people.
We must change this.
Posted Aug 16, 2017 at 11:34 AMUpdated Aug 17, 2017 at 9:51 AM
He was charged with operating under the influence after a crash in Brockton – but it wasn’t related to alcohol consumption, police said.
BROCKTON – A Middleboro man was charged with operating under the influence after a crash in Brockton – but it wasn’t because of alcohol consumption, police said.
Jacob R. McMahon, 25, of Middleboro, was charged with negligent operation of a motor vehicle, disobeying motor vehicle rules and regulations, and operating under the influence of drugs, after he crashed into a parked car in Brockton on Sunday night, according to Brockton police.
At first, McMahon tried to drive away, but heavy damage to his Volkswagen Jetta stopped him from doing so, following the collision at 282 Green St. at 11:22 p.m., Brockton police said.
“He attempted to flee the scene,” said Brockton police Lt. William Hallisey, referring to a police report from the incident. “The Jetta was too badly damaged for him to flee.”
“Police did not detect an odor of alcohol, but he was unsteady on his feet,” Hallisey said. “His eyelids appeared heavy. It looked like he was about to go to sleep. He had trouble keeping his eyes open and maintaining balance. … He said he took one (Paxil pill).”
McMahon hurt his head during the crash, police said.
“He said he struck his head on the windshield,” Hallisey said.
McMahon was not arrested and was instead issued a summons, and he was transported to Good Samaritan Medical Center for treatment and testing.
Hallisey said that McMahon was expected to be tested for drug use as part of the ongoing investigation.
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 beenechoed 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.
So BBC panorama are airing a Panorama investigation tonight into anti-depressant induced violence, and of course, even before the documentary has aired, we have all the pro-SSRI mouthpieces (most notably from the Royal college of Psychiatry UK) coming out en masse to condemn it before it has even been broadcast.
This is no surprise considering the Royal college of psychiatry and most of its members (not just UK psychiatrists but global psychiatrists) have long been in the pocket of the pharmaceutical industry. Of course, most of the mainstream media outlets, fail to mention that very significant fact.
However, despite the melodrama, it was interesting to note the position of Mind (the UK’s biggest and most respected mental health charity) who said:
….”Stephen Buckley, head of information at Mind, said: “Millions of people take SSRIs and other antidepressants and many find them useful in managing their mental health problems. “Side effects from medication can be serious but it’s important to recognise that severe side effects such as those explored in this programme are incredibly rare. “Anyone prescribed medication for a mental health problem should be fully informed about the drug and its side effects so they can make an informed choice about whether it’s the right treatment for them.”…
Stephen Buckley, from Mind, is wise to err on the side of caution, and that is part of what his job entails, however isn’t it interesting that he does not disagree with the findings of the documentary? He says that “severe side effects such as those explored in this programme are incredibly rare“. I agree with him, somewhat, antidepressant induced violent acts are relatively rare, however, anti-depressant induced violent thoughts are perhaps more common than most people realize.
Many people have antidepressant induced violent thoughts and impulses, it’s just Russian Roulette that decides who will act on them, and who won’t..
Seroxat (GSK’s notorious SSRI) causes aggression, akathisia (a feeling of unbearable anxiety), and violent thoughts/dreams/impulses; the whole class of SSRI drugs can cause these reactions. Many tens of thousands of people have been saying this about them for decades. I have experienced these side effects myself, from Seroxat.
There is no disputing this.
Of course, the (owned by the Pharmaceutical industry) Royal College of Psychiatry, and the other organizations with vested interests, will dismiss my experiences, and those of others who were harmed by SSRI’s, as merely anecdotal, but in the same breath they will quote (anecdotally) that that ‘these medicines save lives’. They will then quote the vague and mysterious ‘evidence based medicine’ to back up their stance, but what they won’t tell you is that the ‘evidence base’ is entirely unreliable, and in most cases -utterly corrupted, and in the worse cases- outright lies. They won’t tell you that the pharmaceutical industry is among the most corrupt industries on the planet (see Whisleblower Greg Thorpe’s GSK felony complaint here), and that death from psychiatric drugs in particular is a staggeringly high outcome for many.
A PRESCRIPTION For Murder? is a BBC documentary focusing on the potential effects of prescription antidepressants.
But what is it about? And when can you watch it? Here’s what we know…
What is A Prescription For Murder?
This new Panorama documentary looks into whether prescription antidepressants can turn you into a killer.
Over 40 million prescriptions for SSRI antidepressants were handed out by doctors last year in the UK.
Panorama reveals the devastating side effects on a tiny minority that can lead to psychosis, violence, possibly even murder.
With exclusive access to psychiatric reports, court footage and drug company data, reporter Shelley Jofre investigates the mass killings at the 2012 midnight premiere of a Batman movie in Aurora, Colorado. Twenty-four-year-old PhD student James Holmes, who had no record of violence or gun ownership, murdered 12 and injured 70.
Did the SSRI antidepressant he had been prescribed play a part in the killings?
Panorama has uncovered other cases of murder and extreme violence which could be linked to psychosis developed after the taking of SSRIs – including a father who strangled his 11-year-old son.
Panorama asks if enough is known about this rare side effect, and if doctors are unwittingly prescribing what could be a prescription for murder.
When is A Prescription for Murder? on?
You can catch the show at 9pm on Wednesday July 26, 2017.
If you miss it, you can catch it again on the BBC iPlayer.
Who is Shelley Jofre?
Shelley is a journalist who was born in Irvine, Ayrshire.
She began her career back in 1995 and is now one of the top investigators for Panorama.
Shelley is married and has a daughter.
Who is James Homes and what was the Aurora massacre?
James Eagan Holmes was born December 13, 1987 and is an American convicted mass murder.
He was responsible for the Aurora cinema shooting that killed 12 people and injured 70 others at a Century movie theatre in Aurora, Colorado, on July 20, 2012.
He walked into a midnight screening of Batman movie The Dark Knight Rises and threw two gas canisters into the audience.
Many in the audience thought it was a publicity stunt until he began spraying the crown with the shotgun, then the assault rifle and finally the pistol.
A witness said he went outside and and shot people as they ran.
Cops apprehended Holmes in his car behind the cinema within minutes of the shooting. He told them that he was “The Joker”.
On August 7 2015 Holmes was sentenced to life in prison without parole, avoiding the death penalty because the jury could not come to a unanimous decision.
James Holmes, a young man with no record of violence, murdered 12 people watching Batman in a Colorado cinema in 2012.
Did an SSRI antidepressant, prescribed by a doctor, play a part in the killings?
He slumps wild-eyed across the desk from detectives, with a mess of badly dyed red hair, his clothes hanging off him.
James Holmes looks every inch the monster who coldly executed 12 innocent people and injured dozens more at a midnight screening of the Batman film, The Dark Knight Rises.
Holmes had carried out the killings with an arsenal of weaponry he had accumulated in the preceding weeks. He had planned the shootings down to the tiniest detail, even booby-trapping his own apartment with home-made bombs to divert police resources while he launched the attack.
Watching a recording of his interview at the police station, conducted just hours after he carried out one of the worst mass shootings in recent US history, who could feel anything but loathing for this callous 24-year-old graduate student? When asked how to spell his surname, Holmes cockily replies, “Like Sherlock”.
When left alone with paper bags on his hands to secure forensic evidence, he’s caught on camera using them to talk to one another, like sock puppets.
The only hint he may have some inkling of what he’s just done is when he asks a detective, “There wasn’t any children hurt?” In fact, six-year-old Veronica Moser-Sullivan was the youngest of Holmes’s victims that night in July 2012 – killed as she watched the movie premiere with her mother at the packed cinema in Aurora, Colorado.
Americans have become wearily accustomed to mass shootings. Usually, in the days and weeks that follow, some kind of warped explanation emerges – be it terrorism, revenge or a predisposition to violence. It’s highly unusual for the perpetrator to be taken alive. Usually they are killed or kill themselves at the scene.
Holmes survived, and as the evidence stacked up it looked like another tragic collision of mental breakdown with America’s lax gun laws.
Holmes’s Glock 22 Pistol photographed on the bonnet of his car
Why else would a clever, shy guy with no history of violence, from a loving home, carry out such a heinous attack? Holmes had no enemies, no terrorist ideology to drive him on.
But the student had been seeing a psychiatrist at the University of Colorado Denver and this was no barrier to him buying a handgun, tear gas, full body armour and a semi-automatic rifle.
.223 M&P Assault Rifle photographed outside the cinema
Before he faced a court of law, Holmes was evaluated by a number of psychiatrists. No two doctors reached exactly the same conclusion. There were diagnoses of schizophrenia, schizoid personality disorder, schizotypal disorder – or no diagnosable disorder at all. Some thought Holmes couldn’t legally be held responsible for his crime, on grounds of insanity. Others disagreed, arguing he still knew right from wrong when he carried out the shootings.
When these questions came before a jury two years ago, the verdict was unanimous. Holmes was found guilty on all counts of murder and multiple counts of attempted murder.
Judge Carlos Samour Jr said:
He was led from the dock to jeers of “loser”, as his bewildered parents Bob and Arlene looked on, to begin one of the longest prison terms in US history – 12 life sentences plus 3,318 years in prison. He only narrowly escaped the death penalty.
Holmes is being held in solitary confinement at a maximum security prison in an undisclosed state, because the nature of his crimes make him a target for other prisoners. That’s how he will spend the rest of his days.
Like any other casual observer skimming over the court reporting online, I thought justice had been done, and that this was where Holmes’s story ended. Then I spoke to psycho-pharmacologist and long-time campaigner on the potential dangerous side effects of antidepressants, Prof David Healy.
Healy had been hired as an expert witness in the James Holmes case and had visited him in jail before the trial. The public defender appointed to represent Holmes wanted Healy to evaluate whether the antidepressant sertraline (also known as Lustral in the UK and Zoloft in the US), which Holmes had been prescribed, could have played a role in the mass murder.
Prof David Healy
I have worked with David Healy in the past on a number of investigative films for the BBC’s current affairs programme, Panorama.
These films revealed cases where people with no previous history of suicidal thoughts or violence went on to seriously harm themselves or others after being thrown into a state of mental turmoil by the newer generation of SSRI antidepressants, such as paroxetine and fluoxetine.
Before meeting Holmes, Healy doubted the pills had played a part. But by the end of his prison visit he had reached a controversial conclusion.
He was never called to give evidence at the trial of James Holmes, but he told me in August 2016 that he would have told the court:
SSRIs are thought to work by boosting serotonin levels to the brain.
Stephen Buckley, from mental health charity Mind, says:
He adds that no-one should stop taking medication suddenly, without advice from a health professional.
“If anyone is concerned that they may be experiencing harmful side effects they should speak to their doctor or pharmacist about alternatives.”
Prof Wendy Burn, president of the Royal College of Psychiatrists, says: “In all treatments – from cancer to heart disease – medicines which do good can also do harm. This applies in psychiatry. Current evidence from large-scale studies continues to show that for antidepressants the benefits outweigh the risks.”
David Healy maintains that while antidepressants can be a lifesaver for some, for others they can cause more harm than the original problems they were prescribed to treat.
But what makes a young man plan over months a mass shooting, then carry it out with cold precision? Could antidepressants possibly do that?
‘He was too good’
Arlene and Bob Holmes sat through every day of their son’s trial but rejected all approaches to talk in public about their son out of respect for the victims and their families.
However, a book that Arlene wrote, When the Focus Shifts: The Prayer Book of Arlene Holmes 2013-2014, gives an insight into her thoughts in the run-up to the trial in April 2015.
Arlene and Bob Holmes arrive at the court building
In one section, she describes the effects of taking the lowest dose of an SSRI antidepressant in March 2014:
She continues: “I sit through church service and sift through the Bible, uninspired. I’m fuzzy. Weird dreams. Crying used to be a release. Now I cannot cry, or laugh. I hate this feeling.”
Arlene Holmes, a nurse, wrote that she stopped taking the pills before the trial, telling her doctor she wanted to be able to feel things and to cry if she wanted to.
If she had a bad experience with an SSRI antidepressant, what would she make of David Healy’s view of her son’s case?
I contacted the couple’s lawyer explaining my own background in investigating antidepressants and suggesting that Arlene and Bob Holmes might hold information that could, ultimately, help prevent future tragedies.
A few weeks later an email from Arlene dropped into my inbox. Short and to the point, it requested more information and asked me not to share her contact details with anyone.
“Some people bear my family ill will,” she wrote.
When we finally spoke on the phone, it became clear Arlene and Bob had never seriously considered the effect antidepressants might have had on their son’s behaviour. In fact, they hadn’t even known of David Healy’s involvement as a pre-trial expert witness.
Persuaded that exploring their son’s case in depth may ultimately help others, they reluctantly agreed to a filmed interview. It wouldn’t help their son – they know he will spend the rest of his life in prison.
Approaching their low-rise detached home in a neat suburb of San Diego, what struck me was the sheer ordinariness – a man out washing his car, another mowing his lawn, kids playing baseball in the park. Inside, the Holmes’ house is modest, understated – just like Arlene and Bob.
“We are an introverted family,” says Arlene. “We are not showy but we like having people around. We care about the larger picture in society and we are Christians, we go to church.”
The couple have struggled to understand how their boy could cause so much hurt and pain to others.
“Not in your wildest dreams would you think your son would shoot strangers,” says Arlene. “For someone who loved kids and dogs and always did his homework and his chores. You can’t believe it is possible for anyone to cause that much harm, let alone the man you raised.”
She says they never saw any signs of violence, and that her son had not shown any interest in drink or drugs.
“In retrospect, I think he was too good. Maybe I should have worried about the fact he was so good, but as a mother you can worry about just about anything.”
Bob Holmes, a retired statistician, is a man of few words.
“He was never interested in guns or really even a violent kid, that’s why it was surprising. It came out of nowhere. He seemed happy enough, just pretty much a normal everyday kid growing up, so…” Bob’s voice trails off as though he can’t bear to finish the thought.
They say there had been ups and downs along the way but little to mark them out from any other family.
They moved home when James was 13 and he found the transition hard. He was quiet but he had friends and took part in sports. He cruised through his academic work at school and, later, as an undergraduate.
Bob and Arlene speak about taking James to a counsellor:
The first real hump in the road was when Holmes applied to six top universities to study for a doctorate in neuroscience. Academically bright, his shyness in interviews appeared to work against him. He was rejected by all of them.
“He came home and he just kind of didn’t do much of anything for a while, and he just kind of hung out,” says Bob.
Arlene says her son was sleeping a lot and not going out much.
“So I got mad and I said, ‘You are done with college, you need to do something.’”
Holmes took his mother’s advice and found a job working night shifts in a pill factory while he applied to more universities.
In 2011, he accepted an offer to study neuroscience at University of Colorado Denver and started in the autumn. Not his first choice, says his mother, but it all seemed to be working out fine.
“He still was happy to be at Colorado, talked to us about eventually settling and he eventually borrowed money to buy a town house on the outskirts of Denver,” she says.
Very few of Holmes’s former friends are willing to talk, but one – a young man who knew him well as an undergraduate – spoke to me on condition of anonymity. The Holmes he knew and liked was just as Bob and Arlene described – shy, polite, frugal and smart.
They used to play video games together – strategy games, not the violent kind, he says. There was the occasional beer, but no drugs, parties or girls.
“We were pretty nerdy,” he says.
Discovering someone he was close to could commit mass murder had been “a profound experience”. When he heard what his friend had done, he knew something must have happened to him.
“I still don’t know how to make sense of it,” he says.
Someone who spent time with Holmes in the crucial months before the shootings was Hillary Allen, a fellow graduate student on the neuroscience programme at CU Denver.
Sometimes the friendship was hard work.
“He was kind of quiet and kept to himself. He did have a kind of a quirky sense of humour,” says Allen.
“We were part of a group of scientists so I think everyone’s a bit odd. Maybe he was a little bit more odd than the rest of us, maybe more socially awkward.”
Socially awkward. It’s a phrase that comes up time and again to describe Holmes. It’s what led him to make contact with the university counselling department in the spring of 2012, just months before the shootings.
Cracks had started to appear in Holmes’s apparently effortless success. Over the Christmas break he was diagnosed with glandular fever. Tired and ill for the first couple of months of 2012, he kept going to classes, but his work was going downhill.
The shy and anxious Holmes found giving presentations in front of his classmates particularly hard.
His first proper relationship with fellow graduate student Gargi Datta had also come to an end. Datta didn’t want to speak to me, but according to Arlene Holmes the break-up hit her son hard.
“It was a cordial break-up. That’s the word he used, ‘cordial’. They both parted as friends.”
It was Datta who suggested Holmes seek help at the campus student wellness centre. On 21 March 2012, James Holmes had his first appointment there with psychiatrist Dr Lynne Fenton.
Sifting through the mountain of court testimony and evidence, this date sticks out.
Does it – as the prosecution would argue – mark the point at which Holmes first acknowledges he’s struggling mentally in the perfect storm of his relationship breakdown, academic problems and long-standing social anxiety? A storm that explains why he decided he had nothing to lose and everything to gain from killing as many people as he could?
Or was that date significant – as David Healy would say – because it was the day Lynne Fenton prescribed to James Holmes the antidepressant, sertraline?
First page of Holmes’s notebook
In his first meeting with Lynne Fenton, Holmes was hard to engage but described his anxiety around people. And during that 45-minute session worrying details emerged that he’d never talked about with his family.
Holmes said he was having thoughts of killing people three or four times a day.
Although it sounds alarming, Fenton didn’t regard him as dangerous at that point. The thoughts were abstract, there was no plan or, it seemed, any real intent. She prescribed the antidepressant sertraline to ease his anxiety and obsessive thoughts.
Holmes in custody
In later prison interviews with court-appointed forensic psychiatrist Dr William Reid, Holmes said he’d had intrusive thoughts like this since his teens. Not of actually killing people, rather of wishing them dead to escape from awkward social situations.
According to Reid, these kinds of intrusive thoughts are not uncommon.
“He wasn’t talking about a vengeful hatred,” he says. “He was talking about an aversion to mankind. Being around much of mankind was uncomfortable to him and it wasn’t very rewarding to him so he wanted to avoid it.”
With hindsight, it provides a clear motive, according to Colorado District Attorney, George Brauchler, who successfully prosecuted the case. He says Holmes had a long-standing hatred of mankind – that’s why he killed so many people.
As he puts it, Holmes was “evil”.
District Attorney, George Brauchler
Brauchler says Holmes kept his evil desires at bay until it became clear he wasn’t going to get what he wanted to be happy.
It’s a persuasive argument, and one some experts, and ultimately the jurors, had no trouble in accepting. But the timeline of what happened between Holmes’s first prescription of sertraline and the shootings wasn’t explored at trial.
When you scrutinise that timeline, it raises serious questions about the role of the widely prescribed antidepressant.
Page from Holme’s notebook
Just before he carried out the shootings, Holmes posted to Fenton a notebook he had written in. At times rambling, it gives some contemporaneous insight into his troubled mind. Both William Reid and David Healy agree it’s a valuable piece of evidence.
Holmes wrote about the initial effects of going on sertraline.
The first evidence that his thoughts of killing were turning real came in an online conversation with Gargi Datta on 25 March, four days after starting on sertraline.
At Holmes’s trial, Datta testified that at first she thought he was joking.
But as she challenged him, the details of his delusional theory spilled out.
This theory about increasing his so-called “human capital” by actually killing people was quite different to the abstract thoughts he’d had up until then about wishing people dead to get out of uncomfortable social situations.
Psychiatrists I’ve spoken to agree it was delusional, a sign of psychosis.
Datta was asked in court if he’d ever said anything delusional before this chat. She confirmed he hadn’t.
Forensic psychiatrist Dr Philip Resnick, from Ohio, was engaged as a prosecution expert. He was not called to give evidence at trial.
Dr Philip Resnick
In his first interview on the subject, he told me the “human capital” conversation with Datta was a key moment.
“I don’t think we have evidence of a plan to do it [kill] with an intention to do it before the human capital theory,” he says.
Holmes went back to see psychiatrist Lynne Fenton two days after telling Datta about human capital but he didn’t mention it to her. He did tell Fenton the medication hadn’t helped his obsessive thoughts. She doubled the dose of sertraline from 50mg to 100mg.
David Healy believes this made Holmes’s mental state worse:
He adds: “But when they are causing a problem, increasing the dose is a recipe for disaster.”
Nearly a fortnight after the dose increase on 9 April, the previously shy and awkward Holmes made a move on his classmate, Hillary Allen. His texts to her became uncharacteristically bold. One hot day he messaged her about the clothes she was wearing in class.
“Oh Hillary, Why yuh gotta distract me with those short shorts…?”
“I remember receiving that and just like kind of blushing and being like, I don’t remember what I said, but kind of trying to laugh it off and just trying not to create an awkward situation,” she says.
For David Healy, this was further evidence of the effect sertraline was having on Holmes.
At his fourth appointment with Lynne Fenton on 17 April, Holmes told her his homicidal thoughts had increased, though he still didn’t tell her about his human capital delusion. Fenton’s notes of that meeting documented a decline in his mental state.
“Psychotic level thinking… Guarded, paranoid, hostile thoughts he won’t elaborate on,” she wrote.
Whatever effect the sertraline was having, it certainly wasn’t helping. Healy firmly believes the psychotic-level thinking Fenton noted was a consequence of the medication.
At this appointment, Fenton upped the dose to 150mg. At Holmes’s trial she told the court this was the dose she had always been aiming for.
“It isn’t on her radar that this drug could be causing the kinds of problems that he’s having,” Healy says.
Fenton declined to be interviewed, but a statement from the University of Colorado Denver says patient-doctor confidentiality laws forbid her from talking about Holmes’s care without his consent, which he has not given.
By May, Holmes’s “mission”, as he later described it, got real. He began spending large amounts of money accumulating
weapons. In the notebook he wrote:
By this time, Holmes’s coursework had badly deteriorated. He gave a disastrous final presentation and then failed his exams. He was offered the chance to re-sit but on 11 June dropped out of university. Just before that, he had one last meeting with psychiatrist Lynne Fenton and her colleague.
Holmes’s final presentation
They were so concerned by his state of mind at this appointment they offered to keep treating him free of charge, but Holmes refused. Fenton had the power to detain Holmes under a mental health hold, but she told his trial she felt there were insufficient grounds.
She did contact the campus security team to ask for criminal-record and weapon-permit checks. Holmes was given the all clear. He never told Fenton about the weapons he’d bought or the plans he was making.
Fenton also called Holmes’s mother.
“She said, ‘Do you know that he is not going to continue in school?’” Arlene tells me. “I thought that was the purpose of her phone call, and I said, ‘Did he ask you to call me?’ And she said, ‘No he didn’t want me to call you and he didn’t want you to worry.’
If you haven’t listened to James Moore’s podcast series you really should.
James has notched up 29 Podcasts so far, and I think they are brilliant.
Stevie was prescribed Seroxat in 1996. Like many others, she was told by her doctor (from the propaganda of GSK at the time) that she had a chemical imbalance and that Seroxat would fix this. This was all nonsense of course, and merely just a marketing ploy to get more people on these drugs. More drugs and more patients on them- means more money for Glaxo’s coffers…
GSK are felons, proven criminals and fraudsters, do you think they tell the truth about their drugs?
Of course they don’t.
Do you think they care about people who suffer side effects?