Seroxat Secrets Asks: What Will Be The Long Term Effects Of Seroxat?… (Paxil)


https://seroxatsecrets.wordpress.com/2017/05/06/what-will-be-the-long-term-effects-of-taking-seroxat/

What will be the long term effects of taking Seroxat…?

I wrote this 10 years ago… Still no answers

seroxat secrets…

I often wonder this… what’ll happen 10 or 20 years down the line…?

When I look back on my time on Seroxat, with hindsight I can see the terrible harm it did me then. I can see how it slowly changed ME – the person I was, the person I am… it made me someone different. That is scary. It harmed me physically as well while I was taking it, but at the time none of my illnesses were connected to Seroxat by Doctors.

As for withdrawal, that hit me quite badly. My memories are not clear at all, but I kept a diary during that time and it makes for frightening reading. I don’t pour over it but sometimes I’ll have a look and be instantly transported back in time. But that’s not what I want to talk about.

I’m thinking about the future.

In 2007, I hope that…

View original post 126 more words

“Please don’t forget about me”: Antidepressants and birth defects “I was absolutely distraught”


Good coverage on this site of SSRI -Paxil/Seroxat (antidepressant) induced birth defects scandal.

This is the third of a three part series from the Canada Free Press.

See the website (here) for more..


Part III: “Please don’t forget about me”: Antidepressants and birth defects

“I was absolutely distraught”


Lyam David-Kilker was born on 24 October 2005, the second son of Michelle David and Miles Kilker of Bensalem, Pennsylvania. At birth he seemed like a normal, happy, healthy infant, but all that soon changed. His breathing was labored, and he became lethargic and lost his appetite. His parents took him to the doctors, who delivered devastating news. Lyam was born with multiple cardiac defects: a hole in his atrial septum, a hole in his ventricular septum, along with transposition of the great arteries—the same condition which afflicted Christiane and Amery’s son Daniel. Lyam required two open-heart surgeries and spent the first six months of his life in the hospital.

Shortly before conceiving, Michelle David had been prescribed Paxil for mild anxiety and occasional panic attacks, and she continued to take the drug throughout her pregnancy. After Miles Kilker heard a commercial message on television for the law firm linking Paxil to congenital heart defects, Michelle called the number and was referred to Sean Tracey, a personal injury lawyer from Houston.

Part I: “Please don’t forget about me”: Antidepressants and birth defects
Part II: A gigantic uncontrolled experiment
Part III: I was Absolutely Distraught

During the trial, the plaintiff’s lawyers cited a couple of 2001 emails to GlaxoSmithKline from a woman (not Michelle David) who had taken Paxil while pregnant. The woman’s name was redacted from all court documents. The first email from her, dated 31 May, read:

“My name is [redacted]. I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I’ve been taking Paxil, which is truly a miracle drug. I’ve been panic-free with this drug and have been able to go on with a normal life.

“I was married in October of 2000.My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.

“The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time). To say the least, I was absolutely distraught with this news.I thought this was something that I did, was because I stayed on the Paxil for selfish reasons.

“I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies. My husband and I are ready to try again to get pregnant in the next month or two. I am so nervous. I don’t want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby I want to know upfront. And I will somehow stop taking it for the time being.

 

“Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me.I just want to continue to have a normal life and have the child that I always wanted. Please contact me as soon as possible.

“Please don’t forget about me,Thank you.”

GSK responded:

“Thank you for your inquiry. We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy. Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition. Because patient care is individualized, we encourage patients to direct questions about their medical condition and treatment to their physician. We believe that because your physician knows your medical history, he or she is best suited to answer your questions.

“Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department at 1-888…”.

Continued below…



Congenital malformations associated with this drug

At that time, the prescribing information for Paxil made no mention of the number of reports of congenital malformations associated with this drug, and it was company policy not to tell doctors, patients, or pharmacists, either.

On 1 June, the mystery woman wrote again:

“This response is in regards to an e-mail that I had sent you previously. I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.

“I am in no way insinuating your product did this to my child. I love the product, and I don’t think I could have gotten through my panic attacks without the wonderful help of this miracle drug. I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.

“Please, if you do not have this information, where is this information held? Does anyone do studies like this?Please, any information you may give me would be great.Thanks again for your help.”

GSK responded to the mystery woman’s query by certified mail, asking her to sign a form authorizing the release of her medical records to GSK. The letter never reached her—it was returned as “undeliverable” by the US Postal Service. GSK apparently made no further efforts to communicate with her, although they did send a Medwatch report to the FDA, stating that “mother’s concurrent medications and medical conditions were not specified.” An internal GSK document, dated 13 June 2001, stated the link between Paxil and the cardiac defects suffered by the mystery woman’s unborn fetus was “almost certain.”

 

Continued below…



Lawyers for GSK argued that somebody must have checked the “almost certain” box by mistake. The jury didn’t buy it, and on 29 October 2009 awarded $2.5 million to Lyam Kilker.

Lyam survived, but hardly unscathed. For the rest of his life he will suffer from high blood pressure and diminished energy, and he will need repeat surgeries to replace the grafts covering the holes in his heart.

On 2 July 2012, the United States Department of Justice announced that GlaxoSmithKline had agreed to pay $3 billion to settle claims of illegal marketing of its products, including Paxil—the largest such payout in history. The same day the settlement was announced, the value of GSK shares rose 1.3%.

David Healy is a Professor of Psychiatry at Bangor University and the author of Pharmageddon, and he also testified as an exert witness at the Kilker trial. In a telephone interview he blasted SmithKline Beecham for not following up on early indications that paroxetine could cause birth defects. “They didn’t do what they ought to have done, do the kind of studies that they ought to have done.” He likened their attitude to that of tobacco company executives confronted with evidence of the harm their product could cause: “Let’s not look too closely at this.”

The mystery woman was later identified as Joanne Thomas, and she subsequently filed a wrongful death suit against GSK. On 27 November 2013, the Common Pleas Court of Philadelphia ruled against her on the grounds that the developing fetus (whom she called Ryan) had not reached the age of viability when the pregnancy was terminated. The certificate of fetal death listed Ryan’s gestational age as 21 ¬Ω weeks, whereas 3 days before the pregnancy was terminated, a cardiologist estimated Ryan’s age at 22 weeks. According to Pennsylvania law, a fetus is not considered “viable” until the age of 23 weeks.

Next: Part 4: “Patient safety is our highest concern”


Patrick D Hahn — Bio and Archives |Patrick D Hahn is an Affiliate Professor of Biology at Loyola University Maryland and a free-lance writer. His writing has also appeared in Biology-Online, Loyola Magazine,Popular Archaeology, Natural News,Canada Free Press, and the Baltimore Sun.

Yes Bob… This Shit Really Does Just Write Itself..


Unsurprising to see the revolving door swing so wide, and how blatantly, however it’s a disturbing development nonetheless..


 

http://fiddaman.blogspot.ie/2017/06/trump-nominates-king-spalding-attorney.html

 

Wednesday, June 07, 2017

Trump Nominates King & Spalding Attorney

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Who is Christopher A. Wray?

Well, he’s a litigation partner in King & Spalding’s Washington DC and Atlanta office.

And who, I hear you ask, are King & Spalding?

Well, they’re the law firm who just got spanked in Chicago. They defended GlaxoSmithKline, arguing that their antidepressant, Paxil, did not cause the suicide of Stewart Dolin.

The jury saw through the weak defence and found Glaxo liable.

Prior to joining the firm, Wray served from 2003 to 2005 as the Assistant Attorney General in charge of the U.S. Department of Justice’s (DOJ) Criminal Division, the same department who, in 2012, slammed down a $3 billion fine after GlaxoSmithKline pleaded guilty to a whole host of federal crimes.

So, what duties does one who becomes director at the FBI have to carry out?

Well, he’s basically responsible for its day-to-day operations.

The FBI has jurisdiction over violations of more than 200 categories of federal crimes.

So nice to know that one of King & Spalding’s biggest and wealthiest clients, GlaxoSmithKline, may now have someone to oversee any future criminal behaviour of theirs.

This shit just writes itself.

Nice move, Don.

Bob Fiddaman

60,000 People Had GSK’s Dangerous And Toxic Myodil Dye Injected Into Their Spines…


Just reading through an article from 2013 about an Australian woman who had GSK’s Myodil dye injected into her spine, and in the article it mentions that up to 60,000 other people had Myodil injected into them over the decades. I don’t know if this figure is a global estimate or just an Australian estimate, but either way, it’s extremely disturbing to think that 60,000 people have been crippled by GSK’s Myodil dye and that GSK couldn’t give a damn about their suffering.

Utterly shameful..


https://www.sunshinecoastdaily.com.au/news/artist-lives-with-pain/1829450/

Artist hanging on to hope after 40 years of screaming agony

Internationally renowned artist Philippa Stewart-Hall, from Palmwoods, endures crippling pain every day.
Internationally renowned artist Philippa Stewart-Hall, from Palmwoods, endures crippling pain every day.Iain Curry

PHILIPPA Stewart-Hall wakes in the middle of the night with a blood-curdling scream.

After almost 40 years, it’s something she’s grown used to.

In 1975, Mrs Stewart-Hall was admitted to hospital with a back injury and was subsequently injected with Myodil during a routine Myelogram before her operation.

Myodil was an injectable dye used by doctors for x-rays in myelography.

“They put you on this tray and balance you back and forth like a seesaw so the dye will go through your body,” Mrs Stewart-Hall said.

“They don’t take the dye out … it doesn’t take much to do the damage.”

Three months later Mrs Stewart-Hall knew something was wrong.

“I was still numb in one part of my leg,” she said.

“I was getting shocking cramps, I had to sleep standing up.

“These days it’s getting worse to the point where I will wake up screaming, thinking something is trying to attack my leg.”

Mrs Stewart-Hall has been diagnosed with peripheral neuropathy, but shows symptoms of arachnoiditis.

The constant pain felt is as if her legs are “a conduit for an electrical fault”.

A spokesman for Myodil supplier GlaxoSmithKline said although a link between Myodil and arachnoiditis was not established, they became aware of a possible association in 1971 and immediately warned of potential risk.

Myodil was not withdrawn from the market in Australia, but discontinued in 1987, when newer diagnostic radiographic techniques became available.

In 1999, a court action around Myodil was launched and Glaxo reached a settlement with claimants.

However fewer than 200 people received compensation, despite more than 60,000 people being injected with the drug.

Mrs Stewart-Hall is preparing to visit a neurosurgeon in three weeks to find out if anything can be done to slow down her condition.

“Once the nerve endings are gone, they’re gone,” she said. “I have to put up with it and get on with life.”

Fortunately Mrs Stewart-Hall still has the use of her hands and refuses to let it damage her brain.

The internationally-renowned artist has been a part of “the game” for about 30 years and revels in teaching children and adult beginners the tricks of her trade.

“I’ve got a lot of knowledge and I love to pass it on,” she said.

GSK asks for new trial over claims its anti-depressant labeling contributed to lawyer’s suicide


The manufacturer of an anti-depressant drug is trying to get out from under a $3 million jury judgment, which blamed it for a Chicago lawyer’s suicide, saying a federal judge made multiple mistakes that hamstrung the manufacturer’s defense against the claim its labels failed to warn the drug and its generic equivalent can lead to suicide.

On May 25 in U.S. District Court for Northern Illinois, the United Kingdom-based drug maker GlaxoSmithKline filed a motion for a new trial. The company’s American operations are centered in Philadelphia. GSK developed the anti-depressant Paxil.

Stewart Dolin, of Glencoe, a 57-year-old corporate lawyer with the Chicago firm of Reed Smith LLP, took paroxetine, a generic version of Paxil, for several days in July 2010, before killing himself by stepping into the path of a Chicago Transit Authority train in the Loop. In 2012, Dolin’s widow, Wendy Dolin, sued GSK, alleging the drug company was liable for her husband’s death.

Wendy Dolin argued the drug’s label did not adequately warn the drug could increase suicidal thoughts and behavior. GSK countered it did not make the actual drug the dead man had taken. Rather, paroxetine was made by the Mylan company. GSK further maintained the label’s text had passed muster with the U.S. Food and Drug Administration.

The case went to trial in March 2017, lasting almost five weeks, with the jury deliberating three days before finding GSK to blame April 20. Jurors awarded $3 million to Dolin.

GSK has asked Judge William Hart, who presided over the trial, to overturn the verdict, because plaintiff’s evidence was insufficient to reasonably support its case. If Hart does not accede to that request, GSK then wants Hart to grant a new trial, because GSK said Hart improperly admitted and excluded evidence, and gave off-base instructions to jurors before they deliberated.

One of the numerous miscues Hart committed, in GSK’s view, was to bar GSK’s expert witnesses from testifying against plaintiff’s claim the “hallmark” of suicides caused by Paxil-paroxetine, was their violent nature.

GSK said its experts would have told jurors that Dolin’s method of self-destruction was not uncommon for Chicago in 2010, as there was a cluster of train suicides in summer 2010 set off by a high-profile rail suicide in May that year. Further, the experts would have testified that when white, middle-aged men, like Dolin, kill themselves, they often do so more violently than other demographic groups.

As another example, GSK said Hart also stumbled when he refused to let GSK’s expert witness on the nature and dynamics of large law firms, testify to the pressures the 2008 economic downturn put on firms such as Dolin’s, and in turn, on a lawyer such as Dolin himself. GSK said this testimony would have shown Dolin committed suicide, not because of paroxetine, but because of anxiety and depression from work.

Another GSK expert was barred from testifying that anti-depressants, rather than causing suicides, have significantly reduced such acts.

“The Court (Hart) did not allow for the fair presentation of evidence: it gave Plaintiff free rein to violate basic rules of trial, while precluding GSK from responding and unreasonably restricting the presentation of its case,” GSK argued.

GSK further claimed Hart also fell short in his instructions to jurors as to how they were to approach deliberations, omitting “numerous essential instructions.”

According to GSK, in the instructions, Hart “misled” the jury about the drug maker’s duty to warn users and the FDA’s role in label contents, as well as failed to explain the requirements of a “failure-to-warn” claim.

“These many errors resulted in extraordinary prejudice to GSK, jury confusion, and ultimately a verdict unsupported by the weight of the evidence. A new trial is required,” GSK declared.

GSK is defended by the following firms: King & Spalding, of Atlanta, Ga.; Dentons US LLP, of Chicago; and Phillips Lytle LLP, of Buffalo, N.Y.

Dolin is represented by the Rapoport Law Offices, of Chicago, and Baum Hedlund Aristei & Goldman P.C., of Los Angeles.

Does Paxil (Seroxat) And Suicide Go hand In Hand?


Published on Jun 1, 2017

Via America’s Lawyer: Mike Papantonio discusses the case of Stewart Dolin, a man who committed suicide after taking a generic version of the antidepressant Paxil. Then Mike Papantonio speaks with attorney, Michael Baum, about what the maker of the drug, GlaxoSmithKline, knew about the increased suicide risks associated with the drug.

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Transcript of the above video:

Papantonio: According to The National Institute of Mental Health, in 2015 an estimated 16 million Americans experienced at least one major depressive episode. That’s almost 7% of the population over the age of 18. But Big Pharma doesn’t see that number as 15 million people who are suffering, they look at it as 15 million people they can sell pills to every single month.

There are dozens of different anti-depressants on the market today, with each drug company trying to capture as many of those 15 million patients as possible. And while anti-depressants have shown great promise in treating depression, many of them now carry warnings of an increased risk of suicide. That’s what happened with Stewart Dolin, a Chicago attorney who committed suicide by jumping in front of a train after taking the generic version of the anti-depressant Paxil. Mr. Dolin had only been taking this medication for 5 days when he committed suicide.

Glaxo Smith Kline, the maker of Paxil, had known for years that its medication increased the risk of suicide in patients, and for the longest time they attempted to cover up these dangers to keep their profits flowing. Paroxetine, one of the active ingredients in Paxil, had been studied by GSK since at least 1989 when the company first developed the medication and submitted their application to the FDA. According to some of the earliest studies produced by GSK, Paxil actually showed a decrease in suicidal thoughts and actions compared to placebo groups or at least, that’s the way the company presented it.

As it turns out, GSK was actually manipulating their own data to show an increased risk of suicide and suicide attempts among placebos that didn’t exist in the way it was presented. And again, GSK did this to convince the FDA that its anti-depressant was safe. An internal email from the company from 1999 showed that the studies had been manipulated to count placebo suicide attempts that should not have been counted at all. The internal email also laid out the many ways that GSK was twisting data for their FDA approval.

In 2004, the FDA ordered GSK to include a black box warning for its drug showing an increase in risk of suicide in young users, but it didn’t specifically mention patients over the age of 24. In April of 2006, nearly 7 years after GSK’s own internal documents showed that the company knew it was misrepresenting its findings, GSK finally decided to re-analyze’ its data and found that yes, Paxil does in fact cause a statistically significant increase in suicidal thoughts and actions in adults with Major Depressive Disorder and yet the product label was still not updated to reflect this fact.

That brings us back to the case of Stewart Dolin. Had Glaxo properly warned doctors and patients, and even the FDA, about the dangers they understood 20 years ago, Mr. Dolin might still be alive today. Joining me now to talk about the dangers of Paxil, is attorney, Michael Baum, one of the lawyers who represented the widow of Stewart Dolin in court. Michael, start by telling us about the early studies from Glaxo about what they knew about the safety of Paxil. Give us a rundown, if you would.

Michael Baum: Well, the very earliest studies for their new drug application during the ’80’s led to a safety summary that they generated in 1989 that listed some suicide attempts, and suicides, that did occur during those clinical trials. They identified that some of them occurred during the clinical trials and some of them occurred before the clinical trials, actually began in a phase called the run-in phase. That was in 1989.

Papantonio: Michael, that should have been enough to put them on notice right then that something’s not right.

Michael Baum: Oh yeah.

Papantonio: You look at early signs, this was one of the early signs, wasn’t it?

Michael Baum: Yes. They had 42 suicide attempts that they’d listed and that was about a 3% rate at the time. That should have been viewed as a frequent adverse event. But they reported as if it wasn’t and said it wasn’t a significant risk. They said that people who are depressed tend to commit suicide or have suicide attempts as a problem. They conveyed the impression that it wasn’t an important risk to consider for labeling purposes.

Papantonio: The way it appears you tried this case is that you used their own documents against them. You used their own internal documents and you said this is what they had in their file cabinet while they were lying to the FDA. How did the company present this data to the FDA? Did the FDA bother to even question their findings? What’s your take on that?

Michael Baum: The FDA gave them a pass. In 1990, there was a study by Teicher and Cole that put the world on alert that there might be suicidal behavior and suicidal thoughts associated with antidepressants and the serotonin reuptake inhibitor, new type of antidepressants. The FDA asked all the manufacturers like GSK to go through their studies and compile their suicide data. GSK did that. When they did it, they did not identify that those events had occurred in the pretrial period and the run-in period as having occurred before the trials began. They treated them as if they happened during the trial. That washed out about a nine times greater rate of suicidal behavior among adults.

Papantonio: I’ve tried plenty of these cases and I’m always fascinated by what we find in documents. So many times, the jury actually gets to see the mindset of the company by way of the documents that you produce. What did you find from the documents in this case about what they knew, the dangers of Paxil, and how do you think that impacted the jury in this incredible result that you were able to get? What documents stick out in your mind as far as it showed really the culpability of this company? What’s your thought?

Michael Baum: I’d say there’s three or four that do that. The one I was just getting ready to tell you about is the suicide report they gave to the FDA that reported as if that it reduced suicidal behavior by including events that occurred during the run-in phase and counting them as if they were placebo events to balance out the 42 suicide attempts and the five suicides that occurred on Paxil.

By making that risk look lower or non-existent, they actually published papers in 1995 saying that it reduced suicidal behavior and suicidal thoughts, when it was the opposite. That’s what they gave to their marketing people. We got one of their marketing documents saying, ‘Hey, use this study that reports this data that said it will reduce suicidal behavior to give to all of your doctors.’ That’s a pretty damning document because all those numbers were false.

Papantonio: What you’re describing is just run-of-the-mill fraud. I mean, that’s what you’re describing. There’s nothing dressed up about it because it’s a pharmaceutical company and they got the numbers wrong. This is absolutely black-letter fraud. How much impact did that have on the jury when they see this is a company selling this product they know is going to kill people and they’re committing fraud in the process? What’s your take?

Michael Baum: I think that many of the jurors were very upset about it. We weren’t actually allowed to interview them afterwards. We don’t know exactly what their take was. I can tell you from reading their body language, and the way they reacted to the documents, and the way that GSK’s lawyers tried to minimize them, they weren’t buying it. They bought what the document said. There were the GSK’s own documents.

The one document you referred to earlier in 1999, where internally one of the guys says, ‘Hey, we’ve been counting these pre-baseline, pretrial events as if they were post-trial events. We actually published an article about that. Well, that’s not actually true because we have an elevated rate of suicidal behavior. We need to fix that.’ They didn’t fix it. That’s a pretty document for them.

Papantonio: Michael, tell us about the case you handled for Wendy Dolin, the widow of Stewart. We’ve got about a minute and a half. Just give me a thumbnail sketch about that case, would you?

Michael Baum: This is a guy who had a great life. A really good guy, well-loved by all his friends, his wife, his kids, was making about a million dollars a year, was well-respected in his field, was well-respected within his law firm. Had everything going for him, but he was in the mergers and acquisitions and security side of Reed Smith, which is, you know, a very high-profile law firm.

During the financial collapse in 2008, 2009, it wasn’t good for mergers and acquisitions. They were going through a rough time. He personally pulled through it, but was having some anxiety during the time, was a little depressed about how things were going, but he was having his best year ever. His doctor thought, ‘Oh, you know, let’s give you some Paxil to get you through this.’ He put him on Paxil. A week later he jumped in front of a train. This is a guy that had everything going for him.

Papantonio: The jury came back and they looked at this entire story and concluded what? What was the award in this case?

Michael Baum: The jury found that Paxil, the defective Paxil label caused Stewart Dolin’s death and awarded the family $3 million for the wrongful death. The things that are to takeaway that are important from that is it was generic Paxil and they found that the brand manufacturer, GSK, was liable for having not made the changes to the label about the adult suicidality that they knew about.

Papantonio: Okay. Michael, great job. You’re a fine lawyer. One of the best on the West Coast. I’ve got to commend you. This is a tough case. I followed it. I know how tough it was. Thanks for being out there.

Would The British Labour Party Investigate Seroxat, And The MHRA, If It Got Into Government?


Interesting stuff from the British Labour party manifesto 2017 (see the Spectator for more here).

“…Labour will address historic public-health injustices. We will hold a public enquiry into contaminated blood. We will also hold a public inquiry into medicines, including Valproate, medical devices and medical products licensing and regulation…..”


Valproate has long been causing problems for patients, however Seroxat/Paroxetine has too, therefore I wonder would Labour be willing to investigate GSK and Seroxat?

Furthermore, would they be interested in investigating the MHRA too?

They might not get into power, so they might not get to investigate anything at all, but it’s nice to see a political party recognizing that there are many problems with the licensing of pharma drugs, the drugs themselves, and the regulators.

Seroxat is a historic health injustice. It’s one that is on-going, and it’s high time that it’s put on the current political agenda..

Father Forgives His Dead Daughter’s Boyfriend For Her Paroxetine (Seroxat/Paxil) Induced Murder ..


Quite an amazing story about a truly tragic ‘paroxetine induced murder’ that occurred in the Netherlands. I look forward to the book.

The capacity of the human heart to delve deep into the depths of compassion never ceases to inspire.

From the Guardian:

https://www.theguardian.com/lifeandstyle/2017/may/26/experience-i-made-peace-with-my-daughters-killer

Experience: I made peace with my daughter’s killer

This is not about forgiveness. What happened cannot be changed; this is our way of dealing with it

Eddy Hekman
Eddy Hekman: ‘At 5am, two police officers came to the house and we learned what had happened.’ Photograph: Judith Jockel for the Guardian

My daughter Renske met her boyfriend Samarie on the train. She was heading from the Netherlands to Switzerland; he was an asylum seeker from Benin. They got chatting and exchanged phone numbers. That was how it started. They had a good relationship. He was attentive and they were very respectful towards each other. They spent holidays with me and my wife Lieuwkje.

Just before midnight on 13 April 2011, I saw on the news that a girl had been killed in Baflo, where Renske lived. About an hour later, they showed a picture of the scene, and I recognised her flat. I called the police and said, “I think my daughter is the victim of the incident in Baflo.” At 5am, two officers came to the house and we learned what had happened.

Samarie had picked up a fire extinguisher in the hall and beaten Renske to death. When an officer tried to arrest him, he grabbed his pistol and shot him dead. Samarie was then shot by police five times and taken to hospital. I couldn’t believe it; in the two years that we’d known Samarie, I had never seen him lose his temper. It was so far removed from the man we knew that we couldn’t make sense of it. It was immediately clear to my wife and I that he needed help, and we wanted to try to be there for him; to understand what had happened.

Initially, I thought it was connected to Samarie’s asylum claim. The day before the killing, his final appeal had been rejected and he was told he was being deported. Five weeks later I went to his flat and found a strip of pills. I knew Samarie was taking antidepressants, but I didn’t know what sort. The label said paroxetine, which is a selective serotonin reuptake inhibitor (SSRI), and as a psychologist I knew there are risks associated with it. From talking to Samarie’s psychiatrist, I discovered that he was reducing his dose. I read that in a small number of cases there have been severe side-effects to SSRIs, including outbursts of extreme violence, usually when the dose is being changed.

After a month or two, we contacted his lawyer, but we couldn’t see Samarie because he was still in the prison hospital. We wrote him a letter and he replied saying how sorry he was. In September we visited him for the first time. We wanted to see for ourselves that he was genuinely remorseful. Samarie came into the room in tears, and he and my wife Lieuwkje hugged each other. I shook his hand. We didn’t talk a lot. He was still limping from his injuries.

From then on, we visited once a month. At first, we talked about what had happened with Renske. He said he’d been in a state of anxiety all day and had tried to get help. They had an argument and she tried to stop him walking out; that was when he hit her. When I asked if he had an explanation, he said: “No, you know how much I love her.” The visits allowed us to bear the grief together; it was our way of coping.

The idea of writing a book together came to me in 2014 after Samarie’s trial. He was sentenced to 28 years in prison for double murder. I thought, the circumstances of my daughter’s death are so extraordinary that I need to find a way to put it in words. Renske was a caring, modest young woman. She and Samarie had dreamed of living together one day. As well as losing her, we had lost them as a couple.

Samarie’s sentence was reduced on appeal to five and a half years. Instead of premeditated murder, he was found to have diminished responsibility for the killing of Renske and partial responsibility for the death of the police officer; the appeal court ruled that he had been in a psychotic state. He has now completed his sentence, and been transferred to psychiatric care.

We continue to visit and support Samarie. It’s not about whether we forgive him. What happened can never be erased, for him or for us. I can understand people thinking it’s unbelievable that we can even look each other in the eye, but this is our way of dealing with it. I’ve never thought it was the wrong decision.

As told to Gordon Darroch. Do you have an experience to share? Email experience@theguardian.com

 

 

 

 

 

 

GlaxoSmithKline Ventolin recall hits 1.1M units as drugmaker retrieves half-million more


http://www.fiercepharma.com/manufacturing/gsk-ventolin-recall-hits-1-1m-units-as-drugmaker-retrieves-half-million-more

GlaxoSmithKline has added three more lots of its Ventolin inhalers to its recent recall, bringing the total to more than 1.1 million units.

According to a recent FDA Enforcement Report, the drugmaker this month voluntarily recalled the three lots, amounting to 562,883 of the inhalers used by patients with asthma or COPD to prevent bronchospasms. The class II recall again is because the company discovered an elevated number of units that were out of spec for leak rate.

The company in March had recalled three lots amounting to 593,088 inhalers. This brings the total to 1,155,971 units, which a GSK spokesperson pointed out amounts to about 4%  of total US annual Ventolin volume. The inhalers were made at GSK’s plant in Zebulon, North Carolina.

GSK in late 2015 recalled nearly 130,000 Ventolin inhalers over a similar issue.

In an email Thursday, the GSK spokesperson said the extended voluntary recall “is due to product complaints relating to overly inflated overwraps or pouches”. He said that could could indicate leaking, which may result in the inhaler delivering fewer doses than anticipated on the dose counter. The company again pointed out the recall is not to the consumer level, meaning patients can keep any Ventolin inhalers they have on hand. The voluntary recall is to the retail and wholesaler level, so products are being removed from those channels.

“GSK is committed to supplying high quality product and patient satisfaction, and we sincerely regret any inconvenience this extended voluntary recall may cause,” he said.

Ventolin continues to be a strong-selling product for GSK, which is adding capacity to its production line for the product. While GSK’s top-selling respiratory drug Advair turned in fading sales in 2016, Ventolin had a 23% jump to about $527 million, as a competitor struggled with supplies of a competing COPD drug.

In February, the U.K.-based company informed local authorities it intended to build a $137 million, four-story facility at its site in Scotland for the production of salbutamol, the API in Ventolin.

How FDA Avoided Finding Adult Antidepressant Suicidality (Dr Peter Breggin- Mad In America)


https://www.madinamerica.com/2017/05/how-fda-avoided-finding-adult-antidepressant-suicidality/

How FDA Avoided Finding Adult Antidepressant Suicidality

Peter Breggin, MD

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Doctors often tell patients that antidepressants can only cause suicidal behavior in children and not in adults. Many publications also make the same claim. The false claim is based on the FDA-approved Black Box Warning for antidepressants that warns about an increased rate of suicidality in children, youth and young adults taking antidepressants, but not in adults over age 24. The Black Box Warning specifically summarizes, “Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24.”

The studies that the FDA relied upon for adults over age 24 were dismally flawed and untrustworthy compared to the ones used for children. According to the FDA at the 2006 hearings:

Due to the large number of subjects in the adult analysis, almost 100,000 patients, the adjudication process was left as the responsibility of the sponsors [the drug companies] and was not overseen or otherwise verified by the FDA. This is in contrast to the pediatric suicidality analysis in which the FDA was actively involved in the adjudication (p. 14).”

In addition, the FDA also announced at the 2006 hearings on antidepressant-induced adult suicidality that it did not require a uniform method of analysis by each drug company and an independent evaluator as required with the pediatric sample.

Thus, the FDA was comparing somewhat good apples (the pediatric studies) to rotten apples (the adult studies), while making them seem comparable. The child studies showed that antidepressants can cause suicidality — the adult studies (after age 24) showed nothing other than FDA collusion with the self-serving drug companies. As I have described in my books and scientific articles, drug companies routinely manipulate their data on suicide to avoid any causal connection to their drug (see for example my 2006 paper about GSK and Paxil).

In the case of Eli Lilly, here are two memos by employee Claude Bouchey (pages 2 & 3 of document) written to the hierarchy of the company in which he expresses guilt and shame about changing official investigator reports of Prozac-induced suicide attempt to misleading terms like “overdose” or “depression.”

Ironically, the FDA controlled and monitored the original pediatric studies precisely because the drug companies on their own failed to find any risk of antidepressant-induced suicidality in any age group. Why would the FDA assume these same self-serving drug companies, left on their own again, would spontaneously begin for the first time to conduct honest studies on the capacity of their products to cause adult suicidality?

Furthermore, even in the rotten-apple adult studies, despite the drug company’s manipulations, Paxil (paroxetine) turned out to be causally associated with increased suicidality in depressed adults in an internal FDA review of the data. As a result, in 2006 the FDA then forced the maker of Paxil, GlaxoSmithKline (GSK), to write a “Dear Doctor” letter to all healthcare providers confirming the Paxil/suicidality causal link in adults.

In April 2006, the FDA also made the drug company put a warning in its Full Prescribing Information (label or package insert) about the risk of Paxil causing suicidality in adults with depression; but GSK convinced them to drop it in subsequent years. The warning appeared in the Physician’s Desk Reference (PDR) only once in 2007.

Meanwhile, there are many studies showing that antidepressants do cause suicidality and suicide in adults.

Next time you hear someone say that the FDA studies only showed increased suicidality in children and young adults as opposed to adults, remember that the adult studies, unlike the pediatric studies, were not controlled, monitored or validated by the FDA. This is one more example of the extremes the FDA will go to in order to protect drug companies and their often lethal products.

It was bad enough to find out that antidepressants cause suicidality in children. The drug companies and their minions complained mightily. The FDA and the drug companies were not going to allow a repetition of sufficiently unbiased studies that might conclude that adults are also vulnerable to antidepressant-induced suicide.

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