Tagged: blog

Complelling Description Of Psych Drug (Paxil/Seroxat) Addiction ..


From the Deadmansvitamin Blog

Check it out here:

https://deadmansvitamin.com/2017/06/20/psychiatry-one-brave-man/

Psychiatry And One Brave Man

I recently came upon Michael Priebe’s blog where he tells his story of withdrawal from Paxil and Xanax.   The sheer hell he experienced while doing so and his precise accounting of the complete lack of consideration shown him by psychiatrists.  He really hits the mark on that.

His story is told in 3 parts, but I will put it up in its entirety.  Here is a link to his site if anyone wanted to get into communication with him.
https://www.michaelpriebewriter.com

The bed was soaked yet again, the sheets saturated with a pungent, urgent sweat caused by nightmares and the prescription toxins that were trying to leave my body. Once again the few restless moments of sleep I was able to “enjoy” were interrupted by the nightly ritual of my wife turning on the lights and stripping the bed so that we could lie on a surface that didn’t feel as if Patrick Ewing had just used it as his postgame massage table.

It was still dark outside—predawn hours—but I had to be up for work shortly. I lived just outside of Milwaukee in Waukesha, WI, but I commuted to my post at Madison (technical) College each day, a trip that took an hour and fifteen minutes one way in good traffic that didn’t include getting stalled by the notoriously long freight trains that passed through Waukesha.

I worked in the Testing Center at Madison College, a position that had me dealing not only with large numbers of students most days but also with the daily ups and downs of office interaction with coworkers.

I couldn’t believe I was still functioning at my job. How did people not know about my illness? When would they find out? How would they find out? How long until I had some sort of public breakdown that ended the whole charade?

Or maybe everyone already knew and was too polite to say anything. I mean, how could they miss the rapid weight loss and the sudden and persistent appearance of midnight-black bags under my eyes? I was sure I looked like a zombie, but maybe it was all in my head. I was getting trapped in my head a lot lately.

As my wife tidied up the bed and quietly cursed my relentless night sweats, I worried about the upcoming workday. How would I make the drive in my sleepless condition? How would I survive the office in my anxious condition? Even the tiniest hint of workplace stress might send my compromised system into a panic that exposed my “secret” illness. I wasn’t well-rested or well-nourished enough to survive the ups and downs that define a normal day for most people. I could barely eat or sleep and I hadn’t been able to do either of those things sufficiently for months, ever since making the decision to stop taking the Paxil that had been prescribed to me for anxiety attacks suffered as a 21-year-old college student.

I was now in my mid-thirties, and I was starting to suspect that prescription medicines were causing me anxiety and a host of other problems rather than fixing much of anything. It took me a long time to come to that suspicion, but as they say, Better late than never.

Paxil—one of the biggest rock stars among the SSRI super pills that flooded our society around the millennium—had been causing certain health issues for me, not just physical ones but emotional ones as well. I had little energy or tolerance for exercise, I dealt with stress by drinking and eating too much, I gained weight, I had elevated blood pressure, I had elevated liver enzyme levels, and I just kind of “floated” through many aspects of life, unable to fully engage with existence the way other people did.

As I found myself within striking distance of turning 40, I desperately wanted the sort of healthy, “normal” life that I suspected other people had, so I finally decided the Paxil had to go.

I thought that life would get better when I quit taking the Paxil—remove the problem and life gets better, I reasoned—but I was wrong. And not just a little bit wrong. Once the Paxil was removed from my life, all hell broke loose and I didn’t even see it coming.

And a short time later, when I began cutting out the Xanax that the family doctor had prescribed to go along with my Paxil, all hell broke loose again. And once again, I truly couldn’t have predicted the strange physical pains and extreme mental anguish that would pummel me and not let up for years.

You see, that’s the problem with antidepressant and benzodiazepine withdrawal—especially the drawn-out or ‘protracted” kind like I experienced: you don’t expect it because few people even acknowledge that it exists. Doctors will dismiss you, loved ones will have a hard time relating to you, and all across the world the gigantic pharmaceutical machine will continue to grind its profitable gears without so much as a hiccup. The lines at CVS and Walgreens never get shorter, and people are still willing to turn their emotions and brains over to the modern inventions of profit-driven chemistry.

If you tell someone in the medical establishment that you are sick because of a prescription medication or because you are trying to quit one, they will most likely tell you that it sounds as if you need a different prescription medication.

Withdrawal? What is that?

The clock signaled that it was almost time for me to leave for work. There would be no more sweating in bed wondering about what new withdrawal-related symptoms the day would bring, because it was time to experience it all firsthand again. I always hoped that one morning it would all be over, but like Groundhog Day, each morning seemed to bring more of the same.

I left the relative safety of my bed and made my way across the hall to the spare bedroom that housed the treadmill. The sun was about to rise, and I needed to get the anxiety out of my system somehow. This wouldn’t be the spiritually refreshing, five-mile morning jog of a healthy man on his way out to conquer the world. No, this would be the uncoordinated and breathless five-minute effort of a man who was hoping for a small hint of calm in the anxious storms that were becoming the norm in his life.

When my short session on the treadmill was finished, I showered, dressed for work, and resolved that I would try to survive another day in the strange and terrifying new reality that was my world since quitting Paxil.

I went into the bedroom and kissed my wife goodbye. Fear was visible in my eyes and pulsated from my fragile body language. I felt as if some demonic force (or even a strong wind) could send me through the earth’s crust and into hell at any moment.

“Pray for me,” I told my wife in a desperate voice, and then I went downstairs to get on with the commute.

MORE THAN A GLIMPSE OF HELL PART 2: UNFROZEN

November 15, 2016

I awoke to a heavy circle of pain pressing down over my heart. The day seemed pale and gloomy in a way that was out of line for even the most overcast of winter mornings in Wisconsin. My house was full of family—brothers, in-laws, and a new nephew—but I felt alone, and that strange feeling of isolation swirled around the day’s first moments like an ominous wind.

“Good morning,” my youngest brother said in a singsong voice as he lowered my baby nephew close to my face. Playing the role of good hosts, my wife and I had surrendered our bedroom and were sleeping on an air mattress on the floor of my office. I wanted to stay on that air mattress indefinitely. I didn’t want to be awake. A photographer was scheduled to come over later in the day for family pictures, and I couldn’t imagine how I would play the role of “normal human being” for that.

“Say hello to your Uncle Mike,” my brother said to his firstborn.

Baby Jackson: He was tiny and fresh, a physical manifestation of both life’s beauty and God’s genius. I responded to the sight of his cherubic little face by descending even further into my sludgy pit of depression.

The thick blanket of terror and despair that now suffocated me was unlike anything I could recall feeling before. As dull sunlight tried to creep through the blinds of my office windows—as my one-month-old nephew cooed and stared at his confused uncle—I somehow felt that death was upon me.

Life equals death: that was how my mind was working now.

I’d quit taking Paxil the month before, after almost a decade and a half of ingesting it for the “generalized anxiety” that had been diagnosed by a family doctor and a short self-assessment checklist. Ever since quitting, my life had gotten confusing and sinister in a way that seemed to speak of impending doom.

I was 35 years old, and I truly felt that my best days were behind me.

Looking back on those first months of Paxil withdrawal, I can now recognize that some characteristics of my emotions were bubbling to the surface after years of being suppressed in some way. After spending so much time under the depths of medication, the emotions were understandably waterlogged and confused, so their first attempts to speak came through as some inexplicable depression—the kind one experiences when looking at a precious newborn baby, of course.

During antidepressant withdrawal, a certain numbness slowly gives way to the tingles of normal emotional experience, but nothing feels normal for a long time. In fact, a few months after suffering that baby-induced episode of depression, my younger brother and his wife were visiting again when I was overcome by another confusing sensation, a pain really.

We were watching the movie Ted—that classic, raunchy comedy starring Mark Wahlberg and a stuffed bear—when I noticed something strange happening to my face. It hurt in a way I didn’t recognize.

I’d been having weird body pains ever since taking that last dose of Paxil, but this sort of facial discomfort was a new one. My cheeks ached in a sharp way, especially near the dimpled areas involved in smiling and laughing.

Then I realized, my face was hurting because I’d been smiling and laughing. It wasn’t used to being stretched by such spontaneous displays of joy anymore.

My face had been frozen in some painful mask of withdrawal-induced stoicism for months, but now it was becoming “unfrozen.”

Becoming unfrozen: that’s an apt way to describe the profound and painful thawing process that takes place as prescription medication fades from a person’s mind and body. There is so much blunted awareness that wants to come back to life, and there are so many repressed emotions that want to have a voice, but the person in withdrawal really isn’t ready for such a flood of activity. He or she really isn’t strong enough. The person who was taking medication was flying around the edges of life without truly feeling or noticing thoughts for a long time, and then BAM. The pills are gone, and the icebergs start to melt. It is overwhelming and confusing.

Tears flow for little or no reason—sobs can be sparked by the last few “teachable” minutes of a family sitcom or by the melodrama of a Lifetime movie, for example—and then there is the unprovoked depression, the twisted anxiety, and the legions of thoughts that race day and night.

Day and night the thoughts and emotions run wild and confused, and after several months of this, when all of those thoughts and emotions continue to gather en masse and dance and fornicate like some sleepless group of college students on ecstasy, a person starts to wonder if maybe he’s insane.

And that’s when beginning the prescription madness anew starts to seem like a reasonable idea. Maybe the old pills were necessary. Or maybe some new ones are needed.

I had wanted so badly to be free of the medication, but shortly after quitting Paxil, I began to wonder if maybe it wasn’t time to admit defeat. Maybe I simply had to accept that I was broken in a way that could only be fixed by the contents of little orange bottles. I thought that I’d been making progress—painful progress in small increments, but progress nonetheless—but maybe I’d just been kidding myself.

Maybe the doctors—the ones who had played no small role in creating my current lunacy—really did have the answers, and maybe those answers only existed as 21st-century pills. Despite my misgivings, maybe I needed to go see one of them again, at least to make sure that I wasn’t dying. What was the worst that could happen if I went back to the “experts” in white coats, or maybe even went back to the Paxil or something similar?

I was about to find out.

MORE THAN A GLIMPSE OF HELL (PART 3): THE DOCTORS

January 18, 2017

As the world around me enjoyed a pleasant Saturday afternoon, I sat on my bed trembling, wondering if I was dying or going insane. While other people sipped lattes at coffee shops and ran casual errands or watched movies or college football, I fought to keep a faint grip on some sense of normalcy and well-being. I was 35-years-old and I felt utterly alone, as if I were some unfortunate astronaut whose tether to the mothership had been tragically severed while he was performing exterior maintenance on the craft.

Whoosh. Away I flew into a vast, empty darkness. As I careened by the occasional burning star or foreign sun, I could still see, faintly, the people and the life that I’d left behind. However, like a ghost, I could no longer touch my loved ones or share with them a laugh or a bit of sunny enjoyment on a weekend. I could only wonder about my murky place in the universe and hurt.

Two months or so earlier, I’d quit taking the Paxil that had been prescribed to me in college for that nebulous, modern affliction known as Generalized Anxiety. Since taking my last dose of those pink pills, the world had become a ghoulish place indeed. The physical symptoms of the drug withdrawal were uncomfortable—the constant nausea, chronic insomnia, and damned fatigue were draining—but it was the mental and emotional troubles that were truly frightening.

I could no longer make sense of or enjoy a normal day because my system was a toxic stew of depression, guilt, and dread. And I was routinely getting “trapped” in my own head, sequestered in uncomfortably close quarters with a motley mix of intrusive and negative thoughts. I was alone in such a way even when surrounded by loved ones. I was constantly slipping further and further into that empty darkness, and there only seemed to be one solution: I needed to get back on the Paxil.

Despite all the hard work I’d done up to that point to quit the potent medication—and despite the physical and emotional side-effects that had compelled my decision to quit in the first place—I reluctantly ran backward, back toward the prescription bottle that I still kept in my office, ostensibly in case I needed to pursue an emergency reinstatement such as this.

I fished a little pill from the orange, plastic bottle that had become such a familiar sight over the years, and I swallowed the bitter pharmaceutical hopefully. However, almost immediately I knew there was a problem. My bedroom started spinning and shifting, and I felt a nausea so profoundly upsetting that it seemed as if I were receiving some divine punishment from above—a punishment for crawling back to the devil instead of seeking God in my hour of need.

Because my body had fought so valiantly to rid itself of paroxetine’s chemical intrusions—after my tired mind had perhaps seen some reprieve in the near future—the entirety of my being protested the medication’s sudden return. My systems began to kick and scream, yelling at me, What have you done? My world seemed to be crashing down quickly, so I did what any married man in his midthirties would do under such duress: I called my mom.

“Please, please don’t think less of me for taking the pill,” I cried into the phone. “If I really need this medication because I’m sick, then please don’t think less of me.” I’d said that I was going to stop the medication and get healthy, but now I wasn’t sure what healthy was. Was it quitting the pills or taking them? Was I now sick because I’d been duped into taking the pills, or had I really needed the pills all along because I was born sick, the woeful and unlucky recipient of a deficient serotonin or norepinephrine supply.

As my mother listened to me cry and ramble, I felt like a scared little child who just pretended to be a man at times. Maybe I would never accomplish anything in life, not even the basic goal of sorting out my own wellness.

“You know that your dad and I would never think less of you,” my mom reassured me as only a mother can. Her words made me feel a little less like a failure, but I still felt gut-wrenchingly sick from the pill I’d swallowed. I wondered when the effects of that pill would subside, and I wondered when my wife would be getting home.

Dr. Feelgood was tanned and confident. He had a nice haircut and a paunch that seemed to speak of nice restaurants. He smiled often through the adornment of his goatee, and he often tried to reassure me that we were buddies more than anything. He acted casual and cool by throwing me winks and even the thumb-and-index-finger gunshot on one occasion, and he always gave me more pills when I asked for them.

Now that I was trying to get off the pills, Dr. Feelgood didn’t seem to fully understand me anymore. Either that or he didn’t want to admit to playing any part in the gruesome scene I was now presenting to him. I was in pain, all the time, and I was looking for answers and reassurance.

“Well, any withdrawal effects from the Paxil should have been relatively minor,” Dr. Feelgood said, “and they should have been over after a week or two.”

I couldn’t believe what I was hearing. I’d been off the Paxil—with the exception of that one, ill-advised reinstatement dose—for about four months, and nothing felt close to being over. If my harrowing pains and mental fog weren’t withdrawal, then I was seriously ill with something that seemed willing and able to kill me.

“It sounds like your pains are mostly stress related,” Feelgood said. “We all channel stress in different ways. If you don’t want to take an SSRI antidepressant, then maybe you’d have some luck with Wellbutrin.”

During that first, confusing half year of withdrawal, I ended up trying Wellbutrin, a norepinephrine-dopamine reuptake inhibitor that can apparently be prescribed for just about anything. I would later learn that the medication is marketed as both an antidepressant and as a smoking cessation aid (in addition to being used in an “off-label” manner for ADD and anxiety), and at Feelgood’s suggestion I took the multitalented pharmaceutical for about a week, until I could no longer stand how it filled me with useless adrenaline and agitation.

After the Wellbutrin, I almost tried other prescriptions, too. Every so often at work—when the withdrawal had me feeling as if I were about to lose my mind or go into cardiac arrest—I’d step outside and place a frantic phone call to Feelgood’s office. “Maybe Pill X or Pill Y will help,” I’d suggest to his nurse hopefully, but I never followed through on those suggestions, because the thought of eventually having to tackle yet another pill withdrawal was more than I could stomach. In addition to quitting the Paxil, I’d begun a tapering schedule to quit the Xanax that had been prescribed alongside the Paxil so many years ago (for acute instances of panic), and it was starting to seem like more than coincidence that my body pains and mental confusion increased as my levels of medication decreased.

After a while, I wanted nothing more to do with medications. I just wanted my doctor to define my situation and offer me hope that it would get better. I just wanted to know that I wasn’t dying, really. I wanted expert guidance that would take me through the prescription drug withdrawal process, but unfortunately, Dr. Feelgood didn’t have much to offer in that department.

“You should have quit the Xanax first,” was about all Feelgood had to say when I outlined my situation for him and pressed for withdrawal-specific information. I’m still not sure of the logic behind that statement, but I think he was giving a sly nod to the pain he knew I was yet to endure if I continued to cut my Xanax dosage. I’m almost certain that he had seen my sort of situation before (how could he not have?), but he never came out and said so. Instead, he acted a little confused.

I was starting to feel hopeless. Was I somehow imagining it all? Where besides the Internet could I find information regarding the strange physical and mental symptoms that had been torturing me for months? Where could I turn for help?

Oh, how I wished that I’d never left my first doctor. Some time earlier, when that primary care physician whom I’ll call The Good Doctor had started to get squeamish with my Xanax levels and refused to increase them any further, I’d sought a replacement for him and quickly found a sympathetic goatee in Dr. Feelgood. But now I desperately wished that I’d never switched loyalties.

The Good Doctor was a man who truly cared about his patients. He had a healthy BMI, a clean-shaven face, and a compassionate demeanor. He’d truly seemed to care about me. The Good Doctor had preached about the need to attack anxiety and other illnesses with methods other than pills, and when he didn’t understand something—as was the case when he admitted to being a little green about clinical levels of anxiety—he acknowledged his ignorance and tried to make a wise referral (in my case, a referral to a therapist whom I don’t remember ever calling).

The Good Doctor had been so kind and concerned. He’d talked about total wellbeing and things like exercise and a healthy diet. Appointments with him might last upwards of 40 minutes—well, well past the 15 minutes or 20 minutes that I’m sure the clinic held as sacrosanct “best-practice” parameters—and he was not a man who relished reaching for the prescription pad, which seemed to be a last resort for him.

The Good Doctor was the opposite of Dr. Feelgood in nearly every way—you would never be able to picture him going on the lecture circuit for big pharmaceutical companies or complying with calloused appointment time limits—and after a while, I think he was forced out of the medical establishment because of his unique posture.

One day, after I’d already been seeing Dr. Feelgood for some time, I received a letter from The Good Doctor, a communication he must have sent to all current and former patients. The letter said that he was leaving the medical profession to teach middle school. The Good Doctor said that he was looking forward to helping children learn about the planets.

Because my interactions with Dr. Feelgood had been disappointing—because the medical establishment didn’t seem to recognize prescription drug withdrawal as a condition that might last for months or years—I stayed away from doctors for a while, hoping that my situation would resolve itself so that I wouldn’t feel the need to talk to people in white coats anymore. However, when every new cut to my Xanax dosage brought with it otherworldly pains that left me searching for answers, I relented and made an appointment with Dr. Dipstick, a colleague of Feelgood’s who worked at a clinic across town.

By this time my situation had become more confusing than ever. I was often depressed, perplexed, fatigued, paranoid, and anxious, and new and fantastical body pains arrived on my doorstep regularly like taunting packages that had been sent by GlaxoSmithKline or Pfizer.

When I arrived for my appointment with Dr. Dipstick, I was broken, fragile, and nervous. I was desperately looking for someone to help me, but would he be the one? I tried to remain optimistic. Maybe he would smile and tell me, “The truth is that we see this all the time. We prescribe A LOT of these medications, so we have to help a lot of people get off them, too. Don’t worry, you’re not dying (friendly chuckle), you’re just going through withdrawal. You’re going to be all right, and I’m going to help you until you are fully recovered.”

But Dr. Dipstick didn’t say any of that. Instead, he was at first indifferent and then insulting. He actually made me feel foolish and ashamed for coming to him, and he often seemed confused as to what I wanted out of the visit. I tried to explain to him how I’d been suffering since quitting Paxil and then embarking on a Xanax-reduction schedule, but my words hit a wall. Maybe he was ignorant of prescription drug withdrawal, but if he was, he could have admitted that ignorance and providing a referral to someone else like The Good Doctor would have. Instead, he began to fill the void with blame.

“Do you ever need an eye-opener?” Dipstick asked me accusingly. His full beard made him appear gruff and even menacing.

“I don’t know what that is,” I told him.

“It’s when you need a drink to get going in the morning,” he explained, certain that he wasn’t telling me anything new.

“I don’t understand,” I said.

“Well, you said on your intake form that you drink beer pretty regularly, and just going through your medical history here, I see that you’ve had some elevated ALT and AST liver function numbers in the past.”

I tried to steer the conversation back to the Xanax taper that I was in the midst of—back to the anxiety and pains that increased with each step in that reduction schedule—but he just didn’t seem interested.

“Maybe you could refer me to someone who could guide me through this?” I asked, shaking. “Maybe to someone in your psychiatry department who specializes in anxiety and the medications used to treat anxiety.”

“I don’t know of anyone like that in particular,” Dipstick said flatly. “I can give you the general triage number for psychiatry, and they’ll probably have you speak with a social worker who will assess your needs.”

“How would a social worker help me?” I asked desperately.

“Well, maybe they’d refer you to a substance abuse treatment facility.” Dipstick answered, and my stomach sunk to previously unknown depths of despair.

I was beginning to see a disturbing picture emerge. When I’d been dutifully taking the medications, I’d been a valued patient. The doctors had happily provided with information about “transition periods” and side-effects. But now that I was quitting the medications, I was nothing to them but an addict or neurotic who needed to help himself. They had no medical information for me, and they seemed to have no insight into the many symptoms that were making my life hell.

The visit to Dr. Dipstick was beyond disheartening. I could have gotten more sympathy for my situation by talking to the clerks at the corner gas station, and I could have gotten more information by staying at home and using Google, which would ultimately prove to be an invaluable resource during my ordeal.

The visit to Dipstick was bad, but the paperwork I received from his office several days later was almost worse. Under Reasons for Visit, Dr. Dipstick had written Alcohol Abuse. My mind raced, wondering why he was doing this. Was he a friend of Dr. Feelgood? Was he trying to protect his friend—the one who had seen my Xanax prescription balloon under his watch—from some sort of lawsuit? Whatever the case, the comments he’d added to my official medical record had just further muddied the waters of my situation at the clinic. Those comments would be the first thing that a new doctor would read (if I went to one), so there was now zero chance that I’d get any educated help.

A few days after my visit with Dr. Dipstick, I called his office and spoke with a nurse, relaying to her my concerns about the Reasons for Visit remarks that Dipstick had stamped onto my record. I asked her if she could please have the doctor remove those remarks, and a short while later she got back to me.

“Dr. Dipstick says that he won’t do that,” she said, not unkindly. I was both heartbroken and furious. I wanted to drive to the clinic and confront the doctor in person, but of course, withdrawal had left me too timid and weak for such a heroic effort. Instead, I wrote a letter to the clinic a few months later.

As I wrote my letter, I tried to channel my frustration and righteous anger. I told the clinic about Dr. Dipstick’s dismissive and judgmental demeanor, and I told them about how the increase in my liver enzyme numbers—the increase that Dipstick had attached, along with my withdrawal pains, to beer drinking—appeared to have been just another dangerous effect of the medications I was quitting. Those numbers had returned to normal once I’d quit Paxil and started reducing Xanax dosages, so I felt that such a fact needed to be entered into some official record. I wanted to enter every last bit of my situation into some official record so that future withdrawal cases wouldn’t be dismissed so easily.

But I never sent the letter, just in case I needed an appointment in the future.

As it turned out, I did make another appointment with the clinic, a final visit to Dr. Feelgood that would be my last doctor appointment to date. By that time I’d been off Paxil for nearly 16 months and completely free of Xanax for about four months. New physical and mental pains were still arriving every week, and although I doubted Feelgood had any new insights for me, I wanted him to run some tests to make sure that I wasn’t seriously ill with something other than withdrawal.

“I could prescribe you something for Fibromyalgia pain,” Feelgood suggested almost sheepishly, “but it doesn’t seem like you want to go the medication route anymore.”

I shook my head. “I just want to make sure I’m not dying,” I said.

“Well, we can definitely run some tests,” Feelgood said. “We will definitely try to rule things out.”

 “And I want to start cutting back on my blood pressure medications, too,” I said. “Now that I’m getting healthier, I just don’t think I need them anymore. Certainly not three of them.”

“We can start reducing those and see how it goes,” Feelgood said without much hesitation. He demeanor was friendly, and I even thought I sensed a newfound respect coming from him. I don’t know if he’d ever seen a patient of his successfully quit multiple medications or not, but now that he’d seen me do it, maybe he would have something hopeful to tell future patients who were suffering through similar scenarios. Or maybe I was just imagining increased attention and thoughtfulness on his part. Maybe I just wanted to see something positive in the situation.

Thankfully, my lab results from that last visit to Dr. Feelgood all came back normal. However, the pain of prescription drug withdrawal continued for a good while. Even the blood pressure medications that I was able to give up after getting back to a healthy lifestyle came with a ridiculous amount of withdrawal effects, things that could lead a person to believe that he was losing his mind or dying if he didn’t know better.

Pills do have consequences, even if a trusted doctor is prescribing them and even if health insurance is paying for them. Prescription drug withdrawal is real, even if a relatively small number of people are talking about it. It’s as real as any purported benefits of the medications that are so readily given out nowadays for every ailment under the sun. Think about it: if a designer mix of chemicals is introduced into a person’s system with the intent purpose of altering how the mind and body function, then why wouldn’t there be severe physical and mental repercussions when that mix of chemicals is taken away? I’m now of the opinion that patients should almost always look at prescriptions as a last resort: there are simply too many known instances of modern drugs making people’s physical, emotional, or mental health worse.

Recovery from prescription-drug withdrawal is possible: that’s important for people to know. I’ve now been free of Paxil for almost four years and off of Xanax for a little more than three. I consider myself mostly “cured” of withdrawal (time and healthy self-care habits seem to be the only remedies, by the way), but I still occasionally wonder if I might have some lingering fatigue, confusion, or other symptoms that are the result of taking or quitting the medications (although I realize that such complaints might also just be a common part of approaching 40 in a competitive and stressed-out society). And about the anxiety? I still get flustered and worried at times, but I’ve found that there are ways to fight through such emotions (or avoid them) without making a Faustian deal that involves sacrificing parts of my greater well-being.

I often wonder how different my life might have been if I’d never taken those damned pills in the first place. But such wondering is useless, as useless as the idea that doctors and their pills can keep a person healthy in the first place. True health requires nutritious eating, regular exercise, adequate downtime, meaningful relationships, spiritual enrichment, and professional fulfillment. The Good Doctor would probably tell you that, but unfortunately, he’s not practicing anymore.

Advertisements

The Fiddaman Blog…


http://fiddaman.blogspot.ie/2017/03/glaxo-dont-want-jury-to-see-paxils.html

Glaxo Don’t Want Jury To See Paxil’s “illegitimate” Suicide Figures

http://www.facebook.com/plugins/like.php?href=http://fiddaman.blogspot.ie/2017/03/glaxo-dont-want-jury-to-see-paxils.html&layout=button_count&show_faces=false&width=100&%20action=like&font=arial&colorscheme=light

Yet another objection by GlaxoSmithKline in the eagerly awaited Dolin Vs GlaxoSmithKline Paxil induced suicide trial, set to begin next Tuesday in Chicago.

GSK, it appears, are now bitchin’ about evidence submitted by Wendy Dolin, the widow of Stewart Dolin, that shows how (in a previous trial) the testimony of former FDA employee Dr. Martin Brecher showed that stopping or discontinuing Paxil led to undesirable side effects. (In re Paxil, Case No. CV-01 07937 MRP (C.D. Cal.))

GSK’s objection states…

“Permitting Plaintiff Wendy Dolin to introduce Dr. Brecher’s testimony would be highly and unfairly prejudicial because the jury would be left with the incorrect impression that FDA determined that GSK’s reporting of suicides and suicide attempts in the Paxil NDA was “scientifically illegitimate.”

During Brecher’s original deposition, taken almost 14 years ago, it was learned that Brecher, whilst employed at the FDA, told Glaxo (then SmithKline Beecham) officials that “Paxil was dangerously addictive.” (1)

Glaxo are also objecting to this evidence being submitted in the Dolin trial because, “…the prior case involved a different subject matter than this case.”

Brecher, whilst under oath was also questioned about the suicide figures relating to patients taking Paxil. Here’s part of that deposition. Keyword here is “illegitimate.”

You’ll note that GSK’s attorney’s cite the same thing when Brecher is being asked questions that forms part of their objection in the Dolin case, ergo “It has absolutely nothing to do with this litigation.”

Q (by Mr. Farber): Now, you had the NDA that was submitted in November of ’89 and you took over the job in January of ’90, correct. So you had had – this is prior to the Teicher article now in January by month at least and the NDA had been submitted two months earlier. That NDA had suicide tables and data; did it not?

A: Yes.

Q: And did you through a matter of course in your regular routine review that suicide data?

A: I believe I did.

[Objection and colloquy omitted]

Q: So the data on suicide that you had when the NDA – let’s basically — That will be Exhibit 15.
[Colloquy omitted]

Q: Take a look at that for a minute. Ready?

A: Uh-humm.

Q: Now this table Roman numeral 11.21 talks about attempted suicides and overdoses, Worldwide Data. And at the bottom it indicates the Par safety summary of 10 November of 1989. And you’ll notice up in the right-hand corner of the Worldwide Data that it has all the population that we talked about earlier that you believed I was telling you the truth and I am, the one that says 2,963 under Paroxetine, 1,151 and 554 respectively for placebo; do you see that?

A: Uh-humm.

Q: Okay. Now, here we have attempted suicides on the top line that are further broken down into drug overdose and I’ll save you the time by figuring this out and it’s to their benefit anyway, so the drug overdose category is within the top category, it’s not – it’s not in addition to, it’s a subset of attempted suicides. And my question is the asterisk of two overdoses during the placebo run-in, you see the asterisk on the side, and of the overdoses, attempted suicide, two were – occurred during the run-in period. Let me ask you this: Based on your procedures at FDA – first of all, let – let me back up a minute. Based on your procedures at the FDA, what is a run-in period?

A: Prior to randomization subjects are discontinued from their old medication and given placebo usually for about a week, sometimes shorter.

Q: And how about wash-out, same?

A: That — that period also washes out their previous medication.

Q: So the terms are effectively synonymous for the purposes of …

A: (No verbal response.)

Q: Okay, now, based on FDA procedure and I’ll even elevate that to scientific procedure that you understood scientific procedure to be when you were at the FDA, is it scientifically legitimate to count a suicidal act occurring during wash-out and run-in to the placebo count?

[GSK COUNSEL]: Object to the form of the question. It has absolutely nothing to do with this litigation.

MR. FARBER: You’re going to see a connection if you’re patient here.

A: No, because everybody got placebo.

Q: So it’s scientifically illegitimate way to count, correct?

A: Yeah.

So, it appears that the current crop of Glaxo attorneys involved in defending Paxil in a suicide trial don’t want this evidence seen by a jury, just as the old crop of Glaxo attorneys didn’t want the jury in a Paxil addiction case to see evidence of Paxil induced suicide.

Begs the question; what exactly do Glaxo want the jury to see, just their evidence? A case of having their cake and eating it, perhaps?

The Paxil addiction lawsuit was settled out of court, over 3,000 plaintiffs received a compensatory award (figure unknown)

In the UK, consumers of Paxil (known as Seroxat) have been waiting almost 10 years to find out if they can press ahead and sue GlaxoSmithKline with regard to severe adverse reactions caused by Seroxat. In a recent pre-trial judgment the UK Plaintiffs were told that the outcome of the class action in the USA has no relevance to the UK cases. Glaxo had previously objected that the UK Courts did not need to know this. (2)

A strange judgment given that the relevance is in the word ‘Withdrawal’. Nonetheless, the UK consumers still battle on.

Opening arguments in the Dolin trial commence Tues, March 14 in Chicago. I’ll be writing daily reports on the events.

Bob Fiddaman.

(1) “Paxil was dangerously addictive.”
(2) SANDRA BAILEY & OTHERS Vs GLAXOSMITHKLINE (UK) LIMITED 01/03/2017

Doin v GSK back stories.

Part 2 Of Bob Fiddaman’s Posts On Peter Humphrey’s Recently Filed Lawsuit Against GlaxoSmithKline…


http://fiddaman.blogspot.ie/2016/11/chinawhys-vs-gsk-claims-part-2.html

Sunday, November 20, 2016

ChinaWhys Vs GSK – The Claims – Part 2

Following on from the first parter, Lawsuit Alleges GSK’s Witty Lied to the Media – Part I, today sees part 2 (The claims of ChinaWhys against GSK) – Part 3 (Coming later this week) will focus on the incarceration of Peter Humphrey and his wife, Yu Yinzeng and also the rehiring of accused whistleblower, Vivian Shi)

Here is what Peter Humphrey and his wife, Yu Yinzeng, of ChinaWhys, are alleging…

 – Between 2010-2013 GSK spent nearly $225 million on planning and travel services. Approx 44% of the sampled invoices were inflated and approximately 12% were for events that did not occur.

 – GSK set up a special “crisis management” team in order to bribe a Chinese regulators with money and gifts. A GSK executive attempted to bribe a Chinese investigator with an IPad and a lavish dinner. All bribes were approved by the head of Chinese operations, Mark Reilly.

 – GSK planned to suppress evidence of its illegal bribery activities.

 – As far back as 2008, GSK China deliberately falsified its books and records in order to conceal its illegal practices in China. These included, bribery and promotion of drugs for purposes that have not been approved by the Chinese authorities.

 – GSK paid a patient RMB 50,000, who nearly died after being given Lamictal off-label. Despite having knowledge of Lamictal caussing near death in this patient, GSK still told its reps to promote the use of Lamictal for off-label purposes.

 – GSK targeted ‘persuasive doctors’ in attempts to influence purchasing descions at their hospitals. GSK are to said to have forged a connection with these doctors by taking them to expensive lunches and dinners and also giving them gifts and cash.

 – GSK paid between 500 and 1,000 doctors to go on an all-expenses paid holiday to locations such as Brazil, India, Israel, Greece, Japan and Hungary. GSK covered all costs, including cash to cover meals and sight-seeing excursions. These were disgusied by GSK as “Conference trips.”

 – Head of Chinese operations, Mark Reilly, reeived a bribe in the form of ‘sexual relations’ in return for passing business on to China Comfort Travel, a travel agency who organised ‘conference sevices’ for GSK.

 – GSK paid doctors based on their prescription numbers.

 – GSK’s senior legal counsel, Jennifer Huang, asked private investigator, Peter Humphrey, to investigate the Public Security Bureau and to prepare an analysis of the Chinese political regime. Huang told Humphrey that she wanted to find out who’s who regarding the team who were investigating GSK.

 – Humphrey became concerned that GSK were trying to obstruct the investigation and declined to investigate state secrets.

 – Humphrey was also asked, by GSK, to look into the Ministry of Public Security, the Economic Crimes Investigation Department regarding the relationship between them and  the Public Security Bureau. Humphrey, once again, declined.

 – Head of Chinese operations, Mark Reilly, told Humphrey that the alleged whistleblower, Vivian Shi was “coming after him.” (Humphrey).  Reilly then fled China the following day.

 – GSK China told its employees to “destroy all non-compliant promtional maeterials and gifts.” They also implemented a new email system and deleted emails that were more than a year old. They claimed this was to “reduce unnecessarily legal costs.”



Bob Fiddaman.

Back Stories from the Fiddaman Blog

Glaxo – The Sex Tape Scandal

GSK’s Mark Reilly Accused of Running a “massive bribery network”

I’m Just a Blogger – Here’s GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK’s Sales Reps Want Their Money Back

GSK’s Private Investigator [The Video]

Peter Humphrey’s 2012 Presentation – Pharma Bribery

GSK’s Chinese Whispers and David Cameron

“GSK were really cagey”, Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

GSK CHINA – Bribery was Rife 13 Years Ago

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang…Allegedly

Book Your Holidays With GSK Travel

Andrew Witty… I know narrrrrrrrthing

The Penny Drops for GSK’s Private Investigator.

GSK China Bought Patient’s Silence for $9,000

Lawsuit Alleges GSK’s Witty Lied to the Media – Part I

Dr David Healy… “Study 329 Trick, Treat or Treximet”…


http://davidhealy.org/study-329-trick-treat-or-treximet/

Study 329 Trick, Treat or Treximet

October, 31, 2016 | 21 Comments

Seroxat/Paxil Study 329 : Republic to Empire


Science-with-a-conscience-111

“….I asked Rob whether his company would have launched an internal damage limitation exercise like GSK/SKB did around the Panorama programs about paroxetine: Of course he said – and that it would have probably been successful. Employees would have been reassured that the company – their company- would never have deliberately harmed children. Success of the exercise would have been sustained partly through loyalty to the company but mainly because no one could afford to think too closely about whether it was true. Ask too many questions and you would be out on your ear with no chance of getting a reference for a future job…”

Sally McGregor 2016- Dr David Healy’s Blog.

This is an interesting blog post by Sally McGregor, on Prof Healy’s blog.

Basically it seems that Sally is aiming to give readers a view from the other side of the pharma fence (so to speak). Regular readers will know very well what side of the fence, I’m on.

In her post, Sally explains the state (and mind set) of the industry at the time- and she puts into context -how bad stuff like Seroxat study 329, or the Zyprexa scandal, happens..

And effectively how unethical decisions from the top, trickle down, leading to harm to consumers…

I’m not quite sure I completely go along with the view from this perspective (for reasons which I will explain later) however it’s an interesting and insightful read nonetheless and well worth reading…

 


 

http://davidhealy.org/study-329-republic-to-empire/

Study 329: Republic to Empire

March, 16, 2016 | 1 Comment

Bob Fiddaman Nails Andrew Witty’s Cavalier Attitude About GSK’s Unethical Behavior


“There have been warnings about paroxetine for a long time,” including a 2007 Food and Drug Administration advisory on the risk of increased suicidality when anti-depressants like paroxetine or imipramine are used to treat people age 18 to 24, according to Dr Jon Jureidini of the University of Adelaide in Australia. The authors of the 2001 study did not report this side effect, although the evidence was there, said Dr Jureidini, a co-author of the re-analysis.

“A broad community of people around the world have raised concerns,” he told Reuters news agency.

“Mistakes were made”…. thousands of kids killed themselves because of Seroxat…

All in a day’s work for  GSK’s CEO Andrew Witty..

Minor inconveniences on the road to hoarding his millions it seems…

What’s a few thousand dead kids?

As long as there’s no dent in profits.. that’s the bottom line isn’t it Witty?


http://fiddaman.blogspot.co.uk/2015/10/andrew-witty-art-of-deflection.html

Wednesday, October 28, 2015

Andrew Witty: The Art of Deflection.

Sir Witty should have been a politician. Very adept at answering a question…with a question.

Here’s a recent interview with Evan Davis, Presenter, Newsnight, BBC

Skip to 29.40. Transcript for this section is below video.

Transcript. 29.40

Evan Davis
I’m going to open it to the floor in a second, because we do want to leave half the session for the audience to ask questions. I’ll just finish with kind of a general reflection, because it is interesting, and it’s nice when you talk about the drugs and what they cure, what the treatments are. Don’t you find it very interesting that the pharmaceutical industry has a bad reputation? We read about the China corruption, we read about profits, we read about profiteering. It is an industry that saves lives, no one can dispute that. It’s an industry that produces pills that are completely transforming for people’s welfare. Yet, it’s actually not a terribly popular industry. I just wonder if you can explain that paradox. Is it that you’ve done bad things and that’s been recognized, or is there somehow something the public don’t understand about the industry that makes them feel negative about it? Or am I wrong in thinking there’s a slight [indiscernible] around it?

Andrew Witty
No, clearly – first of all, I think we are, slightly alongside any big industry, or any big institution, there is a bit of that. We are big companies, we’re global. Again, like any big organization, you’re vulnerable to your weakest link in the organization. So if something goes wrong, particularly in today’s social media world – I often think about what it must have been like to run a global company in the 1970s, where you had to wait for the ship to arrive to find out what happened on the other side of the world. Today, the Wall Street Journal calls you before you’ve even heard about something inside your own company. So I do think there is a certain phenomena where – and you see that across many, you look at it in politics, you look at it in newspapers. The hacking stories, all things like that. So I think it’s a bit of that. I do think – let’s be honest, nobody wakes up in the morning hoping that they’re going to need a drug from GSK. You don’t wake up in the morning thinking, actually, if it’s a really good day, I might be diagnosed to be ill and I might need a drug. So we’re not aspirational in that sense. So you start by saying, actually, I’ve got some bad news, because I’ve been told I’m not very well. They then said: we might have some good news, because there’s something we can help you with. Then in some countries, I have to pay for it. Or in Britain, you might go to the doctor and they say: actually, I’d like to give you this, but NICE have said I can’t. So then there’s a whole series of reasonably negative concepts around pricing. So there’s a bit of that. Then you’ve got – actually, we do occasionally make mistakes. Things go wrong. We have inevitably – of course, we go through all the processes with the regulators to get a drug to be as safe and effective as it can possibly be. But the reality is, every time a human takes a drug, it’s like a clinical trial. You don’t really know what’s going to happen. Everybody can react a different way. So on the one hand, what is the story of the drug industry? The story of the drug industry is wonder drugs. On the other hand, it’s danger drugs. Those are the two extremes that we have. It’s kind of unavoidable.

Evan Davis
But you’re saying there are bad apples, and it goes wrong. Is that right, or is it – for example, in the China case. Was it that there was a bad apple and it went wrong, or was it that that was normal behaviour in certain markets, and it just got called out in that particular case?

Andrew Witty
For obvious reasons, I’m not going to get into all the details of that.

Evan Davis
Was that behaviour actually something, or was it just a slight extension of behaviour that is normal?

Andrew Witty
I think the bigger question is, where do you want to go forward?

Evan Davis
No, but just answer that one.

Andrew Witty
There’s no doubt, if you ask the more general question – so there have been concerns over the years of, is the drug industry transparent enough? What’s the relationship of the drug industry with doctors? All of those are kind of concerns – let’s call them concerns or reasons for anxiety, whatever they are. Sometimes they’ve spiked up into real issues. What we’ve really tried to do, and we’re beginning to see some other companies, I think, following a similar direction, is we’ve said: you know what? We get that. We get that transparency is a cause of concern. People are worried that something is being hidden. We didn’t think there was but people – perception is everything, right? So what did we do? We came out and said: we will publish every single bit of clinical data we have in the company. We are the only company to do that at this point. Every single thing. If a researcher wants to know exactly what the data was on patient number – all anonymized, but on Patient 1002, in Clinical Trial 87, from 2002, we will give them that information. All the way through, we’ll do that. We’ve said we will stop all payments to physicians to speak on behalf of the company. It’s a perfectly legal practice, everything the company has done – but we stopped it all.

Evan Davis
But this is a recognition – there is a lot you’ve done to present these things differently. But it is a recognition that it was pretty dysfunctional before, isn’t it? Because publishing data, to me, honestly, doesn’t seem like a great achievement. It just seems to me that that’s what you should be doing with data. Not bribing doctors seems like a thing you would do.

Andrew Witty
I wouldn’t say it’s bribing doctors – it’s perfectly legal to pay. If you went to a physician and said, would you expect to be paid for speaking on behalf of somebody, they will probably say yes. Actually, in most countries in the world, it’s perfectly legal. However, there are risks it can be abused. People can make mistakes. And there are risks that there is a misperception. Just to your point on publication, do you think academics are mandated to publish their data? Do you think universities publish all their failed studies? They don’t, but we do.

One box of chocolates for the first person to tell me how many times Witty deflects the questions put to him.

**Footnote

GSK were forced to be transparent, they didn’t just decide one day that they were going to be the first pharmaceutical company to “open it’s doors” (Halfway)

This from the Department of Justice/GSK agreement

“Among other things, the CIA also requires GSK to implement and maintain transparency in its research practices and publication policies and to follow specified policies in its contracts with various health care payors.”

Also…

“Moving forward, GSK will be subject to stringent requirements under its corporate integrity agreement with HHS-OIG; this agreement is designed to increase accountability and transparency and prevent future fraud and abuse.”

I think the bigger question is why did Witty fail to mention that his company were forced to be more transparent.

I’ll leave the last words to Witty…

“It’s a perfectly legal practice, everything the company has done…”

Bob Fiddaman.

Original video here.

Dr Malcolm Kendrick On Seroxat : Where The Hell Is The Outrage?


Study 329 – where the hell is the outrage?

To quote from the BMJ ‘No correction, no retraction, no apology, no comment…’

Study 329 was started in 1994 by Smith Kline Beecham, which shortly become part of the larger conglomerate Glaxo Smith Kline (GSK). Study 329 looked at the use of paroxetine, an anti-depressant, in adolescents with depression.

Following this study paroxetine was promoted and marketed heavily by GSK as demonstrating, in the words of GKS marketing materials: ‘REMARKABLE Efficacy and safety’. Over two million prescriptions were then written for children and adolescents in the US.

However, in 2002 the FDA considered study 329 to be a ‘failed trial.’ In 2003 the UK recommended that paroxetine should not be used in children and adolescents with depression because it increased the risk of self-harm and potentially suicidal behaviour.

In 2004 the FDA placed a black box warning on all antidepressants in adolescents and children stating that they increased the risk of suicidal thinking and suicidal behaviour in these groups. In 2102 GSK finally agreed to pay £2Bn for fraudulently promoting paroxetine.

But the story does not end here. A group of researchers, who had been heavily critical of this trial, finally managed to get hold of the raw data and carried out a re-analysis under the restoring invisible and abandoned trials (RIAT) initiative. Yes, this saga has been a long one.

The reanalysis was recently published in the BMJ with sadly predictable results. The primary conclusion was that ‘Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was increase in harms in both groups.’

This is in stark contrast to the original trial results. When it was first published it appeared to demonstrate very clearly that paroxetine was both safe and effective in adolescents with depression. According to GSK it demonstrated ‘.remarkable efficacy and safety’ However, using exactly the same trial data, reanalysed by independent researchers, we now find that paroxetine was both useless and damaging.

So, what has been the consequences for those involved in the initial trial and the writing up thereof? For those who read the BMJ, you will know that I am now quoting verbatim here:

  • Despite subsequent FDA and MHRA warning about increased risks of suicidal thinking and behaviour and GSK receiving a record fine, partly for illegal off-label promotion of the drug, the original report has not been retracted or even had a correction
  • Academic and professional institutions have failed to publically address the many allegations of wrongdoing
  • None of the named authors had intervened to correct the record. An internal enquiry by the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) concluded that no further action was necessary
  • Brown University remains silent over its involvement in the study. It refuses even to confirm or deny whether any investigation took place1

I will add to this that a co-author of study 329, Karen Wagner, named eight times in the 2011 US Department of Justice complaint against GSK, is currently the president elect of the American Academy of Child and Adolescent Psychiatry – whose journal, the JAACAP, is where the original study was published.

Taking stock. What do we have? A study was done, and published, demonstrating that paroxetine was safe and effective. The trial data were heavily promoted, resulting in millions of children and adolescents being prescribed paroxetine.

The reality is that this drug was completely ineffective and increased the risk of suicide (amongst other things). This has all been known for many years. The latest re-analysis simply confirms everyone’s worst fears.

So surely someone, somewhere, got punished? No they did not. Not only that, but the original published study has not even been retracted. It still sits in the medical database. A young and innocent researcher could come across it, and reference it, and use data from it to support a grant application for a study to use antidepressants in children.

If this were not all completely and absolutely one hundred per-cent fact, you might think we have a possible plot line for a dystopian novel here. A story of terrible corruption where large corporations can distort data through one hundred and eighty degrees, and get away with a fine. A world where bent researchers promote research that results in more children committing suicide, and then move on positions of greater power and authority – with no censure from anyone. To become presidents of major medical societies, for example.

Frankly I don’t think I would dare to write a novel with a plot so completely outrageous. Surely someone, somewhere, would be punished for this behaviour. Surely the paper would be retracted. Surely a co-author of such a study would not be in line for a prestigious position. Surely the public would rise up in outrage.

In truth, it seems, nothing is going to happen at all. I must dig out 1984 and read it again, just to depress myself even further.

1: BMJ 2015;351:h4629

AllTrials Is A Red Herring… We Need Access To ALL DATA…


For the red herrings see here

Sir Iain Chalmers, coordinator of the James Lind Initiative and co-founder of AllTrials:

“Among pharmaceutical companies, GSK under its current management has led the way in promoting clinical trial transparency and provides a practical mechanism to make trial re-analyses possible. The reanalysis of Study 329 illustrates the knowledge dividends from the company’s new policies and contrasts strikingly with the scientific misconduct that characterised the company’s behaviour under previous management. Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.

Erm no Ian, today’s GSK  (2014) were recently caught bribing hundreds of Chinese doctors and fined 500 Million dollars last year.  You fail to mention this very recent moral indiscretion.

GlaxoSmithKline Found Guilty of Bribery in China

U.K. Drug Maker Handed Largest Ever Corporate Fine in China

This fine was hardly a sign of moral leadership Ian, so don’t be ridiculous..

In regards to GSK’s scientific leadership, while giving the access to data for study 329 is undoubtedly a good thing, the fact that GSK hid it for so long (and promoted Paxil/Seroxat off label to doctors/kids which resulted in kids killing themselves) is not. I am shocked that you would try to spin this as somehow good PR for GSK . Study 329 was abhorrent, Seroxat is a disgrace.

Seriously, what planet are you on Ian?

Where is GSK’s apology for all this carnage?

Publicity from Study 329 contributed to paroxetine being prescribed to “hundreds of thousands” of adolescents, Jureidini said.

Dr David Healy’s  new post, ‘Data Wars‘, raises some very important points in regards to the ‘data transparency debate’.

I have long been suspicious of Alltrials, Ben Goldacre, Simon Wessely, Sense About Science and the various other ‘movers, shakers and consensus makers’ in this debate, and I’ve written several posts about them explaining why:

See these posts of mine for further details-

https://truthman30.wordpress.com/2014/08/15/whats-the-real-story-simon-wessely/

https://truthman30.wordpress.com/2013/11/19/ben-goldacre-bad-pharma/

Call me suspicious by nature, and perhaps I am, however when you’ve been writing, and researching, about GSK’s various unethical shenanigans (for almost 9 years now) you tend to sense when something isn’t quite right. Couple that with a horrendous time on Seroxat, then finding out afterwards that it all could have been prevented if the whole psych/pharma system wasn’t so corrupt, and throw in my sheer determination -for over a decade now- to expose every corner of the Seroxat Scandal, and you end up down some very strange rabbit holes indeed.

The recent expose (restoration of Seroxat Study 329) by the RIAT team, published in the BMJ, caused quite a stir online. Not only did it make headline news, but the responses on social media could warrant many studies in themselves. Paxil/Seroxat harmed many people. These are not ‘anecdotes’, these are people’s lives-

See these posts for details of the impact of Paroxetine world-wide:

https://truthman30.wordpress.com/2015/09/22/i-knew-that-shit-was-poison-12-people-describe-their-young-lives-on-paxil-seroxataropax/

https://truthman30.wordpress.com/2015/09/19/social-media-discusses-paxil-seroxat/

The real world affects of Seroxat (Paroxetine/Aropax/Paxil) have been horrendous for those who were unfortunate enough to have been prescribed it. I’ve known that Seroxat is a dangerous drug since I was first prescribed it in 1998. It was only after I came off it, in late 2001 or thereabouts, that I discovered (courtesy of the BBC through their Panorama programme- “The Secrets of Seroxat‘ documentary) that the problems with Seroxat (of increases in suicide, self harm, akathisia, murder, aggression, withdrawal, dependence etc) were worldwide problems. There was some solace in finding this out from the BBC Seroxat series, however I won’t get those lost Seroxat years back. I won’t get my health back that I lost either, nonetheless an apology from GSK for almost killing me with their drug, lying in PIL’s, and corrupting doctors, would be nice though- but I won’t hold my breath. I was collateral damage, and harm to people like me is factored into GSK’s cost of doing business. To GSK, my life was disposable, so it’s insulting for me when I see people like Ben Goldacre and Sense About Science collude with sociopathic companies like GSK.

I find this extremely disturbing.

Alltrials is a redherring, so is Ben Goldacre’s  transparency agenda. Simon Wessely is too, as are Sense About Science.

I don’t trust any of these people/organizations. I don’t believe patients should either.

Why do I say that?

Well, hundred thousands of kids were likely put at risk from GSK’s promotion of their dangerous Seroxat/Paxil drug off label. Many high profile psychiatrists put their names to the ghost written study 329 and subsequently- the lives of hundreds of thousands of kids were put at unnecessary risk. They were prescribed a drug (Seroxat/Paxil) which has been shown to be harmful. Many died and many were damaged, plus we haven’t even begun to assess the damage to the adults who were prescribed Seroxat.

I was one of those adults. I am one of those people who suffered. What is going to be done?

Where is the outcry about Seroxat killing kids from people like Prof Simon Wessely? (the head of the UK college of Psychiatry).

Where is the utter condemnation from people Dr Ben Goldacre? (A supposed patient advocate).

Where is the press release from Sense About Science castigating GSK for this disgraceful crime?

Where are their statements expressing their utter disgust at this flagrant abuse of vulnerable people? (Depressed people prescribed Seroxat).

They’re simply not there… none of these people/organizations have condemned this scandal.

Instead what we have are organizations like Alltrials basically congratulating GSK (for giving access to a study which was fraudulent in the first place) and helping GSK spin this abhorrent Seroxat study 329 scandal into something positive (quite how they can justify this is beyond me). Notice how Alltrials fail to condemn GSK for putting kids at risk, but how they try to spin this as GSK somehow being the good guys for providing the patient level data to David Healy and the RIAT team.

What Alltrials also fail to draw attention to is- the fact that the process itself was close to impossible (it also took years), and it was through sheer determination and tenacity on behalf of the RIAT team that they got to study the data never mind the pain staking process of attempting to analyze it. Furthermore, what Alltrials also don’t mention is- the RIAT process and Rxisk are looking for the Data – Access to all the data, not just the registering of trials. What use are the trial results and what use are the trials themselves without the data which makes them? We need access to all the data. Alltrials isn’t looking for this- that’s why I don’t trust them.

Alltrials is a red herring, so are Sense About Science-  and along with the true extent of Seroxat harming kids (and adults) that’s what the RIAT team has also just exposed…

See David Healy’s Data Wars for more:

http://davidhealy.org/study-329-data-wars/

Sense about Science

Simon Wessely and Clare Gerrada are the power couple of British Medicine.  He is the current President of the Royal College of Psychiatrists, and she is a recent President of the College of General Practitioners.  When faced with questions about over-prescribing of antidepressants by GPs, she is quick to insist that GPs rarely treat distress and that almost all prescribing is for genuine illness and the drugs work well.  He gives similar messages in respect of psychiatry.

Sense about Science began in Britain 15 years ago with donations from Corporations in the Risk Management Business – from Monsanto through Nuclear Power to Pharma. These donations have vanished from sight now, replaced by endorsements from all major UK universities and journals like The BMJ and support from Charitable Foundations.

SAS’s stated mission would have appealed to someone like SW who had come under attack from a lot of fringe groups in the 1990s for taking a balanced data-driven approach to Chronic Fatigue Syndrome (M.E.).

But SAS has now become a node to handle any messages in the media that might hurt the interests of a company or corporate sector – such as anything to do with vaccination or my recent editorial on So Long and Thanks for all the Serotonin.  BMJ sent this article (as they send all articles) to SAS who got in touch with SW to rustle up statements from Jeff Lieberman types which can be disseminated widely to the media either for citing or as a means to close down stories:

You might not want to take Healy’s work seriously in the light of what these senior figures in the field are saying.

Sense about Science has since spread to Canada, Australia and now the United States and everywhere the mission is the same.

AllTrials & AllData

SAS was a founder of AllTrials.  This sounds like AllData – the hashtag for Restoring Study 329 – but at the moment it is quite the opposite.

There has been close to radio silence from AllTrials in the face of the call for AllData, aside from one stunning press release that more or less credits GSK with the efforts to Restore Study 329.

17th September 2015

Many supporters of AllTrials will be interested in a study published in The BMJ today, a reanalysis of previously hidden clinical trial data. The new research used data from a 1990s clinical trial of the GlaxoSmithKline (GSK) antidepressant drug paroxetine. Today’s findings contradict a 14-year-old analysis of the data referred to as Study 329, which found paroxetine to be safe and effective for treating adolescents with major depression.

The new research is the first reanalysis of a drug study under the RIAT (Restoring Invisible and Abandoned Trials) initiative, which calls on companies and academic funders to publish detailed trial information for independent scrutiny. The RIAT team was able to access the original clinical trial data using GSK’s patient-level data access portal, where researchers can request access to this information.

Tracey Brown, Director, Sense About Science and co-founder of AllTrials:

“When all trials are registered and results reported, it becomes possible for researchers to work out what data are available. GSK has gone further and made its patient level data available to researchers. It is disappointing that there are still so many companies not reporting trials. Researchers, doctors, patients and, in July, their shareholders have said they want transparency about trial results. This will confirm their views.”


Sir Iain Chalmers, coordinator of the James Lind Initiative and co-founder of AllTrials:

“Among pharmaceutical companies, GSK under its current management has led the way in promoting clinical trial transparency and provides a practical mechanism to make trial re-analyses possible. The reanalysis of Study 329 illustrates the knowledge dividends from the company’s new policies and contrasts strikingly with the scientific misconduct that characterised the company’s behaviour under previous management. Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.”

Pontius Andrew?

Faced in 2012 with questions about the $3 Billion fine imposed on GSK, triggered by a sequence of events starting with Study 329 – is it just the cost of doing business? – Andrew Witty snapped back:

“Although corporate malfeasance cases end up looking very big, they often have their origin in just… one or two people who didn’t quite do the right thing. It’s not about the big piece. The 100,000 people who work for GSK are just like you, right? I’m sure everybody who reads the BMJ has friends who work for drug companies. They’re normal people… Many of them are doctors”.

Everything about Study 329 suggests that Andrew is comprehensively wrong. Corporate malfeasance happens when the system is set up so that the efforts of 100,000 well-meaning people get transformed into the worst of outcomes and it then takes the efforts of a few brave people within GSK to alert the outside world to how things are going wrong.


GSK 2 GSK1

Study 329 Is Making Headlines … This From Dr David Healy…


http://davidhealy.org/study-329/

Study 329

September, 16, 2015 | Reply

Dr David Healy : The Troubled Life of Study 329: Consequences of Failure to Retract


The Troubled Life of Study 329: Consequences of Failure to Retract

http://davidhealy.org/the-troubled-life-of-study-329-the-consequences-of-failure-to-retract/
 
September, 8, 2015 | 1 Comment