Daily Mail UK: Happy Pills Can Give You Digestive Problems And Make You More Depressed


Depression levels in Britain continue to spiral.
Last year alone, more than 43 million prescriptions for antidepressants were handed out — 25 per cent more than three years before.
But are antidepressants the panacea we hope them to be?
Drugs such as Prozac were hailed in the early Nineties as wonder pills that would banish depressive blues for good.

But in the past five years, growing scientific evidence has shown these drugs work for only a minority of people.
And now controversial research in a respected journal claims that these antidepressants can make many patients’ depression worse.

This alarming suggestion centres on the very chemical that is targeted by antidepressants — serotonin.
Drugs such as Prozac are known as selective serotonin reuptake inhibitors (or SSRIs).
Their aim is to boost the level of this ‘feel-good’ chemical in the brain.
But the new research, published in the journal Frontiers In Evolutionary Psychology, points out that serotonin is like a chemical Swiss Army knife, performing a very wide range of jobs in the brain and body.
And when we start deliberately altering serotonin levels, it may cause a wide range of unwanted effects.

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These can include digestive problems, sexual difficulties and even strokes and premature deaths in older people, according to the study’s lead researcher Paul Andrews.
‘We need to be much more cautious about the widespread use of these drugs,’ says Andrews, an assistant professor of evolutionary psychology at McMaster University in Ontario, Canada.
Previous research has suggested that the drugs provide little benefit for most people with mild and moderate depression, and actively help only a few of the most severely depressed.
Eminent psychologist Irving Kirsch has found that for many patients, SSRIs are no more effective than a placebo pill.
Two years ago, the Canadian Medical Association Journal reported a 68 per cent increase in risk of miscarriage in women on antidepressants.

Drugs such as Prozac are known as selective serotonin reuptake inhibitors (or SSRIs). Their aim is to boost the level of this ‘feel-good’ chemical in the brain
And research in 2009 on Danish children found a small, but significant, increase in the risk of heart defects among babies whose mothers had used SSRIs in early pregnancy.
There is also growing evidence that long-term use in adults is linked to bleeding in the gut and increased risk of stroke.

The key to understanding these side-effects is serotonin, says Andrews. Serotonin is also the reason why patients can often end up feeling still more depressed after they have finished a course of SSRI drugs.
He argues that SSRI antidepressants interfere with the brain, leaving the patient vulnerable to a ‘rebound’ depression of even greater intensity than before.
‘After prolonged use [when a patient stops taking SSRIs], the brain compensates by lowering its levels of serotonin production,’ he says, adding that it also changes the way receptors in the brain respond to serotonin, making the brain less sensitive to the chemical.
These changes are believed to be temporary, but studies indicate that the effects may linger for up to two years.

Relapsing is not exclusive to SSRI drugs — it is, in fact, seen in all the classes of antidepressant medications —

but Andrews believes that the risk is particularly strong with SSRI drugs.
Moreover, he warns that antidepressants can disrupt all the physical processes that are normally regulated by serotonin, adding that animal studies show only about 5  per cent of the body’s serotonin resides in the brain. Most is housed in the gut.
It is used, among other things, to control digestion, form blood clots at wound sites, and regulate reproduction and growth.
So a drug that interferes with serotonin may cause developmental problems in infants, problems with sexual stimulation and sperm development in adults, digestive problems such as constipation, diarrhoea, indigestion and bloating, and abnormal bleeding and stroke in the elderly.
The drugs may also raise the risk of dementia.
Most disturbingly of all, Andrews’ review features three recent studies which, he says, show that elderly antidepressant users are more likely to die prematurely than non-users, even after taking other important variables into account.

One study, published in the British Medical Journal last year, found patients given SSRIs were more than 4 per cent more likely to die in the next year than those not on the drugs.

‘Serotonin is an ancient chemical,’ says Andrews.

‘It is intimately regulating many different processes, and when you interfere with these things, you can expect that it is going to cause some harm.’

Stafford Lightman, professor of medicine at the University of Bristol, and a leading UK expert in brain chemicals and hormones, says Andrews’ review highlights some important problems, yet it should also be taken with a pinch of salt.
‘This report is doing the opposite of what drug companies do,’ he says.
‘While drug companies selectively present all the positives in their research, this selectively presents all the negatives that can be found.
Both approaches are simplistic. And while SSRIs might possibly cause rebound depression, it is also sadly natural to expect that people with severe depression will see their illness come back, and often in a worse state.
‘Nevertheless, the study is useful in that it is always worth pointing out that there is a downside to any medicine.’
Professor Lightman adds that there is still a great deal we don’t know about SSRIs — not least what they actually do in our brains.

‘It’s a bit embarrassing, but the bottom line is that we don’t really know how they work,’ he says.
‘Basically, we started using these drugs before we understood what they do, because they showed some effectiveness.’

When it comes to understanding why the drugs work only for a limited proportion of patients, U.S. scientists think they might now have the answer.
They think that in many clinically depressed patients, it’s not only the lack of feel-good serotonin causing their depression, but also a failure in the area of the brain that produces new cells throughout our lives.
This area, the hippocampus, is also responsible for regulating mood and memory. Research suggests that in patients whose hippocampus has lost the ability to produce new cells, SSRIs do not bring any benefit.
But why the hippocampus should do this — and how it should be treated — is not clear.
And even if those answers were found, they might still not produce a cure for many cases of depression, because the condition varies so widely in its causes and is so little understood.
What should be sure is that the days of doctors habitually prescribing SSRIs to all and sundry on the basis that they might work, and won’t do any harm anyway, really should be behind us.

Read more: http://www.dailymail.co.uk/health/article-2144406/Happy-pills-digestive-problems-make-MORE-depressed.html#ixzz1utU6CSkv


Seroxat Videos : Staggering …

Bob Fiddaman has just posted links to 49 available Seroxat videos on youtube. This is a staggering amount of web video’s documenting the side effects of a very dangerous drug. And GSK still claim that this drug is effective. Many would beg to differ, GSK.


SATURDAY, MAY 12, 2012

Seroxat/Paxil/Aropax…and Some – The Videos




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GSK: Drug Firms and Their Ties to Doctors


Rules shine light on drug firms’ ties to doctors, raising questions about ethics

Staff Writer

Saturday, April 21, 2012

This photo shows 40-milligram tablets of Lipitor, one kind of statin used for lowering blood cholesterol.
• How this story was developed
• How much area doctors were paid

Helen Carcio, a South Deerfield nurse practitioner, says she’s on a mission to educate other health professionals about treatment for overactive bladders – a quest paid for, in part, by Pfizer, the maker of a drug that treats the condition.

She is among 16 area medical professionals who have received anywhere from $280 to $254,000 from pharmaceutical companies for making speeches, consulting, doing research and for travel and meals, according to recently released documentation about medical professionals’ financial arrangements with pharmaceutical companies.

Carcio, founder and director of the Health & Continence Institute, is a member of Pfizer’s national speakers bureau. The drug company pays her $1,000 to $1,500 per event to speak about overactive bladders. In 2010 she spoke to medical professionals at 11 events.

From July 2009 through 2010, Pfizer paid Carcio $11,649 for consulting, speaking and travel expenses. She also earned $3,750 in 2009 speaking on behalf of GlaxoSmithKline.

Carcio said she lectures for Pfizer because many medical professionals don’t understand overactive bladders.

“I’m trying to take it out of the closet, to talk to providers that are clueless that something can be done about it,” she said. “First you want to get people better, and the majority of us want to be paid for it, but mainly we want to be helpful.”

While legal, the cash relationship between doctors and pharmaceutical/medical device representatives raises questions about conflicts of interest and other ethical issues, leading to federal legislation that will soon require public disclosure of these kinds of transactions.

Carcio is concerned about how people might interpret her relationship with Pfizer.

“I have a passion for making sure women are not incontinent. The more I raise awareness the better, but it’s a Catch-22,” she said. “I’d hate for someone to think I’m on the take, that I’m doing it for the money.”

Carcio says she’s one of the good ones.

“Some do it for the money,” she said of medical professionals who speak on behalf of drug companies. “Some make $150,000 in a year. That would bother me.”

Among the drug companies that have paid Valley doctors are GlaxoSmithKline, Pfizer, Novartis, Eli Lilly, Johnson & Johnson and Merck.

In 2010, Massachusetts doctors received $64 million from pharmaceutical companies, according to the Massachusetts Prescription Reform Coalition, an arm of the Boston-based advocacy group Health Care for All.

The financial relationships between drug companies and doctors will soon be even more transparent. Legislation for the 2010 federal health care overhaul included the Physician Payment Sunshine Act, which will require drug companies to disclose payments to medical professionals.

The details of the act are still being worked out by the Centers for Medicare and Medicaid Services.

The first report detailing the who, what, where, when and how muchof financial arrangements between doctors and pharmaceutical companies will be issued in September 2013.

In the meantime, 12 drug companies are already providing this information either voluntarily or as the result of legal settlements. ProPublica, a nonprofit investigative news outlet, has compiled the payments into a searchable, though incomplete, database (see related story).

Since 2008, the Massachusetts Executive Office of Health and Human Services has been tracking cash transactions between medical professionals and drug and medical device companies through the state’s gift ban law.

Proponents of the Sunshine Act contend that it’s important to make such relationships clear. They say money from drug companies could influence a doctor’s treatment decisions, even if only on a subconscious level.

According to an article titled “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” published in the Journal of the American Medical Association, studies have shown that physicians who meet with drug representatives are more likely to prescribe the drugs the representatives are promoting and decrease the number of generic prescriptions they write.

Alyssa Vangeli, a policy analyst for the Massachusetts Prescription Reform Coalition, said physicians and other health care providers who prescribe medications almost always have the best interest of the patient in mind, “but any kind of payment or financial transaction could potentially influence a doctor,” she said.

“Patients should never have to wonder if their doctor prescribed something because it was best for me or they’ve recently been taken out to an expensive meal by a pharmaceutical company pushing a certain drug,” said Vangeli.

Area doctors, however, say they are not influenced by money, gifts or meals.

“I can only speak for myself,” said Jonathan Bayuk, an allergist and clinical immunologist with offices in Florence, Springfield and Westfield, “but I’ve never been persuaded by a sandwich to change how I take care of patients.”

Marketing with wide reach

The pharmaceutical/medical device industry spends an estimated $20 billion to $57 billion annually to market its products. According to the Pew Research Center, detailing – face-to-face encounters between doctors and representatives – is the largest industry marketing expenditure after pharmaceutical samples.

Most doctors engage in some form of detailing.

More than 90 percent of physicians have some kind of relationship with a drug company representative, according to “A National Survey of Physician-Industry Relationships,” a 2007 article in the New England Journal of Medicine.

The survey reported that, in one year, nearly 80 percent of doctors nationwide received drug samples, 83 percent accepted food or drinks in the workplace, 26 percent received reimbursement or were subsidized for continued medical education, 18 percent were paid for consulting services, 16 percent were paid to speak at events, 9 percent sat on advisory boards and 3 percent enrolled patients in clinical trials.

Since 2008, Massachusetts doctors have been barred by state law from accepting samples, food, drinks or entertainment.

For the most part, Valley doctors who have received money from pharmaceutical companies are being paid to lecture at informational events. Some area physicians have spoken at more than 60 events in a single year, according to the Massachusetts Executive Office of Health and Human Services. Several local medical officials have been hired as consultants and a few received money for research.

Bayuk, for example, has spoken at scores of medical events, and said such engagements can range from small-scale affairs to large conferences. From 2009 to March 2011, Bayuk received at least $124,550 from pharmaceutical companies, mostly compensation for speaking engagements.

Typically pharmaceutical companies ask doctors to speak about the diseases and conditions the drug targets, not about the drug itself. Medical professionals also must follow U.S. Food and Drug Administration regulations about how they talk about drugs. For example, a drug’s risk factors must be addressed.

But Alison Bass, author of “Side Effects,” a book about the suppression of unfavorable research on the antidepressant Paxil, says that typically a speaker will mention a drug manufactured by the sponsoring pharmaceutical firm, saying it is an effective treatment for the disease.

Bass, a journalism professor at Mount Holyoke College in South Hadley, said doctors may be sincere in their endorsements of drugs, based on the data presented in clinical trials. But

she maintains these trials are often flawed.

Drug researchers are more likely to report positive outcomes when a pharmaceutical firm pays for the study, Bass said.

Studies that show negative results may go unpublished, or may even be falsified to present a better outcome. That was the case with Paxil, Bass said.

Brown University professor Martin Keller was paid hundreds of thousands of dollars by SmithKline Beecham (now GlaxoSmithKline) to perform research on Paxil’s effect on teenagers.


Teen participants who reported having suicidal thoughts were miscoded and counted as “noncompliant

,” Bass said. Court documents filed in 2008 in lawsuits against GlaxoSmithKline revealed that adolescents were six times more likely to become suicidal after taking Paxil.

“Money is too influential,” said Bass. She maintains the government, not drug companies, should pay for clinical trials.

From 2009 through March 2011, Bayuk earned speaker’s fees from AstraZeneca, GlaxoSmithKline and Novartis. He said drug companies and the medical community both benefit when he talks at an event. The drug companies spread awareness of their products, and his peers learn of advances in the field.

Bayuk said his medical decisions are in no way influenced by speakers fees he is paid from drug companies. “Not me, but there are some,” he said.

He also noted that when speaking, he may discuss several competing treatment options.

Bayuk says he sees no point in documenting pharmaceutical-physician relationships.

“It’s a total waste of time and money,” he said. “There’s been no impropriety done by me, and I think that’s the truth for 99.9 percent of physicians.”

“I’m a young guy,” he continued. “Maybe in the past there was a problem, but I’ve never seen one. … There’s nothing wrong with disclosing exactly what happens.”

Disclosure can be confusing

But disclosing exactly what happenscan be tricky and it’s one of the sticking points the Centers for Medicare and Medicaid Services are taking comments on as they work on the law’s language. For example, research money is a category that can both compensate a doctor as well as pay for patient care and supplies. Reporting that a doctor received research money could imply that the entire amount was compensation for his work.

Pharmaceutical interest groups and disclosure advocates agree: Financial transactions between pharmaceutical companies and doctors need to be reported with context.

“Patients need to understand that a relationship between their physician and a company does not mean their physician is compromised,” Kate Connors, a spokeswoman for the pharmaceutical industry interest group PhRMA, said in an email. “If anything, they should know that their physician is seen as an expert in his or her field.”

The CME Coalition, a lobbying group for continuing medical education providers, notes that the potential for misinterpretation could encourage doctors to forgo educational opportunities.

Dennis J. Rosen, an Amherst pediatrician, is concerned about how people will look at payments he has received from drug companies.

Rosen, who has been treating children with learning, emotional and attention problems for 42 years, received a total of $254,965 in speaking and consulting fees from Novartis and Shire Pharmaceuticals in 2009 and 2010.

He said he ended those relationships more than a year agobecause he no longer has time for speaking engagements. But he called his work with drug companies “meaningful and educational,” and said it benefited doctors, and subsequently, their patients. When he spoke, Rosen said, he was “fair and honest” about the use of drugs for particular disorders.

The money is not an indication of impropriety, he said.

“I don’t play favorites,” Rosen said of prescriptions. “I use whatever is necessary.”

Kristin Palpini can be contacted at kpalpini@gazettenet.com

Irish former state pathologist claims: “Too many suicides linked to anti-depressants’…


‘Too many’ suicides linked to depression tablets

By Jennifer Hough
Monday, March 05, 2012
A former assistant state pathologist has expressed serious concern about the growing link between anti-depressants and suicide.

Dr Declan Gilsenan said in his 30-year experience carrying out postmortems, he had seen “too many suicides” after people had started taking the drugs and questioned whether GPs were over-prescribing them.

He said the evidence is “more than anecdotal” and he is willing to meet the minister with responsibility for mental health on the issue, as part of a delegation organised by campaigner Leonie Fennell.

Ms Fennell is the mother of Shane Clancy, who took his own life after killing his friend Sebastian Creane.

He had just started a course of anti-depressants and it is believed he took more than the prescribed amount.

At Mr Clancy’s inquest, Dr Gilsenan testified that there were “toxic” levels of citalopram (brand name Celexa or Cipramil) in Mr Clancy’s blood.

Ms Fennell has been campaigning since Mr Clancy’s death to raise awareness about the potential dangers of anti-depressants and is seeking a meeting with Kathleen Lynch, minister of state with responsibility for mental health.

She has enlisted the help of Dr Gilsenan and a former minister, who does not want to be named at this time, but who also has serious concerns regarding side-effects and over-prescribing of the drugs, whose popular brands include Prozac, Zoloft, Lexapro Paxil and Celexa.

“Based on my experience of doing postmortems on people where anti-depressants have been started fairly recently I would have concerns about the link to suicide,” Dr Gilsenan said.

He said the argument will be made that people who start taking anti -depressants are of course depressed, and so could be at risk of suicide. “This will be used against what I am saying, but in my work I have just seen too many cases. There are things like accumulation in the system and dose-related concerns, where people go over a safe level, and I am willing to sit down with the minister and talk to her about these things.”

Dr Gilsenan said doctors need to be more careful when prescribing anti-depressants and people need to be monitored more carefully. “It certainly seems GPs are using anti-depressants very frequently.

These are very important drugs to psychiatry and if they are deemed to be harmful then it’s a big blow to them and that’s why they are defended so much.”

Another expert, Professor David Healy, who also gave evidence at Mr Clancy’s inquest, maintains the pharmaceutical industry is being protected by psychiatry.

In the case of Mr Clancy, the Irish College of Psychiatry came out in defence of the drugs at a time when families in grief were going through a high-profile inquest.
Prof Healy said that although companies are legally obliged to agree that their drugs can cause people to take their lives, psychiatry is not. “Here they offer one of the greatest services they can to companies — they can and regularly do offer apologias for industry. They state in public that not only did the drugs not cause a problem, but that they cannot cause a problem,” he said.

At Mr Clancy’s inquest, Prof Healy stated that in a small but significant minority of patients, using anti-depressants can give rise to violent behaviour.

Read more: http://www.irishexaminer.com/ireland/too-many-suicides-linked-to-depression-tablets-186006.html#ixzz1sEJTAc00

Ireland: SSRI’s, The Psychiatric Paradigm and Mental Health

The tide is turning….


Debate on antidepressants needed

By Ita McSwiney

Wednesday, March 21, 2012

Ita McSwiney outlines some of the concerns surrounding the side-effects of prescribed psychotropic medication

In a personal and human capacity, I would like to add my name to the growing number of people concerned about the side-effects of prescribed psychotropic medication and, in particular, SSRIs, a group of antidepressant medication.

This medication is widely prescribed and its use has almost been normalised in this country in recent years. Data from the General Medical Card Scheme and the Drugs Payment Scheme will attest to the escalating pattern of their use nationally.

I have been working as a nurse in adult mental health services for over 30 years, with the last 12 or more of those as a psychotherapist.

From my experience of my work, I have no doubt that a significant number of people, particularly in the early treatment phase with antidepressants, experience bizarre, and often uncharacteristic thoughts, impulses and images that can be both terrifying and difficult to ignore. Examples disclosed to me in the course of my work that come to mind include:

* A sudden urge to drive across oncoming traffic at speed;

* An impulse to drive their vehicle at speed over unprotected quays, into a wall or over a cliff;

* An urge to physically harm themselves or attack a loved one;

* On one occasion a patient expressed the urge to physically attack me, having spotted a potential weapon near to hand.

While it is difficult to gather scientific data to support this, the website http://www.ssristories.com makes for chilling reading indeed. Data is organised in such a way that this issue can be viewed from a range of perspectives.

And while the information might be more anecdotal than scientific in the strictest sense, the issue cannot be ignored.

Practically all of those referred to me for psychotherapy within the mental health system are already on medication. This would have been prescribed either by their GP (before they were referred to services) or by their psychiatrist within the service.

The only exceptions to this would be those individuals who declined medication in the first place, those who were treated with medication in the past and want an alternative, and those who wish to be supported as they come off medication they are currently prescribed.

There are many forces at play to maintain the usage of medication as the predominant treatment offered to patients in mental health services.

Among these are:


The dominance of the medical model of care in mental health services in this country;

* The vested interests of the powerful pharmaceutical industry and its unhealthy co-dependant and exclusive relationship with the profession of psychiatry;

* A cultural expectation that a GP or mental health service provider has a cure or a pill for every pain, and also the resulting dissatisfaction when someone does not get what they want.

The cost of medication is huge, both in human terms and to the exchequer. The latter was brought home to me recently when a friend of mine, new to mental health services herself and not having a Drugs Payment Scheme card, spent €360 on a new prescription over just a three-week period, while awaiting her application for her scheme card to be processed.

I could only imagine the ongoing cost of keeping thousands on medication long-term. And it is almost always long-term. Just because we do not pay the full amount for our prescription does not mean that it is not costing somewhere.
This money would have paid for a lot of therapy and avoided kicking the problem down the road.

However, we cannot blame any one individual or professional group for the design of the current service delivery, where productivity is measured counting throughput, or “bums on seats”.

And with an inadequate psychotherapy service, or even in some locations the absence of any service, it is hard to blame a medic for prescribing something that will take the painful edges off a person’s suffering, albeit for the short-term at least

More highlighting and discussion of this and related issues is urgently needed.

* Ita Mc Swiney is a psychotherapist and supervisor with The Irish Association of Humanistic Psychotherapy

Read more: http://www.irishexaminer.com/features/debate-on-antidepressants-needed-187775.html#ixzz1qAhcywZo

Paxil (Seroxat) Litigation Court Archive Now Online….

I hadn’t noticed this before, it’s documents relating to various Paxil trials over the years..
Looks interesting..



(thanks to Bunker, I just noticed you linked it in a comment, thank you, hadn’t seen it)

Showing 1-10 of 296 documents
1. Minor changes to draft
Document Date: 19990211
Author: Keller, MB
Corporate Author: Brown University
Recipient: Laden, SK
Document Type: letter
Named Person: Brand, B
Case Number: In Re Paxil, C.P.Ct.PA
Bates Number: par000212926-par000212926
Search Terms in Context: 02-25-99 17:43 SALLY K LADEN STI ID- P . 01 Martin B. Keller, M.D. Mrtry ii. ZurJur hvftam & CJtaumm D^partmwu nf Psyrhiatry ft Unman Behavior BROWN UNIVERSITY Prnvirli-nr*-, Rhode Island 02912 Bmlet Hriiplral Extcuttv* PrjckialriM-irrCknf Emmt Pcn
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Person Copied: McCafferty, JP
Page Count: 1
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/anu38h10

2. Unipolar adolescent study: proposed titration schedule
Document Date: 19930302
Author: NEAL
Recipient: Birmaher, B; Feinstein, C; Geller, B; Keller, MB; Klein, R; Koplewiss, H; Kutcher, S; Meltzer, B; Small, E; Robbins, D; Strober, M; Williamson, D; Waterman, S; Janosky, S; Ryan, N; McCafferty, JP
Document Type: email
Named Person: Lavori, P; Steinhard, R; Shekim, W
Case Number: Smith v. GSK (SuperCtCA)
Bates Number: par000754923-par000754923
Search Terms in Context: TO: Jim McCafferty >4cris Birmaher , VO – 6 ^ V- 3?Oi ^^Cari Feinstein – ¦-• X 1 ^ ¦ ^Barbara Gelier 314 362-6335, •”Marty Keller 401 455-6441, i/Rachei Klein 211 566-6656, ¦¦t^r.ar-z-Ld Kopiewicz “15 470-9291, •Stan Kutcher 416 460-6616, Bruce Meltzer 4C1-435-C515, — ^ileen Small 401-4=5-0516, “tug Robbins 401 436-5149, Ri. ¦i””0l*Li ‘EL’ ‘fOi’Cll 2700; w<^ike Strober 310 206-4446, 7i\7-! 1 1 ' =rr, ;rr <" ¦", t rem: Scott Waterman , Sy 1 vi a Ja no s kv, l/Neai Ryan, Jim McCafferty 215-632-3450 NZAL Organization: WF1C Child Psychobioicgy Date: 3 Feb 93 12:59:59 FST Subject: Unipolar Adolescent Study: F r i o r i ty: n o rrr.a 1 X-mailer: Pegasus Mail v2.3 (R5) . ton siei****** it>iur-?Y*f (AJhjLj> s*rtrr±m (/Kite S7&*c± SfiZ&ty re* v Proposed titration schedule After today’s ;2/3/93) conference phone call it is ver/ clear that reaching consensus on th
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 1
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/aou38h10

3. Manuscript 2000/1310
Document Date: 20000215
Author: Dulcan, MK
Corporate Author: Children’s Memorial Hospital
Recipient: Keller, MB
Document Type: letter
Case Number: Steinberg v. GSK (SuperCtCA)
Bates Number: par000757240-par000757240
Search Terms in Context: J tl ‘; l “lit > IS!( … v ,!.’ >\ ;\. 505 Morris Avenue Springfield. New lersev 07081 August 7, 2001 James McCafferty Senior Scientist GlaxoSmithKline 1250 S Collegeville Rd UP4410 PO Box 5089 Collegeville, PA 19426-0980 RE: PAXIL ADOLESCENT DEPRESSION PAPER Dear Jim: I am pleased to enclose a small supply of reprints of the paroxetine-imipramine adolescent depression paper that was recently published in journal of the American Academy of Child and Adolescent Psychiatry. GSK funded the purchase of the reprints. A total of 300 went to Marty Keller, who is corresponding author on the paper, and the balance is being sent to Zach Hawkins for distribution to the Neuroscience sales force. Samples are also being sent to Rocco and Neil. The paper looks excellent and demonstrates the commitment of GSK to the field of psychiatry. Thank you for your support. Sincerely, Sally K. Laden, MS Associate Editorial Director end cc: .1301 PAR001380128 (973) 376-5655 telephon
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 1
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/asu38h10

7. US Senate inquiry: removal of Mosholdor from FDA advisory committee meeting and other matters
Document Date: 20040803
Author: Grassley, C
Recipient: Viehbacher, C
Document Type: letter; report
Case Number: In Re Paxil, C.P.Ct.PA
Bates Number: par004177597-par004177616
Search Terms in Context: 08/03/04 14:18 FAI 215 751 4184 GLA10SMITHKLINE rB6M£iJ^ 59029 .^46Ph chris vichbrcher “** ,’,.,’I’I’.”’¦’•’¦¦> .^ J ‘^——”^^ 1^ 1*1”’ – ¦ ®001 TD:919 315 U2^60 P’VtVS I ¦¦’ I . .TV •• Facsimile Transmittal SQ4 Hart Senate Pffice Building PHONI Fax _Redacted Redacted To: Mr, Christopher Viehbacher Fax: Redacted From: Chairman Chuck Grasaley Date: August 3,2004 Number of pages transmitted, including cover sheet Notes: Pteasft can Tom Novelll an 202224-C447 for problems with transmissions jE Qj^h_clfluki*L JXintMJu \i^i\Uj/}k (Uwcjl fr, < WRING K*7W.VWJ 1MCN7MTT MlMiKBWl T31YM'V»J SNPWI MtfW CIUiaTf4QMAS. WYDMNG uU.HWTnNNMin cg)|ixa* OM
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 20
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/atu38h10

8. Re: Paxil Data request SAEs
Document Date: 20030716
Author: Kline, T
Recipient: Worth, BJ
Document Type: email
Named Person: David, PA; Murray, JF
Named Organization: Food and Drug Administration
Case Number: Smith v. GSK (SuperCtCA)
Bates Number: par008184244-par008184247
Search Terms in Context: From: Thomas F Kline/SB-OTHER/PHRD/SB PLC To: Brian J Worth/SB-OTHER/PHRD/SB_PLC@SB_PHARM_RD Subject: Re: Paxil data Request Date: 07/16/2003 13:32:26 (GMT-05:00) I sent the below document to FDA via email on Monday July 14th. I needs to be sent hardcopy to FDA also, so can you prepare a submission accordingly. I'll route a cover letter to you in Cards. Thanks, Tom -— Forwarded by Thomas F Kline/SB-OTHER/PHRD/SB_PLC on 16-Jul-2003 13:30 -— Thomas F Kline 14-Jul-2003 15:20 U.S. Regulatory Affairs – Director, Psychiatry Group One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929 (Mail code: FP 1005) Phone: (215) 751-4054; Fax (215)751-4926; GSK Network: Phone 8-288-4054; email: Thomas_F_Kline@GSK.com To: DAVID@cder.fda.gov cc: RAID@SB Subject: Re: Paxil data Request Paul, In response to the Agency's request, please see the attached document regarding possibly related suicide-related SAEs. The two cases of hostility that were identified
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 4
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/auu38h10

9. Publication date for Paroxetine Depression Study
Document Date: 20010227
Author: Laden, SK
Recipient: McCafferty, JP; Im, J; Battin, MR; Kumar, R; Zaninelli, R; Sproull, SA; Hood, SX; Vitale, SM; Smith, TE
Document Type: email
Named Person: Keller, MB
Case Number: In Re Paxil, C.P.Ct.PA
Bates Number: par008960642-par008960642
Search Terms in Context: From: SallyL@stimedinfo.com To: James P McCafferty/DEV/PHRD/SB_PLC; Johnny lm/FPL/Pharms/SB_PLC; Matt R Battin/FPL/Pharms/SB_PLC; Rajinder Kumar/DEV/PHRD/SB_PLC; Rocco 2 Zaninelli/DEV/PHRD/SB_PLC; Scott A Sproull/FPL/Pharms/SB_PLC; Sheila X Hood/FPL/Pharms/SB_PLC;sherriJaffe@cohnwolfe.com; Steven M Vitale/FPL/Pharms/SB_PLC;tania_lyons@mccann.com; Terri E Smith/FPL/Pharms/SB_PLC CC: File@stimedinfo.com;johnr@stimedinfo.com; MarionP@stimedinfo.com;UnaK@stimedinfo.com Subject: Publication date for Paroxetine Adolescent Depression stud y (PAR 329) Date: 02/27/2001 13:20:56 (GMT-05:00) cc: 1301 Hello Paxil Team: We learned this morning that the Journal of the American Academy of Child and Adolescent Psychiatry has scheduled a tentative publication date for this manuscript. According to their editorial offices, proofs will be available in mid-May with publication scheduled for August, 2001. We have offered to help Dr Keller's office proof the galleys in
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 1
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/avu38h10

10. GSK psychiatry projects: Status report March 2003. Seroxat/Paxil Projects (ghostwrite studies 676, 701)
Document Date: 20030301
Document Type: table
Case Number: Smith v. GSK (SuperCtCA)
Bates Number: par010671035-par010671036
Search Terms in Context: A randomized, 676 Wa JAMA January Agreed 3rd draft – some queries Provide comments on multicenter, double-blind, gne 2003 budget of still outstanding 3rd draft placebo-controlled study r 23,800; to assess the efficacy 15,200 and safety of paroxetine already in children and paid; 8,600 adolescents with social still to be anxiety disorder invoiced [12539] D On track S Some delay I Significant delay Updated: [ TIME @ "d-MMM-yy" ] Page 5 pgNbr=1 GSK PSYCHIATRY PROJECTS : STATUS REPORT [MARCH 2003] SEROXAT/PAXIL PROJECTS Publication title Stud iST Target journal [Project code] y™ aut hor Timeline Paroxetine treatment in 704 Ge\\ J Am Acad Child A January children and adolescents er Adoles Psych 2003 with obsessive-compulsive disorder: a randomized, multicenter, double-blind, placebo-controlled clinical trial
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 2
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/awu38h10

Seroxat Secrets Reaches Over Half A Million Web Hits!!!

Simply fantastic news today from the Seroxat Secrets Blog. Over half a million unique web visitors! Brilliant achievement for the author of the blog and also for all those harmed by pharmaceutical drugs and psychiatry! Just last week I noted my blog reaching over 50,000 hits, and Bob Fiddaman’s Blog reaching well over 300,000 hits, that’s almost one million hits between us! Great Stuff guys…


And, I must say I echo the Seroxat Secrets viewpoint when I say that ..

Glaxo must not be allowed to get away with it.

It’s a marathon – not a sprint.
March 13, 2012 — admin
Well, I never… Seroxat Secrets has just passed 500,000 unique visits. That’s half a million hits.

OK, it took a few years to get here, but I hope it’s been worthwhile and that the blog has helped a few people along the way.

My first post was in 2006 and when I started writing I wanted to create an internet resource that would gather together information and links and allow people to make an informed choice about the medication they were taking – or were about to take. I wanted to provide a counterpoint to the lies and spin that pharmaceutical companies turn out under the guise of ‘marketing’.

A few years ago I added a page to Seroxat Secrets, ‘What I believe’ – and it’s still what I believe:

I believe Seroxat is defective and dangerous.
I believe that Glaxo has hidden negative clinical trial data that shows exactly how dangerous a drug it is.
I believe that Seroxat is addictive.
I believe that Seroxat can cause anger, aggression and violence.
I believe that something must be done to help people who suffer terrible problems during withdrawal, as they desperately try to stop taking Seroxat.
I believe that doctors have taken large sums of money from Glaxo to lie about the efficacy and safety of the drug.
I believe that GlaxoSmithKline puts profits before patients – their wealth before our health.
I took Seroxat for 9 years and it took me 22 months to withdraw from the drug little by little. Believe me – I know what I’m talking about.

There is just one thing I’d add to this list today:

Glaxo must not be allowed to get away with it.


Wednesday, March 14, 2012
Seroxat Secrets, Half a Million of Them
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Seroxat Secrets has reached a milestone. The author of the popular blog has just announced that his hits have gone over the half a million mark – that’s great going!

It’s a terrific blog full of useful information about Seroxat, GlaxoSmithKline and the MHRA. The author pulls no punches either, he writes:

A few years ago I added a page to Seroxat Secrets, ‘What I believe’ – and it’s still what I believe:

I believe Seroxat is defective and dangerous.

I believe that Glaxo has hidden negative clinical trial data that shows exactly how dangerous a drug it is.

I believe that Seroxat is addictive.

I believe that Seroxat can cause anger, aggression and violence.

I believe that something must be done to help people who suffer terrible problems during withdrawal, as they desperately try to stop taking Seroxat.

I believe that doctors have taken large sums of money from Glaxo to lie about the efficacy and safety of the drug.

I believe that GlaxoSmithKline puts profits before patients – their wealth before our health.

I took Seroxat for 9 years and it took me 22 months to withdraw from the drug little by little.

Believe me – I know what I’m talking about.

There is just one thing I’d add to this list today:

Glaxo must not be allowed to get away with it.

I met the author of Seroxat Secrets in London a couple of years ago. I hope to meet him again someday soon. The drinks are on me sir.

Seroxat Secrets is a wealth of information and can be viewed HERE


Seroxat: Paroxetine: Profiting from Bad Medicine


The Brown Daily Herald > Opinions > Columns

McGoldrick ’12: Profiting from medicine
Rebecca McGoldrick
Opinions Columnist
Published: Wednesday, March 14, 2012

Medicine — we love it, we praise it, we have faith in it, we take it, but should we trust it? Normally we think researchers, doctors and other health professionals have our best interests at heart, but all too often we forget how corrupting money can be, even in the most virtuous of professions. In recent years there has been a general growing concern about the ethical behavior of pharmaceutical companies and the universities that collaborate with them — unfortunately, Brown included.
In the 1990s, Professor of Psychiatry and Human Behavior Martin Keller conducted a study on paroxetine — a drug marketed as Paxil in the United States and as Seroxat in the U.K. — to see if the drug was a safe and effective treatment for depression in adolescents.

The study was funded by GlaxoSmithKline and the results, which concluded that paroxetine was safe and effective in adolescents, were published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry. With this stamp of approval, the drug was prescribed to thousands of people of all age groups — including teens — for ailments from depression to dizziness. Though it was one of GSK’s most profitable drugs, paroxetine soon racked up stacks of side-effect complaints as serious as dependence and suicide.

According to The Herald, part of the controversy lies in the claim that Keller used selective reporting — he discarded negative findings — to come up with his positive results. But another ethical concern is the alleged claim that a GSK-affiliated employee ghostwrote the study’s results. In other words, the accusation is that Keller accepted money from the pharmaceutical company in exchange for allowing the study’s findings to be written by someone paid by GSK and published under his name. While the jury is still out on this case, it’s a reminder that we shouldn’t assume that money can’t influence the health profession.

In fact, the very structure of this industry consistently puts profits before patients. In 2010 alone, Americans spent more than $307 billion on prescription drugs. Many pharmaceutical company apologists argue that these tremendous revenues are necessary to pay for the costs of research and development.
Sure, research and development is costly, but that doesn’t explain the price of these drugs. The truth is that the major pharmaceutical companies — GSK, Pfizer and AstraZeneca, to name the biggest players — spend twice the amount on marketing and advertisement as they do on research and development. Apologists retort that marketing is necessary to educate health professionals and the public about the innovative drugs they produce in their labs. This ignores the fact that these companies are not producing innovative drugs, but imitation drugs.
Pharmaceutical companies have to spend more on marketing and advertisement because most prescriptions being introduced on the market are not new drugs, but merely imitations of already existing medicines. The lion’s share of this “research and development” either goes towards copying another company’s pill or tweaking the molecular formula of one of their own drugs that’s lost its patent. How many prescription nasal allergy sprays are advertised on television? Do we really need Pfizer’s Lipitor and AstraZeneca’s Crestor if both lower cholesterol? Or what about Nexium — the “healing purple pill” — that was introduced only after Prilosec lost its patent status and became available over the counter? The examples are endless.
Sometimes these copy-cat drugs are actually more dangerous than the ones they’re replacing. Vioxx, for instance, was a hugely profitable drug despite the fact that it was no more effective than aspirin and significantly more fatal.
These billion-dollar companies don’t market their drugs in order to educate us. They do it to secure their own piece of the lucrative drug market. Since there are a handful of other drugs on the market that do exactly the same thing, the aim of these marketing campaigns is to make their brand name and their pill the one that doctors are familiar with and prescribing. The pharmaceutical industry spends nearly $25 billion on things like pens, clocks, sporting event tickets and vacations that advertise to doctors and medical students. This calculated investment provides these mega-corporations enormous returns.
Additionally, pharmaceutical companies consistently seek to create lifestyle drugs — drugs that healthy people take to improve appearance or performance. Nearly every major pharmaceutical company is producing drugs for conditions like hair loss, acne, rosacea or erectile dysfunction. Pharmaceutical companies invest in prescriptions that Americans can afford and believe they need while neglecting to invest in cures and preventive treatments for diseases like malaria that are decimating the developing world.
It is absolutely unacceptable that this industry pushes people to believe that medicine is expensive because research and development is costly. These companies sweep negative clinical trial findings under the rug, invest in developing drugs that may be less effective and more dangerous than ones already on the market and care more about improving a patient’s self-esteem than saving lives.

Brown’s cozy friendship with pharmaceutical companies should concern every one of us. The University’s failure to launch a public investigation into Keller’s research threatens the integrity of other research coming from Brown. Not only does it discredit Brown’s integrity as a research university, but it also threatens patient safety since doctors are misinformed about the negative side-effects of drugs they are prescribing. The University should be devoted to researching medicine for the sake of benefiting humanity, not corporate profits.

Rebecca McGoldrick ’12 is an English concentrator from Andover, N.J. She can be reached at rebecca_mcgoldrick@brown.edu.