British doctor faces action over claims of ‘ghost writing’ for US drug company

What is ‘ghostwriting’? How far will drug companies go to market their products to an unsuspecting and trusting public? This from Sarah Boseley at the Guardian will explain all:

Doctors have been agreeing to be named as authors on studies written by employees of the pharmaceutical industry, giving greater credibility to medical research, according to new evidence.

The Guardian has learned that one of Britain’s leading bone specialists is facing disciplinary action over accusations that he was involved in “ghost writing”.

The wider phenomenon has come to light through documents disclosed in the US courts which have revealed a culture in which doctors agree to “author” studies written by employees of drug firms. The doctors may have some input but do not have access to all the evidence from the drug trial on which the paper’s conclusions are based, the documents showed.

The General Medical Council will call Professor Richard Eastell in front of a fitness to practice committee. Eastell, a bone expert at Sheffield University, has admitted he allowed his name to go forward as first author of a study on an osteoporosis drug even though he did not have access to all the data on which the study’s conclusions were based. An employee of Proctor and Gamble, the US company making Actonel, was the only author who had all the figures.

Experts believe the practice is widespread in Britain. In another alleged example, a consultant cardiologist claims an expert listed as an author on a medical paper died before the research began. Peter Wilmshurst, a heart specialist at the Royal Shrewsbury hospital, is involved in a dispute over a study which he helped design, which involved the insertion of a device to close a hole in the heart.

He claims the manufacturers refused him access to data and he had concerns about the accuracy of the paper, so he refused to sign it off and is not listed as an author. One of those who is named, Wilmshurst said, is a true ghost author. Anthony Rickards, a cardiologist, was involved in preliminary discussions but died before the research was conducted.

The company which sponsored the research, the US firm NMT Medical, is suing Wilmshurst for remarks in a lecture that he made about outcomes in the trial, which were published on a medical journal website. A UK charity, HealthWatch, has launched a fund to support Wilmshurst, who was in 2003 a recipient of its award for challenging misconduct in academic medical research.

The US documents show that Wyeth, one of the biggest companies involved, employed a medical writing agency with the purpose of getting favourable studies about its HRT drug Prempro into prestigious medical journals.

The agency dreamed up ideas for papers about the benefits of the drugs and then wrote an outline and even a first draft before offering it to a doctor who might agree to have his name attached as the author. Although the doctor would see drafts and revisions, critics say that control of the content and message were in the agency’s hands. The memos and emails show that many busy academics signed their approval to the finished paper.

Many of the documents are records of planning meetings, where agency staff list articles that will be written, suggesting possible authors and targeting journals. Concern about ghostwriting caused the UK-based open-access journal PloS Medicine, part of the Public Library of Science, to intervene in a court case brought by women who claim they were harmed by the HRT drug. PloS Medicine, with the New York Times, argued that the public should know what was going on. A US judge agreed to place the documents in the public domain.

Ginny Barbour, editor in chief of PloS Medicine, said she was taken aback by the systematic approach of the agency. “I found these documents quite shocking,” she said. “They lay out in a very methodical and detailed way how publication was planned.”Other documents released through US court action show that GlaxoSmithKline employed a ghostwriting programme named Caspper in which doctors could take credit for medical journal articles written by the company’s consultants.

[Caspper (the friendly Ghost) – a sick joke from Glaxo – I bet they all had a good laugh about that].

The project was aimed at boosting the US sales of an antidepressant called paroxetine, which goes by the brand name Paxil in the US and Seroxat in the UK.

Caspper stood for Case Study Publication for Peer Review. It enabled doctors with positive experiences of Paxil to get into medical journals. A busy doctor could sit back and let a medical writing agency paid by GSK do all their work, from the first draft to getting it accepted for publication by a journal.

The medical writing agency would prepare drafts using whatever material the doctor sent them and create figures and tables. These would go to the doctor for approval. “The author ensures accuracy of material, updates references, supplies missing information, etc,” says the leaflet. Eventually the doctor would complete a sign-off form and the agency would send the paper for publication.

Caspper came to light when internal GlaxoSmithKline documents were released in court action in the US brought by the legal firm Baum Hedland on behalf of patients who claim they were harmed by Paxil. GSK says the programme was discontinued some years ago and that the names of medical writers were included on any published papers.

But Caspper shows there was no dividing line at the time between science and marketing – the leaflet states its purpose is to “strengthen the product positioning and overcome competitive issues”. Doctors and medical journals became part of a promotional campaign, aimed at selling more drugs.

The disciplinary move in the Eastell case comes after he admitted that a statement he signed declaring that all six authors had access to all the statistical data was wrong.

In a letter published in the Journal of Bone and Mineral Research, which carried the original study, he stated: “In the original paper one of the authors, a statistician working for P&G, Ian Barton, had full access to all the data.” The authors had full access to all the analyses of the data that they requested, he said – but those analyses were carried out by the company.

The letter, published in 2007, also acknowledged flaws in the study. A later independent analysis of the data “identified some errors and poor practice”, he wrote. The study was designed to show the strengths of Actonel which was in fierce competition with a rival bone-strengthening drug called Fosamax, made by Merck.

Eastell’s paper concerned a study carried out on behalf of Proctor and Gamble, comparing the bone density of women prescribed Actonel with others who were not. Only the company knew which women were on the drug and which were taking something else.

Eastell’s colleague, Dr Aubrey Blumsohn, wanted the codes which would say which of the patients who suffered fractures had been on the drug. The company refused. Blumsohn took his concerns to Eastell, but in a conversation which Blumsohn says he taped , Eastell said he was concerned that persistent requests might damage the relationship they had with the company. Eastell is said to have told him: “The only thing that we have to watch all the time is our relationship with P&G. Because … we have the big Sheffield Centre Grant [from P&G] which is a good source of income, we have got to really watch it.” .

Tim Kendall, joint director of the National Collaborating Centre for Mental Health, says the problem is the close relationship between doctors and the industry. “Some doctors don’t seem to see the relationship … as problematic.”

A study of 4,000 physicians found that 96% received money from drug companies, and yet “the majority did not see it as a conflict of interest”, he said.

“I do think there needs to be a national debate in this country about the interpenetration of medicine and the pharmaceutical industry.”

Ghost writing was one manifestation of a bigger problem which he believed was the institutional bias of doctors who work closely with and for drug companies. “In mental health 85% of all published trials are funded by the drug industry,” he said. Allowing for the unsuccessful trials the industry does not publish, the figure is probably nearer 95%, he said. Studies have shown that drug company-funded trials are five times more likely to come out with a positive result for the drug than independent trials.

The GMC is criticised by doctors like Wilmshurst and Blumsohn for failing to take a tougher line against doctors involved in dubious research practices.

Jane O’Brien, head of standards and ethics, said that their research guidance specified the importance of honesty in the attribution of authorship. “We would see that as an important issue. If somebody’s name is on something it gives research a credibility that it wouldn’t otherwise have. If somebody had not been involved, we would see that as misleading people as to the credibility of the research.”

She added that the GMC felt it important to play a role in ensuring good conduct in research. About a year ago, she said, they took soundings of bodies that regulate and support research, such as the Medical Research Council, asking whether the GMC should be involved. “The response was yes, because we are the people who can strike doctors off in the end.”

Eastell declined to discuss the hearing. “I do not wish to comment on the case. The proceedings have yet to commence,” he told the Guardian in an email.A spokesperson from the University of Sheffield, where Eastell is professor of bone metabolism, said they were aware of the investigation. “We will be informed by the GMC of any outcome and cannot comment further until we receive this.”

Remember, Glaxo has a track record of not only ghost writing, but hiding negative clinical trail data that would knock sales of its drugs – the story of Seroxat and Study 329 is truly shocking.

Read more here:
More on Paxil and suicide – “Glaxo was aware of this risk, and hid it”

and here:
Let down by the MHRA… again

and here:
Glaxo fails in its responsibility to patients and it hid Seroxat data – it’s official

Internal email shows Glaxo linked birth defect of fetus to Paxil/Seroxat

More from Glaxo’s current trial in the USA.

This from Jef Feeley and Sophia Pearson at Bloomberg:

Sept. 18 — Officials of GlaxoSmithKline Plc, the U.K.’s largest drugmaker, said in 2001 that a birth defect in the fetus of a woman taking its Paxil antidepressant likely was linked to the drug, according to court testimony.

After analyzing a 2001 e-mail from a Paxil user who aborted her fetus because it had a heart defect, Glaxo officials noted in company files they were “almost certain” the drug was related to the problem, Jane Nieman, a former Glaxo drug-safety executive, told a Pennsylvania jury.

“I don’t know who made that assessment, but it’s there,” Nieman testified in a videotaped deposition played yesterday for jurors. Nieman’s testimony came in the trial of another Paxil user’s lawsuit over birth defects suffered by her now 3-year-old son. The state-court trial in Philadelphia is the first of more than 600 cases alleging Glaxo knew Paxil caused birth defects and hid those risks to increase profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Lyam’s mother, Michelle David, blames Paxil for causing her son’s life-threatening heart defects.

Safety Information

Glaxo’s lawyers contend the London-based drugmaker isn’t liable for Lyam’s heart defects and acted responsibly in testing Paxil and updating safety information.

The company’s provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didn’t mention the Paxil litigation.

“It would be inappropriate to comment on evidence during the middle of a trial,” Kevin Colgan, a Glaxo spokesman, said in an e-mail.

Glaxo officials learned about the woman’s experience with Paxil in 2001 after she e-mailed the company seeking information on studies done about Paxil’s links to birth defects, said Nieman, who was the company’s director for evaluation and training for global clinical safety at the time.

The woman, whose identity was withheld by Glaxo, said she’d been taking Paxil for anxiety when she found out she was pregnant, Neiman said. The woman praised Paxil as a “miracle drug” that provided relief from panic attacks, the executive added.

‘Made A Mistake’

“If there is a chance that this might hurt or affect the baby I want to know up front and I will somehow stop taking it for the time being,” the woman said in the e-mail. “I love everything this drug has done for me. Please contact me as soon as possible. Please don’t forget about me.”

Nieman said she didn’t know who at Glaxo made the note in the company’s database that the aborted fetus’ heart defects were likely linked to the woman’s Paxil use.

“Somebody from GSK filled that in,” she said. “There’s a possibility someone made a mistake and checked the box wrong.”

Lawyers for Kilker allege Glaxo mounted a marketing campaign to persuade doctors to write more Paxil prescriptions for pregnant women dealing with anxiety.

The drugmaker undertook that campaign while withholding information about birth-defect reports from doctors, the family contends.

Glaxo’s American depositary receipts, each representing two ordinary shares, fell 7 cents to $38.86 in New York Stock Exchange composite trading. Glaxo rose 1 pence to 1,177 pence in London trading.

The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania (Philadelphia).

To contact the reporters on this story: Jef Feeley in Philadelphia at jfeeley@bloomberg.net; Sophia Pearson in Philadelphia at Spearson3@bloomberg.net.

“If neg, results can bury…” writes Glaxo executive about Paxil/Seroxat

The Philadelphia trial has barely begun and already we are learning more about the way Glaxo does business… rigged drug trials, hidden negative data and fraudulent marketing would seem to be the order of the day once more.

I wonder what new secrets will be revealed next year in London, when Glaxo faces yet more patients injured by Seroxat in the High Court…

Here’s the latest from Bloomberg :

Glaxo Executive’s Memo Suggested Burying Drug Studies

By Jef Feeley and Margaret Cronin Fisk

Sept. 15 (Bloomberg) — An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.

“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.

The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.

Glaxo officials urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.

“They said if there’s any doubt, take it out,” Tracey told jurors. “They do not want to scare anybody. It’s a very competitive marketplace. It’s a multibillion-dollar industry.”

‘Rare Thing’

Glaxo executives contend that the boy’s heart defect wasn’t caused by Paxil, Chilton Varner, one of the company’s lawyers, told jurors today in her opening statement. In court filings, Glaxo has said it appropriately tested and marketed the antidepressant drug.

“When Lyam Kilker was born in 2005, GSK had not received notice” of his specific type of heart defect in connection with Paxil use, Varner said. “The numbers will tell you the defect is a rare thing.”

The Paxil label at that time reported about animal studies, “including the rate of deaths,” she said.

Glaxo didn’t target pregnant women and its sales force didn’t use strong-arm tactics to push prescriptions, Varner said. “Whatever the marketing was, it played no role in Ms. David’s doctors’ decision to prescribe Paxil or Ms. David’s decision” to take the drug, she said.

Rat Studies

Glaxo officials purchased the compound sold as Paxil from a Danish company that had done animal studies showing young rats died after taking low doses of the drug, Tracey said in his opening statement.

One of the company’s scientists noted in internal documents in 1980 that information in the rat studies suggested Paxil “could be” a cause of birth defects, Tracey said. Still, the drugmaker refused for almost 20 years to do studies on why the young rats died, he added.

Tracey told jurors they would see documents in the trial that the company hadn’t turned over to regulators or congressional investigators. “You are going to see docs that have never seen light of day before,” he said.

For example, Tracey pointed to a 1998 internal review by Glaxo of all reports of side effects tied to Paxil and officials found “an alarmingly high number” of birth-defect reports. Even with those concerns, the report was never turned over to the U.S. Food and Drug Administration and “the alarming language” was deleted from it, the lawyer said.

In 2001, the company received a letter from a woman who used Paxil during her pregnancy and decided to abort her fetus after tests showed it had birth defects, Tracey said.

Internal Report

In analyzing the woman’s case, Glaxo officials concluded in an internal report that it was “almost certain” the fetus’s birth defects were caused by his mother’s Paxil use, the family’s lawyer added. Still, the company didn’t turn over its analysis to the FDA or beef up the drug’s warning label, Tracey said.

It wasn’t until after the FDA ordered Glaxo and other makers of antidepressants in 2003 to do more safety studies on their products that Glaxo officials publicly acknowledged that Paxil increased the risk of birth defects, Tracey said.

The lawyer for David, a college nursing student who was a former cheerleader for the National Basketball Association’s Philadelphia 76ers, told jurors that Glaxo hid Paxil’s problems to protect its profits.

Paxil is “the No. 1 asset to this day this company has ever owned,” the attorney said.

‘Quite Different’

Varner said she will present “quite different” evidence on animal tests tied to Paxil.

“The animal testing did not suggest Paxil caused birth defects,” Varner said. The FDA considered the tests when it approved the drug for use by U.S. consumers in 1992, she said.

When Glaxo officials considered offering Paxil for sale in Japan, internal records show executives worried in 1994 they might have to do more safety testing on the antidepressant, said Dr. David Healy, an Irish psychiatrist testifying as an expert for Kilker’s family in the case.

It may be the “type of study we wish to avoid,” Jenny Greenhorn, an official in Glaxo’s international regulatory affairs unit, said in a memo.

Glaxo also is fighting suits in the U.S., Canada and the U.K. over claims that Paxil, also known by the generic name paroxetine, causes homicidal and suicidal behavior. The company has settled some suicide claims, though terms of the settlements haven’t been released.

New York Settlement

In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil may increase suicide risk in young people. The settlement also required Glaxo to publicly disclose the studies.

The company’s provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didn’t mention the Paxil litigation.

“We do not disclose our legal reserves for any specific litigation matter,” Glaxo spokesman Kevin Colgan said earlier this month.

Glaxo American depositary receipts, each representing two ordinary shares, fell 68 cents, or 1.7 percent, to $38.76 in New York Stock Exchange composite trading today. Glaxo fell 14 pence, or 1.2 percent, to 1,175.5 pence in London.

The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania.

To contact the reporters on this story: Jef Feeley in Philadelphia jfeeley@bloomberg.net; Margaret Cronin Fiskmcfisk@bloomberg.net

Remember, Glaxo has a track record of hiding negative clinical trail data that would knock sales of its drugs – the story of Seroxat and Study 329 is truly shocking.

Read more here:
More on Paxil and suicide – “Glaxo was aware of this risk, and hid it”

and here:
Let down by the MHRA… again

and here:
Glaxo fails in its responsibility to patients and it hid Seroxat data – it’s official

Glaxo in court next week – previously secret internal company documents show Glaxo hid adverse data – once again

This from Bloomberg.com via the Truthman:

GlaxoSmithKline to Defend Paxil in Birth Defect Test-Case Trial By Sophia Pearson and Margaret Cronin Fisk

Sept. 11 (Bloomberg) — GlaxoSmithKline Plc, the world’s second-biggest drugmaker, begins a trial in Philadelphia next week in what may be a test case for more than 600 lawsuits over claims its antidepressant drug Paxil causes birth defects.

Patients and their parents claim internal company documents produced for trial show Glaxo failed to warn about the risks of Paxil until forced to do so in 2005 by the U.S. Food and Drug Administration. In a trial set for Sept. 14, Michelle David blames the drug for causing life-threatening heart defects in her son Lyam Kilker, 3.

The London-based company faces two more such trials a month from October through January in state court in Philadelphia. The first group will show both sides how the rest of the lawsuits may fare, said David Logan, dean and professor of law at Roger Williams University in Bristol, Rhode Island.

“These cases are sort of like the canary in the coal mine,” Logan said in a phone interview. “The early cases set the parameters for any global settlement negotiations.”

The medication, approved by the FDA in 1992, generated about $942 million in sales last year, 2.1 percent of the total for the company.

GlaxoSmithKline isn’t liable for Lyam’s heart defects and acted responsibly in testing Paxil and updating safety information, Kevin Colgan, a company spokesman, said by e-mail.

“The scientific evidence simply does not establish that exposure to Paxil during pregnancy caused Lyam Kilker’s condition,” Colgan said. “Very unfortunately, birth defects occur in 3 to 5 percent of all live births, whether or not the mother was taking medication during pregnancy.”

Alert to Doctors

The FDA said in an alert to doctors on Dec. 8, 2005, that preliminary studies suggested Paxil might contribute to heart defects in infants when taken in the first three months of pregnancy. The government asked the company to update the label enclosed with the medicine, changing its birth-defect warning.

The FDA’s action doesn’t prove any connection between Paxil use and birth defects, the company said in court filings.

“Before 2005, more than two decades of studies had found no association between maternal Paxil use and birth defects,” lawyers for Glaxo said July 8 in court papers. “Since 2005, additional studies have been inconclusive with mixed results,” the company said.

“GlaxoSmithKline will show it acted properly and responsibly in conducting its clinical trial program for Paxil, in marketing the medicine, in monitoring its safety once it was approved for use and in updating pregnancy information in the medicine’s label as new information became available,” the company’s Colgan said.

Company Documents

Lawyers for patients claim Glaxo documents show the company knew since 1980 that Paxil could raise the risk of birth defects. They claim Glaxo didn’t sufficiently research the drug before and after it went on the market.

Animal studies didn’t show the drug was safe, company scientist John Baldwin wrote in a March 20, 1980, memo cited in court filings by David’s lawyers.

“There remains the possibility that this compound could be teratogenic at higher dose levels,” he said. A teratogenic agent is one that causes malformations of an embryo or fetus.

“In the face of this warning from Baldwin, GSK chose not to perform any additional animal studies to explore the teratogenic effects of Paxil,” the plaintiffs’ lawyers wrote.

The company in 1993 destroyed raw data from animal studies of the drug, and in 1996, 1998 and 2000 it withheld safety reports of adverse outcomes involving mothers who took Paxil, plaintiffs’ attorneys said in court papers Aug. 10, asking the court to allow punitive damages in the case.

Avoiding Bad Results

The company designed studies to avoid triggering adverse results and stronger warnings, David’s lawyers claim. In 1994, members of the company’s Paxil team supported a low-dose study “as the best way forward and having an acceptably low risk of triggering adverse labeling worldwide,” the lawyers said, quoting minutes of a meeting.

“In 1998, GSK internally concluded that it had received an ‘alarming’ number of abnormal pregnancy adverse events for Paxil and failed to disclose this information to the FDA, physicians or the public,” the lawyers said in the Aug. 10 filing.

Judge Sandra M. Moss, who is overseeing the lawsuits in Philadelphia, denied Glaxo’s motion Aug. 17 to bar punitive damages. She said the company can ask again during the trial.

The company knew the drug was more harmful to pregnant women than cocaine, Sean Tracey, a Houston attorney for David, said during a Sept. 3 pretrial hearing. Glaxo aggressively marketed the drug to women of childbearing age, Tracey said.

Heart Defects

David said she was prescribed Paxil during her first trimester to treat mild anxiety. Lyam was born with defects including two holes in his heart as a result of taking the drug, she said in court papers. The infant underwent multiple surgeries within six months of his birth, she said.

She said wouldn’t have taken Paxil if she knew of the risk and contends that Glaxo failed to warn her or her doctors.

“All of Ms. David’s physicians who prescribed Paxil just prior to and during her pregnancy with Lyam have testified that had they been warned that Paxil could increase the risk of cardiovascular heart defects, they would not have prescribed it to her,” according to court papers.

The company countered at the Sept. 3 hearing that there is no evidence David was taking Paxil at the time Lyam was conceived, and there is no evidence the mother’s doctors considered company promotional materials when prescribing it.

2% Risk for Some

The FDA in 2005 said an analysis of data on Swedish patients showed there was a 2 percent risk of birth defects in babies whose mothers took Paxil early in the pregnancy, twice as high as the risk to the general population. Another study showed the risk was 1.5 percent among Paxil users and 1 percent for those on other antidepressants, the FDA said.

The agency said that while the drug generally shouldn’t be used during pregnancy, its benefits may outweigh potential risks for some expectant mothers who aren’t helped by other medications.

Glaxo is also fighting lawsuits in the U.S., Canada and the U.K. over claims that Paxil, also known by the generic name paroxetine, causes homicidal and suicidal behavior.

The company’s provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didn’t mention the Paxil litigation.

“We do not disclose our legal reserves for any specific litigation matter,” Colgan said.

The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania.

To contact the reporter on this story: Sophia Pearson in Wilmington, Delaware, at spearson3@bloomberg.net; Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net.

There’s a pattern forming here – Glaxo has a track record of hiding negative clinical trail data that would knock sales of its drugs – the story of Seroxat and Study 329 is truely shocking.

Read more here:
More on Paxil and suicide – “Glaxo was aware of this risk, and hid it”

and here:
Let down by the MHRA… again

and here:
Glaxo fails in its responsibility to patients and it hid Seroxat data – it’s official

Emotional side effects of SSRIs – why are patients not warned?

Thanks to the Truthman for this:

Patients should be warned about emotional side effects of antidepressants when they start treatment, British psychiatrists suggest.

The qualitative study of patients taking SSRIs found that the majority of patients experienced a reduction in positive and negative emotions, emotional detachment, changed personality and a feeling of indifference.

Most described a general reduction in the intensity of emotions, so that all their emotions felt flattened or evened out. Others felt they experienced their emotions as thoughts rather than feelings. Most participants described feeling emotionally detached or disconnected and attributed this to their SSRI.

This emotional detachment sometimes extended to a detachment from other people. Specifically, they felt reduced sympathy and empathy and a sense of detachment during social interactions. Almost all participants described not caring about things that used to matter to them, and some felt that their personality had changed in some way.

Writing in the British Journal of Psychiatry, the authors noted that some of the emotional effects described were similar to symptoms of depression, but felt that most participants were able to distinguish between them. Many participants had considered whether they should stop taking their medication, however many viewed the side effects as preferable to the illness they were being treated for. Of note, the authors said, many of the individuals emotional side effects emerged following partial or full recovery from their illness. “Clinicians should therefore also ask routinely about emotional side-effects when they are assessing progress on antidepressants,” they said. “This might compromise asking a broad screening question, and then, if necessary, more specific questions to characterise the nature and extent of the problem.. and its contribution to their decision-making regarding ongoing adherence”.

No shit Sherlock… maybe one day soon we’ll have Glaxo admitting Seroxat/Paxil is addictive and withdrawal from the drug can be hell for many, many people.

Or maybe not.

But don’t worry, our day in the high court is coming soon and then we’ll find out what horror stories Glaxo has been hiding for all these years.

Eli Lilley and Pfizer – both criminal corporations.

And it’s official.

First we had Lilley and the Zyprexa scandal, now we have Pfizer and Bextra (together with an admission of criminal marketing activities involving 13 different Pfizer drugs).

Nice people, eh?

This from ALEX BRUMMER, of the Daily Mail.

America hits out at big pharma 3 September 2009

When the US Department of Justice strikes against corporate wrong-doing, it does so in style.

The massive £1.4bn fine levied on drug maker Pfizer, best known for its little blue pill, will send shockwaves through the pharmaceutical industry.

The charges and larger part of the fine paid by Pfizer relate to the pain relief drug Bextra, which has now been withdrawn from the American market.

The company actively marketed the drug – inherited from Pharmacia – to doctors for the treatment of acute and surgical pain, even though it had not been approved for this purpose.

But more seriously it has admitted to systemic abuse by improperly marketing some 13 different medicines.

Its methods included lavish entertainment of medical professionals at holiday resorts as part of the effort to persuade them to prescribe its compounds.

What is breathtaking is the sheer scale of false and misleading claims made for Bextra in particular.

The firmness of the DofJ action could prove to be a godsend to President Obama as he seeks to reform America’s high-cost health care system.

There has been a long standing belief that the American public has been badly served by the drugs industry, which makes extortionate profits at their expense.

Indeed, last night the New York attorney general Andrew Cuomo charged that Pfizer ‘ripped off’ taxpayers across the country to pad its bottom line.

As part of the deal Pfizer has agreed to post on its website details of any payments or other benefits in kind to doctors or their representatives. There is a similarity here to GlaxoSmithKline’s promise to publish all its research data online following its difficulties in the US with its anti-depression drug Seroxat.

The US authorities have drawn a line in the sand with the severe justice meted out to Pfizer, which saw its shares tumble when the detail of the fine was released. The fine sets an ominous precedent for the other big pharmaceutical firms which find themselves in difficulty with patients, the authorities and the legal system.