In The BMJ: Nurse Explains The Devastating Consequences Of Being Prescribed Seroxat (Paxil) At Age 20…

What’s the difference between an 18 year old and a 20 year old in terms of side effects of Seroxat? (Seroxat is banned for under-18’s but that didn’t stop GSK from pushing it, nor did it stop them from pushing it in adults).
I was 21 when I was prescribed Seroxat, and I was upped my dose to 40mg at one point..
This nurse was zombified on 5mg after a few weeks…
Try it for years.. how do you imagine that would turn out?
GSK have literally been poisoning people to death with Seroxat..
It’s a disgrace…

Feature Research Conduct

No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility

BMJ 2015; 351 doi: (Published 16 September 2015) Cite this as: BMJ 2015;351:h4629

Paroxetine trial reanalysis raises questions about institutional responsibility

I wanted to say thank you for publishing this article. I was once on Paxil myself, as a newly 20 year old, for panic disorder without agoraphobia. While taking just 1/4 of the normal starting dose (5mg was my dose), I displayed flat affect and a “zombie” like appearance. This was within several weeks, about two. I then became suicidal.

For something that is supposed to be an ANTI-depressant, I’m amazed at how PRO mental disorder it truly was.

I’m a very happy woman, and was always a happy teenager. This was not normal. The small, sane part of my brain told me I needed to tell someone I was feeling this way, but I didn’t want to – they would try to stop me if I did tell someone. I will never forget what that feeling was like, and I truly wonder if I am a PTSD patient now because of it.

In the end, I did try to hurt myself. I was very lucky to have my mother and a very close friend stop me and take me to the doctor. They pulled me off Paxil completely and switched me to another SSRI and a benzodiazepine to ease the withdrawal side effects from the Paxil. I’ve been on this SSRI ever since, and it has now been about 10 years.

Everytime I see an article like this, my heart breaks. I truly hope that this research saves other adolescents from experiencing what I went through. I wouldn’t wish it on my worst enemy.

Competing interests: No competing interests


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?

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.


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.”


“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.

GSK Zyloric Petition

I was alarmed to find that the prescription drug ,’Zyloric’ is freely available in Nigeria with a drug information leaflet written in French, and bearing the name and trademark of the pharmaceutical company GlaxoSmithKline, (GSK).
Nigeria has over 300 separate indigenous languages, and its official language is English. French is not spoken anywhere in Nigeria.
As a registered pharmacist in Nigeria, The U.K, and The U.S.A, I know of no other country where a pharmaceutical product is freely availabe without apparent regards to the language(s) of the country it is marketed in.
The information and warning on the information leaflet are meant to alert the user to the safe use of the drug and possible adverse effects. I am particularly concerned about this drug for three reasons.
First, both myself and my father have a condition (gout/hyperuricemia) for which this drug is used, and I have previously been prescribed this drug.
Secondly, there is a story in the Nigerian press where GSK was taken to the Nigerian High Court  after a Nigerian banker allegedly suffered a serious life threatening adverse effect and “health complications” from using Zyloric. ( Surprisingly, Zyloric can still be obtained in Nigeria without an English language drug information leaflet.
Thirdly, and more alarming are the numerous other lawsuits filed against GSK around the world, including a guilty plea to criminal charges resulting in $3Billion in fraud settlement charges (NYTimes,2012). This does not give me much confidence in GSK. Through this petition I hope to raise awareness and stop the double standard where the marketing of pharmaceuticals in Nigeria and other African countries is in any way different from that in Europe or America.
The safety of the patient is  more important than the few pennies it would take to provide an English language information leaflet – which, by the way, is available in other English speaking countries. The English language information leaflet I obtained for allopurinol (the generic form of the drug), warned, among other things, of “A very serious, (possibly fatal) allergic reaction to this drug…..”.
The Journal of American Academy of Dermatology found that allopurinol, the ingredient in Zyloric, causes SJS or Steven-Johnson Syndrome. This is described as a “potentially life threatening disorder of the skin and mucous membrane” ( Patients in Nigeria would also like to know this so they can take informed decisions when using Zyloric. This, in my professional opinion, is the safe and ethical thing to do. Please sign this petition to get GSK to provide adequate information on ZYLORIC, in a language its patients understand. This will help safeguard the health of patients who may unknowingly use this drug without being aware of its possible fatal adverse effects.  

Scientific American: Many Antidepressant Studies Found Tainted by Pharma Company Influence

Many Antidepressant Studies Found Tainted by Pharma Company Influence

A review of studies that assess clinical antidepressants shows hidden conflicts of interest and financial ties to corporate drugmakers

Tom Varco/Wikimedia Commons, CC BY-SA 3.0

After many lawsuits and a 2012 U.S. Department of Justice settlement, last month an independent review found that antidepressant drug Paxil (paroxetine) is not safe for teenagers. The finding contradicts the conclusions of the initial 2001 drug trial, which the manufacturer GlaxoSmithKline had funded, then used its results to market Paxil as safe for adolescents.

The original trial, known as Study 329, is but one high-profile example of pharmaceutical industry influence known to pervade scientific research, including clinical trials the U.S. Food and Drug Administration requires pharma companies to fund in order to assess their products. For that reason, people who read scientific papers as part of their jobs have come to rely on meta-analyses, supposedly thorough reviews summarizing the evidence from multiple trials, rather than trust individual studies. But a new analysis casts doubt on that practice as well, finding that the vast majority of meta-analyses of antidepressants have some industry link, with a corresponding suppression of negative results.

The latest study, published in the Journal of Clinical Epidemiology, which evaluated 185 meta-analyses, found that one third of them were written by pharma industry employees. “We knew that the industry would fund studies to promote its products, but it’s very different to fund meta-analyses,” which “have traditionally been a bulwark of evidence-based medicine,” says John Ioannidis, an epidemiologist at Stanford University School of Medicine and co-author of the study. “It’s really amazing that there is such a massive influx of influence in this field.”

Almost 80 percent of meta-analyses in the review had some sort of industry tie, either through sponsorship, which the authors defined as direct industry funding of the study, or conflicts of interest, defined as any situation in which one or more authors were either industry employees or independent researchers receiving any type of industry support (including speaking fees and research grants). Especially troubling, the study showed about 7 percent of researchers had undisclosed conflicts of interest. “There’s a certain pecking order of papers,” says Erick Turner, a professor of psychiatry at Oregon Health & Science University who was not associated with the research. “Meta-analyses are at the top of the evidence pyramid.” Turner was “very concerned” by the results but did not find them surprising. “Industry influence is just massive. What’s really new is the level of attention people are now paying to it.”

The researchers considered all meta-analyses of randomized controlled trials for all approved antidepressants including selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, atypical antidepressants, monoamine oxidase inhibitors and others published between 2007 and March 2014.

If the authors did not report any conflict of interest, as is typically required, the researchers examined random samples of articles published by the corresponding author in the same year for relevant declarations of conflicts. Two investigators not aware of the author’s names or potential conflicts assessed whether the meta-analysis included any negative or warning statements about the drug in the abstract or conclusion of the article.

Although a third of the papers were written by industry employees; of the majority of authors, 60 percent were independent, university-affiliated researchers with conflicts of interest. For the 53 meta-analyses where the author was not an industry employee and did not report any conflicts of interest, 25 percent had unreported conflicts of interest that the researchers identified in their search and included in their evaluation. “The meta-analyses that have industry links are very different than those that don’t have industry links,” Ioannidis says. Those with industry ties had much more favorable coverage and fewer caveats. “Conversely, when no employees were involved, almost 50 percent had caveats,” Ioannidis says.

Meta-analyses by industry employees were 22 times less likely to have negative statements about a drug than those run by unaffiliated researchers. The rate of bias in the results is similar to a 2006 study examining industry impact on clinical trials of psychiatric medications, which found that industry-sponsored trials reported favorable outcomes 78 per cent of the time, compared with 48 percent in independently funded trials.

Ioannidis believes that pharmaceutical companies should be restricted from funding meta-analyses to safeguard objectivity. He is fine with industry funding for other types of research, “but not when it comes to the final appraisal of whether should patients take this drug or not,” he says.

All of the major pharmaceutical companies were represented in the review, including GlaxoSmithKline; Eli Lilly and Co., maker of the popular antidepressant Prozac (fluoxetine); and Pfizer, which makes Zoloft (sertraline chloride). “As to meta-analyses,” Pfizer is an “active participant” in the conversation “about how to define scientifically robust frameworks for reanalysis of data,” wrote Dean Mastrojohn, Director of Global Media Relations at Pfizer, when reached for comment.

By definition, a meta-analysis should be “as comprehensive as possible a review,” says Andrea Cipriani, a psychiatry professor at the University of Oxford who was not involved with the study. “Clinicians are bombarded by information” and turn to meta-analyses “because they don’t have the time to do a full critical appraisal for themselves. The word means ‘shortcut to a lot of evidence.’”

Cipriani agrees that it is important to point out the manipulation of meta-analyses are by the pharmaceutical industry. “We need to highlight that these meta-analyses are more a marketing tool than a science,” he says. But Cipriani, who had seven articles flagged in the review for reported conflicts of interest, thinks that it is an oversimplification to condemn all studies with industry ties. Rather, Cipriani advocates transparency and says that the main problem is the lack of disclosure. To his credit, even with conflicts of interest present Cipriani included caveats in the conclusion or abstract in two of his papers. He was one of the few researchers with stated conflicts to do so, however.

According to Cipriani, academic journals, the gatekeepers of scientific evidence, are the ones who should be responsible, both for looking into conflicts of interest and weeding out those studies whose conclusions do not match up with the supplied data. That was part of the problem with Study 329, led by Martin Keller, then a professor of psychiatry and human behavior at Brown University, which reported all data accurately but misleadingly downplayed the teen suicide risk and exaggerated the benefits in the conclusions.

But journals often have their own conflicts of interest, something Cipriani acknowledges. Ioannidis and his colleagues originally tried to publish their latest study in psychiatry journals that they thought would be more pertinent, but the reception was cold. “Some people felt pretty angry about it and many of their editors have strong ties to the industry.” Ioannidis says.

Publication bias, where journals have shown a preference for new, positive and exciting results over replication of past studies—an essential part of the scientific process—is also a widespread problem within scientific publishing. This trend exists regardless of funding source or treatments assessed. In a study also published last month Turner found publication bias and inflated results in several National Institutes of Health–funded studies on psychotherapy.

Antidepressants are one of the largest pharmaceutical markets, with sales of $9.4 billion in the U.S. in 2013. Cipriani and Ioannidis believe the problem extends to other drugs with high market value, such as heart and cancer medications. “The whole field needs some soul searching,” Ioannidis says.

Peter Humprey: The rule of law doesn’t really exist in china’

(see Links for BBC Radio Interview of Peter Humphrey)

The rule of law doesn’t really exist in china’

Peter Humphrey was a British corporate investigator who worked in China until he and his Chinese wife were imprisoned after facing trumped-up charges.
Having been released on health grounds and deported back to Britain, Mr Humphrey spoke on the programme.

“The rule of law doesn’t really exist in china,” he said.

“It is constantly violated because law in China is basically manipulated by people with powerful connections.”

The corporate investigator claimed that if somebody has offended you, and you have connections, you can have that person arrested.

“It as a very serious type of corruption which is perverting the progress of justice in China,” he said.

Release date:

23 October 2015

UK’s MHRA Calls Out GSK China Plant Over GMP Non-Compliance

UK’s MHRA Calls Out GSK China Plant Over GMP Non-Compliance

Posted 23 October 2015 By Zachary Brennan


The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released an inspection report that found a GlaxoSmithKline (GSK) manufacturing facility in Tianjin, China was non-compliant with Good Manufacturing Practices (GMPs).

The site manufactures the heartburn treatment Zantac for markets including the UK, Austria, Belgium, Denmark, Finland, Germany, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal and others.

MHRA inspected the site in June and on Friday issued this statement of non-compliance saying the facility “should not be named on any marketing authorizations whilst this statement remains in place,” according to the EU’s EudraGMDP website.

The warnings follow other issues GSK has had in China, including a bribery scandal from a year ago for which the company was fined nearly $500M.


The inspectors identified sterility issues, in addition to primary and secondary packaging deficiencies, as well as problems with quality control testing.

“A critical deficiency was cited with regards to system failures to ensure that the manufacture of medicinal products were fit for their intended use, complied with the requirements of the Marketing Authorisation and did not place patients at risk due to inadequate safety, quality or efficacy,” the MHRA said.

Since 2005, GSK identified tablet discoloration in the stability samples during trials which did not meet the shelf life specification.

“No action was taken to assess the risk of the remaining products in the markets,” MHRA says. “Adverse trends in stability-indicating attributes were observed but not investigated.”

In addition, product impact assessments failed to ensure that the defective product was not potentially supplied to the user, and the company also failed to notify regulators of the discovery of these “defective products.”

GSK was also cited for failing to address the root cause of the issues because of ineffective Corrective and Preventive Actions (CAPA) that weren’t appropriately implemented. The company also failed to conduct effective investigations in a timely manner.


A series of explosions on 12 August, which killed more than 100 people in Tianjin, also had an impact on this same GSK manufacturing facility, according to media reports.

GSK told RAPS it’s looking into the situation.

EudraGMDP Filing

– See more at:

Wall Street Journal: British Investigator Says Prison in China Worsened Health
6:00 pm HKT
Oct 23, 2015

Law & Politics

British Investigator Says Prison in China Worsened Health

Peter Humphrey relaxing with his son, Harvard, after his release from a Chinese prison.

Peter Humphrey, a former private investigator in China who recently won release from a Shanghai prison, this week disclosed he has prostate cancer, a condition he alleges was worsened by terms of a nearly two-year incarceration.

Mr. Humphrey said in a statement and telephone interview from his home in Surrey, England that a prostate problem he experienced while imprisoned — but which went untreated — was recently diagnosed as a malignant cancer. “It wasn’t caught early enough because I was denied the medical attention that I needed,” said Mr. Humphrey.

The 59-year-old Briton said he has begun treatment for his condition but that it could take up to two years for him to know its success.


Mr. Humphrey, a self-employed investigator and former journalist, worked in China for over two decades on behalf of multinational corporations. He spent almost two years in custody in Shanghai during an investigation and subsequent conviction before his early release and deportation in June. Prosecutors alleged that along with his wife and partner, U.S. citizen Yu Yingzeng, Mr. Humphrey violated various statutes related to Chinese personal privacy. The two were released around the same time.

Now Mr. Humphrey says he is making public his health condition as part of a formal complaint by his family in a 50-plus-page report addressed to China’s State Council, or Cabinet. He said the report, which documents his treatment and asks the central government to investigate, was recently delivered to Chinese authorities through diplomatic channels.

As summarized in the statement, the report alleges “abuse of power” by senior members of Shanghai’s Political and Legal Affairs Committee, a Communist Party organization that effectively controls the police, prosecutorial and judicial organs as well individual officials from those bodies.

Among Mr. Humphrey’s allegations is that prison officials as often as weekly requested his signature on a confession before they would permit him to get a full diagnosis and treatment of his prostate, which was giving him trouble behind bars. After pressure from the U.S. and U.K. consulates and despite his refusal to confess, the statement says, Mr. Humphrey was eventually permitted a diagnosis in April, and its dire findings became a basis for his early release.

Chinese officials in the past have defended their handling of Mr. Humphrey, who immediately after his release said his treatment had worsened his health. In June an official at Shanghai Qingpu Prison, where Mr. Humphrey was held, said “his disease was not caused by the detention.” The official added that the prison was able to provide relief but didn’t have the ability to cure Mr. Humphrey. “Every prisoner’s medical care is guaranteed in our prison,” the official said.

British corporate investigator Peter Humphrey leaves the Shanghai No.1 Intermediate People’s Court inside a police vehicle on August 8, 2014.

Also in June, Lu Kang, a spokesman for China’s Foreign Ministry, said that Mr. Humphrey’s claims of mistreatment are “not true” and that “relevant Chinese authorities provided [Mr. Humphrey and his wife] with the due rights and interests,” adding that the couple had satisfied court conditions for sentence reductions.

A Chinese foreign ministry spokeswoman declined additional comment on Friday, while the Shanghai municipal government didn’t immediately respond to questions.

Mr. Humphrey’s statement calls on China’s central government to punish those involved in decisions relating to the case, as well as an unnamed “individual who manipulated” the authorities. It calls for unspecified compensation to Mr. Humphrey and his family.

By telephone, Mr. Humphrey declined to discuss who was or wasn’t a past client of his investigations business ChinaWhys Co. but said the individual who allegedly “manipulated” Shanghai authorities was a former subject of his investigation work.

The statement from Mr. Humphrey coincides with a visit to the U.K. by Chinese President Xi Jinping. “The fact that (the Chinese president) here is significant, and hopefully the central government leadership will investigate what happened in Shanghai,” Mr. Humphrey said.

–James T. Areddy. Follow him on Twitter @jamestareddy.

Study 329: Conflicts of Interest (From Dr David Healy’s Blog)

Study 329: Conflicts of Interest

October, 20, 2015 | Reply

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