Tuesday, June 30, 2015

Channel 5 Respond for Second Time Regarding GSK Deal.






For those who have been following, Channel 5 have replied for a second time regarding their collaboration with British pharmaceutical giant, GlaxoSmithKline.

Basically, in 2013, Channel 5 agreed to place the GlaxoSmithKline brand, Maxi-Nutrition, in the Big Brother house. It is unknown how much GlaxoSmithKline paid Channel 5 for this.

I wrote to Channel 5 and pointed out Glaxo's recent admittance of guilt in the United States, whereby they admitted to making false and misleading claims about a number of their products.

Initially, Channel 5 seemed unconcerned. See emails here.

Channel 5 have now replied for a second time and, as a matter of public interest, I have wrote back to them for a third time.

Here is their reply, followed by mine.

Dear Bob
Thank you for your further e-mails.
The comment to which you make mention was merely intended to make it clear that Channel 5 would not accept advertising or sponsorship for a product about which false or misleading claims were made and was not referring to the past activities of GlaxoSmithKline. Whatever the conduct of the company in the USA in relation to different products, Channel 5 is unaware of any reason which would cause Aquafresh or Maxi-Nutrition products to be undesirable products to be associated with Big Brother.
Channel 5 is a private company and as such is not obliged to comply with Freedom of Information Act (FOI) requests. For further details on the FOI and the organisations to which it applies please visit the following UK Government website:
www.direct.gov.uk/en/Governmentcitizensandrights/Yourrightsandresponsibilities/DG_4003239
Although Viacom is Channel 5’s parent company, we do not divulge contact details for individuals within this company. We would suggest visiting the official Viacom website at www.vimn.com in order to find contact details for personnel at this company.
Thank you for your interest in Channel 5.
Yours sincerely 
Ian
VIEWER ADVISOR


My reply to the above...



Dear Ian,

Thank you for clarifying matters.

It appears that Channel 5 took into account GlaxoSmithKline's guilty plea of false and misleading claims (fraud) and still accepted their advertising/sponsorship. It also appears, if my judgement is correct, that Channel 5 also took into account the current UK litigation against GlaxoSmithKline, litigation that has been on-going for almost 10 years. Once again, Channel 5 decided to go ahead with accepting GlaxoSmithKline's advertising/sponsorship.

It seems quite remarkable that in 2013, despite the above knowledge, Channel 5 agreed to enter into this deal with GlaxoSmithKline, particularly when, one year later, in 2014, the Advertising Standards Authority (ASA) banned an ad for GlaxoSmithKline's MaxiNutrition brand for exaggerating its health benefits. The ASA ruled that because not all of the MaxiNutrition products contained protein, the ad could be misleading to viewers. - Source.

Although this happened approx one year after Channel 5 struck a deal with GlaxoSmithKline, it highlights that the brand featured in the Big Brother House, to millions of viewers, was a brand that was actually misleading Big Brother viewers.

Do Channel 5 have any plans to inform Big Brother viewers of this and/or do Channel 5 have any future plans to work with GlaxoSmithKline again?

Sincerely,

Bob Fiddaman

Author, researcher.

--


Once again, if Channel 5 reply I will, as a matter of public interest, strive to publish what they send me.

As a side note here, Channel 5 and Viacom, even GlaxoSmithKline, may think that I am acting rather churlish chasing this. Truth of the matter is, I don't really care what they think. Personally, I believe GlaxoSmithKline have got away with far too much over the years, often seen making settlements to mothers who have had to abort fetuses because Paxil harmed their child. Or, in other instances, making settlements to mothers who have endured childbirth only to learn that their child has been born with heart defects or skull defects caused by Paxil. I don't like the way their attorneys turned up **mob-handed at Sara Carlin's inquest either, nor the defence they used regarding her suicide. I don't like the way they claim that people taking their antidepressant do not suffer addiction when it's quite clear that Paxil has caused many thousands to suffer addiction. I'm not particularly fond of their attorneys either - yes, I do understand that everyone is entitled to a defence - problem I have is the individual attorneys who know their client has, in the past, hid important suicide information and withdrawal information from the public. In my eyes, they are just as guilty as GlaxoSmithKline.

To be honest, I'm pissed off with companies such as Channel 5 and Viacom and famous people, many of which the public look up to, Jenson Button (McLaren) and  Dame Kelly Holmes, for example, attaching themselves to GlaxoSmithKline without, it seems, caring about Glaxo's past. I'm gobsmacked at the Queen for handing Glaxo's boss a knighthood for 'services rendered to the pharmaceutical industry' - we are talking about the same man who has refused to discuss the Seroxat addiction issue with many patients who, still, struggle to get off the drug his company make. What is it with these people who feel no shame in working alongside or endorsing this pharmaceutical company? Instead of being associated with them they should come out and start asking questions about this company - asking them why they hid the Paxil suicide link in children would be a start. Maybe the likes of Button  and Holmes could then ask Glaxo why they paid leading psychiatrists wads of cash to promote the use of Paxil in children when they knew there was an increased risk of suicide if children took this drug. Or is this just about money?

It's high time companies such as Channel 5 and Viacom were put into the spotlight and asked why they would associate themselves with criminals, yup, it's safe to say that GSK are criminals thanks to the plea of guilty by them in the whistleblower lawsuit which saw them fork out a massive $3 billion in fines. No jail time just a handful of cash from the huge profits made on the very same drugs that they were found guilty, or rather pleaded guilty, to selling whilst misleading the public with false and misleading claims. Not even Hollywood writers and directors could come up with something so perverse and unbelievable!

Many advertising deals are, I assume, struck with GSK. Dinners, gifts and lots of backslapping - nothing ever changes. It, as always, is left to the man/woman on the street to fight their own corners because, it appears, the privileged and the rich just want to continue being more privileged and even richer.

It's kind of sickening and really does leave a bitter taste in my mouth but hey, I'm just the man on the street so who really cares if I feel sickened or not?

I could go on and on...



Bob Fiddaman




Coming Soon.

Seroxat - Emails From The Edge. The second BBC Panorama documentary regarding Seroxat/Paxil addiction.

It's a documentary that, for one reason or another, hasn't really been uploaded anywhere for people who missed it when it was first broadcast in 2003. The first, 'The Secrets of Seroxat' (2002) can be seen here.


**mob-handed (just in case Glaxo's attorney's don't know the definition) - (informal) in or with a large group of people.













Sunday, June 28, 2015

The Seroxat/Paxil Cake.







Cake stars Jennifer Aniston as Claire, a member of a support group for people who are affected by chronic pain. As she learns that one of her fellow group members attempted suicide, Claire becomes obsessed with the woman's story, gets to know the woman's husband, and faces her own inner demons.

I've not seen the movie yet and, to be honest, I had no intentions of seeing it, until, that is, I recently learned that the screenplay for the movie was written by Patrick Tobin.

So, who is Patrick Tobin?


Patrick Tobin


Feb. 13, 1998

Before killing himself, Donald Schell, 60, killed his wife, Rita Schell, 55. their daughter, Deborah Tobin, 31; and Alyssa Tobin, 9 months. Tobin's widower, Tim Tobin, and Donald Schell's sister, Neva Hardy, filed a wrongful-death lawsuit against GlaxoSmithKline (then known as SmithKline Beecham) because they believed that Don Schell acted out of character due to the antidepressant he had been prescribed, Paxil (known as Seroxat in the UK and Europe). Schell had taken just two Paxil pills prior to shooting family members and then himself.

On June 7, 2001, a jury in Cheyenne, Wyoming, found SmithKline Beecham liable for the deaths caused by a Schell. Furthermore, the jury concluded that Paxil could cause someone to commit suicide or homicide and that the drug was in fact a proximate cause of the deaths in this case.

The jury attributed 80 percent of the fault in the case to the drug maker and 20 percent to Donald Schell. Verdict here.

SmithKline, being SmithKline, appealed the decision which saw Tim Tobin et al awarded $6.4 million.

The Tobin family were represented by Andy Vickery and James Fitzgerald.
SmithKline Beecham were represented by Thomas Gorman, Charles Preuss and Tamar Halparin.

During the trial SmithKline internal documents surfaced and showed how they was aware that a small number of people could become agitated or violent from Paxil. Despite this knowledge, Paxil packaging did not include a warning about suicide, violence or aggression.

Before the trial date attorneys representing SmithKline Beecham filed a motion which, if granted by the presiding judge, would have excluded expert testimony from Andy Vickery's two expert witnesses, British psychiatrist Dr. David Healy and Dr. John T. Maltsburger, an associate clinical professor of psychiatry at Harvard Medical School. Their motion was not granted.

Why did SmithKline try to file this motion? Well, they knew that, in the instance of Healy, that he had had access to SmithKline documents that showed results of a Paxil test involving more than 2,000 healthy volunteers taking either the drug or a placebo.

The test showed results of volunteers who had adverse reactions - ranging from insomnia or anxiety to attempted suicide - that Beecham doctors said were either "possibly," "probably" or "definitely" caused by Paxil. Plaintiff attorney, Andy Vickery, pointed out that volunteers in the Paxil test experienced anxiety, nightmares, hallucinations and other side effects definitely caused by the drug - within two days of taking it. As early as four days, one volunteer experienced akathisia, a form of agitation that increases the risk of violence and suicide. Two volunteers attempted suicide after 11 and 18 days, respectively.

SmithKline's attorneys argument was basically that two pills didn't cause this crime but evidence produced during the trial proved otherwise. Vickery showed  results of SmithKline's own Paxil test that showed a whole range of adverse reactions that had, in the main, all occurred within a day or two of the healthy volunteers taking Paxil.

What is striking about the depositions in this trial is the lengths that SmithKline Beecham would go to keep this evidence away from the public, healthcare professionals and medicine regulators.

Ironically, at the time, Dr Ian Hudson, was head of World Safety at SmithKline Beecham. Today, Dr Ian Hudson is the Chief Executive of the British medicine regulator, the MHRA. Parts of his deposition can be seen in the video (The Secrets of Seroxat) below. The documentary was aired on British TV a year after the Tobin verdict.

I'm a bit of a geek when it comes to reading court documents, particularly depositions, none more so than the deposition, in this case, of Dr. Tadataka Yamada who, at the time of his deposition, was Chairman GSK Research and Development at SmithKline Beecham.

During his deposition Yamada was asked the following. I include this because I wish to highlight how SmithKline employees, including Ian Hudson, specialised in answering questions about the Paxil suicide link - One can only assume that their evasiveness was engineered by the attorneys representing SmithKline during this particular trial. I'm also including it because it's a fascinating exchange.

Q.    Suicide is a risk of depression, correct?

A.    That's correct.

Q.    Now, if a patient is on an antidepressant such as Paxil and they become suicidal or more suicidal or actually kill themselves or attempt to do so, then the question that confronts us as we examine that situation is well what caused it or contribute to it.  Was it the depression, was it the drug, was it a combination of both, were there other factors. Would you agree with me that that's the case?

A.    Uh huh.  Yes.

Q.    But if the patient was not depressed and had no other physical condition that we know about that would cause them to become suicidal and yet they became suicidal on the drug, that's the kind of thing that would sort of make us, make our antenna go up, make red flags go off or bells go off?  In other words, concern us; wouldn't it? If people from a healthy study which means that they didn't, did not have any underlying disease process that put them at risk for suicide became suicidal on taking Paxil or any other SSRI drug, would that be a cause for concern that the drug may be causing or contributing to this suicidality?

A.    We would look at all of the data obtained in our healthy volunteers and examine in the proper context.  I can give you an example, examples of drugs that caused people to faint in Phase I studies that we took forward in the clinical studies, because viewed in the proper context the fainting episode was not relevant to the effect of the drug. We have had other circumstances when people would have altered rhythms of the heart during the course of a Phase I study.  That would not necessarily prevent us nor would it the FDA prevent us from continuing on those clinical studies, because bad things happen to people all the time and the temporal relationship does not necessarily imply causation.

Q.    We can certainly agree on that. Can we also agree that if the bad thing happens to a person on a drug and that person is a healthy volunteer that at east we can take some underlying disease process out of the equation in trying to figure out what caused Mr. Jones to have this bad result?

A.    No.  I think the reason why I answered your question originally the way that I did was because nobody's healthy.  See, healthy. I mean you're not healthy and I'm not healthy. We all tomorrow could have some event that we didn't know about, and that event might be temporally associated with drinking a cup of coffee or signing your name.  You know, one can develop a lot of superstitions about what may or may not be associated between an illness and supposed causation that was association, associated in the events starting that illness. So, you know, some people may feel a cold coming on.  They'll do certain things because they think it makes them, it will prevent the cold.  It doesn't mean that whatever they're doing will either prevent the cold or one fact have any bearing on the evolution of that cold.  This is the reason why the FDA and also pharmaceutical companies always take any event that occurs in healthy volunteers in the context of the overall phase of our program to make a decision about whether a Phase, further patients should be exposed to the medication.

In essence here, Yamada cannot give a straight answer regarding healthy volunteers who became suicidal whilst taking Paxil. Instead he deflects it all by claiming that nobody is healthy. It baffles me, then, why SmithKline would label such studies as 'healthy volunteer studies'. Surely, given Yamada's deposition, these studies should be called, 'The we don't know if they are healthy volunteer studies'?

I mean, what is the point of putting healthy volunteer studies into place when you can't even agree if the volunteers are healthy?

What is also striking about the deposition of Yamada is that he testified that a GlaxoSmithKline decision to put proper warning label on Paxil is "never a business decision."

Yet an internal  1997 GlaxoSmithKline document showed otherwise (Fig 1)


Fig 1








Cake.

I've yet to see the  movie, Cake, but look forward to it, if only to see if Patrick Tobin's screenplay relates to the shocking incident of his extended family.

The link between the movie and the Tobin case was brought to my attention by members of The International Coalition For Drug Awareness Facebook group, which is run by Dr Ann Blake-Tracy. Members had posted and commented on a recent Daily Mail article who had wrote "The true story behind Jennifer Aniston's Cake - how movie's scriptwriter was inspired by the brutal murder of his brother's wife, baby daughter and mother-in-law."

The video below highlights the Tobin case and also shows the difficulty people have had when taking or trying to stop Seroxat. It was the first Seroxat documentary screened in the UK in a series of Panorama specials. The BBC commissioned a further three documentaries after this. To date, there has not been any other drug that has been covered regarding its side effects more times than GlaxoSmithKline's Seroxat.

The video will show you yet more evasiveness from the current CEO of the MHRA, Dr Ian Hudson, who remember, at the time, was the World Safety Officer for SmithKline Beecham.

Pay special attention also to GSK's Alistair Benbow. His answers to Shelley Jofre's questions are, at best, staggering!












Bob Fiddaman.


Tobin v SmithKline Beecham Pharmaceuticals Depositions can be found here.

Tobin v SmithKline Beecham Pharmaceuticals Transcripts can be found here.














Thursday, June 25, 2015

GSK's Product Placement - Channel 5 Respond!






Last week I wrote about how I had learned that, in 2013, GlaxoSmithKline and bosses at Channel 5, a UK terrestrial TV channel, had struck a deal to have GSK's product, Maximuscle, placed into the popular TV show Big Brother (Back story)

Here's the email I wrote...

Dear Sir/Madam,
I'd be grateful if you could pass this along to the relevant department at CH 5.
It recently came to my attention that GlaxoSmithKline's product, Maximuscle, was used as a  product placement deal for a Celebrity Big Brother task in 2013.
Whilst I understand, to a small degree, business and advertising revenue, I cannot understand why Channel 5 would agree to placing a product marketed and manufactured by GlaxoSmithKline given that the British pharmaceutical giant, one year previous to collaboration with Ch 5, were fined a record $3 billion in a fraud settlement in the United States.
The criminal charges involved the illegal marketing of the antidepressants Paxil and Wellbutrin and the withholding of data on the health risks of the diabetes medication Avandia.
Paxil (Known as Seroxat in the UK)
Although the antidepressant Paxil is not approved for patients under 18, Glaxo illegally marketed the drug for use in children and teens, offering kickbacks to doctors and sales representatives to push the drug. Many children and teens who took the drug went on to self harm and/or carry out acts of violence on other and/or kill themselves.
Wellbutrin
Glaxo used the help of PR firms and the appeal of lavish vacations to convince medical professionals to prescribe the antidepressant Wellbutrin for weight loss, sexual dysfunction, drug addiction and ADHD, even though the drug is FDA approved only to treat depression. 
Avandia
For seven years, Glaxo failed to report data to the FDA showing that its blockbuster diabetes drug, Avandia, approved in 1999, increased heart risks in patients.
In 2007, the drug was banned in Europe. The European Medicines Agency concluded that the heart risks of Avandia did not justify its blood sugar benefits.
I'd be grateful if a representative of CH 5 could explain why they endorsed a GlaxoSmithKline product on one of its most popular TV programmes given that they (GSK) had one year previously plead guilty and paid $3 billion to resolve fraud allegations and failure to report safety data.
I look forward to you reply.
Sincerely,
-- 

I also sent a copy to Viacom, the owners of Channel 5.


Earlier today I received a response. It's priceless.



Date:  25th June 2015
Dear Bob
Thank you for your recent enquiry regarding Celebrity Big Brother. 
We were sorry to read your concerns regarding a GlaxoSmithKine product being featured in the 2013 series of this programme. Irrespective of any past legal action involving this company in the United States, they are a legitimate company and although some people may have concerns about their business practices, we do not believe that this should preclude them from placing products in a television programme in accordance with the relevant guidelines.
As a commercial television channel we fund our programming and engineering costs through advertisements and programme sponsorship opportunities. However, this does not mean that we will accept advertising or sponsorship from companies or products making misleading or false claims.
Nevertheless, we do appreciate your concerns and we would like to thank you for taking the time to contact us. Your comments on this issue have been logged in our Viewer Enquiries Report for the attention of all relevant personnel.
Thank you for your interest in Channel 5. 
Yours sincerely
Ian
VIEWER ADVISOR

---


I've wrote back the following. You will note where I have highlighted what Channel 5 appear to have missed when doing their homework on the British multi-million pharmaceutical company.


Thank you for your reply.
However, I am somewhat baffled by the line, "this does not mean that we will accept advertising or sponsorship from companies or products making misleading or false claims."
Did you read the Department of Justice Department's verdict?
Here's what GlaxoSmithKline agreed to plead guilty to.

  • GSK agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.

Civil Settlement Agreement
As part of this global resolution, GSK has agreed to resolve its civil liability for the following alleged conduct: (1) promoting the drugs Paxil, Wellbutrin, Advair, Lamictal and Zofran for off-label, non-covered uses and paying kickbacks to physicians to prescribe those drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex; (2) making false and misleading statements concerning the safety of Avandia; and (3) reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.
Off-Label Promotion and Kickbacks: The civil settlement resolves claims set forth in a complaint filed by the United States alleging that, in addition to promoting the drugs Paxil and Wellbutrin for unapproved, non-covered uses, GSK also promoted its asthma drug, Advair, for first-line therapy for mild asthma patients even though it was not approved or medically appropriate under these circumstances. GSK also promoted Advair for chronic obstructive pulmonary disease with misleading claims as to the relevant treatment guidelines. The civil settlement also resolves allegations that GSK promoted Lamictal, an anti-epileptic medication, for off-label, non-covered psychiatric uses, neuropathic pain and pain management. It further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women. It also includes allegations that GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex. The United States alleges that this conduct caused false claims to be submitted to federal health care programs.
GSK has agreed to pay $1.043 billion relating to false claims arising from this alleged conduct. The federal share of this settlement is $832 million and the state share is $210 million.
This off-label civil settlement resolves four lawsuits pending in federal court in the District of Massachusetts under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery.
Avandia: In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleadingrepresentations about Avandia’s safety profile, causing false claims to be submitted to federal health care programs. Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks. GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia. The federal share of this settlement is $508 million and the state share is $149 million.



Not to mention the fact that GSK are also the subject of UK litigation regarding the antidepressant Seroxat. How do you think the plaintiffs in the case against them feel when they see GSK products advertised on your programme? 
Is it possible to make a request under the terms of the FOIA to Viacom or Channel 5? The answer you gave me, to be honest, is quite shocking and someone at Viacom or Channel 5 obviously did not do their homework on GlaxoSmithKline.
Sincerely
Bob Fiddaman.


For me, the above correspondence is of public interest, hence the publication of it on this blog.

I will endeavor to keep readers updated should Channel 5, or indeed Viacom, wish to further answer my query.



Bob Fiddaman.













Wednesday, June 24, 2015

GlaxoSmithKline - Two Lawsuits - One Withdrawal.









What is/was Selacryn?

Selacryn - a drug to combat high blood pressure.

Marketed an manufactured by SmithKline Beckman. **(SKB)

Selacryn was introduced in May 1979 and withdrawn by SmithKline the following January. It lasted just 8 months on the American market.

Why was it withdrawn from the market?

In the United States it was reported that there were 36 deaths and at least 500 severe cases of liver and kidney damage linked to Selacryn.

Should we praise GlaxoSmithKline for withdrawing the drug?

One would think, reading the above, that GlaxoSmithKline (then SKB) acted promptly and swiftly.

Think again.

In June 1984, some 4 years after SKB withdrew Selacryn from the market, they were charged with failing to warn consumers and the Federal Government about the dangerous side effects of Selacryn.

In December 1984 SKB pleaded guilty and three of its medical officials pleaded no contest to charges of failing to report to the Food and Drug Administration the lethal side effects of the blood-pressure drug.

In total there were 34 Federal misdemeanor charges against SKB. They pleaded guilty to all of them.

Three officials of SmithKline's medical affairs department, Dr. Ralph M. Myerson of Merion, Pa., and Dr. Philip J. Tannenbaum of Broomall, and Dr. Theodore Selby of Haverford, a former official, pleaded no contest to 14 counts of failing to file reports.

FDA Fast Tracking

Selacryn was developed by Anphar Laboratories, a subsidiary of Albert Rolland S. A., a French pharmaceutical company. In 1973, SmithKline obtained a license to develop and sell the drug in the United States.

Selacryn was introduced on May 2, 1979, after an unusually speedy review by the F.D.A. Typically the agency's approval of new drugs follows clinical tests on up to 1,500 patients. But, bizarrely,  in April 1979, after Selacryn had been tested on 533 patients, officials of the agency concluded that no further tests were required.

Also, in April 1979, SmithKline and the three company physicians received reports from Anphar Laboratories that Selacryn had damaged patients' livers. The information was translated from French to English at SmithKline headquarters in Philadelphia in May 1979.

SKB never reported this. Instead they continued to market the drug for a further 8 months, reaping in the rewards of sales to an estimated 200,000 patients.

The Punishment

In February 1985 Federal District Judge Edward Cahn placed Glaxo on two years' probation and ordered them to give $100,000 to a child abuse program for failing to promptly report the side effects of a Selacryn. He also ordered them to provide 500 hours of community service.

The three company doctors were sentenced to five years' probation and ordered to perform 200 hours of community service.

The company and doctors were charged with failing to promptly file reports of the drug's harmful effects on kidneys and livers with the Food and Drug Administration. They also were charged with falsely labeling the drug with a statement saying no cause-and- effect relationship existed between the drug and liver damage.

Here's what surfaced during the trial.

In August, 1979, Mervyn Lakin of Phoenix, Ariz., fell ill with an inflamed liver, jaundice, chills, a high fever, the classic symptoms of hepatitis. The 45-year-old internist suspected that a prescription drug he was taking was harming him so he contacted SKB by placing an urgent call on Aug. 9, 1979, to Dr. Ralph M. Myerson, a group director for medical affairs at SmithKline.

Instead of informing the FDA, SmithKline sent a form letter to Lakin in Phoenix requesting additional information. On Sept. 7, 1979, after receiving a brief report from Lakin describing his original symptoms, Selby classified Lakin`s hepatitis as ``unrelated`` to Selacryn .

On receiving this assessment from SKB, Lakin carried out a 'positive rechallenge' on himself: He stopped taking the drug, and the symptoms of hepatitis disappeared; he resumed taking Selacryn, and they reappeared.

With this finding he, once again, contacted SKB. One day later, according to court records, Selby classified the side-effect as "indeterminate," recommended that no unusual or unexpected reaction be reported to the FDA, and sent his report to Myerson and Tannenbaum.

Lakin's adverse reaction report, along with 11 other cases of Selacryn-related liver damage was buried deep in the third volume of a routine, seven-volume, 2,500-page report.

By late December, 1979, or early January, 1980, FDA regulators read the report and realized that a dozen Selacryn users had developed hepatitis symptoms. They called an emergency meeting for Jan. 15, 1980, convening 17 SmithKline corporate officers and medical personnel and 15 FDA officials.

On that day, SmithKline officials revealed to the federal regulators that 40 more Selacryn users had suffered hepatitis reactions. Five of them were dead.

SmithKline's Drug Application, filed with the FDA in 1977 and 1978, showed that the company never tested the clinical trial data by performing positive rechallenges.

On June 22, 1979, seven weeks after the drug went on the U.S. market, representatives of the French company, Anphar Laboratories, met with SmithKline officials in Philadelphia and told them that they had six cases of positive rechallenges that linked Selacryn to liver damage. SmithKline did nothing.

It's unknown whatever happened to Messrs. Myerson, Tannenbaum and Selby. Did SmithKline keep them on their books or did they take a nice little early retirement package? It wouldn't surprise me, in the least, if they went on to higher paid jobs within the company.


Paxil/Seroxat - No Withdrawal

As far as I am aware GlaxoSmithKline or any of their previous names they were known by, never did any positive rechallenges during the Paxil clinical trials. Begs the question, why?

I find it remarkable that one phone call to SKB kicked off a lawsuit against them, particularly when over 9,000 consumers who had experienced Paxil withdrawal signed an online petition where reports of Paxil addiction were summarized by those who signed the petition (Links at bottom)

Here's just a handful of some of those 9,000+ concerns. (Paxil is the brand name of Seroxat in the US and Canada)

I have tried twice to stop taking Paxil. Each time I tried I got severely sick with shakes, vomiting, severe headache and flu like symptoms where I missed several days of work. I was completely incapacitated, I could not even get out of bed as everything seemed to be spinning around. My doctor finally put me back on Paxil but lowered the dosage. I have been taking Paxil now for three years with no hope of withdrawing any time soon. Before I was put on Paxil, I specifically asked my doctor if this medication is habit forming and I was assured that it is not, however, my experience has been one of desperation and extreme fear that I am now dependent on this medication. I need help. - HH - USA
I thought I was the only one feeling the zaps, extreme dizziness, lumps, and emotional detachments. I'm 28 and have been on 60 mg of Paxil for a year. I am terrified to come off of it PP - Canada
I tried suicide on Paxil and my 17 year marriage ended. This drug is dangerous. I am not the same person anymore. I am trying to get off Paxil after four and a half years and the symptoms of withdrawal are so severe that I have chosen to stay on it at this time. - MC - USA
I called the company because my symptoms were so severe. The representative told me I was the exception and to go to my doctor. I specifically asked for instructions on what I could be doing to lessen the side effects and they refused to offer me any assistance. I even asked if I could have my doctor contact them directly so that he could assist me and they refused! DC - USA

Remember, there were over 9,000 of these reports. Are we expected to believe that none of these 9,000 ever contacted GlaxoSmithKline?

We know, through various litigation in the US that GlaxoSmithKline monitor the internet and should act on what they see. Or are these 9,000 reports just anecdotal, ergo meaningless because they wasn't reported through the 'official channels'? Why would anyone want to report an adverse reaction to Glaxo anyway, given that adverse reactions to Selacryn were reported then subsequently ignored?

GlaxoSmithKline are due to defend their corner in the UK where consumers allege that they were not warned that Paxil (known as Seroxat in the UK and Europe) had a propensity to cause severe withdrawal reactions. Not warned that they would have to endure months, sometimes years, injecting a syringe of Seroxat liquid into their mouths because breaking the pill in half just wasn't an option due to the severity of cutting down the dosage by too much. Not warned either about those electric zaps jolting through the head due to the brain trying to readjust to the lack of Seroxat it had come accustomed to over the years. Hey, thanks for that Glaxo!

Despite settling over 3,000 similar Paxil withdrawal/addiction cases in America, GSK believes that there is no merit in the UK litigation. The reason for settling those American lawsuits, claim Glaxo, was to avoid costs for both parties. All 3,000 plaintiffs agreed to sign a confidentiality agreement that a, laid no blame on Paxil for their addiction and b, laid no blame on GlaxoSmithKline. It is unknown how much Glaxo paid to settle this case (All documents were sealed as part of the agreement.)

It takes just one phone call to SKB to spark a lawsuit and investigation into Selacryn.

It takes over 9,000 consumers to report severe withdrawal side effects regarding its best selling antidepressant for GlaxoSmithKline to do... well, um, nothing, at least not for its UK consumers.

How utterly perverse.

Plus ça change, plus c'est la même chose.






Bob Fiddaman.


**Smith, Kline, French, became the SmithKline Corporation in 1976, and then SmithKline Beckman in 1982, after merging with diagnostics company, Beckman Instruments. Glaxo later merged with Wellcome, a company established in the nineteenth century and built up since, to become Glaxo Wellcome. In 2000, the year of the millennium, Glaxo Wellcome and SmithKline Beecham merged to form the name we know today, GlaxoSmithKline.**





Online Seroxat/Paxil Petition.

Seroxat Withdrawal Reports Part I

Seroxat Withdrawal Reports Part II

Seroxat Withdrawal Reports Part III



Selacryn back story here.

Google Selacryn here.











Sunday, June 21, 2015

Big Brother, GSK and Product Placement.





Stumbling on stories usually, for me at least, kicks off a series of events. None more so than the story I stumbled across today.

In 2013 GlaxoSmithKline's Maximuscle protein shakes and Maximuscle-branded gym equipment featured in a fitness task in the 'Celebrity Big Brother' house.

The product placement deal placed Maximuscle protein shakes, Maximuscle-branded gym equipment and accessories and bathroom products in the house. The housemates also wore branded sweat suits.



The partnership was negotiated for GSK by MediaCom with Channel 5's partnerships team and Endemol, the 'Big Brother' creator and production company. (Source)

It's important to look at the timing of this deal. 2013.

With this in mind I have wrote to Channel 5. If they respond I will publish on this blog.

Here's the email.

Dear Sir/Madam,
I'd be grateful if you could pass this along to the relevant department at CH 5.
It recently came to my attention that GlaxoSmithKline's product, Maximuscle, was used as a  product placement deal for a Celebrity Big Brother task in 2013.
Whilst I understand, to a small degree, business and advertising revenue, I cannot understand why Channel 5 would agree to placing a product marketed and manufactured by GlaxoSmithKline given that the British pharmaceutical giant, one year previous to collaboration with Ch 5, were fined a record $3 billion in a fraud settlement in the United States.
The criminal charges involved the illegal marketing of the antidepressants Paxil and Wellbutrin and the withholding of data on the health risks of the diabetes medication Avandia.
Paxil (Known as Seroxat in the UK)
Although the antidepressant Paxil is not approved for patients under 18, Glaxo illegally marketed the drug for use in children and teens, offering kickbacks to doctors and sales representatives to push the drug. Many children and teens who took the drug went on to self harm and/or carry out acts of violence on other and/or kill themselves.
Wellbutrin
Glaxo used the help of PR firms and the appeal of lavish vacations to convince medical professionals to prescribe the antidepressant Wellbutrin for weight loss, sexual dysfunction, drug addiction and ADHD, even though the drug is FDA approved only to treat depression. 
Avandia
For seven years, Glaxo failed to report data to the FDA showing that its blockbuster diabetes drug, Avandia, approved in 1999, increased heart risks in patients.
In 2007, the drug was banned in Europe. The European Medicines Agency concluded that the heart risks of Avandia did not justify its blood sugar benefits.
I'd be grateful if a representative of CH 5 could explain why they endorsed a GlaxoSmithKline product on one of its most popular TV programmes given that they (GSK) had one year previously plead guilty and paid $3 billion to resolve fraud allegations and failure to report safety data.
I look forward to you reply.
Sincerely,
-- 



This should prove interesting if, indeed, they respond.


Bob Fiddaman. 






Saturday, June 20, 2015

A Brilliant Piece of Investigative Journalism






I urge you all to share this far and wide. It's a documentary that was recently aired in Ireland. It will make you sad, it will make you angry. Hopefully it will make you realize that the pharmaceutical companies who feature in this documentary need to be held accountable for the heinous acts they have committed by allowing antidepressants on to the market when they knew all along that they could cause some people to carry out crimes of violence on others.

The FDA and MHRA should also watch. Then, hang their heads in shame.




Bob Fiddaman

UK Seroxat Litigation Update - June 2015








Many of the Seroxat Claimants have received notice this week that unless the Group Action secures funding soon the case against GlaxoSmithKline will be struck out of Court. For those of you who have received the Court Order through the post, don't panic, there is no need to do anything.

Solicitors, funders and insurers are putting together a funding package with no risk of exposure to costs to you and will be filing this in Court.

There really is nothing more to add publicly but if you want further information please contact me here(No media)

Let battle commence.


Bob Fiddaman







Thursday, June 18, 2015

Whooping Cough - Seeing Is Believing





I've always given credit to the marketing moguls at GSK. They, in the past, have convinced people that they have an illness...even when they don't actually have an illness.

I was recently alerted to a new campaign by GSK regarding vaccinations for whooping cough (pronounced 'hooping' in the UK)

The video, even by their standards, is, I believe, typical of fear-mongering.

It depicts a grandmother as a big bad wolf because, it appears, that she didn't get a vaccine shot for whooping cough, ergo she is putting her grandchild at risk.

Ho hum.

The 30 second TV commercial runs with the tagline...

A couple takes their baby to visit their parents. Unfortunately, grandma might have whooping cough and could spread it to their baby. Whooping cough is a dangerous, spreadable disease that can be especially dangerous to infants. Make sure your whooping cough vaccination is up to date to keep your loved ones safe.

Glaxo have even created a special page that tells us all about how grandparents need to get the vaccine because they may be putting their grandchildren at risk.

The website even has a stark warning at the top, a photo depicting, once again, grandma as a nasty big bad wolf. (fig 1)


fig 1


Here's the video.





**If the video doesn't load on this page then it can be viewed here.

Bob Fiddaman.







Wednesday, June 17, 2015

She Feckin Did It!









Imagine waking up Sunday morning to a knock on your door. Your Saturday night quickly forgotten as you open the door and are greeted by the Police, in this instance it was the Irish Garda (An Garda Síochána)

They ask you if you know the whereabouts of your son, furthermore, they tell you that he was involved in an incident where someone was killed.

What would your reaction be?

As your Sunday unfolds you are once again contacted by the law enforcement of your particular country. "Your son," they tell you, "has been found." They continue, "I'm sorry to inform you that your son is dead."

Just comprehend the above scenario. I've tried but plummeting myself into such a scenario really means nothing. Rik Mayall is on my TV, I don't need to put myself in anyone's shoes to feel their pain. I have potatoes on the hob boiling - why would I want to paint a picture of someone else's problem?

Leonie Fennell is a friend, more importantly, she is a mother. It was she that endured the above scenario, along with her husband, Tony.

I've heard them both relive that day and felt sickened. It would be a lie to say I felt their grief, how could I, how could anyone? Yes, of course, as a human I felt their pain, at least a very small amount of it. It's a pain that both Tony and Leonie carry around with them every day.

As the years have rolled on their nightmare has been rehashed in various newspapers and documentaries. Their dead son, Shane, has been labelled and mocked even though an inquest on his death returned an open verdict. This, after it was learned, that Shane stabbed himself in the chest 19 times after fatally wounding a young Irishman.

Psychiatrists, who, in the main, make their name through column inches in the press, have offered their opinion. Shane had a mental illness, he was driven to a mad rage of jealousy, etc, etc, etc.

These same interfering white-coated buffoons ignore the suicide/homicide link related to the drug Shane was taking at the time, Cipramil (citalopram) - marketed in the US as Celexa.

Anyway, I don't want to dwell on the past. Shane's story (the honest truth) can be read on Leonie's blog (link at the end of this article)

So, to the title of this post, "She Feckin Did It!"

Well, I can imagine Leonie now, speed reading through this piece of mine, uttering under her breath words such as 'fecker'. She'd be embarrassed by it all.

You see, despite suffering the heartache of losing her son, despite having fingers pointed at her and her other children, despite the chin-wagging of those that never really knew her son, Leonie has battled on. A popular blog, threatening letters from lawyers representing an Irish psychiatrist and even a trip across to Denmark to visit Lundbeck, the manufacturers of the drug that killed her son, a meeting that was covertly recorded too - much to my delight :-)

So, what do you do when something as hellish as losing a son in such a bizarre manner?

Leonie did what she was driven to do and now she has graduated with a LLB (Legum Baccalaureus or Honours Bachelor of Laws) from ITCarlow.

Leonie set out five long years ago on a journey, she writes...

Five years ago I ventured out of my comfort zone as a scared, scarred and grieving ‘40 something’ – as a third level rookie. I had decided on a ‘Foundation in Law’ course in Dublin’s Institute of Technology, Aungier Street, more by accident than any foregone design. Having attended an information evening (and handing over my Visa card), before I could utter “erm, not quite sure…”, I was duly plonked on a chair and photographed. Soon afterwards I found myself standing on the steps of DIT with a student card in hand, complete with obligitory dodgy student photo. I wasn’t sure whether to laugh or cry, but when I adjusted to the shock – it turned out to be one of my better decisions (the course, not the photo).

The whole story, ITCarlow – My Alma Mater, can be read here.

It's quite an achievement to pass any sort of course, particularly in that of law, which frankly is a mindfield of mind-boggling rules and regulations that we must all, apparently abide by.

I like Leonie's style, not her fashion sense, last I heard she was still wearing flared trousers and tartan scarves around her wrists. I just like her approach to blogging, her approach in offering support to those who need it, her approach to life in general.

Leonie is a funny woman, full of that stereotypical Irish wit. It's a pleasure to know both herself and Tony and their beautiful children. It's also my pleasure to publicly say, Leonie, you feckin did it!

Eiridh tonn air uisge balbh.


Bob Fiddaman.









Friday, June 12, 2015

Paxil Promotional Gifts (Exclusive)







Well, we all know how GSK's reps used to promote Paxil. Concert tickets, tickets to the Superbowl, notepads, pens, lavish dinners, strip bars.

All of the above has come out in various litigation cases against GSK but we, the public, rarely get to see some of the promotional tools used by GSK reps to promote Paxil... until now.

Basically, GSK reps were told by senior management to hand out small tokens of gesture to the doctors they visited - we now know that these small tokens were, at times, expensive tickets to concerts and sporting events. But what was the psychology behind the less expensive gifts handed out? Were they subliminally sending out the message "prescribe Paxil" to doctors and the patients that were seen by these doctors?

Read this post to the end. One of the promotional products will have you  wondering why Glaxo have never been open about one of their certain Paxil Promotional gifts. I promise you, it's well worth seeing.

Promotional Gift #1
Paxil branded calculator.

fiddaman.blogspot.com

Okay, pretty boring one to start off with. Maybe the GSK reps handed these out with the words "You keep on prescribing and we will keep on giving you rewards. You can use the calculator to see how much you can make by prescribing our product"


Promotional Gift #2
Paxil branded Camera

fiddaman.blogspot.com

fiddaman.blogspot.com


Again, nothing really startling about a Paxil camera but it shows how GSK could use these small gifts to subliminally make the doctor think of Paxil.


Promotional Gift #3
Paxil branded back massage

fiddaman.blogspot.com

fiddaman.blogspot.com

When those Paxil reps weren't entertaining doctors at various strip joints, the doctors probably needed some stress relieving product. Complete with batteries too. Nice.


Promotional Gift #4
Paxil branded wall clock

fiddaman.blogspot.com

fiddaman.blogspot.com


Very clever marketing and psychology used by Glaxo here. Think about it. You walk into your doctors office, you feel anxious or depressed about something. You spy the brightly coloured clock on the wall of your doctor's office. It was designed to stand out and even has Paxil tablets at 3,6 and 9 O'clock.


Promotional Gift #5
Paxil branded mouse

fiddaman.blogspot.com

fiddaman.blogspot.com

Yet another constant reminder for the doctor. See's a patient, uses computer to bring up patient's case notes...uses Paxil branded mouse for that particular 'click' - Genius marketing again from GSK. Notice the cute little kayak that is floating inside this mouse on a sea of green. There's a person sitting in the yellow kayak. How serene, quite the opposite to the side effects of Paxil!

Promotional Gift #6
Paxil branded balancing pen

fiddaman.blogspot.com

fiddaman.blogspot.com

Pretty snazzy, huh? Again, it's eye catching, not only for the doctor, but for the patient visiting too. A chrome finish pen that is balancing and floating on a triangular base.  

 Promotional Gift #7
Paxil branded Swiss Army Knife

fiddaman.blogspot.com

fiddaman.blogspot.com

fiddaman.blogspot.com

So, nice little Swiss army pocket knife. Hopefully these never got into the hands of the patients who were suffering the severe withdrawal caused by Paxil or the akathsia caused by Paxil, a precursor to suicidal thoughts and completion of suicide. Amazing huh, given that so many children and teens self-harmed whilst taking Paxil!

Oh, by the way, if you think GSK reps only promoted Paxil in the US, you'd be wrong. Here's a Swiss Army Knife promoted in the UK. For those of you that don't know, Paxil is known as Seroxat in the UK.


fiddaman.blogspot.com


Okay, I've saved the best until last. This one is quite astounding given that it is intended to be used by the patient. It's an example of how Glaxo promoted Paxil and, at the same time, convinced the patient that they had a mental disorder. The device used didn't even have a patent at the time, the patent office probably laughed when they were told how it works...they probably asked for proof too.


Promotional Gift #8
Paxil branded Health Survey Scanner

FRONT

fiddaman.blogspot.com


This is quite brilliant. It's a device that doctors give to patients and, judging by the patient responses, the doctor or device can actually tell the patient if they have depression, generalized anxiety disorder, panic disorder or social anxiety disorder. It's a device that, basically, makes it look like there's an actual science behind diagnosing, when, in actual fact, it's all based on guess work.

Now, let's take a look at the back of the device. This is very revealing and, I am guessing, has never been seen before either by the public (outside of those visiting doctors in the US) or by any US attorney. This highlights how GSK wanted doctors to prescribe Paxil to children, even though it was never granted a licence to treat children. Notice the use of the words carefully then ask yourself why it would be suggested that an adult not use a crayon to fill in his/her answers? How many adults do you know that uses a crayon?

BACK

fiddaman.blogspot.com



Where, I hear you ask, did I get these from?

Well, they are collectibles and are available on Ebay. Quite ironic that these promotional tools that, over the years have been part of a campaign that has led to horrific withdrawals, birth defects and completed suicide, are now exchanging hands for money. Who knows, we may even see Peter Sutcliffe's hammer collection available on Ebay someday soon!


So, there you have it folks. Just a small insight into how GSK persuaded doctors to prescribe Paxil. Next time you read about them denying that they ever promoted Paxil use in children, ask them if they know any adults that use crayons to write with...that doesn't include the heartless reps who promoted the use of this abhorrent drug in children!


Bob Fiddaman








Tuesday, June 09, 2015

Glaxo's PI Released From Prison






Peter Humphrey, the private investigator hired by GlaxoSmithKline to try and reveal the identity of an internal whistleblower, has been released from a Chinese prison after serving close to two years.

Shanghai officials have apparently released Humphrey seven months early due to his battle with cancer.

Back in August 2014 Humphrey was sentenced to two years and six months in jail on charges of "illegally obtaining private information", a fine of 25,000 yuan, and deportation from China. His wife was sentenced to two years in prison on charges of "illegally obtaining private information", and a fine of 15,000 yuan. Prior to this they had been held in Shanghai’s Pudong District Detention House on remand for 13 months.

Reading back the first three paragraphs (above) and you'd assume that Humphrey was a criminal and deserved what he got, however, the story behind his involvement with GSK reads like a John Grisham novel and it's my firm belief that Humphrey and his wife were used as scapegoats by the British pharmaceutical giant.

GSK called upon the services of Humphrey after receiving a series of emails from a whistleblower. At least 23 anonymous emails were sent to government agencies around the country and to GSK’s top management, including Andrew Witty, alleging that bribery was rife in GSK China sales and that the practice was endorsed by senior GSK management.

GSK, being GSK, decided to hire Humphrey to try and find out who was blowing the whistle, the accusations made in the emails, it seemed, was not really concerning for them.

Vivian Shi, who at the time, was the company’s former head of government affairs in the country and the person GSK suspected was trying to damage the company, was investigated by Peter Humphrey and his wife, Yu Yingzeng.

However, Humphrey found nothing that pointed toward Shi as being the whistleblower.

In his report, Mr Humphrey warned the company that, by focusing on Ms Shi, it might not be seeing the wood for the trees. In other words, they should focus on the accusations and not the accuser.

“GSK should be wary of possible operational loopholes that make it vulnerable,” he concluded in the confidential report submitted to his client, adding that such loopholes included “wrongdoings committed by employees or business partners”. [Source 双语新闻Bilingual News]




During his initial investigation, Humphrey also became aware of a sex-tape that was sent in to GSK's senior managers that showed head of GSK's China operations. Mark Reilly, apparently romping with his Chinese girlfriend.

News of the alleged corruption soon fell into the hands of Chinese authorities and after investigating the claims GSK were handed down a fine of £297m, the biggest in Chinese corporate history. Reilly was given a three year suspended sentence for his part in the bribery and deported from China. He was convicted of bribing non-government officials under article 164 of Chinese law.

Humphrey, at the time of his sentence, felt hard done by, I'm sure he still does.

Here we have GSK employees paying as much as £300m in bribes to doctors to increase sales and their mastermind behind this illegal activity (believed to be Reilly) gets a slap on the wrist and is deported from China.

Humphrey's crime, although illegal, was nothing on the scale of GSK's. He and his wife paid Chinese sources to obtain 256 items of private information including identity records, travel records and mobile phone numbers between April, 2009 and July, 2013.

Humprey's son, Harvey, spoke out regarding the harshness of his father's sentence.

“The problem from where I am sitting is the way GSK behaved in this matter and they have not improved since this started… at the beginning [GSK] were saying they were not working with them – they were distancing themselves… There was room where we could have co-operated, to find out what had happened, but they did not extend any helping hand and have gone into full survival mode denying all connection with my parents,” 

Speaking from prison last year Peter Humphrey said that he felt “cheated” by GSK, saying it had not shared with him the full details of the bribery allegations.

It remains to be seen now if Peter Humphrey and his wife speak out about those allegations and how Glaxo, seemingly, turned a blind eye to them.

I wish Mr Humphrey a speedy recovery. I've no doubt that his current illness would have been exasperated by the ordeal and I hope that he can pull through.

His wife is due for release on July 11.

**UPDATE**

Peter Humprey's wife, Yu Yingzeng, has now been released. (Wall Street Journal)


Bob Fiddaman.


BACK STORIES:

Glaxo - The Sex Tape Scandal

GSK's Mark Reilly Accused of Running a "massive bribery network"

I'm Just a Blogger - Here's GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK's Sales Reps Want Their Money Back

GSK's Private Investigator [The Video]

Peter Humphrey's 2012 Presentation - Pharma Bribery

GSK's Chinese Whispers and David Cameron

“GSK were really cagey", Claims Whitehall Official.

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

GSK CHINA - Bribery was Rife 13 Years Ago

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang...Allegedly

Book Your Holidays With GSK Travel

Andrew Witty... I know narrrrrrrrthing