Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Thursday, June 05, 2014

GSK: Writ for Paxil Suicide Case to Be Dismissed - Denied!




Glaxo's attorney's have been hard at it - alas they are coming up against a steadfast gavel in Judge James B. Zagel.

The whole argument stems from a lawsuit surrounding the suicide of Stewart Dolin. In June 2010 Dolin visited his family doctor who wrote him a prescription for Paxil for "work-related anxiety and depression". Dolin's prescription was dispensed but he received the generic form, manufactured by Mylan.

Six days after beginning his course of the generic Paxil, Dolin left his office shortly after having returned from lunch with a business associate. He walked to a nearby Chicago Transit Authority Blue Line station at Washington and Dearborn in downtown Chicago. As a northbound train approached the station, Mr. Dolin leaped in front of it to his death. Blood tests taken with Mr. Dolin’s autopsy were positive for paroxetine.

Glaxo have argued that Dolin took the generic form of Paxil manufactured by Mylan therefore they were not responsible for the side effects [suicide] but Judge Zagel ruled otherwise.

Zagel told Mylan that they would not have to face any trial but said Glaxo was responsible for the generic drug's design and warning label and would have to face negligence claims.

Yesterday  the 7th Circuit denied GSK’s writ questioning Judge Zagel’s ruling. (GSK argued that Judge Zagel’s decision was “patently wrong” and he - Judge Zagel - should be ordered to enter judgment in favor of GSK.)

Their petition for a writ of mandamus was denied.

Back stories:

GSK to Face Negligence Claims in Adult Paxil Suicide Trial

Another Paxil Suicide Adds to Glaxo's Woes

Bob Fiddaman










Glaxo to Settle With More States in $105 Million Deal




Following yesterdays news, that Glaxo had entered into an agreement with the Oregon Department of Justice, comes news of further settlement agreements being reached in the US.

It's now being reported that GSK will pay $105 million to settle claims with California, New York and more than 40 other states that it illegally promoted asthma and antidepressant drugs.

The deal isn't just a monetary one...Glaxo, however, would like the general public to think that it is.

Part of the deal is that Glaxo have to stop using paid doctors to promote its products. Glaxo, after being fined a record breaking $3 billion in 2012 for similar offences, have claimed to be doing this off their own bat...when in fact their hand has been forced by these settlement agreements.

The State of California are to receive $7.1 million, the highest payment to any of the other states mentioned in the agreement. Texas stands to get $6.2 million under the deal, while Pennsylvania and New Jersey stand to receive $4.1 million and $2.45 million

Glaxo have also recently settled many Paxil birth defect cases, a figure that is estimated at $1 billion.

Glaxo have also recently been in the news for bribing doctors in China, Iraq, Poland, United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, Lebanon, Syria and Jordan - back story.

On May 27th the British Serious Fraud Office (SFO) announced that GlaxoSmithKline were being investigated by officials in Britain. I have wrote to the SFO asking them to elaborate on the investigation and also asked them if they will be investigating any bribery or fraud committed in the UK by GlaxoSmithKline. The SFO have wrote back but have, as yet, not announced if they will be investigating bribery or fraud from any of GSK's UK practices.

So, Glaxo settling claims against them left, right and centre at the moment.

They refuse, however, to settle claims brought against them by members of the British public regarding Seroxat [Paxil] and its propensity to cause withdrawal problems. A lawsuit, filed over 10 years ago, sees Glaxo refuse to compensate a number of British consumers who became addicted to Seroxat. Glaxo have refused to enter into any type of settlement agreement and have denied all allegations that Seroxat is addictive. This, despite settling with over 3,000 consumers who made claims against them in the US a number of years ago.

It seems that GlaxoSmithKline, a British company, can pay the consequences of their illegal activities in foreign countries but refuse to do so when they do the same on their own soil.

Don't you just love the British Justice system!

Bob Fiddaman.




Wednesday, June 04, 2014

Oregon Department of Justice Slam GSK for $3.8 million





The Oregon Department of Justice and British pharmaceutical company GlaxoSmithKline have reached a $3.8 million settlement in a lawsuit that accused GSK of, through 2010, marketing the drug Advair for mild asthma though it had only been approved for moderate to severe cases due to risks of the drug.

Oregon Live writes:

The suit also accused GSK of improperly marketing two other drugs between 1999 and 2003. It said the firm deceptively promoted the antidepressant Paxil, known as Seroxat in the UK, as safe for children and adolescents when it was not approved, raising concerns of increased suicide risk. It said GSK improperly promoted another antidepressant, Wellbutrin, for weight loss and sexual dysfunction though it was never approved for those things.
They add, "In the settlement, GlaxoSmithKline admitted no wrongdoing."

GlaxoSmithKline are currently under investigation in a number of countries, including the UK, for alleged bribery and fraud.



Back in 2008 the British Medicines regulator, the MHRA, concluded a four-year investigation into GlaxoSmithKline. The MHRA learned that GSK had committed criminal offences but decided against a criminal prosecution of Britain's largest pharmaceutical company. Instead, the MHRA wrote a letter to, the then, CEO of GlaxoSmithKline, JP Garnier.

The letter, showed how the MHRA's investigation had found that GSK had withheld important safety information regarding the use of Seroxat in children and adolescents.[fig 1 and 2]



fig1


fig2

It is understood that the MHRA did not interview any of its employees with ties to GSK during the four-year investigation.

Ironically, one of those employees, Dr Ian Hudson, who was former world safety officer at GSK [then SmithKline Beecham] is now CEO of the MHRA. [Back story]

Bob Fiddaman










Monday, June 02, 2014

Open Question to GlaxoSmithKline




Have your sales team, including senior management and reps, paid doctors, hospital officials and health institutions to use GSK products in the UK, resulting in the "illegal revenue" of hundreds of millions of British pounds. Or have you, as a company, ever bribed UK government officials?

Just thought I'd throw this question out seeing as you are currently under investigation by the UK authorities.

I do hope the UK authorities move quickly and subpoena your hard drives, drives that you probably started deleting the second you caught wind that the UK Serious Fraud Office would be investigating you.

Oh, and just so you know, I've wrote to the investigators and offered my services - I've told them what to request from you - told them to focus around your promotion of Seroxat and the possible incentives you paid British doctors to prescribe it to kids. That's fraud, right? That's bribery, right?

Oh, I also told them to steer clear of the MHRA, let's face it, they are just an extension of GSK anyway.

Anyway, I may be wrong, hence the question....

Have your sales team, including senior management and reps, paid doctors, hospital officials and health institutions to use GSK products in the UK, resulting in the "illegal revenue" of hundreds of millions of British pounds. Or have you, as a company, ever bribed UK government officials?

You know my email address, right?

Then again, you could just leave a message on my blog, seems like you were on here again earlier.



Bob Fiddaman




Thursday, May 29, 2014

GSK's Sales Reps Want Their Money Back




Where's John Grisham when you need him?

Seriously, you really couldn't make this shit up.

The Financial Times are running with a story that's as jaw-dropping as anything I've read thus far regarding the bribery scandal in China. I had to do a double-take, had I fallen asleep last night and somehow travelled back in time to April 1st? There were no skid marks from DeLorean tyres in my bedroom and my computer told me it was 29/05/2014.

"GSK salesmen want ‘bribes’ reimbursed" is the headline, what follows is pure Grishamism.

GlaxoSmithKline, the UK pharmaceutical company at the centre of a Chinese corruption scandal, is facing protests from junior employees who say the company is refusing to reimburse them for bribes they were ordered to pay by their superiors.
Now some Chinese sales staff are complaining that GSK has denied bonuses, threatened dismissal or refused to reimburse them for bribes they say were sanctioned by their superiors to boost the company’s drug sales. In some cases, managers instructed them to purchase fake receipts that were used to cover up bribes paid in cash or gifts to doctors and hospitals, according to salesmen interviewed by the Financial Times.
In some instances, managers disguised their involvement by using their personal email address to instruct staff to pay bribes and by ordering junior staff to claim on their personal expense accounts – even if the bribe was actually paid out by the manager – according to these people.
In late March, disgruntled staff sent 25 representatives to GSK’s headquarters in Shanghai, where they unfurled a banner that read: “Return my hard-earned money.”

Cor blimey governor, can you Adam and Eve it!

So, let's get this straight.

Glaxo's reps paid bribes out of their own pockets that were later to be reimbursed by the company...and now they are telling Glaxo that they want reimbursing?

Here's the Financial Times again...

“The expenses were paid with our own money, and although the receipts were not compliant, it was our managers who told us to buy the fake receipts,” said one former GSK salesman.

The FT article goes on to explain that some sales reps were warned not to implicate senior staff, in many instances, according to the FT,  management "approached each person [rep] before they were questioned and asked them not to mention his name. He even prepared a story for them to tell the investigator.”

Glaxo have denied that this is a systematic problem throughout their global operation - they've even denied it after other allegations of bribery have surfaced in other countries, namely Iraq, Poland, United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, Lebanon, Syria, Jordan and now the UK. [back story]

We hear the same old line from GSK when they have been caught by investigating officials, citing that they will "cooperate fully with investigators".

I thought long and hard about this line. It's pure psychology. By stating that they will cooperate fully with investigators eases the guilt and, at the same time, paints a picture that Glaxo were unaware what was going on. In essence, "We will cooperate fully with investigators", actually means we've been caught red-handed and will answer any of your questions. We will not offer you any specific evidence unless you ask for it specifically. Glaxo do the same when faced with litigation too.

I find it laughable that reps who knowingly broke rules with their own money now want reimbursing. It's akin to the Yorkshire Ripper billing the tool shop where he purchased his hammer from. Apologies for using such a heinous crime as an analogy - I'm referring to the Yorkshire Ripper and not Glaxo's bribery.

It's been alleged that female sales reps were told to offer sexual favours to doctors in efforts to get them to prescribe more of GSK's drugs. [back story]

Are we to assume then that these female reps will be asking for reimbursement of the contraceptives and/or mouthwash they purchased?

The UK's Serious Fraud Office recently announced that they are investigating GSK. It's highly likely that they will just focus on GSK's illegal activities overseas and won't even bother to look to see if GSK reps have been doing the same here in the UK.

The FT article can be read here. You may have to subscribe to read all the content.

Bob Fiddaman





Wednesday, May 28, 2014

Another Paxil Suicide Adds to Glaxo's Woes







Back in March I wrote about the suicide of Stewart Dolin.

In June 2010 Stewart Dolin visited his family doctor who wrote him a prescription for Paxil for "work-related anxiety and depression".
Dolin's prescription was dispensed but he received the generic form, manufactured by Mylan.
Six days after beginning his course of the generic Paxil, Dolin left his office shortly after having returned from lunch with a business associate. He walked to a nearby Chicago Transit Authority Blue Line station at Washington and Dearborn in downtown Chicago. As a northbound train approached the station, Mr. Dolin leaped in front of it to his death. Blood tests taken with Mr. Dolin’s autopsy were positive for paroxetine.
The complaint alleges that Dolin, "exhibited classic symptoms of akathisia immediately before his death. A nurse alleged to have been on the platform at the same time as Mr. Dolin noticed that Mr. Dolin was “very agitated, pacing back and forth and looking down the tracks.”

Last night Dolin's widow, Wendy, appeared on NBC TV in the US. The interview shows the lengths pharmaceutical companies, in this case Mylan and GlaxoSmithKline, go to protect the name of their brand.

The case, in a nutshell, sees Glaxo argue that Dolin took the generic form of Paxil manufactured by Mylan therefore they were not responsible for the side effects [suicide] The warning on the labelling was insufficient as it did not contain the risk of increased suicidality for adults over the age of 24. Mylan have argued that the product information was written by Glaxo therefore they are not responsible.

Classy huh?

Here's the interview with Wendy.




Bob Fiddaman


A Message From the UK Serious Fraud Office re GSK




GlaxoSmithKline plc investigation

27 May 2014

The Director of the SFO has opened a criminal investigation into the commercial practices of GlaxoSmithKline plc and its subsidiaries.

Whistleblowers are valuable sources of information to the SFO in its cases.  We welcome approaches from anyone with inside information on all our cases including this one - we can be contacted through our secure and confidential reporting channel, which can be accessed via the SFO website.

Notes to editors:

The SFO's secure reporting channel can be accessed here: https://report.sfo.gov.uk/sfo-confidential---provide-information-in-confidence.aspx or via our website home page, www.sfo.gov.uk
The Serious Fraud Office is an independent government department responsible for investigating and prosecuting serious and complex fraud, bribery and corruption. It is headed by the Director, David Green CB QC, who exercises powers under the superintendence of the Attorney General. These powers are derived from the Criminal Justice Act 1987.

The SFO Press Office can be contacted on press.office@sfo.gsi.gov.uk or 020 7239 7316 / 7004 (out of hours: +44 (0) 7557 009 842)

[Source]


I actually went out and purchased a bottle of wine last night on the strength of this latest news.

The SFO may want to investigate the British drug regulator, The MHRA, too. It was they who, after a four-year investigation of GlaxoSmithKline, decided to let Glaxo off with a warning letter. No criminal charges were brought against GSK...even after the MHRA learned during their investigation that GSK had knowingly withheld safety data regarding children taking the antidepressant Seroxat [Known as Paxil in the US]

The MHRA's four year investigation into GlaxoSmithKline failed on a catastrophic level.

Alistair Benbow, who was then Head of European Psychiatry at GSK, claimed on National TV that Seroxat could be safe in children even though his company did not have a licence to recommend it to children. [1]

All the SFO need to do is request disclosure from GSK. Emails, documents and, more importantly, the notes taken by GSK's pharmaceutical reps during their visits to doctors and psychiatrists. Did Glaxo's UK reps offer the same incentives to British doctors as GSK's American, Chinese, Polish and Iraqi reps did?

Once they have these in their possession then I'm sure they will be able to retrace who said what and who they said it to.

It is imperative that the SFO obtain these documents.

The MHRA should have requested the same documents but why would they? They rely on pharmaceutical money, in fact, they are fully funded by the pharmaceutical industry.

The SFO are calling on whistleblowers - good luck. The carrot being dangled isn't really as attractive as the carrot dangled in front of whistleblowers in the US.

I suspect the SFO are merely following up on the alleged bribery in China - they need to do more than follow-up though.

GlaxoSmithKline is infested, it's driven by a culture where sales mean everything.

I do hope the SFO turn over every item they come across, I do hope this is not just them following up on GSK's foreign violations.

There are plenty of experts out there who could help the SFO's investigation, whether they choose to use them is another matter.

No stone unturned is the order of the day here. The SFO will, no doubt, face tough opposition from the current UK government. Deals may be struck given that Glaxo's chairman, Andrew Witty, and the current Prime Minister, David Cameron, are friends and business acquaintances. [2]

One thing is certain though. The eyes of the world are watching.




Bob Fiddaman


[1] Seroxat - The Liars? [Video]

[2] Cronyism, Chinese Style







Tuesday, May 27, 2014

Are GSK Collecting Flags of Nations?




Fined a record-breaking $3 billion in the US for serious violations regarding the promotion of prescription medication to vulnerable patients [including children] - Excuse - "It was all part of an era"

Currently under investigation...

GSK investigated over fraud allegations in China - When the story broke GSK's Andrew Witty had this to say... "there are control mechanisms in place to prevent bribery and other forms of corruption, but that the methods these individuals used “would have been difficult to find using our controls.”

Almost one year later...

GSK's Mark Reilly Accused of Running a "massive bribery network" - Chinese officials investigating claims of bribery and corruption at GlaxoSmithKline's Chinese HQ have accused former head of China operations, Mark Reilly, of "personally running a "massive bribery network"."

Just before this announcement...

GSK - Latest Corruption Scandal In Iraq - The allegations cited include but are not limited to:

Hiring 16 government-employed physicians and pharmacists in Iraq as paid sales representatives for the company while they continued to work for the government.

A government-employed Iraqi emergency-room physician prescribing Glaxo products, even when they weren't in the hospital's pharmacy and a competitor's brand was in stock.

Paying expenses to government-employed doctors to attend international conferences.

Then came...

GSK accused of illegal marketing in Poland - This is what GSK had to say, “Following receipt of allegations regarding the conduct of the programme in the Lodz region, GSK has investigated the matter, using resources from both inside and outside the company. The investigation found evidence of inappropriate communication in contravention of GSK policy by a single employee. The employee concerned was reprimanded and disciplined as a result."

Before the dust could settle...

Jordan and Lebanon - The Next GSK Scandal - GSK has launched an internal investigation into its operations in the United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, Lebanon, Syria, Jordan and Iraq.

"Sales representatives allegedly bribed doctors in Jordan to prescribe Glaxo drugs by issuing free samples that the doctors were then allowed to sell on, according to the emails.

"Glaxo representatives also allegedly permitted Jordanian doctors to bring their spouses on business trips that Glaxo paid for, according to the emails. Doctors were issued with business-class tickets to attend conferences but would exchange them at travel agencies for two economy-class tickets, allowing their spouses or other family members to come along free, a practice local Glaxo employees were aware of, according to the emails."


And now...

GSK faces serious fraud investigation in Britain - Britain's Serious Fraud Office (SFO) has launched a formal criminal investigation into GlaxoSmithKline Plc, posing a new challenge to the drugmaker, which already faces allegations of bribery in China and elsewhere.

Britain's biggest pharmaceuticals company said it had been informed on Tuesday that the SFO had "opened a formal criminal investigation into the group's commercial practices".

GSK said it would cooperate fully but gave no further details in a brief statement. A company spokesman declined to elaborate.

So, let's see.
















GSK have issued a press release regarding the latest fraud allegations in the UK.

The company said it would "co-operate fully" with the SFO.

Um... I don't think you have much say in the matter!

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

It's about time they changed the company tagline, doncha think?


Bob Fiddaman





















When Psychiatry is Debated, it Becomes an 'Attack'.



Mommy, make them stop!


I laughed hard upon reading a recent article published in The Lancet Psychiatry [27 May 2014
doi:10.1016/S2215-0366(14)70232-9]

You see, there's a bunch of psychiatrists who are taking umbrage to those that oppose unwarranted use of antidepressants. The psychiatrist argument smacks of total hypocrisy and lacks any scientific data, preferring instead to quote hearsay whilst using the defence of antidiagnosis and antitreatment groups attacking their belief system [because that's all it is, a belief.]

What's remarkable about this article is pretty much summed up in its final paragraph. My thoughts on this later.

Here we have 5 professionals putting their name to an article, namely, David J Nutt, Guy M Goodwin, Dinesh Bhugra, Seena Fazel and Stephen Lawrie.

They claim they are being targeted by an anti-psychiatry movement when, in fact, they are being asked to debate the issue of antidepressants publicly.

This latest stunt from David J Nutt et al just highlights how psychiatry, when backed into a corner, does everything to avoid going head to head in a public forum with people that disagree with them.

Rather than enter into a public debate they choose to deflect their cowardice by playing the victim.

"Psychiatry is used to being attacked by external parties with antidiagnosis and antitreatment agendas."

"Most of these people are depressed and more than 70% are not taking an antidepressant at the time of death. Blanket condemnation of antidepressants by lobby groups and colleagues risks increasing that proportion"

"Antipsychiatry groups usually claim that depressed patients should be treated with exercise and psychotherapy instead of drugs. However, little controlled evidence exists to support the use of psychotherapy as an alternative to antidepressants in major depression."

"...the anti-psychiatry movement, although now long in the tooth, has revived itself with the recent conspiracy theory that the pharmaceutical industry, in league with psychiatrists, actively plots to create diseases and manufacture drugs no better than placebo."

Nutt et al are so far of the mark here. There are many individuals, myself included, who are not part of groups - choosing instead to go it alone, to speak out against something because it's the right thing to do.

What I find worrying about this article is the bare-faced cheek of it's authors who dismiss claims that the pharmaceutical industry is in league with psychiatrists and then, because the Lancet abide by transparency, reveal the authors ties to the industry.

{Insert canned laughter here}


DJN has received grants and personal fees from Lundbeck and GSK; and personal fees from Lilly, BMS, Otsuka, Servier, and Pfizer. GMG has received grants and personal fees from Servier and Lundbeck; personal fees from Teva, Otsuka, Takeda, Eli Lilly, Merck, GSK, and AstraZeneca; and grants from P1vital. SL has received research funding from Abbvie, Roche, and Pfizer in connection with genetic, brain imaging, and therapeutic studies of people with schizophrenia. He has also been paid by Janssen and Roche to speak at or chair educational meetings about schizophrenia, as well as to contribute to advisory boards about new antipsychotic treatments. The other authors declare no competing interests.
It's laughable.

It's akin to the following hamster claiming that he doesn't know where the carrots are.




And we, the gullible public, are expected to believe Nutt et al because [boo hoo] they are being targeted by antipsychiatry groups.

If Nutt had anything about him, he'd step up to the plate and publicly debate what he thinks he knows about antidepressants and their safety - instead he, with his colleagues, run to the Headmaster because they cannot answer their critics in a public place - ergo they are being bullied, targeted by academics who have different opinions.

"Mommy, make them stop."

A few weeks ago Professor Peter Gøtzsche, Nordic Cochrane Centre, Dr Joanna Moncrieff, University College London and Dr James Davies, University of Roehampton challenged Nutt et all to an open debate. All three are part of The Council for Evidence Based Psychiatry [CEP] - the clue to what they seek is in the title of their organisation - "Evidence Based Psychiatry".

One way to put a stop to this is to stop the pissing match. Go public, sit on a panel - Gøtzsche et al on one side of the table, Nutt et al on the other side.

What we are currently witnessing is fight-hype, we see this, normally in Boxing. Two fighters talk the talk before beating one another in the ring. Difference being, they get in the ring to iron out their problems.

The CEP have challenged Psychiatry but Psychiatry is making excuses, they want to keep their heavy-weight belt and fear they will lose it if they accept the challenge.

We have the CEP in one corner here and Nutt et al in another. The CEP are ready to exchange blows but Nutt et al want protection from the referee. "The CEP are anti-me Mr Referee, do I have to fight them?"

In 2004 Nutt held 300 shares in GlaxoSmithKline and was also a paid consultant for them. It's a pity Nutt didn't add this in his article in the Lancet.

The Lancet Psychiatry article, Attacks on antidepressants: signs of deep-seated stigma?, can be read here [registration needed]




Bob Fiddaman




Friday, May 23, 2014

Blind Date With Vanda's Hetlioz




An American friend of mine sent me an email the other day. She told me how she had seen an ad aired on TV for a drug called Hetlioz (tasimelteon). Apparently, it's a pill to help those who suffer with Non-24-hour Disorder.

I admit I had to look this disorder up. My first thought was, Christ! They want to treat people who refuse to watch Kiefer Sutherland's character Jack Baur in FOX TV's 24?

Alas, I was wrong.

Non-24-hour Disorder, according to Hetiloz manufacturers, Vanda Pharmaceuticals, is...

... a chronic circadian rhythm disorder that occurs when individuals are unable to synchronize their endogenous circadian rhythm to the 24-hour day. Non-24 is most commonly found in blind individuals lacking the ability to perceive light, the primary environmental cue for synchronizing the circadian system daily. In general, individuals with Non-24 suffer from a variety of clinical symptoms as they cycle in-to and out-of phase resulting in disrupted nighttime sleep patterns and/or excessive daytime sleepiness.

Vanda had to convince the American drug regulator, the FDA, that their drug worked and was safe through a series of clinical trials. These trials have been slammed.

For instance...


  • The design of Vanda's primary phase III study changed numerous times, including a complete replacement of the primary endpoint just one month before study results were announced

.

  • The replacement primary endpoint installed to assess tasimelteon's benefit was created by Vanda and has never been used before in sleep-drug clinical trials, nor was it endorsed by the FDA.



  • Vanda was forced to cut in half the patient enrollment into the tasimelteon clinical trials because totally blind patients with non-24 could not be identified. Even then, Vanda was only able to enroll patients by stretching the clinical definition of non-24.



  • Tasimelteon was only able to demonstrate a benefit for non-24 patients by combining data from two phase III studies. Despite Vanda's claims to the contrary, the phase III studies may have actually failed on their own.


[Source]


Despite all of the above, Hetiloz was approved by the FDA earlier this year.

Astroturfing

Now there's a word.

Astroturfing is the practice of masking the sponsors of a message or organization (e.g. political, advertising, religious or public relations) to make it appear as though it originates from and is supported by grassroots participant(s). It is a practice intended to give the statements or organizations more credibility by withholding information about the source's financial connection.

Step forward The National Sleep Foundation.

Trawling through their website I learned that their Non-24-Hour Sleep Wake Disorder section is sponsored by Vanda Pharmaceuticals. I flicked the following email to Vanda...

Dear Sirs,
Many pharmaceutical companies are now suggesting that they are going to be more transparent in regard to clinical trials and sponsorship's etc.
I noticed that the sleep foundation have a section on their website that is sponsored by Vanda Pharmaceuticals.
As a matter of public interest could you tell me if this was a financial arrangement, if so, how much?

In typical Pharmafia fashion Vanda did not reply, opting instead to check me out [fig 1] - Click image to enlarge.



Fig 1

I posed pretty much the same question to the National Sleep Foundation via their Twitter page. [Fig 2]

They had the decency to answer me but didn't really answer the question I put to them.


Fig 2

Not related in any way to Vanda?

Here's the sponsored section on the Sleep Foundation's website [Fig 3] - Click on image to enlarge and read the bottom left of the image.



Fig 3

Alternatively, click here.


I pressed the Sleep Foundation for an answer - to date, they have failed to respond.

I dug a little deeper regarding Vanda's drug Hetiloz.

In July 2013 it was reported that Vanda Pharmaceuticals Inc. were facing at least one shareholder lawsuit surrounding late-stage trials for the company's sleep disorder drug Hetiloz.

In one class-action complaint, Small v. Vanda Pharmaceuticals Inc. et al., it's alleged that Vanda and its officers issued materially false or misleading statements about Tasimelteon’s efficacy and the results of its Phase III clinical trials. Specifically, it is alleged that Vanda changed the design of the  primary Phase III study several times, including a complete replacement of the primary endpoint  one month before results were announced, because the company was in possession of data suggesting that the original primary endpoint was not going to be met; used a replacement primary endpoint that had never been used before in sleep-drug clinical trials and was not endorsed by the FDA; enrolled patients in the Phase III trials by “stretching” the clinical definition of Non-24; and combined data from two Phase III studies in order to demonstrate a benefit for Non-24 patients, where the two Phase III studies failed individually.

The full complaint can be read here.

Amazing that the FDA went ahead and gave a licence to Hetlioz... then again, the FDA are basically an extension of the pharmaceutical industry.

Non-24-hour Disorder is a new one on me. As for the treatment of it, Hetiloz, experiments with rodents revealed fertility impairments, an increase in certain cancers, and serious adverse events during pregnancy at dosages in excess of what is considered the "human dose". [1] [2]

I can only presume that these warnings will be printed in braille for expectant blind mothers?

Then again since when have pharmaceutical companies protected their patients?


Bob Fiddaman 


Blind people need all the facts too



References


[2] Side Effects Drug Center: Hetlioz Warnings and Precautions". RxList. February 10, 2014. "In animal studies, administration of tasimelteon during pregnancy resulted in developmental toxicity (embryofetal mortality, neurobehavioral impairment, and decreased growth and development in offspring) at doses greater than those used clinically."

You can follow the National Sleep Foundation on Twitter here.

  



Wednesday, May 21, 2014

Mental Disorders Are Contagious





I've found proof that mental disorders are contagious.

It's a shocking revelation, I know.

But as a writer, who is pretty much against the use of psychiatric medications, I feel I must relay this information.

I've trawled through hundreds of case files and found a common link that unquestionably proves that mental illnesses are contagious.

I'm surprised this has not been picked up before.

You see, it's quite simple really.

Take 100 patients with varying degrees of social problems ranging from financial worries, sexual problems, relationship problems etc.

Take 100 psychiatrists with varying degrees of clinical experience.

Each patient visits 3 different psychiatrists.

Patient 1 sees 3 different psychiatrists. He/she is diagnosed with 3 different mental disorders.

All patients are diagnosed with brain diseases, some have more diseases than others.

100 patients, who remember just had social problems going on in their lives, each now have a mental disorder or a number of brain abnormalities.

Each illness has been passed on by their psychiatrist.

Ergo - Mental Disorders are contagious.

Signs that show you may have been contaminated.

Keep a lookout for:

1. Various forms of paraphernalia dotted around your psychiatrist's office that advertise pharmaceutical products or companies. Things like mouse-mats, cups, umbrella's, writing pads etc.

2. Check your prescription, if it has the brand name of the drug then it's highly likely that your psychiatrist is a carrier of a mental disorder.

3. Carriers are often in denial. If you question their diagnosis they will talk down to you and tell you not to believe everything you read on the Internet.

4. Carriers often stutter and blush when you ask them for evidence of the mental disorder they have labelled you with.

5. Carriers are often invited to drug company presentations (also known as symposiums). Ask your psychiatrist if they have ever attended any such event.

6. Carriers often tout the chemical imbalance theory. They claim you have one that is causing your mental disorder. Ask them for proof of this, if they can't show you then they have more than likely been infected with a mental disorder themselves.

7. Carriers often play down the risks of the drugs they prescribe you. Ask them...

If the drugs are addictive.

If the drugs can induce homicidal acts.

If the drugs can induce suicide or suicidal thoughts.

If the drugs can increase psychosis.

If the drugs can increase birth defects.

If they answer 'no' to any of the above then the likelihood is that they have been infected.

8. Carriers often suggest that your mental disorder is in your genes. Ask them for scientific proof of this. If they stall, stutter or blush then, chances are, they have been infected.

9. If you are a woman who is pregnant carriers will suggest that your mental disorder will be passed on to your fetus if you do not treat your brain illness. Ask them for scientific proof of this. Refer to # 4.

10. If you spot a copy of The Diagnostic and Statistical Manual of Mental Disorders (DSM) then it's highly likely that your psychiatrist has been infected.


All we need now is some sort of immunization.

No drugs just plain common sense.

Steer clear of the psychiatrist's office.

Bob Fiddaman.




References

Logic in the Human Brain - From the Journal of Common sense






Friday, May 16, 2014

GSK Hiked Product Prices to Fund Bribery Scam





So, this is how it worked folks.

GlaxoSmithKline China, under the management of Mark Reilly, allegedly told sales reps to bribe doctors, hospitals and health institutions. As a result GSK's sales soared from 3.9 billion Yuan in 2009 to 6.9 billion Yuan in 2012.

The video below shows a GSK sales manager...


"If the doctors prescribed more of our drugs they would be rewarded accordingly.
"We would treat them to dinners or buy gifts for their families, sometimes it was even more direct, we just gave supermarket gift cards or cash during holidays."

Obviously GSK would need to balance the books with so much bribery money going out of the door. So, how did they do this?

Well, Chinese authorities have learned that GSK simply inflated drug prices by declaring high cost at Chinese customs.

Authorities found that GSK's drugs were being sold to China at prices that far exceeded the prices they charges other countries, sometimes as much as 8 times. [Fig 1]

I'm guessing that this wasn't just down to Reilly, he must have had help from elsewhere, from senior management in the UK perhaps?



Fig 1


GSK's Mark Reilly, whom I wrote about previously on this blog, faces up to 10 years in prison.


Here's the CCTV News report.





Bob Fiddaman.



Back story

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






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