Monsanto Roundup Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Friday, August 31, 2007

Don't let Pharma poison our children

Thanks to Ken Kramer for the following, I urge you ALL to read and sign.

Fid

As kids head to class again, pharmaceutical companies are ramping up their drug marketing

We need to ramp up informing parents across the country about the mental screening trap.

Please, send this message to everyone you know and urge them to do the same:
I am writing to you on an important matter. There is a psychiatric / pharmaceutical plan to "suicide screen" every child in the United States before they graduate from high school.

Evidence exists that shows massive pharmaceutical backing that will result in even more overdrugging of kids with psychiatric drugs .

Can you take a moment to view this very short video? Click here: http://www.youtube.com/watch?v=RfU9puZQKBY

And then sign and forward this petition http://www.petitiononline.com/TScreen/petition.html to your associates and everyone you know? It already has over 22,500 signatures.

It's simply a race to inform enough parents so something can be done about this.

Related link - HERE

Thursday, August 30, 2007

Paxil/Driving & Health Insurance

Michael Moore's new movie, Sicko, pretty much showed up the United States health care system and health insurance companies as being uncaring bastards... word of warning though, it could soon be the same here in the UK. The FDA have a file on their website that I happened to stumble across, a file that I or others have never seen or heard of before.

It's always been a great wonder to me whether or not it is safe to drive whilst on Seroxat medication. I would strongly urge anyone suffering withdrawal NOT to drive - I would also recommend to anyone to let their partners or friends drive them anywhere - we all know how easy it is to turn into road rage when something happens you don't agree with. I'd guess that the slightest 'mistake' by the driver in front would be enough to tip the driver following over the edge if he/she were on Seroxat.

The AA and RAC don't recognise that it is dangerous for motorists driving whilst under the influence of Seroxat, not just a danger to themselves but to other motorists free from the poison too. Insurance companies here in the UK don't mention it either.

Maybe after this surfaces they will.

GlaxoSmithKline would have us all believe that it is perfectly safe to drive whilst taking Seroxat, I mean there is absolutely nothing wrong with Seroxat now is there?

So where does that leave the drivers? Be warned - If you have an accident whilst out driving and you have been taking Seroxat then you may be liable - it only takes a lawyer for an insurance company to find this particular loophole - I'm just surprised it hasn't been used already!

Maybe an email to some of the top insurance companies out there will (forgive the pun) set the wheels in motion.


Here is the file - DOWNLOAD

Pay particular attention to page 9

"...patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Paxil CR therapy does not affect their ability to engage in such activities."

Aropax (Seroxat) - The Bitterest Pill?

Source: Brisbane Times

Below is an edited version - for full story click HERE

Bitter pills

IT BRINGS a wry smile to people's faces to hear that two drug companies made it into the top 10 most ethical companies in the world. Most of us benefit from medications developed by these multinationals, but we deeply distrust their methods. Old drugs are repackaged for new conditions, generic medicines are opposed, negative research results are withheld and developing countries are forced to pay crippling fees as part of deeply unfair medication pricing structures.

In September 2004 the blockbuster anti-inflammatory Vioxx was suddenly withdrawn from the market by its manufacturer, Merck & Co, after it emerged that the drug increased the risk of heart attack and stroke. At the time 250,000 to 300,000 Australians were taking the drug to treat the symptoms of arthritis. The company is facing more than 14,000 lawsuits in the US and a class action in Australia.

It soon emerged that Merck had either misrepresented or failed to disclose the health risks associated with the drug and that its highly effective public relations machine had capitalised on a generally uncritical medical profession

Merck was not one of the companies that made it into the world's top 10 ethical companies on the Geneva-based Covalence reputation index. Set up to provide a "barometer of how multinationals are perceived in the ethical field", the index classifies companies according to 45 criteria of business contribution to human development, including labour standards, waste management, the social utility of products and human rights policy.

Under those measurements, the drug companies GlaxoSmithKline and Bristol-Myer Squibb came in at No. 8 and No. 9 respectively.

Jon Jureidini is the head of psychological medicine at Adelaide's Women's and Children's Hospital, and the chairman of Healthy Skepticism, a website that exposes pharmaceutical company marketing techniques. He is deeply critical of Glaxo's failure to warn doctors and consumers about the potentially negative side effects of its anti-depressant Aropax/Paxil on children - a charge the drug company strenuously denies.

Jureidini says. "GSK has made mileage out of the fact that they have published two negative studies on the effects on children, but what they don't say is that they had to do that as part of another settlement."

"GSK is being hailed as an ethical company and I am sitting here working on a draft of a paper about their behaviour in relation to the study they publicised saying that Aropax/Paxil was safe and effective for children, whereas in fact the study showed just the opposite," Jureidini says.

"Donations by drug companies to patient self-help and advocacy groups are almost certain to score brownie points on an ethical measure. But many activists see such donations as covert marketing, making these groups advocates for a disease that suits their product," Jureidini says.

Medicines Australia, the pharmaceutical industry self-regulator with drug companies as its members, was quick to congratulate GlaxoSmithKline and Bristol-Myers Squibb on gaining "significant international recognition" for their work. "This is indicative of the pharmaceutical industry as a whole and reflects the value and contribution of the industry to society," Medicines Australia's chief executive, Ian Chalmers, said.

Yet only 18 months ago, the Medical Journal of Australia published a study that found the publication of incomplete or biased pharmaceutical trials is common. Interference was most blatant when the research showed potentially negative effects of a drug or treatment, it found.

Results like this confirm that despite their contribution to the health of people in the world, drug companies have a way to go before they achieve an "A" for ethics.

Wednesday, August 29, 2007

New Benbow quotes... well old but unseen on Seroxat Sufferers

My personality changed so drastically I started to shop lift. I had violent thoughts towards other people - homicidal thoughts, suicidal thoughts.. All of this culminated in me robbing a local garage


"We saw here a case of potential violence and aggression "All the data suggests that actually Seroxat does not cause violence, whereas depression does.
Ally Benbow

Commenting on Mark Hamilton, who claims that the drug turned him into a violent robber.

----


"Depression is the most important cause of suicide, suicidal ideation and suicide attempts. There is no compelling evidence that Seroxat causes suicide and indeed, the adult clinical trial database does not demonstrate that Seroxat causes suicide, suicidal thinking or suicide attempts."
Ally Benbow

Commenting on the warning issued to children about the safety of children

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"The clear message is we are doing something that we think is in the best interests of patients and physicians. We believe this is a major step forward,"
Ally Benbow

Commenting on why Glaxo changes tack after Spitzer assault

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"Unless I am misreading something here it sounds like they [the WHO] will accept funding from you but not from the industry. Worse than this, they will accept funding from you even if they know it originally came from us in order to bypass their own rules. This is hypocritical in the extreme. It makes a complete mockery of attempts at transparency, which should be welcome and which the WHO have called for."
Ally Benbow

Commenting about The World Health Organisation, the drugs company and the $10,000 funding offer

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We are confident that we have acted responsibly not only in conducting the trials but in bringing the information to the attention of the regulator
Ally Benbow

Commenting on GSK being accused of witholding damning data

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...the decision by the MHRA was concerned only with children and teenagers. "It is not related to the use of Seroxat by adults where this treatment has proven effective and has helped millions of people
Ally Benbow

Commenting about the findings that Seroxat can be a danger to under 18s

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Martin B. Keller - Good or Evil?

Sources - Black (1) Red (2)

Dr.Keller is the Mary E. Zucker Professor and Chairman of the Department of Psychiatry and Human Behavior at the Brown University School of Medicine.

Brown University professor who was forced last year to forfeit hundreds of thousands of dollars in state grant money was paid more than $500,000 in consulting fees in 1998, most of it from pharmaceutical companies whose drugs he touted in medical journals and at conferences.

He is also Executive Psychiatrist-in-Chief at the seven Brown University affiliated hospitals.

Dr. Martin Keller of Newton earned more than $842,000 in 1998 while serving as chief of the psychiatry department at Brown, according to financial records. More than half of his compensation came from the pharmaceutical industry, including companies such as Pfizer Inc., Bristol-Myers Squibb, Wyeth-Ayerst, and Eli Lilly, all of which market antidepressants that Keller lauded in a series of medical research reports.

Dr. Keller received his medical training at Cornell University, and completed a medical internship at Bellevue Medical Center in New York City and a psychiatric residency at Massachusetts General Hospital in Boston.

In addition, Keller did not disclose the extent of his financial ties with the companies to the medical journals that published his research in 1998, or to the American Psychiatric Association, which sponsored the meetings at which Keller presented his findings.

His research interests include investigation of nosology and long-term course of psychiatric illnesses, including mood disorders, anxiety disorders and eating disorders, and the effect of treatment of neuropsychopharmacologic compounds and psychotherapy on the short-and long-term clinical course of these illnesses in children, adolescents and adults.

Several ethicists contacted by the Globe say Keller's unusually large consulting fees - he pulled in a total of $556,000 in 1998 and $444,000 in 1997 - constitute the most serious potential conflict they've heard of yet.

Dr. Keller has received over 20 research grants from the National Institute of Health and numerous grants from research foundations and pharmaceutical industry. He serves on numerous professional committees and editorial boards, published over 240 articles for peer-reviewed journals, and has been the recipient of several prestigious awards in recognition of making major contributions to the understanding and treatment of mood disorders.

Keller, meanwhile, is a valuable resource for Brown University, attracting millions in research grants and donations. According to the psychiatry department's annual report and other documents, Keller has brought in about $14.4 million in research funding from pharmaceutical companies and federal agencies since 1993. Approximately $8.4 million has come from the National Institute for Mental Health for research on mental illness.

The most recent honor he received is the 2001 American College of Psychiatrists (ACP) Mood Disorders Lifetime Research Award which he received in February, 2001.

In 1998, Brown was forced to return $300,170 Keller's psychiatry department had collected from Massachusetts for research that state officials say the department never performed. Brown returned the money shortly after the Massachusetts attorney general's office filed a civil lawsuit in Suffolk Superior Court, accusing Brown of breaching research contracts with the Massachusetts Department of Mental Health.

Keller and Study 329:

(3) GlaxoSmithKline conducted a study, numbered 329, in which it examined the efficacy and safety of paroxetine versus placebo in the treatment of adolescent depression. Keller was the lead author on the article (J American Academy of Child and Adolescent Psychiatry, 2001, 762-772) which appeared regarding the results of this study.

(1)

(2)

Seroxat Archives: FDA Will Probe SmithKline On Pitch for Unlicensed Drugs

Thanks to the Truthman for digging this up.

Source: Washington Post 1991

FDA Will Probe SmithKline On Pitch for Unlicensed Drugs

SmithKline last month held three sessions in Baltimore in which a "marketing consultant" met with doctors to discuss nabumetone, a pain-killer and anti-inflammation drug the company is developing. Three more meetings are planned for this month to discuss paroxetine, an antidepressant. Neither has been approved by the FDA.

"Priming prescribing doctors to be poised to write prescriptions for a drug whose safety and effectiveness have not been established to FDA's satisfaction is a practice which FDA has clearly stated to be illegal," Sidney M. Wolfe, a physician and director of the Health Research Group, wrote to FDA Commissioner David A. Kessler. Wolfe asked Kessler to "promptly initiate criminal prosecution" of SmithKline.

"If we find that the invitation was sent out to a large number of physicians," an FDA spokesman said, "it would be considered a promotional activity and not legitimate marketing research. In that case, it would probably violate FDA rules regarding promotion of unapproved drugs."

GSK - committed to improving the quality of human life

MHRA Freedom of Information request

I have not wrote to the MHRA for a while, so I thought I'd give it a shot regarding its members having close ties with GlaxoSmithKline.

I have requested the following information under the Freedom of Information Act:


----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Sent: Wednesday, August 29, 2007 7:19 AM
Subject: FOI Request: MHRA Current GSK Investigation

Dear MHRA,

Under the FOI Act I would like you to answer the following question.

Under the MHRA's current investigation of GlaxoSmithKline, are, or have any of the following members of the MHRA, been involved? If so, whom?

Regards

Robert Fiddaman.


Professor A Blenkinsopp
Professor H Dargie
Dr M Donaghy
Dr J C Forfar
Dr R Leonard
Prof D J Nutt
Professor J F Smyth
Professor Christopher Bucke
Prof Nicholas Mitchison
Dr Brian J Clark
Professor Robert Booy
Professor S M Cobbe
Professor J E Compston
Dr A Glasier
Dr Andrew A Grace
Dr P Hindmarsh
Professor P D Home
Dr R F A Logan
Professor R MacSween
Professor J O’D McGee
Professor David R Matthews
Dr A Smyth
Professor A D Struthers
Professor J C E Underwood
Dr A Gerard Wilson
Dr Rosemary Leonard
Mr David P S Dickinson
Dr Charlotte C D Williamson
Professor Anthony H Barnett
Professor V Krishna K Chatterjee
Professor Albert
Sir Alistair Breckenridge
Dr Ian Hudson

Monday, August 27, 2007

Fund us and we will support your drugs

Just to recap some members of the MHRA and their 'interests in GlaxoSmithKline

Click on the names highlighted and read more about them or why not leave them a message of your outrage

PERSONAL INTERESTS

MEMBER

Professor A Blenkinsopp - GSK Specific – Fees
Professor H Dargie - GlaxoSmithKline Consultancy
Dr M Donaghy - GSK Shares
Dr J C Forfar - GSK Shares
Dr R Leonard - GSK Fees/ Publicity work
Prof D J Nutt - GSK Consultancy Psychotropics and 300 shares (1)
Professor J F Smyth - GSK Consultancy
Professor Christopher Bucke - SKB Shares
Prof Nicholas Mitchison - GSK Shares
Dr Brian J Clark - GSK PHD student funding
Professor Robert Booy - GSK Consultancy
Professor S M Cobbe - GSK Research grant
Professor J E Compston - GSK Consultancy
Dr A Glasier - GSK Shares (£10,000)
Dr Andrew A Grace - GSK Consultancy
Dr P Hindmarsh - GSK Consultancy on growth, probably lapsed by now
Professor P D Home - GSK Consultancy - Another ex-employee of GSK
Dr R F A Logan - GSK Shares
Professor R MacSween - SmithKline Beecham Shares
Professor J O’D McGee - SmithKline Beecham Shares
Professor David R Matthews - GSK Honorarium for advice - Wonder what he has to say about Avandia?
Dr A Smyth - GSK Conference expenses
Professor A D Struthers - GSK Shares
Professor J C E Underwood - GSK Shares
Dr A Gerard Wilson - GSK Consultancy
Dr Rosemary Leonard - GSK Fees/ Publicity work
Mr David P S Dickinson - GSK Fee paid work
Dr Charlotte C D Williamson - GSK Shares
Professor Anthony H Barnett - GSK Advisory work and lectures diabetes related products
Professor V Krishna K Chatterjee - GSK Consultancy on preclinical research with a Vanillord Receptor antagonist (Consultancy end of 2004)
Professor Albert - GSK Shares

Not to mention Alistair Breckenridge (2) (3) (4) (5) and Ian Hudson (6) (7) (8) , both former employees at GlaxoSmithKline, both worked closely with Seroxat, both now work for the MHRA

An 'independent' advisory committee huh?

(1) This is the email of the Departmental Library Representative of which Prof DJ Nutt is the Head of Department


Fid

MHRA - "shite is so often characterized as excellence"

Matthew Holford not happy with the MHRA it seems... join the queue Matt. I wrote on and off to them over a two year period. They are about as transparent as tinted windows!

Matthew's complaint can be read on his blog 'It's Quite an Experience'. I've reproduced it in its entirety here but please do hop over to his blog - he likes a good old rant - as many of you already know with his own section within this blog - See Matthew Holford Rant

Here's his latest offering:

Yellow card report - complaint

I have a keen desire to understand why it is that shite is so often characterized as excellence, so I sent this to the MHRA, copied to Breckenridge, Woods, Vara, Johnson and a whole bunch of daily newspapers:

Dear Sir or Madam,

I would like to complain formally about the fact that my Yellow Card report has not been followed up.

I experienced suicidal ideations coincidental to fluoxetine use, which I take to be about as serious as it can possibly be, short of incapacity or death, and yet I have heard nothing following the receipt of a hard copy of my submission. I would like an explanation for the MHRA's failure to follow up. I wish to be advised of the manufacturer's details (it being a generic drug that I was prescribed). I wish to understand why the system that I was subjected to was so monumentally incompetent, and I imagine the MHRA's contribution will be definitive, in this regard.I would like the explanation to be full, and detailed, with all considerations properly (as assessed by me) discussed. And I would like an apology, please, even though it's a bit late for that.

Best regards

Matthew Holford

Sunday, August 26, 2007

Protect Your Family from Bad Drugs

Am loving Jeffrey Dach, MD's website at the moment. He's just published a newsletter that is well worth the read. You can view it HERE

Here's a few extracts

Over the last 30 years, 20 per cent of drugs approved by the FDA were classified as “BAD Drugs”, meaning that they were later withdrawn from the market or given a black box warning. (1) (2). Why does the FDA approve risky drugs which end up being banned? This question is explored in these two articles (3) (4). “The FDA is incapable of protecting the American Public against another Vioxx”. This is a quote from David Graham MD, director of drug safety at the FDA, during congressional testimony. (5) (6) (7) (8)

How can you tell if you are dealing with a BAD DRUG?

Here are the early warning signs:

1) The drug has been recalled or given a black box warning.
2) The drug is in litigation with numerous lawsuits against the drug company.
3) The drug has been banned in other countries.

Listing of Drugs which have black box warnings: Click Here (9)

Consumer Reports listing of risky drugs: Click Here (12).

Computer Search Engine Listing of Drugs in Litigation. Click Here for Unsafe drugs in litigation (380,000 listings) (14)

SSRI Antidepressants, Prozac, Zoloft, and Paxil Antidepressant Users v. Eli Lilly, Pfizer, and GlaxoSmithKline (39)

Some 200 legal actions have been filed against Eli Lilly, Pfizer, and GlaxoSmithKline, the manufacturers of Prozac (fluoxetine), Zoloft (sertraline), and Paxil (paroxetine) to recover for suicides or homicides by patients. The lawsuits claim that the companies knew about, but hid the documents which showed increased risk of akathisia, a form of agitation causing suicide and violence.

Paxil
Paxil causes serious side effects, agitation, violent or suicidal behavior, painful withdrawal and addiction problems. It may cause birth defects in pregnant women. Paxil has been recklessly prescribed to children when it was proven no more effective than a placebo. Both children and adults taking Paxil have demonstrated suicidal tendencies during treatment, while trying to quit and during withdrawal.



Credit where it's due, we have an MD here who isn't afraid to speak out. This world needs more people like Jeffrey Dach MD, Dr Aubrey Blumsohn, Prof David Healy et al

Fid

Profit numbers for the top five pharmaceutical companies

1. Johnson & Johnson 11,053,000,000
2. Pfizer 19,337,000,000
3. GlaxoSmithKline 9,915,000,000
4. Novartis 7,175,000,000
5. Sanofi-Aventis 5,026,100,000

That's JUST the profits….after all the big salaries and big advertising and all the rest have been paid. Quite a bit of money even using 2007 standards.

Source: Ohio.com

Friday, August 24, 2007

Paroxetine-Induced Hyponatremia in Older Adults

Ever heard of the file drawer effect?

Did GlaxoSmithKline keep this hidden from us all during the Paroxetine clinical trials?

For those of you who don't know hyponatremia is explained here:

Severe hyponatremia may cause osmotic shift of water from the plasma into the brain cells. Typical symptoms include nausea, vomiting, headache and malaise. As the hyponatremia worsens, confusion, diminished reflexes, convulsions, stupor or coma may occur. Since nausea is, itself, a stimulus for the release of ADH, which promotes the retention of water, a positive feedback loop may be created and the potential for a vicious circle of hyponatremia and its symptoms exists.

Basically ladies and gentlemen hyponatremia is the zaps. We all know what the zaps are don't we? It seems GlaxoSmithKline must have known to. Such a valuable tool is the file drawer effect. I'm sure GlaxoSmithKline lawyers know what it is too.

Now I'd like to ask GlaxoSmithKline, the FDA or the MHRA what constitutes an 'older adult'?

Are we to assume that it is someone over the age of 30,40,50,60?

Surprising that the young and the old seem to be being safeguarded by the various studies out there - what about those that don't fall into these catagories? To be honest I'm unsure as to what catagory I would fall into - I'm 43 now, was 33 (I think) when I first took Seroxat.

Now did GlaxoSmithKline throw hyponatremia into the file drawer effect vault as they did with study 329?

You tell me.

Fid

A 12-Week Prospective Study

Tanya J. Fabian, PharmD; Janet A. Amico, MD; Patricia D. Kroboth, PhD; Benoit H. Mulsant, MD; Sharon E. Corey, PhD; Amy E. Begley, MA; Salem G. Bensasi, BS; Elizabeth Weber, RN, CNP; Mary Amanda Dew, PhD; Charles F. Reynolds III, MD; Bruce G. Pollock, MD, PhD

Arch Intern Med. 2004;164:327-332.

Background Older depressed patients are at high risk for development of hyponatremia after initiation of the selective serotonin reuptake inhibitor paroxetine, despite clinical monitoring and preventive management. The purposes of this study were to determine the incidence and etiology of paroxetine-induced hyponatremia in older patients and to identify patient characteristics that may account for variability in susceptibility to this adverse event.

Methods This prospective, longitudinal study was conducted in a university-based ambulatory psychiatric research clinic from August 1999 through September 2001. Patients included 75 men and women aged 63 through 90 years (mean ± SD age, 75.3 ± 6.0 years) who received a diagnosis of a current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, major depressive episode and were prescribed paroxetine. We monitored plasma sodium levels before initiating paroxetine therapy and after 1, 2, 4, 6, and 12 weeks of treatment. In a subset of individuals, we measured levels of antidiuretic hormone, glucose, serum urea nitrogen, and creatinine. Hyponatremia was defined as a plasma sodium level of less than 135 mEq/L after initiation of paroxetine therapy.

Results Hyponatremia developed in 9 (12%) of the 75 patients after initiation of paroxetine treatment. Mean ± SD time to development of hyponatremia was 9.3 ± 4.7 days (median, 9 days; range, 1-14 days; n = 8). In the multivariate regression, lower body mass index and lower baseline plasma sodium level (<138 mEq/L) were significant risk factors for the development of hyponatremia in these patients.

Conclusions Hyponatremia is an underrecognized and potentially serious complication of paroxetine treatment in older patients. Our results provide a foundation for understanding the etiology and risk factors associated with paroxetine-induced hyponatremia.

BEWARE OF GSK

BEWARE OF GSK

A series of posts taken from the Cafepharma forum

Be nice if the posters over there had some balls to include their names.


Anonymous

BEWARE

GSK places sales reps on probation if their sales are low. In turn, reps do illegal things to increase sales in hopes of keeping their jobs. No wonder why GSK is under so much scrutiny - - - what's their motto 'to improve the quality of human life by enabling people to do more, feel better and live longer.' What a phony line that is, they like to pretend they are this respectful, upstanding corporation when in actuality they treat their employees like garbage and only care about the dollars....not human beings. I think most of America is catching on to this crap.

----
Anonymous

GSK is a terrible place to work, I have seen many blood baths over the years that were not warranted.

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Anonymous

Re: BEWARE
And what about HR? Their only purpose is to support and attempt to validate management's discriminatory practices. GSK is a cruel organization that needs to be brought to its knees.

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Anonymous

I've seen DMs toture and abuse people for no reason other than to impress there RVP. These sacrificial lambs had good numbers and were hard workers...this behavior is very common amongst GSK management.

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Anonymous

I've seen reps who were fantastic & number one in everything for many many years & they were screwed by crooked managers & RVP's. It happens all the time. GSK especially SK is 100% dirty crooked politics.

----


Loads more unhappy GSK employees HERE

£££ Drug companies embroiled in tax row £££

Source: baltictimes.com

Aug 22, 2007
By Kimberly Kweder

International pharmaceutical companies operating in Lithuania have become involved in a dispute with the State Tax Inspectorate after the latter accused them of tax evasion and demanded they pay up. The controversy stems from an audit of the activities, since 2005, of several pharmaceutical companies operating in the country. The audit concluded that some Lithuanian branches of international pharmaceutical dealers, whose activities are purportedly limited to marketing, were in fact engaged in trading activities, and therefore should be taxed on products sold.

“According to the findings of the STI audit, activity of some undertakings in Lithuania is not limited to marketing functions alone, i.e. the collected data shows that in fact, trading activity is also in place,” Mr. Darius Alinskas, Deputy Head of State Tax Inspectorate, told The Baltic Times. “During the tax audit, evaded taxes shall be estimated and sanctions anticipated in tax laws shall be applied, i.e. surcharges for late payment and respective fines. Although, we would like to underline that the key objective of the Lithuanian Tax Administration is to stop tax evasion and future utilization of operational models designed for the purpose of tax evasion,” he said. While the STI is not allowed to comment on which specific companies it says were involved, the marketing branches of Eli Lilly, Pfizer and AstraZeneca have come forward to say that they would fight the STI’s demands that they pay.

“We know we can defend our case. They [tax authorities] have the wrong address. We are good corporate citizens and will continue this way,” said Pfizer’s Luxembourg General Manager Raimundas Voihska. Voishka said that the STI was attempting to tax the companies’ Lithuanian branch based on sales invoiced by their parent company in Belgium. Eli Lilly, Pfizer and AstraZeneca branches say they are exempt from the sales tax because they’re not involved in the sales, only in marketing the products. “It’s totally nonsense,” he said. “Which law have we broken?” “They [tax authorities and the government] want to show power and repatriate money. They believe at this rate, they can reduce prices in the pharmaceutical market,” he added. General Director for Lithuania’s AstraZeneca branch Saulius Sabunas also disagrees with the tax authorities’ assessment of the situation. “We don’t sell medicines, we sell ideas,” as he was quoted on LRT’s Web site.

Lithuanian media has estimated the overall amount of taxes the state could be losing each year from tax evasion by the pharmaceutical industry at 100 million litas (29 million euros). Alinskas, however, puts the figure at about half that. “Following calculations, we can make a conclusion that branches of foreign pharmaceutical undertakings – while concealing their factual trading activity – could have evaded up to 50 million of tax per year,” he said.

Last year U.K.-based GlaxoSmithKline (GSK), one of the largest pharmaceutical companies in the world, was forced to pay $3.4 billion to the IRS to settle a transfer pricing dispute dating back 17 years. The IRS alleged that GSK improperly shifted profits from their U.S. to the U.K. entity.

Thursday, August 23, 2007

Is Alistair Benbow Deranged?

Okay, we all know who he is, we all know his stance on Seroxat 'I think patients have nothing to fear taking Seroxat' but did you know he is now defending the diabetes drug, Avandia?

Get outta here Fid I hear you cry. It's true I tells ya, true!

The Truthman sent me a link to an article and I must admit I had to rub my eyes at GMC flavour of the month, Benbow.

The full text can be read here

For convenience I will reproduce the segment which features Benbow once again, I believe, lying through his back teeth and playing down the risk of Avandia:

Alastair Benbow, European medical director for GlaxoSmithKline, said of the study: "It is well recognised that the class of drug can cause fluid retention. It is wholly different from the issue raised previously about heart attacks and cardiovascular deaths." He said the fluid retention issue could be taken care of if the patient was closely monitored and prescribed diuretics. Even heart failure could be treated in hospital. "What is missing here is the benefit these drugs provide." The drugs kept blood sugar levels low, preventing serious effects of the disease such as blindness and amputations, he said.

Fantastic eh? 'Heart failure can be treated in hospital'! Oh well that's alright then - carry on taking Avandia then - don't worry if you have a heart attack, it can be treated in hospital. Is Benbow a disallusioned man? 'What's missing here is the benefits these drugs provide' What? Is Benbow deranged? Is this man on auto pilot when questioned about drugs GlaxoSmithKline manufacture?

So there you have it folks. Alistair Benbow once again defends, what I believe to be poor drugs... and what will be done about it? Nothing!

Rant over

Fid

GlaxoSmithKline (GSK), Novartis International AG (NVS), Hurt by Drug Setbacks, May Lose Flu-Shot Race

Source: Biospace

GlaxoSmithKline (GSK), Novartis International AG (NVS), Hurt by Drug Setbacks, May Lose Flu-Shot Race

GlaxoSmithKline Plc and Novartis AG, two of the world's biggest vaccine makers, may have bet on the wrong technology in the race to develop a better flu shot. The drugmakers are building U.S. factories to grow influenza virus in animal cells as an advance over the decades- old technique of making flu shots using chicken eggs. Now a small, privately held biotechnology company may leapfrog ahead of them with a more advanced method using DNA.

Awwww diddums

Jeffrey Dach MD

A word from Jeffrey Dach MD.

Jeffery left this comment after my post 'When the rot set in at GlaxoSmithKline'

The particular post recieved a lot of interest from pharmaceutical companies and lawyers visiting this blog so much so that Jeffery's comment was overlooked. Anyway, here it is:


According to Dr. Irving Kirsch in Prevention & Treatment, “there is now unanimous agreement that the mean difference between response to SSRI antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the SSRI trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents.

Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome:

1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout)

2) Benzodiazepine sedatives were given to mask the SSRI induced agitation.

3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public.

4) Miscoding suicidal events as "emotional lability", and homicidal events as "aggression" to hide suicidal events from regulators.

5) False attribution of suicide to the placebo arm.

6) Hiring ghost writers to make the medical articles more favorable.

7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public.

For more information and links see my Paxil, Prozac, and SSRI Induced Suicide Newsletter

Jeffrey Dach MD


Doncha just love number 7?

Fid

Wednesday, August 22, 2007

Baby Chase's Parents Sue GlaxoSmithKline

Many thanks to the Truthman for alerting me to this.



Houston, Texas, March 15, 2006: Robert Kwok & Associates, L.L.P. along with Clark, Depew & Tracey, L.L.P. filed the first known baby heart defect case in the Gulf Coast region arising from a pregnant mother’s use of the prescription drug, Paxil®, during her pregnancy.

On November 2, 2005, baby Chase was born with a severe ventricular defect after his mother, Lisa, was prescribed and took Paxil®, a prescription drug manufactured by GlaxoSmithKline, during her pregnancy.

Robert Kwok & Associates, L.L.P. along with Clark, Depew & Tracey, L.L.P. have now obtained the first known jury trial setting in the country on July 16, 2007 for a Paxil® baby heart defect case. Please call Rob Kwok at 1.888.JR.PAXIL or e-mail Rob at rkwok@kwoklaw.com for more information.

For KHOU Ch11 news video click HERE
For KHOU Ch11 top story click HERE
For Dow Jones Newswires story click HERE
For Houston Press Front Page Story click HERE

SOURCE: Paxil Baby Defects

Muzzling Academics, British Style

Phil Dawdy over at Furious Seasons has a pretty amazing post about the case of Rita Pal, a psychiatrist here in the UK who lost her job over linking to a document on his blog.

I'll let Phil explain HERE

Tuesday, August 21, 2007

Psychiatry - An Industry of Death


Like getting blood out of a stone - The Merck Scandal

Source: New York Times

August 21, 2007
Plaintiffs Find Payday Elusive in Vioxx Cases
By ALEX BERENSON

In Carol Ernst’s eyes, two years ago she won a measure of justice.

On Aug. 19, 2005, a Texas jury awarded Mrs. Ernst $253.5 million after concluding that Merck & Company and its painkiller Vioxx had caused the death of her husband, Robert, in 2001. At a news conference after the verdict, Mrs. Ernst said she was pleased that jurors had punished Merck for hiding Vioxx’s heart risks. “This has been a long road,” she said. “I just know that it was a road that I had to run and I had to finish.”

But her comfort was premature. Merck, the third-largest American drug maker, appealed the verdict — which Texas laws on punitive damages automatically reduced to $26.1 million. Until higher courts rule on the appeal, Merck is not obligated to pay. So Mrs. Ernst, 62, has yet to receive any money.

In fact, none of the 45,000 people who have sued Merck, contending that they or their loved ones suffered heart attacks or strokes after taking Vioxx, have received payments from the company. The lawsuits continue, for now in a state of legal limbo, with little prospect of resolution.

In combating the litigation, Merck has made an aggressive, and so far successful, bet that forcing plaintiffs to trial will reduce the number of Vioxx lawsuits and, ultimately, its liability.

Promising to contest every case, Merck has spent more than $1 billion over the last three years in legal fees. It has refused, at least publicly, to consider even the possibility of an overall settlement to resolve all the lawsuits at once.

The strategy’s successes, from the view of Merck and its shareholders, are clear. In the last year, the company has won most of Vioxx cases that have reached juries. Though its stock plunged immediately after the Robert Ernst verdict, it has since risen 80 percent, easily outpacing those of other big drug makers. And estimates of Merck’s ultimate liability, once as high as $25 billion, are now closer to $5 billion, said C. Anthony Butler of Lehman Brothers.

The Merck executive most closely associated with the company’s strategy, Kenneth Frazier, its general counsel, has prospered. In July, Mr. Frazier was promoted to president of the global human health division, where he oversees the marketing and sales forces, half of Merck’s 60,000 employees.

FULL STORY HERE

Sunday, August 19, 2007

SEROXAT Patient Information Leaflet Updated

**Disclaimer**

The following 'rant' contains adult language. Do not read if easily offended

Fid



Well it seems the time has come for GSK to update the patient information leaflet regarding Seroxat. They, I believe, are still in denial that is causes suicidal thoughts in adults, despite overwhelming evidence to the contrary.

A patient information leaflet is the slip of paper the patient uses as a guide when opening his medicine.

Here are some extracts from the updated Seroxat patient information leaflet.

Tell me if your average patient can understand this:

4.3 Contraindications

Paroxetine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs). Treatment with paroxetine can be initiated:

- two weeks after discontinuation of an irreversible MAOI, or

- at least 24hrs after discontinuation of a reversible MAOI (e.g. moclobemide).

Paroxetine should not be used in combination with thioridazine because, as with other drugs which inhibit the hepatic enzyme CYP450 2D6, paroxetine can elevate plasma levels of thioridazine (see Section 4.5, Interactions with other medicinal products and other forms of interaction). Administration of thioridazine alone can lead to QTc interval prolongation with associated serious ventricular arrhythmia such as torsades de pointes, and sudden death.

Crystal clear eh?

Skimming through it I notice there is now no mention of a chemical imbalance - something that was touted around to market Seroxat in the first place!!! Why have they dropped this now? Is it because it was complete and utter bollocks in the first place?

Oooh, and look 'electric shock sensations' - WOW! GSK acknowledging the yellow card reports it seems!

I find the Children and adolescents (7-17 years) section quite sickening - they knew this years ago - to include it on a patient information leaflet now is like telling a child they will burn their hand if they put it in the fire... after they already fucking have!

Paroxetine should not be used for the treatment of children and adolescents as controlled clinical trials have found paroxetine to be associated with increased risk for suicidal behaviour and hostility. In addition, in these trials efficacy has not been adequately demonstrated (see section 4.4 Special warnings and special precautions for use and section 4.8 Undesirable effects).

GSK still however fail to attach special warnings to pregnant mothers. Terminology such as 'Paroxetine should only be used during pregnancy when strictly indicated.' is simply NOT GOOD ENOUGH!

And talk about passing the buck:

The prescribing physician will need to weigh the option of alternative treatments in women who are pregnant or are planning to become pregnant.

WHY OH WHY DON'T YOU COME CLEAN?

How about something like 'Seroxat should NEVER be given to pregnant mothers'


Now, I can bet you the MHRA's slapdash enquiry into GSK will use this updated patient information leaflet and make comment such as - 'GSK have done everything to correct their mistakes... blah blah fucking blah'

I'm angry - can you tell?



Rant over


Fid

Friday, August 17, 2007

Paxil Recall Lawyer Discusses Paxil Addiction

Source: Ezine Articles

By Anna Henningsgaard

Paxil went on the market in 1992 at the height of antidepressant drug popularity. It is a member of the class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs. The SSRI drugs revolutionized antidepressants because they have very few side effects and it is practically impossible to overdose on them. It makes sense not to prescribe a depressed person with pills they can easily overdose with. Though a latecomer to the SSRI market, Paxil grew successful very quickly by gaining FDA approval for very specific conditions like “social anxiety disorder” and “general anxiety disorder”, which were very rare conditions at the time. In running add campaigns, Paxil encouraged people to try their drug if they’d experienced any general anxiety and, as can be expected, sales of Paxil soared.

Commercials for Paxil insist that the drug has no side effects and is not addicting, major selling point. Many doctors and pharmacies will tell you the same thing, that Paxil is not addictive. To the contrary, many patients using Paxil have found it very difficult to quit. Even slowly reducing doses and coming off the drug, many patients have complained of intense stomach pains, diarrhea, intense anxiety, anger, migraines, and an odd electrical zapping whenever they move their heads or eyes. These symptoms are often written off as temporary illness due to discontinuity. After a few months, the symptoms will be diagnosed as a relapse of depression, and what could be prescribed for that? Paxil.

A recent independent study found that as many as 50% of Paxil users experience intense withdrawal from the drug. While some other drugs in the same class, like Prozac and Zoloft, cause similar withdrawal reactions none of them cause reactions this intense. This could be because Paxil has a much shorter half-life than the other antidepressants, and more addicting substances often have short half-lives. The brain likes slow adjustments and cannot handle rapidly changing chemicals.

Class action lawsuits have been filed against Paxil in Britain as well as the United States. The company that produces and markets Paxil refuses to acknowledge that it can be a habit-forming, addictive drug and has not changed its packaging or advertising despite recent cases of addiction. Patients often find no help from doctors or pharmacies, who simply tell them that Paxil is marketed as a non-addictive drug and, for that reason, cannot cause the symptoms being experienced. If you have been put in this uncomfortable position, contact a lawyer and discuss your situation. A class action lawsuit that began with 35 people has grown to over 2000 people, so you are not alone by any means. Talking with a lawyer can make you feel better and give you some hope for justice.

Depression is over-diagnosed, psychiatrist claims

Source: The Guardian

David Batty and agencies
Friday August 17, 2007
Guardian Unlimited

Too many people are being diagnosed with depression when they are merely unhappy, a senior psychiatrist said today.

Normal emotions are sometimes being treated as mental illness because the threshold for clinical depression is too low, according to Professor Gordon Parker.

Prof Parker said depression had become a "catch-all" diagnosis, driven by clever marketing from pharmaceutical companies and leading to the burgeoning prescription of antidepressant drugs.

Writing in the British Medical Journal (BMJ), he said the drugs were being marketed beyond their "true utility" in cases in which people were unhappy rather than clinically depressed.

The psychiatrist, of the University of New South Wales, Australia, said the "over-diagnosis" of depression began in the early 80s, when the diagnostic threshold for minor mood disorders was lowered.

His 15-year study of 242 teachers found that more than three-quarters met the current criteria for depression.

Qualifying symptoms included "feeling sad, blue or down in the dumps" for two weeks, or appetite change, sleep disturbance, drop in libido and tiredness.

The psychiatrist said these symptoms were so common that most people would have them at some point in their lives. Under the current diagnosis guidelines, around one in five adults is thought to suffer depression during their lifetime.

The worldwide boom in the prescription of antidepressants in the past decade has led to criticism of drug companies' marketing campaigns.

In the late 90s, drug companies in Japan prompted recognition of "mild depression" as a condition that required medication.

GlaxoSmithKline ran an awareness campaign in the country about mild depression, which said: "Depression is a disease that anyone can get. It can be cured by medicine. Early detection is important."

Between 1998 and 2003, sales of antidepressants in Japan increase fivefold, according to the pharmaceutical industry analysts IMS Health. GlaxoSmithKline saw sales of its drug Paxil rise from $108m (£54,510,500) to $298m between 2001 and 2003.

However, mental health charities today rejected Prof Parker's assertion that depression was over-diagnosed.

Marjorie Wallace, the chief executive of SANE, said: "It is better to risk over-diagnosis than to leave depression untreated. One in 10 people with severe depression may take their own life."

Her view was supported by another study in the BMJ by Professor Ian Hickie, of Sydney University, who said the suicide rate had been reduced thanks to increased diagnosis of depression.

Ms Wallace added that depression could range from "feeling low to being so disabled that the person may be unable to get out of bed in the morning, sustain relationships or work".

However, she acknowledged that doctors were being forced to over-prescribe antidepressants for low level depression because not enough money was being put into psychological therapies such as counselling.

Dr Andrew McCulloch, the chief executive of the Mental Health Foundation said it was "very unlikely" that depression was over-diagnosed in the UK. He said it was more the case that many people did not seek help because they did not recognise the symptoms of depression.

However, he also agreed that doctors were too readily providing medication when alternative treatments could be more effective.

"Medication is relied upon heavily in the UK by GPs and patients, and is often prescribed when an alternative might have been more suitable," he said.

The World Health Organisation predicts that, by 2020, depression will be the second most serious disease globally after chronic heart disease.


In the late 90s, drug companies in Japan prompted recognition of "mild depression" as a condition that required medication.

GlaxoSmithKline ran an awareness campaign in the country about mild depression, which said: "Depression is a disease that anyone can get. It can be cured by medicine. Early detection is important."

Between 1998 and 2003, sales of antidepressants in Japan increase fivefold, according to the pharmaceutical industry analysts IMS Health. GlaxoSmithKline saw sales of its drug Paxil rise from $108m (£54,510,500) to $298m between 2001 and 2003.

Coincidence? I think not!

Paxil Is A Direct Link To Birth Defects

By J Mundy


When Bonnie was concerned about staying on Paxil she was told not to worry as it was classified as Category B. Tragically, her son died from heart birth defects; five years later she discovered that Paxil is now Category D.

(In December 2005, the FDA asked Glaxo Smith Kline, the manufacturer of Paxil, to change the pregnancy category to D, a stronger warning. Category D means that studies in pregnant women have demonstrated a risk to the fetus.)

“I first started taking Paxil when I was in high school,” says Bonnie (not her real name pending a lawsuit). Then I quit taking it when I got pregnant with my oldest child – I have four kids. But by the time I was pregnant with Keagan, my life had become difficult and I was very depressed; my husband’s job meant that we had to move far away from family and friends and I started taking Paxil again. I called my Mum (she is a nurse) and asked her if there was any risk in taking this drug. She looked it up in the drug book and it was a category B so there were no warnings and no side effects -- this would have been late in 2001.

My husband lost his job again and we moved even farther away, so I stayed on Paxil. I gave birth to Keagan and when he was only six hours old the doctor told me that he had to be transported to Children’s Hospital because his oxygen saturation was low and they had detected a heart murmur.

As soon as he was transferred, Keagan underwent his first heart surgery. He was diagnosed with critical aortic stenosis – his aortic valve wasn’t functioning properly. They also diagnosed him with hypoplastic left heart syndrome (HLHS) -- one of the rarer heart defects which means that the left ventricle is under-functioning or it could be non-existent. He also had endocardial fibroelastosis (EFE).

It was heartbreaking – everything I went through to stay pregnant with him and then to be told that he had severe heart defects…We had family fly in from Canada, from Oregon and Washington. My sister took my kids back to Washington with her. I slept in the hospital almost every night and a lot of my family stayed across the street,in a place like a Ronald Macdonald Charity house.

FULL HEART WRENCHING STORY CAN BE READ HERE

No pill for those annoying TV drug ads

A profound piece of writing from Randy Scholfield. Humour is the best medicine


By Randy Scholfield.

Randy Scholfield is an Eagle editorial writer. His column appears on Fridays. Reach him at 316-268-6545 or rscholfield@wichitaeagle.com.

No pill for those annoying TV drug ads

Watching TV drug ads, do you experience any of the following symptoms: nausea, anxiety, vertigo, depression or projectile vomiting -- followed by an urge to consult your doctor and tell him what pills he should be prescribing to you?

Reader, if you answered "yes" to any of these questions, you may be suffering from Drug Ad Overdose Syndrome, or DAOS.

The nation's pharmaceutical industry pours billions every year into marketing new drugs directly to consumers through TV ads, often to inform and, yes, scare the bejeebers out of us.

GlaxoSmithKline, the makers of antidepressant Paxil CR, warned us about "social anxiety disorder," which might be what you're suffering if you feel nervous and shy at a party or other social function.

Skip the drink -- go straight to the antidepressants!

Toenail fungus is another scourge apparently crippling America. Who knew? Thank God there's a drug to wipe out those little yellow cartoon characters infesting our toenails.

"Restless leg syndrome" is the latest health scare du jour. You've seen the commercials. One in 10 Americans is afflicted, according to the drug company experts.

Many of these TV illnesses are defined by broad, vague symptoms: For RLS, the telltale signs include an "urge to move," "tingly and creepy-crawly feelings in the legs," and so on.

Who hasn't had those at some point? Still, I now wonder whether my occasional bout of "jimmy foot" is a precursor to full-blown RLS, or possibly even Elvis Leg Syndrome.

Could I be a candidate for permanent medical disability? Will I end up a third-rate Elvis impersonator?

If so, Doc, I want to know.

Please, before you fire off those angry letters describing in excruciating detail your RLS history, let me be clear: I have no doubt that some people have serious, real cases of RLS and suffer inordinately. By all means, they should seek medical help.

But I also suspect that many TV-addicted Americans who now think they have RLS probably just need to get more exercise or drink less caffeine or maybe wear leg irons to bed.

You wonder, in some cases, if the cure is worse than the illness

I mean, have you seen the possible side effects of Requip, a popular drug for RLS?

Apparently some users get an undeniable urge to gamble away their life savings.

I'm not kidding.

According to the Requip Web site, among the drug's possible side effects -- including drowsiness, nausea, dizziness and hallucinations (!)--is an "unusual urge to gamble or increased sexual urges and/or behaviors."

Just think: If more people were taking Requip, we might have approved casino gambling in Sedgwick County.

America is a sick, sick place, if you believe the TV ads, with new illnesses and syndromes popping up every few weeks.

Here are some other ailments I have no doubt we'll see test-marketed before long:

• Nervous Whistle Disorder. While whistling while you work could be a sign of happiness, more likely it reveals a deep-seated nervous condition long overlooked by medical science.

Compulsive whistling not only prevents people from reaching their full potential, it annoys the heck out of co-workers and family. Shut up -- just shut up -- with Silencia, a new drug that relaxes the muscles in the sufferers' lips and prevents them from puckering.

Side effects may include lazy lip syndrome, drooling, vampirism, and compulsive and annoying humming.

• Ever worry that you've said the wrong thing in public situations? You're not alone. Millions of Americans suffer from Foot-in-Mouth Disease.

Ropadopamine is the answer. This new miracle drug, an offshoot of horse tranquilizer medications, renders sufferers comatose for weeks at a stretch -- typically 12 to 14 days, although individual results may vary. Upon awakening, most users have no recollection of their embarrassing social faux pas and may even believe they are contestants on "American Idol."

Side effects could include permanent memory loss, festering sores, and spontaneous public renditions of Ethel Merman songs.

If you think you may be suffering from either of these syndromes, I urge you to call a doctor or veterinarian at once and have him prescribe medication against his better judgment. And if you've found yourself growing agitated or offended while reading this column, you might be suffering from Irritable Reader Syndrome.

Don't worry -- a drug is on the way. (Results may vary.)

Thursday, August 16, 2007

GlaxoSmithKline - Snakes, ladders, and spin?

Browsing through the BMJ I found this rather fascinating article which pretty much sums up how GSK works. Its called 'Snakes, ladders and spin' and can be read here

See if it rings any bells for you.

How to make a compelling submission to NICE: tips for sponsoring organisations

Evidence in support of products being assessed by the National Institute for Clinical Excellence can be presented in various ways to make products seem more attractive than they really are

During health technology appraisals the National Institute for Clinical Excellence (NICE) invites sponsors of the technology to make a submission in support of their product. These submissions can be of variable quality. We examine some of the more dubious techniques that can be used by sponsoring organisations to make their products seem attractive to those making reimbursement decisions.

Although the following "advice" is based on real examples of submissions to NICE, it should be remembered that similar biases can be found in academic, peer reviewed publications and that such practices are not the preserve of industry.

Make your technology look effective

Generating the evidence

Compare your intervention with an inactive control; placebo controlled trials are ideal for circumventing clinically relevant head-to-head comparisons.

If forced to use an active control make sure that the comparator is:

Inadequately dosed;

Toxic; or

Ineffective in the patient group studied (for example, select only those who have failed to respond to standard treatment and then use standard treatment as the comparator).

Do not look at long term outcomes; for modelling purposes, extrapolating from short term data is far more flexible.

If the treatment effect may be short lived, switch all the controls to your intervention at the end of the trial. This makes long term assessment impossible, and you can extrapolate the benefits from the early results. Justify this switch on ethical grounds.

To be taken seriously, you must describe at least one analysis as "intention to treat." Do not over-interpret this requirement or stick slavishly to technical definitions. For example, by defining withdrawal criteria to include patients who find the intervention toxic or ineffective, you can avoid collecting follow up data for patients whose inclusion in an intention to treat analysis would be undesirable.

Reporting the evidence

Place most emphasis on the outcome in the trial that produces the most significant results.

Do not be unduly upset if no outcome on its own is statistically significant.

Combine different outcomes—by chance you will often end up with the intersection of two or three sets of outcomes that is highly significant. Report these as a clinically "very important combination."

With a little creativity you will almost certainly be able to find a subgroup of patients with especially good results.

Report mean changes on rating scales as your primary outcome. This way, no one will know how many patients experienced worthwhile clinical improvements.

Always refer to the trials favouring your intervention as the "pivotal" trials.

If your product is a drug and the evidence of efficacy is weak insist that it is a member of a class of drugs.

Conversely, if the class of drugs has little advantage over alternative treatments, insist that your product is unique within that class.

Presentation and framing are all important—a 33% decrease may be better expressed as a 50% increase, and expressing results as a relative risk reduction is usually much more compelling than the equivalent absolute risk reduction.

Minimise the possibility of independent evaluation of the evidence

Suppress the original protocols for trials ("commercial in confidence" is an established justification for this)—this prevents independent reviewers from detecting whether your reported outcomes are results driven, as they will not be able to verify the primary outcome of the trial.

If some of your trials come out with unfavourable results:

Do not report them;

Delay reporting until after the NICE committee makes its decision; or

If these results have already been reported in journals, minimise their importance—find some minor difference in trial design from the studies that give favourable results and emphasise the clinical importance of this.

Make sure it is not possible to reanalyse your results—there are many ways this can be done:

Present your data as an "integrated" analysis. This also conveniently allows you to add and subtract bits to make your case stronger (such as truncating data at an outcome point that maximises the apparent treatment effect);

Leave out the standard deviations and confidence intervals, especially where these do not reach conventional levels of statistical significance;

Present survival curves without giving information on the hazard ratio, withdrawals, or losses to follow up;

Present results in different formats for each trial to prevent independent pooled analyses.


Overwhelm independent technology assessment reviewers by submitting large volumes of data. Aim for 10 000 pages as a minimum. Include rat, elk, sheep, and in vitro tissue studies where possible—you do not want to be accused of holding back potentially useful information.

Ensure that data are delivered at the last possible moment.

If an independent review team have worked in the area insist that the work be given to a team that is coming fresh to the subject.

However, if there is plausible evidence to support your technology, ignore the above. Develop a chummy and cooperative relationship with the review team and provide them with everything they need. (The evidence is more likely to impress the appraisal committee when it is presented by independent reviewers and will thus make your case better than you can.)

The article continues pretty much in the same vain throughout. It has GlaxoSmithKline tactics written all over it wouldn't you say?

GSK - They would say that wouldn't they?

Source: NewsRx

Current study results from the report, "Do NMDA receptor antagonist models of schizophrenia predict the clinical efficacy of antipsychotic drugs," have been published. According to recent research from Verona, Italy, "N-methyl-D-aspartate (NMDA) receptor antagonists, such as ketamine and phencyclidine, induce perceptual abnormalities, psychosis-like symptoms, and mood changes in healthy humans and patients with schizophrenia. The similarity between NMDA receptor antagonist-induced psychosis and schizophrenia has led to the widespread use of the drugs to provide models to aid the development of novel treatments for the disorder."

"This review investigates the predictive validity of NMDA receptor antagonist models based on a range of novel treatments that have now reached clinical trials. Furthermore, it considers the extent to which the different hypotheses that have been proposed to account for the psychotomimetic effects of NMDA receptor antagonist have been validated by the results of these trials," wrote C.H Large and colleagues, GlaxoSmithKline.

The researchers concluded: "Finally, the review discusses some of the caveats associated with use of the models and some suggestions as to how a greater use of translational markers might ensure progress in understanding the relationship between the models and schizophrenia."

Large and colleagues published their study in the Journal of Psychopharmacology (Do NMDA receptor antagonist models of schizophrenia predict the clinical efficacy of antipsychotic drugs? Journal of Psychopharmacology, 2007;21(3):283-301).

Wonder if GSK have a cure?

You can bet they do!

Fid

Wednesday, August 15, 2007

http://www.DangerousMedicine.com

I suggest you all take a look at this forum

Fid




Dear readers,

As part of the NewsTarget Network, we operate a website called DangerousMedicine.com, and it's a public, open-access website where people can post their horror stories about dangerous drugs, hospitals, surgical procedures or anything else related to conventional medicine. The site is intended to shed light on issues that the drug companies, hospitals and the FDA would rather sweep under the rug. After all, the reporting of dangerous drug side effects observed in patients isn't even mandatory: It's VOLUNTARY!

But now, you can share your true stories about the horrors of conventional medicine by posting them on this new site:http://www.DangerousMedicine.com

Everybody has a horror story about doctors, hospitals or drugs. I've seen doctors make outrageous disease determinations from loosely interpreted blood tests (like incorrectly telling patients they have thyroid cancer). I've read about the horrors of bariatric surgery(which kill 1% of patients right on the operating table) and the downright atrocious hospital food served to heart patients that actually worsens their heart conditions. Readers have emailed me stories about medication errors, surgical errors (they removed the wrong kidney!), and outrageous coverage denials by health insurance providers. The horrors of conventional medicine, it seems, have no end. Now is your chance to vent. Share your horror story about a drug side effect, a surgery gone bad, a hospital error or bad doctor experiences, and help us expose the U.S. medical racket for what it truly is: A for-profit system of collusion between drug companies, the FDA, med schools and hospitals, designed to turn a human being into a profit machine.Our goal is to reach 100,000 posts by Christmas.

Post your true story and spread the word! There's no charge to post messages or read other messages.http://www.DangerousMedicine.com

Monday, August 13, 2007

Avandiagate - GSK revise marketing

Source: Marketplace

You can listen to this special report HERE

What to do about Avandia?

With more studies out on the potentially serious side-effects of Avandia, GlaxoSmithKline is trying to revise marketing for its once second-best selling drug. Stephen Beard reports.

The controversial diabetes drug Avandia has been a problem for its maker, GlaxoSmithKline. Research has concluded the drug carries the risk of heart attack. Now, the British pharmaceutical giant may have to cut its sales force in response. From London, Stephen Beard reports.

Glaxo is still insisting that what was once its second-best selling drug is safe. But the company is nevertheless revising its marketing plans. One analyst quoted in the British press suggests that Glaxo could cut its Avandia sales force in the U.S. by 5 percent.

Sales of the drug have slumped, and its future looks uncertain. A study by a leading cardiologist at the Cleveland Clinic has raised serious concerns. He warned that patients on Avandia were much more likely to have a heart attack or stroke. Another study by German researchers came to the same conclusion.

The U.S. Food and Drug Administration is considering the matter. Some of the FDA's advisors have already recommended that Avandia carry a health warning.

Friday, August 10, 2007

Brushed Under The Carpet III

...and are we led to beleive that the following sham of an investigation is still ongoing?

Seroxat controversy deepens with Europe-wide warning on suicide

Source: netdoctor.co.uk 2004


A new warning that the controversial antidepressant Seroxat may increase the risk of suicide in young adults up to the age of 30 is to be issued throughout Europe.

Seroxat is among the biggest selling drugs in the world and is taken by between 600,000 and 800,000 people in the UK, of whom "a significant proportion" are aged under 30, according to the manufacturer, GlaxoSmithKline.

The drug has been at the centre of a government investigation of all selective serotonin re-uptake inhibitors (SSRIs) in the UK over claims that they increase suicide and cause withdrawal problems. The UK Medicines and Healthcare products Regulatory Agency (MHRA) launched the investigation last year but its findings on Seroxat have been overtaken by the European Agency for the Evaluation of Medicinal Products (EMEA), which licenses drugs for use in the EU.

A committee of the agency has recommended that Seroxat, which banned in under-18 year olds in the UK in June last year because of an increased suicide risk, should be prescribed with extra caution in people aged 18 to 29. It says: "There is a possibility of an increased risk of suicide-related behaviour in young adults. As a consequence young adults should be monitored closely throughout treatment."

The recommendation by the EMEA's committee for proprietary medicinal products was made in April and is awaiting ratification by the European Commission, expected in the autumn, when it will become law in member states. The committee also warned about withdrawal symptoms from Seroxat and echoed the prescribing ban for under-18s.

But it has cleared the drug for continued use in Europe on the grounds that the benefit-risk ratio "remains positive". The MHRA endorsed the findings of the EMEA, but it has issued no warning to British doctors about the dangers of the drug in people aged 18 to 29. TheEMEA conducted its safety review in response to a request from the MHRA, in order that prescribing of Seroxat could be harmonised throughout Europe.

Richard Brook, chief executive of Mind, the mental health charity, said: "Why on earth has the MHRA not made more widely known the danger to young adults? It seems extremely bizarre." Janice Simmons of the Seroxat Users Group said: "Its appalling. Unless you tell GPs to monitor people under 30 they won't do it."

Fears that Seroxat was unsafe were aired in two BBCPanorama programmes in 2002 and 2003. They provoked 67,000 calls and 1,400 e-mails, the biggest response in the programme's history, and led to the review by the MHRA. Two weeks after GlaxoSmithKline supplied it with evidence from trials of Seroxat in children carried out years earlier, the drug was banned. The ban in under-18s was extended to all other SSRIs, except Prozac.

GlaxoSmithKline is now facing fraud charges in the United States for allegedly concealing information that the drug caused suicidal behaviour in children and adolescents.

The MHRA is now also examining the implications of studies with all SSRIs for adults. But the outcome of a key part of that review, expected in October, has been upstaged by the EMEA's decision. Mr Brook, who resigned from the MHRA's SSRIs working group earlier this year, said: "It is extremely difficult to see how the MHRA can come to a different decision that contradicts EU law. Government announcements on this issue have perhaps been misleading."

The Department of Health failed to respond to requests for a comment.

Brushed under the carpet II

...and what was the outcome of this?

British drugs giant in Italian bribery investigation

Source: The Guardian 2003

Italian prosecutors are investigating the giving of perks to Italian doctors by the British pharmaceuticals giant GlaxoSmithKline allegedly in return for prescribing more of their drugs.

Investigating police claim they have evidence of a nationwide "bribery system" in which doctors allegedly prescribed 7-8% more Glaxo products each year in return for "freebies" such as Caribbean trips, stereo systems and wine.

In some cases, doctors received cash "gifts" ranging from £300 to £1,000, said the investigating prosecutor, Guido Papalia, in the northern town of Verona, where Glaxo has its Italian headquarters.

Glaxo played down the allegations. "We have a code of conduct and we try to follow it as scrupulously as possible," said Giuseppe Recchia, the spokesman for GlaxoSmithKline in Italy.

"Glaxo is a leader in the world pharmaceutical market. We do not need to do anything here that we do not do in other European countries," Dr Recchia said.

Dr Recchia said the company was awaiting further details of the allegations from the Italian authorities, after financial police searched 48 offices of its sales people throughout the country on February 7.

The police investigation is centred on communications between 30 doctors and 40 Glaxo salespeople between January 2001 and December 2002. Police say that emails, documents and tapped phone calls they have collected suggest more than 3,000 medical professionals may have been involved.

But Dr Recchia argued that "travel" was not a crime, and health professionals had to attend international conferences to have the latest information on pharmaceutical developments.

Glaxo faced similar allegations in Germany last March, over allegedly offering perks such as free World Cup and formula one trips to thousands of German doctors between 1997 and 1999. The company, the biggest drugs firm in Europe, said at the time it would investigate the allegations internally and Europe-wide.

The company said at the time that many positions had been redefined and "responsibilities have changed" because of restructuring after Glaxo Wellcome merged with SmithKline Beecham in 2000.

Glaxo Wellcome was also investigated in 1995, during an Italian crackdown on corporate corruption, for allegedly bribing health ministry officials.

The head of the health ministry's pharmaceuticals department at the time, Duilio Poggiolini, cited Glaxo among several leading pharmaceutical companies which he claimed had paid bribes to secure a place in, and set their prices on, the Italian market.

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