MHRA unveils medicine information resource

Source: MHRA Website

Well, it seems the MHRA have joined forces with Pharma [who else!] and created a new web section on their website. My medicine: From laboratory to pharmacy shelf "...aims to help you find out more about the life cycle of medicines from their first scientific discovery through to licensing and ongoing monitoring."

The pages set out to explain:

How and why medicines are developed
How the process is regulated and monitored
How potential problems can be reported and what you can do to help
Why not all medicines are widely available in the NHS.

Pharmafocus

writes:

"UK regulators and the pharma industry have come together to launch a new website for patients.

The 'mymedicine' site is a joint collaboration between the MHRA and the ABPI, and explains the drug lifecycle and how medicines become available on the NHS."

Karen Miller, a director at the ABPI, said, "More and more people are going online to find out about health-related issues, and while the internet is a superb resource, it contains a lot of disinformation."

I wonder if she means patient advocate blogs? It seems 'timely' that such a unison between the MHRA and the ABPI should come on the back of a recent commissioned report into blogs by the MHRA where it was shown that blogs are quite influential when reporting drugs such as Seroxat.

Phil Dawdy of Furious Seasons wrote: "Included among influential and popular blogs in no particular order were Pharmalot (US), Seroxat Sufferers (UK), Seroxat Secrets (UK), the Carlat Psychiatry Blog (US), Furious Seasons (my All-American blog), Clinical Psychology and Psychiatry (US) and Health Care Renewal (US). For popularity and influence, we ranked right up there with wire services, the London Times and the Wall Street Journal and only slightly trailed the BBC and the New York Times. This is all quite astonishing when you think about it--underfinanced blogs having as much influence as the WSJ! Unthinkable! US blogs that barely mention the MHRA (and usually write about Paxil not Seroxat) being more influential than WebMD--the world has come undone for sure!"

The 'Blog Report' can be downloaded here

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Glaxo Pulls Aids Adverts!

It seems GlaxoSmithKline have been forced to pull their controversial ad campaign that ran under the guise of patient education, so writes the Business Wire

Since Spring of this year Glaxo ran a series of direct-to-consumer print advertisements in magazines such as POZ, a monthly national magazine targeting people living with HIV/AIDS.

During the summer the AIDS Healthcare Foundation [AHF] began an aggressive advocacy effort criticizing GSK for the irresponsible marketing tactics it used in this campaign which led to unflattering news articles in the Wall Street Journal (August 25, 2008) and the Philadelphia Inquirer (August 29, 2008). AHF’s campaign begin last in late August and featured print ads in publications including the Washington Blade and the Village Voice. I highlighted this earlier this month on Seroxat Sufferers.

One ad featured [Click on Picture] a scenic photo of the sun setting over the ocean with what appear to be sailboats floating calmly in the distance. The tag, reads: “First Impressions…”. Upon turning the page, a close-up on the triangular boat sails reveals them to be the fins of sharks. The text on this page: “…Can Be Deceiving. Avoid hidden dangers from changing your HIV medicines.” And, opposite the shark fin image: “If you are thinking about switching your HIV medicine, make sure you know what you’re getting into.” Another similar ad, [Click on picture] with the same text, features a view of a lake, sand dunes, palm trees and fields. A turn of the page reveals a fierce looking lion hiding in the fields.





“AIDS drug advertising has a history of distorting the reality of AIDS treatment in order to generate sales. However, the GSK ads sank to a new low, and we are grateful that they have had the good sense to suspend this marketing campaign,” said AHF President Michael Weinstein. “These ads resort to blatantly exploiting patient fears in order to sell a product, while remaining unconcerned about the potential harm caused to patients who might be scared off treatment altogether, or going on a better course of treatment because of the threats implied by these ads. Frankly, we were disappointed that Poz magazine—a publication targeted to an HIV-positive population—would even run such inflammatory ads. This kind of underhanded negative advertising creates fear of HIV treatment in general, which could dissuade people from seeking treatment at all.”

Another victory for patient advocates. Bravo AHF.

Fid

*Hat Tip - The Truthman

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Two new non-executive directors to join MHRA’s Agency Board

Source: MHRA Website

Two new non-executive directors for the Medicines and Healthcare products Regulatory Agency’s (MHRA) non-executive board have been appointed today by the Appointments Commission - Professor Barrington Furr OBE and Professor Vincent Lawton CBE.

Chairman of the MHRA, Sir Alasdair Breckenridge said; “I look forward to working with Professor Furr and Professor Lawton. I believe their expertise will contribute significantly to the ongoing work of the Agency Board in safeguarding public health and ensuring the accountability of the MHRA.”

Professor Barrington Furr OBE aged 64, lives in Macclesfield, Cheshire. He has worked in ICI’s legacy companies Zeneca and AstraZeneca for over 33 years, from which he retired in 2005. In 1997, Professor Furr was appointed Senior Vice-President of Therapeutic Research for Zeneca, a department of over 600 staff in both the UK and US, responsible for drug development in Cardiovascular and Metabolic Diseases, Infection Cancer and Musculoskeletal Disease (UK), and Neuroscience and Respiratory Diseases (US). Following Zeneca’s merger with Astra in 1999, he was appointed Chief Scientist and Head of Project Evaluation for AstraZeneca Pharmaceuticals and a year later was made head of AstraZeneca’s research Centre in Bangalore, which is committed to developing world medicine.

Conflicts of interest: Professor Furr is a former employee of a large pharmaceutical company and consults for venture capital and biotechnology companies as well as one other pharmaceutical company, Almirall. He is also a trustee of the Breast Cancer Campaign and was a trustee of Cancer Research UK.

Professor Vincent Lawton CBE aged 59, lives in London. He is retired as Managing Director and Vice President Europe of Merck Sharp & Dohme UK (MSD) Ltd with whom he worked for 26 years in senior positions across Europe and North America

Conflicts of interest: Professor Lawton holds some stock in Merck Sharp & Dohme UK Ltd. He has stock options, some of which run until 2016, when they will expire, if they are not cashed or purchased at the option price. He has a small number of stocks in a former US subsidiary of Merck Sharp & Dohme UK Ltd, known as Medco, a pharmaceutical management company and a trustee of the Association of the British Pharmaceutical Industry (ABPI).



Makes you feel somewhat safer huh?

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Cervarix - Promotion or Scaremongering?

With many websites backing use of Glaxo's HPV vaccine, Cervarix, I thought maybe it was time to add some balance to the argument of whether or not this drug is actually needed.

I'm not a scientist, I'm a consumer, and when a drug comes along from a pharmaceutical company who have a history of manufacturing drugs that have caused misery to consumers then I feel it only right to redress the balance.

As a consumer you have the right to be protected against products, production processes and services, which are hazardous to health or life. You also have the right to be informed - to be given the facts needed to make an informed choice, and to be protected against dishonest or misleading advertising and labelling.

It is my belief that these basic rights are being taken away from children...and the parents of children.

I may be accused in certain circles of scaremongering but I believe this is exactly what GlaxoSmithKline are doing with Cervarix. There may be cervical cancer victims damning me to hell because of my beliefs, but I feel really strongly about the way Cervarix is being touted here in the UK.

Let's take a brief look at GSK and their consumer history:

Source: Consumers International

Before GSK's anti-depressant Paxil [Seroxat] was approved for use against social phobia in 1999, the company organized a large public awareness campaign about this condition, renaming it social anxiety disorder. GSK has been accused of grossly exaggerating the number of people that would be suffering from this condition, leading to inappropriate drug use and much higher sales of Paxil.

In 2000 GSK's drug Lotronex had been approved by the FDA for women with irritable bowel syndrome. Months after approval of the drug reports about side effects were sent to the FDA. GSK then voluntary withdrew the drug from the US market. Patient groups, including at least one funded by GSK, wrote letters to the FDA demanding the drug be re-approved. GSK also sponsored the International Foundation for Functional Gastrointestinal Disorders. Its president Nancy Norton spoke at advisory meetings, which were set up by the FDA in order to assess the safety concerns surrounding Lotronex, without revealing that the Foundation received significant amounts of money from the pharmaceutical companies, including GSK. At the time of her appearances, the industry was reportedly funding the Foundation in the order of $600 000 a year.[1]

In 2001, GSK has been warned several times by the FDA (US) to change its promoting activities in the context of Avandia.[2]

In 2002 German authorities started an investigation against GSK for corruption of at least 1600 doctors.[3]

In February 2003, Italian authorities started an investigation against GSK for corruption of over 4,000 of doctors. The total value of illegal gifts would have been €228 million from 1999 to 2002. Because of these incentives, doctors would have prescribed 7-8% more products of GSK per year.[4]

Promotional materials for GSKs antidepressant Paxil have claimed that the drug reduces the likelihood that people will harm themselves. However, data from clinical trials indicated the opposite, namely that people continue to harm themselves.[5]

In 2005 the Dutch Code Commission ruled that GSK had made unjust claims about the necessity of using Seretide in the treatment of COPD in its promotional materials and violated the Code on the Promotion of Medicinal Products.[6] The Commission also showed that GSK had provided unclear and misleading information for Avandamet and Avandia in a mailing to healthcare professionals and ordered the company to stop these practices.[7]

In May 2004, GSK was accused of fraudulent manoeuvres to extend patent protection over its anti-depressant Paxil and its antibiotic Augmentin, in order to prevent generic competition.[8]

Parents Allege Pharmaceutical Giant Tricked Them With Experimental Vaccine

GSK's Seroxat 'may harm sperm'

Just a few things to mull over whilst you ponder whether or not you should give the go-ahead for your child to be vaccinated with GlaxoSmithKline's Cervarix.

It's certainly food for thought.

I also wouldn't strictly adhere to the advice of GSK or the other sites promoting the vaccine. 'Talk with your doctor', seems to be the main deflection yet again. You may recall the term 'Talk with your doctor' appears on the Seroxat information leaflet no less than thirty times. Question you, as parents, have to ask yourselves is, What do doctors know about this vaccine? What do the NHS know about it? What do the MHRA know about it?

Give your children a chance in life, more importantly, give your children's children a chance in life. Research this drug until you have ALL the facts. Don't take the words of GSK, The NHS and The MHRA as gospel. They've been wrong in the past and know doubt they will be wrong again.

Do you really want your child to be a human guinea pig?

I feel really strongly about this, I said weeks ago that something didn't sit right with me - that feeling continues to grow as more and more websites promote this vaccine.

Read the bullet points above and compare them to the 'promotion' of Cervarix. You will see that we are going down the same old road again where the consumer [in this case your children] is being targeted for a drug that we know so little about.

At the end of the day, it's a descision that has to be made but one needs ALL the facts before they can make the right choice.

I don't trust GlaxoSmithKline, I don't trust their ethics. I, for one, would not allow any daughter of mine to be subjected to a vaccine manufactured by GlaxoSmithKline. I hold them personally responsible for causing me an addiction, whatever way they or the regulators dress it up, addiction is what I had and for that I hold them in complete contempt.

I'd hate to see parents lobbying for the banning of this vaccine 10 years down the line, I would hate to see young women campaigning because they were given this drug at such an early age and it has caused them problems later on in life. I am assuming here, but that's all one can do when one does not have all the facts.

I hope I am wrong. I hope this vaccine can prevent cervical cancer. Would Andrew Witty, the CEO of GlaxoSmithKline, be prepared to sign a statement that Cervarix WILL prevent cervical cancer and if it does not then he will be personally held accountable? That would be asking too much.

You see, GlaxoSmithKline, are a company, they are not one single entity one can blame when things go pear shaped. If GlaxoSmithKline were one person, then that person would have been behind bars a very long time ago.

Do your research. You owe to your children.

Fid

[1] R. Moynihan & A. Cassels, Selling Sickness, (Crows Nest/Australia, Allen & Unwin: 2005), p. 156-169.
[2] Oekom research, Corporate responsibility industry report: pharmaceuticals & Biotechnology, February 2005, p.8
[3] K.Werner, H.Weiss, 'Het nieuwe zwartboek wereldmerken en hun praktijken', (Rijswijk 2004), p.301.
[4] The Guardian (February 13, 2003). GSK British drugs giant in Italian bribery investigation; Financial Times (March 15, 2002). German doctors accused of taking bribes.
[5] D. Healy, Let them eat Prozac (Toronto: Lorimer & Co, 2003).
[6] Stichting CGR, K05.008, Boehringer jegens GSK, http://www.cgr.nl/index.cfm?pageid=5758 (12 December 2005).
[7] Stichitng CGR, K05.003, v Ballegooie jegens GSK, http://www.cgr.nl/index.cfm?pageid=5645 (12 December 2005).
[8] Financial Times (May 5, 2004). NY sues GSK over patent manoeuvres.

Related links

GLAXO RECALL CERVARIX VACCINE

Cervarix Tested for Boys!

Natalie Morton, 14 Dies after Cervarix jab

GlaxoSmithKline challenged safety Cervarix anti-cancer vaccine left girl partially paralysed

4,602 Suspected Adverse Reactions to GSK's Cervarix!

Girls used as Guinea Pigs in HPV Trials Admits GSK

GSK - A Catalogue of Disasters!

Glaxo: "Promote More, Feel Better and Live a Life of Luxury"

Glaxo Goes Head-to-Head on HPV

Teenage Girls Sue Over GSK's Cancer Jab, Cervarix!

GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine

HPV Vaccine Video on Youtube

Concerns over GSK's Cervarix vaccine

UP YOURS GLAXO!

Mindy Merck & Gail Glaxo Dilemma

LOLA'S LAND PROMOTING HPV VACCINE

GlaxoSmithKline's Cervarix. Is Your Daughter Safe?

More debate on GSK's Cervarix

Cervical Cancer, Ofsted & GlaxoSmithKline

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Adverse psychiatric side effects of medicines: What’s our responsibility?

Notification of APRIL’s third London conference Thursday 6 November 2008



Adverse psychiatric side effects of medicines: What’s our responsibility?

With additional session on ‘coming off medicines’

‘preparation and coping with withdrawal’’



Did you know?



30% of ADRs are neuropsychiatric
250,000 people a year are admitted to UK hospitals due to ADRs
74% of junior doctors feel their training to prescribe drugs is inadequate
Stopping some drugs may end - or cause symptoms, including aggressive behaviour


Learn about the issues from Internationally renowned researchers, clinicians and academics.

Be better informed and be part of the growing support and advice network - join us on Thursday 6 Nov 2008


Venue Friends House, Euston Road, London NW1 2BJ

Date Thursday 6 November 2008


Speakers and Panel include
Professor Munir Pirmohamed Professor of Pharmacogenetics, Liverpool University. Leader in ADR research

Professor David Healy Professor of Psychological Medicine University of Wales Author of Psychiatric Drugs Explained, The Antidpressant Era, peer reviewed studies of SSRI suicide risk

Charles Medawar Founder Social Audit, Specialist Medicines Policy & Drug Safety co-author Medicines out of Control

Dr Anita Holdcroft Emeritus Professor of Anaesthesia, Imperial College London. Anaesthesia ADR analysis paper 07

Professor Heather Ashton Emeritus Professor Clinical Psychopharmacology Newcastle University and ran a benzodiazepine withdrawal clinic in Newcastle.

Dr Joanna Moncrieff Sen.Lecturer/Hon.Consultant Psychiatrist, member of the Critical Psychiatry Group, author of The Myth of the Chemical Cure

Dr Simon Maxwell Edinburgh Uni/ British Pharmacological Soc. Med Schools Council Safe Prescribing Working Group

Dr Andrew Herxheimer Clin.Pharm. co-author Seroxat ADR Review International Journal of Risk and Safety in Medicine. Former editor Drug and Therapeutics Bulletin

Nigel Meadows H.M.Coroner Manchester City District

Bob Johnson James Nayler Foundation psychiatrist author of Emotional Health

Dr John Halliday Pharmacology & Therapeutics Sub Dean King's College, London

Dr Ben Goldacre Medical doctor writer broadcaster (The Guardain ‘Bad Science’ regular column)
Peter Walsh CEO Action Against Medical Accidents

Clare Milford-Haven Clare’s son James died by suicide 10 days after having anaesthesia

Millie Kieve Founder of the charity APRIL will speak about the patient experience, lack of awareness and how this is costing lives



Programme includes morning break out session - Coming Off Medicines ‘how to prepare and cope with withdrawal’ – session participants will include Professor David Healy, Professor Heather Ashton, Dr Joanna Moncrieff, nurse Adam J Hugroo and psychologist Dr Bob Johnson who will discuss “A review of talking cures for psychoses”



Delegates will include health professionals, GP’s, nurses, psychiatrists, psychologists, practice managers & service users, - all those concerned with patient care and patient safety



The venue: opposite Euston station.



Venue Friends House, Euston Road, London NW1 2BJ

Date Thursday 6 November 2008

Time 9.00 am to 5.00 pm registration from 8.30 am



Cost £125 (invoice can be sent to employer)



£25 Concessions including un-funded health professionals, voluntary organisations



£5 Un-funded nurses, students, service users and carers

Lunch is not provided, reasonably priced food available

We need to cover the cost of this event so please do pay what you can afford to help support APRIL.



Registration Please mail or fax registration form to EYAS Ltd
The registration form and flyer can be downloaded from the home page www.april.org.uk There is a pdf of full flyer and word version of registration form for emailing

Or call EYAS 01243 775 561 or email EYAS at april@eyas.co.uk

Organiser:

APRIL- Adverse Psychiatric Reactions Information Link

Room 6, 380–384 Harrow Road, London W9 2HU +44 (0)20 7266 7599

www.april.org. uk info@april.org.uk

Charity registered in England no 1072305, company limited by guarantee no 3641410

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Is GlaxoSmithKline Behaving Badly in Argentina?

...And they want your children to feel safe taking their HPV Vaccine, Cervarix!

Parents Allege Pharmaceutical Giant Tricked Them With Experimental Vaccine
By AINA HUNTER
SANTIAGO DEL ESTERO, Argentina, Sept. 23, 2008 —


Maria Ester, 23, lives in a crumbling, one-room stucco cottage with her mother and daughter in Santiago del Estero, an Argentine province northwest of Buenos Aires.

Ester's 5-year-old daughter and assorted neighborhood children crowd the room, and a sagging mattress that smells like it belongs to a young bed wetter is the only place for a visitor to sit down.

An adult might find the room oppressive. But from a child's perspective, a benefit to living in a shanty is that no one really minds if you draw on the walls. Ester's walls are colorfully scribbled.

Sharp-featured, with glossy hair and warm, brown skin, Ester's small body is still plump with baby weight. She had another daughter, Michaela, but the 5-month-old died May 28.

Michaela had been one of more than 13,000 Argentine children to participate in a clinical study implemented a little more than a year ago by the London-based GlaxoSmithKline, the world's second-largest drug manufacturer.

Streptococcus pneumoniae is a major cause of meningitis and pneumonia in children in Latin America. More than 12 million pneumonia episodes occur each year in this region in children under five and it is estimated that at least 50,000 children die each year of pneumonia in the region according to 2006 data from UNICEF.

Ester says that if her infant hadn't participated in the study Michaela would still be alive.

Protocol Compas is the name of the study designed to test the efficacy of Synflorix, GSK's experimental pediatric pneumonia vaccine, which can also ward off the bacteria that causes meningitis and ear infections. Synflorix is still in the preapproval stage.

GSK compares Synflorix with Wyeth's hugely successful Prevnar vaccine, which has proved effective in the United States. Besides Argentina, trials are also being conducted in Panama, Chile and Colombia.


The Outsourcing of Clinical Studies
Americans are swallowing more prescription medications than ever, and the ever-increasing appetite for pharmaceuticals has fueled the drug industry's search for cheaper and faster ways to conduct clinical testing.

In 1997, the United States conducted 5 percent of its clinical studies outside of the United States and Western Europe, according to a study conducted by Tufts Center for Drug Development. By 2007, that number had climbed to 29 percent.

Because of the multinational business of major drug companies, and how Americans fit in as U.S.-based employees and stockholders of GSK, as well as consumers of drugs that will be available in the U.S. market, there are global ramifications of clinical testing being conducted around the world.

The lion's share of drug studies has gone to regions with "emerging markets": Eastern Europe and Central Europe, Latin America, and south and Southeast Asia. In order for a region to be of use to a legitimate drug company, the country has to maintain a minimal level of infrastructure, says Mary Jo Lamberti, director of market research at the Boston-based Center Watch, a consulting firm that bills itself as the "Global Destination for Clinical Trials Information."

According to Fortune magazine, it takes about $900 million to bring a new drug to market, and procuring and retaining human subjects typically accounts for about 40 percent of a drug company's budget. Conducting trials in regions considered "poor" by Western standards makes economic sense.

Yet money is not the only factor in the equation, Lamberti says, whose work includes helping pharmaceutical companies find suitable locations for clinical trials. It's easier and takes far less time to find suitable subjects in many developing countries, she says, because they have large "drug naive" populations.

In other words, a large percentage of Americans are already on various medications, so it's difficult to find subjects with unadulterated -- that is, completely unmedicated -- bodies in the United States.

Critics say there is an additional issue that has yet to be taken seriously.

Individual countries generally have their own boards of medical professionals charged with setting standards to ensure the safety of their citizens. And the United States, for example, has an arm of the Food and Drug Administration tasked with overseeing clinical studies performed abroad. The trouble, critics say, is that the standards that exist are sometimes not upheld.

Sonia Shah, author of the 2006 book "The Body Hunters: Testing Drugs on the World's Poorest Patients," tells ABCNews.com that there is a "whole steamrolling industry that needs more and more subjects."

She adds, "[The] political will is not there" to protect the interests of those who put their bodies at risk.


Clinical Study: 'Adverse Events Can Arise'
Pneumococcal diseases -- that is, diseases caused by bacteria that cause pneumonia, middle ear infections, meningitis and blood infections -- are a serious problem in Latin America. According to international health organizations, each year more than 50,000 children die from them.

Dr. Ricardo Ruttiman, the regional medical affairs and research and development director of GlaxoSmithKline responsible for Protocol Compas in Argentina, says the study is being conducted in three Argentine provinces -- Santiago, Mendoza and San Juan. Ruttiman says Compas clinical studies began a little more than a year ago.

Twelve Argentine children who participated in Protocol Compas have died, and of those 12, seven are being mourned in Santiago del Estero, one of Argentina's poorest provinces. Like Ester, many of the parents reportedly blame what they know as Protocol Compas, or simply, Compas.

"Within the COMPAS trial an Independent Data Monitoring Committee (IDMC) oversees safety aspects of the study and ensure that the highest ethical and compliance standards are followed," said Sarah Alspach, director of US Media Relations for GlaxoSmithKline. "The mortality rate of children participating in the COMPAS study is closely monitored by the IDMC and does not exceed the rate in the regions and countries participating in the study."

Some parents say they didn't know that their children were participating in a study at all. Others claim to have been coerced into participating -- a suggestion rebutted by Ruttiman, who told ABCNews.com that participation is always voluntary and that parents "are informed, clearly and in a language they can understand, by experienced medical investigators."

They are informed not only about the benefits, he says, such as round-the-clock access to medical care and vaccinations against diseases such as diphtheria, tetanus and hepatitis, but about potential risks.

Ruttiman says there are few risks. The safety of the drug has already been proved, he says, and the vaccine's efficacy against respiratory infections is only being tested.

He adds that "the vaccines used in this study may cause adverse reactions unknown up to now. & As with any vaccine, unexpected adverse events can arise, including allergic reactions."

Ester, who earns a living cleaning houses, says Michaela is among those who experienced an "adverse event."

Three weeks before Christmas, a nurse's aide came to the Esters' home. The nurse's aide, says Ester, who spoke to ABCNews.com through a translator, told her that doctors at the Eva Peron Children's Hospital, Santiago Del Estero's primary children's hospital, wanted to give Michaela a vaccine.

Ester -- who told her story to ABCNews.com and a small audience that included five neighborhood children sitting as quietly as possible on the pungent bed -- says that a friend had warned her to stay away from Protocol Compas. The friend told Ester that she knew of another new mother whose baby reportedly suffered health problems after participating in the study, according to Ester.

Ester only gave in, she says, when the nurse's aide threatened to go to the police and have her baby taken away from her. "I didn't know if the doctors, the police, the system would take her away, but I was afraid," she added.

Ester soon signed a 12-page consent form she says she couldn't really understand. Then she allowed Michaela to receive her first injection.

Many health-care professionals assert that holding clinical trials in regions with poor health-care systems has the potential to benefit everyone. GSK's Ruttiman points out that because of the high quality of care the children in the study receive, the infant mortality rate is significantly lower in those who participate in Protocol Compas than in those who do not. Ruttiman would not comment on individual cases citing patient privacy.

Benjamin Wilfond, head of Seattle's Treuman Katz Center for Pediatric Bioethics, says that although he is unfamiliar with Protocol Compas, it's difficult to know what really happened between Ester and the nurse's aide.

"I have no doubt that that was how [Ester] experienced the process. And you will not find anyone who will defend coercion," he said. "But I was in Argentina a few years ago, and the internal regulations seemed quite robust. It could very well be true, because even if the process is being appropriately reviewed, it's difficult to monitor what goes on [on] the ground, what individuals take it upon themselves to do. But I would be wary [of such accounts]. The death of a child could be processed in all sorts of ways. It could very well be true. But I am skeptical."

Trading participation in a medical trial for health care has become the standard operating procedure for drug companies and/or their medical contractors, according to Shah. Some see it as win-win, but Shah views the trade as nearly as coercive as the dramatic threat Ester alleges she received.

"The argument I make is that the drug companies are going [abroad] because people have less access to health care," said Shah. "So they offer incentives and the choice is, 'participate in the trial or your children won't get health care.' That's not a choice. Being in an experiment is not the same as standard care. In an experiment [the drug] might work, you might get a placebo or it might be worse than nothing. They might suffer some terrible unforeseen consequence."


Tricked Into Participation?
When it comes to Protocol Compas specifically, Dr. Ana Maria Marchesse of Eva Peron Children's Hospital is one of several Argentine doctors who is highly critical of the study's methodology.

She heads up the Health Professionals' Labor Association, a group of local doctors who alerted La Federacion de Profesionals de la Salud de la Republica Argentina (the Argentinean FDA) of their concerns about possible wrongdoing.

"It's impossible to say whether the 12 babies' deaths are due to the vaccine or not, because half of the [total number of] children were given a placebo," the pediatrician told ABCNews.com through a translator. "But the way the study has been conducted is reprehensible."

A large part of the problem lies in the consent form, says Marchese. The language in the 12-page document is so convoluted, she charges, that even she had to read it more than once to fully grasp its meaning. Another problem is how subjects say they were recruited, Marchese says.

Claudia Nazarena Hoyos, 31, and Alvaro Martin Ovejero, 32, spoke to ABCNews.com in Ovejero's father's kitchen.

Hoyos and Ovejero allege that a Protocol Compas nurse's aide told them that 4-month-old Gabriel, who suffered from bronchial trouble, would probably get better if they allowed him to be a part of the study. Instead, Gabriel died two months after receiving his first injection.

Ovejero, who works as a part-time disc jockey, alleges the couple was misled by the "agente saniterio," a kind of nurse's aide, who told them about the study. "She did not say it was a test. She said it was a vaccine for his lungs that would keep him from getting worse."

One week after the baby received his first injection, says Hoyos, her son began to produce a lot of mucus. His eyes were perpetually runny, and his breathing grew slow and labored.

GlaxoSmithKline denies allegations of ethical misconduct. Ruttiman says the deaths have been analyzed, and says all of them were clearly unrelated to the vaccine. One child died in a choking incident, he says.

"GSK is saddened to hear of any mortality in clinical trials. Safety of patients is always our primary concern in the development of any new treatment or vaccine," Alspach said. "It is, however, important to review such cases in the context of the rates of post-neonatal infant mortality for the country in which the trial is being conducted."

Nevertheless, Ovejero insists that "something in the process was bad," and that his family and the other affected families "want to find out who or what is responsible."


Unintended Consequences
Global health advocates say bad press is making it difficult for doctors working with children in the developing world, even when the doctors have no connection to clinical studies.

The Nigerian state of Kano is one well-publicized example. In 2004, Kano's government refused to take part in the Global Polio Eradication Initiative sponsored by the World Health Organization out of fears that the immunizations constituted a plot to reduce the country's Muslim population.

According to The Associated Press, the boycott was initiated after Pfizer faced accusations made by families and human rights groups of putting about 200 children at risk during what they claimed was a poorly managed meningitis study 11 years ago.

Eleven children died, while others suffered brain damage, according to the Nigerian government, which this summer filed suit against the London- and Connecticut-based pharmaceutical company. The case is still pending.

Although the immunization boycott lasted 10 months, international health experts reportedly noted a rapid polio expansion, in a pattern that radiated from the west African state.

Shah says that the Kano example points to the public health issues at stake when countries lose trust in the pharmaceutical industry. "It's not that drug companies are trying to go out and harm people," she said. "They really hope and believe that their drugs will work."


Back in Argentina Franklin Moyano, Santiago del Estero's health minister, told state news media that the province is conducting an independent investigation into the children's deaths. But the families of the children are taking matters into their own hands.

Ovejero, who wears a T-shirt bearing his late-son's photo, says that the family is planning to take legal action. The family also told Inter Press Service that their lawyer had been offered money to halt any legal action, but they rejected the offer.

A GlaxoSmithKline representative told ABCNews.com that the company was aware of reports in the Argentine press that Ovejero and his wife were offered money through their lawyer, but GSK said in an e-mail response, "The company has acknowledged this information through the articles that have been published in the media. Therefore, we do not have acquaintance of this fact."

In the meantime, Ovejero participates in weekly protest marches on the Plaza Liberdad, the town square. For the last month, every Monday around 7 p.m., close to 20 to 50 parents, extended family members and friends carry signs bearing the blown-up likenesses of their dead babies.

"Gabriel was born with a purpose," said Hoyos, Gabriel's mother. "His purpose was to bring justice."


Copyright © 2008 ABC News Internet Ventures

Hat Tip: The Truthman

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Blanks A Lot Glaxo!

Glaxo's Seroxat under fire again. This time for making men infertile. Not content with making thousands suffer with akathesia and memory loss plus a whole host of reported adverse reactions, Seroxat now seems to be the cause of damaged sperm.

FULL STORY

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

UP YOURS GLAXO!

School bans girls from cancer jab

Governors at Catholic St Monica's High School in Prestwich, Greater Manchester has banned pupils from receiving the new cervical cancer vaccine on its premises. (BBC News)

Governors at St Monica's - which has 1,200 pupils - have sent a letter to parents outlining their concerns about the vaccine.

In it, they question the effectiveness of the injections and point out the possible side effects.

The letter says a number of the school's pupils who took part in a pilot study were subsequently off school suffering from nausea, joint pain, headaches and high fevers.

Only two weeks ago Scottish bishops approved the use of the vaccine in Catholic schools in Scotland.


In June this year, the pharmaceutical giant GlaxoSmithKline won the contract to distribute their vaccine against HPV, Cervarix, in a national vaccination programme.

Just last week, I wrote on here how Lola's Land were promoting the vaccine... or rather the use of it, to their readers. Lola's Land is a fun, interactive site that will advise, inform, entertain and inspire girls aged 9 to 13.

I've wrote to Lola's Land and asked them the same 6 questions that I have put to the MHRA. Lola's Land have kindly answered the questions, I'm waiting on the MHRA to answer to see if the answers contradict. I have also wrote to Jo's Trust, a registered charity dedicated to women, their families and friends affected by pre-cancer and cancer of the cervix. They strangely wrote back and asked me who I was? I've since informed them but they have still yet to answer the questions. According to The Catholic Exchange Jo's Trust are being paid by GlaxoSmithKline.

They write: In 2006, the company donated £5,000 for IT improvements and £1,600 “in recognition of presentations given” by Jo’s Trust at GSK meetings. Also in 2006, GSK donated another £1,300 for Jo’s Trust to attend a cervical cancer medical conference in Paris and £2,500 “medical fellowship award” to lobbying at a Parliamentary Breakfast at the House of Commons.

You can read more about HPV and vaccines here

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

GLAXO SAY "TALK TO YOUR DOCTOR"

On the Seroxat Patient Information Leaflet for it is stipulated no less than 30 times 'Talk to your doctor'.

I'd like to talk to GlaxoSmithKline's doctor, Dr. Alistair Benbow.




Dear Dr. Benbow,

Do you have a tapering program regarding withdrawal of Seroxat? I ask, because the only advice given on the current Seroxat Patient Information Leaflet is that one must taper 'slowly'. How slowly? I would assume that breaking a 10mg Seroxat tablet in half is the recommendation, unless GSK want patients to slice it with a razor blade?

You see Ali, may I call you Ali? It's all well and good telling patients that they have to taper slowly but some guidance would be nice. When a driver approaches a school he is warned by signs to go slow, these signs tell the driver the speed limit. How slow should a patient taper off Seroxat Ali?

It seems your employers are advising patients to seek advice from a professional body that have no experience in SSRi withdrawal. I find this rather strange Ali therefore I am asking you, I take it you must have years of experience in the tapering of Seroxat?

So, do you recommend that a patient break a 10mg tablet in half and decrease their dosage by 5mg or is this too much of a drop Ali?

I know of the Seroxat liquid... thing is Ali, there are still many doctors who do not know of its existence. So, how slowly should a patient taper off using the liquid? How long should it take them Ali? Would 18 months be a kind of ball park figure?

As you are probably aware, I have been Seroxat free for almost three years Ali. Seeing as you are the spokesperson for GSK for all things related to Seroxat, I think you are in a position to advise patients how to taper properly. Whether or not they wish to believe you is their choice but it would be nice if you offered them your wisdom.

As I understand, I am not allowed to talk directly with anyone from GSK, apparently it would be unethical, at least that's how I read it when your employers lawyers wrote to my lawyers.

Perhaps a statement from yourself or your employers regarding tapering would be suitable not only for patients but for doctors too?

So Ali, How slowly must one taper off Seroxat?

Warm regards

Bob Fiddaman

Seroxat Sufferers

***

Footnote:

For campaigners who have issues with other SSRi's, may I suggest you write to the manufacturer concerned and ask them what advice other than 'taper slowly' they can give you.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Dr Thomas Stuttaford Answers Your Questions On Depression and SSRi's

Interesting piece in yesterday's Times Online regarding depression and SSRi's. A selection of readers letters were answered by Dr Thomas Stuttaford, quite what his credentials are is not known. His advice is typical of someone who writes about a subject he clearly does not know about. Once again, those words 'speak with your doctor' appear in his answers to patients questions. Forgive me for being fickle Dr. Struttaford but these patients are asking a doctor...YOU!

It's just typical of the current trend with so called experts drafted in to answer questions they know nothing about. Maybe the Times Online should allow me to answer questions on whether there is a God or not? If I don't know the answers I could always refer the readers to a priest!

Here we have a doctor answering questions, when he cannot deal with a question he refers the 'patient' to a doctor! How utterly absurd. It would be like you or I going in to see our own doctor, asking him a question and him/her referring us to Struttaford. And so the circle continues.

Stuttaford is the medical columnist for The Times he is also a former Conservative Member of Parliament and recently retired as Senior Medical Advisor for Barclays Bank.

This from Wikipedia:

As well as writing books and his work as a columnist for the Times, Stuttaford writes a regular column for the monthly catalogue of Healthspan, an online retailer of vitamin supplements.

The views he presents in The Times' medical column are considered by some to be rather irreverent to the subject matter, and, it is argued, are not always to be considered accurate, and in particular when regarding mental or sexual health, rather more as a right to exercise free speech.[2] His views on the effects of alcohol on health, specifically red wine, are controversial,[citation needed] as he supports moderate consumption of alcohol as being healthy. Stuttaford has often been parodied in the satirical magazine Private Eye as Dr Thomas Utterfraud.

Let's scrutinise the advice he gives out regarding Seroxat and then later SSRi's in general.

Q: I've been prescribed Seroxat (paroxetine) for the past seven years for moderate depression and panic attacks. I've experimented with stopping it several times, on my doctor's advice, but each time the symptoms have returned. I've now reduced the dosage to the minimum (about 10mg a day) and I would be quite happy to continue taking it for the foreseeable future. It has really made a difference to my life. Are there any dangers in long term use of Seroxat or other SSRIs? Jan, Leeds

Stuttaford's answer: (with comment from me)

Long term use of SSRIs is not likely to damage the reader's life as in his case the correct drug of choice has almost certainly been found. And perhaps you could point us to the evidence? What long term study has been carried out on prolonged use of SSRi's? Would you be willing to back your claim with a small bet Dr. Struttaford, say for example, your house? What do you know of serotonin receptors, could long term use of an SSRi destroy the serotonin receptors?


Many depressed patients do discover that they will have to continue taking medication for the foreseeable future. How do they 'discover' this? Is this merely a diversion because the patient cannot get off the drug they have been prescribed?

As in all cases of this sort close liaison with the GP is essential. Why? What does a doctor know about SSRi withdrawal? Perhaps Dr. Struttaford can tell me exactly what training is given to doctors regarding SSRi withdrawal?

It is always necessary to discontinue taking these drugs very slowly. How? Does Dr. Struttaford have a program or at least a guide of how to taper slowly or is he merely reading the information from the standard SSRi patient information leaflet?

No drug that is effective is entirely without side effects. Straight from the book of Pharma

Patients taking an SSRI should be regularly monitored by their doctors to make certain that there is no evidence arising that might suggest bipolar disorder and that their kidney and liver function tests remain normal. Ah, bipolar. So not content with treating depression with an SSRi, the patient may now how bipolar! And no doubt there is another pill for that eh Dr. Struttaford?

Next came Struttaford's unbelievable response to someone suffering with memory loss which they attribute to administering SSRi's.

Q: I have been diagnosed as suffering from severe to moderate depression following a three month period of chronic stress brought on by work. I have been suffering from the stress and depression for the last six months. For the last five months I have been taking anti-depressants starting with 20mg of Citalopram rising to 40mg and for the last ten weeks Venlafaxine XL 225mg. Throughout this period I have been suffering from memory loss. In particular I find it difficult to recall what I did a few minutes ago and on a day to day, week to week and month to month basis. I recently read an article by you in which you stated that a person with damage to the Hippocampus lives only in the present. Is there any other explanation for my memory loss or am I correct in my self-diagnosis of a irreversible damaged Hippocampus which has brought on my current amnesia? Name and address withheld

Struttaford's answer:

No. I don't think that antidepressants cause permanent damage to the hippocampus. Again, have you any scientific evidence? It's comforting to know that these are merely your thoughts Dr Struttaford.

Patients who are depressed suffer from a poor memory partly because so many gloomy thoughts are making them preoccupied. As a result they fail to remember other events in their life. Their thoughts tend to go round and round in never ending and unproductive circles, so called psycho motor retardation. There is however no doubt that many antidepressants do have a reversible adverse effect on memory. I have noticed in my patients that it may also make them slightly slower at doing such intellectual tasks as mental arithmetic. People with permanent damage to their hippocampus, and associated areas, develop a generally poor memory and, as I know to my own cost, a specific inability to recognise and remember faces but not, I am glad to say, personal and clinical details of people. My short term memory is pretty poor Dr Struttaford. It was fine before I was prescribed an SSRi. There are many cases where people [patients, guinea pigs, call them what you will] have complained about short term memory loss after using an SSRi. I have been Seroxat free for almost three years [I think] - such is my memory I cannot actually remember the year without going through notes I have kept. Can you totally write off Seroxat as the cause of my short term memory problem? Remember Dr. Struttaford, I have been off Seroxat for three years or thereabouts, my local shopkeeper has my telephone number now, it was amusing at first. I'd take the three minute walk to the shop to purchase three items, I'd get there and forget what it was I went there for, even when I remembered, I'd pay for them and leave them on the counter. I even have difficulty remembering my 4 digit pin number for my Debit card. Should I go talk to my doctor, doctor?

There are a whole heap of questions aimed at Dr.Struttaford, all from different age groups regarding different SSRi's. It seems the only advice he can actually give is by telling the reader [patient] to go and talk with their doctor. This was basically the whole point of my recent meeting with the MHRA. Doctor's have had no training in SSRi withdrawal, why on earth would someone wish to seek advice from someone who knows nothing about this particular problem? It would be like someone wishing to seek advice on throat infections going to a gynaecologist!

This is the problem that faces every single person who is struggling with SSRi withdrawal, they have nobody to turn to, in fact when they turn to the patient information leaflet they are told to go talk to their doctor [No less than 30 times it states this on the current Seroxat Patient information leaflet] When they turn to the MHRA, N.I.C.E, M.I.N.D or the current Health Minister, they are told pretty much the same. Pateints deserve much better than this. Passing patients from pillar to post is adding to their frustrations and dare I say it, Dr. Stuttaford along with a whole host of others, are actually making the problem worse because you don't have any answers to questions that should have been answered before SSRi's were licenced in the first place!

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
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PAPERBACK COMING SOON

BIG BUCKS... BIG PHARMA DOCUMENTARY

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
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PAPERBACK COMING SOON

Uncomfortably Numb

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

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PAPERBACK COMING SOON

Tough times ahead

I think you'd have to be from the planet Zog if you had no foresight into the 12 months that lay ahead. It seems doom and gloom will envelop a lot of us with ever increasing food and fuel bills. Unemployment figures seem to tell a different story but such is the way of the UK, jobs now are being filled by migrant workers who work for less.

The next 12 months scare me because I know many thousands of people will struggle and fall into 'depression' because they can't make ends meet. A trip to the doctors will more than likely result in the obligatory prescription for some SSRi... and the rollercoaster ride will start.

The next 12 months or so will no doubt be profitable for Pharma as people turn to their 'wonder tablets' to lift themselves out of the doldrums.

I'm no Nostradamus but I can see people turning to their doctors as the financial slump kicks in. The doctor, uneducated in SSRi's, will no doubt hand out prescriptions rather than opt to send the patient to a help group. Fortunately, Seroxat prescriptions are dwindling, thanks, in the main, to media coverage and court cases both sides of the pond. So the doc will move onto to another SSRi then sometime down the line the patient will complain of withdrawal... and the whole cycle of convincing the 'people in power' will begin again.

I can forsee a heavy marketing push by Pharma over the next 12 months. Fortunately, in the UK no advertising of prescribed drugs is allowed but Pharma have ways around that particular law. Mental Health charities will no doubt be offered help [funding] in return to highlight how depression is affecting the millions of Brits who will be going through financial hardship over the impending 12 months or so.

There's only one winner and that's Pharma. They will see the gap and seize it. Doctor's up and down the UK will be the first port of call for the Pharma reps as the families queue for the remedy that will make the bills seem less important. Nothing wrong with walking around like a zombie if it takes away the debt... not literally, but anyone who has taken an SSRi type drug will tell you that once on them there is a feeling of euphoria and that nothing else really matters. So what if the baliff turns up at the door? Just rip up those red letters, it don't matter, the packet of pills will get you through this.

You think the Seroxat scandal was bad? You ain't seen nothing yet!



Fid


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE


AUSTRALIAN ORDERS HERE

Some Interesting Front Page Google Searches

Alistair Benbow - LEFT CLICK

Seroxat - LEFT CLICK

Paxil 329 - LEFT CLICK

Seroxat withdrawal - LEFT CLICK

GSK cover-up - LEFT CLICK

Gone are the days when Pharma ruled the roost!

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Special report: the Seroxat scandal

Published: 07 March 2008

Source: Nursing Times

The government has said it will tighten regulations on reporting of clinical trials following an investigation into the antidepressant, paroxetine (Seroxat).

Government legal experts have ruled that there will be no criminal charges against the drug's manufacturer, GlaxoSmithKline.

The UK drugs regulator, the MHRA, had been monitoring the safety of paroxetine since it was first licensed in the early 1990s.

An investigation by the BBC programme Panorama in 2002 highlighted public concerns about suicidal behaviour among children being treated with the drug, sparking a series of meetings between the MHRA and GSK.

It was only in February 2003 that GSK finally submitted clinical trial data to the MHRA showing that paroxetine caused suicidal ideation, and even then data from adult and paediatric trials were merged.

Full data from the clinical trials in children, demonstrating a causal link between paroxetine and suicidal ideation and behaviour, was finally submitted by GSK to the MHRA in May 2003 – a month before the company was due to submit an application for the drug to be licensed for use with children.

Findings show that 'adverse events' occurred in at least 2% of patients and a rate at least twice that of placebo.

These events included decreased appetite, tremor, sweating, hperkinesia, hostility, agitation, self-harm, and 'emotional lability'.

Emotional lability was a catch-all term for a range of symptoms including suicidal thoughts, attempted suicide, mood swings, crying and self-harm.

The data also revealed doubts about the efficacy of paroxetine, which along with the evidence of suicidal behaviour, caused the MHRA to conclude that it was not safe to use on children aged under 18.

At the time, the MHRA estimated that there were 7-8,000 children aged 18 being treated with the drug.

The MHRA then launched a four-year criminal investigation into whether GSK had delayed submitting the clinical trial data – but the government has now opted not to prosecute because of legal loopholes, which are now due to be closed.

MHRA chief executive Kent Woods said: 'We will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies' obligations to report safety issues.'

GSK has rejected claims that it withheld information. Dr Alastair Benbow, medical director for GSK Europe, said: 'We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour in patients under 18.


'GSK is committed to working with the government, appropriate regulatory authorities and other pharmaceutical companies to take whatever action is necessary to improve legislation and policy in this area.'

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

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PAPERBACK COMING SOON

Author to speak about the background of Paxil

Posted on September 19, 2008 by Keith E. Jacobson
Filed Under Newton people

Newton author Alison Bass will speak about her recently published book “Side Effects,” the true story of a groundbreaking court case and the personal drama that surrounded the making and unmasking of the best selling drug Paxil. Ms. Bass will give an author talk at the Newton Free Library on Thursday, September 25 at 7:30 pm.

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

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PAPERBACK COMING SOON

AC/DC - Back With A Bang!

My day is complete :-)

This one is for Jezza. Thanks for directing traffic to Seroxat Sufferers. You da man.

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

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PAPERBACK COMING SOON

The Great Escape... Starring GlaxoSmithKline

Online Videos by Veoh.com

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

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PAPERBACK COMING SOON

Mindy Merck & Gail Glaxo Dilemma

What a dilemma!

Jane Doe has narrowed down her search for a babysitter to just two applicants, Mindy Merck and Gail Glaxo. Which one should she choose to look after her 3 small children while she goes to work full-time?

She has just recieved both of their CV's through the post. Seroxat Sufferers was their when she opened them.

First Mindy Merck:

HISTORY

Known to have caused an estimated 125,000 heart attacks. In the first of many trials, the jury found Merck guilty of knowingly causing harm to patients by selling Vioxx.

Merck has friends in high places, most notably, Republican Gov. Rick Perry, Governor of Texas.

Merck is quite rich and has recently secured a deal with the FDA to vaccinate children with a drug called Gardasil. There is controvosy over Gardasil, in fact Dr. Diane M. Harper, a lead researcher in the development of the humanpapilloma virus vaccine says giving the drug to 11-year-old girls "is a great big public health experiment."

I think Jane Doe can cross her off the list. Okay, next we have Gail Glaxo, let's see how her CV reads:

HISTORY

Glaxo - Paxil Study 329 plus other crimes against children. Strangely, Glaxo is also vaccinating children in the UK with a drug called Cervarix!

Enough said!


Looks like Jane Doe will have to look elsewhere for a babysitter!

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

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PAPERBACK COMING SOON

GlaxoSmithKline, David Healy & Shelley Jofre

The following is a repost that deserves to be shown again.

The link to the interview is a must listen for all Seroxat sufferers.

On the 1st November 2007 Panorama reporter Shelley Jofre discussed her investigations into the effects of psychiatric drugs and questioned how much faith we should put in the medicines we take. This took place at Coventry University here in the UK and is available via a podcast.

Very interesting podcast it is too, where you will learn much about what Shelley Jofre and David Healy have saw with their own eyes but for legal reasons are not allowed to disclose. Who told them not to? GlaxoSmithKline did!

Shelley became intrigued with Seroxat when she read a small piece in a newspaper in the year 2000, the article was about patients complaints with Seroxat - almost 8 years ago people! Even back then people were complaining that it was difficult to withdraw from and were suggesting that it was addictive.

She goes on to tell the audience that the filming of the first Panorama Seroxat 'Special' Secrets of Seroxat took 8 months to finish. She states that the first programme pretty much relied on the testimony of one man who was Dr David Healy and what was unique about his position was tha he, through a series of legal actions in the United States, had actually been given access to GlaxoSmithKlines 'secret archives', a wealth of confidential material.

All the results of trials they had run before Seroxat had been licensed were in huge vaults and Healy, through American litigation, was granted 3 days to look through the records.

The rest, as you all know is history. Healy's evidence at the Tobin v. GlaxoSmithKline trial , No. 00-CV-0025 (D. Wyo. June 6, 2001) was pretty damning for Glaxo. It resulted in GlaxoSmithKline being found 80% guilty of causing the deaths of Donald Schell's wife, daughter and granddaughter.

David Healy could only relay to Shelley Jofre what he had relayed in the United States courtroom. What he spoke about in court opened Shelley's eyes. Glaxo were of course in a position to argue that it was the illness that had caused Schell to murder his wife, daughter and granddaughter but Healy had found that that Glaxo had done tests on normal, healthy people, even their own employees. These tests seperate out the effects of the illness from the effects of the drug, ie; if you're not depressed why would you then become suicidal or have homicidal thoughts if given a course of Seroxat?

What Healy had found in the healthy volunteer studies was that it was making some people have suicidal thoughts and become aggressive and also the some of the healthy volunteers were having trouble when withdrawing from Seroxat. Compelling evidence I'm sure you'll agree.

Shelley also mentions her 3 interviews with Glaxo mouthpiece, Alistair Benbow. One thing I never spotted before, and kudos to Shelley's observation skills here, was the second programme where Benbow (obviously briefed by Glaxo's lawyers and PR Team) was seen to have a more laid back approach. Head tilted to one side, his collar open, speaking in a sympathetic voice. Watching the video again I can see exactly what she means.

Shelley also speaks of the MHRA - It's a fascinating interview and one that no doubt I will play over and over. The woman deserves honours of the highest order for cracking open GSK... as does David Healy

The podcast can be downloaded here [Right-Click and 'Save As']

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

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PAPERBACK COMING SOON

Prescribing Advice for GPs

Glad to see word is getting out.

MHRA publish SSRI meeting minutes

September 16, 2008 on 1:43 pm

The Medicines and Healthcare products Regulatory Agency have published the minutes of a meeting held with Bob Fiddaman, campaigner and author of the Seroxat Sufferers blog, to discuss withdrawal issues.

The meeting discussed the current warnings in the patient information leaflet and the problems encountered when ending treatment with selective serotonin reuptake inhibitors (SSRIs), but especially paroxetine (Seroxat®). Attention was also drawn to low levels of awareness of withdrawal as a problem and due to this a lack of expertise and support when patients do encounter withdrawal symptoms, for example by using liquid formulations.

Action: Clinicians should be well aware of the potential for withdrawal symptoms associated with SSRIs, especially paroxetine. Using liquid formulations or changing to longer acting treatments (fluoxetine) towards the end of therapy may make treatment withdrawal easier.


Penny seems to be dropping

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

New Blog - HPV Vaccine Myth

http://hpvmyth.blogspot.com/

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

LOLA'S LAND PROMOTING HPV VACCINE

Lola's Land is a fun, interactive site that will advise, inform, entertain and inspire girls aged 9 to 13.

Lolasland.com is fresh, inspirational, positive and content rich. It's a land that girls will love and parents will happily embrace.

On their 'Love Yourself' page, 9 to 13 year old girls and their parents can learn about HPV (Human papillomavirus)



They are told that HPV is a very common sexually transmitted infection and is the main cause of cervical cancer.


What they are NOT told is:

• The FDA has, for four years, known that HPV was not the cause of cervical cancer.


• Why HPV infections are self-limiting and pose no real danger in healthy women.

Here is the FDA document [PDF]

Who are behind this promotion on Lola's Land?

Well according to this article, it's GlaxoSmithKline and the British Government.

Nothing like using children for promotion of a product.

I hope the MHRA read the raw data on this one because if they didn't and kids start dropping down dead or developing cancerous lesions later in life then someone will have to be held accountable!

If Cervarix does not actually prevent cervical cancer then why is it being marketed [advertised] as a long-lasting cancer prevention?

Can GlaxoSmithKline's HPV vaccine, Cervarix, increase the risk of precancerous lesions? If yes, then why are patients or the parents of patients not told this?

Is this Cervarix promotion underhand? Is it legal?

It would be awful in ten or twenty years time to learn that the public had been duped again. It's a very tough decision for any parent to make but they must be given the facts. If Glaxo or Merck are once again hiding data or manipulating numbers then they do so at the expense of our children.

All I am saying is do your research before you consent to your daughter having this vaccine. Don't believe that GlaxoSmithKline and Merck are in this to save children, young women. Ask yourself are GSK and Merck purely in this for the money, their history of paying out claimants in the courts for defective drugs they have manufactured may suggest that making money is their only incentive. [Merck & Vioxx] - [GSK & Paxil]

Here's a good place to start your research regarding Gardasil and HPV

HPV Vaccine Hoax Exposed: FDA Documents Reveal HPV "Not Associated with Cervical Cancer"

I'm glad I have no daughters... I'm glad I no longer put my trust in GlaxoSmithKline. Once bitten you see.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


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GlaxoSmithKline's Cervarix. Is Your Daughter Safe?

Is this advert misleading?

**Ad now mysteriously removed?

Hmmm

GlaxoSmithKline's HPV Vaccine, Cervarix.

A routine immunisation programme for human papillomavirus (HPV) started across the UK on 1 September 2008 for 12–13-year-old girls (school year 8). The vaccine given is called Cervarix, which protects against infection with HPV types 16 and 18.

Here is my following email to the MHRA.

----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Sent: Monday, September 15, 2008 12:02 PM
Subject: FOI - Cervarix, (HPV) vaccine

Dear Sir, Madam,

I wish to learn more of GlaxoSmithKline's HPV Vaccine, Cervarix and the MHRA's stance on it.

Could you confirm the following in writing to me please?


1. Is GlaxoSmithKline's, Cervarix, a vaccine to prevent cervical cancer?

2. Can the Human Papilloma Virus [HPV] cause cervical cancer?

3. Can GlaxoSmithKline's HPV vaccine, Cervarix, increase the risk of precancerous lesions?

4. Is GlaxoSmithKline's HPV vaccine, Cervarix, effective amongst women and girls under the age of sexual consent whom have had prior exposure to HPV?

5. Is GlaxoSmithKline's HPV vaccine, Cervarix, only effective in virgins?

6. As I am aware via the MHRA website [HERE] a routine immunisation programme for human papillomavirus (HPV) started across the UK on 1 September 2008. With this in mind, has any criteria been set-up to ask patients [before administering the vaccine] whether or not they have had sexual intercourse?

I ask all of the above under the Freedom of Information Act.

Yours sincerely,

Bob Fiddaman

---

Seroxat Sufferers

http://fiddaman.blogspot.com

*Interested parties blind copied

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

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Your Daughter... Merck's Lab Rat

In the main I try to stay focused on GlaxoSmithKline and Seroxat on this blog after all I blame Seroxat and its manufacturers for the countless human suffering they have caused.

I'd like to switch my attention to Merck, another pharmaceutical company who, it seems, like to earn billions of dollars/pounds at the expense of children.

Like Glaxo, Merck have been given the contract to vaccinate girls in the US and Canada with Gardasil, Glaxo have 'won' that contract here in the UK to treat girls with Cervarix. I'll be writing about Cervarix in another post.

Okay, it's a given that we all have a choice to decide what drugs our children should and should not be given but with millions of dollars/pounds ploughed into advertisements to persuade us all that these drugs are safe, what chance do we have as parents?

Advocates know slightly better than to take the word of Pharma but the masses don't. It's left to bloggers, freelance journo's et al to raise awareness... yet gain!

Once again, it seems, famous faces have been touting Merck's Gardasil on US TV shows. One such person is Dr. Lisa Masterson, a kind of Hollywood doc who appears on US TV Shows. One recent show she appeared on was MyFox, I believe it's a sister channel of Fox 11 in America though I could be mistaken. Here she answered several questions about Gardasil.

Lisa Masterson: "We're talking about our kids, and that's packed with a lot of emotion and these reactions [Gardasil] go from nausea to paralysis. The thing is, we don't have a strict causal effect, we don't know if the vaccine has actually caused these problems, we have to feel for these people 'cos it's these people's children and you just never know and you go and you take your baby for a vaccine you are trying to do something good for your child also good for the community even on the news this morning we saw about the outbreak of measles, so you know that there is a benefit, this has the potential to cure cancer in women, cervical cancer..."

Wait a minute, Gardasil has the potential to cure cervical cancer? Is that what Merck say? If so, this vaccine could be the find of the century, no, the find of the last 1000 years! Is Dr. Lisa Masterson correct? Does the Gardasil vaccine actually have the potential to cure cervical cancer? Is there a difference in the words 'prevention' and 'cure'? Masterson seems to think so.

Cure - Something that corrects or relieves a harmful or disturbing situation

Prevention - The act of preventing or impeding.

The Food and Drug Administration [FDA] and the Centers for Disease Control [CDC] reviewed side effect reports, they found 94% of side effects reported after vaccination were not serious. There were also 20 deaths reported, the FDA combined with the CDC said, no common pattern that would suggest these were caused by the vaccine. (Source)

Judicial Watch, the public interest group that investigates and prosecutes government corruption, last year released FDA side effect reports showing an increase in adverse events attributed to Gardasil.

It's a tough one to call. Here we have a vaccine that is promoted alongside words no woman wants to hear 'Cervical' and 'Cancer'. Any parent would rejoice if they could prevent this happening to their daughters. In truth, it really is a difficult decision to make, as far as I am aware no long term study was ever carried out by Merck, pretty much the same as GlaxoSmithKline and Seroxat. One only has to look around and see how many people are still suffering at the hands of that particular 'cure'.

Merck pulled their arthritis painkiller, Vioxx, from the market in September 2004. They also agreed a $4.85 billion (£2.42 billion) settlement, one of the biggest in history, with US claimants who blamed the drug for heart attacks and other devastating side-effects.

Vioxx was withdrawn from the market in September 2004, after a study found it doubled the chances of a heart attack or stroke. It emerged that the company's scientists had been concerned for several years about the risks. Vioxx was popular in the US, where it was promoted by American Olympic gold medalists on behalf of the company.

Now, given the choice, would any parent wish to stand in a queue with their daughter and tell them that the vaccine they are about to be given was made by a company who had a known history of manufacturing 'deadly cures'?

You may believe in the hype that is promoted by Merck and the likes of Dr. Lisa Masterson but one fundamental question we as citizens must ask ourselves is 'Do we really trust Merck?'

The choice is yours.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON