Zantac Lawsuit


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

Thursday, September 11, 2008

Coming Soon... Merck v GlaxoSmithKline...

... or rather Gardasil v Cervarix

Something just does not sit right with me about the way these HPV Vaccines have been promoted.

It's totally not related to Seroxat other than children being targeted once again by corporate companies who are going to make billions of pounds/dollars.

This needs investigating and awareness needs to be raised.

Something is sticking in my throat about the way both these vaccines are being promoted. The NHS are promoting it on their webpage and answering questions like politicians.

Is the vaccine safe?

NHS: The vaccine has undergone rigorous safety testing as part of the licensing process required in the UK and other European countries.

Didn't they say that about Thalidomide?

In America Merck were pushing for the vaccine to be mandatory, in fact, in the state of Texas it IS now mandatory.

This stinks!

I'll post soon on this matter

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

Pressured, Schools Review Ties to Drug Firms

Source: Wall Street Journal

By ALICIA MUNDY
September 11, 2008; Page B2

WASHINGTON -- Some major universities are reviewing the way they handle funding from drug companies in the wake of criticism from Sen. Chuck Grassley, who is pressing the federal agency that controls government health-research money to get tougher on universities that don't disclose ties to the industry.

Late Tuesday, Mr. Grassley (R., Iowa) fired the latest salvo, stating in a letter that a researcher for the University of Texas who worked on a National Institutes of Health study involving the GlaxoSmithKline PLC antidepressant Paxil did not disclose more than $150,000 in consulting and speaking fees paid to her by the company. Mr. Grassley has raised similar criticism of other universities, including Stanford, Harvard and University of Cincinnati.

Another 20 universities, including Brown, which was involved with a controversial study on Paxil funded by Glaxo, have been contacted by the Senate Finance committee, on which Mr. Grassley is the ranking Republican, over questions of potential conflict of interest with drug makers.

The director of NIH, Elias Zerhouni, met Tuesday with Senate Finance staff. Mr. Grassley wants NIH to start yanking grants to universities that fail to report their researchers' outside income from drug firms, as required by law.

NIH gave more than $23 billion last year to educational institutions. Dr. Zerhouni has been publicly skeptical about NIH's ability to pull grants, but Mr. Grassley said, "Starting today, the NIH could send a signal that business as usual is over....The simple threat of losing prestigious and sizable NIH grants would force accurate financial disclosure."

Last month, Stanford announced a policy to restrict drug-company funding of continuing medical-education programs. It also removed a renowned researcher as lead investigator on an NIH project, following questions from Mr. Grassley. Harvard has said that it is reviewing its conflict-of-interest policies.

Mr. Grassley made statements about Karen Wagner based on a comparison of records from the University of Texas and from Glaxo. Between 2000 and 2008, Dr. Wagner was engaged in an NIH study on the use of Paxil to treat teenage depression and another study on teen anxiety.

The university's legal counsel said they will look for any discrepancies in Dr. Wagner's disclosure reports. Dr. Wagner did not respond to requests for comment.

The University of Texas has received more than $5 billion from NIH since 2000.

"Universities have been treading on dangerous ground with their increasingly complex financial ties to industry," said Jerome Kassirer, former editor of the New England Journal of Medicine. "They are worried that these things could ultimately affect their tax-free status," he said.

Many faculty members remain on company speakers' bureaus, he added.

Dr. Wagner was considered one of Glaxo's "opinion leaders," speaking at many medical meetings about Paxil, according to documents from civil suits. Paxil has been linked to teenage suicide and suicidal behavior. The company has said the drug is safe. Dr. Wagner was a co-author of the Brown study on Paxil that has come under attack for allegedly overstating the drug's safety.

In 2000, the first year of the NIH grant, Dr. Wagner, who is based at the University of Texas Medical Branch in Galveston, received $53,000 from Glaxo, which included a trip to Paris to speak at a company meeting, Glaxo confirmed.

From 2003 to 2004, while receiving additional funds from Glaxo, Dr. Wagner served on the university's committee policing conflict of interest.

Barry Burgdorf, the university's vice chancellor for legal affairs said there didn't appear to be a major problem with the 15-branch university's disclosure system.

Write to Alicia Mundy at alicia.mundy@wsj.com

*Hat tip: Susan (If you're going through hell keep going Blog)

Read more about the Seroxat Gunslingers here, here and here


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

Tuesday, September 09, 2008

Meeting with MHRA - The minutes

The minutes are available here in pdf format.

For those of you without adobe acrobat I have republished the minutes in full here.

As promised I will unmoderate comments for 24 hours - in other words if you wish to add a comment then you can do so without it first coming to me for moderation.

Any blatent attacks on me or any other campaigners will be removed.

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Read More in The Evidence, However, Is Clear...The Seroxat Scandal [The Ebook]
Chipmunka Publishing ISBN: 978-1-84991-120-7
Paperback coming soon

More & More Complaints Over GSK's Eltroxin


“What started as a trickle of bad reactions to Eltroxin is now an avalanche.”





Adverse reactions to the reformulated thyroid drug Eltroxin have escalated sharply in the last three months, from around 50 to more than 700 people.

National Party associate health spokesperson Dr Jackie Blue says since patients started taking the new formulation earlier this year problems started to surface.

“What started as a trickle of bad reactions to Eltroxin is now an avalanche.”

A reformulated version of the drug was dispensed in June, immediately prompting new side-effects in patients who had been taking the drug for two decades.

Eltroxin is a drug manufactured by GlaxoSmithKline to treat hypothyroidism – an underactive thyroid gland, which regulates heart rate, digestion, physical growth and mental development.

Insufficient hormones made by the gland can damage organs and tissues in every part of the body, slow life-sustaining processes, and lead to life-threatening complications.

Complaints about the new formulation include nausea, fatigue, headaches, hair loss, weight gain and severe depression from over 700 of the 70,000 people taking the drug in New Zealand.

National drug buying agency Pharmac says Medsafe is responsible for the drug.

Medsafe sent the drug to the Institute of Environmental Science & Research (ESR) and found no apparent issues with its contents.

Medsafe group manager Dr Stewart Jessamine issued a statement saying: “GSK has indicated that it no longer manufactures the formulation of levothyroxine previously sold in New Zealand, and that it does not intend to change the formulation of the product it currently supplies in New Zealand, nor supply an alternate product."

"The GSK brand of levothyroxine has been the only brand of product available and supplied in New Zealand for a number of years. It remains the only brand with ministerial consent to market.”

Despite there being no apparent cases of reactions in other markets where the reformulated drug has been dispensed, Dr Blue argues that the drug is also used in pets and “they’ve changed and had adverse reactions as well so it’s very real – it’s not psychosomatic.”

“I’ve spoken to David Cunliffe, the health minister, and the health ministry is aware of it and says it's looking into it, but three months later nothing’s happened.”

Both Dr Blue and Green Party health spokeswoman Sue Kedgley urge people taking the drug to contact carmnz@stonebow.otago.ac.nz the Centre for Adverse Reactions Monitoring (CARM) if they’re taking the drug and have noticed any adverse reactions.

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

Monday, September 08, 2008

Minutes to MHRA Meeting

The minutes to MHRA Meeting should be with me within 48 hours.

I will be leaving the comments unmoderated for a short while but will remove any personal attacks on myself and other campaigners.

I will also delete messages from Jason F from Lorne, Australia who sends me cryptic messages asking me what it is like to lose Funky Munky?

Some very strange people out in cyber land!

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

How a New Policy Led to Seven Deadly Drugs




Source: LA Times
Date: 20 December 2000

Medicine: Once a wary watchdog, the Food and Drug Administration set out to become a "partner" of the pharmaceutical industry. Today, the public has more remedies, but some are proving lethal.


I'd like to concentrate on two of those 7 'deadly' drugs.

Raxar - Glaxo Wellcome

Read withdrawal statement from Glaxo Wellcome HERE


Raxar was indicated for the treatment of a variety of infections including pneumonia, bronchitis, and some sexually transmitted infections.

An estimated 2.65 million patients were treated with Glaxo Wellcome's Raxar before it was found to cause severe cardiovascular events among patients.

Strangely, Glaxo Wellcome ended their statement with:

"Glaxo Wellcome is a research-based company whose people are committed to fighting disease by bringing innovative medicines and services to patients throughout the world and to the healthcare providers who serve them."

Another of the seven 'deadly' drugs mentioned in the Times article from 2000 was Glaxo Wellcome's Lotronex, a prescription medication for the treatment of women with diarrhea-predominant irritable bowel syndrome.



The Food and Drug Administration received voluntary reports linking the company's drug to five deaths and additional bowel surgeries. Glaxo Wellcome's James Palmer, MD, senior vice president and director of Group Medical Regulatory and Product Strategy at Glaxo Wellcome said, "We greatly regret this outcome and believe that Lotronex is effective, that its side effects are manageable, and that the benefits of the product when treating IBS outweigh the risks."



So out of 7 'deadly' drugs - Glaxo Wellcome can be proud that two of their products made the list.



The LA Times article was written in 2000. 8 years on and Glaxo still manage to make headline news with drugs such as Avandia and Seroxat. Today Glaxo tell us that they are 'a leading healthcare company that helps people to do more, feel better and live longer.'

Yeh, forgive me for finishing this piece but... a pig just flew past my window!



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

Saturday, September 06, 2008

Paxil Truth From Ten Year Addict

Source: utahstories.com

September 5th, 2008

The category of drugs Paxil belongs to (SSRIs) have received over 28,000 complaints to the FDA; yet doctors continue to prescribe; commercials continue to appear on TV and patients continue to feel duped into becoming addicted.

Bob Lanou feels duped by his doctor and pharmaceutical companies into believing Paxil was the best treatment for his depression. Lanou, like thousands of other SSRI (Selective Serotonin Reuptake Inhibitors) users was told that the pill would help in overcoming the tragic loss of his daughter, job and girlfriend all within a single week. Lanou says, "At the time I was willing to try anything...I just wish I would have not been so naive and done a little more research." Lanou was not a sufferer of chronic depression or major depression disorder (MDD), instead he had reached a point in life that became extremely difficult and almost unbearable. To seek help in dealing with the trauma of his life situation he made an appointment with his General Practitioner who offered him enough free samples of Paxil to last him for months. Lanou found temporary relief. However, later Lanou would find his relief would come with a price. (More on Lanou later in our story).

SSRIs are used for treatment for nearly every possible psychological disorder SSRIs, and the various subclasses of the drugs, are used to treat everything from mild depression, premature ejaculation, anxiety to eating disorders.

A History of Prozac and SSRIs
Prozac was the first of these pills on the market in the late eighties, and it didn’t take long for SSRIs to become the forth most prescribed class of drugs on the market. Before Prozac, the link to depression and a chemical imbalance in the brain was rare. Instead people visited doctors to treat symptoms of nervousness or anxiety whereby they were often prescribed the popular tranquilizer valium. Today, SSRIs are indeed a cash cow for pharmaceutical companies. The Paxil pill alone has generated over $5 billion dollars of revenue for its maker: Glaxo Smith Klein.

Soon after FDA trials, Prozac was touted as the closest thing to a miracle cure for depression. Previous antidepressants had been very toxic side-effects. Prozac patients felt better with minimal side-effects they were promoted to be a cure for the chemical imbalance in the brain caused by depression. Prozac and other SSRIs were became a nice clean answer to a problem that since its inception has reached epidemic proportions in the United States. Brooke Shields put it well in her classic statement: "Its comforting to discover my depression was directly tied to a biochemical shift."

Celebrities helped to in promoting the pill as the help they really needed which made Prozac something like a nineties pop-icon in its own right. Actors such as Winona Ryder, Johnny Depp as well as many comedians openly admit and talk about their depression and the help they have found from Prozac and others. “Prozac Nation” a film, starring Christina Ricci, also contributed to glamorizing the miracle cure Prozac and other SSRIs.

However, what most consumers of these pills were not informed of is the huge degree of uncertainty about the causes of depression and the long-term side effects of SSRIs.

How SSRIs Work
SSRIs operate in the body at a cellular level. Unlike vitamins, these drugs are fat-soluble, psychotropic drugs, able to permeate through the walls of brain cells--as well as through most water filters, causing many SSRIs to be a contaminant in our water supply. Prozac or Fluoxetine was discovered when scientists began testing compounds to see which had an affect on brain functioning in rats. Many toxins such as Lithium have been used for years as anti-depressants, however the toxic side-effects of salts and metals is kidney damage after long-term usage.

SSRIs work by selectively inhibiting the reuptake process we feel when we are happy. Serotonin is the chemical released in the brain with happiness. Once this natural body chemical is released in the brain, there the reuptake process cleans up house and returns us to a normal state of being.

SSRIs inhibit the reuptake of the neurotransmitter serotonin, however, the side-effect which often presents itself after long term usage is increased serotonin levels will flood presynapic autoreceptors. The body then adapts to this increase by lowering the sensitivity of the autoreceptors. The result is patients like Bob Lanou describe "feeling like a robot" unable to feel extremely happy or sad. The body doesn't react as strongly to serotonin and thus a strong feeling of happiness or euphoria becomes impossible. Besides this most common side effect, there are many other side-effects: (this list was complied from Wikipedia)

anhedonia
nausea
drowsiness or somnolence
headache
clenching of teeth
extremely vivid and strange dreams
dizziness
changes in appetite
weight loss/gain (measured by a change in bodyweight of 7 pounds)
may result in a double risk of bone fractures and injuries
changes in sexual behavior
increased feelings of depression and anxiety (which may sometimes provoke panic attacks)
tremors
autonomic dysfunction including orthostatic hypotension, increased or reduced sweating
akathisia
liver or renal impairment
suicidal ideation (thoughts of suicide)
Photosensitivity (increased risk of sunburn)

These side effects have put the drug companies into action to develop additional pills that counteract the side effects. The following pills have been developed to mitigate some of the side-effects:

bupropion (norepinephrine and dopamine reuptake inhibitor)
buspirone (serotonin receptor agonist)
methylphenidate (stimulant)
mirtazapine (noradrenergic and specific serotonergic antidepressant (NaSSA))
amphetamine (stimulant)
amantadine (antiviral)
pramipexole (dopamine agonist)
ropinirole (dopamine agonist)

Besides the side effects while taking the drug, more problems typically arise when patients attempt to stop taking the drug. This has lead to a whole other can of worms commonly described as "discontinuation syndrome". Bob Lanou describes these symptoms in detail in our video interview. These symptoms include suicidality and aggression as well as akathisia, which is severe inner restlessness.

Its these symptoms, which were never present before using Paxil, that has resulted in a class action law suite filed against Glaxo Smith Klein and several FDA updates to the drug.

While the notion of taking drugs to alliviate the symptoms of other durgs could lead to potentially unlimited profits for big Pharm, more psychatrists and psychologists are believing there must be a better way.

SSRIs are useful in some cases and have helped thousands of people who suffer from chronic depression, however, Dr. Lili Wagner says that patients suffering from depression should first seek counseling and lifestyle change. Wagner believes that SSRIs should be seen as a last resort. It is her hope that patients and doctors will both better understand that depression is not caused by a chemical imbalance in the brain, but moreover our lifestyle choices that patients can change if they make different choices in how they live, work and eat.

Paxil addict, Bob Lanou says in closing that he just wants to tell people, to think before using mind altering psychotropic drugs. Mr. Lanou's anger towards his previous Doctors and the pharmaceutical companies is palpable in the repeated times he has attempted to wean himself off the drug which always results in his inability to sleep due to akathisia and anxiety.


WATCH VIDEO HERE



GLAXO'S TOUTING OF THE CHEMICAL IMBALANCE THEORY HAS ALLOWED THEM TO EARN $5 BILLION OFF THE ONE SINGLE DRUG!



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

Thursday, September 04, 2008

A Musical Break

BOW RIVER- COLD CHISEL






HAVE A NICE DAY - STEREOPHONICS





GLORY DAYS - BRUCE SPRINGSTEEN ON THE LETTERMAN SHOW




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

Pharmaceutical Sales Representative: Oakland, CA (G2BFP2): GlaxoSmithKline


What do they mean?


Job ID 48767
Company Name GlaxoSmithKline
Job Category Sales; Pharmaceutical/Biotech
Location Oakland, CA
Position Type Full-Time, Employee
Experience 2-5 Years Experience
Date Posted August 26, 2008 (Reposted Aug 27)

Preferred qualifications:

The ideal candidate will possess one or more of the following:


-outside (non-retail) sales experience, i.e., requiring the development of a customer base.
-pharmaceutical or medical sales
-experience in the healthcare industry, i.e. interaction with patients or doctors relating to diagnosis, treatment or prescribing- MD, OD, RN, RPh, etc.
-experience educating and influencing "customers" (teachers, counselors, etc.)
• Must have acceptable driving record
• Documentation of success a plus.
• Demonstrated success in influencing a customer group.
• Experience developing and sustaining a customer base.
• Proven ability to positively impact sales in territory.
• Ability to comprehend complex products of a scientific nature.
• Excellent communication, interpersonal and influencing skills.


...The Sales Representative we are seeking understands the needs and preferences of the customer while leveraging their influencing skills to aggressively expand product market share.


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"Obviously doctors are very busy people, and their day is packed with patients. The question is how do doctors get information about medicines and new research into treatments and disease, and one of the easiest ways is this kind of presentation [”dine and dash”]. We think this is a benefit to both physicians and patients.” - Mary Ann Rhyne, GlaxoSmithKline spokesperson 11/11/2002


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

Tuesday, September 02, 2008

Meeting with MHRA

Back from meeting with MHRA.

It was 'constructive'

Minutes will follow over the coming days.

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

GSK: Worst Drugs Ads Ever!


AIDS Healthcare Foundation (AHF) is blasting British multi-national drug giant GlaxoSmithKline (GSK) for a recent series of direct-to-consumer print advertisements that, under the guise of patient education, capitalize on patients' fears of HIV treatment.

AHF believes that marketing tactics employed in GSK's, "First Impressions?Can Be Deceiving" advertising campaign are irresponsible and a ruthless attempt by GSK to maintain dwindling market share while disregarding the negative impact such advertising has on patients' health. In a July 30th letter to Mike Leavitt, Secretary of the U.S. Department of Health and Human Services (HHS), AHF President Michael Weinstein noted: "The attached print ad (part of a series of similar ads run by GlaxoSmithKline) is the most egregious example of this type of advertising. This ad is designed to instill fear in the minds of AIDS patients by telling them that switching AIDS treatment (presumably from GSK drugs) may lead to increased side-effects and potentially treatment failure. This message is GSK's response to the increased number of patients switching from its drugs to newer treatments and seeks to discourage AIDS patients from changing their antiretroviral (ARV) regimens regardless of their medical needs. Further, the explicit message in this ad, 'Avoid hidden dangers from switching your HIV medicine,' is that safety and efficacy information provided by a patient's doctor or the FDA is incorrect or misleading."

According to today's Wall Street Journal: "The ads are part of a larger trend of drug companies taking aim at rival HIV drugs, hinting at side effects and other drawbacks, experts say." The article also noted that: "A development fueling the sharp-elbows advertising: The market for HIV medicines has grown crowded, and companies want to protect their market share."

The two print advertisements in question appeared in the June and July/August issues of POZ, a national monthly magazine targeting those living with HIV/AIDS. Both ads utilize the same scare tactic to dissuade patients from changing their HIV medications. One ad features a scenic photo of the sun setting over the ocean with what appear to be sailboats floating calmly in the background. The text, invitingly, reads: "First Impressions?" Upon turning the page, an ominous image greets you. A close-up on the triangular boat sails reveals them to be the fins of sharks lurking just beneath the water's surface. 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, with the same text, features a scenic view of a placid lake, sand dunes, palm trees and serene fields, that-on the next page-are revealed to be hiding a fierce, hungry-looking lion.

"With these latest ads, GSK has sunk to a new low. The company has resorted to exploiting patient fears in order to sell a product, while remaining unconcerned about the harm caused to patients who are scared off treatment altogether because of GSK's tactics," said AHF President Michael Weinstein. "We are disappointed that POZ magazine-a publication targeted to an HIV-positive population-would run such ads. This kind of underhanded negative advertising creates fear of HIV treatment in general, which could dissuade people from seeking treatment at all. We are also disappointed that, despite repeated communication with the FDA regarding our concerns over a similar GSK ad campaign last year, there appears to be a total lack of oversight of direct-to-consumer advertising of prescription drugs. That is why we are appealing to HHS, in the hopes that our concerns will be heard and these harmful ads pulled."

In addition to writing a letter to HHS, AHF has launched a campaign to raise public awareness of GSK's damaging advertising tactics. AHF's campaign begin last week and features print ads in publications including the Washington Blade, the Village Voice and Los Angeles' Frontiers.

"Unfortunately, GSK's advertising tactics only serve to amplify fears and doubts patients may already have about antiretroviral therapy, making it harder for doctors to treat them," said Homayoon Khanlou, M.D., AHF's Chief of Medicine/U.S. "It is important for patients and their providers to work together to make treatment decisions independent of drug industry advertising that might compromise the doctor/patient relationship and potentially the health of the patient."

http://www.aidshealth.org


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

Monday, September 01, 2008

IP Phishing

It seems that my IP is or has been hacked. I'm currently talking with my Internet provider to try and ascertain what to do about this.

Meantime, here is an article on Phishing

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


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